Transcript Access to Antimalarial Drugs - WHO archives

Access to Antimalarial Medicines
Dr Clive O Ondari
Essential Drugs and Medicines Policy Dept &
Roll Back Malaria Department
World Health Organization
October 2003
Malaria as cause of death of children under 5 yrs,
by WHO region, 2000
Rank
2
% of all deaths
20.3
AFRO
1
EMRO
13
2.5
SEARO
23
0.2
WPRO
–
0.0
AMRO
–
0.0
EURO
–
0.0
WHO - EDM
Leading causes of death for children under 5 yrs,
in the WHO African Region, 2000
Rank
Malaria
1
Respiratory inf.
2
Diarrhoea
3
HIV/AIDS
4
Measles
5
Low birth weight
6
3
% of all deaths
20.3
17.2
12.3
9.0
8.4
5.8
WHO - EDM
Current Situation:






4
Quality of antimalarial drugs has been declining.
The efficacy of (affordable) antimalarial drugs has been declining and
high cost of replacement options.
Over 50% of the population does not have regular access to most vital
essential drugs.
60-90% of the population seek initial treatment from unqualified
sources, i.e. street vendors, kiosks.
Supply of drugs is often inefficient and unreliable.
Use of ineffective drugs leads to inadequate treatment and leads to drug
resistance.
WHO - EDM
SP Therapeutic Failures (1996-2001)
50
45
40
% Failures
35
30
Parasitological
25
20
Clinical
ACTION PHASE
15
10
ALERT PHASE
5
0
5
West
Central
East
WHO - EDM
Problems of resistance to antimalarial drugs



6
Era of availability of cheap and effective drugs has come to
an end
Both CQ & SP cost <US$0.2/adult treatment course, but
resistance to CQ widespread, and to SP increasing
Alternatives for multi-drug resistant falciparum malaria are
x10 expensive
WHO - EDM
Factors leading to development of resistance





7
Lack of guidelines/poor drug treatment policies
Irrational prescribing
Irrational drug use
Drug concentration “tail”
Liberalized, uncontrolled drug market leading to poor quality
products circulating in international and domestic markets
WHO - EDM
The Abuja Declaration, African Summit on Roll
Back Malaria (Abuja, Nigeria), April 2000
Call upon all member states to:
1. “Make treatment of malaria available as peripherally as possible
including home treatment”
2. “Make appropriate treatment available and accessible to the poorest
groups in the community”
Pledge to:
1. “Reduce or waive taxes and tariffs for …antimalarial drugs”
2. “Explore and develop traditional medicine in the area of malaria
control”
8
WHO - EDM
Developing and promoting interventions to improve
access to good quality antimalarial drugs

Rational selection and use
WHO will continue to work with member states to ensure that:
1)
2)
3)
4)
9
Evidence that is accumulated in the clinical practice is used to
develop and update malaria treatment guidelines,
Treatment guidelines form the basis for the development of
essential drugs list
Essential drugs list guide the procurement, distribution and use of
antimalarial drugs
New antimalarial drugs, including novel combinations, are
evaluated adequately and registered in a timely manner.
WHO - EDM
Rational Antimalarial Drug Selection
10
WHO - EDM
Recommended combination antimalarials:




11
Artesunate + amodiaquine
Artesunate + sulfadoxine-pyrimethamine
Artesunate + mefloquine
Artemether + lumefantrine
WHO - EDM
Cost implications of combination therapy
6
5
4
3
2
1
0
12
CQ
SP
MQ
ART/SP ART/M Coartem
WHO - EDM
Global negotiation to reduce price of new antimalarials

Expert consensus that co-formulated artemisinin combination best option for
use where multi-resistant malaria

Artemether/lumefantrine (Coartem) is only medicine of this type currently
licensed


13
Novartis has agreed to provide drug at cost through WHO for 10 years – US$
2.40 for adult treatment
Countries to request, direct or through NGOs
WHO - EDM
Developing and promoting interventions to improve
access to good quality antimalarial drugs

Sustainable financing
Efforts are directed towards:
1) Developing guidelines on sustainable financing
2) Dissemination and promotion of interagency guidelines on
drug donation
3) Advocacy for increased budget allocation for essential
drugs
14
WHO - EDM
Pilot Project on Quality of Antimalarial Products

Project Design :




15
Country selection criteria: “spot light countries” in AFRO
and EMRO
Evaluation of the most widely used antimalarials products in
the regions
Sampling from various levels of the distribution chain
(household, private sector pharmacy, peripheral health units,
district hospital, teaching/referral hospital and district and/or
central medical store
Evaluation of samples on a rapid assessment kit (Mini-lab)
and central laboratory (pharmacopeal tests) in CENQAM,
South Africa
WHO - EDM
Failure rates (%) - Content
100
80
Chloroquine Syrup
60
Chloroquine Tablets
40
Sulphadoxine/Pyrimetham
ine Tablets
20
Su
da
n
e
m
ba
bw
Zi
bi
qu
e
oz
am
a
M
Ke
ny
al
i
M
G
ha
na
G
ab
on
0
16
WHO - EDM
100
80
17
Chloroquine
Tablets
60
40
20
SP Tablets
M
al
i
K
M
en
oz
y
am a
bi
qu
Zi
e
m
ba
bw
e
Su
da
n
0
G
ab
on
G
ha
na
Percent Failure (%)
Failure Rates (%) - Dissolution
WHO - EDM
Pre-qualification of ACT Manufacturers and
Products

Objectives:



To accelerate sustained access to, and use of, good quality
ACTs
To ensure that adequate and effective treatment reaches
significantly greater numbers of people in need
To assist/support the implementation of ACTs in ways that
respond to the specific needs and requests of individual
countries

18
To support drug regulatory agencies in regulating ACTs
WHO - EDM
RBM/EDM Planned Activities - Biennium 20042005

Rational Selection and Use





Affordable Prices for Antimalarial Drugs



19
Collect and collate efficacy and safety data on new AM
Develop training materials for new AM
Assist in the dissemination of training materials
Provide assistance in training activities
Collect information on pricing/prices of antimalarials
Assist countries in the procurement of antimalarials
Collect data on domestic manufacturing - capacity etc
WHO - EDM
RBM/EDM Planned Activities - Biennium 20042005

Providing assistance in ensuring sustainable financing



Strengthening drug supply, quality assurance and
regulatory systems




20
Develop a database on national budgets/expenditures on AM
Develop a database on the availability of AM (esp. ACTs)
Develop guidelines for registration of new antimalarials
Assist countries to evaluate quality and monitor inspection
activities (including pre-qualification of sources of products)
Provide support to training in the areas of pharmaceutical
inspection (GMP) - manufacturing and distribution channels
Initiate the development of monographs for new AM
WHO - EDM