Framework of antimalarial drug policy

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Framework of antimalarial drug policy

• Dr H. Atta
• MO/RBM
• WHO/EMRO

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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

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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

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• Antimalarial Drug policy (AMDP)

National health policy
AMDP
National Drug policy
National malaria Control policy
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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

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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.

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Drug policy- aims

• Reduce morbidity,
• Halt the progression of uncomplicated disease
  into severe and potentially fatal disease,
  thereby reduce malaria mortality,
• Reduce the impact of placental malaria infection
  and maternal malaria-associated anaemia through
  PIT,
• Minimize the development of antimalarial drug
  resistance.

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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).

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Most important

• The choice of first line treatment has the
  greatest economic implications and the greatest
  public health implications.

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Stages of AMDP
Development of policy
Implementation
updating
monitoring
reevaluation
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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

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Developing/revising AMDP Information needed

• Epidemiological situation
• Prevalence, incidence, mortality, seasonality,
  parasite species, efficacy to currently used
  antimalarial drugs
• Access
• properties of available alternative drugs
• Analysis of provider and consumer behaviors
• Analysis of health system capacity to implement
  the revised policy ( regulatory and legislative
  framework.

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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

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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

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Implementation-1

• The key aspects
• Compliance
• Financial, human and technical resources
• Health care infrastructure
• Drug regulation, supply, distribution and quality
  assurance

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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.

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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

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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.

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When to change

• No well-defined criteria for determining the
  level of
• clinical
• or
• parasitological
• failures for replacing the first-line drug

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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

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Position of the countries in relation to TFR
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• Grace periodLow levels of drug failures, 5.
• determine baseline data and trends in drug
  efficacy
• Alert periodTreatment failure rates of 615.
• Evaluate the expected adverse effects of
  increased drug resistance

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• Action periodTreatment failures of 1624.
• 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 periodtreatment failure 25 or above,
• Change the first line drug

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Thank you for your attention