The Island Capsule Newsletter of the Board

January 2004

PRINCE EDWARD ISLAND PHARMACY BOARD

P.O. Box 70 7-20424 Trans Highway ENCLOSURES South Shore Professional Bldg. Crapaud, PEI C0A 1J0 1. Renewal Applications 2004/2005 due March 902-658-2780 (fax 2198) 31, 2004 [email protected] 1. Manual Additions 2. Adverse Drug Reaction Newsletters Registrar: Neila I. Auld, BScPharm 3. Guidelines for providing Flu Office Hours: Monday thru Friday 9am-3pm Immunizations Located on main floor, side entrance and rear of 4. Federal Legislation Update building. ANNOUNCEMENTS MEMBERS Angela Doucette completed her second three- Wally Kowalchuk, Chair & NAPRA Delegate year term with the PEI Pharmacy Board in (Zellers Phcy) December. The Board would like to thank David McLeod , Vice-Chair(A&M Pharmasave) Angela for six years of dedicated service to the Greg Burton, (Medicine Shoppe) pharmacy profession in Prince Edward Island. Linda Gordon-MacEachern (Shoppers Drug) Kerry Murphy (Shoppers Drug) Candace Marcum also recently “retired” from Iain Smith (QEH) her position with the Board. As well, we would Nancy Canham, LayRep like to acknowledge her contribution to the Connie MacKinnon, Layrep profession in PEI. Mar Thomson, Government Rep Jeanine McQuaid has retired from her position REGISTRATIONS as Pharmacy Inspector for the PEI Pharmacy Pharmacists: 150 Board. Many thanks go out to Jeanine for her Permits: 42 + 6 hospitals + Provincial Phcy tireless work traveling the Island with this Students: 26 position. David McLeod has accepted the position as Inspector. This newsletter is distributed to all licensed pharmacists in PEI. Decisions regarding all MANUAL UPDATES matters such as regulations, drug related The Pharmacy Act has been amended to incidents, etc. are published in it. The PEI accommodate future “new” prescribers for Pharmacy Board therefore assumes that all prescription medications by not restricting the pharmacists are aware of these matters. definition of a prescription to an order from only a physician, dentist and veterinarian. It leaves the

1 “door open” to add other health professionals to CPRC had a meting in Ottawa from November this list (such as nurse practitioners, podiatrists, 10th to the 12th, 2003. Issues addressed included: pharmacists, etc.) The Act changes also accommodates pending regulation changes for  Mutual recognition of Pharmacists Drug Scheduling. These changes are included, between US and Canada and pharmacists will be notified when the actual The National Association of Boards of Drug Scheduling Regulations (and other Pharmacy (NABP) reviewed and regulation changes), expected shortly, are evaluated the survey results from both approved. the US and Canadian pharmacists gathered over the past summer. The WEBMAIL conclusion was “the criticality and PEI pharmacists are the highest users of the frequency ratings for the competency NAPRA web mail (e-link) network (percentage statements were extremely similar for wise) in Canada! The Registrar, NAPRA and both groups. The matter of mutually Health Canada are utilizing this system to recognizing pharmacists licensed in the disseminate information in a timely fashion to US and Canada will be moved forward pharmacists across Canada. Eventually, it will with continuing discussions between replace costly mailings that also see delays in NABP and NAPRA. information delivery. As mentioned before, messages from the Board, NAPRA and Health  Request for changes to Entry to Canada can be forwarded automatically to Practice Education members’ regular email addresses. To do so, follow these instructions: Log into your A consultation with national and PEIPB/NAPRA web mail account at provincial/territorial stakeholders is www.napra.ca/express. Your user name is being initiated to seek comments on the [email protected] Click on development of “systematic and “options” on the left hand side of the screen, transparent review process of proposed click on “general”, enter your preferred email changes to entry-to-practice address in the “forward all mail to the following requirements for health professionals”. address” box, and then click “update NAPRA and the individual PRA will be preferences”. involved in the review process. If you have forgotten your original password, or if you have not been assigned a mailbox  Look-alike-sound-alike drug names ([email protected]) and password, contact the Registrar. Sign up soon! The federal government is embarking Over the next few months the system will be upon a process to review drug names utilized more and more to provide pharmacists in coming into the market place. The PEI with up to date information of a regulatory Registrars suggested that including the and public safety nature. diagnostic indication or diagnosis for the prescribed medication with the MUTUAL RECOGNITION AGREEMENT written, verbal or electronic order would The Registrars from across Canada met in prevent many of the medication errors. Ottawa in October to review the Mutual Recognition Agreement as signed in 2000 and  Chair of CPRC requiring a review in 2003-2004. Representatives At the close of the meeting, Ron Guse of and Quebec were in attendance. It was (Registrar from ) was elected agreed that few changes would be necessary in as the Chair of CPRC for the next two- the actual agreement, although supportive year term. documents need updating. There is a strong possibility of having Quebec sign the Agreement subject to the re-tooling of their graduation examinations and progress of competency VERIFIED INTERNET assessments in other provinces. PHARMACY PRACTICE SITES (VIPPS) COUNCIL of PHARMACY REGISTRARS of NAPRA recently launched the Canadian CANADA (CPRC) of NAPRA VIPPS Program. The VIPPS program was developed in 1999 by the National

2 Association of Boards of Pharmacy pharmacist eventually filling the (NABP) in the United States, in prescription must ensure that the response to public concern about the prescription expiry date is set for one safety of pharmacy practice offered year from the date the therapy was through the Internet. In 2003, NAPRA prescribed, as opposed to one year from entered into a licensing agreement with the date first dispensed. Similarly, when NABP to administer the program in a prescription is transferred, the Canada, so that Canadian pharmacies prescription expiry date must be could also be recognized. adjusted to reflect the date originally prescribed (not necessarily dispensed). For a Canadian pharmacy to be VIPPS certified, it must first be accredited by a 3. Am I permitted to dispense a CFC- provincial or territorial licensing body containing corticosteroid metered and operating in accordance with the dose inhaler with the new federal laws of the jurisdiction where it is legislation? physically located and that of the patient As of January 1, 2004, the production it serves. In addition, Canadian and importation of corticosteroid MDIs pharmacies displaying the VIPPS seal containing CFC is prohibited. must have demonstrated compliance with VIPPS criteria, which include This legislation is somewhat different protecting patient confidentiality, from the ban on CFC-containing ensuring the authenticity of salbutamol inhalers in January 2003 prescriptions, and providing meaningful when you were prohibited from selling consultation between patients and CFC-containing salbutamol inhalers. If pharmacists. Canadian VIPPS certified you have CFC-containing corticosteroid pharmacies are held to the high MDIs in stock, you may continue to sell standards set by NAPRA. Further them after January 1, 2004. information on VIPPS certification and applications can be accessed through the This January 2004 milestone marks the NAPRA website: www.napra.org. next step in the federal strategy to eliminate the uses of CFC inhalers. The Q & A IN PRACTICE last phase of the transition strategy will occur on January 1, 2005 when 1. For how long must a pharmacy save production and importation of all other hard copies of prescriptions filled at CFC-containing MDIs will be their facility? prohibited. Federal and provincial legislation requires that a pharmacy save the hard REMINDER FOR PHARMACY copy of a prescription for “two years PERMIT HOLDERS and from the date filled”. In cases with no PHARMACISTS refills authorized, that would be two Pharmacists in Charge are reminded of years from the date filled. Where refills the requirement to report to the office are authorized, that would be two years all the pharmacists in their employ, from the date last filled. In order to whether full time or part time. ensure all refills are covered, Act 13(2): pharmacies should retain prescription The holder of a permit shall notify the records for at least three years from the Registrar whenever there is a change of date originally filled. persons working as a pharmacist, certified clerk or registered student in 2. When a prescription is presented to a his pharmacy. pharmacy 60 days after it was Authorizations 17(a): originally written, for how long is it The holder of a permit shall within valid? seven days of a change with respect to Prescriptions are valid for one year any of the information furnished with from the date prescribed. the application under section 15, so Prescriptions may be “placed on hold” inform the Registrar. This includes on the patient’s file, however, the staffing details.

3 ADVANCED NOTIFICATION Pharmacists also have a responsibility to REQUIRED for RELOCATIONS keep their registration information and RENOVATIONS current. If your pharmacy is relocating to a Authorizations 35: different site, with a new physical The holder of an authorization shall address, our office requires advance without delay notify the Registrar of notification of at least 30 days. A permit any change in the information provided is issued to a pharmacy with respect to a in the most recent application that may specific address. Therefore, the affect the person’s eligibility to practice relocated pharmacy needs a new permit or the Registrar’s ability to contact the of accreditation in order to legally person. operate. Relocation/Inspection forms are available from the Board office. CORTISPORIN E/E SUSPENSION® vs. CORTIMYXIN SOLUTION® If you are planning a pharmacy Pharmacists are reminded that renovation (but remaining at the same Cortimyxin Solution® (Sabex) is not physical address) our office requires equivalent to Cortisporin E/E advance notice of at least 30 days. Suspension®. Cortimyxin Solution® is Although a new permit of accreditation an otic product only and cannot be used is not needed, a site inspection will be in the eye. Cortisporin E/E Suspension® completed. is sterile and can be used in the eye or ear. Note that Cortimyxin Ointment® is NEW REGULATIONS FOR an ophthalmic ointment. NATURAL PRODUCTS Based on a comprehensive consultation THE CANADIAN COUNCIL for process, new Natural Health Products ACCREDITATION of PHARMACY Regulations (NHP Regulations) came PROGRAMS (CCAPP) into effect on January 1, 2004. Health CCAPP is developing standards for the Canada’s Natural Health Products Direct-Entry Pharm.D. program and Directorate will be placing requirements plans to have these approved by May on people who manufacture, package, 2005. It is anticipated the Standards will label, import or distribute NHPs to be modeled on the American standards. ensure that Canadians have ready access It was also decided that, as soon as to natural health products that are safe, funds become available, CCAPP will effective and of high quality. proceed to hire the staff necessary to develop the Pharmacy Technician All manufacturers will be licensed by Accreditation Process. Health Canada. New guidelines will require natural products to meet quality Dr. Jim Blackburn is the new Executive standards, and consistently contain what Director of CCAPP, replacing Dr. is stated on labels. Bruce Schnell. Product licenses will be required for all natural products. Licensed products will now get an 8-digit license number starting with the “NPM” or “DIN-HM” CLOSING/SELLING A for homeopathic products. PHARMACY The PEIPB office requires written Health claims will be permitted for notification of the closure or sale of a licensed products, but only if supported pharmacy, 30 days prior to the closure by adequate scientific evidence showing or sale. Forms are available in pharmacy safety and efficacy. binders, on the website, or by contacting the Registrar. Labels will contain a lot more information. Every licensed product will list active and inactive ingredients, health claims, dosing, proper storage,

4 cautions, contraindications and potential become failure to abide by regulations adverse effects. or standards and possibly “professional misconduct”? These changes will take time to implement, ranging from two years (for This is an excellent question, and site licensing) to six years (for licensing unfortunately one for which there is no of products that have a DIN). Health clear answer. As pharmacists, we make Canada will provide businesses with hundreds of professional judgement working tools and processes to support calls every week. These judgement calls this transition, and a public education are usually decided after consideration program will be initiated this fall. of a number of factors that include the actual wording of regulations or More information on the NHP standards, our past experience and Regulations can be viewed at the knowledge of this specific patient and Natural Health Products web site: their health history, and ultimately “the www.healthcanada.ca/nhpd. best interest of the patient”. It is important to note, however, that “the STANDARDS of PRACTICE for best interest of the patient” is not CANADIAN PHARMACISTS necessarily synonymous with what is Pharmacists recently received the most convenient, or easiest, or most revised copy of the “Standards of inexpensive for the patient, or that the Practice for Canadian Pharmacists”, patient’s wishes must be accommodated developed by NAPRA (the National regardless of all other factors. Association of Pharmacy Regulatory Authorities) and the provincial To quote advice given by the Ontario regulatory authorities, including the College of Pharmacists in response to a PEIPB (PEI Pharmacy Board). These similar question, “When making a Standards, which were previously decision based on professional distributed in the Fall of 2000 and made judgement, you are sure to be on solid available on the PEI section of the ground if your decision is one that any NAPRA web site, were recently reasonable pharmacist would also make; approved for implementation over the if your decision is made in the best next three-year period. The overall goal interest of the patient; and if you of the Standards is to promote safe and document what you did or didn’t do and effective patient-focused care. why”.

“Tool Kits” are available via the INFORMATION ON MARIJUANA NAPRA web site (under the Pharmacy (Reprinted from the College of Practice and Pharmacy Operations Pharmacists’ Newsletter) section), with printed copies available o On September 16, 2003 Health Canada request. The tool kits provide resources through the Drug Strategy and in practice areas such as pharmacy care Controlled Substances Programme, plans, documentation, workflow, facility hosted a stakeholder meeting with design, drug information resources and representatives of the Canadian minimizing medication errors. pharmacists’ community. The focus of the meeting was to discuss alternative Future continuing education programs mechanisms for distributing marijuana will provide pharmacists with for medical purposes in Canada and the information supporting the Standards of feasibility of pharmacists being part of Practice for Canadian Pharmacists. the distribution chain.

PROFESSIONAL JUDGEMENT Health Canada is looking for an (Reprinted from the Newfoundland alternative to the traditional Pharmaceutical Association’s Newsletter) prescription-based system for At times we are told as pharmacists to distribution. Given that the safety and use “professional judgement”. At what efficacy of marijuana has not been point does “professional judgement” proven, it was suggested that

5 practitioners would not be comfortable Be sure the entire dose is swallowed by issuing a prescription. Therefore Health the patient. Check that no drug remains Canada officials are looking at in the cup and engage the patient in alternative methods of distribution, but conversation after witnessing the no final decision has been made. ingestion, thus confirming that no part of the dose remains in the patient’s Since there is insufficient scientific mouth. research regarding the medical benefits of marijuana, the point was made that Carries are doses that the patient takes Health Canada should position home to administer unsupervised. distribution through pharmacies as Prescriptions can be specifically written “facilitating compassionate use”, rather with the words “no carries”, although than alluding to a distributive function, DWI implies no carries. This means that to reflect the patient care aspect you must not supply a dose to the provided by pharmacists. Further patient that would be taken without your meetings with the medical community direct supervision, unless you have have been scheduled. clarified with the prescriber whether carries are acceptable. At this point in time, the Interim Policy for the Provision of Marijuana Seeds If your pharmacy is closed on a and Dried Marijuana Product for weekend or holiday, the DWI directions Medical Purpose in Canada remains in still apply and do not give you place. Eligibility criteria for marijuana authorization to provide carries. In some for medical purposes can be accessed on instances physicians have written a the Health Canada web site at www.hc- prescription for weekdays and a second sc.gc.ca/hecs- prescription for weekends. If carries sesc/ocma/publication/interim_policy/ were provided by the pharmacy that had 5_eligibility_criteria.htm the weekdays prescription, the patient received a double dose by using the The information for health professionals weekend prescription at another is also available at www.hc- pharmacy. sc.gc.ca/hecs- secs/ocma/publication/marijuana/toc. Ensure that doses are not diverted or htm duplicated by checking with the The information for consumers is prescriber before supplying carries. available at www.hc-sc.gc.ca/hecs- sesc/ocma/publication/info_for_patien Prescriptions requiring daily witnessed t/info_for_patient.htm ingestion but permitting carries should specify the number of carries allowed. This usually appears abbreviated as DWI + 2 carries (weekend).

METHADONE: DAILY Caring for an opiod dependent patient WITNESSED INGESTION and requires collaboration among CARRIES caregivers. Always check with the (Reprinted from the College of prescriber when directions are unclear Pharmacists’ Newsletter) or when the patient expresses needs that If you dispense methadone for treatment are not contemplated by the of opiod dependency, pay close prescription’s directions. attention to the requirements for daily witnessed ingestion, often abbreviated BOTTLES AND SIP CUPS as DWI. BETWEEN MEALS (Reprinted from Public Health Services, Dental Program, (BC ) Fraser Health Authority) Those prescriptions require you to Attractive bottles and sip cups are dispense the milligram dose daily to the available in most pharmacies. Misuse of patient and directly observe the patient these feeding devices and the contents while he ingests the methadone drink.

6 they contain can contribute to tooth  Do not send supporting decay in young children. Breast milk, documentation, such as cow’s milk, formula, fruit juice and any certificates or course sweetened drink contain sugars that can brochures. These should be cause tooth decay. If a bottle or a sip sent only if selected for audit. cup containing these liquids is offered  Keep your supporting as a pacifier many times a day the documents in a safe place in chance of developing tooth decay is case you are audited. increased. Watering down juices,  Remember that you must use punches or milk has the same potential the standard professional to cause tooth decay. development log (PDL) form, provided with A bottle habit may be prevented if a cup renewals/licensing and also is introduced between 6 and 12 months available on the web site. of age. A toddler has a bottle “habit”  Remember also that you must when they frequently suck on a bottle as also complete and submit the though it were a pacifier. The bottle is project record for non- used for comfort rather than nutrition. CCCEP/PEIPB/Dalhousie This is a concern because a toddler’s approved CEs. teeth are at risk for tooth decay if they are drinking from a bottle filled with CORRECTION TO APPLICATION anything other than water during rest Please note that the NAPRA fee the and sleep periods. The risk is the same Board pays is $56 per pharmacist, not if a toddler walks around drinking from $52 as indicated on the renewal form. a bottle or sip cup during the day. This would then see the portion of the fee retained by the Board per Milk or juice should be provided at pharmacist decreased to $369 per meal times and water offered as a thirst pharmacist. The overall fee remains at quencher throughout the day. A good $450. way of looking at bottle and sip cup use is that if the bottle or sip cup is provided The Board would like to acknowledge for feeding, it should contain milk. If support from Novopharm towards the it’s provided for comfort, it should distribution of this newsletter. contain water. These tips are an important step towards a lifetime of healthy teeth.

LEARNING PORTFOLIO TIPS Here are a few suggestions arising from this year’s professional development logs.  Try the computer-editable forms. They are easy to download from PEIPB/NAPRA web site. You can save them to your computer and update them whenever you complete a learning activity.  Record the program’s accrediting body and accreditation file number. This helps us verify that a program is accredited, thus confirming that you have satisfied the minimum CE requirements.

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