Selection of essential medicines Suzanne Hill September 2006 Department of Medicines Policy and Standards TBS 2006

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


Outline



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.


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)


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.


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


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


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


Outline



Process

Application lodged

Reviewed internally, published on web

External expert review and comment

Public commentWHO department

comment

Expert Committee review and

recommendation


Outline



The ideal

WHO treatment guideline developed Treatment recommendation made Proposal to update list to reflect new guideline Potential to influence practice





The challenges….



Costa et al, BMJ 2006;332;1115-1124.


No application

No money

…no volunteer


Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice


Outline



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


The WHO Essential Medicines Library:

WHOModel List

WHO Model Formulary(search)


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


Outline




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


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


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


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)


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




Outline



Essential medicines for children


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


Paediatric formulation issues

Technical difficulties of manufacturing

Storage and preparation

Impact of various climates

Taste of the medication

Local factors and practice


Liquids

Short shelf lives

Often require refrigeration

Bulky and heavy (issue for storage and transport)


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


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.


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


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)


www.who.int/medicines

Thank you

Documents

Selection of essential medicines Suzanne Hill September 2006 Department of Medicines Policy and Standards TBS 2006