DOCSLIB.ORG

(12) Patent Application Publication (10) Pub. No.: US 2015/0133421 A1 Bernick Et Al

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
(12) Patent Application Publication (10) Pub. No.: US 2015/0133421 A1 Bernick Et Al US 2015O133421A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0133421 A1 Bernick et al. (43) Pub. Date: May 14, 2015 (54) VAGINAL INSERTED ESTRADIOL (60) Provisional application No. 61/894,411, filed on Oct. PHARMACEUTICAL COMPOSITIONS AND 22, 2013, provisional application No. 61/932,140, METHODS filed on Jan. 27, 2014, provisional application No. 61/745,313, filed on Dec. 21, 2012. (71) Applicant: TherapeuticsMD, Inc., Boca Raton, FL (US) Publication Classification (72) Inventors: Brian A. Bernick, Boca Raton, FL (US); (51) Int. Cl. Julia M. Amadio, Boca Raton, FL (US) A613 L/565 (2006.01) A619/00 (2006.01) (21) Appl. No.: 14/521,002 (52) U.S. Cl. CPC ............. A6 IK3I/565 (2013.01); A61 K9/0036 (22) Filed: Oct. 22, 2014 (2013.01) Related U.S. Application Data (57) ABSTRACT (63) Continuation-in-part of application No. PCT/US 13/ 46433, filed on Jun. 18, 2013, Continuation-in-part of According to various embodiments of this disclosure, phar application No. 14/099,562, filed on Dec. 6, 2013, now maceutical compositions comprising Solubilized estradiol are Pat. No. 8,987.237, which is a continuation of appli provided. In various embodiments, such compositions are cation No. 13/684,002, filed on Nov. 21, 2012, now encapsulated in Soft capsules which may be vaginally inserted Pat. No. 8,633,178. for the treatment of vulvovaginal atrophy. Patent Application Publication May 14, 2015 Sheet 1 of 7 US 201S/O133421 A1 100 102 AGENT 104 106 110 112 ASSEMBLE SUPPOSITORY FIG. 1 210 Patent Application Publication May 14, 2015 Sheet 2 of 7 US 201S/O133421 A1 25 f ---O---Treatment-R --Treatment-T 15 1 O 5 100.0 N=36 2 "o. ---O---Treatment-R 3. o-o O--- --Treatment-T 10.0 - N ---. O-.......... S. --O su s CD i > 1.0 s E 3 ?h 0.1 O 5 10 15 20 25 Time (hr) FIG. 4 Patent Application Publication May 14, 2015 Sheet 3 of 7 US 201S/O133421 A1 14. N=36 e 12 -O , o-. p ', - “...... f , r O 10 t 8 ---O---Treatment-R --Treatment-T Time (hr) FIG. 5 100 N=36 10 ---O---Treatment-R -O-Treatment-T Time (hr) FIG. 6 Patent Application Publication May 14, 2015 Sheet 4 of 7 US 2015/O133421 A1 ---O---Treatment-R - Treatment-T ---O---Treatment-R --Treatment-T Time (hr) FIG. 8 Patent Application Publication May 14, 2015 Sheet 5 of 7 US 201S/O133421 A1 ---O--- R. Reference -- T. Test 100.0 5, 100 e s O s ---O---R: Reference e O- O. -O-T. Test O 's t - e ro- ---- - - - - - - - O S3 & 1.0 0.1 O 5 10 15 20 25 Time (hr) FIG 10 Patent Application Publication May 14, 2015 Sheet 6 of 7 US 2015/O133421 A1 ---O- - - R. Reference Time (hr) FIG. 1 ? 10.0 10 ---O--- R. Reference -- T. Test Time (hr) FIG. 12 Patent Application Publication May 14, 2015 Sheet 7 of 7 US 201S/O133421 A1 12 O 10 ? ---O--- R. Reference p , -H T. Test g 8 ; o 9 O. 6- If Y - - - E --- CD W -- d s s O 4 2 O 5 1O 15 20 25 Time (hr) FIG. 13 100 ---O--- R. Reference : 1 O O 5 1O 15 20 25 Time (hr) FIG. 14 US 2015/O 133421 A1 May 14, 2015 VAGINAL INSERTED ESTRADIOL 0005 Estrogen treatment has proven to be very successful PHARMACEUTICAL COMPOSITIONS AND in controlling menopausal symptoms, including vaginal atro METHODS phy (VVA). Several studies have shown that the symptoms connected with vaginal atrophy are often relieved by estrogen CROSS REFERENCE TO RELATED treatment given either systemically or topically. The existing APPLICATIONS treatments have numerous problems, for example compliance issues with patients not completing or continuing treatment 0001. This application claims priority to the following due to the problems associated with the form of treatment. U.S. patent applications: U.S. Provisional Application Ser. 0006. Accordingly, disclosed herein is, among other No. 61/932,140, entitled “VAGINAL INSERTED ESTRA things, a new soft gel vaginal pharmaceutical composition DIOL, PHARMACEUTICAL COMPOSITIONS AND and dosage form containing solubilized estradiol for the treat METHODS, which was filed on Jan. 27, 2014; U.S. Provi ment of VVA. The soft gel vaginal pharmaceutical composi sional Application Ser. No. 61/894,411, entitled “SOLUBLE tion has been designed to mitigate common limitations found ESTRADIOL CAPSULE FOR VAGINAL INSERTION, with other vaginal forms of estradiol. The soft gel vaginal which was filed on Oct. 22, 2013: U.S. Provisional Applica pharmaceutical composition is expected to ease vaginal tion Ser. No. 61/745,313, entitled “SOLUBLE ESTRADIOL administration, provide improved safety of insertion, mini CAPSULE FORVAGINAL INSERTION, which was filed mize vaginal discharge following administration, and provide on Dec. 21, 2012; U.S. Provisional Application Ser. No. a more effective dosage form with improved efficacy, safety 61/889,483, entitled “Natural Combination Hormone and patient compliance. Replacement Pharmaceutical compositions and Therapies.” which was filed on Oct. 10, 2013: U.S. Provisional Applica SUMMARY tion Ser. No. 61/661,302, entitled “ESTRADIOL PHARMA CEUTICAL COMPOSITIONS, which was filed on Jun. 18, 0007 According to various aspects and embodiments of 2012; U.S. Provisional Application Ser. No. 61/662,265, this disclosure, a softgel vaginal pharmaceutical composition entitled “PROGESTERONE PHARMACEUTICAL COM as a potential treatment for post-menopausal women Suffer POSITIONS,” which was filed on Jun. 20, 2012; U.S. patent ing with moderate to severe symptoms of VVA is provided. application Ser. No. 13/684,002, entitled “Natural Combina 0008 Provided herein is a pessary comprising: a) a thera tion Hormone Replacement Pharmaceutical compositions peutically effective amount of estradiol; and b) a solubilizing and Therapies,” which was filed Nov. 21, 2012; U.S. Patent agent comprising a medium chain oil. Application Serial No. PCT/US2013/023309, entitled 0009. In some embodiments, the pessary comprises about “Transdermal Hormone Replacement Therapies, which was 1 ug to about 25ug of estradiol. For example, the pessary can filed Jan. 25, 2013; and U.S. patent application Ser. No. include about 1 Jug to about 10g of estradiol; and about 10 ug 13/843,362, entitled “Transdermal Hormone Replacement to about 25 ug of estradiol. Therapies, which was filed Mar. 15, 2013. All aforemen 0010. In some embodiments, the estradiol is solubilized. tioned applications are hereby incorporated by reference 0011. In some embodiments, the medium chain oil com herein in their entirety. prises at least one C6-C12 fatty acid or a glycol, monoglyc eride, diglyceride, or triglyceride ester thereof. BACKGROUND 0012. In some embodiments, the solubilizing agent com prises at least one ester selected from the group consisting of 0002 This application is directed to pharmaceutical com an ester of caproic fatty acid, an ester of caprylic fatty acid, an positions, methods, and devices related to hormone replace ester of capric fatty acid, and combinations thereof. For ment therapy. example, the Solubilizing agent can include a caprylic/capric 0003 Postmenopausal women frequently suffer from triglyceride. atrophic vaginitis or Vulvar and vaginal atrophy (hereinafter 0013. In some embodiments, the pessary further com “vulvovaginal atrophy” or “VVA) with symptoms including, prises a capsule. For example, the capsule can be a softgelatin for example, vaginal dryness, vaginal odor, vaginal or Vulvar capsule. irritation or itching, dysuria (pain, burning, or stinging when 0014. Also provided herein is a pessary comprising: a) a urinating), dysparuenia (vaginal pain associated with sexual therapeutically effective amount of estradiol; b) a caprylic/ activity), or vaginal bleeding associated with sexual activity. capric triglyceride; c) a non-ionic Surfactant comprising Other symptoms include Soreness; with urinary frequency PEG-6 palmitostearate and ethylene glycol palmitostearate; and urgency; urinary discomfort and incontinence also occur and d) a soft gelatin capsule. ring (“estrogen-deficient urinary State(s)'). One symptom of 0015. In some embodiments, a pessary provided herein vaginal atrophy is an increased vaginal pH, which creates an comprises about 25ug of estradiol, wherein administration of environment more Susceptible to infections. The mucosal the pessary to a patient provides, in a plasma sample from the epithelium of the VVA patients also reported to show signs of patient: 1) a corrected geometric mean peak plasma concen severe atrophy and upon cytological examination accompa tration (C) of estradiol of about 19 pg.hr/ml to about 29 nied by an increased number of the parabasal cells and a pg.hr/ml; and 2) a corrected geometric mean area under the reduced number of superficial cells. curve (AUC) of estradiol of about 75 pg.hr/ml to about 0004 Each of these VVA-related states manifest symp 112 pg.hr/ml. toms associated with decreased estrogenization of the Vul 0016. In some embodiments, a pessary provided herein Vovaginal tissue, and can even occur in women treated with comprises about 25ug of estradiol, wherein administration of oral administration of an estrogen-based pharmaceutical drug the pessary to a patient provides, in a plasma sample from the product. Although VVA is most common with menopausal patient: 1) a corrected geometric mean peak plasma concen women, it can occur at any time in a woman's life cycle. tration (C) of estrone of about 9 pg.hr/ml to about 14 US 2015/O 133421 A1 May 14, 2015 pg.hr/ml; and 2) a corrected geometric mean area under the the pessary to a patient provides, in a plasma sample from the curve (AUC) of estrone of about 43 pg.hr/ml to about 65 patient: 1) a corrected geometric mean peak plasma concen pg.hr/ml. tration (C) of estrone sulfate of about 4 pg.hr/ml to about 0017.
Load more

Recommended publications
  • OVESTIN PESSARY (0.5Mg)
    NEW ZEALAND DATA SHEET 1. OVESTIN PESSARY (0.5mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 0.5 mg Estriol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary 0.5 mg - white, torpedo formed pessary. One pessary (2.5 g weight) contains 0.5 mg oestriol. Length 26.5 mm; largest diameter 14 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Atrophy of the lower urogenital tract related to oestrogen deficiency, notably • for the treatment of vaginal complaints such as dyspareunia, dryness and itching. • for the prevention of recurrent infections of the vagina and lower urinary tract. • in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery. A diagnostic aid in case of a doubtful atrophic cervical smear. 4.2 Dose and method of administration Dosage OVESTIN is an oestrogen-only product that may be given to women with or without a uterus. Atrophy of the lower urogenital tract 1 pessary per day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 pessary twice a week) is reached. Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery 1 pessary per day in the 2 weeks before surgery; 1 pessary twice a week in the 2 weeks after surgery. A diagnostic aid in case of a doubtful atrophic cervical smear 1 pessary on alternate days in the week before taking the next smear. Administration OVESTIN pessaries should be inserted intravaginally before retiring at night.
    [Show full text]
  • UK Clinical Guideline for Best Practice in the Use of Vaginal Pessaries for Pelvic Organ Prolapse
    UK Clinical Guideline for best practice in the use of vaginal pessaries for pelvic organ prolapse March 2021 Developed by members of the UK Clinical Guideline Group for the use of pessaries in vaginal prolapse representing: the United Kingdom Continence Society (UKCS); the Pelvic Obstetric and Gynaecological Physiotherapy (POGP); the British Society of Urogynaecology (BSUG); the Association for Continence Advice (ACA); the Scottish Pelvic Floor Network (SPFN); The Pelvic Floor Society (TPFS); the Royal College of Obstetricians and Gynaecologists (RCOG); the Royal College of Nursing (RCN); and pessary users. Funded by grants awarded by UKCS and the Chartered Society of Physiotherapy (CSP). This guideline was completed in December 2020, and following stakeholder review, has been given official endorsement and approval by: • British Association of Urological Nurses (BAUN) • International Urogynecological Association (IUGA) • Pelvic Obstetric and Gynaecological Physiotherapy (POGP) • Scottish Pelvic Floor Network (SPFN) • The Association of Continence Advice (ACA) • The British Society of Urogynaecology (BSUG) • The Pelvic Floor Society (TPFS) • The Royal College of Nursing (RCN) • The Royal College of Obstetricians and Gynaecologists (RCOG) • The United Kingdom Continence Society (UKCS) Review This guideline will be due for full review in 2024. All comments received on the POGP and UKCS websites or submitted here: [email protected] will be included in the review process. 2 Table of Contents Table of Contents ................................................................................................................................
    [Show full text]
  • Pessary for Management of Pelvic Organ Prolapse
    Pessary for management of Pelvic Organ Prolapse Cathy Davis Clinical Nurse Specialist Department of Urogynaecology King’s College Hospital, London Definition of Prolapse The descent of one or more of the anterior vaginal wall, posterior vaginal wall, uterus (cervix) or vaginal vault (cuff scar after hysterectomy). The presence of any such sign should be correlated with relevant POP symptoms. (Haylen et al 2016) Risk Factors • Increased intra-abdominal pressure • Chronic cough • Chronic constipation • Weight lifting • Presence of abdominal tumours - fibroids & ovarian cysts • High impact exercise • Age/ Menopause • Obesity Risk Factors contd.... • Smoking • Multiparity • Congenital weakness – rare; due to deficiency in collagen metabolism • Injury to pelvic floor muscles • Iatrogenic/ pelvic surgery - hysterectomy Symptoms of POP • May be asymptomatic – a small amount of prolapse can often be normal • Sensation of a lump or bulge " coming down" - most common • Backache • Heaviness • Dragging or discomfort inside the vagina – often worse on standing /sitting for prolonged periods • Seeing a lump or bulge Symptoms of POP contd.... • Bladder / Urinary symptoms -Frequency -Difficulty initiating voids, low-flow, incomplete bladder emptying -Leakage on certain movements or when lifting heavy objects -Recurrent urinary tract infections • Bowel symptoms -Constipation - Incomplete bowel emptying - May have to digitate to defecate/use aides • Symptoms related to Sex – uncomfortable, lack of sensation Diagnosis of Prolapse • Vaginal examination •
    [Show full text]
  • Combi Soft Gel Pessary & External Cream
    Combi Soft Gel Pessary Canesten & External Cream 500mg vaginal capsule & 2% w/w cream Clotrimazole Read all of this leaflet carefully because it contains important To treat internal thrush, your doctor may recommend that you use the information for you. pessary without the help of an applicator. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. HOW TO USE CANESTEN® COMBI • This medicine has been prescribed for you. Do not give it to anyone else 3. under any circumstances. The Soft Gel Pessary: • If you have any unusual effects after using this product, tell your doctor. Unless directed otherwise by your doctor, the Soft Gel Pessary should be inserted as high as possible into the vagina, preferably before going to sleep IN THIS LEAFLET at night for convenient and comfortable treatment. Wash your hands before removing the foil from the blister pack and again 1. What is Canesten Combi and what is it used for? afterwards when you have used the applicator. 2. Before you use Canesten Combi 3. How to use Canesten Combi 1. Remove the applicator from the packaging. Pull out the plunger A until it 4. Possible side effects stops. Remove the pessary from the foil blister pack and place firmly into the 5. How to store Canesten Combi applicator B. 6. Further information 1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR? Canesten Combi Soft Gel Pessary & External Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms.
    [Show full text]
  • U.S. Medical Eligibility Criteria for Contraceptive Use, 2010
    Morbidity and Mortality Weekly Report www.cdc.gov/mmwr Early Release May 28, 2010 / Vol. 59 U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition department of health and human services Centers for Disease Control and Prevention Early Release CONTENTS The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Introduction .............................................................................. 1 Disease Control and Prevention (CDC), U.S. Department of Health Methods ................................................................................... 2 and Human Services, Atlanta, GA 30333. How to Use This Document ......................................................... 3 Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR Early Release 2010;59[Date]:[inclusive page numbers]. Using the Categories in Practice ............................................... 3 Recommendations for Use of Contraceptive Methods ................. 4 Centers for Disease Control and Prevention Contraceptive Method Choice .................................................. 4 Thomas R. Frieden, MD, MPH Director Contraceptive Method Effectiveness .......................................... 4 Peter A. Briss, MD, MPH Unintended Pregnancy and Increased Health Risk ..................... 4 Acting Associate Director for Science Keeping Guidance Up to Date ...................................................
    [Show full text]
  • Regulations Governing the Classification of Medical Devices (Draft)
    Regulations Governing the Classification of Medical Devices (Draft) Article 1 These Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter “this Act”). Article 2 Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty: 1. Clinical chemistry and clinical toxicology devices 2. Hematology and pathology devices 3. Immunology and microbiology devices 4. Anesthesiology devices 5. Cardiovascular devices 6. Dental devices 7. Ear, nose, and throat devices 8. Gastroenterology and urology devices 9. General and plastic surgery devices 10. General hospital and personal use devices 11. Neurological devices 12. Obstetrical and gynecological devices 13. Ophthalmic devices 14. Orthopedic devices 15. Physical medicine devices 16. Radiology devices Article 3 Medical devices are classified into the following classes according to their risk level: 1. Class I: Low risk 2. Class II: Medium risk 3. Class III: High risk 1 Article 4 Product items of the medical device classification are specified in the Annex. In addition to rules stated in the Annex, medical devices whose function, intended use, or working principle are special may have their classification determined according to the following rules: 1. If two or more categories, classes, or product items are applicable to the same medical device, the highest class of risk level is assigned. 2. The accessory to a medical device, intended specifically by the manufacturer for use with a particular medical device, is classified the same as the particular medical device, unless otherwise specified in the Annex. 3.
    [Show full text]
  • Vaginal Support Pessaries: Indications for Use and Fitting Strategies
    SERIES Vaginal Support Pessaries: Indications for Use and Fitting Strategies Shanna Atnip and Katharine O’Dell ESSARIES P elvic floor disorders are © 2012 Society of Urologic Nurses and Associates common in women, and as the population ages, Atnip, S., & O’Dell, K. (2012). Vaginal support pessaries: Indications for use and these disorders may be fitting strategies. Urologic Nursing, 32(3), 114-125. Pseen more frequently by health ERIES ON care providers (Nygaard et al., Flexible silicone vaginal support pessaries offer a low-risk, effective option for S 2008). When pelvic symptoms treatment of symptoms of pelvic organ prolapse. This first article in a three-part series summarizes clinical recommendations and current evidence related to are associated with loss of struc- pessary indications, choice, and fitting. tural support of the pelvic organs and vagina, vaginal support pes- PECIAL Key Words: Pelvic organ prolapse, pessary, indications, fitting. saries offer an important option S for relief (American College of Objectives: Obstetricians & Gynecologists 1. List the symptoms of pelvic organ prolapse that may be successfully treated [ACOG], 2007). with a vaginal support pessary. Historically, vaginal pessaries have been used to manage pelvic 2. Discuss the various types of pessaries and their uses to treat pelvic organ floor relaxation and were made prolapse. from a variety of materials, 3. Outline the pessary selection process and steps to pessary fitting. including fruit, metal, porcelain, rubber, and acrylic (Shah, Sultan, genic, and washable, and can gen- & Thakar, 2006). Modern pessaries erally be sterilized using an auto- are made from silicone, acrylic, clave, boiling water, or a cold ster- Shanna Atnip, MSN, WHNP-BC, is a Nurse latex, or rubber.
    [Show full text]
  • Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices
    September 12, 2006 NOTICE Our file number: 06-120629-368 Re: Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices Health Canada is pleased to announce the release of the revised Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices. This guidance document supersedes the January 14, 2000 version of the same document. The Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is intended to assist manufacturers in confirming the classification of medical device products after application of the Classification Rules for Medical Devices set out in Schedule 1 of the Medical Devices Regulations. This guidance document has been revised to reflect changes to the risk- based classification of particular medical device groups. Specifically, the following major changes have been made to the document: • the reclassification of specific medical device groups; • the removal of redundant information; • the addition of medical device groups; and • the omission of product groups that do not fit the meaning of a medical device as defined in the Food and Drugs Act. To search for a medical device group within the Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices PDF file, go to Edit/Find and enter a keyword, preferred name code or description in the “Find” field. For instance, to verify the risk-based classification of dental burs, enter “bur” or “drill” in the “Find” field. Please note that this guidance document is provided only as a guide and that in the event of any discrepancy between this document and the Classification Rules for Medical Devices described in the Medical Devices Regulations, the latter shall prevail.
    [Show full text]
  • Treatment of Recurrent Vulvo-Vaginal Candidiasis with Sustained-Release Butoconazole Pessary
    C ase R eport Singapore Med J 2012; 53(12) : e269 Treatment of recurrent vulvo-vaginal candidiasis with sustained-release butoconazole pessary Ling Zhi Heng1, MBBS, Yujia Chen1, MBBS, Thiam Chye Tan1,2, MBBS, MMed ABSTRACT Vulvo-vaginal candidiasis (VVC) is a common infection among women. 5% of women with acute infection experience recurrent vulvo-vaginal candidiasis (RVVC). There is currently no optimal or recommended regime for RVVC. Although antifungal agents, such as imidazoles, have been successfully used as a first-line treatment for acute VVC, its effectiveness is limited in RVVC. This could be due to patient factors, drug application (such as leakage) or dosing factors. A sustained-release (SR) bioadhesive vaginal cream (2% butoconazole nitrate) has incorporated VagiSite technology, a topical drug delivery system that allows SR of the drug. We describe its efficacy and the successful use of a butoconazole-SR formulation in the treatment of two cases of RVVC. Keywords: butoconazole, candidiasis, recurrent vulvo-vaginal Singapore Med J 2012; 53(12): e269–e271 INTRODUCTION Table I. Risk factors for recurrent vulvo-vaginal candidiasis. Candidiasis is a common cause of infective vaginal discharge Risk factors Examples experienced by women. 75% of women experience at least Microbial • Candida albicans species one episode of vaginitis during their lifetime. Recurrent vulvo- • Non-albicans Candida species vaginal candidiasis (RVVC) is defined as four or more episodes Host • Uncontrolled diabetes mellitus • Oestrogen excess – oral contraceptive pills, hormone of symptomatic vulvo-vaginal cadidiasis (VVC) in one year. Up replacement therapy, local oestrogen administration, to 5% of women of childbearing age have experienced RVVC.(1) pregnancy Common symptoms include vaginal discharge, vulvar pruritus, • Antibiotic-induced dyspareunia and dysuria.
    [Show full text]
  • Drug-N-Therapeutics-Committee.Pdf
    Irrational use of medicines is a widespread problem at all levels of health care, but especially GUIDE DRUG AND THERAPEUTICS COMMITTEES: A PRATICAL in hospitals. This is particularly worrying as resources are generally scarce and prescribers in communities often copy hospital prescribing practices. Use of medicines can be greatly improved and wastage reduced if some simple principles of drug management are followed. But it is difficult to implement these principles because staff from many different disciplines are involved, often with no forum for bringing them together to develop and implement appropriate medicines policies. A drug and therapeutics committee (DTC) provides such a forum, allowing all the relevant people to work together to improve health care delivery, whether in hospitals or other health facilities. In many developed countries a well functioning DTC has been shown to be very effective in addressing drug use problems. However, in many developing countries DTCs do not exist and in others they do not function optimally, often due to lack of local expertise or a lack of incentives. Drug and Therapeutics Committees: A Practical Guide provides guidance to doctors, pharmacists, hospital managers and other professionals who may be serving on DTCs and/or who are concerned with how to improve the quality and cost efficiency of therapeutic care. It is relevant for all kinds of DTCs - whether in public or private hospitals and whether at district or tertiary referral level. This comprehensive manual covers a committee’s functions and structure, the medicines formulary process, and how to assess new medicines. The chapters on tools to investigate drug use and strategies to promote rational use are followed by a discussion of antimicrobial resistance and infection control.
    [Show full text]
  • Standard Terms: Introduction and Guidance for Use – V.2.1.3 – 16 November 2018 Contents
    Standard Terms Introduction and Guidance for Use Version 2.1.3 – 16 November 2018 GENERAL PRINCIPLES AND INSTRUCTIONS FOR USE OF THE LISTS OF STANDARD TERMS The lists of Standard Terms were initially drawn up by the European Pharmacopoeia (Ph. Eur.) Commission further to a request of the EU Commission, for use in marketing authorisation applications (MAAs), labelling (including the summary of product characteristics (SmPC)), and electronic communications. The first list was published as a special edition of Pharmeuropa in October 1996. The European Directorate for the Quality of Medicines & HealthCare (EDQM), a Directorate of the Council of Europe based in Strasbourg, France, is responsible for continuing this work. Standard Terms have the double purpose of bringing information to the patient/user/prescriber and distinguishing medicinal products having the same trade-name. Because of the labelling purposes it is imperative that any Standard Term is constructed with a view to the patient and the prescriber. It conveys essential information on the properties and uses of the particular medicinal products. To avoid a proliferation of over-complicated terms, complete information cannot always be included in a Standard Term, and should instead appear elsewhere in the labelling, in particular the package leaflet and SmPC. Since 2017 the scope of the Standard Terms database has also widened to allow the inclusion of certain additional terms that are not intended for use in MAAs, but are used for related purposes such as adverse event reporting (pharmacovigilance) and clinical trials. At the same time, in an effort to encourage greater global harmonisation of electronic communications, applications for terms to describe concepts that are not used in European Pharmacopoeia Commission member states but are used in other regions are also now accepted for consideration.
    [Show full text]
  • Induction of Labour This Is an Update of NICE Inherited Clinical Guideline D
    Issue date: July 2008 Induction of labour This is an update of NICE inherited clinical guideline D NICE clinical guideline 70 Developed by the National Collaborating Centre for Women’s and Children’s Health NICE clinical guideline 70 Induction of labour Ordering information You can download the following documents from www.nice.org.uk/CG070 • The NICE guideline (this document) – all the recommendations. • A quick reference guide – a summary of the recommendations for healthcare professionals. • ‘Understanding NICE guidance’ – information for patients and carers. • The full guideline – all the recommendations, details of how they were developed, and reviews of the evidence they were based on. For printed copies of the quick reference guide or ‘Understanding NICE guidance’, phone NICE publications on 0845 003 7783 or email [email protected] and quote: • N1625 (quick reference guide) • N1626 (‘Understanding NICE guidance’). NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales. This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer and informed by the summary of product characteristics of any drugs they are considering. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity.
    [Show full text]