Framework of antimalarial
drug policy
Dr H. Atta
MO/RBM
WHO/EMRO
AMDP- Definition
An antimalarial treatment policy is a
set of recommendations and
regulations concerning the
availability and rational use of
antimalarial drugs in a country
Rationale of AMDP
• Case management is a key component of
malaria control
• Few antimalarials are suitable for wide-
spread use in public health
• Development of new antimalarials is
expensive, slow and difficult
• Having updated antimalarial drug policy is
essential to regulate availability and
encourage rational use to avoid development
of antimalarial resistance
Antimalarial Drug policy (AMDP)
AMDP
National
National
malaria
Drug
Control
policy
policy
National health policy
AMDP_ Purpose
The primary purpose is promptly, effectively and
safely treating malaria patients by selecting
and making accessible to the populations at
risk of malaria
– safe,
– effective,
– good quality, and
– affordable antimalarial drugs
Effective treatment
The definition varies in different epidemiological
situations:
• In areas of intense transmission:
clinical cure, i.e. clinical remission (no
appearance of signs and symptoms in the 14
days following treatment.
• In areas of low transmission:
parasitological or radical cure, i.e. elimination
of all parasites from the body.
Drug policy- aims
1. Reduce morbidity,
2. Halt the progression of uncomplicated
disease into severe and potentially fatal
disease, thereby reduce malaria mortality,
3. Reduce the impact of placental malaria
infection and maternal malaria-associated
anaemia through PIT,
4. Minimize the development of antimalarial
drug resistance.
The categories for the
treatment
All treatment categories:
• Drugs for 1st, 2 nd, and 3rd line treatment,
• Severe malaria,
• Pregnant women,
• Presumptive treatment,
• Self-treatment,
• Over-the-counter treatment,
• Mass treatment ( in epidemics).
Most important
The choice of first line treatment has the
greatest economic implications and the
greatest public health implications.
Stages of AMDP
Development of
policy
updating Implementation
reevaluation monitoring
Developing and Updating National
Treatment Guidelines
The essential components
• Analysis of technical, social and economic issues
related to malaria control and anti-malarial drug
resistance
• Analysis of the political environment for decision-
making
• Consensus-building among relevant stakeholders
– (policy-makers, researchers, control staff, donors, private
providers, industry and user representatives,
• A supervisory body to oversee the development,
implementation and revision of the policy,
• A regulatory body to ensure adherence to the policy
Developing/revising AMDP
Information needed
1. Epidemiological situation
Prevalence, incidence, mortality, seasonality, parasite
species, efficacy to currently used antimalarial drugs
2. Access
3. properties of available alternative drugs
4. Analysis of provider and consumer
behaviors
5. Analysis of health system capacity to
implement the revised policy ( regulatory
and legislative framework.
Information on drug
characteristics
• Efficacy of the current first line drug
• Efficacy of the alternative drugs
• Cost
• Quality
• Side effects
• Cross resistance
• Drug interactions
• Contraindications
• Effect on Special groups
• Useful therapeutic life
• Acceptability
• Compliance
• Dosage regimen
Assessment of the health system
capacity to implement the policy
Health system needs political support, financial,
managerial, and technical resources to
implement the policy to ensure availability of
drugs at end user level
Careful analysis of many systems
– Health care delivery
– Financing
– Human resources
– Drug supply system
– Supervision
– Referral
– Transport
– Communications
Implementation-1
The key aspects
• Compliance
• Financial, human and technical
resources
• Health care infrastructure
• Drug regulation, supply, distribution and
quality assurance
Implementation
-2
• Establishment of effective public-private
partnerships,
• Education and training of health care staff
and other providers,
• Education and training of community
residents,
• Intercountry actions and information
exchange to optimize implementation,
• Monitoring and evaluation of the policy and its
impact.
The Process of Change
Needs Monitoring
Continuous monitoring and consensus-building
• In vivo therapeutic efficacy studies should be
conducted throughout the country in order to
provide an indication of the geographical
pattern of resistance.
• The tests should be carried out at through
sentinel sites, if not possible at regular
intervals (18 months to 2 years) to provide a
longitudinal perspective
Re-evaluation of AMDP
Signals
• Indication of increase in sever malaria
morbidity and mortality
• Consumer and provider dissatisfaction
with the current policy
• Evidence from therapeutic efficacy tests
• The availability of safe, effective,
acceptable and affordable alternatives.
When to change
No well-defined criteria for
determining the level of
clinical
or
parasitological
failures for replacing the first-line
drug
Level of change
• A cut-off level of 25% treatment failures is a
widely quoted but it is an arbitrary figure.
• The dynamic process of change should be
analysed on the basis of the proportion of
established clinical failures
• The actual cut-off point will depend on many
factors
Position of the countries in
relation to TFR
• Grace period—Low levels of drug
failures, 5%.
determine baseline data and trends in drug
efficacy
• Alert period—Treatment failure
rates of 6–15%.
Evaluate the expected adverse effects of
increased drug resistance
• Action period—Treatment failures of
16–24%.
Evaluate potential drug alternatives and channels of
drug distribution
Be ready for preparing a plan for intervention when
resistance to the first-line drug becomes
intolerable.
• Change period—treatment failure 25%
or above,
Change the first line drug
Thank you for your
attention