Supporting Pharmacovigilance in Developing Countries. The Systems Perspective
(2009; 24 pages) [French] [Spanish]

Strengthening Pharmaceutical Systems (SPS). Supporting Pharmacovigilance in Developing Countries: The Systems Perspective. Submitted to the U.S. Agency for International Development by the SPS Program. Arlington, VA: Management Sciences for Health.


The devastation caused by the HIV/AIDS pandemic helped draw attention to the lack of access to medicines in resource-constrained areas — especially sub-Saharan Africa. In response, new funding sources, such as the President’s Emergency Plan for AIDS Relief, the President’s Malaria Initiative, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, have made unprecedented sums of money available to procure essential medicines, including new products such as antiretroviral (ARV) medicines for HIV/AIDS, artemisinin-based combination therapies (ACTs) for malaria, and second-line medicines for multidrug-resistant tuberculosis. The Global Fund alone has approved grants for over 15.5 billion U.S. dollars (USD ), with almost half allocated for medicines and commodities (Global Fund 2009).

With increased access to essential medicines comes a greater need to monitor and promote the safety and effectiveness of these medicines. Few developing countries, however, have the structures, systems, or resources in place to support medicine safety activities, and countries often lack unbiased, evidence-based information to help guide treatment decisions and promote rational—that is, safe, effective, and cost-effective—use of medicines. In addition, sustained budgetary support for pharmacovigilance and medicine safety activities is generally lacking. The Strengthening Pharmaceutical Systems (SPS) Program has developed a conceptual framework and operational approach to strengthen pharmacovigilance systems. Although designed to be applied in resource-constrained settings, this framework and approach will be useful to all involved in promoting access to and rational use of essential medicines, such as U.S. Agency for International Development (USAID) staff, ministries of health in developing countries, international donors, health care workers, health policy makers, and other stakeholders who recognize the need for strong pharmacovigilance systems...

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