Transcript Ensuring Access to Antimalarial Drugs

Access to Artemisinin-Based Antimalarial
Products
Dr Clive O Ondari
Essential Drugs and Medicines Policy Dept &
Roll Back Malaria (RBM) Department
World Health Organization
Access Framework
1. Rational
3. Sustainable
selection
financing
ACCESS
2. Affordable
prices
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4. Reliable
health and
supply systems
What is RBM?
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RBM = Roll Back Malaria
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Initiated as a WHO/Cabinet project in 1998
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Started UN Agencies movement – UNICEF, UNDP, WB (founding
partners)
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Initiated Global Movement "doing things differently": Regional Dev.
Bank; major partners: USAID, DfID, NGOs, private sector
Regional Initiatives (OAU →African Union)
Country movement: MOH (Nat. Malaria Control Programmes) +
country-level partners: NGOs, community-based organizations, large
private-sector employers (estates, mining and petroleum companies,
etc.)
What is RBM?
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WHY?
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HOW?
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burden of malaria reduced by 50% - 2010
Strategies:
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an assembly of expertise, infrastructure, funding
working together – globally, regionally, nationally
raising awareness
GOAL?
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mechanism for coordinated international approach to fighting malaria
Protecting most vulnerable groups (pregnant women, <5's)
Preventing measures: insecticide-treated bednets (ITNs), in-door
residual spraying (IRS)
Right medicines, right place, right time
Addressing emergencies and epidemics
What environment are we working in?
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Quality of antimalarial medicines has been declining
Efficacy of (affordable) antimalarial medicines has been declining
and high cost of replacement treatment options
>50% of population does not have regular access to most vital
essential medicines
60 - 90% of the population seek initial treatment from unqualified
sources, i.e. street vendors, kiosks (private informal sector)
Supply of medicines is often inefficient and unreliable
Use of ineffective medicines leads to inadequate treatment and
leads to drug resistance
Factors leading to development of resistance
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Lack of treatment guidelines / poor 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
Pilot Project on
Quality of Antimalarial Products
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Project Design:
 Country selection criteria: “spot light countries” in AFRO and
EMRO
 Evaluation of most widely used antimalarials in these regions
 Samples from various levels of distribution chain (household,
peripheral health unit, district, private sector pharmacy, district
hospital, teaching/referral hospital and gvt. medical stores
 Quality testing of samples in central QC laboratory (CENQAM),
South Africa
 Evaluation of results and publication
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Failure rates (%) - Content
100
80
Chloroquine Syrup
60
Chloroquine Tablets
40
Sulphadoxine/Pyrimetha
mine Tablets
20
M
8
da
n
Su
m
ba
bw
e
Zi
ue
biq
oz
am
ny
a
Ke
ali
M
na
Gh
a
Ga
b
on
0
100
80
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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
Selection of antimalarials
Moving towards ACTs
FDC
• Artemether/lumefantrine
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Artesunate + amodiaquine
ACTs
MDT
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Artesunate + SP
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Artesunate + mefloquine
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Amodiaquine + SP
What is required to include ACTs in the
WHO Model List?
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Submission to the Expert Committee on Essential Drugs
by:
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Review by the relevant WHO Department(s) and Expert
Committee(s) - comparison with other drugs on:
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RBM Department
Pharmaceutical Manufacturers
efficacy
safety
cost-effectiveness
public health relevance
Introducing ACTS - Scheme of Events
Private Sector
Wholesaler
Retailer
Registration
Selection
CMS
Procurement
Wide Availability
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Public Sector
Facilities
Cost implications of combination therapy (ACT)
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5
4
3
A
2
1
0
CQ
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SP
AS/AQ
AS/SP
AT/LM AS/MF
What has been done?
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Development of monographs for:
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artemether (tabs, caps, inj);
artemisinin (caps);
artemotil (arteether) (inj);
artenimol (DHA) (tabs);
artesunate (tabs) + mefloquine, proguanil
Antimalarial drug quality survey in 7 African countries
Training (DRA and manufacturers) in GMP and QA: focus on
antimalarials
Clinical screening of traditional medicines for antimalarial activity
(TRM support)
Development of treatment guidelines for malaria
Development of Malaria Medicines and Supplies Service (MMSS)
Global Forecasts/Estimates
Forecasts
for procurement
Adult treatments
Total Morbidity
estimates
2004
30,007,678
50,012,796
2005 - 2006
131,583098
219,305,163
These are conservative (cautious) estimates of the countries that
have changed, that are changing, and that are expected to
change, and which will be deploying ACTs in 2004 and 2005
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USD - Millions
GFATM grants for ACTs
200
200
150
100
50
0
Round 1
Round 2
Award
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6.07
5.2
2.4
Round 3
Cummulative
Round 4
Challenges – Access to ACTs
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Only one fixed dose combination (FDC) available: artemetherlumefantrine (Coartem®), patented and single-source
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All other ACTs: multi-source products, available as individual
products to be co-administered (preferably in course-of-therapy
blister packs)
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Market not primed: few manufacturers, limited experience with
manufacturing and packaging of artemisinin derivatives (highly
hygroscopic), API linked to natural plant production – shortages?
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Relatively new products on the international market – limited
country experience in regulation and procurement
In Jan. 2005: GFATM will support ONLY prequalified medicines!
Pre-qualification of ACT Manufacturers
and Products
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Objectives:
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accelerate access to, and use of, assured quality ACTs
ensure adequate and effective treatment reaches greater
numbers of people in need
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support implementation of ACTs in ways that respond to
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specific needs of individual countries
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Progress:
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support drug regulatory agencies in regulating ACTs
Limited: Coartem® and 1 Artesunate 50mg tab. prequalified
Malaria Medicines and Supplies Services (MMSS)
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What it MMSS?
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What will MMSS do?
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Mechanism for assisting countries to scale-up access to
medicines and other products
Link NMCP with suppliers and other products
How will MMSS operate?
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Creating procurement platform: depository of information on:
 sources and prices
 prequalified suppliers and products
 national quantification of requirements → global estimates
 mechanism for providing support to national programmes and
producers)
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Thank you!
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