Selection of essential medicines

1. Selection of essential medicines Richard Laing and Deidre Dimancesco TBS 2011 Department of Essential Medicines & Pharmaceutical Policies TBS 2008

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

3. 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)

4. 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.

5. 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 2011 list contains 358 active substancesSee Comparative analysis • Next revision 20013

6. 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

7. 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.

8. 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

9. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines • Linking with evidence • New developments

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

12. Recommendation based on… • Public health need • Evidence of comparative effectiveness and safety • Global experience of use / suitability • Cost (indicative prices only) • NOT patent • No formal cost-effectiveness assessment

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

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

16. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines • Linking with evidence • New developments

17. 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

18. http://apps.who.int/emlib/MedicineDisplay.aspx?Language=EN&MedIDName=3%40acetylsalicylic acid

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

20. Selection The WHO Essential Medicines Library, WHO clusters WHO/EMP Clinical guideline Summary of clinical guideline 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

21. 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

22. Outline • What are essential medicines and why have them? • How are they selected? • Linking with treatment guidelines • Linking with evidence • New developments

23. The need for essential medicines for children • When appropriate medicines for children are not available fractions of adult doses are often used • Can be hard for the child to take • Can result in under dosing or over dosing • Syrups which are easier to take are more costly and have more difficult storage/shelf life • Some conditions require children to take several medicines daily

24. Ideal medicines for children • Flexible oral solid dosage forms where possible • Pleasant taste • Stable, long shelf life, not liquid • Simple dosing schedules, weight based • Packaging and labelling to enhance adherence

25. Are essential medicines for children available?

26. Essential medicines for children • A temporary subcommittee was established by the Executive Board in 2007 • To prepare a Model List of Essential Medicines for Children • To determine suitability criteria for dosage forms of medicines for children • To review feasibility of manufacturing appropriate formulations for those priority medicines for which no dosage form for children exists • To identify clinical research gaps regarding safety and efficacy of medicines for children • Since then a separate EML has been maintained

27. 3rd WHO Essential List of Medicines for Children • Expert Committee meeting March 2011 • Total of 269 medicines on the list • Core list: 199 meds • Complementary list: 59 meds • Next meeting 2013

28. Priority essential medicines for children • Use of the WHO EML for children to select • Those medicines that: • Address the main burden of disease in children • Have evidence of benefit • Are included in current treatment guidelines • Are commercially available • Priority list launch in March 2011

29. Causes of death in under 5s 8.1 million deaths per year Black et al. Lancet, 2010 WHO. The World Health Statistics 2010

31. Priority medicines for children • National essential medicine list as a starting point • Priority medicines in national treatment guidelines • Verify the supplier of a quality product • Ensure that the priority medicines are licensed • Make sure that the priority medicines are in the supply chain • Check that health professionals know how to use the priority medicines • Check that there is consumer demand