Evaluation of Pharmacovigilance Practice in Pharmaceutical Companies in Nigeria

Abstract

Nigeria provides strong commercial opportunities for both domestic and multinational pharmaceutical companies. Both local and international regulations require marketing authorization holders to monitor the safety of their pharmaceutical products; however, the extent to which these regulations are being followed is not clear. The objective of this study was to evaluate pharmacovigilance practices in pharmaceutical companies in Nigeria. In this descriptive study, a pretested questionnaire was distributed to 67 pharmaceutical companies based in Lagos, Nigeria. The questionnaire focused on nine basic pharmacovigilance requirements to assess pharmacovigilance practices at each company. A total of 31 companies (46 %) returned the study questionnaire; the majority were domestic companies marketing imported pharmaceutical products. Eight companies (26 %) had a pharmacovigilance unit as an integral part of either the regulatory or the medical unit. There were no standalone pharmacovigilance units. Fewer than ten companies had standard operating procedures for processing individual case safety reports, periodic safety update reports, conducting clinical trials, and training of staff on pharmacovigilance and risk-management plans. We found very little implementation of quality pharmacovigilance systems in the pharmaceutical companies surveyed. Improvements are needed to ensure effective safety monitoring by pharmaceutical companies in Nigeria. Regular inspections, audits, and enforcement of pharmacovigilance guidelines by health authorities would improve and strengthen pharmacovigilance systems in Nigeria.