1. Selection of essential medicines Suzanne Hill September 2006 Department of Medicines Policy and Standards TBS 2006

2. Department of Medicines Policy and Standards TBS 2006 (2) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

3. Department of Medicines Policy and Standards TBS 2006 (3) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

4. Department of Medicines Policy and Standards TBS 2006 (4) The essential drugs concept is nearly universal 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.

5. Department of Medicines Policy and Standards TBS 2006 (5) Essential medicines n The concept of essential medicines A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs n Definition of essential medicines Essential medicines are those that satisfy the priority health care needs of the population (Report to WHO Executive Board, January 2002)

6. Department of Medicines Policy and Standards TBS 2006 (6) Full description of essential drugs (Expert Committee Report, April 2002) Definition: Essential medicines are those that satisfy the priority health care needs of the population Selection criteria: Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost- effectiveness Purpose: Essential medicines are intended to be available within the context of functioning health systems at all times, in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. Implementation: The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.

7. Department of Medicines Policy and Standards TBS 2006 (7) 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 March 2005 list contains 306 active substances n Next revision 2007 The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000

8. Department of Medicines Policy and Standards TBS 2006 (8) 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

9. Department of Medicines Policy and Standards TBS 2006 (9) So what? n Evidence of impact – health outcomes ä Delhi state improved availability of supply ä studies of lack of essential medicines n Evidence of impact – policy, advocacy ä Indirect evidence through impact of listing ARVs ä Linkage with pricing policies ä Linkage with import policies

10. Department of Medicines Policy and Standards TBS 2006 (10) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

11. Department of Medicines Policy and Standards TBS 2006 (11) Process Application lodged Reviewed internally, published on web External expert review and comment Public comment WHO department comment Expert Committee review and recommendation

13. Department of Medicines Policy and Standards TBS 2006 (13) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

14. Department of Medicines Policy and Standards TBS 2006 (14) The ideal n WHO treatment guideline developed n Treatment recommendation made n Proposal to update list to reflect new guideline n Potential to influence practice

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18. Department of Medicines Policy and Standards TBS 2006 (18) The challenges….

19. Department of Medicines Policy and Standards TBS 2006 (19)

20. Department of Medicines Policy and Standards TBS 2006 (20) Costa et al, BMJ 2006;332;1115-1124.

21. Department of Medicines Policy and Standards TBS 2006 (21) n No application n No money n …no volunteer

22. Department of Medicines Policy and Standards TBS 2006 (22) Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

23. Department of Medicines Policy and Standards TBS 2006 (23) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

24. Department of Medicines Policy and Standards TBS 2006 (24) Cochrane reviews n Over 50% of medicines on the 14 th list have a relevant Cochrane review n Useful source of information n Some reviews raise questions over inclusion on the list e.g. antacids, allopurinol

26. Department of Medicines Policy and Standards TBS 2006 (26) The WHO Essential Medicines Library: WHO Model List WHO Model Formulary (search)

27. Department of Medicines Policy and Standards TBS 2006 (27) 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, Guideline Clearing House Statistics: - ATC - DDD WCCs Oslo/Uppsala Selection

28. Department of Medicines Policy and Standards TBS 2006 (28) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

29. Department of Medicines Policy and Standards TBS 2006 (29)

30. Department of Medicines Policy and Standards TBS 2006 (30) The New Emergency Health Kit 1984, 1990, 1998, 2006 Essential medicines and supplies for 10,000 people for three months Consensus between WHO, UNICEF, UNHCR, UNFPA, Red Cross, MSF, OXFAM, missions, IDA

31. Department of Medicines Policy and Standards TBS 2006 (31) 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

32. Department of Medicines Policy and Standards TBS 2006 (32) 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

33. Department of Medicines Policy and Standards TBS 2006 (33) 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)

34. Department of Medicines Policy and Standards TBS 2006 (34) Essential medicines for reproductive health: n Annotated list all WHO resource materials and standard treatment guidelines for RH medicines; link with essential medicines list(s); discrepancies identified n Summary of available Cochrane reviews and other evidence for all RH medicines n List of medicines for which additional evidence is needed; reviews performed and discussed at 14 th Expert Committee n Publication of interagency List of Essential Medicines for Reproductive Health and policy briefs

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37. Department of Medicines Policy and Standards TBS 2006 (37) Outline n What are essential medicines and why have them? n How are they selected? n Linking with treatment guidelines – challenges n Linking with evidence n Onions and other vegetables n New developments

38. Department of Medicines Policy and Standards TBS 2006 (38) Essential medicines for children

39. Department of Medicines Policy and Standards TBS 2006 (39) EML 2005 CoreComplementaryTotal Total No of medication listings 28484368 Listings not assessed 12945174 Listings assessed 15539194 PF indicated 11928148 PF not indicated 361146 PF indicated and on the list 52355 PF indicated and not on the list 672593 PF indicated, not on the list, duplicate listings removed 592383 PF indicated, not on list and available* 29230 PF indicated, not on list and not available* 302153

40. Department of Medicines Policy and Standards TBS 2006 (40) Paediatric formulation issues n Technical difficulties of manufacturing n Storage and preparation n Impact of various climates n Taste of the medication n Local factors and practice

41. Department of Medicines Policy and Standards TBS 2006 (41) Liquids n Short shelf lives n Often require refrigeration n Bulky and heavy (issue for storage and transport)

42. Department of Medicines Policy and Standards TBS 2006 (42) Solid formulations Powders for suspension n Mixed correctly with sterile fluids n Affected by humidity Chewable tablet n Tolerated by children two years and older n Limited dose variation

44. Department of Medicines Policy and Standards TBS 2006 (44) EML for children recommendations n Inclusion of the paediatric formulations on the list that are already commercially available and approved for use in children. n Development of guideline to prioritise the medications where a paediatric formulation needs to be developed. n Comprehensive review of WHO clinical practice guidelines that apply to children to identify if medications needed in the treatment of children are missing form the EML.

45. Department of Medicines Policy and Standards TBS 2006 (45) 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

46. Department of Medicines Policy and Standards TBS 2006 (46) 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 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)

47. Department of Medicines Policy and Standards TBS 2006 (47) www.who.int/medicines Thank you