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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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (3)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (4)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (5)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (6)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (7)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (8)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (9)
Outline
What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (10)
Process
Application lodged
Reviewed internally, published on web
External expert review and comment
Public commentWHO department
comment
Expert Committee review and
recommendation
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (11)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (13)
Outline
What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (14)
The ideal
WHO treatment guideline developed Treatment recommendation made Proposal to update list to reflect new guideline Potential to influence practice
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (15)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (16)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (17)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (18)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (19)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (20)
Outline
What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (21)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (23)
The WHO Essential Medicines Library:
WHOModel List
WHO Model Formulary(search)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (24)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (25)
Outline
What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (26)
Essential medicines for children
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (27)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (28)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (29)
Paediatric formulation issues
Technical difficulties of manufacturing
Storage and preparation
Impact of various climates
Taste of the medication
Local factors and practice
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (30)
Liquids
Short shelf lives
Often require refrigeration
Bulky and heavy (issue for storage and transport)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (31)
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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (32)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (33)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (34)
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?
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (35)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (36)
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
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (37)
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.
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (38)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (39)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (40)
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (41)
Improving use of medicines
Lack of Human Capacity
stock outs
Uhjin Kim, Nauru 2008
Department of Essential Medicines & Pharmaceutical PoliciesTBS 2008 (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 Essential Medicines & Pharmaceutical PoliciesTBS 2008 (46)