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Selection of essential medicines
Suzanne Hill
September 2006
Department of Medicines Policy and StandardsTBS 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
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 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.
Department of Medicines Policy and StandardsTBS 2006 (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)
Department of Medicines Policy and StandardsTBS 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.
Department of Medicines Policy and StandardsTBS 2006 (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 historyof medicine, pharmacy and public health
Médecins sans Frontières, 2000
Department of Medicines Policy and StandardsTBS 2006 (8)
The Essential Medicines Target
S S
All the drugsin the world
Registered medicines
National list ofessential medicines
Levels of use
Supplementaryspecialistmedicines
CHWdispensary
Health center
Hospital
Referral hospital
Private sector
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (11)
Process
Application lodged
Reviewed internally, published on web
External expert review and comment
Public commentWHO department
comment
Expert Committee review and
recommendation
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (14)
The ideal
WHO treatment guideline developed Treatment recommendation made Proposal to update list to reflect new guideline Potential to influence practice
Department of Medicines Policy and StandardsTBS 2006 (15)
Department of Medicines Policy and StandardsTBS 2006 (16)
Department of Medicines Policy and StandardsTBS 2006 (17)
Department of Medicines Policy and StandardsTBS 2006 (18)
The challenges….
Department of Medicines Policy and StandardsTBS 2006 (19)
Department of Medicines Policy and StandardsTBS 2006 (20)
Costa et al, BMJ 2006;332;1115-1124.
Department of Medicines Policy and StandardsTBS 2006 (21)
No application
No money
…no volunteer
Department of Medicines Policy and StandardsTBS 2006 (22)
Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (26)
The WHO Essential Medicines Library:
WHOModel List
WHO Model Formulary(search)
Department of Medicines Policy and StandardsTBS 2006 (27)
The WHO Essential Medicines Library, status 2005
WHOModel List
Summary of clinical guideline
Reasons for inclusionSystematic reviewsKey references
WHO Model Formulary
Link to price information
Quality information:- Basic quality tests- Intern. Pharmacopoea- Reference standards
Clinical guidelineRPS
WHO clusters
MSHUNICEF
MSF
WHO/QSM
WHO/EDM
WHO/EC, Cochrane, Guideline Clearing House
Statistics:- ATC- DDD
WCCs Oslo/Uppsala
Selection
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (29)
Department of Medicines Policy and StandardsTBS 2006 (30)
The New Emergency Health Kit1984, 1990, 1998, 2006
Essential medicines and suppliesfor 10,000 people for three months
Consensus between WHO, UNICEF,UNHCR, UNFPA, Red Cross, MSF, OXFAM, missions, IDA
Department of Medicines Policy and StandardsTBS 2006 (31)
WHO Model List 2004UN 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
WHOICRCFRCMSFUNICEFUNHCRUNFPAIDAEPNOXFAM
UNDP
Department of Medicines Policy and StandardsTBS 2006 (32)
Essential medicines for reproductive health:Discrepancies in international RH lists
75 on UNFPA List
316 on WHO Model List
150 on Interagency RHmedical commodities
194
65
63
66
22
Department of Medicines Policy and StandardsTBS 2006 (33)
Examples of discrepancies:Alternative medicine preferred on WHO EML, or medicines recently deleted from Model List
U R Model Listclotrimazole x x miconazolezalcitabine, delavirdine, amprenavir x see ARV guidedephenylhydramine x promethazineitraconazole, ketoconazole x fluconazolelabetalol x atenololtinidazole x metronidazoleritodrine, terbutaline x salbutamolmethylergometrine x ergometrine
Recently deleted from Model List: spermicides, contraceptive foams/gels, pethidine, iron dextran, (misoprostol)
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (35)
Department of Medicines Policy and StandardsTBS 2006 (36)
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (38)
Essential medicines for children
Department of Medicines Policy and StandardsTBS 2006 (39)
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* 30 21 53
Department of Medicines Policy and StandardsTBS 2006 (40)
Paediatric formulation issues
Technical difficulties of manufacturing
Storage and preparation
Impact of various climates
Taste of the medication
Local factors and practice
Department of Medicines Policy and StandardsTBS 2006 (41)
Liquids
Short shelf lives
Often require refrigeration
Bulky and heavy (issue for storage and transport)
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (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.
Department of Medicines Policy and StandardsTBS 2006 (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
Department of Medicines Policy and StandardsTBS 2006 (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)
Department of Medicines Policy and StandardsTBS 2006 (47)
www.who.int/medicines
Thank you