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Pharmacovigilance systems in developing countries: an evaluative case study in Burkina Faso
Lassane Kabore1, Pascal Millet, Souleymane Fofana
1Ministry of Health, Ouagadougou, Burkina Faso.
Drug Safety
|April 13, 2013
Summary
Burkina Faso
Area of Science:
- Pharmacovigilance and drug safety monitoring in Sub-Saharan Africa.
- Public health and pharmaceutical regulation in developing countries.
Background:
- Burkina Faso implemented a formal pharmacovigilance system in 2008.
- This system addresses the need to monitor new medicines for malaria, HIV/AIDS, and meningitis.
- The system aims to ensure the safety and effectiveness of deployed pharmaceuticals.
Purpose of the Study:
- To evaluate the early-stage pharmacovigilance system in Burkina Faso.
- To identify areas for improvement using a comprehensive, system-based approach.
Main Methods:
- A descriptive cross-sectional study was conducted in Burkina Faso.
- Key informants from the National Drug Authority (NDA), public health programs (PHPs), and hospitals were interviewed.
- Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT) and document review.
Main Results:
- The National Drug Authority (NDA) scored 70% in performance.
- Key weaknesses include lack of specific laws, national guidelines, and insufficient stakeholder coordination.
- While local risks are not yet identified, external safety alerts lead to regulatory actions like marketing authorization modifications and medicine withdrawals.
Conclusions:
- Strengthening the legal framework and structures for pharmacovigilance is crucial.
- Improved coordination among stakeholders is necessary for effective risk management.
- Investment is needed for the system to manage local medicine-related risks and serve as a public health tool.
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