Pharmacovigilance in Public Health Programmes

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Pharmacovigilance in Public Health Programmes

• Dr M.R. Couper
• Quality Assurance and Safety Medicines
• Essential Drugs and Medicines Policy, WHO

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• Pharmacovigilance Programmes
• Public Health Programmes
• How to integrate pharmacovigilance into public
  health

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Pharmacovigilance

• The science and activities relating to the
  detection, assessment, understanding and
  prevention of adverse effects or any other
  drug-related problem.

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Aims of Pharmacovigilance

• to improve patient care and safety
• to improve public health and safety
• to contribute to the assessment of benefit, harm,
  effectiveness and risk of medicines,
• to promote education and clinical training
• to promote effective communication to the public
• to promote rational and safe use of medicines

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Major advances in pharmacovigilance

• Broadening scope to include traditional
  medicines, medical devices, counterfeit products,
  medical errors, counterfeit drugs.
• Sophisticated technology such as Bayesian
  Confidence Neural Network.
• Communications- The Erice Declaration Dialogue
  in Pharmacovigilance

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Guidelines in pharmacovigilance

• Guidelines for setting up a national
  pharmacovigilance centre
• A guide to detecting and reporting adverse drug
  reactions
• The importance of pharmacovigilance
• Pharmacovigilance in Public Health

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Pharmacovigilance in industrialized countries

• Considered an essential part of drug regulation
• Well-established systems for more than 25 years
• Regulatory systems - well-developed

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Pharmacovigilance in developing countries -
realities

• Easier access to any drug
• Regulation may not be well developed
• Quality issues
• Expired drugs
• Still considered a luxury

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Opportunities for PV in developing countries

• Use of traditional / alternative medicine
• Concern about safety of vaccines, cosmetics
• Drugs as a political issue
• USE OF DRUGS IN PUBLIC HEALTH PROGRAMMES

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Public Health

• Public health or community health is defined as
  the science and art of preventing disease,
  prolonging life and promoting health and
  efficiency through organized community effort.

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Types of Public Health Programmes

• Education
• Lifestyle and behavioral changes
• Environmental modifications
• Nutritional interventions
• Drug administration programmes
• Mass control programmes
• Case specific programmes
• Individual treatment programmes

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Examples of Public Health Programmes in WHO

• Malaria programme
• Lymphatic filaraiasis programme
• Helminths programme
• Trachoma programme
• HIVAIDS programmes
• Vaccines programme
• Herbal medicines programme

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Strengths of Public Health Programmes

• Well established programmes using a limited
  number of drugs or vaccines
• Quality of product can be assured
• Large populations involved
• Numbers can be defined
• Operate according to standard guidelines
• Well-funded with international support

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Changing needs in Public Health

• Greater public expectations for access
• New drugs introduced
• Better communication needed for professionals and
  consumers

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Weaknesses of Public Health Programmes

• No direct contact with a physician
• Disease may not be well-diagnosed
• Insufficient follow-up
• Patient information is inadequate

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Weaknesses of Public Health Programmes (Cont.)

• Newer, more potent products or combinations of
  products are being used
• Vulnerable populations such as pregnant women,
  children and old people
• NO METHOD FOR SAFETY MONITORING

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Two separate systems

• Pharmacovigilance Programmes
• Staff
• Resources

• Public Health Programmes
• Staff
• Resources

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Pharmacovigilance in public health
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REPORTING SYSTEM FUNCTIONAL AND STRUCTURAL
RELATIONSHIP
T r a c h o m a t i s
F i l a r i a s i s
T u b e r c u l o s i s
M a l a r i a
V a c c i n e s
W.H.O Programmes
INTERNATIONAL ADVISORY GROUP
WHO-PV (UMC)
MINISTRY OF HEALTH
F i l a r i a s i s
T u b e r c u l o s i s
M a l a r i a
V a c c i n e s
PV National Centres
National public health Programmes
NATIONALADVISORYGROUP
Health workers
Patients
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Roles of the various parties

• PH Programme Programme Manager
• PV Programme PV Officer
• Advisory Panels
• WHO

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Role of Programme Manager

• Collect data on
• Health outcome
• Morbidity, mortality
• Incidence and prevalence of disease
• ADRs
• Evaluate data and follow-up

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Role of Pharmacovigilance Officer

• Establish a data-base for ADRs
• Analyse and evaluate ADR data
• Submit important data to a review panel
• Follow-up if necessary

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Role of the Advisory Panel

• Reviewing and advising on ADR data collected in a
  PH Programme
• Providing advice for all safety monitoring
  schemes of the PH Programme
• Providing advice on training in safety monitoring
• Providing advice on further operational research
  issues if deemed necessary

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Role and function of WHO

• serve as a repository of information
• integrate activities
• encourage and support operational research
• develop policies
• respond to special issues in drug safety
• develop and promote training materials

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Future of PV in Public Health Programmes

• Institutional development and capacity building
• Conducive Environment
• Networks are crucial
• Global advocacy is essential

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Pharmacovigilance in Public Health Programmes

• PHARMACOVIGILANCE IS NOT A LUXURY
• IT MUST BE INTEGRATED INTO PH PROGRAMMES
• SAFETY IS YOUR RESPONSIBILTY