Pharmacovigilance in Nigeria: An Overview
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LEADING ARTICLE
Pharmacovigilance in Nigeria: An Overview Abimbola Olowofela1
•
Annie Fourrier-Re´glat2,3,4,5 • Ambrose O. Isah1,6
Published online: 19 January 2016 Ó Springer International Publishing Switzerland 2016
Abstract Nigeria was admitted into the WHO International Drug Monitoring Programme in 2004. That marked a new era of pharmacovigilance in Nigeria. Nigeria is a large country in sub-Saharan Africa with essentially a homogenous black population of over 170 million people, a significant disease burden (communicable and noncommunicable) and consequent medication use. Inevitably, the need for medicine safety is becoming increasingly appreciated by the government, health-care workers and patients. Pharmacovigilance activities in Nigeria are coordinated by the National Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug Administration and Control (NAFDAC—the drug regulatory agency in Nigeria). NPC serves as a repository for reported adverse drug reactions from health workers and also liaises with other international groups such as the WHO, US Food and Drug Administration and the European Medicines Agency in improving drug safety in Nigeria. Increasing participation of the public in drug safety is also a major thrust of the NPC and the contributions of public-health programmes in this resource-poor & Abimbola Olowofela [email protected] 1
Clinical Pharmacology and Therapeutics Unit, Department of Medicine, University of Benin, Benin-City, Edo State, Nigeria
2
University of Bordeaux, 33000 Bordeaux, France
3
CIC Bordeaux CIC1401, 33000 Bordeaux, France
4
CHU Bordeaux, 33000 Bordeaux, France
5
INSERM, U657, 33000 Bordeaux, France
6
National Drug Safety Advisory Committee, National Agency for Food and Drug Administration and Control, Federal Ministry of Health, Abuja, Nigeria
setting to pharmacovigilance cannot be overemphasised. The provisions of a unique policy to define the responsibilities of the stakeholders in pharmacovigilance, as well as training of the health-care workers, are a few of the achievements of the agency in charge of pharmacovigilance in Nigeria.
Key Points Pharmacovigilance is a growing entity in Nigeria, the largest homogenous black population in Sub-Saharan Africa with a morbidity mix resulting in complex medication use. The profile of adverse reactions and burden is yet to be fully characterised in this resource-poor setting. The Nigerian National Pharmacovigilance Centre is in charge of pharmacovigilance activities in the country and interacts with the public, health workers, patients, marketing authorisation holders and the WHO and other international agencies. A stand-alone pharmacovigilance policy has been approved in Nigeria.
1 Introduction Nigeria is a developing nation in the West African subregion with a large population of 170 million persons and a myriad of health- and medicine-related problems. The morbidity and mortality related to medication use has not been formally quantified in the country. However, poor
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recognition
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