Selection of essential medicines

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

2. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

3. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

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. Essential medicines • The concept of essential medicines A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs • 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. 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. 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 • March 2005 list contains 306 active substances • Next revision 2007 The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000

8. 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

9. So what? • Evidence of impact – health outcomes • Delhi state improved availability of supply • studies of lack of essential medicines • Evidence of impact – policy, advocacy • Indirect evidence through impact of listing ARVs • Linkage with pricing policies • Linkage with import policies

10. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

11. Process Application lodged Reviewed internally, published on web External expert review and comment WHO department comment Public comment Expert Committee review and recommendation

13. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

14. The ideal • WHO treatment guideline developed • Treatment recommendation made • Proposal to update list to reflect new guideline • Potential to influence practice

18. The challenges….

20. Costa et al, BMJ 2006;332;1115-1124.

21. No application • No money • …no volunteer

22. Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

23. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

24. Cochrane reviews • Over 50% of medicines on the 14th list have a relevant Cochrane review • Useful source of information • Some reviews raise questions over inclusion on the list e.g. antacids, allopurinol

26. The WHO Essential Medicines Library: WHO Model Formulary (search) WHO Model List

27. Selection The WHO Essential Medicines Library, status 2005 WHO clusters WHO/EDM Clinical guideline Summary of clinical guideline RPS WHO/EC, Cochrane, Guideline Clearing House WHO Model Formulary 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

28. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

30. The New Emergency Health Kit1984, 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. 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

32. 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

33. 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)

34. Essential medicines for reproductive health: • 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 • Publication of interagency List of Essential Medicines for Reproductive Health and policy briefs

37. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines – challenges • Linking with evidence • Onions and other vegetables • New developments

38. Essential medicines for children

40. Paediatric formulation issues • Technical difficulties of manufacturing • Storage and preparation • Impact of various climates • Taste of the medication • Local factors and practice

41. Liquids • Short shelf lives • Often require refrigeration • Bulky and heavy (issue for storage and transport)

42. Solid formulations Powders for suspension • Mixed correctly with sterile fluids • Affected by humidity Chewable tablet • Tolerated by children two years and older • Limited dose variation

44. EML for children recommendations • Inclusion of the paediatric formulations on the list that are already commercially available and approved for use in children. • Development of guideline to prioritise the medications where a paediatric formulation needs to be developed. • 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. The WHO Model List of Essential Medicines is a model 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

46. 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 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)

47. Thank you www.who.int/medicines