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BMC Pharmacol Toxicol. 2018 May 31;19(1):27. doi: 10.1186/s40360-018-0217-2.

Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators.

Author information

1
Department of Clinical Pharmacology and Therapeutics, University of Benin, Benin-City, Edo State, Nigeria. felabimbola@yahoo.com.
2
Department of Medicine, University of Benin Teaching Hospital, Benin-City, Nigeria. felabimbola@yahoo.com.
3
Inserm, Bordeaux Population Health Research Center, team, Pharmacoepidemiology, University Bordeaux, UMR 1219, F-33000, Bordeaux, France.
4
Bordeaux PharmacoEpi, INSERM CIC1401, F-33000, Bordeaux, France.
5
CHU de Bordeaux, Pôle de santé publique, Service de Pharmacologie médicale, F-33000, Bordeaux, France.
6
Department of Clinical Pharmacology and Therapeutics, University of Benin, Benin-City, Edo State, Nigeria.
7
Department of Medicine, University of Benin Teaching Hospital, Benin-City, Nigeria.
8
National Drug Safety Advisory Committee, National Agency for Food and Drug Administration and Control, Federal Ministry of Health, Abuja, Nigeria.

Abstract

BACKGROUND:

WHO pharmacovigilance indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of pharmacovigilance at peripheral centres. This study evaluated the status of pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the pharmacovigilance system in the zone.

METHODS:

A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively.

RESULTS:

A total of six hospitals were visited and all institutions had a pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of pharmacovigilance activities characterised all centres.

CONCLUSION:

This study has shown an urgent need to strengthen the pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of pharmacovigilance may be the first steps to improve pharmacovigilance activities in the tertiary hospitals.

KEYWORDS:

Adverse drug reaction reporting; Nigeria; Pharmacovigilance; Tertiary hospitals

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