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