1. Selection of essential medicines
Suzanne Hill
November 2008
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 2007 list contains 340 active substances
Next revision 2009

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 Expert Committee review and recommendation 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

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

21. 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

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

24. The WHO Essential Medicines Library, status 2005
Selection
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

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

26. Essential medicines for children

27. Causes of death in under 5s
World Health Report, 2005

28. EML 2005
Core
Complementary
Total
Total No of medication listings
284 84
368
Listings not assessed
129 45
174
Listings assessed
155 39
194
PF indicated
119 28
148
PF not indicated 36 11 46
PF indicated and on the list 52 3 55
PF indicated and not on the list 67 25 93
PF indicated, not on the list, duplicate listings removed 59 23 83
PF indicated, not on list and available* 29 2 30
PF indicated, not on list and not available* 21 53

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

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

31. Powders for suspension
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

32. Survey of 29 countries: Problems with Children's Medicines for Malaria, TB and HIV
Lack of appropriate paediatric formulations
Artemisinin derivatives in tablet form only
No paediatric dose forms available for isoniazid, pyrazinamide, ethambutol, rifampicin
Many countries no paediatric HIV medicines
Cost of medicines
ARV syrup formulations, artemisinin combinations
Need for standard methods for adapting adult medicines for use in children
Costs of special storage conditions for unstable products

33. Survey of 29 countries: Problems identified for other acute and chronic illnesses in childhood
Availability of suitable formulations
Vitamins & minerals, some antibiotics and anti-infectives, anti-epileptic medicines, cardiovascular medicines, cytotoxic drugs
Costs of medicines
Anti-infective agents, cytotoxic drugs, insulin pens, steroid inhalers for asthma, vaccines
Other issues
Lack of standardised dosing measures, breaks in cold chain for vaccines, storage costs for drugs, lack of paediatric guidelines and formulary

34. Are essential medicines for children available?

36. Source: International Drug Price Indicator Guide, 2005; median price

37. Terms of reference for sub committee
(1)To prepare a list of medicines for children, based on their clinical needs and the burden of disease, that the WHO Expert Committee on the Selection and Use of Essential Medicines can use to revise and regularly update the WHO Model List of Essential Medicines to include missing essential medicines for children:
(2) To determine suitability criteria for dosage forms of medicines for children, with particular attention to conditions prevailing in the developing countries:
(3) To review the feasibility of manufacturing appropriate formulations for those priority medicines for which no dosage form for children currently exists, specifically considering requirements for use in resource‐limited settings and availability of data on efficacy and safety in the appropriate age groups:
(4) To identify the clinical‐research gaps regarding safety and efficacy of essential medicines for children in order to improve suboptimal prescribing and dosing, and to facilitate regulatory approval of paediatric formulations:
(5) To report to the Expert Committee on the Selection and Use of Essential Medicines in

41. Improving use of medicines

43. Lack of Human Capacity

44. stock outs
Uhjin Kim, Nauru 2008

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