Africa Pharmacovigilance Meeting 2012: Ensuring Quality and Safety of Medicines in Sub-Saharan Africa

With an increasing number of individuals in African countries having access to essential medicines, there is a greater need to monitor and promote safety, quality, and effectiveness of medicines. The burden of adverse events from poor product quality, adverse drug reactions, and medication errors pose great challenges to health care systems, besides the impact on morbidity and mortality. Yet few developing countries have the structures, systems, or resources in place to conduct pharmacovigilance activities, and countries often lack unbiased, evidence-based information to help guide regulatory and patient safety decisions.

To address this critical gap, the U.S. Agency for International Development (USAID)-funded Strengthening Pharmaceutical Systems (SPS) Program, led by Management Sciences for Health (MSH), conducted a study of pharmacovigilance systems and performance in sub-Saharan Africa in 2011, led by individual focus country National Regulatory Authorities, with support from an interagency agreement between the U.S. Food and Drug Administration (FDA) and USAID.

From April 18-20, 2012 a Pharmacovigilance Meeting will be held in Nairobi, Kenya to launch the new Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance report.

Written and published by SPS based on the study, the report addresses the pharmacovigilance systems gap and provides a comprehensive description and analysis of these particular systems and their performance in sub-Saharan Africa. The data was compiled in 2011 using more than 400 literature reviews and assessments in 46 sub-Saharan African countries.

The Pharmacovigilance Meeting -- which is being hosted by the Ministry of Health, Kenya; the Pharmacy and Poisons Board; the USAID-funded, MSH-led, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program; and the USAID-funded, MSH-led Health Commodities and Services Management (HCSM) Program -- will bring together partners from the African Regulatory Authorities, The World Health Organization (WHO), The Bill & Melinda Gates Foundation, European Medicines Agency, Centers for Disease Control and Prevention (CDC), FDA, USAID, and other key stakeholders to disseminate the study findings and facilitate a dialogue around common needs and opportunities.

The meeting also includes a two-day intensive workshop where national regulatory authorities, national immunization programs, and public health program representatives from sub-Saharan African countries will share their current practices and collectively identify operational tools and guidelines needed to implement pharmacovigilance activities with a systems perspective.

For more information about the meeting, visit the 2012 Pharmacovigliance Meeting website.
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New report: Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance Read the report.



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