1. 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

2. Department of Medicines Policy and Standards TBS 2005 (2) National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) By Dec.1999: 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings 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. Achievements

3. Department of Medicines Policy and Standards TBS 2005 (3)  135 countries have treatment guidelines, formularies Achievements Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

4. Department of Medicines Policy and Standards TBS 2005 (4) Training in rational prescribing has expanded in universities throughout the world n Problem-based pharmacotherapy n In 18 languages n For medical students, clinical officers n Measurable improvement in prescribing n Now also: Teacher’s Guide to Good Prescribing Achievements

5. Department of Medicines Policy and Standards TBS 2005 (5) Unfinished agenda Irrational use of drugs is a widespread hazard to health n Half of 102 countries surveyed regulate drug promotion n By age 2 children in some areas have had > 20 injections n 15 billion injections per year - half of them unsterile n 25-75% of antibiotic prescriptions are inappropriate

6. Department of Medicines Policy and Standards TBS 2005 (6) 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 Selection

7. Department of Medicines Policy and Standards TBS 2005 (7) The Essential Medicines Target SS All the drugs in the world Registered medicines National list of essential medicines Levels of use Supplementary specialist medicines CHW dispensary Health center Hospital Referral hospital Private sector Selection

8. Department of Medicines Policy and Standards TBS 2005 (8) Clinical guidelines and a list of essential medicines lead to better prevention and care List of common diseases and complaints Training and Supervision Financing and Supply of drugs Treatment guidelines Treatment choice Prevention and care Selection Essential medicines list/ National formulary

9. Department of Medicines Policy and Standards TBS 2005 (9) History of the WHO Model List of Essential Drugs n 1977 First Model list published, ± 200 active substances n List is revised every two years by WHO Expert Committee n 2002 Revised procedures approved by WHO n 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 Selection

10. Department of Medicines Policy and Standards TBS 2005 (10) Use of the WHO Model List of Essential Drugs n 156 countries have a national list of essential drugs n Major agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List n Sub-sets of the Model List: ä UN list of essential drugs for emergencies: 85 drugs ä New Emergency Health Kit: 55 drugs for 10,000 people/3m n Normative tools follow the Model List: ä WHO Model Formulary ä International Pharmacopoea ä Basic Quality Tests and reference standards Selection

11. Department of Medicines Policy and Standards TBS 2005 (11) The WHO Model List of Essential Medicines is a model product, model process and public health tool n Independent Membership of the Committee, careful consideration of conflict of interest n Transparent process, standard application, web review n Link to evidence-based clinical guidelines n Systematic review of comparative efficacy, safety, cost- effectiveness and public health relevance n Rapid dissemination, electronic access n Regular review Selection

12. Department of Medicines Policy and Standards TBS 2005 (12) Dissemination of 13th Model List March 200313th Expert Committee April 2003List of recommendations, introduction and 13th Model List in English on WHO web site; announcement on electronic networks May 2003Model List in Arabic, Chinese, French, Russian and Spanish in hard copy and on WHO web site Jan 2004Model Formulary updated, printed, on web site May 2004Summary of report and its public health impact submitted to WHO Executive Board July 2004Technical Report Series 920 printed, on web site Selection

13. Department of Medicines Policy and Standards TBS 2005 (13) WHO Model Formulary First edition, December 2002 n WHO priced publication (SFr 40, SFr 20) n Two prints: 7,000 and 10,000 copies n Web version as PDF file and searchable database n CD-ROM (searchable and downloadable) n Translated into Arabic, Russian, Spanish – but not printed

14. Department of Medicines Policy and Standards TBS 2005 (14) WHO Model Formulary 2004 Second edition, January 2004 n Updated to follow 13 th Model List n Web version as PDF file and searchable database n CD-ROM with data base and Word-document n Document "How to develop a national formulary using the WHO Model Formulary" developed and added to CD-ROM n Arabic, Russian and Spanish 2002 translations updated to reflect changes (using special software to track changes) n Spanish version issued in hard copy, on web n Arabic and Russian on CD-ROM and on web

15. Department of Medicines Policy and Standards TBS 2005 (15) The WHO Essential Medicines Library: Available for public access by March 2003 WHO Model List WHO Model Formulary (search) Selection

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

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

18. Department of Medicines Policy and Standards TBS 2005 (18) The New Emergency Health Kit 1984, 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 Emergency Health Kit

19. Department of Medicines Policy and Standards TBS 2005 (19) WHO Model List 2004 UN List of Emergency Relief Items New Emergency Health Kit 1998 316 88 55 Selection of emergency relief items Adaptations made: ORS, antimalarials, syringes, emergency contraception WHO ICRC FRC MSF UNICEF UNHCR UNFPA IDA EPN OXFAM UNDP Emergency Health Kit

20. Department of Medicines Policy and Standards TBS 2005 (20) Essential medicines for Reproductive Health: Discrepancies in international RH lists 75 on UNFPA List 316 on WHO Model List 150 on Interagency RH medical commodities 194 65 63 6 6 22 EMs for RH

21. Department of Medicines Policy and Standards TBS 2005 (21) Examples of discrepancies: Alternative medicine preferred on WHO EML, or medicines recently deleted from Model List URModel List clotrimazolexxmiconazole zalcitabine, delavirdine, amprenavirxsee ARV guide dephenylhydraminexpromethazine itraconazole, ketoconazolexfluconazole labetalolxatenolol tinidazolexmetronidazole ritodrine, terbutalinexsalbutamol methylergometrinexergometrine Recently deleted from Model List: spermicides, contraceptive foams/gels, pethidine, iron dextran, (misoprostol) EMs for RH

22. Department of Medicines Policy and Standards TBS 2005 (22) Essential Medicines for Reproductive Health: Current status of joint review project 1. Annotated list all WHO resource materials and standard treatment guidelines for RH medicines; link with essential medicines list(s); discrepancies identified 2. Summary of available Cochrane reviews and other evidence for all RH medicines 3. List of medicines for which additional evidence is needed; reviews performed and discussed at 14 th 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 EMs for RH

23. Department of Medicines Policy and Standards TBS 2005 (23) Conclusions n Model List is a valuable public health tool (model product, model process); now fully evidence-based n Essential Medicines Library is the only public web site with access to all WHO clinical guidelines and medicine-related information n WHO Model Formulary text available in English, Spanish, Russian and Arabic, as basis for national formularies n Important role for WHO to promote international consensus in medicine selection (emergency medicine, reproductive health)

24. Department of Medicines Policy and Standards TBS 2005 (24) www.who.int/medicines Saving lives with the right (to) medicines