selection of essential medicines suzanne hill november 2008 department of essential medicines &...

Selection of essential medicines

Suzanne Hill

November 2008

Department of Essential Medicines & Pharmaceutical Policies TBS 2008

Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (2)

Outline

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


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 2007 list contains 340 active substances Next revision 2009


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


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.


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

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


Outline



The ideal

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



Essential medicines for children


3 34

8

10

17

19

27

10

injuries

AIDS

measles

malaria

others

diarrhoeal diseases

pneumonia

other neonatalcauses

neonatal severeinfections

Causes of death in under 5s

World Health Report, 2005


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


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


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


Proportion of medicines in EML, STGs, CMS and NGO stores

0

10

20

30

40

50

60

70

80

90

100

CAMEROUN

CONGO

DRC

ETHIOPIA

GHANA

KENYAM

ALI

NIGERIA

RWANDA

SENEGAL

TANZANIA

TCHAD

UGANDA

ZAMBIA

% o

f m

edic

ines

ava

ilab

le

EML STG CMS NGO

Are essential medicines for children available?


Availability of 22 medicines for children from International NGO Medicine Suppliers

0

5

10

15

20

25

1 2 3 4 5 6 7

NGO Medicines Suppliers

Nu

mb

er

of

med

icin

es a

vailab

le


Ratio of liquid/solid dosage form prices for sample of ARVS

0

1

2

3

4

5

6

7

8

9

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


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 2009.


Improving use of medicines

Lack of Human Capacity

stock outs

Uhjin Kim, Nauru 2008


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

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