Opadeyi Abimbola O, Fourrier-Réglat Annie, Isah Ambrose O
Department of Clinical Pharmacology and Therapeutics, University of Benin, Benin-City, Edo State, Nigeria.
Department of Medicine, University of Benin Teaching Hospital, Benin-City, Nigeria.
BMC Pharmacol Toxicol. 2018 May 31;19(1):27. doi: 10.1186/s40360-018-0217-2.
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.
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.
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.
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.
世界卫生组织的药物警戒指标已被推荐为改善药物警戒活动的有用工具。面临诸多与药品相关问题的尼日利亚，正在推动基层中心药物警戒工作的发展。本研究评估了尼日利亚南南地区三级医院的药物警戒状况，以期改善该地区的药物警戒系统。
在该国南南地区随机选取的六家三级医院开展了一项横断面描述性调查。数据收集采用世界卫生组织核心药物警戒指标。本研究对评估用语进行了措辞调整，以适用于三级医院环境。数据以定量和定性方式呈现。
共走访了六家医院，所有机构均设有药物警戒中心，但只有三家可被描述为功能正常或部分功能正常。只有一个中心为药物警戒活动提供了资金。值得注意的是，其中一家医院没有国家药品不良反应报告表。各中心数据库中发现的上一年度药品不良反应报告数量从无到26份不等，只有一个中心将其报告全部提交给了国家药物警戒中心。记录在案的与药物相关的住院病例很少，范围从0.0985/1000到1.67/1000，所有中心的药物警戒活动记录都很差。
本研究表明，迫切需要加强尼日利亚南南地区的药物警戒系统。改善病历记录以及加强药物警戒的制度化，可能是改善三级医院药物警戒活动的第一步。
