malaria treatment policies: the challenge, strategies and the options sota, nairobi, kenya 12 th...
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Malaria treatment policies: the challenge, strategies and
the optionsSOTA, Nairobi, Kenya
12th June 2002
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Global Malaria Control Strategy
• Early diagnosis and effective treatment of malaria illness
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Some factors preventing effective case management
• Failure to recognize malaria
• Failure to recognize signs of severe malaria
• Use of inappropriate or inadequate courses of treatment
• Poor adherence to tx guidelines at health facility level
• Poor adherence at the household level
• Poor availability and access to drugs
• Use of poor quality drugs
• Use of ineffective drugs due to drug resistance
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Challenges to antimalarial drug policy
• Widespread resistance to common antimalarials e.g. chloroquine
• Mounting resistance to replacement therapies e.g. sulphadoxine-pyrimethamine (SP)
• New therapies are more expensive and have more complicated treatment regimens
• Availability of poor quality or substandard drugs
• Home treatment; private sector more difficult to control
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Challenges to antimalarial drug policy [2]
Equitable access to reduce
mortality and morbidity
Emphasis on community management
Reduces development of resistance
Emphasis on regulation and controlled use
Access Rational Use
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Changing national treatment policies
Need a rational approach for decision making for:• When to change national first line treatment
– AFRO guidelines:
› 15-25% drug resistance alert phase
› ≥ 25% drug resistance is action phase
• “Evidence” for changing policy~ Drug resistance and monitoring
~ Attitudes and practices
~ Behaviors
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Efficacy vs. effectiveness
Program effectiveness:• Drug efficacy• Drug use determinants
~ Availability
~ Affordability
~ Acceptability
~ Compliance– Frequency and total number of doses
– Adverse effects and acceptability
– Ability of users and mothers to follow directions
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Efficacy vs. effectivenesse.g. SP
• Parasite clearance=80%• Availability=90%• Affordability=100%• Compliance=100% (single dose/DOT)
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Efficacy vs. effectivenesse.g. SP
80%
72% 72% 72%
0%
20%
40%
60%
80%
100%
effe
ctiv
enes
s
Eff icacy Availability Affordability Compliance
drug use determinants
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Efficacy vs. effectivenesse.g. Artesunate/SP
• Parasite clearance=99%• Availability=50%• Affordability=50%• Compliance=50%
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Efficacy vs. effectivenesse.g. Artesunate/SP
99%
50%
24.75%
12.38%
0%
20%
40%
60%
80%
100%
eff
ec
tiv
en
es
s
Efficacy Availability Affordability Compliance
drug use determinants
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Changing national treatment protocols:Factors to consider
• Efficacy and safety
• Adverse effects
• Compliance (ease of use, acceptability, formulation)
• Cost
• Ability to curb resistance development
• Ability to reduce transmission (gametocytocidal)
• Useful therapeutic life
• Use in young children and pregnant women
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Changing national treatment protocols:Other factors to consider
• Biological vs. clinical diagnosis• Quality• Rational use• Reduce availability/demand of undesired product• Role of regulation
~ Regulate undesirable drugs
~ Decrease availability
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Changing national treatment protocolsOther factors to consider
• Financial burden for change~ Direct cost: more expensive drugs~ Indirect cost: retraining of HW, new STGs etc.
• Capacity of health system to implement policy• Provision for Intermittent Preventive Therapy (IPT)
for pregnant women• Home management• Engage the private sector (franchising, subsidies,
social marketing, incentives)
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Options for replacement therapies
• Continue using SP until it is no longer effective (potential of compromising the use of other antifolates under development)
• Amodiaquine monotherapy (cross-resistance with CQ)
• Mefloquine, Malarone etc. but, not without problems
• Combination therapy but not without consideration to issues
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Artemisinin based combination therapy
Advantages of ACT:• High efficacy and rapid clearance of parasites• Experience in SE Asia shown to slow down the
development of resistance• Artemisinin reduces gametocyte carriage thus
reduces malaria transmission
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Issues concerning use of ACT
• Limited experience in Africa
• Lack of safety data in pregnant women
• Higher cost
• Need for better diagnosis
• Compliance, packaging
• Issues of misuse due to role in severe malaria
• All monotherapies must be replaced with CT
• Public vs Private sector
• Which combinations?
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Cost comparison of adult tx courses of available new combinations in relation to selected monotherapies
0
0.5
1
1.5
2
2.5
3
Cost (US$)
CQ
SP
AQ
MQ
ART
Q
Coartem
ART/SP
ART/AQ
ART/MQ
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Cost
• Incremental cost of AQ+AS rather than AQ+SP: US$1.10 per patient
• Tanzania: 16 million cases annually• Increased cost of US$17.6 million (annually)• Total annual government expenditure on health:
US$ 5.5 per capita (malaria: US$ 0.42 per capita)
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Lessons learned
Need for documentation of lessons learned and a framework for a rational approach to drug policies and implementation
• Examples:~ Malawi: Difficulties in implementation
~ Kenya: SP deregulation
~ Zambia: Cost of combination therapy
~ Uganda: CQ + SP (pre-packaging etc.)
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Malaria Action Coalition
• USAID mechanism for focusing funds towards an integrated work plan
• Goal: The attainment of the Abuja goals for the treatment of malaria and the control of malaria during pregnancy
• Partners: WHO/CDC/MNH/RPM Plus• Funds channeled to partners through field support and
“core” funds to provide support to address these programmatic challenges of antimalarial drug policy development and implementation