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Current State of Pharmacovigilance in African Countries
Background: Although the urgency of strengthening pharmacovigilance programs in developing countries is increasingly being recognized, little is known about pharmacovigilance in Africa.
Objective: To describe and evaluate the pharmacovigilance situation in Africa.
Methods: A standardized questionnaire assessing the pharmacovigilance situation in Africa was carried out between May 1st and August 31st 2013. It was designed to collect information on the structures, processes, and impact of pharmacovigilance activities and was distributed via e-mail to pharmacovigilance contact persons or appropriate Ministry of Health representatives.
Findings: 80% of respondents answered the questionnaire representing 32 African countries. Key findings included: thirty-one countries (97%) have a national center or unit of pharmacovigilance. 75% (n=24) of countries have a national policy, regulation or legislation for pharmacovigilance activities and 25% (n=8) of countries still have not implemented any form of regulation. Fifteen countries (47%) confirmed the presence of a budget for pharmacovigilance activities. 75% (n=24) of responding countries have staff working full time to undertake pharmacovigilance activities, while 25% (n=8) do not have full time personnel. 31% (n=10) of countries have never sent any individual case safety reports (ICSRs) to the Uppsala Monitoring Centre and 62% (n=20) use VigiFlow® technology. The average number of Adverse Drug reactions from physician is 0.062 ± 0.08 reports. The average score on structural indicators among respondent countries is 11.93 ± 3.78 (from a maximum of 16) and the average score on process indicators is 4.03 ± 2.66 (from a maximum of 9).
Conclusion: There is profound heterogeneity with respect to the strength of pharmacovigilance systems in Africa that needs to be recognized and supported.
Learning Areas:
Conduct evaluation related to programs, research, and other areas of practiceLearning Objectives:
Describe the current situation of drug safety systems and policies in African countries
Evaluate drug safety systems performance in African countries
Compare the performance of drug safety policies between African countries
Keyword(s): Health Assessment, International Health
Qualified on the content I am responsible for because: I have been practicing pharmacy for over 10 years and hold a PhD in Health Services Research from the Brown University School of Public Health, a PharmD from the University of Illinois, and an MPH from Harvard University. I was an active participant at the inaugural conference on Drug Safety in the Arab World and am a member of the WHO Collaborating Center Working Group on Pharmacovigilance in the Arab world, based in Morocco.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.