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Selection of essential medicines

Selection of essential medicines. Hans V. Hogerzeil, MD, PhD, FRCP Edin Director Medicines Policy and Standards September 2005. Department of Medicines Policy and Standards TBS 2005. National Essential Drugs List. < 5 years. (127). > 5 years. (29). No NEDL. (19). Unknown.

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Selection of essential medicines

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  1. Selection of essential medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin Director Medicines Policy and Standards September 2005 Department of Medicines Policy and StandardsTBS 2005

  2. National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) Achievements The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings By Dec.1999: 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.

  3. Achievements Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice 135 countries have treatment guidelines, formularies

  4. Problem-based pharmacotherapy In 18 languages For medical students, clinical officers Measurable improvement in prescribing Now also: Teacher’s Guide to Good Prescribing Achievements Training in rational prescribing has expanded in universities throughout the world

  5. Unfinished agenda Irrational use of drugs is a widespread hazard to health • Half of 102 countries surveyed regulate drug promotion • By age 2 children in some areas have had > 20 injections • 15 billion injections per year - half of them unsterile • 25-75% of antibiotic prescriptions are inappropriate

  6. Selection Example of challenge:New essential drugs are expensive Antibiotics for gonorrhoea: 50-90x price of penicillins Antimalarial drugs: chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x) atovaquone-proguanil $40/pp (400x) Antituberculosis: $15 for DOTS vs $300 for MDR (20x) Antiretrovirals: $300-600/year; but 38 countries with a drug budget <$2 pp/year

  7. Selection The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use CHW S S dispensary Health center Supplementary specialist medicines Hospital Referral hospital Private sector

  8. Selection Clinical guidelines and a list of essential medicines lead to better prevention and care List of common diseases and complaints Treatment choice Treatment guidelines Essential medicines list/ National formulary Training and Supervision Financing and Supply of drugs Prevention and care

  9. Selection History of the WHO Model List of Essential Drugs • 1977 First Model list published, ± 200 active substances • List is revised every two years by WHO Expert Committee • 2002 Revised procedures approved by WHO • April 2003 list contains 315 active substances The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000

  10. Selection Use of the WHO Model List of Essential Drugs • 156 countries have a national list of essential drugs • Major agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List • Sub-sets of the Model List: • UN list of essential drugs for emergencies: 85 drugs • New Emergency Health Kit: 55 drugs for 10,000 people/3m • Normative tools follow the Model List: • WHO Model Formulary • International Pharmacopoea • Basic Quality Tests and reference standards

  11. Selection The WHO Model List of Essential Medicines is amodel product, model process and public health tool • Independent Membership of the Committee, careful consideration of conflict of interest • Transparent process, standard application, web review • Link to evidence-based clinical guidelines • Systematic review of comparative efficacy, safety, cost-effectiveness and public health relevance • Rapid dissemination, electronic access • Regular review

  12. Selection Dissemination of 13th Model List March 2003 13th Expert Committee April 2003 List of recommendations, introduction and 13th Model List in English on WHO web site; announcement on electronic networks May 2003 Model List in Arabic, Chinese, French, Russian and Spanish in hard copy and on WHO web site Jan 2004 Model Formulary updated, printed, on web site May 2004 Summary of report and its public health impact submitted to WHO Executive Board July 2004 Technical Report Series 920 printed, on web site

  13. WHO Model Formulary First edition, December 2002 • WHO priced publication (SFr 40, SFr 20) • Two prints: 7,000 and 10,000 copies • Web version as PDF file and searchable database • CD-ROM (searchable and downloadable) • Translated into Arabic, Russian, Spanish – but not printed

  14. WHO Model Formulary 2004 Second edition, January 2004 • Updated to follow 13th Model List • Web version as PDF file and searchable database • CD-ROM with data base and Word-document • Document "How to develop a national formulary using the WHO Model Formulary" developed and added to CD-ROM • Arabic, Russian and Spanish 2002 translations updated to reflect changes (using special software to track changes) • Spanish version issued in hard copy, on web • Arabic and Russian on CD-ROM and on web

  15. Selection The WHO Essential Medicines Library: Available for public access by March 2003 WHO Model Formulary (search) WHO Model List

  16. Selection The WHO Essential Medicines Library, status 2005 WHO clusters WHO/EDM Clinical guideline Summary of clinical guideline RPS WHO Model Formulary WHO/EC, Cochrane, BMJ-CE Reasons for inclusion Systematic reviews Key references WHO Model List WHO/QSM MSH UNICEF MSF Statistics: - ATC - DDD Quality information: - Basic quality tests - Intern. Pharmacopoea - Reference standards Link to price information WCCs Oslo/Uppsala

  17. Selection Future plans for biennial revisions of Model List and Model Formulary '03 '04 '05 '06 '07 13th Model List (2003) xxxxxxxxx Model Formulary 2004 …...xxxxxxxxx 14th Model List (2005) xxxxxxxxx Model Formulary 2006 ……xxxxxxxx

  18. Emergency Health Kit The New Emergency Health Kit1984, 1990, 1998 Essential medicines and supplies for 10,000 people for three months Consensus between WHO, UNICEF, UNHCR, UNFPA, Red Cross, MSF, OXFAM, missions, IDA

  19. Emergency Health Kit Selection of emergency relief items 316 WHO Model List 2004 UN List of Emergency Relief Items 88 UNDP WHO ICRC FRC MSF UNICEF UNHCR UNFPA IDA EPN OXFAM New Emergency Health Kit 1998 55 Adaptations made: ORS, antimalarials, syringes, emergency contraception

  20. EMs for RH Essential medicines for Reproductive Health:Discrepancies in international RH lists 75 on UNFPA List 6 316 on WHO Model List 6 194 63 150 on Interagency RH medical commodities 65 22

  21. EMs for RH Examples of discrepancies:Alternative medicine preferred on WHO EML, or medicines recently deleted from Model List U R Model List clotrimazole x x miconazole zalcitabine, delavirdine, amprenavir x see ARV guide dephenylhydramine x promethazine itraconazole, ketoconazole x fluconazole labetalol x atenolol tinidazole x metronidazole ritodrine, terbutaline x salbutamol methylergometrine x ergometrine Recently deleted from Model List: spermicides, contraceptive foams/gels, pethidine, iron dextran, (misoprostol)

  22. EMs for RH Essential Medicines for Reproductive Health:Current status of joint review project • Annotated list all WHO resource materials and standard treatment guidelines for RH medicines; link with essential medicines list(s); discrepancies identified • Summary of available Cochrane reviews and other evidence for all RH medicines • List of medicines for which additional evidence is needed; reviews performed and discussed at 14th Expert Committee Next steps: International consensus on essential RH medicines; standardization of essential non-drug RH items; guideline for inclusion of RH items in national lists of essential medicines

  23. Conclusions • Model List is a valuable public health tool (model product, model process); now fully evidence-based • Essential Medicines Library is the only public web site with access to all WHO clinical guidelines and medicine-related information • WHO Model Formulary text available in English, Spanish, Russian and Arabic, as basis for national formularies • Important role for WHO to promote international consensus in medicine selection (emergency medicine, reproductive health)

  24. Saving lives with the right (to) medicines www.who.int/medicines

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