selection of essential medicines
DESCRIPTION
Selection of essential medicines. Hans V. Hogerzeil, MD, PhD, FRCP Edin Director Medicines Policy and Standards September 2005. Department of Medicines Policy and Standards TBS 2005. National Essential Drugs List. < 5 years. (127). > 5 years. (29). No NEDL. (19). Unknown. - PowerPoint PPT PresentationTRANSCRIPT
Selection of essential medicines
Hans V. Hogerzeil, MD, PhD, FRCP Edin
Director
Medicines Policy and Standards
September 2005
Department of Medicines Policy and StandardsTBS 2005
Department of Medicines Policy and StandardsTBS 2005 (2)
National Essential Drugs List
< 5 years (127)> 5 years (29)No NEDL (19)Unknown (16)
By Dec.1999:
156 countries with EDLS
1/3 within 2 years
3/4 within 5 years
The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings
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.
Achievements
Department of Medicines Policy and StandardsTBS 2005 (3)
135 countries have treatment guidelines, formularies
Achievements
Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice
Department of Medicines Policy and StandardsTBS 2005 (4)
Training in rational prescribing has expanded in universities throughout the world
Problem-based pharmacotherapy
In 18 languages
For medical students, clinical officers
Measurable improvement in prescribing
Now also: Teacher’s Guide to Good Prescribing
Achievements
Department of Medicines Policy and StandardsTBS 2005 (5)
Unfinished agenda
Irrational use of drugs is a widespread hazard to health
Half of 102 countries surveyed regulate drug promotion
By age 2 children in some areas have had > 20 injections
15 billion injections per year - half of them unsterile
25-75% of antibiotic prescriptions are inappropriate
Department of Medicines Policy and StandardsTBS 2005 (6)
Example of challenge:New essential drugs are expensive
Antibiotics for gonorrhoea: 50-90x price of penicillins
Antimalarial drugs: chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x)atovaquone-proguanil $40/pp (400x)
Antituberculosis: $15 for DOTS vs $300 for MDR (20x)
Antiretrovirals: $300-600/year; but 38 countries with a drug budget <$2 pp/year
Selection
Department of Medicines Policy and StandardsTBS 2005 (7)
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
Selection
Department of Medicines Policy and StandardsTBS 2005 (8)
Clinical guidelines and a list of essential medicines lead to better prevention and care
List of common diseases and complaints
Training andSupervision
Financing and Supply of drugs
Treatment guidelines
Treatment choice
Preventionand care
Selection
Essential medicines list/ National
formulary
Department of Medicines Policy and StandardsTBS 2005 (9)
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
April 2003 list contains 315 active substances
The first list was a major breakthrough in the historyof medicine, pharmacy and public health
Médecins sans Frontières, 2000
Selection
Department of Medicines Policy and StandardsTBS 2005 (10)
Use of the WHO Model List of Essential Drugs
156 countries have a national list of essential drugs
Major agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List
Sub-sets of the Model List: UN list of essential drugs for emergencies: 85 drugs New Emergency Health Kit: 55 drugs for 10,000 people/3m
Normative tools follow the Model List: WHO Model Formulary International Pharmacopoea Basic Quality Tests and reference standards
Selection
Department of Medicines Policy and StandardsTBS 2005 (11)
The WHO Model List of Essential Medicines is amodel 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
Selection
Department of Medicines Policy and StandardsTBS 2005 (12)
Dissemination of 13th Model List
March 2003 13th Expert Committee
April 2003 List of recommendations, introduction and 13th Model List in English on WHO web site; announcement on electronic networks
May 2003 Model List in Arabic, Chinese, French, Russian and Spanish in hard copy and on WHO web site
Jan 2004 Model Formulary updated, printed, on web site
May 2004 Summary of report and its public health impact submitted to WHO Executive Board
July 2004 Technical Report Series 920 printed, on web site
Selection
Department of Medicines Policy and StandardsTBS 2005 (13)
WHO Model Formulary
First edition, December 2002 WHO priced publication (SFr 40, SFr 20) Two prints: 7,000 and 10,000 copies Web version as PDF file and searchable database CD-ROM (searchable and downloadable) Translated into Arabic, Russian, Spanish – but not printed
Department of Medicines Policy and StandardsTBS 2005 (14)
WHO Model Formulary 2004
Second edition, January 2004 Updated to follow 13th Model List Web version as PDF file and searchable database CD-ROM with data base and Word-document Document "How to develop a national formulary using the WHO
Model Formulary" developed and added to CD-ROM Arabic, Russian and Spanish 2002 translations updated to reflect
changes (using special software to track changes) Spanish version issued in hard copy, on web Arabic and Russian on CD-ROM and on web
Department of Medicines Policy and StandardsTBS 2005 (15)
The WHO Essential Medicines Library: Available for public access by March 2003
WHOModel List
WHO Model Formulary(search)
Selection
Department of Medicines Policy and StandardsTBS 2005 (16)
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, BMJ-CE
Statistics:- ATC- DDD
WCCs Oslo/Uppsala
Selection
Department of Medicines Policy and StandardsTBS 2005 (17)
Future plans for biennial revisions of Model List and Model Formulary
'03 '04 '05 '06 '07
13th Model List (2003) xxxxxxxxx
Model Formulary 2004 …...xxxxxxxxx
14th Model List (2005) xxxxxxxxx
Model Formulary 2006 ……xxxxxxxx
Selection
Department of Medicines Policy and StandardsTBS 2005 (18)
The New Emergency Health Kit1984, 1990, 1998
Essential medicines and suppliesfor 10,000 people for three months
Consensus between WHO, UNICEF,UNHCR, UNFPA, Red Cross, MSF, OXFAM, missions, IDA
Emergency Health Kit
Department of Medicines Policy and StandardsTBS 2005 (19)
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
Emergency Health Kit
Department of Medicines Policy and StandardsTBS 2005 (20)
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
EMs for RH
Department of Medicines Policy and StandardsTBS 2005 (21)
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)
EMs for RH
Department of Medicines Policy and StandardsTBS 2005 (22)
Essential Medicines for Reproductive Health:Current status of joint review project
1. Annotated list all WHO resource materials and standard treatment guidelines for RH medicines; link with essential medicines list(s); discrepancies identified
2. Summary of available Cochrane reviews and other evidence for all RH medicines
3. List of medicines for which additional evidence is needed; reviews performed and discussed at 14th Expert Committee
Next steps: International consensus on essential RH medicines; standardization of essential non-drug RH items; guideline for inclusion of RH items in national lists of essential medicines
EMs for RH
Department of Medicines Policy and StandardsTBS 2005 (23)
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 all WHO 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 2005 (24)
www.who.int/medicines
Saving lives with the right (to) medicines