New report on the Safety of Medicines in Sub-Saharan Africa

With an increase in access to new essential medicines in Africa, 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.

Safety of Medicines in sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance which has been developed by the USAID funded and Management Sciences for Health (MSH) implemented SPS Program, addresses this gap and provides a comprehensive description and analysis of pharmacovigilance 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.

This thorough work presents critical findings—achievements made to date and challenges countries are faced with—and recommendations to enhance medicine safety systems in developing countries. All stakeholders including regulators, public health program managers, pharmaceutical industry, donors, health care workers, and patients can take key messages from this report on their roles and responsibilities that will lead to actions to improve patient safety and health outcomes.

This study was made possible through an interagency agreement between the US Food and Drug Administration (FDA) and USAID. The combined support enabled the SPS Program to implement the study. The opinion expressed in this report does not necessarily reflect the official position of the FDA, the USAID or the US Government. The contents are the responsibility of MSH.

Recent comments about the report:

“Regulatory authorities have responsibility beyond getting the product to the market. The lip service that is currently paid to post-marketing surveillance is well documented by this report….”
Margareth Ndomondo-Sigonda, African Medicines Regulator

“Patient safety should be at the center of all we do. This study has highlighted how far we are from that goal…. But it is not without hope. In its recommended strategies, the report shows opportunities exist for everyone to act. What is needed is the will to act now!”
Eva Ombaka, Visiting Lecturer, St. John’s University, Tanzania, and formerly with the Ecumenical Pharmaceutical Network

“The result of the study clearly showed little efforts by public health programs. Monitoring and ensuring the safe use of medicines are critical to the success of these programs. Global partners must, as a matter of urgency, integrate in their planning phase, functional medicine safety systems to monitor the effects of donated products.”
Paul Orhii, Director General, National Agency for Food and Drug Administration and Control, Nigeria

“Pharmacovigilance is a critical component of health systems and of importance to all stakeholders, regulators, industry, health workers, and patients—for whom it may well be a matter of life and death.”
Alex Dodoo, Director, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, Accra, Ghana

Pharmacovigilance 2012 Meeting

Increasing numbers of individuals in African countries have access to essential medicines, and the critical need for strong surveillance and adverse event reporting systems is evident. Though pharmacovigilance infrastructure is beginning to be deployed more widely in Africa, there is limited data on the actual performance from a systems perspective.

To address this critical gap, the Strengthening Pharmaceutical Systems (SPS) Program 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 the U.S. Agency for International Development (USAID).

The 2012 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, WHO, BMGF, EMA, CDC, FDA, USAID, and other key stakeholders to disseminate the study findings and facilitate a dialogue around common needs and opportunities.

The meeting includes a one-day launch of the study publication, Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance, followed by a two-day intensive workshop where countries will share their current practices and collectively identify operational tools and guidelines needed to implement pharmacovigilance activities with a systems perspective.

Simultaneous translation in French will be provided throughout the meeting.

We look forward to your attendance at this exciting event.

For any questions, please contact  pharmacovigilance@msh.org.