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Review of Non-Physician Prescribing and Administration of under the Regulated Health Professions Act, 1991

Submission to the Health Professions Regulatory Advisory Council

November 12, 2008

55 St. Clair Avenue West; Suite 812; Box 27 Toronto, Ontario M4V 2Y7

Tel 416.327.3132 Fax 416.327.8219 Email [email protected] Website www.cmo.on.ca

Questionnaire for Health Professions

PROFESSION INFORMATION

1. Name of the health regulatory college, professional association or organization responding to this questionnaire. If this response is from more than one organization, please list the names of the organizations.

College of Midwives of Ontario (CMO), in association with the Association of Ontario Midwives (AOM).

2. Address/website.

55 St. Clair Avenue West Suite 812, Box 27 Toronto ON M4V 2Y7

Website - www.cmo.on.ca Email - [email protected]

3. Telephone and fax numbers.

Telephone: 416-327-3132 Fax: 416-327-8219

4. Contact person (including day telephone numbers and e-mail address).

Deborah Adams, Registrar College of Midwives of Ontario Telephone: 416-327-3901 Email: [email protected]

5. List other professions, organizations or individuals who could provide relevant information. Please provide contact names, addresses and contact numbers where possible.

There are a number of professions, organizations and individuals who could provide relevant information applicable to the proposed changes, including midwifery and maternity stakeholders, regulatory bodies, professional associations, and academic institutions.

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Midwifery Stakeholders

Kelly Stadelbauer, Executive Director Jody Hendry, Coordinator Association of Ontario Midwives Ontario Midwifery Program 789 Don Mills Road, Suite 608 1075 Bay Street, 9th Floor Toronto, ON M3C 1T5 Toronto, ON 5S 2B1 416-425-9974 416-327-7540

Susan James, Director Holliday Tyson, Project Director Laurentian University Ryerson University Midwifery Education Program International Midwifery Pre- Health Sciences Department Registration Program 935 Ramsey Lake Road 285 Victoria Street, Suite 604 Sudbury, ON P3E 2C6 Toronto, ON M5B 1W1 705-675-1151 x 3951 416-979-5000 x 7685

Eileen Hutton, Director Judy Rogers, Director McMaster University Ryerson University Midwifery Education Program Midwifery Education Program Michael G. DeGroote Centre for 350 Victoria Street, Suite 582 Learning & Discovery (MDCL) Toronto, ON M5B 2K3 Third Fl, 3103 416-979-5000 x 7678 1200 Main St W Hamilton, ON L8N 3Z5 905-525-9140 x 26651

Canadian Midwifery Regulators Consortium (CMRC)

Jane Kilthei, Registrar Janice Erickson, Registrar College of Midwives of British Columbia College of Midwives of Manitoba 1682 West 7th Avenue, Suite 210 235-500 Portage Avenue Vancouver, BC V6J 4S6 Winnipeg, MB R3C 3X1 604-742-2234 204-783-4520

Heather Cameron, Registrar Dominique Porret, Presidente Alberta Health Disciplines Committee Ordes Sages Femmes du Quebec 10th Floor, Telus Plaza, North Tower 204 rue Notre-Dame, Ouest 10025 Jasper Avenue bureau 400 Edmonton, AB T5Y 4M2 Montreal, QC H2Y 1T3 780-422-2733 514-286-1313

Diane Rach, Member Gisela Becker, Midwife Alberta Midwifery Committee The Midwifery Program of the Fort 35 Silvergrove Court NW Smith Health & Social Services Calgary, AB T3B 5A3 Authority 403-286-5256 Box 995 905-525-9140 x 26651 Fort Smith, NT X0E 0P0 867-872-6253

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Kris Robinson, Chair, CMRC Jeannette Hall, Registrar Clinical Midwifery Specialist, Winnipeg Health Professional Licensing, Regional Health Authority Department of Health & Social Services St. Boniface General Hospital Box 1320 - CST - 8 D2045 - 409 Taché Avenue Yellowknife, NT X1A 2L9 Winnipeg, MB R2H 2A6 867-920-8058 204-235-3720

Patty Eadie, Director College of Midwives of Manitoba 235-500 Portage Avenue Winnipeg, MB R3C 3X1 204-783-6860

Federation of Health Regulatory Colleges of Ontario (FHRCO)

Felecia Smith, Registrar Irwin Fefergrad, Registrar College of Chiropodists of Ontario Royal College of Dental Surgeons of 180 Dundas Street, West, Suite 2102 Ontario Toronto, ON M5G 1Z8 6 Crescent Road; 3rd, Floor 416- 542-1333 Toronto ON M4W 1T1 416-961-6555

Kathie Wilkie, Registrar Linda Gough, Registrar College of Medical Laboratory College of Medical Radiation Technologists of Ontario Technologists of Ontario 36 Toronto Street; Suite 950 170 Bloor Street West, Suite 1001 Toronto, ON M5C 2C5 Toronto, ON M5S 1T9 416-861-9605

Anne Coghlan, Executive Director Murray J. Turnour, Registrar College of Nurses of Ontario College of Optometrists of Ontario 101 Davenport Road 6 Crescent Road, 2nd. Floor Toronto, ON M5R 3P1 Toronto ON M4W 1T1 416-928-0900 416-962-4071

Deanna Williams, Registrar Dr. Rocco Gerace, Registrar Ontario College of Pharmacists College of Physicians and Surgeons 483 Huron St of Ontario Toronto ON M5R 2R4 80 College Street 416-962-4861 Toronto ON M5G 2E2 416-967-2600

Jan Robinson, Registrar Christine Robinson, Registrar College of Physiotherapists of Ontario College of Respiratory Therapists of 375 University Avenue Ontario Suite 901 180 Dundas Street, West, Suite 2103 Toronto ON M5G 2J5 Toronto ON M5G 1Z8 416-591-3828 416-591-7800

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Other

Coalition of Ontario Regulated Health Professions’ Associations (CORHPA) Dr. Robin Hesler, President Canadian Association of Medical Radiation Technologists 1000 - 85 Albert Street, Ottawa, Ontario K1P 6A4 613- 234-0012

Dr. Andre Lalonde, Executive Vice President The Society of Obstetricians and Gynaecologists of Canada (SOGC) 774 Echo Drive Ottawa, ON K1S 5N8 613-730-4192

Jan Kasperski, Executive Director and CEO Ontario College of Family Physicians (OCFP) 357 Bay Street, Mezzanine Level Toronto, ON M5H 2T7 416-867-9646

FOR PROFESSIONAL ASSOCIATIONS

6. Names and positions of the senior directors and officers.

Kelly Stadelbauer, Executive Director Association of Ontario Midwives (AOM) Phone: (416) 425-9974, Ext. 230 Email: [email protected]

President: Katrina Kilroy, RM Vice-President: Lisa Weston, RM Secretary: Mary Ann Leslie, RM Treasurer: Jane Erdman, RM Member at Large: Elissa Press, RM Member at Large: Anne Wilson, RM East Regional Coordinator: Jane Somerville, RM South Central Regional Coordinator: Tracey Franklin, RM South East Regional Coordinator: Sara Stainton, RM South West Regional Coordinator: Kelly Gascoigne, RM West Regional Coordinator: Madeleine Clin, RM North Regional Coordinator: Eileen Abbey, RM

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7. Length of time the association has existed as a representative organization for the profession.

The AOM was incorporated November 2, 1989.

8. List name(s) of any provincial, national or international association(s) for the profession with which your association is affiliated or who may have an interest in this application. Please provide contact names, addresses, contact numbers and e-mail address where possible.

Canadian Association of Midwives Tonia Occhionero, Executive Coordinator #442-6555 chemin de la Côte-des-Neiges Montréal, Québec H3S 2A6 Phone: 514-807-3668 Fax: 514-738-0370 Email: [email protected]

Canadian Midwifery Regulators Consortium Secretariat College of Midwives of Manitoba 235 - 500 Portage Ave Winnipeg, Manitoba R3C 3X1 Phone: 204.783.4520 Fax: 204.779.1490 Chairperson: Kris Robinson

CURRENT AUTHORIZED ACTS AND REGULATIONS

9. Do current authorized acts and regulations reflect best practices for the prescribing or administration of drugs in the course of practice of members of your profession?

No. The current legislated authority for midwives in regard to prescribing and administering drugs is outdated and does not accurately reflect the day-to-day activities, functions, roles and responsibilities of midwives as primary maternity care providers practicing to meet the current standard of care.

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PROPOSED CHANGES TO AUTHORIZED ACTS AND REGULATIONS

10. Please describe in detail any proposed changes to current authorized acts and regulations that would reflect best practices for:

a) prescribing of drugs by members of your profession, or b) administration of drugs by members of your profession.

We have noted that this questionnaire uses both “class” and “category” of . To avoid confusion we have chosen to define our use of the term “therapeutic category” in the proposed regulatory amendments. We intend the term to mean “a group drugs which treat a particular disease”. In this submission we intend the term “category” to refer to that definition, in specific relation to the proposed drug chart (see below).

We have recently (June 2008) re-submitted a request to the Regulatory Programs Unit (RPU) to amend the CMO’s Designated Drugs Regulation to include antibiotics, as well as a number of other specific drugs. The submission also included a request that midwives be authorized to prescribe and/or administer any substance on the order of a physician (see Appendix A for details).

In this HPRAC review of non-physician prescribers we are proposing that the existing list of drugs in the midwifery Designated Drugs Regulation be rescinded and replaced with a regulation that includes therapeutic categories of drugs, specific to the clinical indication. Within this framework midwives will be authorized to prescribe and/or administer any drug from a category specified in the chart, within the scope of midwifery. Further, we recommend that the regulatory mechanism for clinical regulations be revised to ensure responsive and timely revision to keep up with current practice.

The therapeutic categories and indications we propose are included in the chart below. Indication Therapeutic Category • Repair of episiotomies and lacerations Anaesthetics (local) • Relief of pain in labour * • Intra-partum chemoprophylaxis for Group B Antibiotics strep • Treatment of topical bacterial infections common to pregnancy and the postpartum period • Treatment of breast infection • Treatment of urinary tract infection • Prophylaxis of ophthalmia neonatorum • Treatment of lower reproductive tract infections

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Indication Therapeutic Category • Treatment of candidiasis Antifungals • Treatment of maternal nausea and vomiting Anti-nauseants/Anti-emetics • Treatment of herpes simplex virus Antivirals • Induction of labour Cervical ripening agents • Prevention of conception Contraceptives ** • Treatment of skin inflammation and Corticosteroids hemorrhoids • Relief of pain in labour Epidural analgesia (continuous infusion maintenance) • Enhancement of milk production Galactagogues • Treatment of anaphylaxis related to the Histamine antagonists administration of drugs, vaccines or sera • Viral prophylaxis in the neonate Immune globulins • Viral prophylaxis or treatment of the woman in pregnancy or the postpartum period • Prevention of Rh disease • for pain relief in labour or the Inhaled general anaesthetics immediate postpartum • Prophylaxis or treatment of dehydration Intravenous fluids • Treatment of hypovolemia • As a route of administration for • Treatment of uterine hypertonus Nitrates • Relief of inflammation and pain Non-steroidal anti-inflammatories • Reversal of opiate-induced Opiate antagonists • Induction or augmentation of labour Oxytocics • Oxygen for maternal and neonatal Therapeutic gases resuscitation • Prophylaxis and treatment of uterine atony Uterotonic agents and postpartum hemorrhage • Establishing an immune response Vaccines ** • Nutritional therapy and support and supplements

* The Canadian Midwifery Regulators Consortium (CMRC) has been working with Health Canada’s Office of Controlled Drugs and Substances (OCDS) since 2004 to authorize midwives’ access under the Controlled Drugs and Substances Act. This process involved a review of the profession by OCDS to ensure that the appropriate education, standards and quality assurance provisions are in place or can be put in place to ensure the safety of the public (see appendix B for the CMRC’s submission to OCDS). OCDS has recently proposed changes to regulations under the Controlled

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Drugs and Substances Act to permit midwives and other designated practitioners (e.g. NPs and podiatrists) to “possess, administer, prescribe, sell or provide and/or transport” certain controlled substances as defined by the regulation. These changes are proposed in recognition of changing practice roles, evolving scopes of practice, and the need to increase client access to care. We have included in the chart above as a place holder in anticipation of the OCDS authorizing midwives’ access to that category of drug.

** Contraceptives are proposed as a component of well-woman care, and therefore limited to the proposed extended class of midwifery (see the midwifery HPRAC scope of practice review for details). Vaccines are also proposed as a component of the extended class (for well-baby and well-woman care), with the exception of the Hepatitis B vaccine, which midwives are currently authorized to administer to newborns.

We also recognize the connection between communicating a diagnosis and the provision of treatment. To that end we would note that the CMO recommended in its full scope of practice review submission that “Communicating a diagnosis within the scope of practice of midwifery” be included as an authorized act in the Midwifery Act.

11. Why are these changes necessary? What regulatory or clinical practice purposes would be served by such changes? How would they advance patient care and patient safety?

Both the drug regulation and the regulatory amendment process are barriers for midwives working to their full scope of practice and competency. Currently, the Designated Drugs Regulation limits midwives to a specified list of drugs that they are legally authorized to prescribe and/or administer on their own authority, as well as under direction from a physician. Limiting midwives to a specified list of drugs leads to numerous problems and inefficiencies, and poses potential risks to the client (see question 16 for further details).

Authorizing categories of drugs according to indications, as opposed to individually listed pharmaceuticals, will enable midwives to provide routine primary maternity care within their scope of practice. In doing so, it will allow for the “right care provider” at the “right time”, freeing up physicians to consult on cases where they are truly needed and enabling midwives to work to their full scope as primary care providers for low-risk women and their infants.

Access to drug categories (which was submitted as a proposal to the Regulatory Program Unit in December 2004), as opposed to the individual pharmaceuticals included in the current list, would greatly enhance midwives’ capacity to stay apace of emerging best practices as primary care providers. The standards regarding the use of antibiotics, in particular, are regularly changing as bacteria become resistant to specific courses of treatment and new, and sometimes older, antibiotics become effective.

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Emerging bacterial resistance means that any list of drugs will inevitably become dated. Under the current regulatory system new drugs are difficult to add to the list and there will be an inevitable lag between development of new drug regimes and implementation by midwives. Giving midwives access to categories of drugs will ensure that they have the resources to provide the best standard of care to women over the long term.

Further, authorizing drug categories will better enable midwives to provide care in accordance with evidence-based best practices. Revising the regulatory mechanism for regulations related to clinical practice will enable the CMO, and by extension midwives, to respond to ongoing changes in the standard of practice in maternity care in a timely way. To illustrate, midwives are not currently authorized to prescribe antibiotics in labour for those clients who are Group B Strep (GBS) positive. “It is estimated that 15 - 40% of all pregnant women are GBS colonized. Between 40 - 70% of colonized mothers pass the bacteria onto their babies during the birthing process. While most babies are not affected by the bacteria, a very small number (1- 2%) of these babies will go on to develop a GBS infection. Babies who are infected with GBS may have mild to severe problems which may affect their blood, brain, and spinal cord.” 1 Because midwives are currently not authorized to prescribe antibiotics in labour to clients at risk of transferring GBS to their newborns, a consult with a physician is required to gain access to the very standard prescribed prophylactic treatment. Midwives, as primary maternity care providers, have the competency and necessary education to manage these clinical scenarios. In instances where there is no established medical directive from a physician, timely access to care can be impeded by this inability to prescribe antibiotics (for example, if the doctor is in surgery and can’t assess the patient). When antibiotics are not administered four hours prior to delivery (as recommended by the Canadian Pediatric Society) a 24-hour postpartum hospital stay is required, as opposed to a three-hour stay. Changing the regulation to include categories of drugs for midwives would address this problem.

Midwives have a clear standard that is effective in supporting appropriate discussion, consultation and transfer of care to their physician colleagues (Indications for Mandatory Discussion, Consultation and Transfer of Care). The current drug list works counter to this standard in two ways. Firstly, there are instances that do not require consultation or transfer of care but where members need to refer women to physicians simply because of the lack of authority to prescribe a needed (e.g. antibiotics for urinary tract infection). Secondly, our members’ experience demonstrates that the need to involve physicians to write a prescription once the appropriate discussion or consultation has taken place (e.g. for an oxytocic to induce labour) represents a strain on the midwife/physician relationship and/or results in the physician insisting on assuming primary care of the woman. Significant delays to treatment and costs to the health care system occur when clinically unnecessary consults with or referrals to physicians are required due to restrictions created by the current drug regulation.

Changing the drug regulation to include categories of drugs will also bring Ontario in line with the standard of midwifery care across the country. Saskatchewan, Manitoba and

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the Northwest Territories name in the midwifery legislation the categories of drugs that are required within the scope of providing maternity and newborn care. It is currently a proposed amendment in Quebec and BC, where the drug regulation is located in the College’s bylaws, and is therefore under College control. There has been no evidence of abuse of this authority from any Canadian jurisdiction. In fact, the scope of practice for midwives naturally limits the usage and prescription of drugs. Midwives are committed to a non-interventionist approach to care, and while they are eager to have the tools available to them to provide a broader scope of maternity care to their clients, midwifery philosophy dictates an appropriate use of technology.2 Enabling the flexibility for midwives to adapt to new research evidence that has been translated into professional guidelines will allow midwifery to stay abreast of change. As well, there has been exponential growth in the promotion of national professional guidelines and we, as regulators, expect members to adopt these guidelines (as they pertain to the midwifery scope of practice) as they become the community standard.

12. Are the proposed changes considered part of current routine practice of the profession, and authorized to members by medical directives, orders or delegation? Please describe. If authorized by medical directives, orders or delegation, is this approach inadequate or insufficient? Please explain.

The changes outlined here are proposed with the intention of removing the need for delegation or medical directives for drug administration and prescription by midwives working within their legislated scope, and will thus create greater uniformity in delivering the standard of care across the province.

Using physicians to access medications that are part of routine maternity care is a poor use of health care resources. Examples of this inefficiency include the following:

• In hospitals where the integration of midwives into the maternity care system has not been effective or is currently underway, it can be difficult for midwives to obtain the necessary and appropriate physician involvement. • In hospitals that have limited obstetrical resources, the midwife may find herself having to call a physician who is not on site – often in the middle of the night - to obtain orders for something routine and that she could easily address with her own knowledge and skill set. This can be burdensome to physicians who are already struggling with what the Ontario College of Family Physicians (OCFP) has labeled eroding working conditions and can, understandably, be detrimental to the professional relationship. • Since a woman’s labour and delivery cannot be scheduled, immediate access to orders is often necessary. This urgency can represent an unnecessary stress for both midwives and physicians.

The proposed changes are well within the current skill set of midwifery. Midwives are

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primary maternity health professionals who provide care to women with low-risk pregnancies and to their infants, and this includes the authority to prescribe and administer medications.

13. Would the proposed changes result in an enhanced or changed scope of practice for the profession?

Yes. Amending the drug regulation will support the proposed changes to the midwifery scope of practice (May 2008 submission to HPRAC), as well as the drivers behind the proposal:

a. To reflect current and emerging maternity care best practices b. To allow responsiveness to community needs (i.e. the needs of women and care providers) c. To provide more flexibility for members d. To support members' participation in interprofessional care e. To enable midwives to contribute to solving the maternity care crisis f. To support efficient use of the health care system g. To allow timely, seamless, efficient, and cost effective access to primary maternity care

Specifically, midwives will have the authority to treat urinary tract infections, some commonly occurring lower reproductive tract infections, and some postpartum infections. They will no longer be required to consult with a physician for prescribing antibiotics for their clients who are GBS positive, and they will maintain primary care during inductions and augmentations. Midwives registered to work in the extended scope of practice will be authorized to prescribe hormonal contraception as a component of well-woman care, and administer some vaccines as a component of well- baby and well-woman care.

14. Please describe in detail any changes or additions that would be required to the controlled acts that are now authorized to the profession and what, if any, limitations or conditions should be attached to the authorized act.

Add: communicating a diagnosis Limitation imposed: within the scope of midwifery

Add: putting an instrument, hand or finger beyond the anal verge Limitation imposed: for the purpose of the administration of suppository medications and routine perineal repair procedures

Please see the May 2008 HPRAC Scope of Practice submission for more information

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regarding the CMO’s proposed amendments to midwives’ controlled acts.

15. (a) Has the profession submitted a request to the Ministry of Health and Long-Term Care for changes or additions to the list of drugs that are included in the regulation under the profession-specific act? If yes, please attach copies of the submissions, and indicate when the request was made.

Yes, see appendix A. The original request was made in 2003, a revised submission was provided in September 2005 and further revisions were provided in June 2008 at the request of the Ministry of Health and Long-Term Care (see question 31 for further information regarding the submission timeline).

(b) Are there additions or changes, since the submission was made, that HPRAC should now consider? Please describe in detail.

There are two additions included in this submission that do not appear in the previous drug regulation amendment proposal currently with the Ministry: antibiotics for the treatment of some commonly occurring lower reproductive tract infections (including some STIs) and hormonal contraception.

The CMO was advised by Ministry staff as part of the submission process for the recent proposed amendments that they were unwilling to consider a proposal for treatment of STIs as part of the amendment to the drug regulation. This component of care was included as part of the proposed enhancements to the midwifery scope of practice and so the relevant medications are also proposed in this submission.

Hormonal contraception is a new addition. It has been included as a component of well- woman care, as proposed in the May 2008 Scope of Practice submission to HPRAC. In that regard, it would be a component of the extended category of midwifery registration (see full May 2008 submission for details).

(c) If a formal submission has not been made at this time, what are the exact changes you now propose to current legislation and regulations?

N/A

RISK OF HARM

16. What additional risk of harm to the patient or client might result from the proposed changes? How would your profession manage this risk?

The additional risk of harm to midwifery clients that may occur as a result of the proposed changes is that one of the ‘five rights’ of dispensing drugs might be violated.

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The five rights are: right medication, right dose, right time, right route and right patient. However, midwives are currently authorized to prescribe and administer medications and are therefore already educated and competent in regard to mitigating these risks. Midwives are, in fact, considerably less likely to make an error regarding the ‘right patient’ since they have very well-established relationships with their clients. The other risks related to the ‘five rights’ are also less likely since midwives dedicate a significant amount of time to explaining the details of the drug and its use to the client as a component of informed choice.

Further, midwives are self-regulated health professionals, and are therefore understood to be capable of making the clinical risk of harm judgements required of any health care professional in the provision of care. Self-regulation means that a profession is responsible for defining and monitoring the practice of its members in the public interest and in accordance with governing legislation. As the regulatory body of the profession of midwifery, the CMO already assesses the risk of harm associated with the drug regulation and the broader scope of practice, and will continue to act in that capacity as changes are made.

The CMO’s Indications for Mandatory Discussion, Consultation and Transfer of Care document is a valuable tool that clearly outlines the clinical situations wherein midwives are required to consult with a physician due to increased risk. This document is a cornerstone of the profession and the collaborative relationships that midwives develop with physicians, and will be updated accordingly. Further, a standard on prescribing and administering drugs for midwives will be developed to accompany the amended drug regulation, which will establish the necessary guidelines and parameters required for the safe application of the revised regulation. This standard will include those clinical situations where midwives will be required to consult with a physician if a client is not responsive to the prescribed treatment. It will be based on existing practice standards that are used in maternity care (for example, SOGC clinical guidelines).

Finally, the CMO has a rigorous Quality Assurance Program (appendix C), consisting of six components: data collection, professional development, peer case review, client satisfaction evaluation, self-assessment, and practice audits. Each of these components contributes to decreasing the risk of harm for midwifery clients in Ontario, and the updated drug regulation will be included in the program.

While the CMO and other midwifery stakeholders are well situated to mitigate the risk of harm to midwifery clients, supports from the broader system are required to fully integrate the proposed scope of midwifery drug practice into the maternity care system. As one example, midwives will require support from the nursing staff in the monitoring of inductions prior to active labour, which can last more than 24 hours.

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EDUCATION AND CONTINUING COMPETENCY

17. How does your profession require demonstration of competencies for pharmacotherapy?

1. Midwifery Education Program (MEP): a. Competencies for pharmacotherapy are tested as part of the Pharmacology course, as well as in the Life Sciences course and in Midwifery Clinical courses. Students are required to obtain 70% in order to pass. b. Clinical competency is evaluated on an on-going basis as part of the clinical placement performance. In assessment of clinical performance at each level throughout the program, Pharmacology comprises one of 5 areas of evaluation (along with assessment skills; care management skills; clinical skills; communication; and professional skills). This signifies the importance that is placed on the students’ knowledge and skill in administering and prescribing therapeutic drugs (see appendix D). 2. International Midwifery Pre-registration Program (IMPP): The International Midwifery Pre-registration Program is Ontario’s bridging program for internationally educated midwives. The IMPP has six years of experience partnering with the Midwifery Education Program in the delivery of MEP-equivalent curriculum for internationally trained midwives. The program has demonstrated that it has the capacity to adapt to the MEP curriculum, as well as meet the requirements of the CMO. Further, the IMPP has the demonstrated capacity to develop and implement the necessary distance education programs 3. Entry to Practice Examination The Canadian Midwifery Regulators Consortium (CMRC) has developed and implemented a national registration exam for all applicants for registration as a midwife in the regulated jurisdictions of Canada. “The Canadian Midwifery Registration Exam (CMRE) is a national written examination designed to assess applicants for midwifery registration to ensure that they meet entry-level competency standards set out in the Canadian Competencies for Midwives (appendix F). Its goal is to ensure that midwives gaining registration are competent and safe practitioners providing a consistent standard of care across Canada.” 3 The Canadian Competencies that form the basis for the examination must, by necessity, reflect the common standards across the country. Ontario’s differences, due to delays in regulatory changes, have meant that certain questions have been left out of the exam, leaving these areas to be assessed by each province.

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18. Please provide pharmacotherapy course content in the current educational curriculum and demonstrate how it ensures the minimum qualifications for the prescribing or administration of drugs by members of your profession.

The Midwifery Education Program in Ontario provides students with extensive background in pharmacology and pharmacotherapy (see appendix G for a sample of the course syllabus Pharmacotherapy from McMaster University). As the syllabus describes, this course provides an overview of basic concepts in pharmacy, pharmacology and therapeutics relevant to the practice of midwifery in Ontario. Content areas include pharmacokinetics, , adverse drug reactions during pregnancy, drug transfer through lactation and pharmacology in the neonate.

In addition, students are exposed to additional concepts of pharmacology and therapy in a more integrated manner in Life Science for Clinical Practice. In this course, concepts of general microbiology include the growth and structure of bacteria, viruses and eukaryotic microbes with emphasis on those of importance in pregnancy and in neonates. It also discusses the concept of microbial control, including common disease organisms in wound infection, puerperal sepsis, neonatal infection and sexually transmitted microbial disease (e.g. Chlamydia, gonorrhea, etc.) and virology, with discussion of hepatitis viruses, human immunodeficiency virus (HIV), human papillomavirus (HPV), cytomegalovirus (CMV), human T-lymphotropic virus (HTLV) and herpes viruses. This course also covers aspects of pharmacology, specifically including principles of microbial growth and control with antibiotics. All major families of antibiotics and anti-fungals are covered, as well as anti-virals. The mode of action of all antibiotics is discussed and the principles of antibiotic sensitivity, hospital acquired infection, mechanisms of antibiotic resistance and superinfection are addressed. Principles of drug metabolism, dosing and clearance are covered in the pharmacotherapy course.

Administration, prescribing and documentation of actions is covered in midwifery clinical courses beginning with the Clinical Skills for Midwifery Practice in the fall term of second year, and continuing as an integrated part of the situation based tutorials. As discussed in question17 above, students are evaluated throughout their clinical placement on their proficiency with administration of pharmaceuticals, their ability to prescribe, as well as their general knowledge of drug therapy as it pertains to women in their care.

19. Does the health professional college require continuing education and training for members to ensure competency in the prescribing or administration of drugs? Please be specific and provide documentation to the extent possible. Please describe how the college ensures its members keep pace with advancements in pharmacotherapy, pharmacology and patient safety.

Members are expected to maintain clinical competency regarding the drug regulation as a matter of routine professional development, but this has been a frustrating process as

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it has demonstrated that the drug regulation is very dated.

The College has established continuing competency requirements for its members in other areas, and these mechanisms can easily be adapted to manage the continuing education monitoring that will be required for the proposed amendments to the drug regulation. Members will be required to participate in continuing education (CE) through the College’s Quality Assurance Program (QAP), and information bulletins will be developed to assist members in keeping pace with clinical developments.

20. Please indicate what college documents are available to members on the prescribing or administration of drugs, including relevant standards of practice, rules and guidelines. Are these documents current? Please include the documents with the submission.

The CMO has the following documents that are relevant to the prescribing and administration of drugs for members. They are current. Please see appendix H for details.

• Core competencies • Indications for Mandatory Discussion, Consultation and Transfer of Care • Essential equipment, supplies and medications • Recommendation for Midwife Certification for Care of Women Receiving Epidural Pain Relief in Labour • Draft Standard for Prescribing and Administering Drugs (submitted with the most recent proposal to amend the drug regulation)

21. Please describe current competencies, education and training of members of the profession to perform any of the proposed changes.

It is important to recognize that midwives currently prescribe and administer drugs on their own authority. Students in the MEP and IMPP are well prepared to undertake this expanded role as part of their responsibility in the primary care of pregnant women and newborn infants. The enhanced pharmacopeia that is being sought as part of this review will be well understood by graduates of the programs.

MEP students learn and are examined on drug categories within a specific pharmacotherapy course. The use of appropriate prescription or administration of drugs is included in ongoing and increasingly complex clinical scenarios that students encounter in their tutorial sessions. In addition, practice in prescribing and administering drugs is provided throughout clinical placements. The additions to the drug regulation would not be challenging for graduates of the program. Students gain experience in prescription of drugs as part of the current program, and that experience can readily be transferred to the prescribing of additional drug classifications such as oral contraceptives and antibiotics. Methods of drug administration will need to be reviewed

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to ensure that all methods are adequately addressed as part of current curriculum. Enhanced emphasis on drug dose calculation and management of administration could be beneficial.

22. Do all members of the profession have the competencies to perform any proposed activity related to the prescribing and/or administration of drugs?

Members who are already in practice may or may not have the knowledge and skills to perform within the proposed changes to the drug regulation, based on their original training. Approximately one-quarter of our members obtained their original training outside of Canada and many of them have worked in places where midwives have a very broad scope and prescribing authority. However, we plan to require all currently registered members to undergo training and certification with respect to the proposed changes to assess and ensure the competency of each member.

The International Midwifery Pre-registration Program (IMPP) has the demonstrated capacity and is willing and committed to developing continuing education workshops and Distance Education courses to support changes to the College’s drug regulation. Further, the Association of Ontario Midwives (AOM) has the ability to provide continuing education through e-modules and workshops with content that is both theoretical and clinical. They have an established record of providing continuing education to midwives.

23. What effect would the proposed change in the prescribing or administration of drugs have on members of your profession who are already in practice?

a) How will the members become current with the changes, and how will their competency be assessed?

The appropriate courses will be made available to our members quickly and with tangible measures in place to evaluate the members’ acquisition of the knowledge/skill. The International Midwifery Pre-registration Program (IMPP) is currently about to launch a number of distance education courses, including pharmacology. As far back as 2004 we discussed their capacity to have continuing education content available across the province through their distance education capabilities. The IMPP, the MEP and the AOM have expressed their support and willingness to work with the CMO on the development of high quality educational opportunities to support members’ acquisition of the skills needed to incorporate the proposed changes. These programs could be made a mandatory component of the Quality Assurance Program continuing education requirements.

b) What additional competencies, education and training would be required for all (or some additional) members of the profession to perform any proposed activity?

Midwives in Ontario already possess considerable formal training in all aspects of

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pharmacology and pharmacy having to do with the pregnant woman and newborn, and many of the drugs proposed in this submission are currently administered by midwives but under the order of a physician. However, in order to ensure continued client safety the addition of new drugs to the midwifery armamentarium will require some additional education for the practicing midwives and midwifery students. This material would chiefly involve direct instruction about the indications for the drugs, their modes of action and safe prescribing practice. The material could be delivered as face-to-face sessions, though it is likely that eLearning by standalone web-based learning modules, webinars and web conferencing would be more efficient (see questions 22 and 23a above for more information).

c) What quality improvement or quality measurement programs do you have in place and what additional programs would be put into place?

Currently the CMO ensures that members maintain competence and competencies through several mechanisms. Members are required through the annual renewal of their registration to maintain current certification in obstetrical emergency skills, neonatal resuscitation and cardiopulmonary resuscitation. The registration regulation also contains requirements for members to attend a minimum number of births, both in the hospital and in the home, in a given period of time in order to maintain registration.

The Quality Assurance Program (QAP) requires participation in a variety of quality assurance activities and annual reporting on a member’s fulfillment of requirements (see appendix C). We have the ability to make specific courses mandatory as part of the program requirements and already have the procedures in place to monitor compliance. Further, through the QAP practice audit process we annually select members and their practices at random to undergo a complete audit of their midwifery practice. We will put the necessary requirements and monitoring in place through our QAP to ensure member compliance and competence related to the proposed expansion of prescribing authority.

We do not anticipate that the proposed changes will create significant additional demands on the profession. To the contrary, we believe the recommended changes will assist in the provision of a seamless delivery of services to the client.

Through our QAP both the CMO and members have already demonstrated a long- standing commitment to patient safety, which is a commitment that will be renewed with the introduction of any extensions of midwifery drug regulation. The QAP facilitates the implementation of practice modification tools, encourages learning from incidents, near misses, adverse events and fosters the use of principles of high reliability organizations.

d) What educational bridging programs will be necessary for current members?

We have been working with the International Midwifery Pre-registration Program to

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ensure that a comprehensive pharmacy course will be available as a distance education format to ensure all members are able to access the required upgrading (see appendix E for the IMPP’s draft pharmacology module). As described above, current members will need to be educated about the specific categories being proposed but this will be an extension of current knowledge, as opposed to the acquisition of an entirely new skill. Please see question 22 for further details on how this bridging education will be provided.

PUBLIC INTEREST

24. Describe how the proposed changes are in the public interest. Please consider and describe the influence of any of the following factors or other relevant matters:

a) Patient safety

Safety through better access to care

Enhancing midwives’ authority to prescribe and administer drugs will increase women’s access to the appropriate treatment at the point of care for routine pregnancy-related conditions, as well as during labour and in the postpartum. The Ontario Maternity Care Expert Panel (OMCEP) was clear in their vision that “every woman in Ontario has access to high quality, woman and family-centred maternity care as close to home as possible.” 4 This is particularly relevant for those midwifery clients living in underserviced communities, where access to family physicians is steadily declining, and emergency departments are over-burdened. Further, as it stands, varying hospital inventory and the availability of specific drugs represents a significant problem for midwives. If a drug that is included in our current drug list is not on hand in the hospital where they are working, the regulation leaves them with no authority to use the drug or drugs that are available. Access to categories will remove this barrier to safe, effective care.

Safety through changes to the system

The CMO strongly supports the exploration of alternate mechanisms for regulations. Midwifery regulatory colleagues in other provinces report more flexibility in a framework that provides by-law making authority for the profession (e.g. drug lists and other clinical aspects of the profession). We also understand that in Ontario there are professions (lawyers, public accountants) that have been granted rule-making authority, thereby setting a precedent and practice to guide the development of the use of this approach to the regulation of health professions.

The CMO believes that risk to patient safety currently exists because of the regulatory amendment process, which restricts our ability to amend regulations in time to reflect

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current best practices and therefore restricts members in providing care. This is evidenced by the changes to scope that are needed to bring Ontario’s midwives in line with midwives in other regulated jurisdictions in the country. The current process, which prevents the CMO from readily updating the lists of drugs (an area of evidence-based health care that evolves continuously) hinders the CMO in fulfilling its mandate of the protection of the public and contributes to the erosion of the province’s health care system.

b) Epidemiological trends in illness and disease

In terms of maternity care provision, changes in the population of childbearing women impact the type of care that is required. For example, the increase in the average maternal age, as well as in rates of obesity and the concomitant associated risk of increased blood pressure, genetic anomalies and overall greater morbidity have resulted in the necessity for midwives to order the recommended tests. As the population changes, so does the provision of care, and currently many of the tests and medications that midwives require access to are not included in the CMO’s regulated lists.

Further, new approaches to treatment are often evolutionary: research results are reported; clinical practice begins to change (first in teaching centres and then expanding to the broader community); and clinical guidelines are issued (for example, by the Centres for Disease Control and Prevention, Health Canada, SOGC, etc.). In the physician-based system doctors simply change their clinical practice, yet for other health care professions the response to changing medical trends and best-practices may be reliant on regulatory changes. In Ontario this has severely limited practitioners’ ability to respond and keep pace with changes to best practices (for example, the CMO has had a drug regulation amendment proposal in front of the MOHLTC for four years).

c) Access to care and coordination of care

If not addressed, the maternity care crisis in Ontario will worsen as the population increases and professionals and institutions become more stretched. The OMCEP report noted that a key to ensuring the sustainability of the maternity care system in Ontario is finding a good balance between primary maternity care provided by family physicians and midwives and specialist maternity care provided by obstetricians. Excellence in the system will come from ensuring there is effective collaboration when needed between these groups.

Amending the drug regulation, as well as the regulatory amendment process, will allow midwives to work to their full scope of practice as primary maternity care providers. Midwives currently provide dedicated maternity care, prenatal education and lactation support, and can effectively monitor the need for, and make referrals to the appropriate specialist.

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In short, the ability of midwives to work to the optimal extent of their scope and skills is not only in the public interest but the most efficient, safe and productive method of reducing the “gap” in service and will “ensure the system’s capacity to meet local patient and population health needs.” 5

d) Wait times for health care services

Midwives, with an enhanced pharmacopeia, will increase access to treatment for midwifery clients at the point of care, and will reduce clinically unnecessary referrals to specialists. Decreasing wait times for accessing treatment is in the public interest.

The Wait Times Expert Panel commissioned by the Ministry of Health and Long-Term Care in 2006 concluded in their January 2007 report that “family physicians and nurse practitioners are finding that working in collaborative relationships with one another, and with other health professionals, enables them to provide comprehensive and patient- centric health care. Interprofessional teams utilize the combined skills and expertise of different professionals recognizing that often no single provider or discipline is able to meet all the health care needs of many of the populations served in a sustainable fashion.” If midwives are to contribute equally to the care of low-risk women they require a drug authority similar to that which family physicians have in maternity care. Equipping midwives, through an expanded drug regulation, to participate more fully in these interdisciplinary teams will contribute to the entrenchment of a system that is sustainable, that meets the needs of the population and reduces wait times for health services.

In addition to the obvious benefits to midwifery clients, this change will also contribute to reducing the burden on family physicians already stretched to meet the needs of their patients and it will help to contain costs since the system will not have to pay for an unnecessary visit to a physician. Further, this change may influence the number of women who will elect to give birth at home, thus significantly reducing health system costs. Even if a small proportion of women who are GBS positive would choose a homebirth if their midwives could prescribe the necessary antibiotics, this could result in a significant number of otherwise low risk homebirths. Every time a woman chooses to give birth at home system costs are reduced, and a hospital bed is freed up.

“…The current need for consultations can lead to unnecessary delays in women receiving intrapartum antibiotics (which can result in prolonged postpartum hospital stays) as well as effective pain management. Furthermore, these consultations are resulting in increased costs for the ministry of health. The change in scope of practice for registered midwives would increase their autonomy and improve working relationships between midwives and physicians.”

Letter from 4 obstetricians Jan 18, 2006

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e) Best practices of the profession

Midwives have a distinctive model of care and they adhere to the best practices that define that model of care (for example, informed choice and continuity of care). They also work within the health care system alongside family physicians and obstetricians as primary care providers, and adhere to the best practice guidelines of the broader maternity care profession.

As the first Canadian province to regulate midwifery, Ontario was a national leader in developing the scope of practice needed to provide the best quality of primary maternity care for midwifery clients. However, many of the decisions regarding the profession were made 25 years ago as a part of the Health Professions Legislative Review. The provinces that have since regulated midwifery have gone further to allow midwives to provide primary care that ensures the best continuity of care possible to women choosing to have a midwife-assisted birth. International best practices in regulation have also surpassed this province, as evidenced by the International Confederation of Midwives (ICM) essential competencies for midwifery practice (appendix I). As a result, Ontario is no longer at the leading edge. The proposed regulatory amendments will bring Ontario’s midwives into line with the other provincial standards and with the current best practices in prescribing and administering drugs in maternity care.

f) Promotion of collaborative practice

Midwives, who have always worked from a philosophical base that recognizes and utilizes the benefits of collaborative care, are well poised to be active contributors to effective interprofessional care (IPC). Midwives are required, through the CMO’s Indications for Mandatory Discussion, Consultations, and Transfer of Care standard, to collaborate with physicians in a clearly articulated framework. The proposed regulatory changes to midwives’ authority to prescribe and administer drugs will enable them to participate more completely in primary maternity care and to the full extent of their skills; something which both the OMCEP report and the Multidisciplinary Collaborative Primary Maternity Care Project (MCP2) report found to be critical to the success of interdisciplinary teams. Further, the proposed amendments could improve relationships between care providers, as both family physicians and midwives would be providing the same routine maternity care services, and future collaborative initiatives could address more pressing issues facing the professions and the families they serve. Midwives’ access to antibiotics, in particular, will enable collaboration at the appropriate professional level.

Both OMCEP and MCP2 have examined IPC specifically in regard to maternity care and concluded that midwives have a key role to play in the provision of quality interprofessional care. The proposed changes to the midwifery drug regulation will

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enhance midwives’ capacity to provide care to low-risk women and their babies at a level that is similar to a family physician. This will support the recommendation that primary maternity care providers should have overlapping competencies, to better meet the needs of the community while working in interprofessional environments. Providing midwives with the prescribing and administering authority needed to maintain responsibility for the care they are already providing (i.e. primary maternity care) would enable midwives to better contribute to IPC.

g) Professional competencies not currently recognized

As primary care providers, midwives have the clinical decision-making skills to provide safe, effective care to their clients. The proposed changes to the drug regulation builds on these skills and will support members in providing enhanced continuity of care to women through the prenatal, intrapartum, and postpartum periods. This will reduce the number of clinically unnecessary consultations and will allow midwives to provide care to their full competency level, including diagnosing and treating commonly occurring pregnancy-related conditions.

25. How would the proposed change affect other health professions? The public? Describe the effect the proposed change in the prescribing and/or administration of drugs might have on:

a) Health human resources

Health Force Ontario reports that “trend data indicates that Ontario faces a significant reduction in its health human resources workforce by 2010”, and that “unless new ways of practising health care are introduced, Ontario will face a significant shortage of health care workers and Ontarians will risk receiving sub-optimal care.” 6 This same crisis is threatening maternity care in the province and country, and will require considerable planning and resources to resolve. Health Force Ontario has indicated that there is a commitment to “developing new provider roles and new models of care that will make the best use of all our skills and resources” 7 as part of the effort to resolve sustainability issues across the health system. The proposed changes to the midwifery drug regulation will support a better balance between primary and specialist care, ensuring that the province’s other obstetrical resources are better used through the removal of the need for unnecessary consultation regarding issues or aspects of care that are well within the midwifery skill set.

Adding to the difficulty of effective health human resource planning for maternity care is the fact that there are limited ways of predicting the future supply and distribution of caregivers.8 Midwives, as the only growing maternity care profession in Ontario, are the exception to this situation. Midwives are a consistent and predictable resource and are poised to play an even more significant role in solving the maternity care crisis.

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b) Enhancement of quality of services

The proposed amendments will result in enhanced continuity of care for midwifery clients, as well as increase the safety of this care (through timely access to medications and treatment). The changes will support a reduction in adverse sequelae resulting from delays to treatment at the point of care. To illustrate, urinary tract infections (UTI) occur in 5-11% of normal pregnancies and, if they are left untreated, can lead to a kidney infection, which in turn can develop into pyelonephritis and a concurrent risk for preterm labour. Midwives screen for UTIs but are not currently authorized to treat their clients who test positive for this condition, as antibiotics are not currently included in their pharmacopeia. Midwifery clients with UTI must be referred to their family physician for treatment, which we know causes difficulty for many women due to the shortage of family physicians in Ontario, and then have a prescription written and filled for the drugs required. This restriction creates a considerable cost for the medical system in additional health care billing and is a poor use of physician’s services. If a woman’s untreated UTI leads to a kidney infection she will be hospitalized, which is an added burden to the health care system. Most critically, the current arrangement delays treatment, which leads to a prolongation in the UTI and exacerbation of symptoms. Research evidence indicates that prompt treatment of asymptomatic UTI will lead to a tenfold decrease in the rate of pyelonephritis.9

The same scenario unfolds for midwifery clients who test positive for certain lower reproductive tract infections (chlamydia, gonococcal infections, herpes simplex virus, and bacterial vaginosis). The Public Health Agency of Canada’s STI Guidelines 10 recommend immediate treatment for all of these conditions. The delay associated with referring midwifery clients to family physicians and walk-in clinics poses potential risks to both the mother and fetus.

c) Access to services

The proposed changes would support midwives in providing the services of a primary maternity care professional, which in turn will mean better access to services for midwifery clients. They will also reduce the number of referrals and transfers to physicians increasing their availability and improving access for women who require the expertise of a specialist.

d) Service efficiency

As mentioned, the proposed changes will mean that midwifery clients will have access to enhanced care, at the point of care. There will be a reduced number of clinically unnecessary referrals to physicians, which in turn will result in reduced overall cost for the health care system.

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e) Direct patient benefits/costs

For women who have chosen to enter into a midwife’s care, the proposed drug regulation changes will have the benefit of improving access to care. This will be achieved by removing barriers to midwives providing a fuller spectrum of primary care services (e.g. treatment of commonly occurring urinary tract infections) so that women do not have to seek care elsewhere. The benefits to this will be clinical (i.e. earlier treatment for the UTI and the avoidance of potential negative outcomes related to delayed treatment); practical (i.e. not having to make the visit to a family physician to obtain a prescription); and reassuring (i.e. being able to receive care from a provider with whom they have an established relationship).

Not being able to obtain the needed care related to their pregnancy or birth from a single provider could result in increased financial costs. Women who must travel any distance to see a physician may incur additional costs. Travel that requires an absence from work may increase costs to the woman since the absence may be unpaid. There may also be reduced productivity for the employer.

A primary tenet of midwifery care is continuity of care, which has been documented as enhancing maternal/infant outcomes. 11 Continuity will be enhanced by every change to the midwifery drug regulation that removes the necessity of referral to a physician simply to obtain the medications that are a part of ‘routine’ maternity care, and that are within the midwife’s skill set (e.g. GBS prophylaxis).

f) Benefits and costs to the broader health care service delivery system

The proposed changes will benefit the broader health care service delivery system in a number of ways. These include:

• Enhancing midwives’ ability to participate in interprofessional care. • Decreasing the duplication of care currently created by the need for consultation for prescriptions that are within a midwife’s skill set to provide. Each visit to a physician has associated costs that would be reduced or removed by the proposed amendments. • Relieving pressure on already stretched family physician and specialist resources. The Janus Report includes the finding that half of the physicians in Toronto and 73% in Ontario reported that there were insufficient numbers of family doctors. The members also reported (71% in Toronto and 66% in the rest of Ontario) that there were insufficient specialists. The decreased quality of work/life balance for physicians has been noted by the Ontario College of Family Physicians (OCFP), which stated that the reduction in supply, the increased attrition, and the practice of most new graduates of doing locums for the family

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physicians has caused an erosion of the working conditions for remaining physicians. The increased workload makes it difficult to provide the broad scope of services and practice according to the four principles of family medicine. The Janus report states that “the average family doctor in Ontario works seventy hours a week and takes call once every five or six days.” 12 • Relieving pressure on obstetricians and allowing their valuable and limited time and resources to be directed toward high-risk pregnancies. The College of Family Physicians of Canada (CFPC) reports that 18.2% of family physicians rate the access that their patients have to obstetricians as only fair and that 7.3% rate this access as poor. It is reasonable to assume that access will become even more difficult as the number of births in Ontario rises.

g) Benefits and costs associated with wait times

As noted in question 24 (d), the Wait Times Expert Panel concluded that delays in accessing a primary care provider often lead people to seek care at emergency departments and walk-in clinics.” 13 The cost of these visits represents an additional avoidable and unnecessary burden to the province’s health system. We believe that it would be reasonable to expect that the proposed changes, by allowing women – specifically those with limited or no access to a family physician – better access to more direct service from their midwife, would decrease the number of women who made visits to walk-in clinics and emergency departments.

“I am writing to pass on information from our annual review of client satisfaction questionnaires…. In the last two years, we have received comments indicating that midwives should be able to prescribe medications that are presently outside of our pharmacopoeia. …another client indicated that she had mastitis on Christmas Eve, her midwife clearly identified the problem…. Treatment was delayed by a day due to the difficulty of accessing medical care during the holiday. The client believes that it is inappropriate for a skilled primary caregiver not to be able to prescribe this treatment. We hope these examples demonstrate the current needs of Ontario midwifery clients and can assist the College in your work to change the drug regulation.”

Letter from a Midwife Jan 27, 2005

h) Interprofessional care delivery

Please see question 24 (f) for further information.

The amendments proposed in this submission are a response to needs identified at the community level, and are intended to enhance midwives’ participation in interprofessional care. Currently, clinically unnecessary consultations comprise a large portion of those interactions between midwives and physicians, which has resulted in

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frustration on both sides.

26. Are members of your profession in favour of the proposed changes? Please describe any consultation process and the response achieved.

Members have been requesting amendments to the drug regulation for many years, and have been vocal in their disappointment regarding the extended length of time of the amendment process. The CMO has held formal consultations with members over the last several years in regard to numerous iterations of drug regulation amendments, beginning with a member symposium in 2001. Most recently the College surveyed members regarding the proposed changes to the midwifery scope of practice (submitted to HPRAC May 2008). Of the 267 midwives who responded to the survey (64% of the membership), 98% supported the addition of antibiotics for the treatment of GBS, mastitis, UTIs and bacterial vaginosis. Further, 90% supported the inclusion of antibiotics for the treatment of some sexually transmitted infections (STIs). They also recognize the need for extended training regarding this expansion. Some of their comments included:

“As a rural midwife this would make me an effective primary maternity care provider in this area. Reduced services have caused many clients hours in emergency rooms because I cannot prescribe these medications yet I have diagnosed them and sent them to the doctor for the drugs. Costly to health care system and the client’s health and well being.”

“In each of these instances midwives have ample opportunity to become competent in prescribing antibiotics appropriately. In the cases where infection exists, the woman would be so glad not to have to make yet another appointment with another health care provider... especially when she is feeling so unwell. In the case where the woman is GBS positive, it would more appropriately utilize the health care system and lower costs overall.”

“VERY needed in our scope of practice to decrease double dipping into the system and decrease waiting time for clients to access appropriate antibiotic coverage.” In the same survey of the membership we asked whether they support the inclusion of the following in the drug regulation:

Mumps/Measles/Rubella vaccine: 89% in favour Varicella Immune globulin: 88% in favour Childhood vaccinations: 61% in favour

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The comments received regarding the inclusion of these drugs in the regulation indicated support from the profession, particularly for those midwives practicing in underserviced communities where an extended scope of midwifery practice would be a benefit to women and families. However, the survey was able to provide limited context regarding the extended scope proposal, and therefore some midwives indicated that they would not support this item for their own practice (in well-serviced communities), but commented that they recognize the value that it could hold for other midwives in the province.

PRESCRIBING: DRUG REGULATIONS UNDER PROFESSIONAL ACTS

27. Please describe challenges faced by members of the profession as a result of listing specific drugs in regulation schedules made under the profession- specific act.

The most significant challenges have been the delay in access to treatment for midwifery clients, the frustration felt by midwives as well as other care providers who are then required to fill the gap, the cost that this has meant for the health care system, and the barriers that is has created in regard to midwives practicing to their full scope on interprofessional teams. To illustrate, the following comments were made by members as a part of the recent survey regarding the scope of practice review:

“Obstetricians have complained to us that they feel it is ridiculous that we cannot order antibiotics and a few have even told me that I should be speaking with my College about this limitation. It often causes OB annoyance as they must be woken in the night to consult for GBS prophylaxis at times.”

“I don't want to limit what I can use antibiotics for- this is likely to change as time goes on. It should be my College that tells me what I can use antibiotics for not the drug regulation- we need classes of drugs not something this prescriptive.”

“It is absolutely unbelievable that we have to consult for these things. It is a misuse of public money to have them go to their GP for these things.”

“I have had clients become very sick while running around trying to get a prescription for antibiotics from their family doctor or sitting in emergency rooms for hours when they should be at home resting and breastfeeding their babies, trying to get a breast infection treated that I have already diagnosed. Similarly, prenatal UTIs get out of hand and put women at risk of preterm labor because of delays in treatment.”

“This is the change I would most want to see, it is a waste of time and resources to consult for GBS prophylaxis and other pregnancy and postpartum related antibiotics.”

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“Many physicians in our conservative hospital also agree with changing this regulation. It would save time & aggravation for both midwife & physician.”

28. If classes of drugs, rather than a list of specific drugs, were included in the proposed regulations, please describe how this would impact the members of the profession and the college. What, if any, additional education and training, competency review, or updates to clinical guidelines or standards of practice would be required?

As noted, the addition of categories of drugs in the midwifery regulation, as opposed to the current list of drugs, would have a significant impact on the members of the profession. It would allow midwives to provide care to their full scope of practice without clinically unnecessary referrals to physicians. It will allow for the “right care provider” at the “right time” by freeing up physicians to consult on cases where they are truly needed while enabling midwives to work providing full scope primary care for low-risk women and their infants.

In terms of the impact on the College and continuing education the CMO, along with the midwifery education programs and the Association of Ontario Midwives, has established a working group to address these issues (as a part of the overall scope of practice review). The CMO is currently conducting a systemic review of its policies and standards, including the drug regulation and the relevant supporting documents. This work will continue as the HPRAC non-physician prescribing project moves forward. The inclusion of categories of drugs, as opposed to the current list, will result in a more streamlined process for regulation. The CMO reviews the drugs included in the list to ensure they meet the current best practice standards. Categories of drugs will mean that the individual medication review procedure will take place as part of the midwives’ clinical practice and in relation to the provision of care. As trained and knowledgeable professionals, midwives will have the competency to keep up-to-date on best practices in pharmaceuticals.

The midwifery education programs, as noted in questions 17 through 23, are well poised to incorporate the proposed amendments into the curriculum of the MEP and the IMPP, and to develop continuing education workshops and distance education courses to support changes to midwifery's drug regulation. Further, they are prepared and able to develop remedial individualized courses to address challenges experienced by practicing midwives adapting to a revised drug regulation.

The additions to the current midwifery curriculum, as well as the development of the upgrading courses for practicing midwives, will provide students and members with the necessary knowledge of the foundations of pharmacotherapy, as well as the specifics of pharmacokinetics, toxicology, adverse drug reactions during pregnancy and lactation and pharmacology in the neonate.

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29. If classes of drugs, rather than a list of specific drugs were included in the regulation, what conditions should be attached, if any, to the classes? Should the broad purpose, indications, or some other reference be specified (e.g. for pain relief in labour; for smoking cessation; for treatment of sexually transmitted diseases; in emergency; refill). Please comment in detail.

Please refer to the chart in question 10 for details. We are proposing that the category of drug associated with specific clinical indications be set out in the drug regulation. This format was modeled after the College of Midwives of BC submission for categories of drugs in their current regulatory amendments. This format will provide midwives with general parameters for treatment, but will allow the flexibility required in situations where the best practices in maternity care evolve and change. Because the scope of midwifery practice is specific to maternity care for low-risk women and their infants, the clinical indications are correspondingly specific. The list of indications for drug treatment is much more narrow than, for example, one would encounter in nursing where there is a much broader scope of practice. Further, midwives have a demonstrated commitment to a non-interventionist, evidence-based approach to maternity care, which influences their approach to pharmacotherapy, and results in a lower rate of overall drug utilization among midwives.14, 15, 16

30. If classes of drugs, rather than a list of specific drugs were included in the regulation, how would you classify the drugs for your profession? Are there circumstances where a drug class would not be appropriate in a regulation schedule for the profession? Are there situations where a combination of class and list of specific drugs would better respond to the competencies of the profession?

Categories of drugs with the indications specified will provide the proper limitations and parameters for midwives to provide safe care, and the regulation will be accompanied by a CMO standard that details the clinical specifications for each category and indication as they pertain to the midwifery scope of practice. As mentioned, the scope of midwifery practice is very specific, thus there are limited circumstances in which drugs would be prescribed or administered. Midwifery education currently includes information about these scenarios and their drug treatment. There are no situations where a combination of category and list of specific drugs would better respond to the competencies of the profession.

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31. If applicable, please describe in general your profession’s experience with requests for changes to drug regulations, including specifics of the requests made, regulation changes that followed, if possible the time required for changes to regulations, and what, if any, proposed changes were, or were not, approved by government.

The CMO has been requesting amendments to the drug regulation since October 2003. It began when one of the two medications listed in the CMO’s designated drug regulation to treat postpartum hemorrhage, Ergonovine, became unavailable due to a raw material shortage. The CMO notified the Ministry of Health and Long-Term Care (MOHLTC) that this posed a clinical risk for midwifery clients and inquired about the process for an urgent amendment. We were informed that there was an expedited process that we could access, but that this process would still take months to finalize. In actual fact it took one year.

Because the CMO was concerned with the significant amount of time required for the expedited amendment process we looked for alternatives for our members to ensure they were able to continue providing safe care to their clients. We approached the CPSO to discuss the establishment of a medical directive process for our respective members to address this issue. Unfortunately, this process, too, would be months in the making. We learned about the Special Access Program of Health Canada and made this information available to all midwives.

This situation caused considerable stress among our members and required considerable efforts on the part of the CMO. Any options for addressing this situation were not within our immediate control. At the time we were advised by the MOHLTC to identify one medication to expedite the required amendment to the drug regulation. We chose Carboprost Tromethamine as it was identified as the third line choice in the SOGC’s clinical practice guideline. Carboprost Tromethamine was not added to the midwifery drug regulation until September 11, 2004, nearly a year after the original request was made.

However, during the consultation required by the Ministry members informed the College that Carboprost Tromethamine has significant drawbacks, particularly in a homebirth setting, and they felt that there was a more appropriate choice of medication and that they would prefer to have an option regarding which drug to use. The Ministry’s direction to choose one medication limited the College’s ability to respond to members concerns. This situation clearly illustrated the need for a drug regulation that provides for categories of drugs, and a more responsive and flexible regulatory amendment process for regulations affecting clinical practice.

Following that experience, in December 2004 the CMO submitted a request to include categories of drugs in the regulation, as opposed to the list, in an effort to ensure that situations like the one referenced above would not adversely influence the care

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midwives provide to their clients. As of July 2005, we had received no response to this request, and inquired about its status. In September 2005 we were informed that Ministry would not support the inclusion of categories of drugs, and we were asked to submit an amendment listing the drugs. That submission was made by the CMO in December 2005, and since then we have been asked to re-submit the supporting documents two additional times. The most recent amendment request to the midwifery drug regulation was submitted in June 2008. To date, we have received no indication that it is moving forward.

COLLABORATION

32. Do members of your profession practice in a collaborative or team environment where a change in drug regulations or legislation would contribute to multidisciplinary health care delivery? How would relations between professionals working in a team be impacted?

The proposed changes to the midwifery drug regulation would support the recommendation from the Multidisciplinary Collaborative Primary Maternity Care Project (2006) that midwives and family physicians should have overlapping scopes of practice. The proposal would also promote the definition of the multidisciplinary care model outlined in the report, which states that:

“The model is designed to promote the active participation of each discipline in providing quality care. It is woman-centred, respects the goals and values of women and their families, provides mechanisms for continuous communication among caregivers, optimizes caregiver participation in clinical decision-making (within and across disciplines), and fosters respect for the contribution of all disciplines.”

The principles of the Multidisciplinary Collaborative Primary Maternity Care Model reflect and embody the foundational principles of the midwifery profession in Ontario. Midwifery, as it is currently regulated and practiced, is an inherently collaborative profession. In the provision of continuous maternity care midwives work in both intra and interprofessional teams, in small midwifery groups, as well as alongside physicians, nurses and other health care professionals. Midwives are mandated to collaborate and consult through the CMO’s Indications for Mandatory Discussion, Consultation and Transfer of Care (IMDCTC) guideline (appendix J), which sets out the clinical situations wherein midwives are required to consult with a physician. This document has been used since the regulation of midwifery as an effective tool to support and guide collaborative care between midwives and physicians. In its report, OMCEP recommended that hospitals use this standard as the basis for local consultation and transfer of care protocols. To that end, the CMO is well situated to provide evidence and experience-based recommendations to HPRAC regarding regulatory features that may enhance interprofessional collaboration between health professions in Ontario.

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What additional standards would be required (e.g. record-keeping, referral protocols)?

The CMO’s Indications for Mandatory Discussion, Consultation and Transfer of Care document, which has proven to be a dynamic and effective tool for midwives and physicians, will be amended accordingly. Midwives and other health care professionals will be educated regarding the changes to current consultative processes. Further, the College will develop the necessary drug standard to provide parameters and guidelines for midwives prescribing and administering drugs to accompany the indications-based regulation.

Please describe any consultation process, agreements or other arrangements that have occurred with other professions.

As a part of the mandated regulatory amendment process, we have consulted with members and stakeholders twice on the proposed changes to the current list of drugs that midwives are authorized to prescribe and administer. Further, as part of the recent scope of practice review the CMO undertook a wide consultation process with other regulated professions (through both their regulatory colleges and associations), with hospital administrators, with midwifery transfer payment agencies, and with other midwifery and maternity system stakeholders. Through this survey, we have identified the need for concerted communications to inform other health care professionals of the proposed changes, in order to avoid confusion at the clinical practice level. To this end, we have begun the process of sharing information with relevant organizations regarding both the current and proposed scope of midwifery practice, including the drug regulation, in an effort to enhance professional awareness of the role that midwives play in both the community, as well as in hospitals. For example, an article regarding midwives’ prescribing authority has recently been developed in collaboration with the Ontario College of Pharmacists (OCP), for publication in the CMO newsletter. We have shared the information with the OCP, and we understand that they are considering including an article in their newsletter, as a reference for pharmacists working with midwives writing prescriptions.

OTHER JURISDICTIONS

33. Describe any obligations or agreements on trade and mobility that may be affected by the proposed changes for the profession. What are your plans to address any trade/mobility issues?

The CMO is one of the six parties to the Midwifery Mutual Recognition Agreement (MRA) that came into effect July 1, 2001. The other current parties are British Columbia, Alberta, Manitoba, Northwest Territories and Quebec. The MRA allows provinces to

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place limitations or conditions on an applicant’s registration only if it is to address a significant difference in competency required for registration and practice in the accepting jurisdiction. Of all the provinces that are signatories, Ontario is the province that has the most restrictive drug regulation. The requested expansion to update the drug regulation will bring Ontario’s midwives in line with the other regulated provinces and will mean that Ontario midwives will not need to have conditions imposed on their license if they register in these other provinces (for a full review of the jurisdictional differences see question 34).

34. What is the experience in other Canadian jurisdictions? What is the experience in international jurisdictions?

Ontario was the first Canadian jurisdiction to regulate the profession of midwifery, and as such the College of Midwives of Ontario has paved the way for other provinces and territories to adopt legislation regulating midwives. More than half of Canada’s midwives practice in Ontario, and three of the six universities offering baccalaureate midwifery education programs throughout Canada are in Ontario.

Unfortunately, the Ontario scope of midwifery care has remained stagnant in areas while other jurisdictions have progressed in their ability to provide cost effective, client centred services. As noted by the Ontario Maternity Care Expert Panel:

Ontario was the first province in Canada to regulate midwifery but both the Association of Ontario Midwives (AOM) and the College of Midwives of Ontario (CMO) report that the profession encounters great difficulty in updating regulations to reflect growing knowledge or even to reflect practice changes already in place in other provinces. The inflexibility of Ontario midwifery regulations means midwives in Ontario have difficulty keeping in step with advances in maternity care and national midwifery and medical standards of care. For example, midwives in Ontario are licensed to prescribe specific drugs according to regulation. The intent was to facilitate routine care during pregnancy, labour and birth and in the postpartum period. Unfortunately, the College has found itself unable to update the regulation in a timely manner as new drugs have been approved and adopted. This creates a serious barrier to midwives’ ability to provide care in accord with best practice guidelines and, since they must turn to physicians to prescribe the more efficacious medications, to practice to their full scope. The pharmacopoeia of Ontario midwives is less inclusive of routine treatments than in other provinces more recently regulated. This creates frustration for all professionals involved because of the need for medical consultations in routine situations so that specific treatments can be applied (e.g. Group B Strep prophylaxis). It also creates additional costs to the system as physicians are required to provide pro forma approvals for courses of treatment that all care providers know are appropriate.” 17

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The legislative and regulatory amendments we propose in this submission will bring Ontario’s midwives in line with the current midwifery drug authority across Canada. While the framework for midwifery drug regulation varies according to province/territory (appendix K), the proposed changes can be found in several of the other jurisdiction’s legislation. Proposed Amendment to the Provinces/Territories with authority CMO’s Drug Regulation Saskatchewan BC – in current proposal Change to Categories Manitoba – (for some indications the drug is named) format Quebec – in process Northwest Territories

Saskatchewan Include Hormonal BC – in current proposal Contraception (oral, Manitoba (oral and Depo-Provera only) injection, patch) Northwest Territories

Saskatchewan – access to drug category antibiotics Alberta – for GBS & mastitis Include Antibiotics - BC - for GBS & mastitis – (UTI in current proposal) general Northwest Territories

Manitoba Quebec – in process anitoba Include Antibiotics – Saskatchewan treatment of STI’s Northwest Territories

Saskatchewan – limited to within the scope of midwifery Include authorization BC – “Make a midwifery diagnosis” – in current proposal to communicate a Alberta diagnosis Quebec

Manitoba** Include authorization Saskatchewan to administer BC suppository Quebec medications Northwest Territories

BC Include vaccinations Quebec Northwest Territories

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* Saskatchewan is the most recent province to regulate midwifery (March 2008) and as such is still in the process of developing its policies and standards. They have, in the meantime, adopted those of Manitoba while in the process of finalizing them. The information above was provided to the CMO by the Saskatchewan College of Midwives registrar. ** These competencies aren’t specified in Manitoba legislation but midwives do perform them.

Internationally, the scope of midwives’ prescribing authority varies greatly from country to country. For those industrialized countries wherein midwives practice solely in the hospital, they generally have a similar drug authority as nurses. In other jurisdictions where midwives work as autonomous maternity care providers their scope of prescribing authority depends on the local legislation. Some independent midwives are not authorized to prescribe or administer any medications (e.g. in some American states), while others have a very broad prescribing authority. For example:

Midwives in New Zealand have prescribing rights within the Midwifery Scope of Practice. There is no defined list of drugs that a midwife may prescribe. Rather, midwives are entitled to prescribe any drugs which may be necessary for a woman and/or baby for whom the midwife is providing care on her own responsibility. This means that midwives may prescribe drugs in pregnancy, labour and birth and up to six weeks after the birth where the woman is having an uneventful experience and where there is no reason for consultation or referral to a specialist. Midwives may not prescribe drugs for women or babies for complications requiring specialist referral.18

COSTS AND BENEFITS

35. What are the potential costs and benefits to the public and the profession of the proposed changes? Please consider and describe the economic impact, costs and benefits to:

a) patients

(Please refer to question 25a for more information).

b) broader health care service delivery system

The proposed changes will benefit the broader health care service delivery system in a number of ways. These include:

• Providing direct cost savings to the health care system through reduced numbers of referrals to physicians for routine prescriptions and consultations for the

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prophylactic treatment of GBS.

• Enhancing midwives’ ability to participate in interprofessional care. Collaborative practice is more successful when all practitioners are working to the fullest extent of scope and skill set. Studies of successful collaborative practice have shown increased benefits for clients, including the improvement of status, a more efficient care process, and more positive ratings of their care.19 • Relieving pressure on already stretched family physician and specialist resources. • Midwives, who are funded for an entire course of care, not for individual services, and who are dedicated maternity care providers, are a predictable and reliable resource within the provincial system. • Contributing to better access to care in underserviced areas. It has been noted that expansion of the midwifery role “may also be seen as beneficial to the health-care system in reducing costs and providing professional and technical skills where a doctor is not present. The use of midwives in an extended or expanded role responds to issues of recruitment and retention of doctors in acute care facilities. It may also provide better access to services and an improved level of care for the consumer in the geographically isolated areas.” 20

c) educational sector

Since the CMO will be working with the province’s midwifery education programs to ensure that all current members of the CMO and all future graduates of the programs have the level of skill and experience needed to practice safely within an expanded prescribing authority, there will be education requirements that will have to be met. However, we do not think that these will be significant or that they will represent a significant burden for the following reasons:

• the current MEP curriculum addresses or could readily be modified to address the additional competencies that will be required by the proposed changes

• Ryerson University, through the International Midwifery Pre-registration Program, has the capacity to develop and offer a variety of distance education programs to meet the needs of practising midwives who require additional education

• the close working relationship between CMO, the AOM and the MEP allows efficient collaboration around any new or emerging educational requirements

• the existing, well-established infrastructure for clinical placements

• the availability of other continuing education options (e.g. those offered by the Michener Institute for Applied Health Sciences)

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d) regulatory sector

There will be no economic impact on the CMO. The required regulatory mechanisms are already in place to manage the drug regulation and monitor midwives’ compliance.

e) the profession

There will be costs for the profession in terms of upgrading to meet the enhanced educational requirements. Professional development funding is available to registered midwives through their funding agreement with the Ministry of Health and Long-Term Care. Additional costs would be borne by the individual but could be used as a tax deduction.

A comprehensive plan to ensure that members receive the necessary education and support will be developed with the intent of providing flexibility and not over-burdening individuals. System issues such as compensation will need to be part of this plan and will involve input from the Ministry of Health and Long-Term Care and other stakeholders.

ADDITIONAL INFORMATION

36. Is there any other relevant information that HPRAC should consider when reviewing your submission?

The provincial health care system has a resource in midwifery that, with an adoption of a few changes, could greatly decrease costs and increase the quality of, and access to, maternity care in the province.

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1 SOGC’s Group B Streptococcus Infection in Pregnancy. Available online at http://www.sogc.org/health/pregnancy- groupb_e.asp

2 For example, see: Alexander, J., Anderson, T., Cunningham, S. An evaluation by focus group and survey of a course for Midwifery Ventouse Practitioners. Midwifery, Vol. 18 (2002), 165-172.

3 Canadian Competencies for Midwives. Available online at http://cmrc-ccosf.ca/files/pdf/National_Competencies_ENG.pdf

4 Ontario Maternity Care Expert Panel (OMCEP) report Emerging Crisis, Emerging Solutions (2006), p. 3. Available online at http://www.cmo.on.ca/communications.asp

5 OMCEP p. 25 quoting Health Canada

6 http://www.healthforceontario.ca/HealthcareInOntario/About_Ontario_Health_Care.aspx

7 http://www.healthforceontario.ca/HealthcareInOntario/About_Ontario_Health_Care.aspx

8 OMCEP p. 19

9 Nicolle LE. “Asymptomatic bacteriuria: when to screen and when to treat.” Infect Dis Clin North Am. 2003 Jun; 17(2): 367-94

10 Public Health Agency of Canada’s Guidelines on Sexually Transmitted Infections, 2006. Available online at http://www.phac-aspc.gc.ca/std-mts/sti_2006/sti_intro2006-eng.php

11 Rogers, J. Sustainability and Collaboration in Maternity Care in Canada: Dreams and Obstacles. Canadian Journal of Rural Medicine, 8(3), (2003): 193-198.

12 Where Have Our Family Doctors Gone? A Brief History of the Family Physician Shortage in Ontario. (1999). Available online at www.ocfp.on.ca/include/asp/FileDownload.asp?getFile=%7BC371D0D6-19CF-4B9E-AA4D-396B4ABCB506%7D)

13 Primary Care-Family Practice Wait Times Expert Panel report January 2007. Available online at www.health.gov.on.ca/transformation/wait_times/providers/reports/wt_primary_care_rep_02_20070110.pdf)

14 Janssen et al. Outcomes of Planned Hospital Birth Attended by Midwives Compared with Physicians in British Columbia. Birth, (2007) 34:2.

15 Rosenblatt et al. Interspecialty differences in the obstetric care of low-risk women. American Journal Public Health; (1997) 87(3): 344–351.

16 Tucker et al. Should Obstetricians see women with normal pregnancies? A multicentre, randomized, controlled trial of routine antenatal care by general practitioners and midwives compared with shared care led by obstetricians. British Medical Journal; (1996) 312: 554.

17 OMCEP p. 132

18 New Zealand Council of Midwives http://www.midwiferycouncil.org.nz/main/Registprogs/

19 Kelleher, K. Collaborative Practice - Characteristics, Barriers, Benefits, and Implications for Midwifery. Journal of Nurse-Midwifery, 43(1), (1998): 8-11.

20 Watson, J., Mills, A., Turnbull, B., Evaluation of the extended role of the midwife: the voices of midwives. International Journal of Nursing Practice, 2002; 8, 257-264.

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INDEX

Appendix A: Most recent CMO Drug Regulation amendment submission and the accompanying draft Standard for the Prescribing and Administration of Drugs

Appendix B: CMRC’s submission to the Office of Controlled Drugs and Substances regarding narcotics (to be submitted at a later date)

Appendix C: CMO’s Quality Assurance Regulation and Member’s Kit

Appendix D: Midwifery Education Program – Clinical Placement Evaluation Form

Appendix E: Canadian Competencies for Midwives

Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Appendix G: Midwifery Education Program – Pharmacotherapy sample course syllabus

Appendix H: CMO documents relevant to the prescription and administration of drugs, including: Core competencies Indications for Mandatory Discussion, Consultation and Transfer of Care Essential equipment, supplies and medications Recommendation for Midwife Certification for Care of Women Receiving Epidural Pain Relief in Labour Draft Standard for Prescribing and Administering Drugs (submitted with the most recent proposal to amend the drug regulation)

Appendix I: International Confederation of Midwives essential competencies for midwifery practice

Appendix J: CMO’s Indications for Mandatory Discussion, Consultation and Transfer of Care (IMDCTC) Guideline

Appendix K: Provincial/Territorial Midwifery Drug Regulations

College of Midwives of Ontario Page 1 of 1 Non-Physician Prescribing Applicant Questionnaire Appendix A: Most recent CMO Drug Regulation amendment submission and the accompanying draft Standard for the Prescribing and Administration of Drugs

Proposed O. Regulation 884/93 (Designated Drugs) under the Midwifery Act, 1991 07/10/08

1. (1) For the purposes of paragraph 3 of section 4 3of the Act, the following substances are designated as substances that a member may administer by injection on the member’s own responsibility:

Ampicillin - for the purpose of the prevention of neonatal group B streptococcal disease Bupivacaine – for the purpose of local anaesthesia for episiotomy and/or the repair of tears Carbetocin Carboprost tromethamine Cefazolin - for the purpose of the prevention of neonatal group B streptococcal disease Chloroprocaine – for the purpose of local anaesthesia for episiotomy and/or the repair of tears Clindamycin - for the purpose of the prevention of neonatal group B streptococcal disease hydrochloride Epinephrine hydrochloride Ergonovine maleate Erythromycin - for the purpose of the prevention of neonatal group B streptococcal disease Hepatitis B immune globulin Hepatitis B vaccine Intravenous fluids Lidocaine hydrochloride with or without epinephrine – for the purpose of local anaesthesia for episiotomy and/or the repair of tears Measles-mumps-rubella virus vaccine Oxytocin Penicillin G - for the purpose of the prevention of neonatal group B streptococcal disease Phytonadione RhD immune globulin Varicella Zoster immune globulin

(2) For the purposes of paragraph 3 of section 4 of the Act, a member may prescribe or administer by injection or any substance on the order of a member of the College of Physicians and Surgeons of Ontario

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Appendix A: Most recent CMO Drug Regulation amendment submission and the accompanying draft Standard for the Prescribing and Administration of Drugs

2. For the purposes of paragraph 3 of section 4 of the Act, the following substances are designated as substances that a member may administer by inhalation on the member’s own responsibility:

Nitrous oxide Therapeutic oxygen

3. For the purposes of paragraph 7 of section 4 of the Act, the following drugs are designated as drugs that a member may prescribe on the member’s own responsibility:

Amoxicillin-clavulanic acid – for the purpose of treating mastitis Cephalexin – for the purpose of treating mastitis Ciprofloxacin (oral) Clotrimazole Clindamycin (oral) Cloxacillin (oral) Diclofenac (oral) Domperidone – for the promotion of lactation succinate-pyridoxine hydrochloride Ergonovine maleate (oral) Erythromycin ophthalmic ointment Folic acid (oral; greater than 1mg/dose) Hepatitis B immune globulin Hepatitis B vaccine Hydrocortisone anorectal therapy compound Metronidazole (oral) Miconazole Misoprostol – for the prevention of postpartum hemorrhage Mupirocin- valerate-miconazole (topical) Naproxen (oral) Nitrofurantoin – for the treatment of urinary tract infections Nystatin Phytonadione RhD immune globulin Sulfamethoxazole-trimethoprim (oral) Trimethoprim – for the treatment of urinary tract infections

4. A member may administer, prescribe or order any drug or substance that may be lawfully purchased or acquired without a prescription.

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Appendix A: Draft Standard for Prescribing and Administering Drugs

College of Midwives of Ontario CMO Standard: Prescribing and Administering Drugs Approved at Council May 28, 2008

June 17, 2008

CMO STANDARD: Prescribing and Administering Drugs

The following standard applies to the substances that have been added to the College of Midwives drug regulation (as of amended date), which midwives are able to independently prescribe and administer for their clients in the community, hospital or other sites of midwifery practice. Midwives may not independently prescribe or administer any drugs or substances other than those specified by the Designated Drugs regulation of the Midwifery Act. Midwives are expected to ensure that they remain informed of the current clinical requirements and maintain their competencies in regard to these substances.

Antibiotics

When prescribing and administering antibiotics midwives are expected to adhere to recommendations to minimize the risk of developing antibiotic resistance. The safest effective available agent should be prescribed and administered. Antibiotics, intravenous: 1. Group B Streptococcus Ampicillin, Cefazolin, Clindamycin, Erythromycin, Penicillin G Intravenous (IV) antibiotics may only be prescribed and administered on the member’s own responsibility to the expectant mother for the prophylaxis of neonatal Group B streptococcus during the intrapartum period. When a pregnant woman tests positive for Group B streptococcus and she is allergic to penicillin G, laboratory confirmation of drug sensitivities to the culture should be obtained to ensure that the most appropriate antibiotic is selected. Ampicillin is an alternative choice to penicillin, and cefazolin is recommended in penicillin allergic patients. In patients at high risk for anaphylaxis to penicillin, intravenous clindamycin or erythromycin is recommended.1

1 Centre for Infectious Disease Preventions and Control, Canadian Task Force on Preventive Health Care’s Prevention of Early-onset Group B Streptococcal Infection in the Newborn) (updated 2002). Available online at http://www.ctfphc.org/

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Appendix A: Draft Standard for Prescribing and Administering Drugs

Intravenous antibiotics cannot be prescribed on the member’s own responsibility in any other situation. Antibiotics, oral:

Oral antibiotics may only be prescribed by the member in the course of routine provision of midwifery care. This includes treatment for:

1. Urinary tract infections (UTI)

Ciprofloxacin, Sulfamethoxazole-trimethoprim, Nitrofurantoin, Trimethoprim Oral (PO) antibiotics should be prescribed after culture and sensitivities have been identified. Sulfamethoxazole-trimethoprim and trimethoprim should be avoided in first trimester of pregnancy due to increased risk of neural tube defects (NTDs). If clinically required during first month of pregnancy, a high dose of folic acid (4mg/day) should be given to prevent NTDs.2 Sulfamethoxazole-trimethoprim should be avoided in the last 2 to 6 weeks of pregnancy since sulfonamides may displace bilirubin from albumin binding sites and cause kernicterus in infants, especially at preterm. Fluoroquinolones (e.g., ciprofloxacin) and tetracyclines should not be prescribed during pregnancy unless the benefit outweighs the risk and all other antibiotic options have been eliminated.

If symptoms persist after the prescribed course of treatment referral to a physician for

consultation is required.

2. Mastitis Amoxicillin-clavulanic acid, Cephalexin, Ciprofloxacin, Clindamycin, Cloxacillin Antibiotics are prescribed only for fever and signs and symptoms of blocked duct that do not resolve within 24 hours or are worsening quickly after non-pharmacological treatment.

SOGC clinical practice guidelines no. 149, September 2004. “The prevention of early-onset neonatal group B streptococcal disease.” JOGC, Sept 2004: 826-32

2 Medication Safety in Pregnancy and Breastfeeding, by Gideon Koren MD, Motherisk

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Appendix A: Draft Standard for Prescribing and Administering Drugs

If symptoms persist after the prescribed course of treatment referral to a physician for consultation is required.

3. Bacterial Vaginosis Clindamycin, Metronidazole Women with a past history of premature labour and who have Bacterial Vaginosis (BV), whether or not it is symptomatic, may benefit from treatment with antibiotics. Bacterial vaginosis during pregnancy is associated with premature rupture of the membranes, chorioamnionitis, preterm labour, preterm birth and post-cesarean delivery endometritis. During pregnancy, treatment is recommended for symptomatic patients and asymptomatic women with BV who have had a previous preterm birth. The goal is to reduce the risk of preterm prelabour rupture of the membranes and low birth weight.

If symptoms persist after the prescribed course of treatment referral to a physician for consultation is required.

Antibiotics, topical:

1. Breast and Nipple Pain

Mupirocin-betamethasone valerate-miconazole

Topical antibiotics may be used as part of a therapeutic regime for breast and nipple pain. All Purpose Nipple Ointment is a combination antibiotic, antifungal and low dose steroid cream that may be used to treat persistent nipple pain. It is used as a topical treatment for candidiasis of the nipple in the breastfeeding woman, with or without secondary bacterial infection. The cream should be applied sparingly to the nipples after each feeding and not washed or wiped off, even prior to the next feed. All Purpose Nipple Ointment is not recommended for use in pregnancy. While generally well tolerated, All Purpose Nipple Ointment should not be used over large areas of the skin, and is not intended for prolonged use.

If the condition has not improved within a week referral to a physician for consultation is required.

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Appendix A: Draft Standard for Prescribing and Administering Drugs

Non-steroidal anti-inflammatory drugs (oral) 1. Postpartum Pain Diclofenac, Naproxen Oral non-steroidal anti-inflammatory drugs (NSAIDS) may be used to treat postpartum pain. The general approach to the use of NSAIDs in any population is to use the lowest dose for the shortest period of time to reduce the risk of any adverse events including GI bleeding. NSAIDs should not be given to clients who are asthmatic or allergic to ASA. Ibuprofen is the least potent of the NSAID group and at formulations up to 400 mg is available as an OTC. Naproxen and acetaminophen have been proven to have the same effect on postpartum pain.3 Anti-hemorrhagics and oxytocics

1. Management of postpartum bleeding Carbetocin, Misoprostol Oxytocics and anti-hemorrhagics are to be used for the management of postpartum bleeding on the member’s own responsibility. The choice of agent and method of administration will be dependant upon the clinical scenario and the local community standard and availability of these medications. Carbetocin - off label

Carbetocin (e.g., Duratocin®) is approved for use in Canada for the prevention of uterine atony and postpartum hemorrhage following elective cesarean section under epidural or spinal anesthesia. It was shown to be effective for the off-label treatment of postpartum hemorrhage following vaginal birth, and is used as a second-or-third line agent in Ontario hospitals, used only after oxytocin and ergonovine maleate, where available, have been attempted.

Carbetocin is not approved by the College of Midwives of Ontario to treat anything other than postpartum hemorrhage.

Misoprostol – off label

3 Skovlund et al, European Journal of Clinical Pharmacology, 1991, Volume 40, Number 6, pg. 539-542.

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Appendix A: Draft Standard for Prescribing and Administering Drugs

Misoprostol is a synthetic prostaglandin E1 analog that is approved for use as an antisecretory agent with protective effects on the GI mucosa. It was shown to be effective for the off-label treatment of postpartum uterine atony or postpartum hemorrhage uncontrolled by the use of oxytocin. Misoprostol is a second-or-third line agent, used only after oxytocin and ergonovine maleate, where available, have been attempted. Misoprostol should not be taken by anyone with a history of allergy to prostaglandins. If misoprostol is administered as a third line agent in response to a postpartum hemorrhage occurring out-of-hospital, transport to hospital and consultation with a physician is indicated. The use of misoprostol for prevention of PPH or for the induction of labour is currently under evaluation. Its use for induction of labour in the presence of a living fetus is restricted to clinical trials. Midwives CANNOT prescribe or order misoprostol for this application. However, where a physician has ordered misoprostol for induction of labour in a non-viable pregnancy, the midwife may continue to be involved in the woman’s care.

Misoprostol is not approved by the College of Midwives of Ontario to treat anything other than postpartum hemorrhage.

Other Drugs

1. Domperidone - off label Domperidone is an antidopaminergic drug approved for the treatment of nausea and vomiting. It has been used off-label to enhance breastmilk production in women where non-pharmacologic methods have proven ineffective and/or in women with a previous history of inadequate milk supply. Domperidone must not be given intravenously. Caution should be used in patients with hepatic disease and with those taking , since they may antagonize the effect of the domperidone in the GI tract. It should not be co-administered with ketoconazole due to the increased risk of QTc prolongation and associated heart .

Domperidone is not approved by the College of Midwives of Ontario to treat anything other than inadequate milk supply. As noted in the CMO’s Mandatory Indications for Discussion, Consultation and Transfer of Care, if the newborn has not regained birth weight by three weeks

postpartum, consultation with a physician is required.

2. Measles / Mumps / Rubella (MMR) Vaccine

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Appendix A: Draft Standard for Prescribing and Administering Drugs

(e.g., M-M-R® II, Priorix®) Women found to be rubella-susceptible during the antenatal period should be offered MMR vaccine in the immediate postpartum period. Women without detectable antibodies or no prior vaccination for rubella should be immunized only if they are not pregnant at vaccination time and if pregnancy is avoided for 1 month following vaccination. MMR vaccine should not be administered to individuals who are pregnant (the possible effect on the fetus is not known), have acute febrile respiratory or other infections, or any acute illness, have a history of sensitivity to neomycin or gelatin; have blood dyscrasias, lymphomas or other generalized malignancies; have untreated active tuberculosis; or are undergoing treatment with immunosuppressive agents of any kind. Breastfeeding is not a contraindication to receiving this vaccination. Whenever vaccines are administered the midwife must send a record of immunization to the physician to whom care is transferred at 6 weeks postpartum. A record of immunization should also be sent to the local public health unit in communities where this is required. 3. Varicella Zoster immune globulin

(e.g., VariZIG™) Varicella zoster immune globulin is recommended for susceptible people, including pregnant women, provided that significant exposure has occurred. Administration of varicella zoster immune globulin is recommended for prevention or reduction of severity of maternal infections within 4 days of exposure to the varicella zoster virus. Greatest effectiveness of treatment is expected when it is begun within 4 days of exposure; treatment after 4 days is of uncertain value. Pregnant women may be at a higher risk of complications from chickenpox than healthy adults. The decision to administer varicella zoster immune globulin to a pregnant woman should be evaluated on an individual basis. The clinician should consider the patient's health status, type of exposure, and likelihood of previous unrecognized varicella infections before deciding whether to administer varicella zoster immune globulin. If after careful evaluation of all available information, which may include the use of reliable and sensitivity tests for varicella antibody, a normal pregnant woman with significant exposure to varicella is believed susceptible, varicella zoster immune globulin may be administered. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when varicella zoster immune globulin is administered to a nursing mother.

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Appendix B – to be submitted at a later date Appendix C: CMO’s Quality Assurance Program

College of Midwives of Ontario Quality Assurance Regulation (Final Approval – March 1999)

March 1999

Regulation Made under the Midwifery Act, 1991 GENERAL PART III QUALITY ASSURANCE

DEFINITIONS AND COMPONENTS OF PROGRAM

6. In this Part,

“assessor” means an assessor appointed under section 81 of the Health Professions Procedural Code;

“Chair” means the Chair of the Quality Assurance Committee;

“Committee” means the Quality Assurance Committee;

“member” means a member who holds a general certificate of registration or a certificate of registration requiring supervision;

“practice group” means, in relation to a member, a group of one or more other members with whom the member is associated and, if the member is not associated with other members, means the member.

7. (1) The quality assurance program of the College shall include the following components:

1. Provision of clinical information. 2. Continuing education and professional development. 3. Peer case review. 4. Quality of care evaluation. 5. Self-assessment. 6. Practice audits.

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7. Remediation of behaviour and remarks of a sexual nature.

(2) The quality assurance program shall be administered by the Committee.

(3) The Chair may appoint a panel to carry out any of the powers or functions of the Committee under the Act.

(4) A panel shall consist of at least three people, at least one of whom shall be a person who is not a member and who is appointed to the Committee by the Lieutenant-Governor in Council.

8. (1) Sections 9 to 19 do not apply to a member who has ceased to practise midwifery for at least one year.

(2) The Committee may, upon application, grant an exemption from any of the requirements of sections 9 to 19 to a member by reason of illness or maternity leave or in any other extenuating circumstances.

PROVISION OF CLINICAL INFORMATION

9. (1) Upon request by the Committee, a member shall provide the Committee with information relating to the care given by the member to clients. The information shall be in the form specified by the Committee.

(2) If the Committee so requests, the information provided under subsection (1) shall relate to care given to clients during a specified period of time.

(3) A member shall ensure that clients are not identified in the information provided under subsection (1).

CONTINUING EDUCATION AND PROFESSIONAL DEVELOPMENT

10. (1) A member shall participate in continuing education and other professional development activities for the purpose of maintaining and enhancing the member’s knowledge, skill and judgment.

(2) A member shall maintain an annual record of his or her participation in continuing education and professional development activities and shall submit the record to the Committee on request.

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(3) The record shall include,

(a) particulars of his or her learning needs as identified by the member; and

(b) the content, date, duration, location and, if applicable, the name of the sponsor of each continuing education and professional development activity engaged in by the member.

(4) The Committee may require the record to be maintained in a form provided by the Committee.

(5) The member shall retain records of continuing education and professional development activities for at least 10 years from the date the member participated in the activities.

PEER CASE REVIEW

11. (1) A member shall participate in at least six peer case reviews in every 12- month period commencing January 1 of each year.

(2) In a peer case review, a group of at least four members belonging to at least two different practice groups meet to discuss clinical care of clients.

(3) A peer case review shall be conducted in accordance with College guidelines published by the College and distributed to members and shall include the following elements:

1. A presentation of a case history and of how the case was managed by one of the members participating in the review.

2. A discussion of the application of College regulations, standards, guidelines and policies to the case.

3. The observations and feedback of the participants.

(4) A member shall maintain an annual peer case review record in which the member records the names of the members who carried out each peer case review and the date and duration of each review. The record shall be submitted to the Committee on request.

(5) A member shall keep the peer case review record for at least 10 years from the date the review was held.

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QUALITY OF CARE EVALUATION

12. (1) A member shall provide every client with a quality of care evaluation form within six months of being discharged from care and request that the client complete the form and return it to the member’s practice group.

(2) The evaluation form shall not identify the client.

(3) A member shall make a record of any action taken in response to a client‘s evaluation and shall submit the record to the College on request.

(4) The Committee may require that the quality of care evaluation form and the form of the record of action taken be in a form provided by the Committee.

(5) A member shall retain a completed evaluation form for at least 10 years from the date the evaluation form is returned to the member’s practice group.

(6) A member shall retain the record of action taken in response to a client’s evaluation for at least 10 years from the date the action was taken.

SELF-ASSESSMENT

13. (1) At the request of the Registrar, a member shall complete a self-assessment questionnaire provided by the Committee and return it to the College.

(2) A member who fails to return a completed self-assessment questionnaire to the College when requested to do so by the Registrar shall, if so required by the Committee, participate in a practice audit.

PRACTICE AUDIT

14. (1) Each year, the College shall select at random the names of members required to undergo a practice audit.

(2) A member shall undergo a practice audit by an assessor if his or her name is selected at random and the College may require a member to undergo a

College of Midwives of Ontario Page 4 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix C: CMO’s Quality Assurance Program practice audit if the member has failed to return a completed self-assessment questionnaire under subsection 13 (2).

15. A practice audit shall be conducted by an assessor and may include,

(a) requiring a member to provide the assessor with such forms and other documents used in the member’s practice;

(b) an examination of the member’s client records; and

(c) an interview with the member.

16. (1) An assessor shall, within a period of time specified by the Committee, provide a written report of a practice audit to the Committee and to the member whose practice was the subject of the audit.

(2) The member whose practice was the subject of a practice audit may make written representations to the Committee within 14 days of receiving the written report of the practice audit.

17. (1) After considering the report and any representations made by the member, the Committee may decide,

(a) that no action is required;

(b) subject to section 19, to require the member to undertake the remediation or other action specified by the Committee to correct any deficiency disclosed by the practice audit; or

(c) to refer the member to the Executive Committee.

(2) After the member has had an opportunity to undertake the remediation or other action specified, the Committee may require the member to undergo a follow-up practice audit.

(3) The Committee shall not require that a member undergo more than one follow- up practice audit.

18. (1) Subject to section 19, the Committee may direct the Registrar to impose terms, conditions or limitations on a member’s certificate of registration for a specified period not exceeding six months if the member’s knowledge, skills and judgment are found to be unsatisfactory and,

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(a) the member fails to undertake the remediation or other action specified by the Committee; or

(b) the member fails to successfully complete the remediation or other action specified by the Committee.

(2) If the Registrar imposes terms, conditions or limitations on a member’s certificate of registration for a specified period pursuant to a direction given by the Committee under subsection (1), the Committee may direct the Registrar to remove the terms, conditions or limitations before the end of the specified period if the Committee is satisfied that the deficiency has been remedied.

19. If the Committee proposes to require a member to undertake remediation under section 17 or to direct the Registrar to impose terms, conditions or limitations on the member’s certificate of registration under section 18, the Committee shall give the member written notice of the proposal and at least 14 days from the receipt of the notice to make written representations to the Committee. The Committee shall consider any representations made by the member before making a final decision under section 17 or 18.

REMEDIATION OF BEHAVIOUR AND REMARKS OF A SEXUAL NATURE

20. Sections 21 to 24 apply to matters relating to sexual abuse as defined in clause 1 (3) (c) of the Health Professions Procedural Code that are referred to the Committee by,

(a) the Complaints Committee, pursuant to paragraph 4 of subsection 26 (2) of the Health Professions Procedural Code; and

(b) the Executive Committee, pursuant to section 79.1 of the Health Professions Procedural Code.

21. (1) If a matter referred to in section 20 in respect of a member is referred to the Committee, the Committee shall require the member to undergo a psychological or other assessment to determine whether the member should undergo therapy, counseling, education or other specified measures.

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(2) The person conducting the assessment shall provide a written report of the results of the assessment to the Committee and shall make such recommendations as he or she considers appropriate.

(3) The Committee shall give the member a copy of the report and recommendations together with a notice informing the member of the right to make a written submission respecting the recommendations in accordance with subsection 22 (2).

(4) After considering the report and recommendations and a submission made by the member, if any, the Committee may require the member to attend or participate in an education, counseling or therapy program or to take such other measures as may be specified by the Committee.

(5) If the member refuses to undergo an assessment as required under this section, to attend or participate in a program or to take any other measure specified by the Committee, the Committee may, subject to subsection 22 (3), direct the Registrar to impose specified terms, conditions or limitations on the member’s certificate of registration for a specified period of up to six months.

22. (1) A member has the right to make a written submission to the Committee,

(a) before the Committee requires the member to attend or participate in a program or to take any other measure specified by the Committee under subsection 21 (4); and

(b) before the Committee makes a direction under subsection 21 (5).

(2) The member shall be given at least 14 days from the day the member receives the report and recommendations under subsection 21 (3) to make written submissions to the Committee.

(3) The Committee shall give the member notice of its intention to make a direction under subsection 21 (5) and at least 14 days from the date the member receives the notice to make written submissions to the Committee.

23. The Committee shall direct the Registrar to remove the terms, conditions or limitations imposed on the member’s certificate of registration under subsection 21 (5) before the end of the specified period if the Committee is satisfied that the terms, conditions or limitations are no longer needed.

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24. If a term, condition or limitation has been imposed on a member’s certificate of registration for a specified period under subsection 21 (5) and, at the end of the period, the member continues to refuse to undergo an assessment, to attend or participate in a program or to take any other measure specified by the Committee, the Committee shall refer the matter to the Executive Committee.

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MIDWIFERY EDUCATION PROGRAM Clinical placement evaluation form

V Pharmacology:

A. Pharmacologic Agents

1. Describes common pharmacologic agents used in providing midwifery care and their appropriate use, precautions, side effects, etc.

2. Demonstrates thorough knowledge of pharmacologic agents used in the care of woman in situations frequently encountered by midwives, e.g., antibiotics for maternal and newborn conditions, antifungals.

3. Demonstrates knowledge of pharmacologic agents used in emergency situations; e.g., antihemorrhagics, anticonvulsants, drugs used in newborn resuscitation.

B. Demonstrates competence in the administration of various medications.

C. Shows increasing knowledge of alternative remedies and the status of information to support their use.

D. Keeps a written file (no particular format) of pharmacologic substances and alternative remedies encountered in client contacts and is knowledgeable about the substance.

E. Documents administration of pharmacological substances appropriately.

F. Demonstrates the ability to write a prescription.

Satisfactory Student consistently performs at the appropriate level.

Unsatisfactory Student varies from adequate to inadequate in performance and/or demonstrates areas where competence is deficient or does not meet basic clinical expectations.

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Canadian Midwifery Regulators Consortium

CANADIAN COMPETENCIES FOR MIDWIVES

Please note that while in this document we have used the generic feminine pronouns, the terms “midwife” and “midwives” are meant to include both male and female midwives.

PREAMBLE:

This document, Canadian Competencies for Midwives has been developed for two reasons: to provide a base for the development of national assessment processes and to provide information to internationally-educated midwives about what Canadian midwives are expected to know and do. This document outlines the knowledge and skills expected of an entry-level midwife in Canada. Entry level midwives are defined as those who have been assessed as eligible to start practising in Canada, after they meet provincial/territorial requirements, in the full scope of practice and without supervision requirements on their registration.

The Canadian Competencies for Midwives is compatible with provincial/territorial competency statements but it does not replace them. Since midwifery in Canada is regulated by province or territory, provincial/territorial competency documents take precedence over this national document and are the ultimate source of information about what a midwife is expected to know and do in any specific province or territory. There is a high degree of similarity in the entry-level competencies required by the various Canadian jurisdictions regulating midwifery. However, some additional competency requirements can be found in provincial and territorial documents.

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CANADIAN MODEL OF MIDWIFERY PRACTICE:

While there are provincial/territorial differences in how midwifery is legislated, organized, and practised, the basic model of midwifery practice is the same across all regulated jurisdictions in Canada. Midwives provide care from early pregnancy through to at least six-weeks postpartum to women and their infants. The description below provides context for the competencies outlined in this document.

Health and Well-being Midwifery care in Canada is based on a respect for pregnancy and childbirth as normal physiological processes. Midwives promote wellness in women, babies, and families, taking the social, emotional, cultural and physical aspects of a woman’s reproductive experience into consideration.

Informed Choice Canadian midwives respect the right of women to make informed choices about all aspects of their care. Midwives actively encourage informed decision-making by providing women with complete, relevant, and objective information in a non- authoritarian manner.

Autonomous Care Providers Canadian midwives are fully responsible for the provision of primary health services within their scope of practice, making autonomous decisions in collaboration with their clients1. When midwives identify conditions requiring care that is outside of their scope of practice, they make referrals to other care providers and continue to provide supportive care. Midwives collaborate with other health professionals in order to ensure that their clients receive the best possible care.

Continuity of Care Canadian midwives are committed to working in partnership with the women in their care. Midwives spend time with their clients in order to build trusting relationships and provide individualized care. Individual or small groups of midwives provide continuity of care to women throughout pregnancy, labour, birth, and up to at least six weeks postpartum. A midwife known to the woman is available on-call throughout her care.

Choice of Birth Setting Canadian midwives respect the right of each woman to make an informed choice about the setting for her birth. Midwives must be competent and willing to provide care in a variety of settings, including home, birth centres, and hospitals.

Evidence-based Practice Canadian midwives are expected to stay up-to-date with regard to research on maternity care issues, to critically appraise research, and to incorporate relevant findings into their care.

1 Clients are women who have contracted to work with and receive care from a specific midwife or midwives.

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I. GENERAL COMPETENCIES

A. The entry level midwife should have the knowledge and skills to: 1. provide care and advice to the woman and her family during pregnancy, labour, birth and the postpartum period; 2. exercise appropriate clinical judgment as an autonomous primary-care provider; 3. provide culturally appropriate and sensitive care; 4. provide education, health promotion and counseling related to childbearing, parenthood, and family planning for the woman, her family and the community; 5. facilitate informed decision making by providing the woman with both time and the necessary information to make choices during pregnancy, labour, birth and the postpartum period; 6. communicate effectively with the woman, her family and her support people; 7. develop, implement and evaluate, with the woman, an individualized plan for midwifery care; 8. provide continuity of care throughout the childbearing cycle; 9. assist the woman and her family in planning for an appropriate place of birth 10. provide care in a variety of out-of-hospital and in-hospital settings; 11. promote normal birth; 12. conduct births and care for the woman and the newborn on her own responsibility; 13. identify risk factors before and during pregnancy, labour, birth and the postpartum period; take appropriate action; and/or consult or refer as appropriate; 14. order, perform and interpret results of screening and diagnostic tests in accordance with provincial/territorial regulations and standards; 15. prescribe, order and administer pharmacologic agents in accordance with provincial/territorial regulations and standards; 16. recognize abnormal conditions, recommend and initiate treatment and/or consult or refer as appropriate; 17. critically review, appraise and apply new information, including research findings, relevant to midwifery practice; 18. provide information about care alternatives including options, risks and benefits, and assist client decision-making; 19. use technology appropriately; 20. use emergency measures when necessary; 21. limit the spread of disease by using appropriate infection control measures; 22. establish and maintain comprehensive, relevant and confidential records; 23. provide care consistent with the philosophy and ethics of midwifery care in Canadian jurisdictions; 24. assist the woman and her family to access appropriate community resources; 25. act as an advocate for the client in all aspects of her care. 26. communicate the scope of practice of a registered midwife, including limitations of practice.

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SPECIFIC COMPETENCIES

II. EDUCATION AND COUNSELLING

A. The entry level midwife should have the knowledge of: 1. the principles and processes of informed decision-making; 2. the principles of adult education, communication and counseling; 3. theoretical approaches to prenatal and early parenting education; 4. the impact of life experiences on childbearing and early parenting; 5. historical, social and cultural influences on childbearing and early parenting; 6. issues related to abuse and discrimination; 7. issues related to grief and loss.

B. The entry level midwife should have the ability to: 1. be present with and attentive to the woman throughout her childbearing experience; 2. assess the well-being of the woman in the context of her family and community and provide her with information, education and support according to her needs; 3. facilitate the process of informed decision-making, 4. utilize a broad range of communication skills including reflective listening; 5. provide prenatal and early parenting education to enhance the woman’s confidence and competence in childbearing and parenting; 6. assist the woman and her family in planning and preparing for the birth experience and early parenting; 7. facilitate integration of the birth experience(s) for the woman and her family; 8. provide information and resources to the woman and her family regarding self- care, normal postpartum progress, including its emotional and psychological aspects, and signs and symptoms of common postpartum complications; 9. provide information and resources to the woman and her family regarding infant growth, development, behaviour, nutrition, feeding and care, including the benefits and practice of breastfeeding. 10. counsel and support the woman and her family in responding to grief and loss during childbearing.

III. ANTEPARTUM CARE

A. The entry level midwife should have the knowledge of: 1. general anatomy and physiology including detailed knowledge of the reproductive systems; 2. physical, emotional, sexual and social factors and changes associated with pregnancy, including those likely to influence its outcome; 3. genetics, embryology and fetal development and their implications; 4. nutritional requirements during pre-conception and pregnancy; 5. the management of common discomforts of pregnancy;

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6. methods for diagnosing pregnancy, establishing due date, and assessing gestational age and the progress of pregnancy; 7. screening and diagnostic tests available during pregnancy; 8. common substances and therapies used during pregnancy and their effects, side-effects and interactions; 9. environmental, occupational, biologic and pharmacologic hazards to the woman and the fetus; 10. variations of normal and abnormalities which may occur during pregnancy; 11. infections prior to and during pregnancy and their implications; 12. principles and procedures for responding to fetal malpresentation, such as external cephalic version.

B. The entry level midwife should have the ability to: 1. obtain a comprehensive health history, including both medical and psychosocial information; 2. assess nutritional intake and provide or recommend counselling as appropriate; 3. address common discomforts associated with pregnancy; 4. recommend appropriate therapies which may be used during pregnancy; 5. perform a complete physical examination of the woman; 6. perform ongoing physical assessments of the woman during pregnancy to detect abnormalities, and initiate treatment and/or consult or refer as appropriate; 7. perform a vaginal exam and assess the soft and bony structures of the pelvis, uterine size, shape, consistency and mobility, and cervical and vaginal health; 8. perform a speculum exam to assess cervical and vaginal health and obtain the necessary specimens to determine the presence of sexually transmitted infections, vaginal infections and cytological changes; 9. perform venipuncture and capillary puncture; 10. confirm pregnancy; 11. perform abdominal palpation and fundal height measurement to assess uterine size, fetal position and presentation, and to estimate fetal size, number, and gestational age; 12. assess fetal well being through such methods as fetal heart auscultation and evaluation of fetal movement.

CARE DURING LABOUR, BIRTH AND THE IMMEDIATE2 POSTPARTUM PERIOD

IV. Intrapartum Care –

A. The entry level midwife should have the knowledge of: 1. the normal process of labour including the mechanisms of labour and birth;

2 In this document the CMRC uses the word “immediate” to refer to the hours immediately after the birth when the midwife is providing care until mother and newborn are stable. In some Canadian jurisdictions the word “immediate” is also used in legislation to refer to the complete six-week postpartum period. Use of this definition of the word “immediate” here is not intended to contradict that broader definition.

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2. maternal pelvic anatomy and anatomy of the fetal skull and its landmarks as relevant to assessing fetal position and the progress of labour; 3. physiologic changes associated with the transition from fetus to newborn; 4. indicators of maternal and fetal well-being; 5. requirements for a safe birthing environment; 6. comfort and support measures for labour and birth; 7. physiologic methods to facilitate labour; 8. normal variations and abnormalities of the fetal heart rate and methods of assessing the fetal heart in labour; 9. the principles of clean and aseptic technique and universal precautions; 10. the significance of ruptured membranes and methods for reducing risks of infection; 11. abnormalities of labour, birth and the immediate postpartum period; 12. prevention, assessment and management of exhaustion, dehydration and ketonuria during labour; 13. techniques to prevent and reduce perineal trauma; 14. indications and procedure for episiotomy; 15. indications and procedure for repair of lacerations and episiotomy; 16. prevention, recognition and management of postpartum hemorrhage; 17. pharmacological agents and other substances and therapies used during the intrapartum period; 18. emergency measures, obstetrical procedures and interventions; 19. neonatal resuscitation and stabilization.

B. The entry level midwife should have the ability to: 1. provide emotional and physical support to the labouring woman and her support people; 2. assess the onset and progress of labour and take appropriate actions; 3. recognize variations of normal and abnormal labour patterns and identify probable causes and potential interventions when indicated; 4. assess the fetal heart with a fetoscope, doppler and electronic fetal monitor, interpret findings and take action when appropriate; 5. determine status of the membranes and perform amniotomy when indicated; 6. assess amniotic fluid; 7. assess the bladder and perform urinary catheterization as necessary; 8. assess the need for pharmacologic and non-pharmacologic measures during labour, birth and the immediate postpartum period; 9. prescribe, order and administer pharmacologic agents as necessary in the intrapartum in accordance with provincial/territorial regulations and standards; 10. administer injections and , insert intravenous catheters and administer intravenous fluids and medications in accordance with the provincial/territorial regulations and standards; 11. protect the perineum, avoid unnecessary episiotomy and minimize lacerations; 12. perform an episiotomy when indicated; 13. assist and support the spontaneous vaginal birth of the baby;

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14. recognize signs of separation of the placenta; assist in the delivery of, and inspect the placenta; 15. collect cord blood samples; 16. examine the perineal and vulval areas for lacerations, hematomas and abrasions and repair lacerations and episiotomies in accordance with provincial/territorial regulations and standards; 17. prevent, recognize and manage postpartum hemorrhage and maternal shock; 18. recognize maternal and newborn complications and initiate emergency measures as required; 19. provide immediate assessment and care of the newborn, including assessment of respiratory and cardiac status and temperature maintenance; 20. support the newborn’s transition immediately following the birth; 21. perform neonatal resuscitation according to provincial/territorial regulations and standards; 22. assist and support the early initiation of breastfeeding.

V. CARE OF THE WOMAN DURING THE POSTPARTUM PERIOD, INCLUDING BREASTFEEDING

A. The entry level midwife should have the knowledge of: 1. maternal anatomy and physiology in the postpartum period, and the normal progress of the postpartum period; 2. anatomy of the breast, physiology of lactation and principles of effective breastfeeding, including the normal process and necessary conditions and factors for its success; 3. management of common discomforts of the postpartum period; 4. postpartum complications, including complications of breastfeeding, and their management; 5. emotional, psychological, social, cultural and sexual aspects of the postpartum period, breastfeeding and early parenting; 6. nutritional requirements of women during the postpartum period, including for lactation; 7. the health benefits of breastfeeding for mother and infant; 8. the influence of environmental, occupational, and biological factors on breastfeeding; 9. pharmacological agents and other substances and therapies used during the postpartum period and their effect on breastfeeding; 10. stimulation and suppression of lactation; 11. family planning, methods of contraception and their risks and benefits.

B. The entry level midwife should have the ability to: 1. assess the health and monitor the progress of the woman in the postpartum period; 2. assist the mother to establish and maintain breastfeeding, or her alternate chosen method of infant feeding;

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3. identify special or abnormal maternal or infant situations that may influence breastfeeding, and develop an appropriate plan; 4. use appropriate therapies to support effective breastfeeding; 5. facilitate the introduction of the new family member; 6. recognize postpartum complications, including postpartum depression, and take appropriate action, including consulting or referring when indicated; 7. prescribe, order and administer appropriate pharmacologic agents as necessary in the postpartum period in accordance with provincial/territorial regulations and standards; 8. conduct a six week postpartum assessment of the woman, including vaginal and speculum examination where appropriate; 9. counsel clients in decision-making and use of contraceptive methods; 10. provide appropriate referrals for ongoing care; 11. facilitate the closure of the midwife-woman relationship.

VI. CARE OF THE NEWBORN AND THE YOUNG INFANT

A. The entry level midwife should have the knowledge of: 1. anatomy and physiology of the newborn; 2. newborn assessment, including gestational age assessment; 3. growth and development of the healthy newborn; 4. the nutritional needs of the newborn including properties of breast milk and infant formula, and methods of infant feeding; 5. newborn screening and diagnostic testing; 6. abnormal conditions in the newborn; 7. prophylactic medications commonly administered to the newborn; 8. effects of prescriptive and non-prescriptive substances on the newborn, including those excreted through the breast milk; 9. environmental, biological and pharmacologic hazards to the newborn; 10. the physical and emotional needs of the newborn including appropriate safety considerations; 11. issues related to circumcision.

B. The entry level midwife should have the ability to: 1. perform a complete physical examination of the newborn; 2. provide ongoing newborn care and assessment of well-being and development; 3. recognize complications in the newborn and make appropriate referrals as necessary; 4. administer medications and immunizations to the newborn according to provincial/territorial regulations and standards; 5. perform a heel puncture to obtain blood samples; 6. provide information to parents regarding available public health and community resources, and make appropriate referrals for ongoing care.

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VII. WELL WOMAN CARE, SEXUALITY AND GYNECOLOGY

A. The entry level midwife should have the knowledge of: 1. physiological and psychosocial components of human sexuality in general and during the childbearing cycle; 2. physiological and psychosocial aspects of human fertility; 3. normal reproductive health and signs and symptoms of pathology; 4. factors involved in women’s responses to pregnancy, and resources for counseling and referral, including for women seeking termination.

B. The entry level midwife should have the ability to: 1. assess the woman’s reproductive and sexual health; 2. provide well-woman care according to provincial/territorial regulations and standards; 3. inform and advise clients on issues of human sexuality, fertility and unplanned pregnancies, and make referral where appropriate; 4. support a woman seeking termination of pregnancy and make referrals when requested; 5. provide information on various methods of contraception.

VIII. PROFESSIONAL, INTER-PROFESSIONAL, LEGAL AND OTHER ASPECTS OF THE PROFESSION

A. The entry level midwife should have the knowledge of: 1. current issues in midwifery at local, provincial, national and international levels; 2. the general structures and principles of the Canadian health care system; 3. legislation and public health policies and procedures relevant to midwifery nationally and in the province/territory in which she practises; 4. the history and philosophy of the midwifery profession in Canada; 5. the structure and function of professional and regulatory midwifery organizations in Canada; 6. community standards of care and the roles and responsibilities of other health care providers and their scopes of practice in the province/territory in which she practises; 7. the process of teambuilding and engaging in professional and inter-professional partnerships; 8. legal requirements of midwifery practice, including those respecting privacy and freedom of information, informed consent and informed choice, recording and reporting, and provincial/territorial data collection requirements; 9. the code of ethic, regulations and standards for midwifery in the province/territory in which she practises.

B. The entry level midwife should have the ability to: 1. work in a collegial manner with other caregivers in a variety of settings;

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2. communicate and collaborate effectively and professionally with midwifery colleagues, students and other caregivers; 3. practise in accordance with provincial/territorial codes of ethics and other ethical frameworks and standards guiding midwifery practice.

IX. PROFESSIONAL DEVELOPMENT

A. The entry level midwife should have knowledge of: 1. methods for assessing statistical evidence and critically appraising the research literature; 2. continuing education and quality assurance programs and requirements for the ongoing evaluation of midwifery practice; 3. midwifery practice management.

B. The entry level midwife should have the ability to: 1. engage in reflective practice; 2. share midwifery knowledge and participate in midwifery-related research; 3. recognize her personal and professional boundaries and limitations, practise appropriate self-care, and seek support when needed.

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ADVANCED COMPETENCIES:

There are a number of advanced competencies that midwives in Canada may perform in certain jurisdictions and/or in certain circumstances, when provincial/territorial regulations and standards allow it. A few of the competencies that are considered “advanced” in one jurisdiction are considered “entry-level” in another. Currently there is no agreement on advanced competencies and this remains an area of difference between Canadian provinces and territories. There is, however, some initial discussion at a national level with regards to how advanced competencies may be recognized. It is expected that this discussion will continue and may result in a national statement regarding advanced competencies.

These advanced competencies include but are not limited to:

1. epidural monitoring; 2. application of scalp electrodes; 3. pharmacologic augmentation of labour; 4. induction of labour for post-dates pregnancy; 5. performing vacuum extraction; 6. first surgical assist at cesarean sections; 7. suturing of 3rd degree tears; 8. evacuation of the uterus; 9. fitting barrier methods of contraception; 10. prescribing contraceptives; 11. inserting umbilical vein catheters in the newborn; 12. providing well-baby care after six weeks postpartum and to healthy newborns in general; 13. providing well-woman care after six weeks postpartum and to healthy women in general.

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

APPLIED PHARMACOLOGY FOR MIDWIVES

Independent Study Module

International Midwifery Pre-registration Program G. Raymond Chang School of Continuing Education Ryerson University

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TYSON LUONG WILSON Welcome to Applied Pharmacology for Midwives

Table of Contents

Section 1: Concepts in Pharmacology...... 6 Objectives ...... 6 Concepts in Pharmacology ...... 7 Three Phases of Drug Delivery...... 11 Key Terms – Basic Concepts in Pharmacology ...... 13 Key Terms – Drug Classes, Schedules and Categories ...... 13 Key Terms – Methods of Drug Delivery...... 14 Key Terms – What Happens After a Drug Has Been Administered ...... 16 Key Terms – ...... 18 Key Terms – Drugs for Autonomic Disorders ...... 18 Key Terms – Drugs for , Daytime Sedation and Insomnia...... 21 Key Terms – Drugs for Seizures...... 22 Key Terms – Drugs for Behavioural, Emotional, and Mood Disorders, and Psychoses ...... 23 Key Terms – Drugs for Fever and Pain ...... 24 Key Terms – Drugs for Local and General Anesthesia...... 26 Key Terms – Drugs for Coagulation Disorders...... 26 Key Terms – Drugs for Hypertension...... 28 Key Terms – Drugs for Shock and Anaphylaxis...... 30 Key Terms – Drugs for Inflammation, Allergies, and Immune Disorders...... 31 Key Terms – Drugs for Bacterial Infections...... 33 Key Terms – Drugs for Fungal, Viral, and Parasitic Diseases ...... 36 Key Terms – Drugs for Pulmonary Disorders...... 37 Key Terms – , Minerals, and Herbs ...... 38 Section 1: Concepts in Pharmacology Self-Testing Multiple Choice Questions ...... 40 Section 1: Concepts in Pharmacology Answer Key to Multiple Choice Questions...... 54 Section 2: Designated Drugs for Administration by Midwives ...... 64 Objectives ...... 64 Pregnancy Drug Risk Categories: A, B, C, D and X...... 65 Professional Responsibilities and Governance...... 67 Designated Drugs -Antenatal Care ...... 68 Drug Reference Cards - Designated Drugs Used in Antenatal Care...... 69 Dimenhydrinate...... 69 Doxylamine succinate-pyridoxine hydrochloride...... 69

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Diphenhydramine hydrochloride ...... 70 Epinephrine hydrochloride...... 70 RhD Immune Globulin...... 71 Clotrimazole...... 71 Miconazole...... 72 Acetaminophen ...... 73 Acetaminophen + Codeine...... 73 Hydrocortisone anorectal therapy compound ...... 74 Antenatal Scenarios ...... 74 Scenario 1: Ji Len...... 74 Scenario 2: Mojghan Nazran...... 74 Scenario 3: Jenny Kassel...... 75 Scenario 4: Vivika Steinberg ...... 75 Scenario 5: Farrah Khalaf ...... 75 Reference Cards - Designated Drugs Used in Intrapartum Care...... 76 Oxytocin...... 76 Ergonovine Maleate ...... 77 Carboprost ...... 78 Nitrous Oxide/Oxygen ...... 78 Lidocaine HCl with or without Epinephrine...... 79 Intrapartum Scenarios...... 80 Scenario 1: Lee-Yan...... 80 Scenario 2: Marilyn Bell ...... 80 Scenario 3: Susan Bisiek...... 80 Reference Cards - Designated Drugs Used in Newborn Care...... 81 Designated Drugs – Newborn ...... 81 Erythromycin ophthalmic ointment ...... 81 Phytonadione (Vitamin K) ...... 82 Nystatin ...... 82 Hepatitis B Immune Globulin ...... 83 Newborn Scenarios ...... 83 Scenario 1: Vai Chiu ...... 83 Scenario 2: Baby Rodriguez...... 83 Section 2: Designated Drugs for Administration by Midwives Self-Testing Multiple Choice Questions ...... 84 Section 2: Designated Drugs for Administration by Midwives Answer Key to Multiple Choice Questions ...... 86 Writing a Prescription...... 88 Exercise 1: Prescription for Diclectin ...... 88 Exercise 2: Prescription for Clotrimazole...... 90 Exercise 3: Prescription for Acetaminophen and Codeine ...... 91

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Putting it All Together – Drugs in Midwifery Practice...... 92 Drug Reference Card Exercise ...... 95 Over the Counter Drugs commonly used by Pregnant Women: ...... 99 Prescription Drugs commonly used by pregnant women:...... 99 Safety of drugs in pregnancy and breastfeeding...... 100 Section 3: Standards and Guidelines For Prescribing, Ordering and Administering Controlled Substances...... 101 Objectives ...... 101 Controlled Substances Available for use by Midwives in Canada...... 103 Drug Reference Card Exercise ...... 106 Section 3: Narcotics and Controlled Substances ...... 120 Self-Testing Multiple Choice Questions ...... 120 Section 3: Narcotics and Controlled Substances Answer Key to Multiple Choice Questions...... 135 Section 4: Antibiotics...... 145 Amoxicillin...... 145 Ampicillin ...... 146 Azithromycin...... 147 Bacitractin...... 148 Cephalexin...... 148 Cefazolin...... 149 Cefixime ...... 150 Ceftriaxone ...... 151 Ciprofloxacin...... 152 Clavulanic acid ...... 153 Clindamycin...... 154 Cloxacillin ...... 155 Cotrimoxazole ...... 156 Dicloxacillin ...... 157 Doxycylin ...... 157 Erythromycin...... 158 Fusidic acid...... 159 Gentamycin...... 159 Mupirocin ...... 160 Nitrofurantoin ...... 160 Spectinomycin ...... 161 Trimethoprim...... 162 Miconazole ...... 163 Acetaminophen ...... 164 Objectives ...... 173 Antibiotics...... 174

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Penicillin G...... 174 Cefazolin ...... 175 Erythromycin...... 176 Clindamycin ...... 177 Vancomycin ...... 179 Gentamycin ...... 179 Amoxicillin ...... 180 Ampicillin ...... 181 Proposed Amendments to Drug Regulation ...... 182 Self-Testing Scenarios: Indications for Antibiotics...... 184 Scenario 1: Prenatal...... 184 Scenario 1: Intrapartum...... 184 Scenario 1: Postpartum ...... 184 Section 4: Antibiotics...... 188 Self-Testing Multiple Choice Questions ...... 188 Section 4: Antibiotics...... 189 Answer Key to Multiple Choice Questions ...... 189

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Section 1: Concepts in Pharmacology

Objectives

After completing this module the student will be able to understand:

1. How pharmacology and therapeutics are related 2. How medications are classified as traditional drugs, biologics, and natural alternatives 3. How prescription drugs are classified according to safety in pregnancy categories to protect the fetus 4. How regulations and standards exist to protect the public 5. How drugs can be described by a chemical, generic or trade name 6. Generic drugs are less expensive and may be substituted for therapeutically equivalent brand name products 7. How drugs can be administered by three routes: enteral, parenteral, and topical 8. The three phases of drug delivery: administration, pharmacokinetics, and pharmacodynamics 9. How physical properties of drugs affect how drugs reach their target cells 10. The four concepts of drug transport: Administration, distribution, metabolism, and excretion 11. The concept of drug half-life 12. Key terms and concepts in pharmacology 13. Concepts of drug dependence 14. An overview of drugs for seizures, anxiety, depression and insomnia

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Concepts in Pharmacology

1. Pharmacology and 2. Medications are classified as therapeutics are related traditional drugs, biologics, and natural alternatives Therapeutics means the treatment of and prevention of disease. Drugs are chemical agents used to treat Pharmacology is the “study of or prevent disease by creating a medicine.” Pharmacotherapeutics biologic response in the body. means applying drugs to treat disease. Therapeutic drugs are classified as substances produced chemically or naturally. Biologics are natural agents produced by animal cells on microorganisms. Alternative drug therapies include herbs, plant extracts, and dietary supplements.

3. Prescription drugs are classified 4. Drug regulations and standards according to safety in pregnancy exist to protect the public categories to protect the fetus. In Canada, the Health Protection The FDA places all drugs into Branch enforces regulations under the categories A, B, C, D or X. Category Canadian Food and Drugs Act. A is the safest, and Category X is the • Drug use is controlled by schedules most dangerous to the fetus. Canada outlined in the Canadian Food and and the United States use the same Drugs Act. system. • Schedule G drugs are controlled drugs. • Schedule H drugs are restricted drugs. Schedule F drugs require a prescription in order to be given to a client.

5. Drugs have more than one name 6. Generic drugs are less expensive than trade name drugs Drugs can be described by a chemical, generic or trade name. There are pros Generic drugs may be substituted for and cons to naming drugs in these the brand name product’s equivalent. different ways.

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Drugs can be administered by 3 routes:

• Enteral • Parenteral • Topical

Enteral Parenteral Topical

• Oral (PO) • Intravenous (IV) • Transcutaneous • Buccal • Intra-arterial (IA) • Transdermal • Sublingual (SL) • Intracoronary (IC) • Transmucosal • Rectal (PR) • Intradermal (ID) • Opthalmic • Subcutaneous (SC) • Otic • Intramuscular (IM) • Vaginal • Intrauterine • Intraosseous • Intrathecal • Epidural • Intraperitoneal (IP) • Intrasynovial

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7. Enteral route 8. Parenteral route

Drugs may be administered orally, Administration by the parenteral route sublingually or rectally, collectively involves injection into the circulatory called the enteral route. Oral system, through the skin or into the medications may be in the form of body cavities. Drugs administered liquids or solids. Liquid forms of directly into the blood vessels may be drugs reach their target cells more given intravenously or intra-arterially. quickly than solids. Drugs administered into body cavities may be given intrathecally, epidurally, intraperitoneally, or directly into the joint spaces. Injectible drugs reach their target cells most quickly.

9. Topical Route 10. Delivery of drugs involves three phases. Topical routes include the surface of the skin, ears eyes, mucous The delivery of drugs involves membranes such as nasal and administering the drug (dispensing the respiratory passageways, vagina, and drug), the pharmacokinetic phase (how the uterus. Drugs applied topically the drug moves through the body), and may provide local or systemic effects. the pharmacodynamic phase (how the Transdermal patches release drugs drugs works in the body). into the . Drugs administered to mucous membranes are transmucosal drugs. Drugs applied to reproductive openings are available in salves, 11. Physical properties of drugs creams, gels, foams, suppositories or affect how drugs reach their tablets. target cells.

Drugs administered to the ears or eyes Medications are available in either may be for the purposes of injectible, solid, liquid or gas form. lubrication, infection, maintaining Injectible forms of medications reach proper physiological function and/or their target cells most quickly. Solid support diagnostic tests. and liquid forms reach their target cells at a slower rate. College of Midwives of Ontario Page 9 of 189 Non-Physician Prescribing Applicant Questionnaire

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12. Pharmacokinetics explains how 13. Absorption - the first step in the body handles drugs. drug transport

Pharmacokinetics deals with how drugs Absorption is the first step in drugs move throughout the body. There are reaching their target cells. Absorption four components of drug transport: involves movement of the drug from absorption, distribution, metabolism the site of administration across the and excretion. body’s membranes. Drug absorption is affected by many factors.

14. Distribution – how drugs are 15. Metabolism – how drugs are

transported throughout the made less or more active.

body.

Metabolism occurs mainly in the

How the drug is distributed throughout and to a lesser extent in other organs

the body continues the process of drugs such as the gastrointestinal tract and

reaching their target cells. Factors the kidneys. Metabolic liver enzymes

affecting distribution include drugs are usually less active in younger and

being bound to plasma protein, the older clients. Drugs will likely have

blood brain barrier, the blood-placental enhanced effects in these two client

barrier, and the blood –testicular populations. Prodrugs are drugs that

barrier. are converted into their active forms

upon metabolism in the body.

16. Excretion – the elimination of 17. Rate of elimination and half-life

drugs from the body. characteristics.

The kidneys, lungs, sweat glands, The elimination of a drug is defined as

mammary glands and gall bladder are the amount of drug removed from the

the organs mainly responsible for the body. Plasma half-life is the amount of

excretion of drugs from the body. time needed for half of the drug to be

eliminated from the body. The rate of

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Three Phases of Drug Delivery

Phase 1

Administration

Enteral

Parenteral

Topical

Phase 2 Pharmacokinetics

Absorption

Distribution

Metabolism

Excretion

Phase 3 Pharmacodynamics

Efficacy

Potency

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Key Terms – Basic Concepts in Pharmacology

Biologics Chemical agents that produce biological responses within the body; they are synthesized by cells of the human body, animal cells, or microorganisms

Clinical pharmacology An area of medicine devoted to the evaluation of drugs used for human therapeutic benefit

Formulary Lists of drugs and drug recipes commonly used by pharmacists

Natural alternative therapies Herbs, natural extracts, vitamins, minerals, or dietary supplements

Pathophysiology The study of diseases and the functional changes occurring in the body as a result of diseases

Pharmaceutics The science of preparing and dispensing drugs

Pharmacology The study of medicines; the discipline pertaining to how drugs improve the health of the human body

Pharmacopoeia Medical reference summary indicating standards of drug purity, strength, and directions for synthesis

Pharmacotherapeutics Treatment of diseases by the use of drugs

Therapeutics The branch of medicine concerned with the treatment of disease and suffering

Key Terms – Drug Classes, Schedules and Categories

Bioavailability The ability of a drug to reach the bloodstream and its target tissues

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Combination drug Drug product with more than one active generic ingredient

Controlled substance In Canada, it is a drug subject to guidelines outlined in Part III, Schedule G of the Canadian Food and Drugs Act

Generic name Nonproprietary name of d drug assigned by the government

Mechanism of action How a drug exerts its effects

Pregnancy category System for grouping drugs based upon how safe they are for the unborn

Prototype drug An original, well-understood model drug from which other drugs in a pharmacological class have been developed

Restricted drug In Canada, a drug not intended for human use, covered in Part IV, Schedule H of the Canadian Food and Drugs Act

Scheduled drug In the U.S., a term describing a drug placed into one of five categories (I through V) based on its potential for misuse or abuse

Teratogen A Chemical substance that harms a developing fetus or embryo

Trade name Proprietary name of a drug assigned by the manufacturer; also called the brand name or product name

Key Terms – Methods of Drug Delivery

Dissolution The dissolving process of solid drug preparations; the longer it takes for drugs to dissolve, the more delayed their onset of action

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Enteral The major route by which drugs enter the body through the digestive tract Epidural Method of parenteral drug delivery where drugs are injected into the space overlying the dura mater

Intra-arterial Method of parenteral drug delivery where drugs are injected into the arterial circulation

Intradermal Parenteral drug delivery with drugs injected into the dermis of the skin, e.g. TB test

Intramuscular Method of parenteral drug delivery where drugs are injected into layers of muscle beneath the skin

Intraperitoneal Method of parenteral drug delivery where drugs are injected into the abdominal cavity

Intrathecal Method of parenteral drug delivery where drugs are injected into the spinal subarachnoid space

Intravenous Method of parenteral drug delivery where drugs are injected into the veous circulation

Oral Method of enteral drug delivery in which drugs are swallowed, chewed, or allowed to slowly dissolve in the mouth

Parenteral The major route by which drugs enter the body by a way other than the digestive tract, usually by injection

Rectal Method of enteral drug delivery where drugs are administered by way of the rectum

Solubility The ability to dissolve or mix

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Subcutaneous Method of parenteral drug delivery where drugs are injected into the hypodermis of the skin, e.g. Insulin

Sublingual Method of enteral drug delivery where drugs are placed under the tongue

Topical The route by which drugs are placed directly onto the skin and mucous membranes

Transdermal Method of drug delivery, usually by a patch, where drugs are absorbed across the layers of the skin for the purpose of entering the bloodstream

Transmucosal Method of topical drug delivery were drugs are applied directly to mucosal membranes, including the nasal and respiratory pathways and reproductive openings

Viscosity The thickness of a liquid

Key Terms – What Happens After a Drug Has Been Administered

Absorption The process of moving a drug across body membranes

Agonists Drugs that are capable of binding with receptors in order to induce a cellular response

Antagonists Drugs that block the response of another drug

Biotransformation The metabolism of chemical conversion of drugs from one form to another that mayresult in increased or decreased activity

Blood-brain barrier An anatomical structure that prevents some substances from gaining access into the brain

Blood-placental barrier

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An anatomical structure that prevents some substances from moving into the bloodstream of the fetus

Distribution The process of transporting drugs through the body

Enterohepatic recirculation Recycling of drugs and other substances by the circulation of bile through the intestine and liver

Excretion The process of removing substances from the body

First-pass effect A mechanism whereby drugs are absorbed across the intestinal wall and enter into the hepatic portal circulation

Half-life The length of time required for a drug to decrease its concentration in the plasma by one- half of the original amount

Pharmacodynamics The study of how the body responds to drugs and natural substances

Pharmacokinetics The study of how drugs are handles by the body

Potency The power or strength of a drug at a specified concentration of dose

Rate of elimination The amount of drug removed from the body during a specified period of time

Receptor The structural component of a c ell to which a drug binds in a dose-related manner in order to produce a response

Receptor theory A cellular mechanism by which most drugs produce their effects

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Key Terms – Substance Abuse

Addiction The continued use of a substance despite its negative health and social consequences

Classic withdrawal Unpleasant symptoms experienced when a physically dependent client discontinues the use of an abused drug

Designer drugs Drugs that are produced in a laboratory and are intended to mimic the effects of other psychoactive controlled substances

Opioid Substance obtained from the unripe seeds of the poppy plant

Physical dependence The condition of experiencing unpleasant withdrawal symptoms when a substance is discontinued

Psychodelics Substances that alter perception and reality

Psychological dependence An unpleasant, intense craving for a drug after it has been withdrawn

Substance abuse The use, bus self-administration, of a drug that does not conform to the medical or social norms within the client’s given culture or society

Tolerance The process of adapting to a drug over a period of time, and subsequently requiring higher doses to achieve the same effect

Key Terms – Drugs for Autonomic Nervous System Disorders

Acetylcholine Primary neurotransmitter of the parasympathetic nervous system; also present at somatic neuromuscular junctions and at sympathetic preganglionic nerves

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Adrenergic A term relating to nerves that release norepinephrine or epinephrine

Adrenergic-agonist Another name for a sympathomimetic drug

Adrenergic-blocker Drug that blocks the actions of the sympathetic nervous system

Alpha-receptor Type of subreceptor found in the sympathetic nervous system

Anticholinergic Drug that inhibits the action of acetylcholine at its receptor

Autonomic nervous system Portion of the peripheral nervous system that gives involuntary control over smooth muscle, cardiac muscle, and glands

Beta-receptor Type of subreceptor found in the sympathetic nervous system

Central nervous system Division of the nervous system consisting of the brain and spinal cord

Cholinergic A term relating to nerves that release acetylcholine

Cholinergic-agonist Another name for a parasympathomimetic drug

Cholinergic-blocker Drug that blocks the actions of the parasympathetic nervous system

Fight-or-flight response Signs and symptoms produced when the sympathetic nervous system is activated

Ganglion A collection of cell bodies located outside the CNS

Muscarinic

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Type of cholinergic-receptor found in smooth muscle, cardiac muscle, and glands

Neuron Cell that is the functional unit of the nervous system

Neurotransmitter A chemical mediator that is released by nerves at synapses and neuromuscular junctions

Nicotinic Type of cholinergic-receptor found in ganglia of both the sympathetic and parasympathetic nervous systems

Norepinephrine Primary neurotransmitter in the sympathetic nervous system Parasympathetic nervous system Portion of the autonomic system that is active during periods of rest and which produces the rest or relaxation response

Parasympathomimetics Drugs that mimic the actions of the parasympathetic nervous system

Peripheral nervous system Division of the nervous system containing a nervous tissue outside of the CNS, including the autonomic nervous system

Postsynaptic nerve Nerve in the synapse that has receptors for the neurotransmitter

Presynaptic nerve Nerve that releases the neurotransmitter into the synaptic cleft

Rest-or-relaxation response Signs and symptoms produced when the parasympathetic nervous system is activated

Somatic nervous system Consists of ne res that provide voluntary control over skeletal muscle

Sympathomimetic Drug that stimulates or mimics the sympathetic nervous system

Synapse

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Junction between two consisting of a presynaptic nerve, a synaptic cleft, and a postsynaptic nerve

Synaptic cleft Physical space between two neurons that must be crossed by the neurotransmitter

Key Terms – Drugs for Anxiety, Daytime Sedation and Insomnia

Anxiolytics Drugs that relieve anxiety

Barbiturates Class of drugs derived from barbituric acid; they act as CNS and are used for their and anti-seizure effects

Benzodiazepines Class of drugs used to treat anxiety and insomnia

Depressants Drugs that lower neuronal activity within the central nervous system

Hypnotic A drug that causes sleep

Limbic system Area in the brain responsible for emotion, learning, memory, motivation, and mood

Non-REM sleep Sleep characterized by little or no movement of the eyes

Rebound insomnia Increased sleeplessness that occurs when long-term anti-anxiety or medication is discontinued

REM sleep Sleep characterized by quick, scanning movements of the eyes

Reticular formation A network of neurons found along the entire length of the brain stem connected with the reticular activating system

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Sedatives Drugs that relax or calm the client

Sedative-hypnotic Drug that, when given in lower doses, produces a calming effect and, when given in higher doses, produces sleep

Sleep debt Sleep deficit that may be accompanied by unfavorable effects, such as impaired judgment, depression, and slowed reaction time

Tranquilizer Drug that produces a calm or tranquil feeling

Key Terms – Drugs for Seizures

Anti-seizure drugs Drugs that treat seizures

Convulsions Uncontrolled muscle contractions or spasms that occur in the face, torso, arms, or legs

Delirium tremens Sometimes called DTs; a serious and sometimes fatal condition that develops during withdrawal that is characterized by tremors, disorientation, confusion, and an altered state of consciousness

Eclampsia Condition whereby seizures and/or a develop in a client with pre-eclampsia

Epilepsy Disorder of the CNS characterized by seizures and/or convulsions

Generalized seizures Seizures that travel throughout the entire brain on both sides

Partial seizures Seizures that start on one side of the brain and travel a short distance before stopping

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Pre-eclampsia Condition where hypertension develops because of pregnancy or recent pregnancy. Hypertension is accompanied by proteinuria and/or edema

Seizures Symptom of epilepsy characterized by abnormal neuronal discharges within the brain

Status epilepticus Condition characterized by repeated seizures or one prolonged seizure attack that continues for at least 30 minutes

Key Terms – Drugs for Behavioural, Emotional, and Mood Disorders, and Psychoses

Clinical depression Disorder characterized by depressed mood, lack of energy, abnormal eating patters, and feelings of despair, guilt, and misery Major depression Disorder characterized by at least five symptoms of clinical depression

Mania Disorder characterized by an expressive, impulsive, excitable, and over-reactive nature

Manic depression Disorder characterized by extreme and opposite feelings, such as and depression, or calmness and rage; also called bipolar disorder

Mood disorders Disorders involving a change in behaviour, such as clinical depression, emotional swings, or manic-depression

Mood enhancers Drugs that combat depression by enhancing mood

Mood stabilizers Drugs that level mood to treat bipolar disorder and mania

Monoamine oxidase inhibitors Drugs inhibiting monoamine oxidase, an enzyme that terminates the actions of neurotransmitters such as dopamine, norepinephrine, epinephrine, and serotonin

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Narcolepsy Disorder characterized by uncontrolled attacks of sleep

Negative symptoms Symptoms that subtract from normal behaviour; signs that are used to assist with the diagnosis of schizophrenia

Neuroleptic malignant syndrome A potentially fatal condition cause d by some anti-psychotic medications; symptoms include an extremely high body temperature, drowsiness, changing blood pressure, irregular heartbeat, and muscle rigidity

Neuroleptics Drugs used to treat psychoses

Positive symptoms Symptoms that add on to normal behaviour; signs that are used to assist with the diagnosis of schizophrenia

Schizoaffective disorder disorder with symptoms similar to schizophrenia and mood disorders

Schizophrenia Type of psychosis characterized by abnormal thoughts and through processes, withdrawal from other people and the outside environment, and apparent preoccupation with one’s own mental state

Selective serotonin reuptake inhibitors Drugs that selectively inhibit the reuptake of serotonin into nerve terminals

Serotonin syndrome Set of signs and symptoms associated with overmedication with antidepressants

Tricyclic antidepressants Dugs with a three ring chemical structure that inhibit the reuptake of norepinephrine and serotonin into nerve terminals

Key Terms – Drugs for Fever and Pain

Acute pain Short-term sensation tat is uncomfortable or hurtful; a sharp and intense pain

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Analgesic Drug used to reduce or eliminate pain

Antipyretic Drug that reduces fever

Aura Sensory cue such as bright lights, smells, or tastes that precede a migraine

Chronic pain A long term sensation that is uncomfortable or hurtful; a persistent, dull ache

Endogenous Chemicals produced naturally within the body that decrease or eliminate pain; they closely resemble the actions of

Migraine Severe headache preceded by auras that may include nausea and vomiting

Narcotic Natural or synthetic drug related to morphine; may be used as a broader legal term referring to (LSD); CNS , marijuana, and other illegal drugs

Nociceptors Receptors connected with nerves that receive and transmit pain signals to the spinal cord and brain

Opiate Morphine-like substance extracted from the poppy plant

Opioid Natural or synthetic morphine-like substance

Prostaglandins Chemicals released after tissue damage, leading to pain, inflammation, and other body reactions

Tension headache Common type of head pain caused by stress and relieved by non-narcotic analgesics

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Key Terms – Drugs for Local and General Anesthesia

Anesthesia Medical procedure involving drugs that block the transmission of nerve impulse and cause loss of sensation and/or consciousness

Epidural anesthesia Type of regional anesthesia where drugs are injected into the epidural space of the spinal cord

General anesthesia Medical procedure that produces loss of sensation throughout the entire body and

Infiltration anesthesia Type of local anesthesia performed in preparation for a dental or medical procedure; local anesthetics are injected and infiltrate into the skin

Local anesthesia Loss of sensation to a relatively small part of the body without loss of consciousness

Nerve block anesthesia Technique for anesthetizing an area by injecting a blocking agent directly around a nerve

Spinal anesthesia Regional anesthesia where drugs are injected into the spinal subarachnoid space

Surface (topical) anesthesia Procedure where local anesthetics are applied to the surface of the body in order to numb the skin and mucous membranes

Key Terms – Drugs for Coagulation Disorders

Activated partial thromboplastin time Blood test used to determine how long it takes clots to form in order to regulate heparin dosage

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Anticoagulant An agent that inhibits the formation of blood clots

Antifibrinolytics Drugs used to prevent and treat excessive bleeding from surgical sites

Antithrombin III Protein that prevents abnormal clothing by inhibiting thrombin

Clotting factors Substances contributing to the process of blood clotting

Coagulation The process of blood clotting

Coagulation cascade Complex series of steps by which blood flow stops

DVT Deep vein thrombosis

Embolus A blood clot carried in the bloodstream

Fibrin An insoluble protein formed from fibrin by the action of thrombin in the blood-clotting process

Fibrinolysis Removal of a blood clot

Hemostasis The slowing or stopping of blood flow

Low molecular weight heparins Heparin-like drugs that inhibit blood-clotting

Platelet Cell involved in the blood-clotting process

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Plasmin Enzyme formed from plasminogen that dissolves blood clots

Plasminogen Protein that prevents fibrin clot formation

Prothrombin Blood protein converted to thrombin in the blood-clotting process

Prothrombin activator Enzyme in the coagulation cascade that converts prothrombin to thrombin

Prothrombin time Blood test used to determine the time needed for plasma to clot to regulate warfarin dosage

Thrombin Enzyme that causes clotting by forming thrombin

Thromboembolic disease Disorders where clients have blood clots

Thrombolytics Drugs used to dissolve existing blood clots

Thrombus Blood clot

Tissue plasminogen activator Natural enzyme and a drug that dissolve blood clots

Key Terms – Drugs for Hypertension

Aldosterone Hormone released by the adrenal cortex that regulates sodium reabsorption

Alpha1-receptors Adrenergic receptors found in vascular smooth muscle

Angiotensin II

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Chemical released in response to falling blood pressure that causes vasoconstriction and release of aldosterone

Angiotensin-converting enzyme Enzyme responsible for converting angiotensin I to angiotensin II

Antidiuretic hormone (ADH) Hormone produced by the hypothalamus that stimulates the kidneys to conserve water

Baroreceptors Nerves located in the walls of the atria, aortic arch, vena cava, and carotid sinus that sense changes in blood pressure

Beta 1 receptors Adrenergic receptors primarily found in the heart

Beta 2 receptors Adrenergic receptors found in organs other than the heart

Blood volume Amount of blood in the vascular system

Bradycardia A condition of slow heartbeat

Cardiac output Amount of blood pumped by each ventricle in one minute

Chemoreceptors Nerves located in the aortic arch and carotid sinus that sense changes in oxygen content, pH, or carbon dioxide levels in the blood

Diastolic pressure Blood pressure during the relaxation phase of heart activity Dieresis Urine flow

Diuretic Substance that increases urine flow

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Electrolytes Charged substances in the blood such as sodium, potassium, , chloride, and phosphate

Hyperkalemia High amounts of potassium in the blood

Hypokalemia Low amounts of potassium in the blood

Hypertension High blood pressure

Lumen The inside diameter of a hollow tube such as a blood vessel

Orthostatic hypotension Fall in blood pressure that occurs when someone changes position from recumbent to upright

Peripheral resistance The amount of friction encountered by blood as it travels through the vessels

Reflex tachycardia Temporary speeding up of heart rate that occurs when blood pressure falls

Stroke volume Volume of blood pumped out by a ventricle in a single beat

Systolic pressure Blood pressure during the contraction phase of heart activity Vasomotor center Area of the medulla that controls baseline blood pressure

Key Terms – Drugs for Shock and Anaphylaxis

Anaphylactic shock Type of shock caused by an acute allergic reaction

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Antigen Anything that is recognized as foreign by the immune system and produces an immune reaction

Hypovolemic shock Type of shock caused by loss of fluids such as occurs during hemorrhaging, extensive or severe vomiting of diarrhea

Neurogenic shock Type of shock resulting from brain or spinal cord injury

Septic shock Type of shock caused by severe infection in the bloodstream

Shock Condition in which there is inadequate blood flow to meet the body’s needs

Key Terms – Drugs for Inflammation, Allergies, and Immune Disorders

Allergic rhinitis Syndrome of sneezing, itchy throat, watery eyes, and nasal congestion resulting from exposure to antigens; also known as hay fever

Alternate-day therapy Taking a drug every other day in order to minimize side effects

Anaphylaxis Acute allergic response to an antigen that results in severe hypotension and may cause death if untreated

Antibody Protein produced by the body in response to an antigen; used interchangeably with the term immunoglobulin

Antigen A foreign organism or substance that induces the formation of antibodies

Booster

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An additional dose of a vaccine given months or years after the initial dose to increase the effectiveness of the vaccine

Bradykinin A chemical released by cells during inflammation that produces pain and effects similar to those of histamine

Cushing’s syndrome A condition of having too much corticosteroids in the blood

Cytokines Chemicals produced by white blood cells, such as interleukins, leukotrienes, interferon, and tumor necrosis factor, that guide the immune response

Cytoxic T-cell Type of lymphocyte that directly attacks and destroys antigens

H1-receptor Site located on smooth muscle cells in the bronchial tree that is stimulated by histamine

H2-receptor Site located on cells of the digestive system that is stimulated by histamine

H1-receptor antagonist Drug that blocks the effects of histamine in smooth muscle in the bronchial tree

Helper T-cell Type of lymphocyte that coordinates both the humoral and cell-mediated immune responses and that is the target of the human immunodeficiency virus

Histamine Chemical released by mast cells in response to an antigen that causes dilation of blood vessels, smooth muscle constriction, tissue swelling, and itching

Humoral immunity A specific body defense mechanism involving the production and release of antibodies

Hyperemia Increase in blood supply to a part or tissues space causing swelling, redness, and pain

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Immunoglobulin Proteins produced by the body in response to an antigen; used interchangeably with the term antibody

Immunosuppressant Any drug, chemicals, or physical agent that lowers the natural immune defense mechanisms of the body

Inflammation Non-specific body defense that occurs in response to an injury or antigen

Leukotriene Chemical released by cells during inflammation that produces effects similar to those of histamine

Lympthocyte Type of white blood cell formed in lymphoid tissue

T-cell Type of lymphocyte that is essential for the cell-mediated immune response

Tinnitus Ringing in the ears

Titer Measurement of the amount of a substance in the blood

Toxoid Substance that has been chemically modified to remove its harmful nature but is still able to elicit an immune response in the body

Transplant rejection When the immune system recognizes a transplanted tissue as being foreign and attacks it

Vaccine Preparation of microorganism particles that is injected into a client to stimulate the immune system, with the intention of preventing disease Key Terms – Drugs for Bacterial Infections

Acquired resistance When a microbe is no longer affected by a drug following treatment with anti-infectives

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Aerobic Pertaining to an oxygen environment

Anaerobic Pertaining to an environment without oxygen

Antagonism Type of drug interaction where one drug inhibits the effectiveness of another

Antibiotic Substance produced by a micro-organism that inhibits or kills other micro-organisms

Bacilli Bacteria that are oblong in shape; also called rods

Bacteriocidal Substance that kills bacteria

Bacteriostatic Substance that inhibits the growth of bacteria

Broad-spectrum antibiotic Anti-infective that is effective against many different gram positive and gram negative organisms

Chemoprophylaxis Use of a drug to prevent an infection

Cocci Bacteria that are spherical in shape

Culture and sensitivity test Laboratory test used to identify bacteria and to determine which antibiotic is most effective

Gram-negative Bacteria that do not retain a purple stain because they have an outer envelope

Gram-positive

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Bacteria that stain purple because they have no outer envelope

Host flora Normal micro-organisms found in or on a client

Mutations Permanent, inheritable changes to DNA

Narrow-spectrum antibiotic Anti-infective that is effective against only one or a small number of organisms

Nephrotoxicity An adverse effect on the kidneys

Nosocomial infections Infection acquired in a healthcare setting such as a hospital, physician’s office, or nursing home

Ototoxicity An adverse effect on hearing

Pathogen Organism that is capable of causing disease

Photosensitivity Condition that occurs when the skin is very sensitive to sunlight

Spirilla Bacteria that have a spiral shape

Superinfection Condition caused when a micro-organism grows rapidly as a result of having less competition in its environment

Toxin Chemical produced by a micro-organism that is able to cause injury to its host

Virulence The severity of disease that an organism is able to cause

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Key Terms – Drugs for Fungal, Viral, and Parasitic Diseases

Acquired immune deficiency Syndrome (AIDS) Disease caused by the human immunodeficiency virus (HIV)

Anemia Shortage of functional red blood cells Antiretroviral Type of drug effective against retroviruses

Capsid Protein coat that surrounds a virus

Dermatophytic Superficial fungal infection

Dysentery Sever diarrhea that may include bleeding

Fungi Kingdom of organisms that includes mushrooms, yeasts, and moulds

Host An organism that is being infected by a microbe

Influenza Common viral infection; often called flu

Leukopenia Abnormally low number of white blood cells

Mycoses Diseases caused by fungi

Phlebitis Inflammation of veins

Virus Non-living particle containing nucleic acid that is able to cause disease

Yeast

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Type of fungus that is unicellular and divides by budding Key Terms – Drugs for Pulmonary Disorders

Alveoli Dilated sacs at the end of the bronchial tree where gas exchange occurs

Antitussive Drug used to suppress cough

Asthma Chronic inflammatory disease of the airways

Bronchi Primary passageway of the bronchial tree that contains smooth muscle

Bronchioles Very small bronchi

Bronchoconstriction Decrease in diameter of the airway due to contraction of the bronchial smooth muscle

Bronchodilation Increase in diameter of the airway due to relaxation of bronchial smooth muscle

Bronchospasm Rapid constriction of the airways

Chromic bronchitis Chronic disease of the lungs characterized by excess mucous production and inflammation

Dry powder Devise used to convert a sold drug to a fine powder for the purpose of inhalation

Dyspnea Shortness of breath

Emphysema Terminal disease characterized by dilation of the alveoli

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Expectorant Drug used to increase bronchial secretions

Expiration Movement of air out of the lungs

Inspiration Movement of air into the lungs

Metered dose inhaler Device used to deliver a precise amount of drug to the respiratory system

Mucolytic Drug used to loosen thick mucous

Nebulizer Device used to convert liquid drugs into a find mist for the purpose of inhalation

Perfusion Blood flow through a tissue or organ

Pharynx Passageway for food from the mouth to the esophagus and for air from the nose to the larynx

Respiration Exchange of oxygen and carbon dioxide

Status asthmaticus Acute form of asthma requiring immediate medical attention

Trachea Passageway for air from the pharynx to the bronchi

Ventilation Process by which air is moved into and out of the lungs

Key Terms – Vitamins, Minerals, and Herbs

Dietary supplement

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Non-drug substance regulated by the DSHEA

Folic acid B vitamin that is a coenzyme in protein and nucleic acid metabolism; also known as Hemoglobin Substance in a red blood cell that contains iron and transports oxygen and CO2

Herb Plant with a soft stem that is used for healing or as a seasoning

Hypervitaminosis Excess intake of vitamins

Intrinsic factor Chemical secreted by the stomach that is required for absorption of

Major mineral (macromineral) Inorganic compound needed by the body in amounts of 100 mg or more daily

Pernicious (megaloblastic) anemia Type of anemia usually caused by lack of secretion of intrinsic factor

Provitamin An inactive chemical that is converted to a vitamin in the body

Recommended Dietary Allowance (RDA) Amount o f vitamin or mineral needed daily to avoid a deficiency in a healthy adult

Trace mineral Inorganic compound needed by the body in amounts of 20mg or less daily

Vitamins Organic compounds required by the body in small amounts

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Section 1: Concepts in Pharmacology Self-Testing Multiple Choice Questions

1. Parenteral routes include:

1. Sublingual 2. Intravenous 3. Vaginal 4. Subcutaneous 5. Intramuscular

a) 2, 3, 4 b) 2, 4, 5 c) 1, 2, 5 d) 1, 3, 5

2. Topical routes include:

1. Buccal 2. Intramuscular 3. Otic 4. Vaginal

a) 1, 2, 4 b) 1, 2 c) 3, 4 d) 1, 2, 3

3. Drugs of different dosage forms reach their target cells most quickly in the following order:

a) Gaseous, liquid, solid, injection b) Liquid, solid, gaseous, injection c) Injection, gaseous, liquid, solid d) Gaseous, liquid, injection, solid

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4. The stages of pharmacodynamics include:

1. Absorption 2. Distribution 3. Metabolism 4. Excretion

a) 1, 2, 4 b) 1, 2, 3, 4 c) 2, 3, 4 d) 1, 2, 3

5. Absorption of a drug describes:

a) How a drug is distributed throughout the body b) How a drug moves from the site of administration across the body’s membranes c) How the drug is moves below the skin after buccal administration d) How effective a drug is within cells

6. Distribution of a drug describes:

a) How a drug is distributed throughout the body b) How a drug moves from the site of administration across the body’s membranes c) How the drug is removed from the body after it exhibits its therapeutic effects d) How the drug is made less or more active in the body

7. Metabolism of a drug describes:

a) How a drug is distributed throughout the body b) How a drug assists in burning calories c) How the drug is removed from the body after it exhibits its therapeutic effects d) How the drug is made less or more active in the body

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8. Pathophysiology is the study of:

a) Medicines b) Diseases and the functional changes occurring in the body as a result of diseases c) The study of life and living matter d) The study of medicines; the discipline pertaining to how drugs improve the health of the human body

9. In Canada generic drugs may be substituted for brand name drugs:

a) When the pharmacist has determined that bioavailability is equivalent b) When the client does not have private insurance to cover drug costs c) For drugs classified as a) and b) d) In all situations where generic drugs have been approved as bioavailably equivalent

10. Betty Lu is a G1P0 woman who is presenting with the following problems during her pregnancy: Urinary tract infection, headaches, back pain, and difficulty sleeping. Which of the following is most likely to be safe?

a) Penicillin V for urinary tract infection b) Acetaminophen for headaches c) Naproxen for body aches and pains d) Diazepam for difficulty sleeping

11. A drug administered by the enteral route is one given by any route other than the digestive tract.

a) True b) False

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12. Medications delivered by the oral route generally have a faster onset of action than the IM route.

a) True b) False

13. The deepest type of injecting made into the skin is called an intradermal injection.

a) True b) False

14. Transmucosal drugs are generally those delivered to the upper and lower respiratory tract and reproductive openings.

a) True b) False

15. Why might rectal drugs be administered to a client?

a) The client is unconscious b) The client is experiencing nausea or vomiting c) The client is an infant who cannot swallow pills d) All of the above are correct

16. Which of the following is major advantage of IV drug administration?

a) The duration of drug action can be controlled b) It is relatively free from the possibility of harmful effects c) A precise concentration of drug can be administered into the bloodstream d) The metabolism of drug action can be controlled

17. Which of the following drug delivery methods would most likely produce the fastest onset of action?

a) Intravenous b) Intramuscular

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c) Sublingual d) Rectal 18. Which of the following drug delivery methods might be used when fast delivery to the cerebral spinal fluid is necessary?

a) Intraperitoneal b) Intrathecal c) Epidural d) Transmucosal

19. Which of the following statements is true about IV infusions?

a) Single drug doses are generally administered over a shorter period of time b) A flow regulator is always used to regulate drug flow c) Quick delivery of IV drugs is not possible with IV infusion d) Drug doses are generally administered by way of a syringe, port and needle

20. The deepest of the skin layers is the:

a) Epidermis b) Dermis c) Hypodermis d) Muscular layer

21. A drug with a half-life of 5 hours will take longer to be eliminated from the body than a drug with a half-life of 10 hours.

a) True b) False

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22. The term potency refers to the ability of a drug to produce a more intense response as the concentration is increased.

a) True b) False

23. The process that describes how drugs are transported in the body is:

a) Absorption b) Distribution c) Metabolism d) Excretion

24. The term used to describe how much of a drug is available to produce a biological response is:

a) Volume of distribution b) Rate of elimination c) Bioavailability d) Half-life

25. Which of the following is most important regarding excretion mechanisms and the breasts?

a) Drugs excreted into breast milk may significantly harm the nursing infant b) The breasts are a modified type of sweat gland c) Urea and other waste products are eliminated naturally from the breasts d) Natural alternative agents are considered safe and are not excreted into breast milk

26. Antagonists:

a) Are sometimes referred to as facilitators of drug action b) Can only produce an effect by interacting with receptors c) Inhibit or block the action of agonist drugs d) All of the above choices are correct

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27. :

a) Is the active ingredient in marijuana b) Decreases co-ordination and thought processes c) Affects the mainly the nervous, cardiovascular, and endocrine systems d) Applied by patch helps 75% of smoking clients to remain -free

28. The sleep disorder drug for which clients often fake or change prescriptions is:

a) b) c) d) Opioids

29. Fatima is G3P2 woman who is 24-weeks pregnant and has fainted twice in the last month when standing quickly from sitting or lying down.

a) This is due to a rise in blood pressure which is caused by standing up quickly. No treatment is indicated. b) This is called orthostatic hypotension, which can be relieved with administration of beta blocker medication. c) The heart pumps more slowly when standing quickly from a sitting or lying position. Fatima should be assessed by a cardiologist d) A drop in blood pressure occurring when standing quickly from a sitting or lying position in pregnancy is orthostatic hypotension. Fatima should get up more gradually to avoid fainting. No treatment is indicated.

30. Drug therapy for phobias, obsessive-compulsive disorders, and post-traumatic stress disorders mainly involves long-term administration of drugs.

a) True b) False

31. The reasons for insomnia should be investigated thoroughly before considering drugs as a route course of therapy. In many cases drugs are not an appropriate choice given the risk of dependence.

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a) True b) False

32. Benzodiazepines, barbiturates, and non-barbiturates are classified as CNS depressants.

a) True b) False

33. Stages of non-REM and REM sleep are relatively unaffected by most sedative and sedative-hypnotic drugs.

a) True b) False

34. Although alcohol should be avoided with barbiturates and non- CNS depressants, it may be safely consumed with benzodiazepines.

a) True b) False

35. Episodes of immediate and intense apprehension and/or terror refer to:

a) Anxiety b) Panic c) Phobia d) Post-traumatic stress

36. Drugs meant to address anxiety on a more limited basis are called:

a) b) c) Mood disorders drugs d) Antidepressants

37. The important brain centre responsible for unconscious responses to extreme stress is the:

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a) Limbic system b) Reticular formation c) Reticular activating system d) Hypothalamus

38. Which of the following terms may be used to describe benzodiazepines?

a) Sedative b) Hypnotic c) Tranquilizer d) All of the above

39. Which of the following statements is true about reestablishing a healthful sleep regimen?

a) Drinking alcohol close to bedtime helps one to sleep. b) Eating a moderate meal close to bedtime helps one to sleep. c) Going to sleep each night at the same time. d) Sedatives and may be useful for insomnia if taken long term

40. Phenobarbital:

a) Is a short-acting barbiturate and is therefore more useful for brief medical procedures b) Stimulates liver enzymes and thereby may increase its own metabolism with repeated dosing c) Is mainly limited in drug therapy to induction of sleep d) Poses no affect on levels of folate (B9) or in the body

41. Diazepam:

a) Suppresses neuronal activity within the limbic system b) Enhances impulses that might be transmitted to the reticular activating system c) Has little effect if any on tolerance d) Is relatively limited in its range of therapeutic usefulness

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42. Clients with epilepsy often do not present with symptoms.

a) True b) False

43. The goal of anti-seizure medication is to completely suppress neuronal activity in the brain

a) True b) False

44. Abnormal mineral fluxes and blood glucose or protein levels may explain the occurrence of most seizures during pregnancy or childbirth

a) True b) False

45. Some anti-seizure medications may influence the rate of drug metabolism, decreasing the effectiveness of other drug therapies.

a) True b) False

46. In severe case of alcohol withdrawal, clients may experience seizures; however, anti- seizure medication is generally not given due to interactions with alcohol in the client’s bloodstream.

a) True b) False

47. Attention-deficit disorder (ADD) is 4 to 8 times more likely to occur in boys.

a) True b) False

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48. MAO Inhibitors (MAOIs) are drugs of choice for the treatment of simple depression.

a) True b) False

49. Tricyclic anti-depressants (TCAs) produce fewer cardiovascular side effects and therefore are less dangerous than MAOIs.

a) True b) False

50. Clients taking lithium should be placed on a salt-free diet to increase the effectiveness of the drug.

a) True b) False

51. Many clients suffering from schizophrenia have family members who have experienced the same disorder

a) True b) False

52. A family history of depression raises the risk for a client to experience biological depression.

a) True b) False

53. The most widely prescribed medication for attention-deficit disorder (ADD) is:

a) (Ritalin) b) Dextroamphetamine (Dexedrine)

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c) (Dexoxyn) d) Pemoline (Cylert)

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54. Methylphenidate (Ritalin) produces its effects by activating what portion of the brain?

a) Cerebellum b) Hypothalamus c) Pituitary d) Reticular activating system

55. Methylphenidate (Ritalin) is closely related to which class of drugs?

a) Amphetamines b) Monoamine oxidase inhibitors c) Tricyclic antidepressants d) Phenothiazines

56. Which of the following is not a common symptom of clinical depression?

a) Lack of energy b) Sleep disturbances c) d) Feelings of despair or guilt

57. Seasonal affective disorder (SAD) is a type of ______that may be treated with drug therapy.

a) ADD b) Psychosis c) Bipolar disorder d) Clinical depression

58. A client who has bipolar disorder will exhibit signs of both clinical depression and

a) Psychosis b) Schizophrenia c) Mania d) ADD

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59. Rapid shifts in emotions from profound depression to euphoria and hyperactivity are characteristic of:

a) Psychosis b) Bipolar disorder c) Schizophrenia d) ADD

60. Which of the following would least likely be used to treat clinical depression?

a) Monoamine oxidase inhibitors b) Tricyclic antidpressants c) Selective serotonin reuptake inhibitors d) Phenothiazines

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Section 1: Concepts in Pharmacology Answer Key to Multiple Choice Questions

1. Parenteral routes include:

1. Sublingual 2. Intravenous 3. Vaginal 4. Subcutaneous 5. Intramuscular

a) 2, 3, 4 b) 2, 4, 5 c) 1, 2, 5 d) 1, 3, 5

2. Topical routes include:

1. Buccal 2. Intramuscular 3. Otic 4. Vaginal

a) 1, 2, 4 b) 1, 2 c) 3, 4 d) 1, 2, 3

3. Drugs of different dosage forms reach their target cells most quickly in the following order:

a) Gaseous, liquid, solid, injection b) Liquid, solid, gaseous, injection c) Injection, gaseous, liquid, solid d) Gaseous, liquid, injection, solid

4. The stages of pharmacodynamics include:

1. Absorption 2. Distribution 3. Metabolism 4. Excretion

a) 1, 2, 4 b) 1, 2, 3, 4

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c) 2, 3, 4 d) 1, 2, 3

5. Absorption of a drug describes:

a) How a drug is distributed throughout the body b) How a drug moves from the site of administration across the body’s membranes c) How the drug is moves below the skin after buccal administration d) How effective a drug is within cells

6. Distribution of a drug describes:

a) How a drug is distributed throughout the body b) How a drug moves from the site of administration across the body’s membranes c) How the drug is removed from the body after it exhibits its therapeutic effects d) How the drug is made less or more active in the body

7. Metabolism of a drug describes:

a) How a drug is distributed throughout the body b) How a drug assists in burning calories c) How the drug is removed from the body after it exhibits its therapeutic effects d) How the drug is made less or more active in the body

8. Pathophysiology is the study of:

a) Medicines b) Diseases and the functional changes occurring in the body as a result of diseases c) The study of life and living matter d) The study of medicines; the discipline pertaining to how drugs improve the health of the human body

9. In Canada generic drugs may be substituted for brand name drugs:

a) When the pharmacist has determined that bioavailability is equivalent b) When the client does not have private insurance to cover drug costs c) For drugs classified as a) and b) d) In all situations where generic drugs have been approved as bioavailably equivalent

10. Betty Lu is a G1P0 woman who is presenting with the following problems during her pregnancy: Urinary tract infection, headaches, back pain, and difficulty sleeping. Which of the following is most likely be considered safe? For those not recommended give a rationale based on your knowledge of drug schedules and/or pregnancy risk categories. Use a drug guide to help with your answers if necessary.

a) Penicillin V for urinary tract infection b) Acetaminophen for headaches c) Naproxen for body aches and pains d) Diazepam for difficulty sleeping

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11. A drug administered by the enteral route is one given by any route other than the digestive tract.

a) True b) False

12. Medications delivered by the oral route generally have a faster onset of action than the IM route.

a) True b) False

13. The deepest type of injecting made into the skin is called an intradermal injection.

a) True b) False

14. Transmucosal drugs are generally those delivered to the upper and lower respiratory tract and reproductive openings.

a) True b) False

15. Why might rectal drugs be administered to a client?

a) The client is unconscious b) The client is experiencing nausea or vomiting c) The client is an infant who cannot swallow pills d) All of the above are correct

16. Which of the following is major advantage of IV drug administration?

a) The duration of drug action can be controlled b) It is relatively free from the possibility of harmful effects c) A precise concentration of drug can be administered into the bloodstream d) The metabolism of drug action can be controlled

17. Which of the following drug delivery methods would most likely produce the fastest onset of action?

a) Intravenous b) Intramuscular c) Sublingual d) Rectal 18. Which of the following drug delivery methods might be used when fast delivery to the cerebral spinal fluid is necessary?

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a) Intraperitoneal b) Intrathecal c) Epidural d) Transmucosal

19. Which of the following statements is true about IV infusions?

a) Single drug doses are generally administered over a shorter period of time b) A flow regulator is always used to regulate drug flow c) Quick delivery of IV drugs is not possible with IV infusion d) Drug doses are generally administered by way of a syringe, port and needle

20. The deepest of the skin layers is the:

a) Epidermis b) Dermis c) Hypodermis d) Muscular layer

21. A drug with a half-life of 5 hours will take longer to be eliminated from the body than a drug with a half-life of 10 hours.

a) True b) False

22. The term potency refers to the ability of a drug to produce a more intense response as the concentration is increased.

a) True b) False

23. The process that describes how drugs are transported in the body is:

a) Absorption b) Distribution c) Metabolism d) Excretion

24. The term used to describe how much of a drug is available to produce a biological response is:

a) Volume of distribution b) Rate of elimination c) Bioavailability d) Half-life

25. Which of the following is most important regarding excretion mechanisms and the breasts?

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a) Drugs excreted into breast milk may significantly harm the nursing infant b) The breasts are a modified type of sweat gland c) Urea and other waste products are eliminated naturally from the breasts d) Natural alternative agents are considered safe and are not excreted into breast milk

26. Antagonists:

a) Are sometimes referred to as facilitators of drug action b) Can only produce an effect by interacting with receptors c) Inhibit or block the action of agonist drugs d) All of the above choices are correct

27. Nicotine:

a) Is the active ingredient in marijuana b) Decreases co-ordination and thought processes c) Affects the mainly the nervous, cardiovascular, and endocrine systems d) Applied by patch helps 75% of smoking clients to remain tobacco-free

28. The sleep disorder drug for which clients often fake or change prescriptions is:

a) Amphetamines b) Barbiturates c) Benzodiazepines d) Opioids

29. Fatima is G3P2 woman who is 24-weeks pregnant and has fainted twice in the last month when standing quickly from sitting or lying down.

a) This is due to a rise in blood pressure which is caused by standing up quickly. No treatment is indicated. b) This is called orthostatic hypotension, which can be relieved with administration of beta blocker medication. c) The heart pumps more slowly when standing quickly from a sitting or lying position. Fatima should be assessed by a cardiologist d) A drop in blood pressure occurring when standing quickly from a sitting or lying position in pregnancy is orthostatic hypotension. Fatima should get up more gradually to avoid fainting. No treatment is indicated.

30. Drug therapy for phobias, obsessive-compulsive disorders, and post-traumatic stress disorders mainly involves long-term administration of anxiolytic drugs.

a) True b) False

31. The reasons for insomnia should be investigated thoroughly before considering drugs as a route course of therapy. In many cases drugs are not an appropriate choice given the risk of dependence.

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a) True b) False

32. Benzodiazepines, barbiturates, and non-barbiturates are classified as CNS depressants.

a) True b) False

33. Stages of non-REM and REM sleep are relatively unaffected by most sedative and sedative-hypnotic drugs.

a) True b) False

34. Although alcohol should be avoided with barbiturates and non-barbiturate CNS depressants, it may be safely consumed with benzodiazepines.

a) True b) False

35. Episodes of immediate and intense apprehension and/or terror refer to:

a) Anxiety b) Panic c) Phobia d) Post-traumatic stress

36. Drugs meant to address anxiety on a more limited basis are called:

a) Anxiolytics b) Sedatives c) Mood disorders drugs d) Antidepressants

37. The important brain centre responsible for unconscious responses to extreme stress is the:

a) Limbic system b) Reticular formation c) Reticular activating system d) Hypothalamus

38. Which of the following terms may be used to describe benzodiazepines?

a) Sedative b) Hypnotic c) Tranquilizer d) All of the above

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39. Which of the following statements is true about reestablishing a healthful sleep regimen?

a) Drinking alcohol close to bedtime helps one to sleep. b) Eating a moderate meal close to bedtime helps one to sleep. c) Going to sleep each night at the same time. d) Sedatives and hypnotics may be useful for insomnia if taken long term

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40. Phenobarbital:

a) Is a short-acting barbiturate and is therefore more useful for brief medical procedures b) Stimulates liver enzymes and thereby may increase its own metabolism with repeated dosing c) Is mainly limited in drug therapy to induction of sleep d) Poses no affect on levels of folate (B9) or vitamin D in the body

41. Diazepam:

a) Suppresses neuronal activity within the limbic system b) Enhances impulses that might be transmitted to the reticular activating system c) Has little effect if any on tolerance d) Is relatively limited in its range of therapeutic usefulness

42. Clients with epilepsy often do not present with symptoms.

a) True b) False

43. The goal of anti-seizure medication is to completely suppress neuronal activity in the brain

a) True b) False

44. Abnormal mineral fluxes and blood glucose or protein levels may explain the occurrence of most seizures during pregnancy or childbirth

a) True b) False

45. Some anti-seizure medications may influence the rate of drug metabolism, decreasing the effectiveness of other drug therapies.

a) True b) False

46. In severe case of alcohol withdrawal, clients may experience seizures; however, anti-seizure medication is generally not given due to interactions with alcohol in the client’s bloodstream.

a) True b) False

47. Attention-deficit disorder (ADD) is 4 to 8 times more likely to occur in boys.

a) True b) False

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48. MAO Inhibitors (MAOIs) are drugs of choice for the treatment of simple depression.

a) True b) False

49. Tricyclic anti-depressants (TCAs) produce fewer cardiovascular side effects and therefore are less dangerous than MAOIs.

a) True b) False

50. Clients taking lithium should be placed on a salt-free diet to increase the effectiveness of the drug.

a) True b) False

51. Many clients suffering from schizophrenia have family members who have experienced the same disorder

a) True b) False

52. A family history of depression raises the risk for a client to experience biological depression.

a) True b) False

53. The most widely prescribed medication for attention-deficit disorder (ADD) is:

a) Methylphenidate (Ritalin) b) Dextroamphetamine (Dexedrine) c) Methamphetamine (Dexoxyn) d) Pemoline (Cylert)

54. Methylphenidate (Ritalin) produces its effects by activating what portion of the brain?

a) Cerebellum b) Hypothalamus c) Pituitary d) Reticular activating system

55. Methylphenidate (Ritalin) is closely related to which class of drugs?

a) Amphetamines b) Monoamine oxidase inhibitors c) Tricyclic antidepressants d) Phenothiazines

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56. Which of the following is not a common symptom of clinical depression?

a) Lack of energy b) Sleep disturbances c) Hallucinations d) Feelings of despair or guilt

57. Seasonal affective disorder (SAD) is a type of ______that may be treated with drug therapy.

a) ADD b) Psychosis c) Bipolar disorder d) Clinical depression

58. A client who has bipolar disorder will exhibit signs of both clinical depression and

a) Psychosis b) Schizophrenia c) Mania d) ADD

59. Rapid shifts in emotions from profound depression to euphoria and hyperactivity are characteristic of:

a) Psychosis b) Bipolar disorder c) Schizophrenia d) ADD

60. Which of the following would least likely be used to treat clinical depression?

a) Monoamine oxidase inhibitors b) Tricyclic antidpressants c) Selective serotonin reuptake inhibitors d) Phenothiazines

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Section 2: Designated Drugs for Administration by Midwives

Objectives

After completing this module the student will be able to:

1. Be familiar with designated drugs utilized by midwives 2. Be knowledgeable about relevant provincial governance documents 3. Understand which drugs Registered Midwives can prescribe on their own authority 4. Understand which drugs Registered Midwives can administer only on the order of a physician 5. Write a prescription 6. Create and use information cards to enhance safe practice 7. Be familiar with pregnancy drug risk categories A, B, and C

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Pregnancy Drug Risk Categories: A, B, C, D and X

The US Food and Drug Administration (FDA) has established a system of categories which classify medications into various risk levels when used in pregnancy. This system is also in use in Canada. The categories are:

A: Studies performed on animals and women have not demonstrated an increased risk to the fetus during pregnancy. Examples: Diclectin Levothyroxine Ferrous fumarate

B: Studies performed on animals have demonstrated no harm to the fetus, but no well controlled studies have been performed on women.

OR

Studies performed on animals have demonstrated an adverse effect, but well- controlled studies performed on women have not demonstrated any risk to the fetus. Examples: Amoxicillin Penicillin V Insulin (Humulin R)

C: Studies performed on animals have shown an adverse result. There have been no adequate studies performed on women.

OR

No adequate studies performed on animals or pregnant women have been performed. Examples: Acetaminophen Acyclovir Furosemide

D: Adequate studies or observational studies have been performed on pregnant women have proved a risk to the fetus. However, the benefits of therapeutic use of the drug may outweigh the potential risk. The use of the drug may be warranted if the situation is life-threatening or where drugs which are determined to be safer are ineffective. Examples: Amitriptyline Tetracycline Hydrochlorothiazide

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X: Controlled studies have demonstrated that there is a risk to the fetus. The use of this drug is contraindicated in women who may become pregnant. Examples: Thalidomide Tretinoin Oxymetholone

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Professional Responsibilities and Governance

Responsibilities

It is the responsibility of every Registered Midwife to be familiar with the following information related to designated drugs

• Drug names • Clinical indications • Recommended dosages • Side effects • Contraindications

Governance

Section 4 of An Act respecting the regulation of the Profession of Midwifery (1991): “…a member is authorized…to perform the following:

• Administering, by injection or inhalation, a substance designated in the regulations

• Prescribing drugs designated in the regulations

Ö Every midwife is responsible for the content of the CMO Registrant’s Binder which contains all midwifery governance documents

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Designated Drugs -Antenatal Care „ Dimenhydrinate „ Doxylamine succinate-pyridoxine hydrochloride „ Diphenhydramine hydrochloride „ Epinephrine hydrochloride „ Intravenous fluids „ RhD Immune Globulin „ Clotrimazole „ Miconazole „ Acetaminophen with or without 8 mg codeine „ Hydrocortisone anorectal therapy compound

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Drug Reference Cards - Designated Drugs Used in Antenatal Care

Dimenhydrinate • Trade Name: Gravol • Classification: Antiemetic, antihistamine, • Pregnancy Risk Category: B • Available forms: • Oral (capsules, tablets, liquids): OTC • Injectable (IM and IV): Rx • Indications: • Nausea and vomiting: as an adjunct to Diclectin for NVP; for acute episodes (GI infections) – may be given in conjunction with IV rehydration • Sedation: for prodromal labour • Usual dosage: 50 to 100 mg q 4-6h PO; 50mg q4-6h IM/IV prn • Adverse Effects: Drowsiness, constipation, dry mouth • Contraindications: sensitivity

Doxylamine succinate-pyridoxine hydrochloride • Trade Name: Diclectin • Classification: Anti-nauseant for NVP • Pregnancy Risk Category: A • Available forms: • Delayed-release tablets: Rx • Indications: • Nausea and vomiting of pregnancy • Usual Dosage: Two tablets at bedtime • Adverse Effects: drowsiness, , urinary retention, insomnia • Contraindications: No data available

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Diphenhydramine hydrochloride • Trade Name: Benadryl, Allerdryl, Nytol, Unisome; also in Benylin (cough syrup) • Classification: Antihistamine, antitussive • Pregnancy Risk Category: B • Available forms: • Oral (capsules, tablets, liquid): OTC • Topical (2% cream): OTC • Injectible: Rx • Indications: • Anaphylaxis • Seasonal allergies • Non-productive cough (URTI) • Skin rash in third trimester (PUPPS) • Sedation (prodromal labour) • Narcotic sensitivity (pruritis) • Usual Dosage: 25-50 mg q4-6hPO not to exceed 400mg/day; 10-50mg IM/IV not to exceed 400mg/day • Adverse Effects: Dizziness, drowsiness • Contraindications: Sensitivity; acute asthma attack

Epinephrine hydrochloride • Trade Name: Adrenalin, Epipen • Classification: , cardiac , vasopressor • Pregnancy Risk Category: C • Available forms: • Injectible (1:1000; 1: 10000): Rx • : Rx • Indications: • Anaphylaxis • Usual Dosage: 0.5 mg IV, repeat in 5 minutes if necessary • Adverse Effects: Tremors, anxiety • Contraindications: Hypersensitivity

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RhD Immune Globulin • Trade name: RhoGAM, WinRho SDF, BayRho-D • Classification: Immune globulin • Available forms: • Injectible: Rx • Pregnancy Risk Category: C • Indications: • Prevention of isoimmunization in non-sensitized Rh negative women; given both antenatally (at 28 weeks) and postpartum in Rh negative women who have given birth to an Rh positive baby • Contraindications: • isoimmunization; acceptance by Jehovah’s witnesses an individual conscience decision; written consent may be required for administration

Clotrimazole • Trade name: Canesten • Classification: Antifungal • Pregnancy Risk Category: B • Available forms: • Topical cream: OTC • Vaginal suppositories: OTC • Indications: • Vulvovaginal candidiasis • Cutaneous candidasis • Usual Dosage: Thin layer applied and massaged into affected area twice a day • Adverse Effects: Redness, stinging • Contraindications: hypersensitivity

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Miconazole • Trade Name: Monistat, Micazole • Classification: Antifungal • Pregnancy Risk Category: B • Available forms: • Topical cream: OTC • Vaginal suppositories: OTC • Indications: • Vulvovaginal candidiasis Usual Dosage: Adverse Effects: Contraindications: hypersensitivity

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Acetaminophen • Trade Name: Tylenol • Classification: • Pregnancy Risk Category: C • Available forms: • Oral (capsules, tablets, liquid): OTC • Indications: • Analgesia • Antipyretic • Usual Dosage: • Adverse Effects: • Contraindications: sensitivity; caution re: high doses, long term use re: liver function

Acetaminophen + Codeine • Trade Name: Tylenol #1 (8 mg codeine) • Classification: Opioid analgesic combination • Pregnancy Risk Category: C • Available forms: • Oral (capsules, tablets, liquid): OTC • 8 mg codeine: OTC • Indications: Analgesia postpartum • Usual Dosage: • Adverse Effects: • Contraindications: sensitivity; caution re: high doses, long term use re: liver function

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Hydrocortisone anorectal therapy compound • Trade Name: Anusol HC, Rectogel HC, Proctodan HC, Protofoam HC • Classification: Antipruritic, anti-inflammatory topical • Pregnancy Risk Category: C • Available forms: • Topical (gel, ointment, foam) • Suppositories • Indications: Hemorrhoid care (pregnancy and postpartum) • Usual Dosage: • Adverse Effects: • Contraindications: sensitivity

Antenatal Scenarios

Scenario 1: Ji Len

Ji Len is a primigravid woman in the 24th week of her pregnancy. Some of the information from her antenatal file includes: Age 40, VDRL negative, Blood Group A-, Hgb 108 g/dL

What intervention requiring a designated drug will the midwife be discussing and possibly providing within the next few weeks? What are the factors which will determine whether this intervention is indicated?

Scenario 2: Mojghan Nazran

You are at the annual Midwives’ Picnic which your practice and your clients celebrate together every June. One of your clients, Mojghan Nazran, is helping in the kitchen when she suddenly clutches her throat, is unable to breathe, and falls to the floor. By the time you reach her, her face is dark blue in colour. You suspect a food allergy. What will you do?

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Scenario 3: Jenny Kassel

Jenny Kassel is 18 weeks pregnant and calls you to complain that every time she has sexual intercourse she gets a yeast infection. She has tried probiotics, yogourt treatment, garlic, drinking a lot of water and avoiding sugar, coffee, and alcohol. She says she has always been prone to yeast infections, but they have usually responded to natural treatments. Now, she says, “Nothing seems to be effective.” She has a thick cottage cheese-like vaginal discharge and a red swollen vulva. Describe your assessment and management.

Scenario 4: Vivika Steinberg

Vivika Steinberg is 29 weeks pregnant and has continued to have headaches every few weeks. They are the same kind of “cluster headaches” she has experienced for the last five years related to eye strain, and shoulder tightness from sitting too long at the computer. She has been trying to avoid taking medication of any kind during pregnancy but she needs to give a presentation at work tonight and wants to know if she can safely take pain relief for her headache. Describe your assessment and management.

Scenario 5: Farrah Khalaf

Farrah Khalaf is 14 weeks pregnant, G3P2. She experienced nausea and vomiting with her first two pregnancies but she is finding it unbearable this time. Her vomiting has been so acute that she has not held down food or fluids for the past three days. She is unable to care for her toddlers because she feels so ill and has called her mother to help care for them. As a result of continued vomiting, the hemorrhoids she developed in her last two pregnancies are protruding and are extremely painful. She phones you feeling desperate for help. Describe your assessment and management.

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Reference Cards - Designated Drugs Used in Intrapartum Care

Designated Drugs Used in Intrapartum Care „ Oxytocin „ Ergonovine Maleate „ Carboprost „ Nitrous Oxide/Oxygen „ Lidocaine HCl with or without Epinephrine

Oxytocin • Trade Name: Oxytocin (also know as Syntocinon and Pitocin) • Classification: oxytocic hormone; uterotonic • Pregnancy Risk Category: A • Available forms: Injectible • Indications: • Active management of third stage of labour (postpartum hemorrhage) • Induction of labour • Usual Dosage: • 10 u IM, 20 u in 1000 cc NS or RL IV, 5 u IV push) • Adverse Effects: • Contraindications: hypersensitivity; (in labour) non-reassuring FHR, CPD

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Ergonovine Maleate • Trade Name: Ergotrate • Classification: Postpartum hemorrhage • Pregnancy Risk Category: Fetal risk cannot be ruled out • Available Forms: • Injectible: Rx • Indications: • Postpartum hemorrhage • Usual Dosage: • Administered IM (0.2 mg) or IV (0.1 mg); can be repeated up to maximum cumulative doses of 1.25 mg • Adverse Effects: Nausea, vomiting • Contraindications • Hypertension, retained placenta

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Carboprost • Trade Name: Hemabate • Classification: oxytocic, PGF2 analogue • Pregnancy Risk Category: C • Available forms: • Injectible (requires refrigeration) • Indications: • Postpartum hemorrhage resistant to treatment • Usual Dosage: • IM (0.25 mg), q 15 – 90 min intervals to a maximum of 2 mg • Adverse Effects: • Nausea, vomiting, diarrhea • Contraindications: Severe cardiac, renal, pulmonary or hepatic disease

Nitrous Oxide/Oxygen • Trade Name: Nitronox, Entonox (refers to the machinery used to blend the gases) • Classification: anesthetic • Pregnancy Risk Category: • Available form: • Inhalant • Indications: • Pain relief in advanced first stage or during second stage labour • During suturing • Usual Dosage: • Adverse Effects: • Contraindications: Woman unable to self-administer

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Lidocaine HCl with or without Epinephrine • Trade name: Xylocaine • Classification: Anesthetic • Pregnancy Risk Category: B • Available forms: • Injection • Topical • Indications: • Local anesthetic for suturing • Topical application for “pre-freezing” prior to perineal infiltration • To minimize discomfort of IV cannulation in hand or forearm • Usual Dosage: • Adverse Effects: • Contraindications: hypersensitivity

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Intrapartum Scenarios

Scenario 1: Lee-Yan

Lee-Yan is a 40-year-old G3P2 client who is in labour for a planned hospital birth at 41 weeks gestation. She is experiencing this labour as faster and more intense than the previous two. Although she did not have any pharmaceutical pain relief with her last two labours she is feeling panicked and thinks that she would like to have an epidural. When you perform a vaginal exam her cervix is 8cm dilated and the membranes spontaneously rupture with clear fluid five minutes later. Lee-Yan is having trouble coping and says this is the worst pain she has ever experienced, and says, “Can’t you give me something to help me with the pain?” What pharmaceutical options might you consider to support Lee-Yan and provide pain relief?

Scenario 2: Marilyn Bell

Marilyn Bell has just given birth after a 8 hour first stage and 90-minute second stage labour. Prenatally, you discussed active management of the third stage of labour, and she requested no oxytocin injection unless it was required. Her hemoglobin at 38 weeks was 130g/dL so you proceed with a plan for physiological management of third stage of labour. The placenta delivers spontaneously eight minutes after the birth of the baby, and blood loss at 10 minutes postpartum is approximately 400 mL. At one hour postpartum Marilyn has a full bladder and wants to walk to the toilet. As she stands up, she feels faint and there is a gush of blood followed by approximately 700 mL of clots. Describe your assessment and management.

Scenario 3: Susan Bisiek

Susan Bisiek has just given birth to a 4500g baby and when you examine Susan’s perineum you find a large second-degree laceration. Describe you will prepare the perineum for suturing.

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Reference Cards - Designated Drugs Used in Newborn Care

Designated Drugs – Newborn „ Erythromycin ophthalmic ointment „ Phytonadione „ Nystatin „ Hepatitis B Immune Globulin

Erythromycin ophthalmic ointment • Trade Name: Diomycin • Classification: antibiotic • Pregnancy Risk Category: B • Available forms: • Ointment (0.5%) • Indications: • Prophylactic against ophthalmia neonatorum • Public Health Law • Usual Dosage: • Adverse Effects: • Contraindications: none for infants

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Phytonadione (Vitamin K) • Trade Name: Not applicable • Classification: Fat-soluble vitamin • Pregnancy Risk Category: C • Available forms: • Injectible • Infant – 1 mg/0.5 mL • Adult – 10 mg/mL • Injectible form may be administered orally • Indications: • Prevention of hemorrhagic disease of the newborn • Contraindications: none known for infants • Usual Dosage: • Adverse Effects: • Contraindications:

Nystatin • Trade Names: Candistatin, Nilstat, Nyaderm • Classification: antifungal • Pregnancy Risk Category: C • Available forms: • Suspension (100,000 u/mL) • Cream • Powder • Vaginal suppositories • Indications: • Treatment of oral candiasis, diaper candidiasis in babies • Nipple candidiasis in mothers • Vulvovaginal candidiasis • Usual Dosage: • Adverse Effects: • Contraindications: hypersensitivity

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Hepatitis B Immune Globulin • Trade Name: BayHep B • Classification: Vaccine • Pregnancy Risk Category: C • Available Forms: • Injectible (given within 7 days of birth) • Indications: • Immunization against all subtypes of Hepatitis B virus in newborns born to Hepatitis B-positive women • Usual Dosage: • Adverse Effects: • Contraindications: none known for infants

Newborn Scenarios

Scenario 1: Vai Chiu

Vai Chiu gave birth to a healthy 3000g baby. In her files it states that she is positive for Hepatitis B. How will you treat her baby?

Scenario 2: Baby Rodriguez

Baby Rodriguez is 29 days old. He has been breastfeeding well until 2 days ago when he became irritable and cried with breastfeeding and diaper changes. His mother reports that he has white patches in his mouth and a red, raised rash around the anus. On examination of Baby Rodriguez you assess that candidias is present on the mother’s nipples and Baby Rodriguez’s mouth and anus. What will your treatment be?

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Section 2: Designated Drugs for Administration by Midwives Self-Testing Multiple Choice Questions

1. A teratogen is:

a) A substance having the potential to infection in HIV-positive users b) Any substance that will harm a developing fetus or embryo c) A drug used exclusively for research purposes d) A drug whose use is restricted without a prescription

2. Which of the following drug categories is the safest in terms of its teratogenic effects?

a) Category A b) Category B c) Category C d) Category D

3. The most harmful pregnancy risk category is:

a) Category AB b) Category C c) Category X d) Category D

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4. For the following questions match the Pregnancy Risk Categories in Column II with their descriptions in Column I

Column I Column II

a. Studies have NOT shown a risk to women or to the fetus

______Category A b. Use of this drug MAY cause harm to

the fetus, but it may provide benefit

to the mother if a safer therapy is not ______Category B available

c. Animal studies HAVE shown a risk ______Category C to the fetus, but controlled studies

have not been performed in women

______Category D d. Studies HAVE shown a significant

risk to women and to the fetus

______Category X e. Animal studies have NOT shown a risk to the fetus, or if they have, studies in women have not confirmed this risk.

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Section 2: Designated Drugs for Administration by Midwives Answer Key to Multiple Choice Questions

1. A teratogen is:

a) A substance having the potential to infection in HIV-positive users b) Any substance that will harm a developing fetus or embryo c) A drug used exclusively for research purposes d) A drug whose use is restricted without a prescription

2. Which of the following drug categories is the safest in terms of its teratogenic effects?

a) Category A b) Category B c) Category C d) Category D

3. The most harmful pregnancy risk category is:

a) Category AB b) Category C c) Category X d) Category D

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4. For the following questions match the Pregnancy Risk Categories in Column II with their descriptions in Column I

Column I Column II

a) Studies have NOT shown a risk to women or to the fetus

b) Use of this drug MAY cause harm ______Category A to the fetus, but it may provide

benefit to the mother if a safer

therapy is not available ______Category B

c) Animal studies HAVE shown a

risk to the fetus, but controlled ______Category C studies have not been performed

in women

______Category D d) Studies HAVE shown a

significant risk to women and to

the fetus ______Category X

e) Animal studies have NOT shown a risk to the fetus, or if they have, studies in women have not confirmed this risk.

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Writing a Prescription

What do you need to write?

• Client’s name, address, phone number (on pharmacy record, can contact client)

• Drug • Directions for administration • Amount (either number of tabs, size of vial/tube) • Signature and provider number

Exercise 1: Prescription for Diclectin

Write a prescription for Diclectin for Sarah Shaw who lives at 349 Sumach Road

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Rx Date______

Name______

Address______

Repeat______times

Signature______

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Exercise 2: Prescription for Clotrimazole

Write a prescription for clotrimazole for ______name____ for vaginal candidiasis. ___Name___ lives at 533 St. Andrew Lane.

Rx Date______

Name______

Address______

Repeat______times

Signature______

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Exercise 3: Prescription for Acetaminophen and Codeine

Moshjan Nadira lives at 2465 Milton Road. Moshjan is seven days postpartum and is experiencing perineal pain after a forceps delivery combined with a recurrent low-grade migraine headache. Write a prescription for acetaminophen and codeine appropriate for Moshjan’s situation.

Rx Date______

Name______

Address______

Repeat______times

Signature______

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Putting it All Together – Drugs in Midwifery Practice

It is important for Canadian Midwives to know legislation, standards of practice, designated drugs for administration by midwives, and community protocols may vary depending on geographic location.

The following two pages provide a description of what midwives may prescribe and pharmaceutical agents in usage in one province at the time of publication. These requirements will change over time and it is the responsibility of the Registered Midwife to be familiar with the details of the scope of practice in midwifery where she/he is practicing.

Midwives may Prescribe: • Prenatal vitamins, iron, antifungals, which may be covered by the client’s drug benefit program only if they are prescribed, not if they are bought over the counter • Compression stockings for varicosities (manufacturers often supply prescription pads) • Physiotherapy • Massage therapy • Abdominal support slings (in order for them to be covered by benefit programs)

Drugs on order of MD • Oxytocin for induction • Probably will require local “certification”: concentrations and protocols vary among institutions • Epidural analgesia • Continuous infusion maintenance: drugs used and protocols vary among institutions

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Narcotics • Morphine HCl • Meperidine HCl (Demerol) • Usually with dimenhydrinate (Gravol) or promethazine HCl (Phenergan) • Fentanyl (intravenously, patient-controlled) • Used for prodromal labour or for pain relief in labour • Must be knowledgeable about potential for respiratory depression in mother and baby • Effects on FHR tracings • Effects of meperidine on breastfeeding • Prepared for need for resuscitation in newborn if administered close to birth • Naloxone (Narcan)

Cervical Ripening Agents • Cervidil • Prepadil • Prostin

Barbiturates • Seconal (very rarely used)

Sedatives • Benzodiazapines • Diazepam (Valium) • Lorazepam (Ativan)

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Drug Reference Cards

Why do midwives need them?

To enhance safe practice where drugs are a part of care

• Easy reference for drugs most commonly encountered or used by clients or administered by midwives

• Information essential to provision of safe care, such as dosages, adverse effects, contraindications to use

• You can purchase drug information cards where you buy nursing or medical information texts or you can create your own

• You can customize your drug information cards to include prescribing guidelines and additional information specific to midwifery practice in your setting

Sources of Drug Information

• CPS: Compendium of Pharmaceuticals and Specialties • Advantage: Canadian • Disadvantages: Expensive, often need to know trade name to find drug

• Canadian Drug Pocket Clinical Reference Guide • Advantages: Canadian, compact • Disadvantages: less thorough information

• Nursing drug guides: • Advantages: usually thorough in information and well-organized • Disadvantages: often American, make sure you get one with Canadian information included

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Drug Reference Card Exercise

Sample Drug Reference Card to Review morphine injectible • Trade Name: Not applicable • Classification: Opioid analgesic: prescription • Pregnancy Risk Category: C • Available forms: • Injectible 10 mg/mL ampoules • Injectible 2 mg/mL ampoules • Indications: • Severe pain; pain relief for prodromal labour or active labour • Usual Dosage: • 5 – 20 mg IM q4h prn (usually with 50 mg dimenhydrinate or 25 mg Phenergan) • Adverse effects: • CNS: drowsiness, dizziness, confusion, headache, sedation • CV: palpitations, bradycardia, change in BP, shock, • EENT: tinnitus, blurred vision, miosis, diplopia • GI: nausea, vomiting, , constipation, cramps, biliary tract pressure • GU: urinary retention • HEMA: thrombocytopenia • INTEG: rash, urticaria, bruising, flushing, diaphoresis, pruritis • RESP: respiratory depression, respiratory arrest, apnea • Contraindications: hypersensitivity, addiction (opioid), hemorrhage, bronchial asthma, increased intracranial pressure • Contraindications: hypersensivity

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Complete the following three drug reference cards for meperidine, cervidil, diazepam

meperidine

• Trade name:

• Classification:

• Pregnancy Risk Category:

• Available forms:

• Indications:

• Usual Dosage:

• Adverse effects:

• Contraindications:

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cervidil

• Trade name:

• Classification:

• Pregnancy Risk Category:

• Available forms:

• Indications:

• Usual Dosage:

• Adverse effects:

• Contraindications:

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diazepam

• Trade name:

• Classification:

• Pregnancy Risk Category:

• Available forms:

• Indications:

• Usual Dosage:

• Adverse effects:

• Contraindications:

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Over the Counter Drugs commonly used by Pregnant Women: Î Antacids • Tums, Rolaids (calcium carbonate) • Gaviscon (aluminum hydroxide, magnesium trisillicate) • Zantac (ranitidine) • Pepcid AC (famotidine)

Î Pain relief • Tylenol (acetaminophen) • Non-steroidal anti-inflammatory (NSAID) drugs – especially late in pregnancy – may cause premature closure of ductus ateriosus (e.g. ibuprofen – Advil, Motrin – and ASA)

Prescription Drugs commonly used by pregnant women:

Î Antibiotics • Tip: if necessary, inquire about antibiotic therapy at time that GBS swab is done

Î Anti-depressants • Selective serotonin reuptake inhibitors (SSRIs) • paroxetine (Paxil) • fluoxetine (Prozac) • sertraline (Zoloft) • citalopram (Celexa)

Î Asthma medications • (Ventolin) • terbutaline (Bricanyl) • (Pulmicort) • fluticasone (Flovent)

Î Thyroid medication • levothyroxine (Synthroid, Eltroxin)

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Safety of drugs in pregnancy and breastfeeding

Pregnancy and breastfeeding are both unique situations in which the fetus, newborn, and infant are at risk from drugs taken by the mother, and transmitted via the placenta or through breast milk. Due diligence by midwives regarding risk prevention and reduction is a critical part of midwifery care.

• Be aware of all drugs taken by the client, with our without a prescription

• If you don’t know what a drug is, look it up and learn about it

• When documenting medications be careful to use correct spelling and dosages

• If you have concerns about medications prescribed by other providers or taken without prescription, work collaboratively with physicians and other appropriate health care providers to assess and help the client manage drug use. Do not provide independent advice to women about medications prescribed by other care providers

• There are numerous text and journal sources addressing the risks of medications in pregnancy and during breastfeeding. One reputable website for midwives and clients to research safety of drugs is www.motherisk.org

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Section 3: Standards and Guidelines For Prescribing, Ordering and Administering Controlled Substances

This section reflects standards and guidelines under consideration in proposed legislative changes at the time of publication. It may not reflect the place of controlled substances in the scope of midwifery practices in some jurisdictions.

Objectives

After completing this module the student will be able to:

1. Independently prescribe, order, and administer controlled substances to women and newborns in midwifery care.

2. Understand the standards and guidelines of narcotics for prescribing, ordering, and administering controlled substances.

3. Identify indications for use of controlled substances.

4. Use appropriate routes of administration and dosage limits.

5. Be aware of contraindications and recognize adverse effects of controlled substances.

6. Follow standards for control and abuse prevention.

The following are national standards and guidelines for midwives to independently prescribe, order and administer controlled substances to women and, where indicated, newborns in their care, as designated under federal and provincial/territorial regulation.

These standards and guidelines provide midwifery indications, routes of administration and upper dosage limits where appropriate, adverse effects and contraindications for the use of these drugs, as well as standards for control and abuse prevention.

Storage and administration of narcotics:

All narcotics at the midwifery practice must be kept under lock and key.

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A physician’s order is required in order to administer narcotics to a client.

Upon administration of narcotics a client the client’s surname and initials must be printed on the narcotic administration record each time a dose is administered to the client. The midwife must sign her full signature and qualifying initials (RM). The midwife must sign the narcotics out at the time of administration. Another entry must be made if another dose is administered to the client at a later time.

Any midwife leaving the practice facility must return the key immediately.

Use of fentanyl and morphine epidurals

Indications for use: Epidural analgesia during first and second stage labour

Epidural analgesia during caesarean section

When considering a client for epidural use, the client should meet the following criteria:

The client needs epidural analgesia during first and second stage labour or Caesarean section

The client is mentally alert and able to understand the procedure

The client does not have a history of substance abuse

The client has not experienced hypersensitivity to morphine or fentanyl in the past

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Controlled Substances Available for use by Midwives in Canada

Controlled Substances for Use in Prodromal Labour

• lorazepam (Ativan)

• oxazepam (Serax)

Controlled Substances for Use in Active Labour

• Fentanyl citrate

• Morphine sulphate

• Meperidine (Demerol)

• Naloxone (Narcan) Controlled Substances for Use in the Postpartum Period

• Tylenol No. 2

• Tylenol No. 3

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S Drug Information

Lorazepam (Ativan®). Lorazepam is a that can be used for therapeutic rest during prodromal labour, particularly where anxiety is a factor.

Standard Midwives may only prescribe, order or administer lorazepam on their own authority for therapeutic rest in prodromal labour and not for any other purpose. Administration under any other circumstance must be on the order of a physician. All practitioners caring for an individual taking a benzodiazepine should be aware that long-term use can result in dependency and withdrawal symptoms when the medication is discontinued.

Guidelines for Administration Dose and administration: Usual dose is 1-2 mg sublingually. Lorazepam by injection should not be used in an obstetric situation. Dose may be repeated 12 hours later if needed and labour is not yet active. No more than two consecutive doses should be given. The sublingual tablet, when placed under the tongue will dissolve in approximately 20 seconds. The woman should not swallow for at least 2 minutes to allow sufficient time for absorption.

Adverse effects: Lorazepam is given for the purpose of promoting sleep or rest in early labour. It may cause drowziness, blurred vision, dizziness and impair concentration. Women taking this medication should not operate machinery or drive a vehicle. It should not be taken in combination with alcohol or other sedating medications. Other potential side effects include lack of muscle coordination, nausea, constipation, visual disturbances, skin rash, and loss of bladder control. If breathing difficulties, fainting, rash or hypotension are experienced a physician should be contacted immediately.

Clinical judgement should be exercised as the half-life of lorazepam is 12 to 15 hours, the half-life of the conjugate is 16 to 20 hours, and lorazepam does cross the placental barrier. Should labour progress more rapidly than anticipated, naloxone may be required and should be readily available for administration to the mother or neonate. Physician consultation is required after administration if naloxone needs to be administered.

Contraindications: Lorazepam should not be taken in conjunction with alcohol. Benzodiazepines should not be used with women who have the following medical conditions: glaucoma, liver or kidney impairment, hyperkinesias, hypoalbuminaemia,

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module myasthenia gravis, or any type of organic brain disorder. Benzodiazepines should not be given to women with a history of drug abuse or dependency. Before prescribing, ordering or administering a benzodiazepine to a woman with a depressive, chronic psychotic, phobic or obsessive behavioural disorder or potential suicidal tendancies, consultation with a physician is required.

Benzodiazepines are contraindicated in the first trimester of pregnancy because of the potential for congenital malformations. Women taking these drugs to treat anxiety disorders should be advised of the risk and offered alternate approaches to therapy. Prolonged doses of benzodiazepines during pregnancy may cause with resulting withdrawal symptoms in the newborn. While a physican may prescribe a benzodiazepine for postpartum psychosis, these medications do enter breast milk and, if used by nursing mothers, midwives should watch for possible sedation, feeding difficulties and in the newborn.

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Drug Reference Card Exercise

X lorazepam

• Trade Name: Ativan

• Classification:

• Pregnancy Risk Category: D

• Available Forms:

• Indications:______

______

• Usual Dosage: 1 – 2 mg SL

• Adverse Effects:______

______

• Contraindications: Lorazepam should not be taken with alcohol.

Using the information provided in the Drug Information section complete each drug card.

Scenario 1: Carmen Doulabi Carmen Doulabi is a midwifery client, 38 years old, G1P0, and is at 40 weeks +2 days. She has had a normal pregnancy, and she has called you in early prodromal labour at 1:30 am with mild contractions every 10 to 15 minutes. In clinic he day before, her cervix was soft, 1 cm dilated with no effacement. She has felt fetal movement and amniotic membranes are intact. Having been reassured by you, she tries to go to sleep, but finds after 6 hours she is still awake and walking around her house nervously She is now very tired but anxious. She would like to be given something to help her sleep before active labour is established, and you assess that she is an appropriate candidate for a 2 mg dose of lorazepam sublingually. What factors did you consider before you made this decision?

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S Drug Information

Oxazepam (Serax). Oxazepam is a benzodiazepine that may be used for therapeutic rest during prodromal labour.

Standard Midwives may only prescribe, order or administer Oxazepam on their own authority for therapeutic rest in prodromal labour and not for any other purpose. Administration under any other circumstance must be on the order of a physician. All practitioners caring for an individual taking a benzodiazepine should be aware that long-term use can result in dependency and withdrawal symptoms when the medication is discontinued.

Guidelines for Administration Dose and administration: Usual dose is 15 or 30 mg orally. Oxazepam by injection should not be used in an obstetric situation. Dose may be repeated 8 or 12 hours following first dose if active labour is not yet established. No more than two consecutive doses should be given.

Adverse effects: Oxazepam is given for the purpose of promoting sleep or rest in early labour. It may cause drowziness, blurred vision, dizziness and impair concentration. Women taking this medication should not operate machinery or drive a vehicle. It should not be taken in combination with alcohol or other sedating medications. Other potential side effects include lack of muscle coordination, nausea, constipation, visual disturbances, skin rash, and loss of bladder control. If breathing difficulties, fainting, rash or hypotension are experienced a physician should be contacted immediately.

Clinical judgement should be exercised as the half life of Oxazepam is 5 to 15 hours and it does cross the placental barrier. Should labour progress more rapidly than anticipated Naloxone may be required and should be readily available for administration to the mother or neonate. Physician consultation is required after administration if Naloxone needs to be administered.

Contraindications: Oxazepam should not be taken in conjunction with alcohol. Benzodiazepines should not be used with women who have the following medical conditions: glaucoma, liver or kidney impairment, hyperkinesias, hypoalbuminaemia, myasthenia gravis, or any type of organic brain disorder. Benzodiazepines should not be given to women with a history of drug abuse or dependency. Before prescribing, ordering or administering a benzodiazepine to a woman with a depressive, chronic

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module psychotic, phobic or obsessive behavioural disorder or potential suicidal tendancies, consultation with a physician is required. Benzodiazepines are contraindicated in the first trimester of pregnancy because of the potential for congenital malformations. Women taking these drugs to treat anxiety disorders should be advised of the risk and offered alternate approaches to therapy. Prolonged doses of benzodiazepines during pregnancy may cause physical dependence with resulting withdrawal symptoms in the newborn. While a physican may prescribe a benzodiazepine for postpartum psychosis, these medications do enter breast milk and, if used by nursing mothers. midwives should watch for possible sedation, feeding difficulties and weight loss in the newborn.

X oxazepam

• Trade Name: Serax

• Classification:

• Pregnancy Risk Category:

Available Forms:______

• Indications: Therapeutic rest during prodromal labour

• Usual Dosage: ______

• Adverse Effects: Excessive drowsiness, dizziness, blurred vision, impaired concentration

• Contraindications: Oxazepam should not be taken with alcohol

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Scenario 2: Jennifer Rowat Jennifer Rowat is a midwifery client, G3P2 and she is 41 weeks gestation. She calls you at midnight in prodromal labour after 2 hours of mild contractions every 10 to 15 minutes. She is feeling very anxious and remembers the pain she experiencec in her last labour and want to know if there is anything you can give her to help her rest. In addition, she was treated for postpartum depression for one year after her second baby, and thinking about this is making her more anxious. How can you respond to Jennifer’s needs? Describe how you will assess if she is an appropriate candidate for oxazepam, and what your decision is.

Drug Information

Fentanyl citrate Fentanyl Citrate (fentanyl) is a short-acting opioid that is administered intravenously as an analgesic for pain relief in labour.

Standard Midwives may only prescribe, order or administer fentanyl on their own authority for the purpose than pain relief in labour and not for any other purpose. Administration under any other circumstance must be on the order of a physician. Naloxone should be readily available for administration to the mother or neonate. Physician consultation immediately after administration is required if Naloxone needs to be given.

Guidelines for Administration Fentanyl is useful in early active labour, when a multiparous woman having a rapid, intense labour is requesting analgesia, and for women who wish pain relief and have a contraindication to epidural analgesia or where epidural is not available.

Dose and administration: Dilute 100 micrograms (2mls – 2cc ampoule) into 8mls normal saline to obtain 10 mls solution (concentration 10mcg/ml) and give IV during a contraction. The recommended weight-based dose is 0.5 mcg/kg over 30 seconds waiting 5 minutes for effect and repeating every 5 minutes until satisfactory pain relief or a total maximum dose of 2mcg/kg/hr (or 200mcg/hr, or 4 doses in 1 hr) has been given. Alternatively, with continuous maternal O2 saturation monitoring, doses up to 1mcg/kg (max 100mcg) can be given initially with repeat dosing every 15 -20 minutes to a total of 200mcg/hr (or 2 doses). Once a total does of 3 mcg/kg has been administered epidural or other alternate pain relief measures should be considered.

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Fentanyl has an onset time of 3 -5- minutes, takes peak effect in 5 – 15 minutes, a duration effect of < 1 hour, a maternal T ½ of less than 1 hour and a neonatal T ½ of 1 – 6 hours. It has no active metabolites and produces less maternal sedation, nausea, and vomiting than morphine.

Adverse effects: As with other opioids, fentanyl can depress maternal and newborn respiration. Extra caution should be observed if fentanyl use continues for more than 5 hours or a total dose of 300 mcg has been administered. The larger the maternal dose, the more likely the neonate is to be depressed. O2 saturation monitoring of the newborn is advised for at least 2 hrs after birth whenever more than 250 mcg have been given. As with any narcotic, watch for aspiration, drowsiness, hypotension, obtunded reflexes in addition to respiratory depression.

Monitoring: One to one care must be provided. Monitor maternal vital signs, including respirations, and sedation scores for 30 minutes after IV fentanyl administration, then hourly for 4 hours.

Monitor maternal oxygen saturation for 5 minute periods if bolus does of 2 mcg/kg or total doses greater than 200mcg/hr are used or if morphine or meperidine has been administered IM in the 3 hours preceding IV fentanyl administration. A physician should be consults if O2 saturations falls below 94%.

Contraindications: Fentanyl should not be used when the woman has PIH, is hypotensive or hypovolemic, has liver or kidney disease, is obese (BMI greater than 35), in preterm labour, at high risk of emergency caesarean delivery (e.g. breech) or has respiratory compromise (e.g. severe asthma, cystic fibrosis) or is allergic to fentanyl. Fentanyl should not be used in the presence of non-reassuring fetal heart tones or in the second stage of labour. Fentanyl should be used with caution in multiple pregnancy, where a woman has a history of difficult intubation or who has already received more than one dose of a longer acting narcotic in labour.

Fentanyl citrate

Trade Name:

Classification:

Pregnancy Risk Category: C

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Available Forms:

Indications: Used in early active labour for multiparous women having rapid, intense labour; for women who need analgesia but have contraindications to epidurals

Usual Dosage: ____ mcg/__ mL in ___mL of normal saline to obtain 10 mL of solution to be given IV during a contraction

Adverse Effects: Respiratory depression for both the mother and baby, drowsiness, hypotension

Contraindications: ______

______

Drug Information

Morphine sulphate Morphine suphate (morphine) is an opioid that can administered intramuscularly as an analgesic for pain relief in labour.

Standard Midwives may only prescribe, order or administer morphine on their own authority for the purpose of pain relief in labour and not for any other purpose. Administration under any other circumstance must be on the order of a physician. Naloxone should be readily available for administration to the mother or neonate. Physician consultation immediately after administration is required if Naloxone needs to be given.

Guidelines for Administration Morphine has a similar analgesic action as Demerol (Meperidine), but with less nausea and fewere significant side effects for the neonate. As morphine is more sedating and has a longer half life than fentanyl, it should be reserved for early labour analgesia when intramuscular administration will provide longer relief, or for women who do not want IV access in labour.

Dose and administration: Usual dose is 10 – 15 mg IM every 4 hours. IM injections act in 15 – 20 minutes, peak effect is in 40-50 minutes, and effect duration is 3 – 4 hours.

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Morphine may also be given in a 3 – 5 mg dose IV bolus every 10 minutes prn for 1 -2 hours of relief. IV administration may be particularly appropriate for the nulliparous woman seeking pain relief in early active first stage. Morphine should not be administered subcutaneously as consistency of uptake and effectiveness cannot be determined.

Morphine has a maternal T ½ life of 1 hour and a neonatal T ½ life of 6 hours. It has no active metabolites. Morphine may be used up to 4 hours prior to anticipated delivery. Most infants delivered 3 hours after a dose have been found to have no detectable cord levels.

Dimenhydrinate (Gravol) 25 mg IV or 25 -50 mg IM is often given with morphine to counteract the side effects of nausea and vomiting. (The two drugs are compatible in a syringe for only 15 minutes.) While it is considered safe, Gravol may produce some sedation.

Adverse effects: As with other opioids, morphine can depress maternal and newborn respiration. The larger the maternal dose, the more likely the neonate is to be depressed. As with any narcotic, watch for aspiration, drowsiness, hypotension, obtunded reflexes, in addition to respiratory depression and urinary retention.

Monitoring: Assess maternal and fetal well-being prior to morphine administration, 15 minutes post administration and every 1 to 4 hours thereafter. Determine cervical dilation prior to administration. Generally a nullipara should be less than 7 cm and a multipara less than 4 cm. With IM administration, protocols in some centres allow the woman to be discharged home in early labour if both mother and fetus are well.

Contraindications: Morphine should not be used in the presence of non-reassuring fetal heart tone, in late first stage active labour, or the second stage of labour.

X Morphine sulphate

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• Trade Name:

• Classification:

• Pregnancy Risk Category: C

• Available Forms:

• Indications: For analgesia during labour

• Usual Dosage: ______

• Adverse Effects: CNS depression, respiratory depression, nausea, pruritis

• Contraindications: ______

• ______

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S Drug Information

Meperidine (Demerol) Meperidine is an opioid analgesic that is used to relieve moderate to severe pain during labour.

Standard Midwives may…

Guidelines for Administration Dose and administration: Usual dose is 50 to 100 mg IM or SC when contractions occur at regular intervals, with an onset of action of 10 to 15 minutes. The dose may be repeated 1 to 3 hours as needed.

Adverse effects: Respiratory depression, drowsiness, sedation, weakness, headache, nausea, vomiting, constipation, pruritis.

Contraindications: Hypersensitivity, addiction.

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meperidine

• Trade Name: Demerol

• Classification:

• Pregnancy Risk Category: C

• Available Forms:

• Indications: ______

______

• Usual Dosage: 50 to 100 mg SC or IM when contractions occur regularly; repeat 1-3h prn

• Adverse Effects: drowsiness, dizziness, CNS depression

• Contraindications: hypersensitivity, addiction to narcotic substances

Drug Information

Naloxone Hydrochloride (Narcan®). Naloxone Hydrochloride (naloxone) is used to reverse narcotic-induced depression in the neonate.

Standard Naloxone should be given to a newborn with respiratory depression as a result of administration of a narcotic analgesic to the mother in labour. Physician consultation immediately after administration is required if naloxone needs to be given.

Guidelines for Administration Dose and administration: The usual newborn dose is 0.1 mg/kg. (Neonatal Resuscitation Program Standard). Give rapidly by IV or ET. IM and SC routes also acceptable. May repeat dosage at 2-3 minute intervals.

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Naloxone is available in concentrations of 0.4 mg/mL and 1 mg/mL. Choose 1 mg/mL concentration when available as this will result in a smaller volume to be administered.

Concentration Dosage Weight Total dose Total mL 0.1 mg/kg 0.4 mg/mL 3 kg 0.3 mg 0.75 mL 0.25 mL/kg 0.1 mg/kg 1.0 mg/mL 3 kg 0.3 mg 0.3 mL 0.1 mL/kg

X naloxone Trade Name: Narcan

Classification:

Pregnancy Risk Category: C

Available Forms:

Indications:

Usual Dosage: ______

______

Adverse Effects: drowsiness, nervousness, increased pulse, nausea, vomiting

Contraindications: Hypersensitivity, respiratory depression

S Drug Information

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Acetaminophen with Codeine (Tylenol with Codeine) Tylenol #2, Tylenol #3

Tylenol #2 and Tylenol #3 are used for analgesia in the postpartum period.

Standard Midwives may prescribe Tylenol #2 and Tylenol #3….

Guidelines for Administration Dose and administration: Usual dose is 1 to 2 tablets by mouth every 4 to 6 hours as needed for postpartum pain.

X acetaminophen compound (acetaminophen 300 mg, 15 mg, codeine 15 mg Trade Name: Tylenol # 2, Atasol 15

Classification: Analgesic

Pregnancy Risk Category: C

Available Forms:

Indications: ______

______

Usual Dosage: 1 or 2 tablets q4h prn

Adverse Effects: CNS depression, constipation, shortness of breath, pruritis

Contraindications: Hypersensitivity to acetaminophen, caffeine or codeine

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X acetaminophen compound (acetaminophen 300 mg, caffeine 15 mg, codeine 30 mg) Trade Name: Tylenol #3, Atasol 30

Classification: Analgesic

Pregnancy Risk Category: C

Available Forms:

Indications:

Usual Dosage:

Adverse Effects: ______

Contraindications: ______

______

STANDARDS for Control and Prevention of Diversion or Abuse of Controlled Substances

Midwives may only prescribe, order or administer the above controlled substances within the above standards and guidelines and to a woman or newborn under their professional treatment where the drug is required for the purposes outlined above. It is unethical and prohibited for a midwife to prescribe or administer any of the above controlled substances to herself/himself or to a member of her/his immediate family.

Prescriptions should be written so that they are difficult to alter. Prescription pads should be stored out of sight in the office and never left unattended in a medical bag. Verbal prescriptions are not permitted. No refills are allowed. Midwives are required to maintain records for all purchasing, receiving, prescribing, ordering, administering or disposing of controlled substances within their midwifery practice by following hospital protocols and midwifery regulatory standards for such records, including maintaining a log book that tracks any controlled substances transported or stored outside of a hospital.

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If any of these controlled drugs are to be destroyed because they are out of date or no longer needed, destruction by the midwife must be witnessed by another midwife, a physician, a registered nurse, nurse practitioner or a pharmacist. Unwanted supplies of these drugs may also be surrendered to the pharmacist from whom they were obtained.

Midwives must take reasonable steps to protect controlled substance from loss or theft. Any losses or thefts must be reported to Health Canada’s Office of Controlled Substance, to the midwife’s provincial or territorial midwifery regulatory body and if required, to a law enforcement agency.

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Section 3: Narcotics and Controlled Substances Self-Testing Multiple Choice Questions

1. The most commonly abused drugs are illegal substances

a) True b) False

2. Several drugs once used for therapeutic purposes are now considered illegal

a) True b) False

3. Which of the following statements about addiction is not correct?

a) Addiction is most likely a neurobiological problem linked closely to the client’s psychological state and social setting b) In some cases, addiction may begin with the client’s medical need for treatment of an illness c) The therapeutic use of narcotics and sedatives creates large numbers of addicted clients. d) Attempts to predict a client’s addictive tendency using psychological profiles or genetic markers have largely been unsuccessful.

4. Despite their potential to cause dependence, opioids are often used for pain relief because they:

a) Help the client sleep b) Can be taken once a day c) Are more efficacious than other analgesics d) Produce less withdrawal than other addictive drugs

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5. When a person has an overwhelming desire to take a drug and cannot stop, this is directly referred to as:

a) Addiction b) Dependence c) Tolerance d) Withdrawal

6. Physical dependence refers to an altered physical condition caused by the nervous system adapting to repeated drug use.

a) True b) False

7. Once a client becomes psychologically dependent and the substance is discontinued, classic withdrawal symptoms occur

a) True b) False

8. Immunity is a condition in which progressively higher doses of the drug is required in order to produce the same effect.

a) True b) False

9. The most common method by which nicotine enters the body is through the inhalation of cigarette, pipe, or cigar smoke.

a) True b) False

10. Marijuana smoke does not produce a significantly higher risk of lung cancer than cigarette smoke.

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a) True b) False

11. Drug effects from hallucinogens are highly variable and dependent upon the mood and expectations of the user and the surrounding environment in which the drug is used.

a) True b) False

12. Amphetamines, , methylphenidate, and caffeine are examples of misused CNS stimulants.

a) True b) False

13. Most abused CNS depressants are either controlled or illegal.

a) True b) False

14. Lorazepam is used by midwives

a) To treat agitation during early active labour b) To facilitate therapeutic rest during prodromal labour c) To slow tetanic contractions during pre-labour d) To help calm the woman so she can focus on coping with regular contractions

15. Lorazepam must only be administered under a physician’s order.

a) True b) False

16. Lorazepam by injection is never indicated in obstetric situations

a) True

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b) False

17. The usual dose of lorazepam in an obstetric situation is:

a) 1 mg to 2 mg PO b) 0.5 mg PO c) 1 mg to 2 mg S/L d) 0.5 mg to 1 mg S/L

18. Asking the woman to not swallow for ______allows for proper absorption of lorazepam

a) 1 minute b) 2 minutes c) 30 seconds d) 5 minutes

19. Lorazepam has a half-life of

a) 2 to 12 hours b) 12 to 15 hours c) 10 to 20 hours d) 12 to 24 hours

20. Side effects of lorazepam include

1) Dizziness 2) Restlessness 3) Nausea 4) Increased alertness

a) 1, 2, 3 b) 1, 3 c) 2, 3, 4 d) 1, 4

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21. This drug should always be available to reverse any effects of lorazepam

a) Norepinephrine b) Dimenhydrinate c) Naloxone d) Magnesium sulphate

22. Lorazepam should not be administered in the second trimester.

a) True b) False

23. Oxazepam belongs to the drug class of:

a) Anti-convulsants b) Benzodiazepines c) Anti-arrythmias d) Narcotic analgesics

24. The usual dose of oxazepam is

a) 10 mg or 15 mg PO b) 15 mg or 30 mg PO c) 15 mg or 20 mg PO d) 5 mg or 10 mg PO

25. It is safe to administer oxazepam for up to 3 consecutive doses

a) True b) False

26. A physician should be contacted immediately if a woman experiences any of the following after administration of oxazepam

a) Fainting b) Difficulty breathing

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c) Rash d) All of the above

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27. Benzodiazepines can cause ______when used in the first trimester of pregnancy

a) Feeding difficulties in the baby. b) Withdrawal symptoms in baby c) Congenital malformations d) Postpartum depression in the mother

28. Benzodiazepines can be used without worry postpartum because they do not enter breast milk

a) True b) False

29. Fentanyl can only be prescribed by a physician during labour

a) True b) False

30. Fentanyl is used only during the ______stage of labour a) Late b) Early active c) Transitional d) Fourth

31. The usual dose of fentanyl is

a) 1 mcg/kg over 1 minute b) 2 mcg/kg over 1 hour c) 0.5 mcg/kg over 30 seconds d) 0.5 mcg/kg over 1 minute

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32. The maximum dose of fentanyl, without maternal O2 saturation monitoring that should not be exceeded is:

a) 3 doses in two hours b) 4 doses in one hour c) 3 doses in one hour d) 4 doses in two hours

33. The maximum dose of fentanyl that can be given when maternal O2 saturation is monitored is:

a) 0.5 mcg/kg, repeated every 10 to 15 minutes, to a maximum of 100 mcg/hour b) 1 mcg/kg, repeated every 15 to 20 minutes, to a maximum of 200 mcg/hour c) 1 mcg/kg, repeated every 20 to 30 minutes, to a maximum of 200 mcg/hour d) 2 mcg/kg, repeated every 20 to 30 minutes, a maximum of 100 mcg/hour

34. Once administered you can expect fentanyl to take effect

a) Almost immediately b) In 3 to 5 minutes c) In 5 to 10 minutes d) In 20 minutes

35. Fentanyl has a maternal half-life of

a) 30 minutes b) 1 hour c) 90 minutes d) 2 hours

36. Fentanyl has a neonatal half-life of

a) 5 to 10 hours b) 30 minutes to 2 hours c) 1 to 6 hours d) 2 to 8 hours

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37. Fentanyl may produce fewer side effects, compared to morphine

a) True b) False

38. As fentanyl can cause respiratory depression, it may be important to monitor the neonate’s O2 saturation after birth for at least

a) 30 minutes b) 2 hours c) 3 hours d) 1 hour

39. Maternal O2 saturation should be monitored every ______if morphine or meperidine has been given to the woman before fentanyl has been administered

a) 20 minutes b) 5 minutes c) 30 minutes d) 1 hour

40. Some contraindications against the use of fentanyl include:

1) Pregnancy induced hypertension 2) Maternal obesity 3) Diabetes 4) Kidney disease

a) 2, 4 b) 1,3, 4 c) 1, 2, 4 d) 2, 3, 4

41. Morphine may be administered in an obstetric situation by subcutaneous route only

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a) True b) False

42. Midwives may prescribe morphine for pain in labour only

a) True b) False

43. Meperidine (Demerol) is sometimes preferred over morphine because it causes fewer side effects

a) True b) False

44. Morphine should be reserved for times when it is predicted that longer periods of relief will be needed or when the woman does not want an IV inserted.

a) True b) False

45. The usual dose of morphine is

a) 4 to 6 mg every 6 hours b) 10 to 15 mg every 4 hours c) 5 to 10 mg every 4 hours d) 2 to 4 mg every 4 hours

46. After administration, you can expect morphine to take effect in

a) 5 to 10 minutes b) 15 to 20 minutes c) 10 to 30 minutes d) 20 to 40 minutes

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47. ______can be given at the same time to relieve ______that may result from administering morphine. The two drugs are compatible in the same syringe for ______

a) Dimenhydrinate; nausea and vomiting; 15 minutes b) Dimenhydrinate; pruritis; 15 minutes c) Diphenhydramine; pruritis; 20 minutes d) Diphenhydramine; nausea; 20 minutes

48. Before administering morphine it is important to assess the woman’s ______.

a) Frequency of contractions b) Cervical dilation c) Fundal height d) Blood pressure

49. Naloxone is used as an ______to narcotics, to ______their effects

1) Antidote 2) Synergistic agent 3) Reverse 4) Enhance

a) 2, 3 b) 1, 3 c) 2, 4 d) 1, 4

50. A physician should be consulted immediately after the administration of naloxone

a) True b) False

51. The usual dose of naloxone for a newborn is

a) 0.2 mg/kg b) 0.1 mg/kg

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c) 0.2 mg/100 g d) 0.1mg/100 g 52. Midwives are allowed to give verbal prescriptions to clients only for products containing acetaminophen and codeine.

a) True b) False

53. It is acceptable to co-sign for wastage of narcotics with a midwifery student.

a) True b) False

54. ______Name______is getting her birthing bag ready for the delivery of her client’s baby. She needs to obtain some narcotics for the birth from the midwifery practice. She will:

a) Take the drugs and sign them out after the birth so she can record what she used during the birth. b) Sign them out with a second midwife as a witness and log the names and quantities of the drugs she has taken into her log book. c) Sign out the drugs she needs without a witness and let another midwife know before she leaves the midwifery practice clinic. d) Not sign them out as all midwives should know that the drugs will be used for a birth anyway, so no record keeping is necessary.

55. ______Name____ is making sure her birthing bag is ready for the next deliver and notices that she has a number of expired narcotics in the birthing bag. What are the proper procedures for disposal of the expired narcotics?

a) Record that the narcotics are expired and dispose of them without a witness b) Discard them as they are expired and can no longer be used. c) Record that they are expired in the logbook, discard them with a second midwife as a witness, and obtain the second midwife’s signature for disposal of the expired narcotics d) Discard the narcotics and then ask for second midwife’s signature in the logbook.

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56. ____Name_____ is at a birth and uses only part of an ampoule of fentanyl. Proper procedure dictates that the midwife must

a) Discard the remainder and then ask for a second midwife’s signature. b) Obtain a co-signature of the second midwife before disposal of the remainder of the narcotic. c) Record only the dose that she gave to the client. d) Have the client verify the dose that was given.

57. The following are drugs that the midwife may inject on her/his own responsibility, according to the Midwifery Act, 1991:

1) Ketorolac 2) Carboprost 3) Lidocaine 4) Meperidine

a) 1, 2, 4 b) 2, 3 c) 1, 4 d) 3, 4

58. The registered midwife requires a physician’s order in order to use the following medications in the practice of midwifery.

a) Acetaminophen with codeine b) Clotrimazole c) Dimenhydrinate d) RhD immune globulin

59. A registered midwife requires a physician’s order to inject the following medications:

a) Phytonadione b) Hepatitis B vaccine c) Epinephrine d) Antibiotics

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60. The registered midwife may administer the following on her/his own responsibility:

a) Intravenous fluids for rehydration b) Narcotics c) Barbiturates d) Sedatives

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Section 3: Narcotics and Controlled Substances Answer Key to Multiple Choice Questions

1. The most commonly abused drugs are illegal substances

a) True b) False

2. Several drugs once used for therapeutic purposes are now considered illegal

a) True b) False

3. Which of the following statements about addiction is not correct?

a) Addiction is most likely a neurobiological problem linked closely to the client’s psychological state and social setting b) In some cases, addiction may begin with the client’s medical need for treatment of an illness c) The therapeutic use of narcotics and sedatives creates large numbers of addicted clients. d) Attempts to predict a client’s addictive tendency using psychological profiles or genetic markers have largely been unsuccessful.

4. Despite their potential to cause dependence, opioids are often used for pain relief because they:

a) Help the client sleep b) Can be taken once a day c) Are more efficacious than other analgesics d) Produce less withdrawal than other addictive drugs

5. When a person has an overwhelming desire to take a drug and cannot stop, this is directly referred to as:

a) Addiction b) Dependence c) Tolerance d) Withdrawal

6. Physical dependence refers to an altered physical condition caused by the nervous system adapting to repeated drug use.

a) True b) False

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7. Once a client becomes psychologically dependent and the substance is discontinued, classic withdrawal symptoms occur

a) True b) False

8. Immunity is a condition in which progressively higher doses of the drug is required in order to produce the same effect.

a) True b) False

9. The most common method by which nicotine enters the body is through the inhalation of cigarette, pipe, or cigar smoke.

a) True b) False

10. Marijuana smoke does not produce a significantly higher risk of lung cancer than cigarette smoke.

a) True b) False

11. Drug effects from hallucinogens are highly variable and dependent upon the mood and expectations of the user and the surrounding environment in which the drug is used.

a) True b) False

12. Amphetamines, cocaine, methylphenidate, and caffeine are examples of misused CNS stimulants.

a) True b) False

13. Most abused CNS depressants are either controlled or illegal.

a) True b) False

14. Lorazepam is used by midwives

a) To treat agitation during early active labour b) To facilitate therapeutic rest during prodromal labour c) To slow tetanic contractions during pre-labour d) To help calm the woman so she can focus on coping with regular contractions

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15. Lorazepam must only be administered under a physician’s order.

a) True b) False

16. Lorazepam by injection is never indicated in obstetric situations

a) True b) False

17. The usual dose of lorazepam in an obstetric situation is:

a) 1 mg to 2 mg PO b) 0.5 mg PO c) 1 mg to 2 mg S/L a) 0.5 mg to 1 mg S/L

18. Asking the woman to not swallow for ______allows for proper absorption of lorazepam

a) 1 minute b) 2 minutes c) 30 seconds d) 5 minutes

19. Lorazepam has a half-life of

a) 2 to 12 hours b) 12 to 15 hours c) 10 to 20 hours d) 12 to 24 hours

20. Side effects of lorazepam include

1) Dizziness 2) Restlessness 3) Nausea 4) Increased alertness

a) 1, 2, 3 b) 1, 3 c) 2, 3, 4 d) 1, 4

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21. This drug should always be available to reverse any effects of lorazepam

a) Norepinephrine b) Dimenhydrinate c) Naloxone d) Magnesium sulphate

22. Lorazepam should not be administered in the second trimester.

a) True b) False

23. Oxazepam belongs to the drug class of:

a) Anti-convulsants b) Benzodiazepines c) Anti-arrythmias d) Narcotic analgesics

24. The usual dose of oxazepam is

a) 10 mg or 15 mg PO b) 15 mg or 30 mg PO c) 15 mg or 20 mg PO d) 5 mg or 10 mg PO

25. It is safe to administer oxazepam for up to 3 consecutive doses

a) True b) False

26. A physician should be contacted immediately if a woman experiences any of the following after administration of oxazepam

a) Fainting b) Difficulty breathing c) Rash d) All of the above

27. Benzodiazepines can cause ______when used in the first trimester of pregnancy

a) Feeding difficulties in the baby. b) Withdrawal symptoms in baby c) Congenital malformations d) Postpartum depression in the mother

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28. Benzodiazepines can be used without worry postpartum because they do not enter breast milk

a) True b) False

29. Fentanyl can only be prescribed by a physician during labour

a) True b) False

30. Fentanyl is used only during the ______stage of labour

a) Late b) Early active c) Transitional d) Fourth

31. The usual dose of fentanyl is

a) 1 mcg/kg over 1 minute b) 2 mcg/kg over 1 hour c) 0.5 mcg/kg over 30 seconds d) 0.5 mcg/kg over 1 minute

32. The maximum dose of fentanyl, without maternal O2 saturation monitoring that should not be exceeded is:

a) 3 doses in two hours b) 4 doses in one hour c) 3 doses in one hour d) 4 doses in two hours

33. The maximum dose of fentanyl that can be given when maternal O2 saturation is monitored is:

a) 0.5 mcg/kg, repeated every 10 to 15 minutes, to a maximum of 100 mcg/hour b) 1 mcg/kg, repeated every 15 to 20 minutes, to a maximum of 200 mcg/hour c) 1 mcg/kg, repeated every 20 to 30 minutes, to a maximum of 200 mcg/hour d) 2 mcg/kg, repeated every 20 to 30 minutes, a maximum of 100 mcg/hour

34. Once administered you can expect fentanyl to take effect

a) Almost immediately b) In 3 to 5 minutes c) In 5 to 10 minutes d) In 20 minutes

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35. Fentanyl has a maternal half-life of

a) 30 minutes b) 1 hour c) 90 minutes d) 2 hours

36. Fentanyl has a neonatal half-life of

a) 5 to 10 hours b) 30 minutes to 2 hours c) 1 to 6 hours d) 2 to 8 hours

37. Fentanyl may produce fewer side effects, compared to morphine

a) True b) False

38. As fentanyl can cause respiratory depression, it may be important to monitor the neonate’s O2 saturation after birth for at least

a) 30 minutes b) 2 hours c) 3 hours d) 1 hour

39. Maternal O2 saturation should be monitored every ______if morphine or meperidine has been given to the woman before fentanyl has been administered

a) 20 minutes b) 5 minutes c) 30 minutes d) 1 hour

40. Some contraindications against the use of fentanyl include:

5) Pregnancy induced hypertension 6) Maternal obesity 7) Diabetes 8) Kidney disease

a) 2, 4 b) 1,3, 4 c) 1, 2, 4

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d) 2, 3, 4

41. Morphine may be administered in an obstetric situation by subcutaneous route only

a) True b) False

42. Midwives may prescribe morphine for pain in labour only

a) True b) False

43. Meperidine (Demerol) is sometimes preferred over morphine because it causes fewer side effects

a) True b) False

44. Morphine should be reserved for times when it is predicted that longer periods of relief will be needed or when the woman does not want an IV inserted.

a) True b) False

45. The usual dose of morphine is

a) 4 to 6 mg every 6 hours b) 10 to 15 mg every 4 hours c) 5 to 10 mg every 4 hours d) 2 to 4 mg every 4 hours

46. After administration, you can expect morphine to take effect in

a) 5 to 10 minutes b) 15 to 20 minutes c) 10 to 30 minutes d) 20 to 40 minutes

47. ______can be given at the same time to relieve ______that may result from administering morphine. The two drugs are compatible in the same syringe for ______

a) Dimenhydrinate; nausea and vomiting; 15 minutes b) Dimenhydrinate; pruritis; 15 minutes c) Diphenhydramine; pruritis; 20 minutes d) Diphenhydramine; nausea; 20 minutes

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48. Before administering morphine it is important to assess the woman’s ______.

a) Frequency of contractions b) Cervical dilation c) Fundal height d) Blood pressure 49. Naloxone is used as an ______to narcotics, to ______their effects

1) Antidote 2) Synergistic agent 3) Reverse 4) Enhance

a) 2, 3 b) 1, 3 c) 2, 4 d) 1, 4

50. A physician should be consulted immediately after the administration of naloxone

a) True b) False

51. The usual dose of naloxone for a newborn is

a) 0.2 mg/kg b) 0.1 mg/kg c) 0.2 mg/100 g d) 0.1mg/100 g

52. Midwives are allowed to give verbal prescriptions to clients only for products containing acetaminophen and codeine.

a) True b) False

53. It is acceptable to co-sign for wastage of narcotics with a midwifery student.

a) True b) False

54. ______Name______is getting her birthing bag ready for the delivery of her client’s baby. She needs to obtain some narcotics for the birth from the midwifery practice. She will:

a) Take the drugs and sign them out after the birth so she can record what she used during the birth.

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b) Sign them out with a second midwife as a witness and log the names and quantities of the drugs she has taken into her log book. c) Sign out the drugs she needs without a witness and let another midwife know before she leaves the midwifery practice clinic. d) Not sign them out as all midwives should know that the drugs will be used for a birth anyway, so no record keeping is necessary.

55. ______Name____ is making sure her birthing bag is ready for the next deliver and notices that she has a number of expired narcotics in the birthing bag. What are the proper procedures for disposal of the expired narcotics?

a) Record that the narcotics are expired and dispose of them without a witness b) Discard them as they are expired and can no longer be used. c) Record that they are expired in the logbook, discard them with a second midwife as a witness, and obtain the second midwife’s signature for disposal of the expired narcotics d) Discard the narcotics and then ask for second midwife’s signature in the logbook.

56. ____Name_____ is at a birth and uses only part of an ampoule of fentanyl. Proper procedure dictates that the midwife must

a) Discard the remainder and then ask for a second midwife’s signature. b) Obtain a co-signature of the second midwife before disposal of the remainder of the narcotic. c) Record only the dose that she gave to the client. d) Have the client verify the dose that was given.

57. The following are drugs that the midwife may inject on her/his own responsibility, according to the Midwifery Act, 1991:

1) Ketorolac 2) Carboprost 3) Lidocaine 4) Meperidine

a) 1, 2, 4 b) 2, 3 c) 1, 4 d) 3, 4

58. The registered midwife requires a physician’s order in order to use the following medications in the practice of midwifery.

a) Acetaminophen with codeine b) Clotrimazole c) Dimenhydrinate d) RhD immune globulin

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59. A registered midwife requires a physician’s order to inject the following medications:

a) Phytonadione b) Hepatitis B vaccine c) Epinephrine d) Antibiotics

60. The registered midwife may administer the following on her/his own responsibility:

a) Intravenous fluids for rehydration b) Narcotics c) Barbiturates d) Sedatives

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Section 4: Antibiotics

This section still Under Development

Amoxicillin

• Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B, Readily crosses the placenta with no significant teratogenic risk. Appears in breast milk in low concentration, - compatible with breast- feeding.

• Available Forms:

- PO

• Indications: - Bronchitis, Pharyngitis, -Urinary Tract Infection -Chlamydial infections in Pregnancy -Prophylaxis for Dental, Oral, Respiratory and Cardiac problems.

• Usual Dosage: - Adults and Children >20kg – 250mg every 8 hours for 7 to 10 days - Children < 20kg – 40mg/kg/day every 8 hours

• Adverse Effects: -Gastrointestinal: Nausea, Vomiting, Diarrhea, Anorexia, Epigastric distress, and Gastritis. - Hematologic: Anemia, Thrombocytopenia, Eosinophilia, and Leucopenia - Hypersensitivity: A Morbilliform, Erythematous, and Urticarial Rush. • Contraindications: - History of allergic reaction to Penicillins

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Ampicillin

• Trade Name: Not applicable • Classification: Antibiotic, Semisynthetic Penicillins

• Pregnancy Risk Category: B, Should be used in pregnancy when the benefit outweighs the risk

• Available Forms: - PO - IM - IV

• Indications: - Bacterial respiratory tract infections - Urinary Tract Infections - Gastrointestinal Infections - Bacterial Meningitis - Septicemia - Endocarditis

• Usual Dosage: - 250-500mg x 6 hourly, continue for 48-72 hours after patient is asymptomatic - 8 –14 g daily in equally divided doses every 3 – 4 hours - 2 g single dose

• Adverse Effects: - Rush - Abdominal cramps, Nausea, Vomiting and Oral Candidasis - Pain at injection site

• Contraindications: - History of allergic reaction to Penicillins

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Azithromycin

• Trade Name: Zithromax

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: - Tablets: 250, 500, and 600 mg. - Suspension 100 mg/ teaspoon, 200 mg/teaspoon, 167 mg/teaspoon or 1 g/packet. - Powder for Injection: 500 mg.

• Indications: • Fights bacteria in the body: respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

• Usual Dosage: - Two 250 mg tablets taken on the first day followed by one 250 mg tablet taken at the same time (usually five days). - The first dose is often a "double dose," twice as much as the remainder of the doses given. For acute bacterial sinusitis, Azithromycin way be taken once daily for three days. - The usual dose for prevention of mycobacterium avium complex (MAC) infections in persons with HIV infection is 1,200 mg taken once weekly.

- The children's dose of Azithromycin (liquid suspension) is based on body weight. When used to treat otitis media (middle ear infection) in children, a course of treatment shorter than 5 days may be used (either 3 days or 1 day, depending on the dose used).

- Azithromycin may also be given by injection to treat severe pneumonia or pelvic inflammatory disease

• Adverse Effects: - Hives; difficulty breathing; swelling of your face, lips, tongue, or throat - Diarrhea that is watery or bloody - Chest pain, uneven heartbeats - Nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools jaundice (yellowing of the skin or eyes). - Dizziness, tired feeling, or headache - Vaginal itching or discharge; or mild itching or skin rash.

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• Contraindications: - Contraindicated in patients with known hypersensitivity to Azithromycin

Bacitractin

• Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: Not applicable

• Available Forms: - IM - Compresses or Instillations (Solution) - Inhalation

• Indications: - Treatment of infants with: Pneumonia and Empyema caused by Staphylococci - Secondary infected wounds, ulcers - Eye infection - Susceptible infections of the upper and lower respiratory tract

• Usual Dosage: - Infants under 2500g – 900 units/kg//24 hours in 2 or 3 divided doses - Infants over 2500g - 1000 units/kg//24 hours in 2 or 3 divided doses - 500 – 1000 units/ml for skin or - 250 units/ml for intranasal therapy

• Adverse Effects: - Nausea and Vomiting - Rush - Albuminuria, Cylindruria, Azotemia, Rising blood levels without any increase in dosage

• Contraindications: History of previous hypersensitivity or toxic reaction to it

Cephalexin

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• Trade Name: Keflex or Sporidex

• Classification: Antibiotic

• Pregnancy Risk Category: B, Safe to use in pregnancy, compatible with breast-feeding

• Available Forms: - PO - IV

• Indications: Mild or moderate infections of the: - Respiratory tract - Genitourinary tract - Bone and joints - Skin and soft tissues • Usual Dosage: - 1g/daily in divided doses every 6 hours (for adults) 7 –10 days - 25 – 50mg/kg in divided doses every 6 hours (for children) 7 – 10 days

• Adverse Effects: - Nausea, Vomiting, Diarrhea - Rarely: rush, mild transient neutropenia and anaphylaxis

• Contraindications: Patients with known allergy to cephalosporin

Cefazolin • Trade Name: Ancef

• Classification: Antibiotic

• Pregnancy Risk Category: B,

• Available Forms: - IM - IV

• Indications: - Urinary tract infection - Lower respiratory tract infection - Soft skin tissue infection

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- Prevention of surgical site infection - Prevention of infection in the presence of foreign bodies - Bone and joint infections - Genital infections - Septicemia

• Usual Dosage: - Preoperative prophylactic: 1 gram IV administered ½ hour to 1hour prior to start of surgery or 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively. - Moderate to severe infections: 500mg – 1g every 6 – 8 hrs - Mild infections: 250mg – 500mg every 8 hrs - Acute Urinary tract infection: 1g every 12hrs - Pneumonia: 500mg every 12 hrs - Severe, life-threatening infections (septicemia): 1 - 1.5g every 6 hrs

• Adverse Effects: - Rush, itching, pruritus, fever, anaphylaxis - Nausea, vomiting, diarrhea, stomach cramps, anorexia, colitis - Neutropenia, Leucopenia, Thrombocytopenia, - Injection site: burning, cellulites, and phlebitis - Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received. - As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received

• Contraindications: - Persons with hypersensitivity to Cephalosporin group of antibiotics.

Cefixime • Trade Name: Suprax

• Classification: It is an oral third generation cephalosporin antibiotic

• Pregnancy Risk Category: B

• Available Forms: - PO

• Indications: - Gonorrhea - Tonsillitis - Pharyngitis - Acute bronchitis

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-Urinary tract infection • Usual Dosage: - Adults and Children (weighing more than 50 kg or older than 12 yr of age): PO 400 mg daily. - Children 6 mo to 12 yr of age: PO 8 mg/kg/day as a once-daily dose or in 2 divided doses of 4 mg/kg every 12 h. - Uncomplicated Gonorrhea Adults: PO 400 mg as a single dose.

• Adverse Effects: - Dizziness, headache, seizure (less than 2%). - Facial edema, pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria - Diarrhea, nausea, loose or frequent stools, flatulence, abdominal pain, dyspepsia, vomiting, pseudomembranous colitis. - Acute renal failure, candidiasis, genital pruritus, transient elevations in BUN or creatinine, vaginitis - Eosinophilia, leukopenia, neutropenia, transient thrombocytopenia - Anaphylactic reactions (including shock and death), angioedema, drug fever, serum sickness–like reactions • Contraindications: Allergy to cephalosporin group of antibiotics.

Ceftriaxone

• Trade Name: Rocephin • Classification: Third-generation cephalosporin antibiotic • Pregnancy Risk Category: B, This medication should not be used during pregnancy unless the benefits outweigh the risks. • Available Forms: - IM - IV

• Indications: - Pneumonia - Bacterial Meningitis - Lyme disease, Typhoid Fever - Gonorrhea - In pediatrics, it is commonly used in febrile infants between 4 and 8 weeks of age who are admitted to the hospital to exclude sepsis

• Usual Dosage:

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To treat bacterial infections, The dose administered is also based on age, body size, and kidney and liver function. For moderate to severe infections in adults, 1 g to 2 g daily given once every 24 hours or divided into 2 equal doses and given every 12 hours. For uncomplicated gonorrhea in adults, one dose of 250 mg is injected into a muscle. For children 12 years of age and under, the dose is based on body weight and is given every 12 hours. The maximum daily dose for adults and children is 4g. (from 4 to 14 days to several weeks.

• Adverse Effects:

• Dizziness, Nausea, Vomiting, Feeling unwell • Headache • Mild diarrhea • Stomach pain • Taste disturbances • Vaginal itching or discharge (e.g., yeast infection)

• Contraindications:

• is allergic to Ceftriaxone, other cephalosporins (e.g., Cephalexin), Penicillins (e.g., penicillin, Amoxicillin), or to any of the ingredients of the medication • is a newborn or premature infant who has high bilirubin in the blood • is a newborn who is also receiving calcium-containing intravenous solutions (calcium- containing solutions should not be given within 5 days of Ceftriaxone in infants up to 10 weeks of age)

Ciprofloxacin

• Trade Name: Cipro

• Classification: is a synthetic antibiotic

• Pregnancy Risk Category: C

• Available Forms: - PO: Tablets 100mg, 250mg, 500mg and 750mg

• Indications: - Infections of the skin, sinuses, bone, lung, ear, abdomen and bladder - Sexually transmitted infections, some forms of infectious diarrhea, and typhoid fever.

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• Usual Dosage: - Adults: ranges from 250 mg to 750 mg twice daily. - For sexually transmitted infections, the dose is given once as a single dose (250mg).

• Adverse Effects: - Headache, nausea, diarrhea - Pain: joint, muscle, abdominal - Swelling: in shoulders, hands or calves of legs - Jaundice - Chest pain, irregular heart rate, difficulty to breathe - Skin rash, blistering, loosening or peeling

• Contraindications:

• is allergic to Ciprofloxacin or any other ingredient of the medication • is allergic to other Quinolone antibiotics • is taking Tizanidine

Clavulanic acid

• Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

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Clindamycin

• Trade Name: Dalacin Cleocin

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • PO (capsules 150mg and 300mg, solution 75mg/5ml) • IV • Topical (gel) • PV (suppositories, in combination with Clotrimazole IP) • Indications: - To treat infections caused by susceptible anaerobic bacteria: of the respiratory tract, skin and soft tissue infections, and peritonitis. In patients with hypersensitivity to Penicillins, Clindamycin may be used to treat infections caused by susceptible aerobic bacteria as well. - To treat bone and joint infections, particularly those caused by Staphylococcus aureus - To decrease the risk of premature births in women diagnosed with bacterial vaginosis during early pregnancy to about a third of the risk of untreated women. - To treat toxoplasmosis - Topical application can be used to treat mild to moderate acne. - Malaria

• Usual Dosage: - It can be given in combination with Primaquine to treat Pneumocystis carinii pneumonia: PO dose is: 300 to 450 mg every 6 hours for 21 days. IV: dose is 600 to 900 mg every 6 hours or 900 mg every 8 hours - To treat toxoplasmosis, the initial dose is: 600mg every 6 hours for 6 weeks or decreased dose to 300-450mg every 6-8 hours • Adverse Effects: - Diarrhea, pseudomembranous colitis, nausea, vomiting, abdominal pain or cramps, rash, and/or itch. - High doses (both intravenous and oral) may cause a metallic taste, and topical application may cause contact dermatitis - Anaphylaxis

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• Contraindications:

• Hypersensitivity to drug/class/components. • Ulcerative colitis or history of colitis • Caution if impaired liver function or renal function

Cloxacillin • Trade Name: Cloxapen and Orbenin.

• Classification: is an antibiotic in the class of Penicillins. It fights bacteria in body.

• Pregnancy Risk Category: B

• Available Forms: - PO: Capsules 250 and 500mg; Suspension 120mg/5ml

• Indications: - To treat a wide variety of infections, including sinusitis, strep throat, pneumonia, respiratory tract, ear infections, dental abscesses, skin infections, and STDs like gonorrhea and syphilis, infections of the genital and urinary tract.

• Usual Dosage:

- Adults: 250-500mg every 6 hours - Children: 25mg per pound of body weight, in 4 divided doses, daily

• Adverse Effects:

• An allergic reaction (shortness of breath; closing of throat; hives; swelling of lips, face, or tongue; rash; or fainting); • Seizures; • Severe watery diarrhea and abdominal cramps; • Unusual bleeding or bruising. • Vomiting, black tongue or sore mouth

• Contraindications: - People who have ever had an allergic reaction to another penicillin or to a cephalosporin

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Cotrimoxazole • Trade Name: Septrin, Bactrim

Classification: An Antibiotic preparation made up of a mixture of Trimethoprim and Sulfamethoxazole. • Pregnancy Risk Category: C

• Available Forms: - PO: tablets, suspension (Single strength: 80mg Trimethoprim + 400mg Sulfamethoxazole) and (Double strength: 160mg Trimethoprim + 800mg Sulfamethoxazole) - Injections 5ml ampoule

• Indications -Treatment and prophylaxis of pneumonia caused by Pneumocystis jirovecii (formerly identified as P. carinii) (Commonly seen in immunocompromised patients including those suffering from HIV/AIDS) - Infections caused by Listeria monocytogenes, Nocardia spp., Stenotrophomonas maltophilia (Zanthomonas maltophilia) - Melioidosis - Shigellosis - Traveler’s diarrhoea - Prophylaxis of cerebral toxoplasmosis in HIV patients - Whipple's disease - Respiratory tract infections - UTI and renal infections • Usual Dosage: - For prevention of PCP: take until the immune status recovers to an acceptable levels and is maintained for at least 3-6month. 1). 1 tablet of double strength or 2 tablets of regular strength x 3times per week 2). 1 tablet of regular strength x ones daily - For treatment of PCP: 21 complete days 1). 15-20mg/kg/day of the Trimethoprim component IV 2). 2 tablets of double strength of Cotrimoxazole x 8 hours daily

• Adverse Effects: - Nausea, vomiting, anorexia - Rush, allergic skin reaction - Liver dysfunction - Blood abnormalities • Contraindications:

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- Hypersensitivity to drug/class/components - Infants less than 2 month

Dicloxacillin

• Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Doxycylin • Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

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• Contraindications:

Erythromycin • Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • PO • IM • IV • Ophthalmic

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Flucloxacillin • Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

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• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Fusidic acid

• Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Gentamycin • Trade Name: Garamycin

• Classification: Antibiotic

• Pregnancy Risk Category: D

• Available Forms: • IV • Ophthalmic Topical

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• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Mupirocin • Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Nitrofurantoin • Trade Name:

• Classification:

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• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Penicillin G

• Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • IV

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Spectinomycin • Trade Name:

• Classification:

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• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Trimethoprim

• Trade Name:

• Classification:

• Pregnancy Risk Category:

• Available Forms:

• Indications:

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Vancomycin

• Trade Name: Not applicable

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• Classification: Antibiotic

• Pregnancy Risk Category: C

• Available Forms: • PO • IV

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Miconazole • Trade Name: Monistat, Micazole

• Classification: Antifungal

• Pregnancy Risk Category: B

• Available Forms: - Topical cream: OTC - Vaginal suppositories: OTC

• Indications: - Vulvovaginal candidiasis - Jock Itch - Athlete’s foot - Angular cheilitis (lip disorder)

• Usual Dosage - Oral gel 24mg/ml (20mg/)

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- External skin treatment: Topical cream: 2%; Combination: 2% cream with 1% hydrocortisone, once a day for 7 days - Pessaries: 200 mg or 100 mg - Vaginal cream: 2% - Combination: 2% cream with either 100mg or 200 mg Pessaries. - 400 mg insert or ovule or suppository Insert a vaginal insert/ovule/suppository high in the vagina at bedtime • Adverse Effects: - Unlike some Miconazole is absorbed by the intestinal tract when used orally or vaginally, which may lead to drug interaction

• Contraindications: - Hypersensitivity - Skin rush Warnings:

1. Use only if you have already had a vaginal yeast infection diagnosed by a physician and you have the same symptoms now, otherwise consult your physician. These symptoms include itching and burning of the vagina and, sometimes, a white discharge.

2. If there is no improvement in 3 days or if symptoms have not disappeared within 7 days, then consult a physician as not all vaginal infections are caused by yeast.

3. Consult a physician if you have abdominal pain, fever or foul-smelling vaginal discharge before or during use of this medication.

4. If symptoms recur within 2 months consult a physician.

5. If you are pregnant, or think you may be pregnant or are nursing, do not use this product except on the advice of a physician.

6. Do not use in children under 12 years of age except on the advice of a physician.

7. If skin rash or new irritation occurs, discontinue use.

8. If you are at increased risk for sexually transmitted diseases, have multiple partners or change partners often, consult a doctor before starting each treatment.

Acetaminophen

• Trade Name: Tylenol

• Classification: Analgesic, Antipyretic

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• Pregnancy Risk Category: C

• Available Forms: - Oral (capsules, tablets, liquid, gelcaps, chewable tablets): OTC - Suppositories

• Indications: - Analgesia - Antipyretic

• Usual Dosage: - (PO) For adults is 325 to 650 mg every 4 to 6 hours. The maximum daily dose is 4 grams. The oral dose for a child is based on the child's age, and the range is 40-650 mg every 4 hours.

• Adverse Effects: - High dose-usage (greater than 2,000 mg per day) does increase the risk of upper gastrointestinal complications such as stomach bleeding.

• Contraindications: - Sensitivity; caution re: high doses, long term use re: liver function

Acetaminophen + Codeine • Trade Name: Tylenol #1 (8 mg codeine)

• Classification: Opioid analgesic combination

• Pregnancy Risk Category: C

• Available Forms: - Oral (capsules, tablets, liquid): OTC - Each tablet contains: 300mg of Acetaminophen, 15mg of Caffeine and 8mg of Codeine Phosphate

• Indications: - Analgesia postpartum

• Usual Dosage: - 1to 2 tab. Every 4-6hrs

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• Adverse Effects: - Dizziness - Lightheadedness or feeling faint - Drowsiness - Nausea or vomiting - Unusual tiredness or weakness - Constipation - Loss of appetite - Trouble sleeping

• Contraindications: - Caution re: high doses, long term use re: liver function - This medication should not be taken by anyone who is allergic to acetaminophen, codeine, or any of the ingredients of the medication.

Hydrocortisone anorectal therapy compound • Trade Name: Anusol HC, Rectogel HC, Proctodan HC, Protofoam HC

• Classification: Antipruritic, anti-inflammatory topical

• Pregnancy Risk Category: C

• Available Forms: - Topical (gel, ointment, foam) - Suppositories

• Indications: Hemorrhoid care (pregnancy and postpartum)

• Usual Dosage: - Ointment: Bathe and dry the affected anal area. Apply the ointment into the anus using the applicator provided, and also to the surface of the anus in the morning and at bedtime, and after each bowel movement, or as directed by your doctor.

Suppositories: Bathe and dry the affected anal area. Insert 1 suppository into the anus morning and evening and after each bowel movement or as directed by your doctor.

• Adverse Effects: (Not common or rare)

• Dizziness • Dry, scaly skin

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• Increase in appetite • Increased sweating • Lightened skin colour • Sensation of spinning • Thin, fragile skin • Thinning of hair on scalp • Unusual weight gain

• Contraindications: - Anyone allergic to any of the ingredients of the medications - Anyone with tuberculosis, fungal, or viral infections of the skin

Nitrous Oxide/Oxygen

• Trade Name: Nitronox, Entonox

• Classification: Anesthetic

• Pregnancy Risk Category: B

• Available Forms: Inhalation from a cylinder at pressure of 137 bar or from a pipeline supply

• Indications: - Pain relief in advanced first stage or during second stage labour - During suturing or minor surgical procedures - To ease pain during trauma

• Usual Dosage: Self administered - 50% of nitrous oxide (N2O or laughing gas)+ 50% of oxygen (O2): Its analgesic effect is strong – equivalent to 5 to 10mg of morphine - Entonox should thus be used accordingly, e.g. use should begin 30s before a contraction becomes painful in labour. It is removed from the body unchanged via the lungs, and does not accumulate under normal conditions, explaining the rapid offset. - The gas is administered using a face mask or mouthpiece; gas flow is controlled by a sensitive demand-valve activated by the patient's inspired breath. This allows pressurized gas from the cylinder to flow through a pressure regulator into the lungs at a steady rate.

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Longer and deeper breaths allow greater volumes of gas to be taken into the lungs if necessary.

• Adverse Effects: - May make feel sick - Dries mouth out

• Contraindications: - Woman unable to self-administer - Where there is artificial, spontaneous or traumatic pneumothorax - If there is an air embolism - In cases of decompression sickness - Where there is abdominal distension or suspected bowel obstruction - In maxillo-facial injuries.

Lidocaine HCl with or without Epinephrine

• Trade name: Xylocaine • Classification: Anesthetic • Pregnancy Risk Category: B, Excreted in breast milk • Available forms: -IV -IM -Topical • Indications: -Local anesthetic for suturing -Topical application for “pre-freezing” prior to perineal infiltration -To minimize discomfort of IV cannulation in hand or forearm • Usual Dosage: - 20 or 50ml of fliptop vial contains Lidocaine HCL1% - 20ml of fliptop vial contains Lidocaine 1-2% or epinephrine 1:100000 - Episiotomies, Suturing: 5-20ml -Use IM route for emergency situations (eg, no IV access, no ECG monitoring) only. Use 10% solution, only, for injection. Deltoid muscle is preferred IM site. Switch to IV route as soon as possible. -When giving by IV route, use only 1 to 2% solutions of drug. Use only Lidocaine specifically labeled for IV use (without preservatives or epinephrine). Do not administer with other agents. -When giving by topical route, apply thinly and to smallest area possible. Do not apply to abraded or otherwise injured areas of skin

• Adverse Effects: - Hypotension, bradycardia, cardiovascular collapse, cardiac arrest

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- Dizziness, drowsiness, confusion, visual disturbances - Local: Phlebitis, burning, stinging - Difficulty in speaking, breathing and swallowing • Contraindications: hypersensitivity - Hypotension - Bradycardia - Heart problems

Erythromycin ophthalmic ointment

• Trade Name: Diomycin

• Classification: antibiotic • Pregnancy Risk Category: B • Available forms: • Ointment (0.5%) • Indications: • Prophylactic against ophthalmia neonatorum • Public Health Law • Usual Dosage: - In the treatment of superficial ocular infections, a ribbon approximately 1cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. -For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant. • Adverse Effects: - The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions. Contraindications: none for infants

Phytonadione (Vitamin K)

• Trade Name: Not applicable • Classification: Fat-soluble vitamin • Pregnancy Risk Category: C • Available forms:

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- Injectible: SC IM IV - Injectible form may be administered orally • Indications: • Prevention of hemorrhagic disease of the newborn • In the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by or interference with vitamin K activity • hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;

• Usual Dosage: - Infant – 05 ml – 1 ml SC within 1hour after birth - Adult – 10 mg/ml, may be diluted with 0.9% Sodium Chloride or 5% Dextrose

• Adverse Effects: -The possibility of allergic sensitivity, including an anaphylactoid reaction, should be kept in mind following parenteral administration.

-Transient "flushing sensations" and "peculiar" sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

-Pain, swelling, and tenderness at the injection site may occur.

-Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans.

• Contraindications: - Contraindications: none known for infants - Hypersensitivity to any component of this medication in adults.

Nystatin

• Trade Names: Candistatin, Nilstat, Nyaderm • Classification: Antifungal • Pregnancy Risk Category: C • Available forms: • Suspension (100,000 u/mL) • Cream • Powder

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• Vaginal suppositories • Indications: • Treatment of oral candiasis, diaper candidiasis in babies • Nipple candidiasis in mothers • Vulvovaginal candidiasis • The skin cream, ointment, and powder are used to treat fungal skin infections. • The vaginal cream and vaginal tablets are used to treat vaginal infections caused by Candida albicans. • Usual Dosage: Oral suspension (liquid): 100,000 units (1 mL of suspension) three or four times’ daily, dropped into the side of the mouth and swallowed. This dose applies to all ages. The solution should be held in the mouth for some time and gargled before swallowing. Dosage may be increased for severe or difficult to treat infections. The bottle should be shaken before use. Oral tablets: The usual dose is one tablet (500,000 units) three times daily. In adults, this dosage can be increased to two tablets three times daily if necessary. Skin cream, ointment, or powder: Cream, ointment, or powder should be applied liberally to affected areas one to four times daily. Vaginal cream: The usual dose is one full applicator inserted into the vagina daily. In severe infections, a dose of one applicator every 12 hours may be given. Usually, treatment is given for two weeks. Treatment should be continued during menstruation. Vaginal tablets: The usual dose is one tablet inserted high into the vagina using the applicator, once or twice daily. Usually, treatment is given for two weeks. Treatment should be continued during menstruation. • Adverse Effects: - Diarrhea - Nausea or vomiting - Stomach pain - Rash - Vaginal or skin irritation (with skin cream, skin ointment, vaginal cream, or vaginal tablets)

Contraindications: hypersensitivity Nystatin suspension contains significant amounts of sucrose; therefore, people with diabetes should use it cautiously.

Hepatitis B Immune Globulin • Trade Name: BayHep B • Classification: Vaccine • Pregnancy Risk Category: C • Available Forms: • Injectible (given within 7 days of birth) • Indications: • B-positive women

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• Usual Dosage: The use of this vaccine must be officially recorded. Federal law requires that the manufacturer's name and lot number; name, address, and phone number of the person giving the vaccine; and the date of administration be recorded in the patient's permanent medical record. The immune response to HBV varies among individual children. Therefore, a medical professional should determine the HBV dose. In general, the recommended doses are as follows:

• Newborns: 2.5 to 20 micrograms injected into the anterolateral thigh muscle within seven days of birth or at the first visit to the physician's office, and one month and six months after the first dose, for a total of three doses. • Newborns: 10 to 20 micrograms injected into the thigh muscle within seven days of birth and one month, two months, and 12 months after the first dose, for a total of four doses. • Older child or adolescent: 2.5 to 20 micrograms injected into the deltoid arm muscle, with additional doses one month and six months after the first injection, for a total of three doses. • Adverse Effects:

Although most children experience no side effects from HBV, the most common side effects are as follows:

-Fatigue or irritability in up to 20 percent of children

-Soreness at the point of the injection, lasting one to two days, in about one out of eleven children and adolescents

-A mild to moderate fever in one out of 14 children and adolescents

• Contraindications: none known for infants

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This section reflects standards and guidelines under consideration in proposed legislative changes at the time of publication. It may not reflect the place of controlled substances in the scope of midwifery practices in some jurisdictions

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Objectives

After completing this module, the student will be able to:

• Be familiar with the antibiotics relevant to the care of pregnant and postpartum women and their newborns. • Be knowledgeable about relevant provincial governance documents as they pertain to antibiotic use • Understand which drugs Registered Midwives can prescribe on their own authority • Be familiar with pregnancy and postpartum risk factors related to antibiotics

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Antibiotics • Group B streptococcus prophylaxis • Penicillin G • Cefazolin • Erthyromycin • Clindamycin • Vancomycin • Other • Gentamycin • Amoxicillin • Ampicillin

Penicillin G • Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • IV

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Cefazolin

• Trade Name: Ancef

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • IM • IV

• Indications: • Urinary tract infection • Lower respiratory tract infection • Soft skin tissue infection • Prevention of surgical site infection • Prevention of infection in the presence of foreign bodies • Bone and joint infections • Genital infections • Septicemia

• Usual Dosage: • Preoperative prophylactic: 1 gram IV administered ½ hour to 1hour prior to start of surgery or 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively. • Moderate to severe infections: 500mg – 1g every 6 – 8 hrs • Mild infections: 250mg – 500mg every 8 hrs • Acute Urinary tract infection: 1g every 12hrs • Pneumonia: 500mg every 12 hrs • Severe, life-threatening infections (septicemia): 1 - 1.5g every 6 hrs

• Adverse Effects: • Rush, itching, pruritus, fever, anaphylaxis • Nausea, vomiting, diarrhea, stomach cramps, anorexia, colitis • Neutropenia, Leucopenia, Thrombocytopenia, • Injection site: burning, cellulites, and phlebitis • Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received. • As with other cephalosporins, reports of increased BUN and creatinine levels, as

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

well as renal failure, have been received

• Contraindications: • Persons with hypersensitivity to Cephalosporin group of antibiotics

Erythromycin

• Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • PO • IM • IV • Ophthalmic

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Clindamycin

• Trade Name: Dalacin C

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • PO (capsules 150mg and 300mg, solution 75mg/5ml) • IV • Topical (gel) • PV (suppositories, in combination with Clotrimazole IP)

• Indications: • To treat infections caused by susceptible anaerobic bacteria: of the respiratory tract, skin and soft tissue infections, and peritonitis. In patients with hypersensitivity to Penicillins, Clindamycin may be used to treat infections caused by susceptible aerobic bacteria as well. • To treat bone and joint infections, particularly those caused by Staphylococcus aureus • To decrease the risk of premature births in women diagnosed with bacterial vaginosis during early pregnancy to about a third of the risk of untreated women. • To treat toxoplasmosis • Topical application can be used to treat mild to moderate acne. • Malaria

• Usual Dosage: • It can be given in combination with Primaquine to treat Pneumocystis carinii pneumonia: PO dose is: 300 to 450 mg every 6 hours for 21 days. IV: dose is 600 to 900 mg every 6 hours or 900 mg every 8 hours

• To treat toxoplasmosis, the initial dose is: 600mg every 6 hours for 6 weeks or decreased dose to 300-450mg every 6-8 hours

• Adverse Effects: • Diarrhea, pseudomembranous colitis, nausea, vomiting, abdominal pain or cramps, rash, and/or itch. • High doses (both intravenous and oral) may cause a metallic taste, and topical

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application may cause contact dermatitis

• Anaphylaxis

• Contraindications:

• Hypersensitivity to drug/class/components • Ulcerative colitis or history of colitis • Caution if impaired liver function or renal function

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Vancomycin • Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: C

• Available Forms: • PO • IV

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

Gentamycin • Trade Name: Garamycin

• Classification: Antibiotic

• Pregnancy Risk Category: D

• Available Forms: • IV • Ophthalmic • Topical

• Indications:

• Usual Dosage:

• Adverse Effects:

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

• Contraindications:

Amoxicillin

• Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B, Readily crosses the placenta with no significant teratogenic risk. Appears in breast milk in low concentration, - compatible with breast-feeding.

• Available Forms:

- PO

• Indications: - Bronchitis, Pharyngitis, Pneumonia -Urinary Tract Infection -Chlamydial infections in Pregnancy -Prophylaxis for Dental, Oral, Respiratory and Cardiac problems.

• Usual Dosage: - Adults and Children >20kg – 250mg every 8 hours for 7 to 10 days - Children < 20kg – 40mg/kg/day every 8 hours

• Adverse Effects: -Gastrointestinal: Nausea, Vomiting, Diarrhea, Anorexia, Epigastric distress, and Gastritis. - Hematologic: Anemia, Thrombocytopenia, Eosinophilia, and Leucopenia - Hypersensitivity: A Morbilliform, Erythematous, and Urticarial Rush. • Contraindications: - History of allergic reaction to Penicillins

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Ampicillin • Trade Name: Not applicable

• Classification: Antibiotic

• Pregnancy Risk Category: B

• Available Forms: • PO • IV

• Indications: •

• Usual Dosage:

• Adverse Effects:

• Contraindications:

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Proposed Amendments to Drug Regulation

1. For the purposes of Paragraph 3 Section 4 of the Act, the following substances are designed as substances that a member may prescribe and/or administer by injection on the member’s own responsibility:

Antibiotics Amoxicillin Ampicillin Azithromycin Bacitractin Cephalexin Cefazolin Cefixime Ceftriaxone Ciprofloxacin Clavulinic acid Clindamycin Cloxacillin Cotrimoxazole Dicloxacillin Doxycyclin Erythromycin Flucloxacillin Fusidic acid Mupirocin Nitrofurantoin Penicillin G Spectinomycin Trimethoprim

2. For the purposes of Paragraph 3 of Section 4 of the Act, the following substances are designed as substances that a member may administer by inhalation on the member’s own responsibility:

Nitrous oxide Therapeutic oxygen

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3. For the purposes of Paragraph 3 of Section 4 of the Act, a member may uses or administer by injection or inhalation any drug or substance on the order of a member of the College of Physicians and Surgeons of Ontario

4. A member may prescribe, administer of order any drug or substance that maybe be lawfully purchased without a prescription.

5. This regulation comes into force…

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Self-Testing Scenarios: Indications for Antibiotics

Scenario 1: Prenatal

Scenario 1: Intrapartum

Scenario 1: Postpartum

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CMO Rationale for Proposed Drug Regulation Amendments August 25, 2005

Proposed Medication & Indication Rationale References Ampicillin IV The current standard of care recommend by the Society of “Prevention of group B streptococcal Cefazolin IV Obstetricians and Gynecologists of Canada (SOGC) and the infection in newborns: Clindamycin IV Center for Disease Control (USA) is IV antibiotic prophylaxis Recommendation statement from the Erythromycin IV in labour. Treatment with IV antibiotics in labour is thought to Canadian Task Force on Preventive Penicillin G, IV prevent early neonatal onset group B strep disease. Penicillin Health Care.” Can. Med Assc. J., Apr G is the preferred agent for treatment. 2002; 166:928-930.

In situations where Pencillin G is not available: Ampicillin is Centre for Disease Control. “Prevention an acceptable alternative for IV prophylaxis for GBS. of Perinatal Group B streptococcal Cefazolin is the recommended treatment for a woman who is Disease: Revised Guidelines from the penicillin allergic but not at risk for anaphylaxis. CDC.” Aug 16, 2002; 51(RR11):1-22. Clindamycin is the treatment of choice for women who are known penicillin allergic with risk for anaphylaxis SOGC clinical practice guidelines no Erythromycin is the alternate choice for women who are 149, September 2004. “The prevention known to be penicillin allergic with risk for anaphylaxis of early-onset neonatal group B streptococcal disease.” JOGC, Sept 2004:826-832.

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Amoxicillin It is within the midwifery scope of practice to test for Canadian STD Guidelines from Azithromycin sexually transmitted infections. These tests are done Health Canada (1998) Erythromycin routinely in pregnancy. This is an important preventative health measure which permits detection, treatment and the (for the treatment of Chlamydia) avoidance of transmission of infection (for both sexual contact and the fetus at birth). There is no situation where one would not treat a positive swab for Chlamydia while in expeditious way to treat would be for midwives to prescribe. In populations typically at high risk for STIs the need to organize a consultation with a physician increases the chance that this person may be lost to follow up. Furthermore, because midwives have an established relationship with our clients it may be easier to obtain information on past sexual contacts. It is the midwives scope to test for sexually transmitted Canadian STD Guidelines from Cefixime infections. These tests are done routinely in pregnancy. Health Canada (1998) Ceftriaxone IM This is an important preventative health measure which Spectinomycin IM permits detection, treatment and the avoidance of transmission of infection (for both sexual contact and the (for the treatment of Gonococcal fetus at birth). There is no debate about the importance of infections) treating a swab positive for gonorrhea in pregnancy. In the case of a positive swab the most expeditious way to treat would be for midwives to prescribe. In populations typically at high risk for sexually transmitted infections (STI) the need to organize a consultation with a consultation with a physician increases the chance that this person may be lost to follow up. As well, because midwives have an established relationship with our clients it may be easier to obtain information on past sexual contacts.

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Section 4: Antibiotics Self-Testing Multiple Choice Questions

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Appendix F: International Midwifery Pre-registration Program draft pharmacology module

Section 4: Antibiotics Answer Key to Multiple Choice Questions

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MIDWIFERY EDUCATION PROGRAM PHARMACOTHERAPY Page 1

MIDWIF 2F03 — MCMASTER UNIVERSITY SESSION DATES Thursday, September 4 - Wednesday, December 17, 2008 (Classes end Monday, December 1, 2008; Final Exam period: Dec. 3 - 17 ‘08)

Class (all students) — Mondays 1330 - 1420 pm *CNH 104 1430 - 1530 pm *CNH 104 Thursdays 1530 - 1630 pm *CNH 104 (CNH=Chester New Hall)

* (with exceptions as noted in the “Mac Midwifery Schedule Fall ‘08” which is posted on Learnlink under "Midwifery Program;" "MWC Non-Clinical Courses;" "Pharmacotherapy;" "Course Outline")

Tutorial (midwifery) — Mondays 1530 - 1630 Room: HSC 1A3 * (with exceptions as noted in the “Mac Midwifery Schedule Fall ‘08”)

First class — Thursday, Sept. 4, 2008 (1530 - 1630) CNH 104

NO CLASS — Monday, October 13, 2008 - Thanksgiving

Midterm Examination — Thurs., October 16, 2008 1530 - 1620 HSC 1A3 FINAL EXAMINATION — Date, time, & room: To Be Announced (during exam period December 3 - 17 ‘08)

COORDINATORS/TUTORS Dr. Bruce Wainman Cathy Fan, Course Coordinator office McMaster University McMaster University Dept. of Pathology & Molecular Faculty of Health Sciences, Medicine, j Midwifery Education School of Nursing, Health Program, Michael DeGroote Centre Sciences Centre, Room 2J40F for Learning & Discovery, 3rd Floor Room MDCL-3105 office hours By Appointment By Appointment (contact by e- mail to make an appointment) telephone 905-525-9140, x26659

fax 905-523-6459 E-mail [email protected] [email protected] ter.ca

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COURSE DESCRIPTION

This course is an overview of basic concepts in pharmacy, pharmacology and therapeutics relevant to the practise of midwifery in Ontario. Content areas include pharmacokinetics, toxicology, adverse drug reactions during pregnancy, drug transfer through lactation and pharmacology in the neonate.

COURSE OBJECTIVES

The student shall be able to:

Demonstrate an understanding of the pharmacological basis of action of all drugs in the midwifery pharmacopoeia. Demonstrate an understanding of the pharmacological basis of common over- the-counter medications as related to pregnancy, lactation, postpartum and newborn care.

Demonstrate a knowledge of the principles of ordering and prescribing medications.

GRADING

Assignments (presentation)...... 15% Midterm examination...... 35% Final examination...... 50%

ASSIGNMENTS

Each student will make one presentation during the course.

The topic of the presentation is to be: The administration, fate and mechanism of action of a drug in the midwifery pharmacopeia

The presentation is to be 10 minutes with 5 minutes for questions and will take place in November (Nov.10 & 24) and in early December (Dec. 1), 2008.

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EXAMINATIONS

Midterm: There will be a 50-minute exam on Thurs. Oct. 16, 2008 from 1530 - 1620 in HSC 1A3. The midterm exam is worth 35% and is comprised of multiple choice and short answer questions. Rewrites are not permitted.

Final: There will be a two (2) hour exam within the final exam period of December 3 - 17, 2008. (Date, time, and room: To Be Announced). The final exam is worth 50% and is comprised of multiple choice and short answer questions. Rewrites are not permitted.

REQUIRED TEXTS

Courseware — There is NO courseware for this course. `Lecture outlines will be posted on Learnlink under - "Midwifery Program;" "MWC Non- Clinical Courses;" "Pharmacotherapy;" "McMaster Midwifery Pharmacology Lectures '08" (for nursing & midwifery students); "McMaster MIDWIFERY ONLY Lectures & Info Fall'08" (midwifery specific lectures)

RECOMMENDED TEXTS

Tortora & Grabowski. Principles of Anatomy & Physiology, 10th ed. John Wiley & Sons, 2003 ISBN #0-471-41501-4 (same text used last year for Anatomy & Physiology)

Harvey RA, Champe PC. Lippincott’s Illustrated Reviews: Pharmacology, 4th ed. ISBN: 978-0-7817-7155-9

ACADEMIC DISHONESTY POLICY STATEMENT

Academic dishonesty consists of misrepresentation by deception or by other fraudulent means and can result in serious consequences, e.g., the grade of zero on an assignment, loss of credit with a notation on the transcript (notation reads "Grade of F assigned for academic dishonesty"), and/or suspension or expulsion from the university.

It is your responsibility to understand what constitutes academic dishonesty. For information on the various kinds of academic dishonesty, please refer to the Academic Integrity Policy, specifically Appendix 3, located at: http://www.mcmaster.ca/univsec/policy/AcademicIntegrity.pdf

Pharm\course outln mac fall08 revised Sept. 3, 2008 Appendix H: Core Competencies

January 1994

CORE COMPETENCIES: A FOUNDATION FOR MIDWIFERY EDUCATION RECOMMENDATIONS OF THE MIDWIFERY INTEGRATION PLANNING PROJECT TO THE INTERIM REGULATORY COUNCIL ON MIDWIFERY

INTRODUCTION

Core competencies provide a foundation for midwifery education programs. They reflect the fundamental knowledge and skills expected of a new graduate of a midwifery school. Effective midwifery education requires a balance of theoretical and clinical experience. After educational preparation, the entry level midwife should be capable of providing midwifery care as defined in the International Definition of a Midwife:

"[The midwife] must be able to give the necessary supervision, care and advice to women during pregnancy, labour and the postpartum period, to conduct deliveries on her own responsibility, and to care for the newborn infant. This care includes preventative measures, the detection of abnormal conditions in mother and child, the procurement of medical assistance and the execution of emergency measures in the absence of medical help. She has an important task in counselling and education, not only for [women] but also within the family and the community. The work should involve antenatal education and preparation for parenthood, and extends to certain areas of gynecology, family planning and child care. She may practice in hospitals, clinics, health units, domiciliary conditions or in any other service."

This definition is endorsed by the

Association of Ontario Midwives Curriculum Design Committee Midwifery Task Force-Ontario Interim Regulatory Council on Midwifery Task Force on the Implementation of Midwifery in Ontario International Confederation of Midwives International Federation of Gynaecologists and Obstetricians Midwives Alliance of North America World Health Organization

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Core competencies are guidelines for midwifery education and evaluation. Core competencies should be interpreted in the context of the scope of practice of midwifery. They do not indicate standards for midwifery practice. Midwifery practice is defined by the Transitional Council of the College of Midwives of Ontario Standards of Practice and Guidelines to the Scope of Practice. This document may need review and revision as midwifery practice evolves in response to the needs of communities throughout Ontario.

COMPONENTS OF MIDWIFERY CARE 1

General

A. The entry level midwife should have the knowledge and skills to:

1) Provide the necessary care and advice to women during pregnancy, labour and the postpartum period

2) Provide care focussed on the woman and her family

3) Promote normal birth and use technology appropriately

4) Conduct deliveries on her own responsibility and to care for the newborn

5) Provide care in a variety of settings, including the home, birth centre and hospital

6) Provide care consistent with the Philosophy of Midwifery Care in Ontario2

7) Provide continuity of care over the childbearing cycle

8) Facilitate informed choice

9) Provide education and counselling for childbearing to the woman, her family and the community

1 It is difficult to find appropriate terms to describe "the clients" of midwives. We use the terms client(s), woman, and woman and her family, and support people. We see the woman as the primary client of the midwife and the primary decision-maker during childbearing. We wish to be inclusive of family members and support people as defined by the woman. We hope our choice of terms reflects this approach.

2 Philosophy of Midwifery Care in Ontario, Interim Regulatory Council on Midwifery, August 1990.

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10) Utilize preventative measures, health education and promotion

11) Apply research findings to midwifery practice

12) Document relevant physical, emotional and social information about clients throughout the childbearing cycle respecting the confidentiality of information given

13) Recognize abnormal conditions and suggest appropriate treatment and/or make appropriate referrals

14) Administer pharmacologic agents as specified by regulation

15) Assist the woman and her family in planning for an appropriate place of birth

16) Evaluate risk factors during pregnancy, labour and the postpartum period

17) Use emergency measures in the absence of medical help

Education and Counselling

A. The entry level midwife should have knowledge of:

1) The principles of informed choice

2) Adult education, communication and counselling

3) Theoretical approaches to prenatal and parent education

4) Issues related to grief and loss in childbearing

5) Community resources available

B. The entry level midwife should have the ability to:

1) Communicate effectively with clients and their support people

2) Assess the emotional status of the woman in her social context

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3) Assist the woman and her family in planning and preparing for the birth experience and early parenting

4) Support the woman and her family in responding to loss during childbearing

5) Evaluate and respond to clients' educational needs

6) Assess the effectiveness of her own counselling skills

7) Provide information about care alternatives, including options, risks and benefits, and assist client decision-making

8) Provide prenatal education

Collaboration with Other Caregivers

A. The entry level midwife should have knowledge of:

1) Community standards of care, including midwifery and medical standards

2) Medical terminology relevant to the reproductive cycle

B. The entry level midwife should have the ability to:

1) Communicate effectively with other caregivers facilitating referral, consultation and collaboration when appropriate

2) Act as an advocate for the client in all aspects of her care

Antepartum Care

A. The entry level midwife should have the knowledge of:

1) The importance and functions of antepartum care

2) Female anatomy and physiology with emphasis on the menstrual cycle, conception and pregnancy

3) Physical, emotional and social change of pregnancy

4) Physical, emotional and social factors likely to influence pregnancy outcome

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5) Clinical applications of genetics, embryology and fetal development

6) Nutritional requirements for pregnancy

7) The physiology and treatment of common discomforts during pregnancy

8) Methods for diagnosing pregnancy, establishing due date, and assessing current gestational age and the progress of pregnancy

9) Screening and diagnostic tests used during pregnancy

10) Pharmacologic agents used during pregnancy

11) Environmental and biological hazards to pregnancy women

12) Causes, recognition and treatment of abnormalities of pregnancy

13) Implications of STDs and vaginal infections during pregnancy

14) Principles and procedure of external cephalic version

B. The entry level midwife should have the ability to:

1) Assess the pregnant woman's general health and well-being

2) Assess nutritional status and provide appropriate counselling

3) Obtain a family, medical and social history

4) Confirm pregnancy

5) Perform a pelvic and speculum examination and assess the soft and bony structures of the pelvis

6) Obtain maternal blood pressure, pulse, respirations, temperature and weight measurements, and recognize abnormal findings

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7) Perform abdominal palpation and fundal height measurement to assess uterine size, fetal position, presentation and number and estimate fetal size and gestational age

8) Auscultate fetal heart

9) Evaluate fetal movement

10) Assess presence and degree of edema

11) Check for costal vertebral angle tenderness

12) Check for clonus and deep tendon reflexes

13) Perform venipuncture and finger puncture

14) Perform a screening physical assessment including examination of the head, neck, thyroid, ear, nose and throat, teeth, chest, breasts, heart and vascular system, extremities, abdomen and neurological system

15) Obtain cervical and vaginal specimens

16) Interpret results of routine screening and diagnostic tests

Intrapartum Care

A. The entry level midwife should have knowledge of:

1) The normal process of labour including the mechanisms of labour and birth

2) Assessment of maternal and fetal well-being

3) Assessment of the onset and progress of labour and birth

4) Comfort and support measures during labour and birth

5) Use of physiologic methods to facilitate labour

6) Anatomy of the fetal skull and its landmarks

7) Fetal heart rate patterns

8) Aseptic technique and its application during labour

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9) Significance of ruptured membranes and methods for reducing risks of infection

10) Abnormalities of labour

11) Assessment and treatment of dehydration and ketonuria during labour

12) Techniques to protect the perineum, avoid episiotomy and minimize lacerations

13) Indications and procedure for episiotomy

14) Indications and procedure for repair of lacerations or episiotomy

15) The action and appropriate administration of anti-hemorrhagic agents

16) Pharmacologic agents used during the intrapartum period

17) Emergency measures, obstetrical procedures and interventions

B. The entry level midwife should have the ability to:

1) Provide appropriate emotional and physical support to the labouring woman and her support people

2) Conduct a spontaneous labour and delivery

3) Assess the onset and progress of labour

4) Assess frequency, duration and intensity of uterine contractions

5) Assess effacement and dilation of the cervix

6) Identify and determine station of the fetal presenting part, and assess position, presentation, attitude, and the presence of moulding or caput

7) Assess fetal heart tones with a fetoscope, doppler and electronic fetal monitor

8) Recognize abnormal fetal heart patterns, identify probable causes and potential interventions

9) Recognize abnormal labour patterns and identify probable causes and potential interventions

10) Determine status of the membranes and perform amniotomy if appropriate

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11) Recognize a full bladder and catheterize when indicated

12) Protect the perineum, avoid episiotomy and minimize lacerations

13) Perform and repair episiotomy when indicated

14) Recognize signs of separation of the placenta, conduct the delivery of and inspect the placenta

15) Recognize and manage postpartum hemorrhage appropriately

16) Inspect the perineal and vulval areas for lacerations, hematomas, and abrasions and repair appropriately

17) Perform immediate newborn assessment and care

18) Perform neonatal resuscitation*

19) Collect cord blood

20) Recognize the signs of maternal shock and initiate treatment

21) Perform injections, insert an intravenous catheter and administer IV fluids when appropriate

22) Administer inhalants as specified by regulation

* intubation is not a core competency for entry level midwives

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Postpartum Care of the Newborn

A. The entry level midwife should have knowledge of:

1) Anatomy and physiology of the newborn

2) Newborn assessment and gestational age assessment

3) Signs and symptoms of newborn abnormalities

4) Newborn screening and diagnostic testing

5) Prophylactic medications commonly used for the newborn

6) Nutritional needs of the newborn, properties of breast milk and infant formula, and methods of infant feeding

B. The entry level midwife should have the ability to:

1) Provide newborn care and assessment including assessment of respiratory and cardiac status and maintaining temperature in the immediate postpartum

2) Perform a newborn assessment

3) Assess the well-being of the newborn in the first six weeks of life

4) Administer eye prophylaxis and vitamin K

5) Assess newborn jaundice and initiate appropriate management

6) Perform a heel puncture to obtain samples for PKU and other screening tests

7) Educate parents regarding newborn behaviour and care

Postpartum Care of the Mother

A. The entry level midwife should have knowledge of:

1) Anatomy and physiology of the postpartum period including lactation

2) Postpartum assessment of the woman

3) Emotional and psychological aspects of postpartum, breastfeeding and early

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parenting

4) Postpartum discomforts and appropriate treatments

5) Nutritional requirements for women during the postpartum period

6) Principles of breastfeeding and management of common breastfeeding problems

7) Stimulation and suppression of lactation

8) Assessment and management of postpartum complications

B. The entry level midwife should have the ability to:

1) Assess the health and monitor the progress of the woman postpartum

2) Educate clients regarding self-care, normal postpartum progress, and signs and symptoms of common postpartum complications

Sexuality and Gynecology

A. The entry level midwife should have knowledge of:

1) Sexuality during the childbearing year

2) Anatomy and physiology of the reproductive systems through the life cycle

3) Anatomy and physiology of the female breast

4) Physiology and psychosocial components of human sexuality

5) Common issues of sexuality and methods for counselling or referral

6) Methods of birth control and family planning and their risks and benefits

7) Factors involved in decision-making about unplanned or unwanted pregnancies and resources for counselling and referral

8) Variations of normal reproductive health and signs and symptoms of pathology

9) Screening and diagnostic tests for well-woman care including appropriate inter- vention or referral

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B. The entry level midwife should have the ability to:

1) Perform a bimanual and speculum exam to assess uterine size, shape, consistency and mobility, and cervical and vaginal health

2) Obtain the necessary specimens to evaluate the presence of STDs, vaginal infections and cytological changes

3) Counsel clients in decision-making regarding contraceptive methods

4) Instruct clients in the use of contraception

5) Fit diaphragms and cervical caps

Professional, Legal and Other Aspects

A. The entry level midwife should have knowledge of:

1) The history and philosophy of midwifery in Ontario

2) The history, role and function of the governing body

3) The history, role and function of the professional association

4) The Standards of Practice for Midwifery

5) The Code of Ethics for the practice of Midwifery

6) All legislation pertaining to the practice of midwifery

7) The medical-legal context for midwifery practice in Ontario

College of Midwives of Ontario Page 11 of 11 Non-Physician Prescribing Applicant Questionnaire Appendix H: Indications for Mandatory Discussion, Consultation and Transfer of Care

Approved December 2, 1999 Effective June 15, 2000

INDICATIONS FOR MANDATORY DISCUSSION, CONSULTATION AND TRANSFER OF CARE

As a primary caregiver, the midwife together with the client is fully responsible for decision-making. The midwife is responsible for writing orders and carrying them out or delegating them in accordance with the standards of the College of Midwives.

The midwife discusses care of a client, consults, or transfers primary care responsibility according to the Indications for Mandatory Discussion, Consultation and Transfer of Care.1 The responsibility to consult with a family physician/general practitioner, obstetrician and/or specialist physician lies with the midwife. It is also the midwife’s responsibility to initiate a consultation within an appropriate time after detection of an indication for consultation. The severity of the condition and the availability of a physician(s) will influence these decisions.

The informed choice agreement between the midwife and client should outline the extent of midwifery care, in order to make clients aware of the scope and limitations of midwifery care. The midwife should review the Indications for Mandatory Discussion, Consultation and Transfer of Care with the client.

1 For a discussion of how this document is used to guide decisions about choice of birth place, see Indications for Planned Place of Birth.

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DEFINITIONS

Category 1: Discuss with another midwife or with a physician

It is the midwife’s responsibility to initiate a discussion with or provide information to another midwife or physician, with whom the care is shared, in order to plan care appropriately.

Category 2: Consult with a physician

It is the midwife’s responsibility to initiate a consultation and to clearly communicate to the consultant that she is seeking a consultation. A consultation refers to the situation where a midwife, in light of her professional knowledge of the client and in accord with the standards of practice of the College of Midwives, or where another opinion is requested by the client, requests the opinion of a physician competent to give advice in this field. The midwife should expect that:

The consultation involves addressing the problem that led to the referral, an in-person assessment of the patient, and the prompt communication of the findings and recommendations to the patient and the referring professional.

Following the assessment of the patient by the consultant(s), discussion can occur between the health professional and consultant regarding future patient care.2

The consultation can involve the physician providing advice and information and/or providing therapy to the woman/newborn or prescribing therapy to the midwife for the woman/newborn.

Consultation must be documented by the midwife in her records in accord with the regulations of the College of Midwives.

After consultation with a physician, primary care of the client and responsibility for decision-making together with the client either:

2 “Clinical Practice Parameters and Standards for Consultation and Transfer of a Woman/Newborn in or from a Birth Centre Where Only Midwives Provide Primary Care, to a Physician/Health Facility,” College of Physicians and Surgeons of Ontario, December 23, 1993.

College of Midwives of Ontario Page 2 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix H: Indications for Mandatory Discussion, Consultation and Transfer of Care

a) continues with the midwife, or b) is transferred to a physician.

Once a consultation has taken place and the consultant’s findings, opinions and recommendations are communicated to the client and the midwife, the midwife must discuss the consultant’s recommendations with the client and ensure the client understands which health professional will have responsibility for primary care.

Where urgency, distance or climatic conditions make an in-person consultation with a physician not possible, the midwife should seek advice from the physician by phone or other similar means. The midwife should document this request for advice, in her records, in accord with the requirement of the College of Midwives and discuss with the client the advice received.

The consultant may be involved in, and responsible for, a discrete area of the client’s care, with the midwife maintaining overall responsibility within her scope of practice. Areas of involvement in client care must be clearly agreed upon and documented by the midwife and the consultant.

The College of Midwives has agreed that:

One health professional has overall responsibility for a patient at any one time and the patient’s care should be co-ordinated by that health professional whose identity should be clearly known to all of those involved and documented in the records of the referring health professional and consultant. Responsibility could be transferred temporarily to another health professional, or be shared between health professionals according to the patient’s best interests and optimal care; however, transfer or sharing of care should only occur after discussion and agreement among patients, referring health professionals, and consultants.3

Category 3: Transfer to a physician for primary care

When primary care is transferred, permanently or temporarily, from the midwife to a physician, the physician, together with the client, assumes full responsibility for subsequent decision-making. When primary care is transferred to a physician, the

3 “Clinical Practice Parameters and Standards for Consultation and Transfer of a Woman/Newborn in or from a Birth Centre Where Only Midwives Provide Primary Care, to a Physician/Health Facility,” College of Physicians and Surgeons of Ontario, December 23, 1993.

College of Midwives of Ontario Page 3 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix H: Indications for Mandatory Discussion, Consultation and Transfer of Care midwife may provide supportive care4 within her scope of practice, in collaboration with the physician and the client.

4 Supportive care is defined in the Standard on Supportive Care.

College of Midwives of Ontario Page 4 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix H: Indications for Mandatory Discussion, Consultation and Transfer of Care

INDICATIONS: Initial History and Physical Examination

Category 1: • adverse socio-economic conditions • age less than 17 years or over 35 years • cigarette smoking • grand multipara (para 5) • history of infant over 4500 g • history of one late miscarriage (after 14 completed weeks) or preterm birth • history of one low birth weight infant • history of serious psychological problems • less than 12 months from last delivery to present due date • obesity • poor nutrition • previous antepartum hemorrhage • previous postpartum hemorrhage • one documented previous low segment cesarean section • history of essential or gestational hypertension • known uterine malformations or fibroids

Category 2: • current medical conditions for example:5 cardiovascular disease, pulmonary disease, endocrine disorders, hepatic disease, neurologic disorders • family history of genetic disorders • family history of significant congenital anomalies • history of cervical cerclage • history of repeated spontaneous abortions • history of more than one late miscarriage or preterm birth • history of more than one low birth weight infant • history of gestational hypertension with proteinuria and adverse sequelae • history of significant medical illness • previous myomectomy, hysterotomy or cesarean section other than one documented previous low segment cesarean section • previous neonatal mortality or stillbirth • rubella during first trimester of pregnancy

• significant use of drugs or alcohol • age less than 14 years

5 Refer to Guidelines to Antepartum Consultations for Clients of Midwives to Anaesthesia, July 1996.

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Category 3: • any serious medical condition, for example: cardiac or renal disease with failure or insulin dependent diabetes mellitus

INDICATIONS: Prenatal Care

Category 1: • presentation other than cephalic at 36 completed weeks • no prenatal care before 28 completed weeks • uncertain expected date of delivery • uncomplicated spontaneous abortion less than 12 completed weeks

Category 2: • anemia (unresponsive to therapy) • documented post term pregnancy (42 completed weeks) • fetal anomaly • inappropriate uterine growth • medical conditions arising during prenatal care, for example: endocrine disorders, hypertension, renal disease, suspected significant infection, hyperemesis • placenta previa without bleeding • polyhydramnios or oligohydramnios • gestational hypertension • isoimmunization • serious psychological problems6 • sexually transmitted disease • twins • vaginal bleeding other than transient spotting • presentation other than cephalic, unresponsive to therapy, at 38 completed weeks

Category 3: • cardiac or renal disease with failure • insulin dependent diabetes • multiple pregnancy (other than twins) • gestational hypertension with proteinuria and/or adverse sequelae • symptomatic placental abruption

6 Notwithstanding the requirement for consultation with a physician, consultation may be with another appropriate health care professional; for example, a mental health worker.

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• vaginal bleeding, continuing or repeated • placenta previa after 28 completed weeks

INDICATIONS: During Labour and Birth

Category 1: • no prenatal care • non-particulate meconium

Category 2: • breech presentation • preterm labour (34 - 37 completed weeks) • prolonged active phase • prolonged rupture of membranes • prolonged second stage • retained placenta • suspected placenta abruption and/or previa • third or fourth degree tear • twins • unengaged head in active labour in primipara • preterm prelabour rupture of membranes (PPROM) between 34 and 37 completed weeks • particulate meconium • gestational hypertension

Category 3: • active genital herpes at time of labour • preterm labour (less than 34 completed weeks) • abnormal presentation (other than breech) • multiple pregnancy (other than twins) • gestational hypertension with proteinuria and/or adverse sequelae • prolapsed cord or cord presentation • placenta abruption and/or previa • severe hypertension • confirmed non-reassuring fetal heart patterns, unresponsive to therapy • uterine rupture • uterine inversion • hemorrhage unresponsive to therapy • obstetric shock • vasa previa

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INDICATIONS: Post Partum (Maternal)

Category 2: • suspected maternal infection e.g. breast, abdomen, wound, uterine, urinary tract, perineum • temperature over 38° C (100.4° F) on more than one occasion • persistent hypertension • serious psychological problems7

Category 3: • hemorrhage unresponsive to therapy • postpartum eclampsia • thrombophlebitis or thromboembolism • uterine prolapse

INDICATIONS: Post Partum (Infant)

Category 1: • feeding problems8 • failure to pass urine or meconium within 24 hours of birth

Category 2: • 34 to 37 weeks gestational age • infant less than 2,500 g • less than 3 vessels in umbilical cord • excessive moulding and cephalhematoma • abnormal findings on physical exam • excessive bruising, abrasions, unusual pigmentation and/or lesions • birth injury requiring investigation • congenital abnormalities, for example: cleft lip or palate, congenital dislocation of hip, ambiguous genitalia • abnormal heart rate or pattern • abnormal cry • persistent abnormal respiratory rate and/or pattern • persistent cyanosis or pallor • jaundice in first 24 hours • suspected pathological jaundice after 24 hours

7 Notwithstanding the requirement for consultation with a physician, consultation may be with another appropriate health care professional; for example, a mental health worker. 8 Notwithstanding the requirement for discussion with a physician or midwife, discussion may be with another appropriate health care professional; for example, a lactation consultant.

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• temperature less than 36° C, unresponsive to therapy • temperature more than 37.4° C, axillary, unresponsive to non- pharmaceutical therapy • vomiting or diarrhea • infection of umbilical stump site • significant weight loss (more than 10% of body weight) • failure to regain birth weight in three weeks • • failure to pass urine or meconium within 36 hours of birth • suspected clinical dehydration

Category 3: • APGAR lower than 7 at 5 minutes • suspected seizure activity • major congenital anomaly requiring immediate intervention, for example: omphalocele, myelomeningocele • temperature instability

College of Midwives of Ontario Page 9 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix H: CMO Standard – Essential Equipment, Supplies and Medications

January 1994 Revised September 22, 2004

ESSENTIAL EQUIPMENT, SUPPLIES AND MEDICATIONS

The following list is the minimum required equipment, supplies and medications, necessary for the provision of safe and appropriate care in a home birth setting. There may be further equipment and supplies that midwives may choose to carry depending on their clients’ needs in individual settings.

It is expected that all equipment and supplies will be appropriately cleaned, disinfected, sterilized and fully functional in order to ensure client safety1.

EQUIPMENT Regular fetoscope Doppler fetoscope Adult Stethoscope Infant Stethoscope Sphygmomanometer and adequate sized cuffs Thermometer Baby scale Ophthalmoscope or other suitable method for assessing red reflex Infant resuscitation bag and mask Sterile speculum Heat source for the baby (i.e. heating pad) Suitable time-keeping device Four hemostats One pair scissors for cord cutting One pair scissors for episiotomy Needle driver Mosquito forcep

1 Routine Practices and Additional Precaution for Preventing the Transmission of Infection in Health Care, July 1999 http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/99vol25/25s4/index.html; Preventing the Transmission of Bloodborne Pathogens in Health Care and Public Service Settings, May 1997 http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/97vol23/23s3/index.html.

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Appendix H: CMO Standard – Essential Equipment, Supplies and Medications

Scissors for suturing Ring forceps Portable suction equipment

SUPPLIES Cord blood tubes Cord clamps or ties Sterile gloves Clean gloves Sterile lubricant Infection control supplies as needed to meet public health guidelines and directives 2 Urinalysis supplies Blood drawing supplies and tubes Amnicator or suitable method for assessing amniotic fluid Maternal non-rebreathing oxygen mask Feeding tubes (8 Fr.) Syringes Needles IV supplies IV fluids Urinary catheters Amnihook or suitable alternative for rupturing membranes Infant oropharyngeal airways Suture material Sharps and points waste container Antiseptic solution

MEDICATIONS Oxygen – sufficient for transport of mother and baby Oxytocic drugs Epinephrine hydrochloride (1:1,000) Diphenhydramine hydrochloride (Benadryl) Local anesthetic Eye prophylaxis Vitamin K

2 Preventing Respiratory Illnesses In Community Settings - Infection Control and Surveillance for Febrile Respiratory Illness (FRI) in Community Settings in Non-Outbreak Conditions, March 2004 www.health.gov.on.ca/english/providers/program/pubhealth/sars/sars_mn.html#1

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Appendix H: Recommendation for Midwife Certification for Care of Women Receiving Epidural Pain Relief in Labour

Approved October 1, 1997

RECOMMENDATION FOR MIDWIFE CERTIFICATION FOR CARE OF WOMEN RECEIVING EPIDURAL PAIN RELIEF IN LABOUR

This recommendation is written with the understanding that the responsibility for epidural analgesia throughout the course of labour and delivery rests with the anaesthetist at all times.

When a client under the primary care of a midwife chooses epidural analgesia for pain relief, the midwife shall consult with an anaesthetist. This consultation may occur at any time during the antepartum or intrapartum period, in order to provide for informed consent.

The College of Midwives recommends that a midwife who wishes to provide continuing monitored care for epidural anaesthesia be certified annually. A midwife may provide continuing monitored care for epidural analgesia if she has been certified in a hospital to do so. The College of Midwives recommends that certification include demonstration of knowledge of the theoretical and practical aspects of epidural care.

The College of Midwives also recommends that certification programmes include a process of initial certification and a process of annual recertification.

Epidural analgesia is an intervention which a midwifery client may require. The provision of epidural analgesia monitored care is an additional certification which a midwife may elect to obtain. Certification in this skill is not a requirement for the practice of midwifery.

The College of Midwives recommends the following framework for certification:

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A. Initial Certification Initial certification shall depend upon knowledge of:

1. the nature, mechanism, and perceptions of pain during parturition.

2. the anatomy of the epidural space.

3. the pharmacology, action, and side effects of local anaesthetics and narcotics used in epidural analgesia.

4. the effects of epidural analgesia on the progress of labour.

5. the advantages, disadvantages and contraindications of epidural analgesia.

6. anaesthetic requirements for preparation of the client for epidural analgesia including: Πexplanation of risks, benefits and alternatives Πpatient history, physical, and laboratory tests Πresuscitation equipment and drugs Πintravenous access and volume loading Πequipment for placement of the epidural catheter under sterile conditions

7. recognition of, response to, and management of immediate anaesthetic complications of epidural analgesia including: Πhypotension Πseizures Πhigh spinal anaesthesia

8. technique of epidural insertion to include: Πpositioning Πanaesthetic technique Πcomplications of needle and catheter placement Πsecuring the epidural catheter and maintaining sterility at the catheter site

9. initiation of epidural block to include: Πpositioning Πmonitoring the test dose and the initial therapeutic dose

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10. maintenance of analgesia in first stage of labour to include monitoring of: Πbolus dose top-ups Πcontinuous infusions Πcatheter integrity monitoring

11. maintenance of analgesia in the second stage and third stages of labour when required.

12. postpartum management to include: Πcatheter removal and care of epidural site Πambulation Πmanagement of late complications of epidural analgesia

Initial certification shall also depend upon demonstration of competence when assessed by the Anaesthetist-in-Chief or designate. This assessment is to include the demonstration of:

1. familiarity with the location of equipment for resuscitation.

2. assistance with the insertion of epidural catheter according to the hospital policies and procedures.

3. familiarity with the set-up and functioning of the epidural infusion.

4. provision of appropriate client care and monitoring during the process of epidural infusion.

5. ability to document appropriately.

6. ability to identify problems and implement appropriate interventions.

7. knowledge of when to adjust the rate of an infusion pump.

8. knowledge of when to call anaesthetist.

9. removal of epidural catheter as per hospital policy and procedure.

The process for certification could reasonably include the demonstration of competence in the provision of continuing monitored care to women who require epidural analgesia. In addition, the midwife would complete a pre-reading package,

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successfully pass a written test and oral/practical component which could include mock scenarios to be administered by the Anaesthetist-in-Chief, or designate.

B: RECERTIFICATION 1. The process of annual recertification would likely depend on the number of epidurals monitored by the midwife in the preceding 12 months. Where the midwife had monitored fewer than 5 epidurals over that period, recertification could involve the same process as initial certification.

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Appendix H: Draft Standard for Prescribing and Administering Drugs

College of Midwives of Ontario CMO Standard: Prescribing and Administering Drugs Approved at Council May 28, 2008

June 17, 2008

CMO STANDARD: Prescribing and Administering Drugs

The following standard applies to the substances that have been added to the College of Midwives drug regulation (as of amended date), which midwives are able to independently prescribe and administer for their clients in the community, hospital or other sites of midwifery practice. Midwives may not independently prescribe or administer any drugs or substances other than those specified by the Designated Drugs regulation of the Midwifery Act. Midwives are expected to ensure that they remain informed of the current clinical requirements and maintain their competencies in regard to these substances.

Antibiotics

When prescribing and administering antibiotics midwives are expected to adhere to recommendations to minimize the risk of developing antibiotic resistance. The safest effective available agent should be prescribed and administered. Antibiotics, intravenous: 1. Group B Streptococcus Ampicillin, Cefazolin, Clindamycin, Erythromycin, Penicillin G Intravenous (IV) antibiotics may only be prescribed and administered on the member’s own responsibility to the expectant mother for the prophylaxis of neonatal Group B streptococcus during the intrapartum period. When a pregnant woman tests positive for Group B streptococcus and she is allergic to penicillin G, laboratory confirmation of drug sensitivities to the culture should be obtained to ensure that the most appropriate antibiotic is selected. Ampicillin is an alternative choice to penicillin, and cefazolin is recommended in penicillin allergic patients. In patients at high risk for anaphylaxis to penicillin, intravenous clindamycin or erythromycin is recommended.1

1 Centre for Infectious Disease Preventions and Control, Canadian Task Force on Preventive Health Care’s Prevention of Early-onset Group B Streptococcal Infection in the Newborn) (updated 2002). Available online at http://www.ctfphc.org/

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Appendix H: Draft Standard for Prescribing and Administering Drugs

Intravenous antibiotics cannot be prescribed on the member’s own responsibility in any other situation. Antibiotics, oral:

Oral antibiotics may only be prescribed by the member in the course of routine provision of midwifery care. This includes treatment for:

1. Urinary tract infections (UTI)

Ciprofloxacin, Sulfamethoxazole-trimethoprim, Nitrofurantoin, Trimethoprim Oral (PO) antibiotics should be prescribed after culture and sensitivities have been identified. Sulfamethoxazole-trimethoprim and trimethoprim should be avoided in first trimester of pregnancy due to increased risk of neural tube defects (NTDs). If clinically required during first month of pregnancy, a high dose of folic acid (4mg/day) should be given to prevent NTDs.2 Sulfamethoxazole-trimethoprim should be avoided in the last 2 to 6 weeks of pregnancy since sulfonamides may displace bilirubin from albumin binding sites and cause kernicterus in infants, especially at preterm. Fluoroquinolones (e.g., ciprofloxacin) and tetracyclines should not be prescribed during pregnancy unless the benefit outweighs the risk and all other antibiotic options have been eliminated.

If symptoms persist after the prescribed course of treatment referral to a physician for

consultation is required.

2. Mastitis Amoxicillin-clavulanic acid, Cephalexin, Ciprofloxacin, Clindamycin, Cloxacillin Antibiotics are prescribed only for fever and signs and symptoms of blocked duct that do not resolve within 24 hours or are worsening quickly after non-pharmacological treatment.

SOGC clinical practice guidelines no. 149, September 2004. “The prevention of early-onset neonatal group B streptococcal disease.” JOGC, Sept 2004: 826-32

2 Medication Safety in Pregnancy and Breastfeeding, by Gideon Koren MD, Motherisk

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Appendix H: Draft Standard for Prescribing and Administering Drugs

If symptoms persist after the prescribed course of treatment referral to a physician for consultation is required.

3. Bacterial Vaginosis Clindamycin, Metronidazole Women with a past history of premature labour and who have Bacterial Vaginosis (BV), whether or not it is symptomatic, may benefit from treatment with antibiotics. Bacterial vaginosis during pregnancy is associated with premature rupture of the membranes, chorioamnionitis, preterm labour, preterm birth and post-cesarean delivery endometritis. During pregnancy, treatment is recommended for symptomatic patients and asymptomatic women with BV who have had a previous preterm birth. The goal is to reduce the risk of preterm prelabour rupture of the membranes and low birth weight.

If symptoms persist after the prescribed course of treatment referral to a physician for consultation is required.

Antibiotics, topical:

1. Breast and Nipple Pain

Mupirocin-betamethasone valerate-miconazole

Topical antibiotics may be used as part of a therapeutic regime for breast and nipple pain. All Purpose Nipple Ointment is a combination antibiotic, antifungal and low dose steroid cream that may be used to treat persistent nipple pain. It is used as a topical treatment for candidiasis of the nipple in the breastfeeding woman, with or without secondary bacterial infection. The cream should be applied sparingly to the nipples after each feeding and not washed or wiped off, even prior to the next feed. All Purpose Nipple Ointment is not recommended for use in pregnancy. While generally well tolerated, All Purpose Nipple Ointment should not be used over large areas of the skin, and is not intended for prolonged use.

If the condition has not improved within a week referral to a physician for consultation is required.

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Appendix H: Draft Standard for Prescribing and Administering Drugs

Non-steroidal anti-inflammatory drugs (oral) 1. Postpartum Pain Diclofenac, Naproxen Oral non-steroidal anti-inflammatory drugs (NSAIDS) may be used to treat postpartum pain. The general approach to the use of NSAIDs in any population is to use the lowest dose for the shortest period of time to reduce the risk of any adverse events including GI bleeding. NSAIDs should not be given to clients who are asthmatic or allergic to ASA. Ibuprofen is the least potent of the NSAID group and at formulations up to 400 mg is available as an OTC. Naproxen and acetaminophen have been proven to have the same effect on postpartum pain.3 Anti-hemorrhagics and oxytocics

1. Management of postpartum bleeding Carbetocin, Misoprostol Oxytocics and anti-hemorrhagics are to be used for the management of postpartum bleeding on the member’s own responsibility. The choice of agent and method of administration will be dependant upon the clinical scenario and the local community standard and availability of these medications. Carbetocin - off label

Carbetocin (e.g., Duratocin®) is approved for use in Canada for the prevention of uterine atony and postpartum hemorrhage following elective cesarean section under epidural or spinal anesthesia. It was shown to be effective for the off-label treatment of postpartum hemorrhage following vaginal birth, and is used as a second-or-third line agent in Ontario hospitals, used only after oxytocin and ergonovine maleate, where available, have been attempted.

Carbetocin is not approved by the College of Midwives of Ontario to treat anything other than postpartum hemorrhage.

Misoprostol – off label

3 Skovlund et al, European Journal of Clinical Pharmacology, 1991, Volume 40, Number 6, pg. 539-542.

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Appendix H: Draft Standard for Prescribing and Administering Drugs

Misoprostol is a synthetic prostaglandin E1 analog that is approved for use as an antisecretory agent with protective effects on the GI mucosa. It was shown to be effective for the off-label treatment of postpartum uterine atony or postpartum hemorrhage uncontrolled by the use of oxytocin. Misoprostol is a second-or-third line agent, used only after oxytocin and ergonovine maleate, where available, have been attempted. Misoprostol should not be taken by anyone with a history of allergy to prostaglandins. If misoprostol is administered as a third line agent in response to a postpartum hemorrhage occurring out-of-hospital, transport to hospital and consultation with a physician is indicated. The use of misoprostol for prevention of PPH or for the induction of labour is currently under evaluation. Its use for induction of labour in the presence of a living fetus is restricted to clinical trials. Midwives CANNOT prescribe or order misoprostol for this application. However, where a physician has ordered misoprostol for induction of labour in a non-viable pregnancy, the midwife may continue to be involved in the woman’s care.

Misoprostol is not approved by the College of Midwives of Ontario to treat anything other than postpartum hemorrhage.

Other Drugs

1. Domperidone - off label Domperidone is an antidopaminergic drug approved for the treatment of nausea and vomiting. It has been used off-label to enhance breastmilk production in women where non-pharmacologic methods have proven ineffective and/or in women with a previous history of inadequate milk supply. Domperidone must not be given intravenously. Caution should be used in patients with hepatic disease and with those taking anticholinergics, since they may antagonize the effect of the domperidone in the GI tract. It should not be co-administered with ketoconazole due to the increased risk of QTc prolongation and associated heart arrhythmias.

Domperidone is not approved by the College of Midwives of Ontario to treat anything other than inadequate milk supply. As noted in the CMO’s Mandatory Indications for Discussion, Consultation and Transfer of Care, if the newborn has not regained birth weight by three weeks

postpartum, consultation with a physician is required.

2. Measles / Mumps / Rubella (MMR) Vaccine

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Appendix H: Draft Standard for Prescribing and Administering Drugs

(e.g., M-M-R® II, Priorix®) Women found to be rubella-susceptible during the antenatal period should be offered MMR vaccine in the immediate postpartum period. Women without detectable antibodies or no prior vaccination for rubella should be immunized only if they are not pregnant at vaccination time and if pregnancy is avoided for 1 month following vaccination. MMR vaccine should not be administered to individuals who are pregnant (the possible effect on the fetus is not known), have acute febrile respiratory or other infections, or any acute illness, have a history of sensitivity to neomycin or gelatin; have blood dyscrasias, lymphomas or other generalized malignancies; have untreated active tuberculosis; or are undergoing treatment with immunosuppressive agents of any kind. Breastfeeding is not a contraindication to receiving this vaccination. Whenever vaccines are administered the midwife must send a record of immunization to the physician to whom care is transferred at 6 weeks postpartum. A record of immunization should also be sent to the local public health unit in communities where this is required. 3. Varicella Zoster immune globulin

(e.g., VariZIG™) Varicella zoster immune globulin is recommended for susceptible people, including pregnant women, provided that significant exposure has occurred. Administration of varicella zoster immune globulin is recommended for prevention or reduction of severity of maternal infections within 4 days of exposure to the varicella zoster virus. Greatest effectiveness of treatment is expected when it is begun within 4 days of exposure; treatment after 4 days is of uncertain value. Pregnant women may be at a higher risk of complications from chickenpox than healthy adults. The decision to administer varicella zoster immune globulin to a pregnant woman should be evaluated on an individual basis. The clinician should consider the patient's health status, type of exposure, and likelihood of previous unrecognized varicella infections before deciding whether to administer varicella zoster immune globulin. If after careful evaluation of all available information, which may include the use of reliable and sensitivity tests for varicella antibody, a normal pregnant woman with significant exposure to varicella is believed susceptible, varicella zoster immune globulin may be administered. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when varicella zoster immune globulin is administered to a nursing mother.

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INTERNATIONAL CONFEDERATION OF MIDWIVES

ESSENTIAL COMPETENCIES FOR BASIC MIDWIFERY PRACTICE 2002

INTRODUCTION

The International Confederation of Midwives (ICM) is a federation of midwifery associations representing midwives in 72 nations of the world. The ICM works closely with all UN agencies in support of Safe Motherhood, primary health care strategies for the world's families, and the definition and preparation of the midwife. In keeping with the aims of the ICM, the ICM/WHO/FIGO international Definition of the Midwife (1992) , the ICM International Code of Ethics for Midwives (1993), the ICM Global Vision for Women and Their Health (1996) and requests from member associations, the ICM has taken the lead in defining these essential competencies for midwives.

Throughout this document, the term "competencies" is used to refer to both the broad statement heading each section as well as the basic knowledge, skills and behaviours required of the midwife for safe practice in any setting. They answer the question: "What does a midwife do?" and are evidence- based. (See Appendix 1)

It is fully understood that these competencies may be considered maximum in some areas of the world, and minimum in other areas. Some knowledge and skills have been separated into a category, "additional". This allows for variation in the preparation and practice of midwives throughout the world, depending on the needs of their local community and/or nation.

Likewise, in recognition that midwives receive their knowledge and skills from several different educational pathways, these competencies are written for generic use by midwives and midwifery associations responsible for the education and practice of midwifery in their country or region. The essential competencies are guidelines for those interested in developing midwifery education, and information for those in government and other policy arenas who need to understand who a midwife is, what a midwife does, and how the midwife learned to be a midwife.

It is expected that the document will undergo continual evaluation as it is used world-wide and as the health care needs of childbearing women and families change.

KEY MIDWIFERY CONCEPTS

The key midwifery concepts that define the unique role of midwives in promoting the health of women and childbearing families include: partnership with women to promote self-care and the health of mothers, infants and families; respect for human dignity and for women as persons with full human rights; advocacy for women so that their voices are heard; cultural sensitivity, including working with women and health care providers to overcome those cultural practices that harm women and babies;

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 1 a focus on health promotion and disease prevention which views pregnancy as a normal life event. Midwives recognise that equity of status for women will bring the greatest impact on global maternal- child health by ensuring adequate nutrition, clean water and sanitation; so they are committed to the improvement of basic living conditions as well as providing competent midwifery services.

SCOPE OF MIDWIFERY PRACTICE

The scope of midwifery practice used throughout this document is built upon the ICM/WHO/FIGO international Definition of the Midwife (1992). Midwifery practice includes the autonomous care of the girl-child, the adolescent and the adult woman prior to, during and following pregnancy. This means that the midwife gives necessary supervision, care and advice for women during pregnancy, labour and the postpartum period. The midwife conducts deliveries on her own responsibility and cares for the newborn infant. This care includes primary health care supervision within the community (preventive measures); health counselling and education for women, the family and the community including preparation for parenthood; the provision of family planning; the detection of abnormal conditions in the mother and child; the procurement of specialised assistance as necessary (consultation or referral); and the execution of primary and secondary emergency measures in the absence of medical help. Midwifery practice is ideally conducted within a community-based health care system that may include traditional birth attendants, traditional healers, other community-based health workers, doctors, nurses and specialists in referral centres.

THE MIDWIFERY MODEL OF CARE

The Midwifery Model of Care is based on the premise that pregnancy and birth are normal life events. The Midwifery Model of Care includes: monitoring the physical, psychological, spiritual and social well- being of the woman and family throughout the childbearing cycle; providing the woman with individualised education, counselling and antenatal care; continuous attendance during labour, birth and the immediate postpartum period; ongoing support during the postnatal period; minimising technological interventions; and identifying and referring women who require obstetric or other specialist attention. This model of care is woman-centred and therein lies its accountability.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 2

THE FRAMEWORK FOR DECISION-MAKING IN MIDWIFERY CARE

Midwives assume responsibility and accountability for their practice, applying up-to-date knowledge and skills in caring for each woman and family. The safety and overall well-being of the woman is of foremost concern to the midwife. The midwife strives to support a woman's informed choices in the context of a safe experience. The midwife's decision-making process utilises a variety of sources of knowledge and is dynamic, responding to the changing health status of each woman. Midwives involve women and their families in all parts of the decision-making process and in developing a plan of care for a healthy pregnancy and birth experience.

STEP 1: Collect information from the woman, from the woman's and the infant's records, and from any laboratory tests in a systematic way for a complete assessment. STEP 2: Identify actual or potential problems based on the correct interpretation of the information gathered in Step 1. STEP 3: Develop a comprehensive plan of care with the woman and her family based on the woman's or infant's needs and supported by the data collected. STEP 4: Carry out and continually update the plan of care within an appropriate time frame. STEP 5: Evaluate the effectiveness of care given with the woman and her family, consider alternatives if unsuccessful, returning to STEP 1 to collect more data and/or develop a new plan.

GUIDING STATEMENT TO MEMBER ASSOCIATIONS

The essential competencies for basic midwifery practice that follow are based on the values, vision, strategies and actions used by those who attend to the health needs of women and childbearing families. Member associations are encouraged to use this ICM statement of competencies, as needed in their countries, in the education, regulation and development of standards of practice for midwives as well as in policies needed to strengthen midwifery.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 3 ESSENTIAL COMPETENCIES FOR BASIC MIDWIFERY PRACTICE MAY 2002

GENERIC KNOWLEDGE, SKILLS AND BEHAVIOURS FROM THE SOCIAL SCIENCES, PUBLIC HEALTH AND THE HEALTH PROFESSIONS

Competency #1: Midwives have the requisite knowledge and skills from the social sciences, public health and ethics that form the basis of high quality, culturally relevant, appropriate care for women, newborn and childbearing families.

Basic Knowledge and Skills:

1. Respect for local culture (customs). 2. Traditional and modern routine health practices (beneficial and harmful). 3. Resources for alarm and transport (emergency care). 4. Direct and indirect causes of maternal and neonatal mortality and morbidity in the local community. 5. Advocacy and empowerment strategies for women. 6. Understanding human rights and their effect on health. 7. Benefits and risks of available birth settings. 8. Strategies for advocating with women for a variety of safe birth settings. 9. Knowledge of the community - its state of health including water supply, housing, environmental hazards, food, common threats to health. 10. Indications and procedures for adult and newborn/infant cardiopulmonary resuscitation. 11. Ability to assemble, use and maintain equipment and supplies appropriate to setting of practice.

Additional Knowledge and Skills

12. Principles of epidemiology, sanitation, community diagnosis and vital statistics or records 13. National and local health infrastructures; how to access needed resources for midwifery care. 14. Principles of community-based primary care using health promotion and disease prevention strategies. 15. National immunisation programs (provision of same or knowledge of how to assist community members to access to immunisation services)

Professional Behaviours - The midwife:

1. Is responsible and accountable for clinical decisions. 2. Maintains knowledge and skills in order to remain current in practice. 3. Uses universal/standard precautions, infection control strategies and clean technique. 4. Uses appropriate consultation and referral during care. 5. Is non-judgmental and culturally respectful. 6. Works in partnership with women and supports them in making informed choices about their health. 7. Uses appropriate communication skills. 8. Works collaboratively with other health workers to improve the delivery of services to

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 4 women and families.

PRE-PREGNANCY CARE AND FAMILY PLANNING METHODS

Competency #2: Midwives provide high quality, culturally sensitive health education and services to all in the community in order to promote healthy family life, planned pregnancies and positive parenting.

Basic Knowledge of:

1. Growth and development related to sexuality, sexual development and sexual activity. 2. Female and male anatomy and physiology related to conception and reproduction. 3. Cultural norms and practices surrounding sexuality, sexual practices and childbearing. 4. Components of a health history, family history and relevant genetic history. 5. Physical examination content and investigative laboratory studies that evaluate potential for a healthy pregnancy. 6. Health education content targeted to reproductive health, sexually transmitted infections (STIs), HIV/AIDS and child survival. 7. Natural methods for child spacing and other locally available and culturally acceptable methods of family planning. 8. Barrier, steroidal, mechanical, chemical and surgical methods of contraception and indications for use. 9. Counselling methods for women needing to make decisions about methods of family planning. 10. Signs and symptoms of urinary tract infection and common sexually transmitted infections in the area.

Additional Knowledge of:

11. Factors involved in decisions relating to unplanned or unwanted pregnancies. 12. Indicators of common acute and chronic disease conditions specific to a geographic area of the world, and referral process for further testing/ treatment. 13. Indicators of and methods of counselling/referral for dysfunctional interpersonal relationships including sexual problems, domestic violence, emotional abuse and physical neglect.

Basic Skills:

1. Take a comprehensive history. 2. Perform a physical examination focused on the presenting condition of the woman. 3. Order and/or perform and interpret common laboratory studies such as haematocrit, urinalysis or microscopy. 4. Use health education and basic counselling skills appropriately. 5. Provide locally available and culturally acceptable methods of family planning. 6. Record findings, including what was done and what needs follow-up.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 5

Additional Skills:

7. Use the microscope. 8. Provide all available methods of barrier, steroidal, mechanical, and chemical methods of contraception. 9. Take or order cervical cytology smear (Pap test)

CARE AND COUNSELLING DURING PREGNANCY

Competency #3: Midwives provide high quality antenatal care to maximise the health during pregnancy and that includes early detection and treatment or referral of selected complications.

Basic Knowledge of:

1. Anatomy and physiology of the human body. 2. Menstrual cycle and process of conception. 3. Signs and symptoms of pregnancy. 4. How to confirm a pregnancy. 5. Diagnosis of an ectopic pregnancy and multiple fetuses. 6. Dating pregnancy by menstrual history, size of uterus and/or fundal growth patterns. 7. Components of a health history. 8. Components of a focused physical examination for antenatal visits. 9. Normal findings [results] of basic screening laboratory studies defined by need of area of the world; eg. iron levels, urine test for sugar, protein, , bacteria. 10. Normal progression of pregnancy: body changes, common discomforts, expected fundal growth patterns. 11. Normal psychological changes in pregnancy and impact of pregnancy on the family. 12. Safe, locally available herbal/non-pharmacological preparations for the relief of common discomforts of pregnancy. 13. How to determine fetal well-being during pregnancy including fetal heart rate and activity patterns. 14. Nutritional requirements of the pregnant woman and fetus. 15. Basic fetal growth and development. 16. Education needs regarding normal body changes during pregnancy, relief of common discomforts, hygiene, sexuality, nutrition, work inside and outside the home. 17. Preparation for labour, birth and parenting. 18. Preparation of the home/family for the newborn. 19. Indicators of the onset of labour. 20. How to explain and support breastfeeding. 21. Techniques for increasing relaxation and pain relief measures available for labour. 22. Effects of prescribed medications, street drugs, traditional medicines and over-the- counter drugs on pregnancy and the fetus. 23. Effects of smoking, alcohol use and illicit drug use on the pregnant woman and fetus. 24. Signs and symptoms of conditions that are life-threatening to the pregnant woman; eg. pre-eclampsia, vaginal bleeding, premature labour, severe anaemia.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 6

Additional Knowledge of:

25. Signs, symptoms and indications for referral of selected complications and conditions of pregnancy: eg. asthma, HIV infection, diabetes, cardiac conditions, post-dates pregnancy. 26. Effects of above named chronic and acute conditions on pregnancy and the fetus.

Basic Skills :

1. Take an initial and ongoing history each antenatal visit. 2. Perform a physical examination and explain findings to woman. 3. Take and assess maternal vital signs including temperature, blood pressure, pulse. 4. Assess maternal nutrition and its relationship to fetal growth. 5. Perform a complete abdominal assessment including measuring fundal height, position, lie and descent of fetus. 6. Assess fetal growth. 7. Listen to the fetal heart rate and palpate uterus for fetal activity pattern. 8. Perform a pelvic examination, including sizing the uterus and determining the adequacy of the bony structures. 9. Calculate the estimated date of delivery. 10. Educate women and families about danger signs and when/how to contact the midwife. 11. Teach and/or demonstrate measures to decrease common discomforts of pregnancy. 12. Provide guidance and basic preparation for labour, birth and parenting. 13. Identify variations from normal during the course of the pregnancy and institute appropriate interventions for: a. low and/or inadequate maternal nutrition b. inadequate fetal growth c. elevated blood pressure, proteinuria, presence of significant oedema, severe headaches, visual changes, epigastric pain associated with elevated blood pressure d. vaginal bleeding e. multiple gestation, abnormal lie at term f. intrauterine fetal death g. rupture of membranes prior to term 14. Perform basic life saving skills competently. 15. Record findings including what was done and what needs follow-up.

Additional Skills:

16. Counsel women about health habits; eg. nutrition, exercise, safety, stopping smoking. 17. Perform clinical pelvimetry [evaluation of bony pelvis]. 18. Monitor fetal heart rate with doppler. 19. Identify and refer variations from normal during the course of the pregnancy, such as: a. small for dates [light]/large for dates [heavy] fetus b. suspected polyhydramnios, diabetes, fetal anomaly (eg. oliguria)

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 7 c. abnormal laboratory results d. infections such as sexually transmitted infections (STIs), vaginitis, urinary tract, upper respiratory e. fetal assessment in the post-term pregnancy 20. Treat and/or collaboratively manage above variations from normal based upon local standards and available resources. 21. Perform external version of breech presentation.

CARE DURING LABOUR AND BIRTH

Competency #4: Midwives provide high quality, culturally sensitive care during labour, conduct a clean and safe delivery, and handle selected emergency situations to maximise the health of women and their newborn.

Basic Knowledge of :

1. Physiology of labour. 2. Anatomy of fetal skull, critical diameters and landmarks. 3. Psychological and cultural aspects of labour and birth. 4. Indicators that labour is beginning. 5. Normal progression of labour and how to use the partograph or similar tool. 6. Measures to assess fetal well-being in labour. 7. Measures to assess maternal well-being in labour. 8. Process of fetal passage [descent] through the pelvis during labour and birth. 9. Comfort measures in labour: eg. family presence/assistance, positioning, hydration, emotional support, non-pharmacological methods of pain relief. 10. Transition of newborn to extra-uterine life. 11. Physical care of the newborn - breathing, warmth, feeding. 12. Promotion of skin-to-skin contact of the newborn with mother when appropriate. 13. Ways to support and promote uninterrupted [exclusive] breastfeeding. 14. Physiological management of the 3rd stage of labour. 15. Indications for emergency measures: eg. retained placenta, shoulder dystocia, atonic uterine bleeding, neonatal . 16. Indications for operative delivery: eg. fetal distress, cephalo-pelvic disproportion. 17. Indicators of complications in labour: bleeding, labour arrest, malpresentation, eclampsia, maternal distress, fetal distress, infection, prolapsed cord. 18. Principles of active management of 3rd stage of labour.

Basic Skills:

1. Take a specific history and maternal vital signs in labour. 2. Perform a screening physical examination. 3. Do a complete abdominal assessment for fetal position and descent. 4. Time and assess the effectiveness of uterine contractions. 5. Perform a complete and accurate pelvic examination for dilation, descent, presenting part, position, status of membranes, and adequacy of pelvis for baby. 6. Follow progress of labour using the partograph or similar tool for recording. 7. Provide psychological support for woman and family. 8. Provide adequate hydration, nutrition and comfort measures during labour.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 8 9. Provide for bladder care. 10. Promptly identify abnormal labour patterns with appropriate and timely intervention and/or referral. 11. Perform appropriate hand manoeuvres for a vertex delivery. 12. Manage a cord around the baby's neck at delivery. 13. Cut an episiotomy if needed. 14. Repair an episiotomy if needed. 15. Support physiological management of the 3rd stage of labour. 16. Conduct active management of the 3rd stage of labour including: a. Administration of uterotonic agents b. Controlled cord traction c. Uterine massage after delivery of the placenta, as appropriate 17. Guard the uterus from inversion during 3rd stage of labour. 18. Inspect the placenta and membranes for completeness. 19. Estimate maternal blood loss. 20. Inspect the vagina and cervix for lacerations. 21. Repair vaginal/perineal lacerations and episiotomy. 22. Manage postpartum haemorrhage. 23. Provide a safe environment for mother and infant to promote attachment. 24. Initiate breastfeeding as soon as possible after birth and support exclusive breastfeeding. 25. Perform a screening physical examination of the newborn. 26. Record findings including what was done and what needs follow-up.

Additional Skills :

27. Perform appropriate hand manoeuvres for face and breech deliveries. 28. Inject local anaesthesia. 29. Apply vacuum extraction or forceps. 30. Manage malpresentation, shoulder dystocia, fetal distress initially. 31. Identify and manage a prolapsed cord. 32. Perform manual removal of placenta. 33. Identify and repair cervical lacerations. 34. Perform internal bimanual compression of the uterus to control bleeding. 35. Insert intravenous line, draw bloods, perform haematocrit and haemoglobin testing. 36. Prescribe and/or administer pharmacological methods of pain relief when needed. 37. Administer oxytocics appropriately for labour induction or augmentation and treatment of postpartum bleeding. 38. Transfer woman for additional/emergency care in a timely manner.

POSTNATAL CARE OF WOMEN

Competency #5: Midwives provide comprehensive, high quality, culturally sensitive postnatal care for women.

Basic Knowledge of :

1. Normal process of involution and healing following delivery [including after an abortion].

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 9 2. Process of lactation and common variations including engorgement, lack of milk supply, etc. 3. Maternal nutrition, rest, activity and physiological needs (eg. bladder). 4. Infant nutritional needs. 5. Parent-infant bonding and attachment; eg. how to promote positive relationships. 6. Indicators of sub-involution eg. persistent uterine bleeding, infection. 7. Indications of breastfeeding problems. 8. Signs and symptoms of life threatening conditions; eg. persistent vaginal bleeding, urinary retention, incontinence of faeces, postpartum pre-eclampsia.

Additional Knowledge of:

9. Indicators of selected complications in the postnatal period: eg. persistent anaemia, haematoma, embolism, mastitis, depression, thrombophlebitis. 10. Care and counselling needs during and after abortion. 11. Signs and symptoms of abortion complications.

Basic Skills :

1. Take a selective history, including details of pregnancy, labour and birth. 2. Perform a focused physical examination of the mother. 3. Assess for uterine involution and healing of lacerations/repairs. 4. Initiate and support uninterrupted [exclusive] breastfeeding. 5. Educate mother on care of self and infant after delivery including rest and nutrition. 6. Identify haematoma and refer for care as appropriate. 7. Identify maternal infection, treat or refer for treatment as appropriate. 8. Record findings including what was done and what needs follow-up.

Additional Skills :

9. Counsel woman/family on sexuality and family planning post delivery. 10. Counsel and support woman who is post-abortion. 11. Evacuate a haematoma. 12. Provide appropriate antibiotic treatment for infection. 13. Refer for selected complications.

NEWBORN CARE (up to 2 months of age)

Competency #6: Midwives provide high quality, comprehensive care for the essentially healthy infant from birth to two months of age.

Basic Knowledge of:

1. Newborn adaptation to extra-uterine life. 2. Basic needs of newborn: airway, warmth, nutrition, bonding. 3. Elements of assessment of the immediate condition of newborn; eg. APGAR scoring system for breathing, heart rate, reflexes, muscle tone and colour. 4. Basic newborn appearance and behaviours.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 10 5. Normal newborn and infant growth and development. 6. Selected variations in the normal newborn; eg. caput, moulding, mongolian spots, haemangiomas, hypoglycaemia, hypothermia, dehydration, infection. 7. Elements of health promotion and prevention of disease in newborn and infants. 8. Immunisation needs, risks and benefits for the infant up to 2 months of age.

Additional Knowledge of:

9. Selected newborn complications, eg. jaundice, haematoma, adverse moulding of the fetal skull, cerebral irritation, non-accidental injuries, causes of sudden infant death. 10. Normal growth and development of the preterm infant up to 2 months of age.

Basic Skills:

1. Clear airway to maintain respirations. 2. Maintain warmth but avoid overheating. 3. Assess the immediate condition of the newborn; eg. APGAR scoring or other assessment method. 4. Perform a screening physical examination of the newborn for conditions incompatible with life. 5. Position the infant for breastfeeding. 6. Educate parents about danger signs and when to bring the infant for care. 7. Begin emergency measures for respiratory distress (newborn resuscitation), hypothermia, hypoglycaemia, cardiac arrest. 8. Transfer newborn to emergency care facility when available. 9. Record findings, including what was done and what needs follow-up.

Additional Skills:

10. Perform a gestational age assessment 11. Educate parents about normal growth and development, child care. 12. Assist parents to access community resources available to the family. 13. Support parents during grieving process for congenital birth defects, loss of pregnancy, or neonatal death. 14. Support parents during transport/transfer of newborn. 15. Support parents with multiple births.

Appendix 1. Background to the evidence-base of the competencies

Between 1995 and 1999 a modified Delphi Technique was carried out for seven rounds to establish the Provisional Essential Competencies for Basic Midwifery Practice. As agreed by the International Council (the Confederation’s governing body) in 1999, the competencies were field-tested by 17 ICM member associations throughout 2001. The extensive field testing was undertaken by 1,271 practising midwives, 77 educator groups (total of 312 educators), and 79 senior level midwifery student groups (total of 333 individuals) from 22 countries; and 25 regulators from 20 countries. A total of 214 individual competency statements within six domains were presented for consideration

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 11 and comment. Almost all of the competencies were supported by a great majority of the persons/groups involved in the testing, with many receiving universal support. In April 2002 the ICM International Council discussed and adopted the Essential Competencies for Basic Midwifery Practice, therewith establishing it as an official ICM document.

Laan van Meerdervoort 70 – 2517 AN The Hague – The Netherlands Tel: + 31 70 3060520 – fax: + 31 70 3555651 – email: [email protected] Website: www.internationalmidwives.org 12 Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

Approved December 2, 1999 Effective June 15, 2000

INDICATIONS FOR MANDATORY DISCUSSION, CONSULTATION AND TRANSFER OF CARE

As a primary caregiver, the midwife together with the client is fully responsible for decision-making. The midwife is responsible for writing orders and carrying them out or delegating them in accordance with the standards of the College of Midwives.

The midwife discusses care of a client, consults, or transfers primary care responsibility according to the Indications for Mandatory Discussion, Consultation and Transfer of Care.1 The responsibility to consult with a family physician/general practitioner, obstetrician and/or specialist physician lies with the midwife. It is also the midwife’s responsibility to initiate a consultation within an appropriate time after detection of an indication for consultation. The severity of the condition and the availability of a physician(s) will influence these decisions.

The informed choice agreement between the midwife and client should outline the extent of midwifery care, in order to make clients aware of the scope and limitations of midwifery care. The midwife should review the Indications for Mandatory Discussion, Consultation and Transfer of Care with the client.

1 For a discussion of how this document is used to guide decisions about choice of birth place, see Indications for Planned Place of Birth.

College of Midwives of Ontario Page 1 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

DEFINITIONS

Category 1: Discuss with another midwife or with a physician

It is the midwife’s responsibility to initiate a discussion with or provide information to another midwife or physician, with whom the care is shared, in order to plan care appropriately.

Category 2: Consult with a physician

It is the midwife’s responsibility to initiate a consultation and to clearly communicate to the consultant that she is seeking a consultation. A consultation refers to the situation where a midwife, in light of her professional knowledge of the client and in accord with the standards of practice of the College of Midwives, or where another opinion is requested by the client, requests the opinion of a physician competent to give advice in this field. The midwife should expect that:

The consultation involves addressing the problem that led to the referral, an in-person assessment of the patient, and the prompt communication of the findings and recommendations to the patient and the referring professional.

Following the assessment of the patient by the consultant(s), discussion can occur between the health professional and consultant regarding future patient care.2

The consultation can involve the physician providing advice and information and/or providing therapy to the woman/newborn or prescribing therapy to the midwife for the woman/newborn.

Consultation must be documented by the midwife in her records in accord with the regulations of the College of Midwives.

After consultation with a physician, primary care of the client and responsibility for decision-making together with the client either:

2 “Clinical Practice Parameters and Standards for Consultation and Transfer of a Woman/Newborn in or from a Birth Centre Where Only Midwives Provide Primary Care, to a Physician/Health Facility,” College of Physicians and Surgeons of Ontario, December 23, 1993.

College of Midwives of Ontario Page 2 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

a) continues with the midwife, or b) is transferred to a physician.

Once a consultation has taken place and the consultant’s findings, opinions and recommendations are communicated to the client and the midwife, the midwife must discuss the consultant’s recommendations with the client and ensure the client understands which health professional will have responsibility for primary care.

Where urgency, distance or climatic conditions make an in-person consultation with a physician not possible, the midwife should seek advice from the physician by phone or other similar means. The midwife should document this request for advice, in her records, in accord with the requirement of the College of Midwives and discuss with the client the advice received.

The consultant may be involved in, and responsible for, a discrete area of the client’s care, with the midwife maintaining overall responsibility within her scope of practice. Areas of involvement in client care must be clearly agreed upon and documented by the midwife and the consultant.

The College of Midwives has agreed that:

One health professional has overall responsibility for a patient at any one time and the patient’s care should be co-ordinated by that health professional whose identity should be clearly known to all of those involved and documented in the records of the referring health professional and consultant. Responsibility could be transferred temporarily to another health professional, or be shared between health professionals according to the patient’s best interests and optimal care; however, transfer or sharing of care should only occur after discussion and agreement among patients, referring health professionals, and consultants.3

Category 3: Transfer to a physician for primary care

When primary care is transferred, permanently or temporarily, from the midwife to a physician, the physician, together with the client, assumes full responsibility for subsequent decision-making. When primary care is transferred to a physician, the

3 “Clinical Practice Parameters and Standards for Consultation and Transfer of a Woman/Newborn in or from a Birth Centre Where Only Midwives Provide Primary Care, to a Physician/Health Facility,” College of Physicians and Surgeons of Ontario, December 23, 1993.

College of Midwives of Ontario Page 3 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care midwife may provide supportive care4 within her scope of practice, in collaboration with the physician and the client.

4 Supportive care is defined in the Standard on Supportive Care.

College of Midwives of Ontario Page 4 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

INDICATIONS: Initial History and Physical Examination

Category 1: • adverse socio-economic conditions • age less than 17 years or over 35 years • cigarette smoking • grand multipara (para 5) • history of infant over 4500 g • history of one late miscarriage (after 14 completed weeks) or preterm birth • history of one low birth weight infant • history of serious psychological problems • less than 12 months from last delivery to present due date • obesity • poor nutrition • previous antepartum hemorrhage • previous postpartum hemorrhage • one documented previous low segment cesarean section • history of essential or gestational hypertension • known uterine malformations or fibroids

Category 2: • current medical conditions for example:5 cardiovascular disease, pulmonary disease, endocrine disorders, hepatic disease, neurologic disorders • family history of genetic disorders • family history of significant congenital anomalies • history of cervical cerclage • history of repeated spontaneous abortions • history of more than one late miscarriage or preterm birth • history of more than one low birth weight infant • history of gestational hypertension with proteinuria and adverse sequelae • history of significant medical illness • previous myomectomy, hysterotomy or cesarean section other than one documented previous low segment cesarean section • previous neonatal mortality or stillbirth • rubella during first trimester of pregnancy

• significant use of drugs or alcohol • age less than 14 years

5 Refer to Guidelines to Antepartum Consultations for Clients of Midwives to Anaesthesia, July 1996.

College of Midwives of Ontario Page 5 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

Category 3: • any serious medical condition, for example: cardiac or renal disease with failure or insulin dependent diabetes mellitus

INDICATIONS: Prenatal Care

Category 1: • presentation other than cephalic at 36 completed weeks • no prenatal care before 28 completed weeks • uncertain expected date of delivery • uncomplicated spontaneous abortion less than 12 completed weeks

Category 2: • anemia (unresponsive to therapy) • documented post term pregnancy (42 completed weeks) • fetal anomaly • inappropriate uterine growth • medical conditions arising during prenatal care, for example: endocrine disorders, hypertension, renal disease, suspected significant infection, hyperemesis • placenta previa without bleeding • polyhydramnios or oligohydramnios • gestational hypertension • isoimmunization • serious psychological problems6 • sexually transmitted disease • twins • vaginal bleeding other than transient spotting • presentation other than cephalic, unresponsive to therapy, at 38 completed weeks

Category 3: • cardiac or renal disease with failure • insulin dependent diabetes • multiple pregnancy (other than twins) • gestational hypertension with proteinuria and/or adverse sequelae • symptomatic placental abruption

6 Notwithstanding the requirement for consultation with a physician, consultation may be with another appropriate health care professional; for example, a mental health worker.

College of Midwives of Ontario Page 6 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

• vaginal bleeding, continuing or repeated • placenta previa after 28 completed weeks

INDICATIONS: During Labour and Birth

Category 1: • no prenatal care • non-particulate meconium

Category 2: • breech presentation • preterm labour (34 - 37 completed weeks) • prolonged active phase • prolonged rupture of membranes • prolonged second stage • retained placenta • suspected placenta abruption and/or previa • third or fourth degree tear • twins • unengaged head in active labour in primipara • preterm prelabour rupture of membranes (PPROM) between 34 and 37 completed weeks • particulate meconium • gestational hypertension

Category 3: • active genital herpes at time of labour • preterm labour (less than 34 completed weeks) • abnormal presentation (other than breech) • multiple pregnancy (other than twins) • gestational hypertension with proteinuria and/or adverse sequelae • prolapsed cord or cord presentation • placenta abruption and/or previa • severe hypertension • confirmed non-reassuring fetal heart patterns, unresponsive to therapy • uterine rupture • uterine inversion • hemorrhage unresponsive to therapy • obstetric shock • vasa previa

College of Midwives of Ontario Page 7 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

INDICATIONS: Post Partum (Maternal)

Category 2: • suspected maternal infection e.g. breast, abdomen, wound, uterine, urinary tract, perineum • temperature over 38° C (100.4° F) on more than one occasion • persistent hypertension • serious psychological problems7

Category 3: • hemorrhage unresponsive to therapy • postpartum eclampsia • thrombophlebitis or thromboembolism • uterine prolapse

INDICATIONS: Post Partum (Infant)

Category 1: • feeding problems8 • failure to pass urine or meconium within 24 hours of birth

Category 2: • 34 to 37 weeks gestational age • infant less than 2,500 g • less than 3 vessels in umbilical cord • excessive moulding and cephalhematoma • abnormal findings on physical exam • excessive bruising, abrasions, unusual pigmentation and/or lesions • birth injury requiring investigation • congenital abnormalities, for example: cleft lip or palate, congenital dislocation of hip, ambiguous genitalia • abnormal heart rate or pattern • abnormal cry • persistent abnormal respiratory rate and/or pattern • persistent cyanosis or pallor • jaundice in first 24 hours • suspected pathological jaundice after 24 hours

7 Notwithstanding the requirement for consultation with a physician, consultation may be with another appropriate health care professional; for example, a mental health worker. 8 Notwithstanding the requirement for discussion with a physician or midwife, discussion may be with another appropriate health care professional; for example, a lactation consultant.

College of Midwives of Ontario Page 8 of 9 Non-Physician Prescribing Applicant Questionnaire Appendix J: Indications for Mandatory Discussion, Consultation and Transfer of Care

• temperature less than 36° C, unresponsive to therapy • temperature more than 37.4° C, axillary, unresponsive to non- pharmaceutical therapy • vomiting or diarrhea • infection of umbilical stump site • significant weight loss (more than 10% of body weight) • failure to regain birth weight in three weeks • failure to thrive • failure to pass urine or meconium within 36 hours of birth • suspected clinical dehydration

Category 3: • APGAR lower than 7 at 5 minutes • suspected seizure activity • major congenital anomaly requiring immediate intervention, for example: omphalocele, myelomeningocele • temperature instability

College of Midwives of Ontario Page 9 of 9 Non-Physician Prescribing Applicant Questionnaire Midwifery Regulation Page 1 of 7

Home > Alberta > Statutes and Regulations > Alta. Reg. 328/1994 > Complete text Français English

Midwifery Regulation, Alta. Reg. 328/1994

Citation: Midwifery Regulation, Alta. Reg. 328/1994 Enabling Statute: Health Disciplines Act, R.S.A. 2000, c. H-2 URL: http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html Version downloaded by CanLII on 2008-08-18

(Consolidated up to 119/2003)

ALBERTA REGULATION 328/94

Health Disciplines Act

MIDWIFERY REGULATION

Table of Contents

1 Definitions 2 Eligibility for registration 3 Temporary registration

4 Renewal of registration 5 Training programs and examinations 6 Register 7 Use of title 8 Practice of midwifery 9 Autonomous practice and medical consultation 10 Standards of conduct 11 Practice Review 12 Liability insurance 13 Coming into force

Schedules

Definitions

1 In this Regulation,

(a) “Act” means the Health Disciplines Act;

(b) “assessment” means the gathering of information about the health status of the client, analysis and synthesis of that data, and the making of a clinical judgment or diagnosis;

(c) “Association” means the Alberta Association of Midwives;

(d) “Board” means the Health Disciplines Board;

(e) “Committee” means the Midwifery Health Discipline Committee established under section 9(1) of the Act; http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Midwifery Regulation Page 2 of 7

(f) “midwife” means a person who is registered pursuant to this Regulation;

(g) “primary health care provider” means a person who

(i) is directly accessible to clients without referral from another health professional,

(ii) is authorized to provide health services within a defined scope of practice without supervision by a member of another health profession,

(iii) co-ordinates health related services and makes referrals to other health professionals when appropriate, and

(iv) ensures continuity of care;

(h) “registrar” means the registrar of the designated health discipline of midwives. AR 328/94 s1;251/2001

Eligibility for registration

2(1) For the purposes of section 22(a) of the Act, a person is eligible to be registered as a midwife if that person

(a) has satisfactorily completed a program of studies approved by the Board,

(b) has satisfactorily completed an examination approved by the Board,

(c) has

(i) within the 2 years immediately preceding the date of application, met the requirements of clause (a),

(ii) within the one year immediately preceding the date of application, satisfactorily completed a refresher program approved by the Board, or

(iii) maintained competence by actively engaging in the practice of midwifery in accordance with criteria established by the Committee,

(d) has completed and submitted to the registrar the forms prescribed by the Minister, and

(e) has paid the application fee and registration fee prescribed by the Minister.

(2) Notwithstanding subsection (1)(a), (b) and (c), a person is eligible to be registered as a midwife

(a) if the Committee is satisfied that the person has attained a level of competence equivalent to that required under subsection 1(a), (b) and (c) because of directly related training, examinations and practice, or

(b) if the person successfully completes any training or examinations, or consents to any terms, conditions or limitations on registration or practice, required by the Committee under section 23(5)(b) of the Act. AR 328/94 s2;251/2001;27/2002

Temporary registration

3(1) Notwithstanding section 2, for the purposes of section 22(a) of the Act, a person is eligible to be registered as a midwife on a temporary basis if the Committee is satisfied, on the basis of generally accepted criteria, that temporary registration is appropriate.

(2) A person who is registered pursuant to subsection (1) may engage in the practice of midwifery under a type and level of supervision specified by the Committee and subject to any terms, conditions or limitations imposed by the Committee.

(3) Temporary registration may be granted for a maximum period of one year and may, on application and at the discretion of the Committee, be extended for not more than one additional period of not more than one year. AR 328/94 s 3;251/2001

Renewal of registration

4(1) For the purposes of section 24(3)(a) and (b) of the Act, a midwife is eligible for an annual renewal of registration if the midwife has paid the renewal fee prescribed by the Minister and has http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Midwifery Regulation Page 3 of 7

(a) within the 2 years immediately preceding the date of submission of the application for renewal of registration, met the requirements of section 2(1)(a),

(b) within the one year immediately preceding the date of submission of the application for renewal of registration, satisfactorily completed a refresher program approved by the Board, or

(c) maintained competence by actively engaging in the practice of midwifery in accordance with the criteria established by the Committee.

(2) For the purposes of section 24(1) of the Act, the date for submission of an application for renewal of registration is May 1.

(3) Notwithstanding subsection (1), a midwife is eligible for an annual renewal of registration

(a) if the Committee is satisfied that the midwife has maintained a level of competence equivalent to that required under subsection (1)(a), (b) or (c) because of directly related training or practice, or

(b) if the midwife successfully completes any training and examinations, or consents to any terms, conditions or limitations on registration or practice, required by the Committee under section 24(7) of the Act. AR 328/94 s4;251/2001;27/2002

Training programs and examinations

5 For the purposes of section 23(5)(a) and 24(7)(a) of the Act, the training programs and examinations that the Committee may require are the following:

(a) a refresher program approved by the Board;

(b) the examination referred to in section 2(1)(b);

(c) all or part of a program of studies referred to in section 2(1)(a) as prescribed by the Committee or any other training the Committee considers appropriate. AR 328/94 s5;251/2001

Register

6(1) The registrar shall enter in the register

(a) the name, mailing address, practice status and registration number of each midwife, and

(b) any terms, conditions or limitations imposed on a midwife’s practice by the Committee under section 2, 3 or 4 of this Regulation or Part 4 of the Act.

(2) A midwife shall forthwith notify the registrar of any change in name, mailing address or practice status.

Use of title

7 A person registered pursuant to this Regulation may use the name “midwife”.

Practice of midwifery

8 A midwife may

(a) provide counselling and education related to childbearing,

(b) carry out assessments necessary to confirm and monitor pregnancies,

(c) advise on and secure the further assessments necessary for the earliest possible identification of pregnancies at risk,

(d) identify the conditions in the woman, fetus or newborn that necessitate consultation with or referral to a physician or other health professional,

(e) care for the woman and monitor the condition of the fetus during labour,

(f) conduct spontaneous vaginal births, http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Midwifery Regulation Page 4 of 7

(g) examine and care for the newborn in the immediate postpartum period,

(h) care for the woman in the postpartum period and advise her and her family on newborn and infant care and family planning,

(i) take emergency measures when necessary,

(j) perform, order or interpret screening and diagnostic tests in accordance with Schedule 1,

(k) perform episiotomies and amniotomies and repair episiotomies and lacerations not involving the anus, anal sphincter, rectum and urethra,

(l) prescribe and administer drugs in accordance with Schedule 2, and

(m) on the order of a physician relating to a particular client, administer any drugs by the route and in the dosage specified by the physician.

Autonomous practice and medical consultation

9(1) In respect of normal pregnancy, a midwife may, in accordance with the guidelines approved by the Board,

(a) engage in the practice of midwifery as a primary health care provider, and

(b) provide services in a variety of settings.

(2) If medical conditions exist or arise during the course of midwifery care that may require management by a physician, a midwife shall consult with a physician in accordance with the guidelines approved by the Board.

(3) If the result of the consultation under subsection (2) is a determination that management by a physician is required, the midwife shall transfer primary responsibility for care, or aspects of care, to a physician and may engage in the practice of midwifery in collaboration with the physician, to the extent agreed to by the client, physician and midwife.

Standards of conduct

10 A midwife shall

(a) execute all duties in accordance with generally accepted standards of practice and professional ethics and be guided at all times by the welfare, best interests and informed consent of the client,

(b) work within, be limited by and inform clients regarding

(i) the midwife’s scope of practice and individual ability,

(ii) any terms, conditions or limitations on registration or practice imposed by the Committee, and

(iii) the practical limitations imposed by the environment or equipment at hand,

(c) maintain currency in knowledge and skill in the practice of midwifery and enhance knowledge and skill in accordance with new developments in procedures or equipment,

(d) work to encourage high standards of performance and research in the practice of midwifery,

(e) refer any incompetent, illegal or unethical professional conduct by colleagues or other health care personnel to the appropriate authorities,

(f) hold in confidence all client information unless the midwife is permitted by the client or required by the Act or any other enactment or by order of a court to disclose the information, and

(g) comply with government standards and reporting requirements.

Practice Review

11(1) A Practice Review Committee is established consisting of

(a) 3 midwives,

(b) 2 consumer representatives, and http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Midwifery Regulation Page 5 of 7

(c) one member of the College of Physicians and Surgeons of Alberta

appointed by the Association, in accordance with the guidelines approved by the Board.

(2) The Practice Review Committee may, on its own initiative, and shall, at the request of the Board, conduct a review of the practice of a midwife in accordance with guidelines approved by the Board.

(3) After each review under subsection (2), the Practice Review Committee may provide advice and make recommendations to the midwife as to the practice of midwifery by that midwife.

(4) If, in the course of a review of the practice of a midwife,

(a) the Practice Review Committee discovers conduct or competence problems it believes warrant disciplinary action, or

(b) the midwife does not co-operate with the Practice Review Committee in carrying out the review, the Practice Review Committee shall refer the matter to the Midwifery Committee and the referral shall be treated as a complaint under Part 4 of the Act.

(5) The Practice Review Committee may inquire into, report to and advise the Midwifery Committee in respect of:

(a) the assessment and development of educational, experiential and practice standards that are conditions precedent to registration or renewal of registration under this Regulation,

(b) the evaluation of desirable standards of competence of midwives generally, and

(c) the practice of midwifery generally.

Liability insurance

12 A midwife shall carry professional liability insurance with an insurer acceptable to the Board and in an amount that is at least the minimum level of coverage required by the Board.

Coming into force

13(1) This Regulation except for Schedule 2 comes into force on August 1, 1995.

(2) Schedule 2 comes into force on the coming into force of an order of the Lieutenant Governor in Council under section 1(1)(v) of the Pharmaceutical Profession Act that authorizes midwives to prescribe drugs.

Schedule 1

1 A midwife may order, collect samples for and interpret the report of the following screening and diagnostic tests:

(a) for a woman:

(i) chemistry: blood glucose;

(ii) cytology: cervical smears (Pap smears);

(iii) haematology: haemoglobin, haematocrit, white blood cell count, differential, platelet count, red blood cell morphology, sickle cell solubility, Kleihauer;

(iv) microbiology:

(A) cervical and vaginal cultures (including sensitivities where relevant) for group B streptococcus, gonorrhoea, chlamydia, yeasts, trichomonas, and gardenerella;

(B) urine for culture and sensitivities; swabs for culture and sensitivities (eg. wounds, episiotomies);

(C) viral swabs (herpes);

(v) serology/immunology: blood group and type with antibody screen, repeat antibody testing, hepatitis, human immunodeficiency virus antibody, rubella antibody, toxoplasmosis antibody, syphilis serology, cytomegalo virus antibody, maternal serum biochemical screening and varicella titre;

(vi) pregnancy tests (blood and urine); http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Midwifery Regulation Page 6 of 7

(vii) urine: routine, microscopic urinalysis;

(b) for a newborn:

(i) haemoglobin, haematocrit, white blood cell count with differential, neonatal metabolic screen, glucose, direct coombs, direct antiglobulin test and bilirubin;

(ii) microbiology samples: cord and eye cultures;

(iii) serology/immunology: screen to evaluate possible congenital syphilis, rubella and herpes simplex; blood group and type with antibody screen.

2 A midwife may perform and interpret the results of the following screening and diagnostic tests:

(a) urine (dip stick urinalysis);

(b) pregnancy test (urine);

(c) blood glucose: adult and newborn (stix method).

3 A midwife may order and interpret the report of an ultra sound test: obstetrical for diagnostic purposes only.

4 A midwife may order and perform non-stress tests and interpret the results of non-stress tests.

AR 328/94 Sched.1;119/2003

Schedule 2

1 A midwife may prescribe and administer the following substances in accordance with the guidelines approved by the Board:

Antibiotics for prophylactic treatment of Group B streptococcus and treatment of mastitis Antifungal agents considered safe in pregnancy and for newborns Calcium gluconate Carboprost Dimenhydrinate Diphenhydramine hydrochloride Doxylamine succinate-pyridoxine hydrochloride Entonox Epinephrine hydrochloride maleate Erythromycin ophthalmic ointment Hepatitis B Immunoglobulin Hydralazine Hydrocortisone Intramuscular or intravenous oxytocin Intravenous fluids Lidocaine hydrochloride with or without epinephrine Magnesium Sulphate Naloxone Phytonadione Promethazine RhD immune globulin Therapeutic oxygen

2 A midwife may administer, prescribe or order any drug or substance that may lawfully be purchased or acquired without a prescription.

AR 328/94 Sched.2;82/98;119/2003

Copyright of the Statutes and Regulations belongs to the Province of Alberta. Official copies of Alberta legislation are available from the Alberta Queen's printer. The Alberta Statutes and Regulations collections are subject to this Copyright and Disclaimers Statements. http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Midwifery Regulation Page 7 of 7

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http://www.canlii.org/ab/laws/regu/1994r.328/20080818/whole.html 11/12/2008 Appendix K: Provincial/Territorial Midwifery Drug Regulations

COLLEGE OF MIDWIVES OF BRITISH COLUMBIA Proposed Amendments -May 2008 (This is a consolidation of previous requests from Sept 05 to the present) MIDWIVES REGULATION

Definitions

1. In this regulation

“aboriginal” means relating to the Indian, Inuit or Métis peoples of Canada;

“aboriginal midwifery” means (a) traditional aboriginal midwifery practices such as the use and administration of traditional herbs and medicines and other cultural and spiritual practices,

(b) contemporary aboriginal midwifery practices which are based on, or originate in, traditional aboriginal midwifery practices, or

(c) a combination of traditional and contemporary aboriginal midwifery practices;

“midwifery diagnosis” means a clinical judgment of a woman’s physical or mental condition, or that of her newborn, to determine whether the condition can be addressed by interventions within the registrant’s scope of practice to achieve outcomes for which the registrant is accountable or whether consultation with or transfer of care to another health professional is required;

“reserve” means a reserve as defined in the Indian Act.

Designation

2. (1) Midwifery is designated as a health profession.

(2) The “College of Midwives of British Columbia” is the name of the college established under section 15 (1) of the Act for midwifery.

Reserved title

3. No person other than a registrant may use the title “midwife” or a variation or abbreviation or an equivalent in another language.

Scope of practice

4. (1) A registrant may practice midwifery.

(2) Subject to the bylaws, registrants may (a) assess, monitor, and care for women during normal pregnancy, labour, delivery and the postpartum period,

College of Midwives of Ontario Page 1 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

Midwives Regulation Regulation Issued: March 1995 Consolidated request for Amendments May 2008 (b) counsel, support and advise women during pregnancy, labour, delivery and the postpartum period,

(c) manage labour and spontaneous normal vaginal deliveries,

(d) care for, assess and monitor the healthy newborn, and

(e) provide advice and information regarding care for newborns and young infants during the three months the year following birth, and

(f) deliver well-woman care and contraceptive services to women during the interconceputal period1.

(3) Subject to the bylaws, aboriginal registrants may practise aboriginal midwifery.

Reserved acts

5. (1) Subject to section 14 of the Act, no person other than a registrant may, for the purposes of midwifery,

(a) make a midwifery diagnosis;

(b) conduct internal examinations of women during pregnancy, labour, delivery and the postpartum period;

(c) manage labour and normal, spontaneous vaginal deliveries;

(d) put an instrument, hand or finger(s) (i) beyond the point in the nasal passages, where they normally narrow2; (ii) beyond the pharynx3; (iii) beyond the opening of the urethra4; (iv) beyond the labia majora for the purpose of; i. conducting internal examinations of women during pregnancy, labour, delivery and the postpartum period; ii. performing episiotomies and amniotomies and repairing episiotomies and simple lacerations; (v) beyond the anal verge5; perform episiotomies and amniotomies and repair episiotomies and simple lacerations;

(e) prescribe, order or administer drugs and substances specified in Schedule 1 to this regulation, and compound, dispense, administer by any method, prescribe or give an order to compound, dispense or administer by any method

(i) a drug specified in Schedule I of the Drug Schedules Regulation, B.C. Reg. 9/98, and included in a category described in Schedule A or B of this regulation,

College of Midwives of Ontario Page 2 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

(ii) a narcotic or targeted substance that a registrant is authorized under the Controlled Drugs and Substances Act (Canada) to possess, dispense, administer, prescribe or transport, or

(iii) a drug that may lawfully be dispensed or sold without a prescription,

(d.1) compound, dispense or administer by any method a drug, barbiturate, narcotic or targeted substance that a medical practitioner prescribes or gives an order for, or

(f) give an order for, collect samples for, perform or interpret the results and reports of screening and diagnostic tests specified in Schedule 2 to this regulation described in section 45 (d) of the Medical and Heath Care Services Regulation, B.C. Reg. 426/97.

(2) Subsection (1) does not apply on a reserve to an aboriginal person who practised aboriginal midwifery prior to the coming into force of this regulation.

Reserved acts for specialized practice

5.1 (1) A registrant for the purposes of practicing midwifery may (a) provide or perform an act described in section 5 (1);

(b) put an instrument, hand or finger(s) (i) beyond the labia majora for the purpose of conducting a vacuum assisted delivery of a newborn6; (ii) into an artificial opening of the body for the purpose of assisting with the surgical delivery of a newborn.7

(c) insert acupuncture needles under the skin for purposes consistent with the midwife’s scope of practice8

(2) In order to perform any of the reserved acts set out in 5.1 (1) (b) (i) and (ii) and (c) a registrant must have successfully completed a certification program established or approved by or under the bylaws to ensure that the registrant is qualified and competent to provide or perform that service in the practice setting in which it is to be carried out.

Limitations on practice

6. (1) Registrants must (a) advise clients to consult a medical practitioner for a medical examination during the first trimester of pregnancy, and

(b) consult with a medical practitioner regarding any deviations from the normal course of pregnancy, labour, delivery and the post-partum period that indicate pathology and transfer responsibility when necessary, and.

(c) consult with a medical practitioner if the result or report of a test in item 4 of Schedule 2 is abnormal.

College of Midwives of Ontario Page 3 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

(1.1) A registrant may act under section 5 (1) (d) or (d.1) only in respect of childbearing women and their neonates.

(1.12) A Subject to subsection (1.3), a registrant may act under section 5 (1) (d) in respect of

(a) prescribe or administer a substance in item 1 (2) of Schedule 1 only for intrapartum chemoprophylaxis for Group B Strep, a drug included in a category described in Column 1 of Schedule A or B of this Regulation only for a purpose shown opposite in Column 2,

(b) prescribe or administer a substance in item 1 (3) of Schedule 1 only for therapeutic rest in prodromal labour, a narcotic only for the purpose of pain relief in labour or the postpartum period, and

(c) order and administer a drug in item 2 of Schedule 1 only in emergency conditions and in consultation with a medical practitioner, and a targeted substance only for the purpose of therapeutic rest in prodromal labour and only for or by oral or sublingual administration.

(d) administer a drug in item 3 of Schedule 1 only after consulting with and on the order of a medical practitioner.

(1.3) A registrant may act under section 5 (1) (d) in respect of

(a) a drug included in a category described in Column 1 of Schedule B of this Regulation for a purpose shown opposite in Column 2,

(b) a narcotic for the purpose of pain relief not included in subsection (1.2) (b), and

(c) a narcotic or targeted substance for the purpose of treatment of nausea and vomiting

only if the registrant has successfully completed a certification program established, required or approved by or under the bylaws to ensure registrants are qualified and competent to provide or perform those services.

(1.4) A registrant may act under section 5 (1) (d.1) only after consulting with a medical practitioner.

(1.5) Subsection (1.4) does not apply in respect of a drug, narcotic or targeted substance described in section 5 (1) (d) if the registrant is acting in accordance with subsections (1.1) to (1.3). (1.6) It is a limit or condition on the provision or performance of a service by a registrant that the registrant must provide or perform the service in accordance with

(a) all standards, limits and conditions for the practice of midwifery in relation to that service, and (b) all standards of professional ethics for registrants, including standards for the avoidance of conflicts of interest,

established by the board of the college. (2) and (3) Repealed.

College of Midwives of Ontario Page 4 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

Patient relations program

7. The College of Midwives is designated for the purposes of section 15.1 (2) (f) of the Act.

Section Spent

8. Spent

1 This allows the midwife to perform pap smears, fit barriers methods of contraception and carry-out other well-woman assessments on women of child-bearing age between pregnancies. All of the skills required are already entry-level midwifery competencies.

2 This reserved action authorizes the midwife to suction the newborn, essential to her current scope of practice

3 This authorizes the midwife to intubate the newborn, essential to her current scope of practice.

4 This authorizes the midwife to catheterize women in labour or the postpartum, essential to her current scope of practice.

5 This allows the midwife to assess perineal repairs, administer medications and carry out maneuvers to assist in the emergency delivery of a newborn, essential to her current scope of practice.

6 This allows the midwife with special certification to carry out vacuum assisted deliveries, a skill that is important for midwives in rural and remote communities to have in order for women to have access to safe maternity services at all times (e.g. if the midwife is sharing call with a physician and covering all maternity call for a given period).

7 This allows the midwife with special certification to take on the role of first surgical assist at a caesarean delivery for reasons as noted above.

8 This allows the midwife with special certification to provide acupuncture treatment for a limited number of midwifery indications (e.g. relieving pain in labour as demonstrated to be effective by randomized controlled trial)

College of Midwives of Ontario Page 5 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

SCHEDULE A

Column 1 Column 2

Category Description Purposes

Antibiotics • intra-partum chemoprophylaxis for Group B strep • treatment of topical infection • treatment of breast infection • treatment of urinary tract infection • prophylaxis of ophthalmia neonatorum

Anaesthetics • repair of episiotomies and lacerations • treatment of topical inflammation • localized pain prophylaxis

Anti-fungals • treatment of candidiasis

Anti-nauseants / Anti-emetics • treatment of nausea and vomiting

Contraceptives • prevention of conception

Corticosteroids • treatment of skin inflammation and haemorrhoids

Galactagogues • enhancement of breast milk production

Histamine antagonists • treatment of anaphylaxis related to the administration of drugs, vaccines or sera

Immune globulins • prophylaxis in the neonate • prophylaxis or treatment of the woman in pregnancy or the postpartum period

Inhalants • pain relief in labour or the immediate postpartum

Intravenous fluids • prophylaxis or treatment of dehydration or blood loss • as a route of administration for medications • neonatal resuscitation

Narcotic antagonists • reversal of narcotic-induced depression

College of Midwives of Ontario Page 6 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

Nitrates • treatment of hypertonic uterine contractions with non-reassuring fetal status

Non-steroidal anti- • relief of inflammation and pain inflammatories

Sympathomimetics • treatment of anaphylaxis or allergic reaction following the administration of a drug, vaccine or serum • neonatal resuscitation

Uterotonic agents • prophylaxis and treatment of uterine atony and postpartum haemorrhage

Vaccines • establishing an immune response

Vitamin and mineral • nutritional therapy and support supplements

SCHEDULE B

Column 1 Column 2

Category Description Purposes

Antibiotics • treatment of infection not included in Schedule A

Cervical ripening agents • induction of labour

Epidural analgesia • pain relief (continuous infusion maintenance)

Oxytocin (intravenous • induction or augmentation of labour infusion)

College of Midwives of Ontario Page 7 of 8 Non-Physician Prescribing Applicant Questionnaire Appendix K: Provincial/Territorial Midwifery Drug Regulations

College of Midwives of Ontario Page 8 of 8 Non-Physician Prescribing Applicant Questionnaire Midwifery Regulation Page 1 of 16

Home > Manitoba > Statutes and Regulations > Man. Reg. 68/2000 > Complete text Français English

Midwifery Regulation, Man. Reg. 68/2000

Citation: Midwifery Regulation, Man. Reg. 68/2000 Enabling Statute: Midwifery Act, C.C.S.M. c. M125 URL: http://www.canlii.org/mb/laws/regu/2000r.68/20080818/whole.html Version downloaded by CanLII on 2008-08-18

THE MIDWIFERY ACT LOI SUR LES SAGES-FEMMES (C.C.S.M. c. M125) (c. M125 de la C.P.L.M.)

Midwifery Regulation Règlement sur les sages-femmes

Regulation 68/2000 Règlement 68/2000 Registered June 13, 2000 Date d'enregistrement : le 13 juin 2000

CONTENTS TABLE DES MATIÈRES

Section Article

1 Definitions 1 Définitions

REGISTRATION INSCRIPTION

2 Registers 2 Registres 3 Applications for registration 3 Demandes d'inscription 4 Registration of practising midwives 4 Conditions d'inscription des 5 Election to practice in a specified setting sages-femmes pratiquantes 6 Information on register of practising 5 Choix d'exercer dans un milieu midwives déterminé 7 Temporary registration 6 Renseignements au Registre des 8 Registration of non-practising midwives sages-femmes pratiquantes 9 Registration of students 7 Conditions d'inscription temporaire 10 Renewals 8 Inscription des sages-femmes non 11 Cancellation pratiquantes 9 Inscription des étudiants 10 Renouvellement des inscriptions 11 Annulation des inscriptions

PRACTICE REQUIREMENTS CONDITIONS D'EXERCICE

12 Screening and diagnostic tests 12 Tests de dépistage et de diagnostic 13 Medications 13 Médicaments 14 Minor surgical and invasive procedures 14 Chirurgie mineure et procédé effractif 15 Standards of practice 15 Travail et accouchement 16 Professional liability insurance 16 Assurance de responsabilité professionnelle

All persons making use of this consolidation are reminded that it has Veuillez noter que la présente codification n'a pas été sanctionnée par no legislative sanction. Amendments have been inserted into the base le législateur. Les modifications ont été apportées au règlement de regulation for convenience of reference only. The original regulation base dans le seul but d'en faciliter la consultation. Le lecteur est prié should be consulted for purposes of interpreting and applying the law. de se reporter au règlement original pour toute question Only amending regulations which have come into force are d'interprétation ou d'application de la loi. La codification ne contient consolidated. This regulation consolidates the following amendments: que les règlements modificatifs qui sont entrés en vigueur. Le présent ??/??. règlement regroupe les modifications suivantes : ??/??.

06/00 1

http://www.canlii.org/mb/laws/regu/2000r.68/20080818/whole.html 11/12/2008 Midwifery Regulation Page 2 of 16

MIDWIFERY M125 -- M.R. 68/2000

MISCELLANEOUS PROVISIONS DISPOSITIONS DIVERSES

17 Committee to select public 17 Comité de sélection des représentants representatives du public 18 Review of this regulation 18 Révision du présent règlement 19 Coming into force 19 Entrée en vigueur

Schedule A Laboratory and Diagnostic Tests Annexe A Tests de laboratoire et de diagnostic Schedule B Medications and Devices Annexe B Médicaments et appareils Schedule C Minor Surgical and Invasive Procedures Annexe C Chirurgies mineures et procédés effractifs

DEFINITIONS DÉFINITIONS

Definitions Définitions 1 In this regulation, 1 Les définitions qui suivent s'appliquent au présent règlement. "Act" means The Midwifery Act; ( Loi )

continuité des soins Soins à la même femme

"continuity of care" means providing care to the pendant au moins quatre visites prénatales, le same woman through at least four prenatal travail et l'accouchement, examen du nouveau-né visits, labour and delivery, the newborn et au moins une visite postnatale. ("continuity of examination and at least one postnatal visit; care") ( continuité des soins )

Loi

La Loi sur les sages-femmes. ("Act") "primary midwife" means a midwife who assumes primary responsibility for providing all

sage-femme primaire Sage-femme assumant

aspects of midwifery care, including prenatal, la responsabilité principale de la prestation de intrapartum and postpartum care, and care of tous les soins reliés à l'exercice de la profession the newborn. ( sage-femme primaire )

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de sage-femme, notamment les soins prénatals, pernatals et postnatals et les soins du nouveau-né. ("primary midwife")

REGISTRATION INSCRIPTION

Registers Registres 2 In addition to the registers of practising 2 En plus du Registre des sages-femmes midwives and students referred to in section 10 of pratiquantes et du Registre des étudiants que prévoit the Act, the registrar shall maintain a register of l'article 10 de la Loi, le registraire tient un registre temporary practising midwives and a register of des sages-femmes pratiquant à titre provisoire et un non-practising midwives. registre des sages-femmes non pratiquantes.

Applications for registration Demandes d'inscription 3(1) Every person who applies for registration 3(1) Les personnes qui désirent se faire must submit a completed application form to the inscrire remettent une demande d'inscription registrar together with the fee provided for in the dûment remplie au registraire ainsi que les droits by-laws. que prévoient les règlements administratifs.

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3(2) Every application must disclose the 3(2) Les demandes d'inscription contiennent following information about the applicant and his or les renseignements indiqués ci-après sur leur auteur her practice of midwifery or of any other profession, et leur exercice de la profession de sage-femme ou de whether in Manitoba or in another jurisdiction: toute autre profession, que ce soit au Manitoba ou ailleurs : (a) a finding by a professional regulatory body of professional misconduct, incompetence, or an a) les conclusions de faute professionnelle, incapacity or lack of fitness to practise; d'incompétence, ou d'incapacité ou de manque d'aptitude à exercer auxquelles est arrivé un (b) a current proceeding by a professional organisme de réglementation professionnel; regulatory body in relation to professional misconduct, incompetence or an incapacity or b) les procédures en cours entreprises par un lack of fitness to practise; organisme de réglementation professionnel en raison d'une faute professionnelle, (c) a denial of registration by a professional d'incompétence ou d'une incapacité ou d'un regulatory body; manque d'aptitude à exercer;

(d) an inquest or a civil action; c) tout refus d'un organisme de réglementation professionnel d'inscrire l'auteur de la demande; (e) a professional liability insurance claim; d) toute enquête ou poursuite civile; (f) a conviction for a criminal offence. e) toute demande d'indemnisation au titre d'une assurance responsabilité professionnelle;

f) toute déclaration de culpabilité à l'égard d'une infraction criminelle.

REGISTRATION OF INSCRIPTION DES PRACTISING MIDWIVES SAGES-FEMMES PRATIQUANTES

Registration requirements: practising midwives Conditions d'inscription des sages-femmes 4(1) The requirements for registration as a pratiquantes practising midwife are as follows: 4(1) Les conditions qu'une personne doit remplir pour se faire inscrire à titre de sage-femme 1. The applicant must have satisfactorily pratiquante sont les suivantes : completed one of the following: 1. La personne doit, selon le cas : (a) The applicant must complete a program of studies leading to a degree, diploma or a) avoir terminé avec succès un programme certificate in midwifery. The program must be d'études menant à un grade, à un diplôme ou acceptable to the college and must be based à un certificat de sage-femme, programme on the core competencies of midwifery que l'Ordre juge acceptable et qui se fonde established by the college. sur les compétences fondamentales que l'Ordre a établies; (b) The applicant must complete an assessment process approved by the college b) se soumettre avec succès à une évaluation, of the applicant's ability to perform the core que l'Ordre a approuvée, de ses competencies of midwifery. connaissances, expérience, compétences et savoir-faire.

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2. The applicant must have conducted at 2. La personne doit avoir assisté à au least 40 births and attended at least twenty moins 40 accouchements dont au moins vingt à of them as primary midwife. At least 10 of the titre de sage-femme primaire. Au moins dix de ces births must have been conducted during the accouchements doivent avoir eu lieu au cours des two years before the date of application. deux ans précédant la demande d'inscription. De ces dix accouchements, cinq doivent avoir eu lieu 3. The applicant must have conducted at ailleurs qu'à hôpital et cinq à l'hôpital. least 75 prenatal examinations and 75 postnatal examinations and provided 3. La personne doit avoir fait au continuity of care to at least three women. moins 75 examens prénatals et 75 examens postnatals et avoir assuré la continuité des soins 4. The applicant must produce evidence that he à au moins trois femmes. or she is competent in neonatal resuscitation and cardiopulmonary resuscitation. 4. La personne doit fournir la preuve de sa compétence en réanimation néonatale et 5. The applicant must have completed an cardiopulmonaire. introductory session approved by the college about the practice of midwifery in Manitoba. 5. La personne doit avoir terminé un stage d'initiation approuvé par l'Ordre au sujet de l'exercice de la profession de sage-femme au Manitoba.

4(2) In addition, an applicant under 4(2) En outre, les personnes que vise le subsection (1) must intend to practise as a midwife paragraphe (1) doivent avoir l'intention d'exercer la within three months after the date of the application. profession de sage-femme dans les trois mois qui suivent leur demande d'inscription.

4(3) To maintain registration as a practising 4(3) Pour maintenir leur inscription à titre de midwife, a midwife must assume primary sages-femmes pratiquantes, les sages-femmes responsibility for providing all aspects of midwifery doivent assumer la responsabilité principale de la care, including prenatal, intrapartum, and prestation de tous les soins reliés à l'exercice de la postpartum care of the newborn, in accordance with profession de sage-femme, notamment les soins the standards of practice established by the college. prénatals, pernatals et postnatals de l'enfant, en conformité avec les normes d'exercice qu'a établies l'Ordre.

Election to practise in specified setting Choix d'exercer dans un milieu déterminé 5 For three years after this regulation 5 Pendant les trois années qui suivent comes into force, a person who is eligible for l'entrée en vigueur du présent règlement, les registration as a practising midwife under section 4 personnes qui peuvent se faire inscrire à titre de may elect to be registered as a midwife who attends sages-femmes pratiquantes sous le régime de births only in a specified setting. Once registered, l'article 4 peuvent choisir de se faire inscrire comme such a midwife is entitled to practise in accordance sages-femmes assistant aux accouchements with the election unless his or her registration is uniquement dans un milieu déterminé. Une fois cancelled, suspended or not renewed or further inscrites comme telles, ces sages-femmes ont le droit conditions have been placed on it. d'exercer en conformité avec leur choix, à moins que leur inscription ne soit annulée, suspendue ou non renouvelée ou qu'elle n'ait été assortie d'autres conditions.

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Information in register of practising midwives Renseignements au Registre des sages-femmes 6(1) For the purpose of clause 10(2)(e) of the pratiquantes Act, the following additional information is to be 6(1) Pour l'application de l'alinéa 10(2)e) de included in the register of practising midwives: la Loi, le Registre des sages-femmes pratiquantes doit contenir les renseignements supplémentaires (a) each midwife's name, home address and suivants : telephone number and business address and telephone number; a) le nom des sages-femmes, leur adresse et numéro de téléphone à la maison ainsi que leur (b) the midwife's registration number and the adresse et numéro de téléphone au travail; date and type of registration; b) le numéro d'inscription des sages-femmes (c) where appropriate, the educational or training ainsi que la date et le type de leur inscription; program in which the midwife is engaged; c) s'il y a lieu, le programme d'études ou de (d) the date the midwife's registration is cancelled formation que suivent les sages-femmes; or not renewed. d) la date d'annulation ou de non renouvellement de l'inscription des sages-femmes.

6(2) A midwife shall notify the registrar 6(2) Les sages-femmes informent sans tarder promptly of any change in the information referred le registraire de tout changement apporté aux to in clause (a) or (c). renseignements que vise l'alinéa a) ou c).

6(3) For the purpose of clause 10(3)(d) of the 6(3) Pour l'application de l'alinéa 10(3)d) de Act, all of the information referred to in la Loi, les renseignements que vise le paragraphe (1) subsection (1) is public information, other than a sont du domaine public, à l'exception de l'adresse et midwife's home address and home telephone du numéro de téléphone à la maison des number. sages-femmes.

TEMPORARY REGISTRATION INSCRIPTION TEMPORAIRE

Requirements for temporary registration Conditions d'inscription temporaire 7 An applicant qualified to practise 7 Les personnes qui sont habilitées à midwifery in another jurisdiction who wishes to exercer la profession de sage-femme dans un autre practise in Manitoba in a particular circumstance is ressort et qui désirent exercer au Manitoba dans des eligible for temporary registration as a practising circonstances particulières peuvent obtenir leur midwife if he or she inscription temporaire à titre de sages-femmes à la condition qu'elles : (a) applies to the registrar stating the particular circumstance and the proposed length of time a) en fassent la demande au registraire en that he or she wishes to practise; and indiquant les circonstances particulières et la durée prévue de l'exercice de la profession; (b) provides evidence satisfactory to the college that he or she is qualified in the other b) fournissent à l'Ordre des preuves jurisdiction and has a level of competence satisfaisantes comme quoi elles sont habilitées à equivalent to that required for registration under exercer dans un autre ressort et qu'elles ont un section 4. niveau de compétences équivalent à celui exigé pour l'inscription que prévoit l'article 4.

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REGISTRATION OF INSCRIPTION DES SAGES-FEMMES NON-PRACTISING MIDWIVES NON PRATIQUANTES

Registration of non-practising midwives Inscription des sages-femmes non pratiquantes 8 An applicant is eligible for registration 8 Peuvent se faire inscrire comme as a non-practising midwife if he or she meets the sages-femmes non pratiquantes les personnes qui requirements of subsection 4(1) but does not intend remplissent les conditions énoncées au to practise midwifery in the three-month period paragraphe 4(1) mais qui n'ont pas l'intention following the date of application. d'exercer la profession de sage-femme dans les trois mois qui suivent la date de leur demande d'inscription.

REGISTRATION OF STUDENTS INSCRIPTION DES ÉTUDIANTS

Registration of students Inscription des étudiants 9 In addition to the students referred to in 9 Outre les étudiants que vise l'article 16 section 16 of the Act, a person who is completing a de la Loi, les personnes qui complètent un cours de refresher of his or her education and experience, recyclage professionnel recommandé par la which has been recommended by the board of Commission d'évaluation peuvent se faire inscrire à assessors, is eligible to be registered as a student. titre d'étudiants.

RENEWAL OF REGISTRATION RENOUVELLEMENT DES INSCRIPTIONS

Renewal of registration Renouvellement des inscriptions 10 A midwife is entitled to have his or her 10 Les sages-femmes peuvent faire registration renewed by renouveler leur inscription :

(a) paying the registration fee provided for in the a) en versant les frais d'inscription que prévoient by-laws; les règlements administratifs;

(b) providing any information that the college b) en fournissant les renseignements que l'Ordre may require in the form and within the time set exige, et ce, en la forme et dans les délais qu'il by the college; and prescrit;

(c) providing evidence of continuing competency c) en produisant la preuve de leur compétence in accordance with criteria established by the continue en conformité avec les normes qu'a college. établies l'Ordre.

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CANCELLATION OF REGISTRATION ANNULATION DES INSCRIPTIONS

Cancellation of registration Annulation des inscriptions 11(1) The registrar shall inform the 11(1) Le registraire informe le Comité des complaints committee if he or she is satisfied on plaintes lorsqu'il a des motifs raisonnables de croire reasonable grounds that a midwife qu'une sage-femme :

(a) has failed to disclose any of the information a) n'a pas fourni tous les renseignements required by subsection 3(2); or qu'impose de divulguer le paragraphe 3(2);

(b) has made a false or misleading statement in b) a fait une fausse déclaration ou une assertion an application for registration or for renewal of trompeuse dans sa demande d'inscription ou de registration or in responding to a query or renouvellement d'inscription ou encore dans une communication from the college. réponse faite à une demande de renseignements ou à une communication de l'Ordre.

11(2) After reviewing a matter referred to it 11(2) Après l'examen d'une affaire qui lui a été under subsection (1), the complaints committee may renvoyée en vertu du paragraphe (1), le Comité des direct the registrar to cancel the midwife's plaintes peut ordonner au registraire d'annuler registration. l'inscription de la sage-femme.

PRACTICE REQUIREMENTS CONDITIONS D'EXERCICE

Screening and diagnostic tests Tests de dépistage et de diagnostic 12 A midwife may order and receive reports 12 Les sages-femmes peuvent demander et of the screening and diagnostic tests listed in obtenir les rapports des résultats des épreuves de Schedule A. dépistage et de diagnostic énumérées à l'annexe A.

Medications Médicaments 13(1) A midwife may prescribe and administer 13(1) Les sages-femmes peuvent prescrire et the medications listed in Part 1 of Schedule B. administrer les médicaments énumérés à la partie 1 de l'annexe B.

13(2) Under a physician's direction, a midwife 13(2) Les sages-femmes peuvent, sous la may administer the medications listed in Part 2 of direction d'un médecin, administrer les Schedule B. médicaments énumérés à la partie 2 de l'annexe B.

Minor surgical and invasive procedures Chirurgie mineure et procédé effractif 14 A midwife may perform the minor 14 Les sages-femmes peuvent exécuter les surgical and invasive procedures listed in actes de chirurgie mineures et de procédé effractif Schedule C. énumérés à l'annexe C.

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Standards of practice Normes d'exercice 15 A midwife shall comply with the 15 Les sages-femmes se conforment aux standards of practice approved by the college, normes d'exercice que l'Ordre a approuvées, y including standards concerning the following: compris les normes régissant :

(a) transfer of care to a physician; a) le transfert des soins à un médecin;

(b) out-of-hospital births; b) les accouchements ailleurs qu'à l'hôpital;

(c) in-hospital births; c) les accouchements à l'hôpital;

(d) record-keeping; d) la tenue des dossiers;

(e) continuing competency. e) le maintien de la compétence.

Professional liability insurance Assurance de responsabilité professionnelle 16(1) Subject to subsection (2), a midwife 16(1) Sous réserve du paragraphe (2), les shall carry professional liability insurance of not less sages-femmes souscrivent une assurance de than $7,000,000. per occurrence or $14,000,000. per responsabilité professionnelle d'au moins 7 millions year, issued by a company licensed to carry on de dollars par accouchement ou de 14 millions de business in the province. dollars par année auprès d'un assureur autorisé à faire des affaires dans la province.

16(2) A midwife is not required to carry 16(2) Les sages-femmes qui travaillent et qui professional liability insurance if he or she is pratiquent leur profession exclusivement pour le exclusively employed by a regional health authority compte d'un office régional de la santé ne sont pas and does not practice midwifery outside the scope of tenues de souscrire une assurance de responsabilité the employment. professionnelle.

MISCELLANEOUS PROVISIONS DISPOSITIONS DIVERSES

Committee to select public representatives Comité de sélection des représentants du public 17(1) The committee referred to in 17(1) Le Comité que vise l'alinéa 8(5)a) de la clause 8(5)(a) of the Act, which is to recruit and Loi et qui est chargé de recruter et de sélectionner les select public representatives to serve on the council représentants du public devant siéger au Conseil et and college committees, shall consist of the following aux autres comités de l'Ordre se compose des members: membres suivants :

(a) one person appointed by the Women's Health a) une personne nommée par la Women's Health Clinic; Clinic;

(b) one person appointed by the college who is a b) un membre de l'Ordre que nomme ce dernier; member of the college; c) une personne nommée par le comité (c) one person appointed by the standing permanent créé en vertu de l'alinéa 8(5)b) de la committee established under clause 8(5)(b) of the Loi; Act; d) deux personnes qui ne sont pas membres de (d) two persons who have used the services of a l'Ordre et qui ont déjà eu recours aux services midwife who are not members of the college. d'une sage-femme.

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17(2) The persons referred to in clause (1)(d) 17(2) Les personnes que vise l'alinéa (1)d) sont are to be selected by the members appointed under choisies par les membres nommés en vertu des clauses (a), (b) and (c) from nominations received alinéas a), b) et c) parmi les candidatures soumises from the public. One of them must be a resident of par le public. L'une de ces femmes doit être résidente northern or rural Manitoba. du nord ou d'une région rurale du Manitoba.

17(3) The first members of the committee 17(3) Le mandat des premiers membres du appointed under clauses (a) and (b) are to serve for Comité nommés en application des alinéas a) et b) a two-year term and the remainder are to serve for a est de deux ans. Celui des autres membres est de three-year term. Thereafter, members are to serve for trois ans. Par la suite, le mandat de tous les a three-year period. membres est de trois ans.

17(4) No person may serve as a member of the 17(4) Il est interdit d'accomplir plus de deux committee for more than two consecutive terms. mandats consécutifs comme membre du Comité.

17(5) The committee shall develop the criteria 17(5) Le Comité établit les critères et les and the process for nominating and selecting public méthodes de mise en candidature et de sélection des representatives to serve on the council and college représentants du public devant siéger au Conseil et committees. aux comités de l'Ordre.

Review of this regulation Révision du présent règlement 18 Not later than 5 years following the day 18 Dans les cinq années qui suivent la date this regulation comes into force, the college shall d'entrée en vigueur du présent règlement, l'Ordre :

(a) review the effectiveness of the operation of this a) en revoit l'efficacité et consulte, à ce sujet, les regulation after consultation with such persons personnes dont l'opinion lui paraît utile; affected by the regulation as the college considers appropriate; and b) le modifie ou l'abroge, s'il le juge indiqué.

(b) if it considers it advisable amend or repeal the regulation.

Coming into force Entrée en vigueur 19 This regulation comes into force on 19 Le présent règlement entre en vigueur en proclamation of The Midwifery and Consequential même temps que la Loi sur les sages-femmes et Amendments Act, S.M. 1997, c. 9. modifications corrélatives, c. 9 des L.M. 1997.

May 23, 2000 COUNCIL OF THE Le 23 mai 2000 POUR LE CONSEIL DE COLLEGE OF MIDWIVES L'ORDRE DES SAGES- OF MANITOBA FEMMES DU MANITOBA

Carol M. Scurfield Carol M. Scurfield

Margaret Haworth-Brockman Margaret Haworth-Brockman

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SCHEDULE A ANNEXE A

LABORATORY AND DIAGNOSTIC TESTS TESTS DE LABORATOIRE ET DE DIAGNOSTIC

Chemistry: Chimie : Bilirubin total Bilirubine totale Bilirubin conjugated Bilirubine conjuguée blood tests to detect genetic abnormalities in the Analyse sanguine pour la détection des fetus anomalies du foetus blood tests to detect the genetic carrier status of Analyse sanguine pour le dépistage des porteurs the mother du gène de la mère glucose testing Épreuve de glycémie urinalysis - routine (includes microscopic) Examen habituel de l'urine (y compris examen au newborn metabolic screening microscope) Dépistage des maladies métaboliques nouveau-né

Haematology: Hématologie CBC with differential count Hémogramme avec numération différentielle Kleihauer Test de Kleihauer red blood cell indices Indices globules rouges

Immunohaematology: Immunohématologie antibody screen Détection des anticorps blood group Groupe sanguin direct antiglobulin test (DAT) Test de Coombs direct

Cytology: Cytologie cervicovaginal specimens Échantillons cervico-vaginaux

Bacteriology: Bactériologie culture and antibiotic sensitivity bacterial: Sensibilité aux antibiotiques et aux cultures vaginal, cervical, urine and other (includes bactéries : gonorrhoea, chlamydia, group B vaginale, cervicale, uroculture et autres (y streptococcus) compris la blennorragie, la chlamyde et le culture virus (herpes) streptocoque du groupe B) wet preparation for fungus, trichomonas and clue Culture - virus (herpès) cells Préparation par voie humide champignons, trichomonas et bâtonnet court adhérant aux cellules épithéliales dans les vaginites

Immunology: Immunologie pregnancy test (urine and blood) Test de grossesse (urine et sang) Rubella Rubéole toxoplasmosis Toxoplasmose HIV antibody Anticorps anti-VIH VDRL VDRL hepatitis associated antigen or antibody Immuno-essai - anticorps et antigène de immunoassay l'hépatite

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Diagnostic imaging: Imagerie diagnostique pelvic and obstetrical ultrasound Ultrasons pelviens et obstétriques

X-ray: Radiographie abdominal and pelvic Radiographie abdominale et pelvienne

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SCHEDULE B ANNEXE B

MEDICATIONS AND DEVICES MÉDICAMENTS ET APPAREILS

Part 1: Medications and devices that a Partie 1 : Médicaments et appareils que midwife may prescribe and peuvent prescrire les sages-femmes : administer:

1. antibiotics for the treatment of 1. Antibiotiques pour le traitement des vaginal/cervical infections, including infections vaginales/cervicales, y compris la gonorrhea, chlamydia, bacterial vaginosis, blennorragie, la chlamyde, la vaginose trichomonas and group B streptococcus bactérienne, la trichomonas et le streptocoque du groupe B. 2. antiemetic for the treatment of nausea and vomiting in pregnancy 2. Antiémétique pour le traitement de la nausée et des vomissements pendant la grossesse. 3. anti-fungal agents for maternal vaginal infections and thrush in the infant 3. Antifongiques pour le traitement des infections vaginales maternelles et du 4. anti-haemorrhoidal agents with muguet chez les bébés. hydrocortisone 4. Agents antihémorroïdaux avec 5. BCG vaccine hydrocortisone.

6. crystalloid or colloid intravenous solutions 5. Vaccin BCG.

7. dextrose 10% solution 6. Solutions intraveineuses crystalloïdales ou colloïdales. 8. epinephrine 1:10,000 solution and epinephrine 1:1,000 solution 7. Solution de dextrose à 10 %.

9. hepatitis B immune globulin, hepatitis B 8. Solution d'épinéphrine à 1:10 000 et vaccine à 1:1 000.

10. inhalation analgesic eg. nitrous oxide and 9. Immunoglobuline antihépatite B et vaccin oxygen (N2O2/O2) contre l'hépatite B.

11. intrauterine contraceptive devices, 10. Analgésique par inhalation - oxyde nitreux et diaphragms, cervical caps oxygène (N2O2/O2).

12. 1-2% lidocaine solution for injection 11. Matériel contraceptif intra-utérin, diaphragmes, capes cervicales. 13. neonatal ophthalmic prophylaxis 12. Solution de lidocaïne à 1-2 % pour injection. 14. oral contraceptive pills, depoprovera 13. Prophylaxie ophtalmique néonatale. 15. oxygen 14. Contraceptifs oraux, Depo-Provera.

15. Oxygène.

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16. oxytocin and ergometrine for post-partum 16. Ocytocine et ergométrine pour usage use post-partum.

17. prostaglandins F2 17. Prostaglandine F2.

18. RH immunoglobulin 18. Immunoglobine Rh.

19. tryptophan 19. Tryptophane.

20. vitamin K for the neonate 20. Vitamine K pour nouveau-né.

21. OTC (over-the-counter) medication commonly 21. Médicaments en vente libre d'usage habituel used in conditions arising in pregnancy. pour les états pathologiques attribuables à la grossesse. 22. Sodium bicarbonate for resuscitation of the newborn 22. Bicarbonate de sodium pour la réanimation du nouveau-né.

Part 2: Medications that a midwife may Partie 2 : Médicaments que les sages-femmes administer under the direction of a peuvent administrer sous la direction physician: d'un médecin.

1. other antibiotics 1. Autres antibiotiques.

2. AZT to HIV positive mothers and their 2. AZT pour les mères et les nouveaux-nés VIH newborns. séropositifs.

3. calcium gluconate 3. Gluconate de calcium

4. cervical ripening agents 4. Agents de mûrissement cervical.

5. epidural analgesia e.g. continuous infusion 5. Analgésie péridurale à perfusion continue. maintenance 6. Solution d'hydralazine. 6. hydralazine solution 7. Solution de sulfate de magnésium. 7. magnesium sulphate solution 8. Analgésiques narcotiques (y compris 8. narcotic analgesics (including acetaminophen acétaminophène contenant 15 et 30 mg de with 15 mg. and 30 mg. codeine) codéine).

9. narcotic antagonists eg. naloxone 9. Antagonistes des morphiniques - hydrochloride hydrochloride de naloxone.

10. oxytocic for induction/augmentation of 10. Oxytociques pour le déclenchement/ labour l'augmentation du travail.

11. sedatives 11. Sédatifs.

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SCHEDULE C ANNEXE C

MINOR SURGICAL AND CHIRURGIES MINEURES INVASIVE PROCEDURES ET PROCÉDÉS EFFRACTIFS

1. amniotomy 1. Amniotomie.

2. bladder catheterization 2. Cathétérisme vésical.

3. episiotomy 3. Épisiotomie.

4. fitting cervical caps and diaphragms for 4. Ajustement des capes cervicales et des contraceptive purposes diaphragmes à des fins de contraception.

5. injections 5. Injections.

6. insertion of intrauterine contraceptive devices 6. Pose du matériel contraceptif intra-utérin.

7. intravenous cannulation 7. Canulation intraveineuse.

8. oral intubation of the neonate 8. Intubation orale du nouveau-né.

9. repair of episiotomy and tears not including 9. Réparation de l'épisiotomie et des déchirures, fourth degree tears. Repair of the anal sauf les déchirures de quatrième degré. sphincter and periurethral tears are Réparation du sphincter anal et des permissible with advanced training approved déchirures périurétrales pour autant que les by the college. sages-femmes aient suivi une formation avancée approuvée par l'Ordre. 10. taking of cytological smears for cancer screening 10. Cytodiagnostic pour l'identification par frottis des cellules cancéreuses. 11. venipuncture 11. Ponction veineuse. 12. placement of an umbilical venous catheter in the newborn 12. Pose d'un cathéter ombilical veineux chez le nouveau-né.

The Queen's Printer L'Imprimeur de la Reine for the Province of Manitoba du Manitoba

14 06/00

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Drug Schedules Regulations, 1997 Page 1 of 7

Home > Saskatchewan > Statutes and Regulations > R.R.S. c. P-9.1 Reg. 2 > Complete text Français English

Drug Schedules Regulations, 1997, R.R.S. c. P-9.1 Reg. 2

Citation: Drug Schedules Regulations, 1997, R.R.S. c. P-9.1 Reg. 2 Information under The Pharmacy Act, 1996 Chapter P-9.1 Reg 2 (effective January 1, about this 1998) as amended by Saskatchewan Regulations 105/97, 73/2003, text: 20/2004, 119/2005 and an Errata notice published in the Gazette January 20, 2006 and 83/2007.Last update posted: 19 Mar 2008 Enabling Pharmacy Act, 1996, S.S. 1996, c. P-9.1 Statute: URL: http://www.canlii.org/sk/laws/regu/p-9.1r.2/20080818/whole.html Version downloaded by CanLII on 2008-08-18

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DRUG SCHEDULES, 1997 P-9.1 REG 2

The Drug Schedules Regulations, 1997

being

Chapter P-9.1 Reg 2 (effective January 1, 1998) as amended by Saskatchewan Regulations 105/97, 73/2003, 20/2004, 119/2005 and an Errata notice published in the Gazette January 20, 2006 and 83/2007.

NOTE: This consolidation is not official. Amendments have been incorporated for convenience of reference and the original statutes and regulations should be consulted for all purposes of interpretation and application of the law. In order to preserve the integrity of the original statutes and regulations, errors that may have appeared are reproduced in this consolidation.

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P-9.1 REG 2 DRUG SCHEDULES, 1997

Table of Contents

1 Title 1.1 Interpretation 1.2 Practitioners prescribed 2 Drug schedules 3 Schedules establishment and amendment 4 Dispensing and selling drugs 5 Storing of Schedule II drugs 6 Prescription privileges physician 7 Prescription privileges dentist 8 Prescription privileges optometrist 9 Prescription privileges veterinarian 9.1 Prescription privileges pharmacists 9.2 Prescription privileges nurse practitioner 9.3 Prescription privileges midwife 10 R.R.S. c.P-9.1 Reg 1 repealed 11 Coming into force

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DRUG SCHEDULES, 1997 P-9.1 REG 2

CHAPTER P-9.1 REG 2 The Pharmacy Act, 1996 Title 1 These regulations may be cited as The Drug Schedules Regulations, 1997. Interpretation 1.1 In these regulations, "Act" means The Pharmacy Act, 1996. 25 Jly 2003 SR 73/2003 s3.

Practitioners prescribed 1.2 For the purposes of clause 2(t) of the Act, the following health care professionals are prescribed as practitioners: (a) registered nurses who are entitled pursuant to The Registered Nurses Act, 1988 to practise in the nurse practitioner category; (b) optometrists; (c) pharmacists; (d) midwives. 7 May 2004 SR 20/2004 s3; 21 Sep 2007 SR 83/ 2007 s3.

Drug schedules 2(1) Three drug schedules are established as set forth in this section. (2) Schedule I, entitled "Prescription Drugs", consists of the following: (a) the drugs listed in the schedules to the Narcotic Control Regulations (Canada) other than a drug mentioned in section 36 of those regulations; (b) the drugs listed in Schedule F of the Food and Drug Regulations (Canada) other than a drug listed in Part II of that Schedule: (i) that is not in a form suitable for use by a human; or (ii) for which the main product panel of both the inner label and the outer label clearly indicates that the drug is for veterinary use only; (c) the drugs listed in the schedule to Part G of the Food and Drug Regulations (Canada); (d) those drugs determined by the council pursuant to section 3. (3) Schedule II, entitled "Non-Prescription Restricted Access Drugs", consists of the following: (a) pseudoephedrine, pseudoephedrine hydrochloride or pseudoephedrine sulphate, but only with respect to products in which pseudoephedrine, pseudoephedrine hydrochloride or pseudoephedrine sulphate is the single active ingredient; (b) those drugs determined by the council pursuant to section 3.

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P-9.1 REG 2 DRUG SCHEDULES, 1997

(4) Schedule III, entitled "Pharmacy Only Non-Prescription Drugs", consists of those drugs determined by the council pursuant to section 3. 1 Aug 97 cP-9.1 Reg 2 s2; 12 Dec 97 SR 105/97 s3; 25 Nov 2005 SR 119/2005 s3.

Schedules - establishment and amendment 3(1) Council shall determine the additional drugs to be listed in Schedule I by way of administrative bylaw. (2) Council may delete a drug listed in Schedule I that appears in any of the schedules mentioned in clauses 2(2)(a) to (c) by way of administrative bylaw. (3) Council may determine the additional drugs to be listed in Schedule II by way of administrative bylaw. (4) Council shall determine the drugs to be listed in Schedule III by way of regulatory bylaw. 1 Aug 97 cP-9.1 Reg 2 s3; 12 Dec 97 SR 105/97 s4; 25 Nov 2005 SR 119/2005 s4.

Dispensing and selling drugs 4(1) A licensed pharmacist may sell a drug listed in Schedule I to the public only on the authority of a prescription issued by a practitioner who is a member of a category of practitioners authorized to prescribe the drug. (2) Subject to section 23 of the Act, Schedule II and Schedule III drugs may only be sold to the public in a pharmacy. (2.1) A licensed pharmacist shall not sell products containing more than 3600 mg of pseudoephedrine, pseudoephedrine hydrochloride or pseudoephedrine sulphate as the single active ingredient to a member of the public in a single transaction. (3) A licensed pharmacist may sell a drug listed in Schedule II or III to the public without a prescription. 12 Dec 97 SR 105/97 s5; 25 Nov 2005 SR 119/ 2005 s5.

Storing of Schedule II drugs 5 Drugs listed in Schedule II are to be stored in a secure location that: (a) is in the pharmacy; and (b) is not accessible to the public. 12 Dec 97 SR 105/97 s6.

Prescription privileges - physician 6(1) A duly qualified medical practitioner may, subject to the terms, conditions and restrictions of a licence issued pursuant to The Medical Profession Act, 1981, prescribe any drug listed in Schedule I, II or III that is intended for the purpose of treating humans.

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DRUG SCHEDULES, 1997 P-9.1 REG 2

(2) A physician who possesses qualifications similar to those of a duly qualified medical practitioner and who is licensed pursuant to a law of another jurisdiction in Canada providing for the granting of licences to physicians to practise their profession may, subject to the terms, conditions and restrictions of that licence, prescribe any drug listed in Schedule I, II or III that is intended for the purpose of treating humans. 1 Aug 97 cP-9.1 Reg 2 s6; 25 Jly 2003 SR 73/ 2003 s4.

Prescription privileges - dentist 7(1) A dentist registered and licensed pursuant to The Dental Profession Act, 1978 may, subject to the terms, conditions and restrictions of a licence issued pursuant to The Dental Profession Act, 1978, prescribe any drug listed in Schedule I, II or III that is intended for the purpose of providing dental treatment to humans. (2) A dentist who possesses qualifications similar to those of a dentist mentioned in subsection (1) and who is licensed pursuant to a law of another jurisdiction in Canada providing for the granting of licences to dentists to practise their profession may, subject to the terms, conditions and restrictions of that licence, prescribe any drug listed in Schedule I, II or III that is intended for the purpose of providing dental treatment to humans. 1 Aug 97 cP-9.1 Reg 2 s7; 25 Jly 2003 SR 73/ 2003 s5.

Prescription privileges - optometrist 8(1) An optometrist registered and licensed pursuant to The Optometry Act, 1985 may, subject to the terms, conditions and restrictions of a licence issued pursuant to The Optometry Act, 1985, prescribe pharmaceutical agents, within the meaning of The Optometry Act, 1985, listed in Schedule I, II or III for the purpose of providing eye treatment to humans. (2) An optometrist who possesses qualifications similar to those of an optometrist mentioned in subsection (1) and who is licensed pursuant to a law of another jurisdiction in Canada providing for the granting of licences to optometrists to practise their profession may, subject to the terms, conditions and restrictions of that licence, prescribe pharmaceutical agents, within the meaning of The Optometry Act, 1985, listed in Schedule I, II or III for the purpose of providing eye treatment to humans. 1 Aug 97 cP-9.1 Reg 2 s8; 25 Jly 2003 SR 73/ 2003 s6.

Prescription privileges - veterinarian 9(1) A veterinarian registered and licensed pursuant to The Veterinarians Act, 1987 may, subject to any terms, conditions and restrictions of a licence issued pursuant to The Veterinarians Act, 1987, prescribe any drug listed in Schedule I, II or III that is intended for the purpose of treating animals. (2) A veterinarian who possesses qualifications similar to those of a veterinarian mentioned in subsection (1) and who is licensed pursuant to a law of another jurisdiction in Canada providing for the granting of licences to veterinarians to practise their profession may, subject to the terms, conditions and restrictions of that licence, prescribe any drug listed in Schedule I, II or III that is intended for the purpose of treating animals. 1 Aug 97 cP-9.1 Reg 2 s9; 25 Jly 2003 SR 73/ 2003 s7.

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P-9.1 REG 2 DRUG SCHEDULES, 1997

Prescription privileges pharmacists 9.1 A licensed pharmacist may, subject to the terms, conditions and restrictions in his or her licence, prescribe any drug listed in Schedule I that is an oral contraceptive if, in the circumstances, the provision of a sufficient quantity of the drug for emergency contraception is required to meet the patient's needs. 25 Jly 2003 SR 73/2003 s8.

Prescription privileges - nurse practitioner 9.2 Subject to the Controlled Drugs and Substances Act (Canada) and the bylaws of the Saskatchewan Registered Nurses' Association, a registered nurse who is entitled pursuant to The Registered Nurses Act, 1988 to practise in the nurse practitioner category may prescribe any drug listed in Schedule I, II or III that is intended for the purpose of treating humans. 7 May 2004 SR 20/2004 s4.

Prescription privileges midwife 9.3 Subject to the Controlled Drugs and Substances Act (Canada), The Midwifery Act, The Midwifery Regulations, the bylaws of the Saskatchewan College of Midwives and any terms or conditions in his or her licence, a midwife who is entitled pursuant to The Midwifery Act to practise midwifery may prescribe any drug listed in Schedule I, II or III that is intended for the purpose of providing midwifery care. 21 Sep 2007 SR 83/2007 s4.

R.R.S. c.P-9.1 Reg 1 repealed 10 The Drug Schedules Regulations are repealed. 1 Aug 97 cP-9.1 Reg 2 s10.

Coming into force 11(1) Subject to subsections (2), (3) and (4), these regulations come into force on the day on which section 1 of The Pharmacy Act, 1996 comes into force. (2) If section 1 of The Pharmacy Act, 1996 comes into force before these regulations are filed with the Registrar of Regulations, these regulations come into force on the day on which they are filed with the Registrar of Regulations. (3) Subject to subsection (4), section 8 comes into force on the day on which sections 8 and 9 of The Optometry and Ophthalmic Dispensers Professions Amendment Act, 1996 comes into force. (4) If sections 8 and 9 of The Optometry and Ophthalmic Dispensers Professions Amendment Act, 1996 come into force before these regulations are filed with the Registrar of Regulations, section 8 comes into force on the day on which they are filed with the Registrar of Regulations.

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