Assessment of the State of Pharmacovigilance in Secondary Hospitals in the Federal Capital Territory of Nigeria, Using WHO Pharmacovigilance Indicators.

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-11-01 Epub Date: 2024-09-24 DOI:10.1007/s43441-024-00703-9
Augustus Chukwuebuka Ezeodimegwu, Francis Chibuike Iloabuchi, Ifunanya Mary-Ann Onyia, Cynthia Chidubem Eze, Gabriel Ezenri, Princess Chidimma Onyekwuo, Chukwuebuka Vincent Ihemegbulam, Abdulmuminu Isah
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Abstract

Background: The importance of pharmacovigilance (PV) in ensuring drug safety, especially in the detection and prevention of adverse drug reactions (ADRs) is critical. However, PV activities in Nigeria still face many challenges, such as very low spontaneous reporting rates, and inadequate training and funding. This study assessed the state of pharmacovigilance in the federal capital territory of Nigeria (FCT), using WHO pharmacovigilance indicators.

Methods: A cross-sectional questionnaire-based survey was carried out among secondary healthcare facilities in the FCT. The WHO Pharmacovigilance Indicators Questionnaire, which consists of the structural, process and outcome measures, was used to collect data from the focal person for pharmacovigilance at all the consenting facilities. Descriptive statistics were used to summarize all variables. Ethical approval was obtained from the Ethics Review Committee of the FCT development authority.

Results: Of the 14 secondary healthcare facilities in the FCT, 11 agreed to the study (response rate = 84.6%). Among the respondents, 4 (36.4%) were females, and 2 (18.2%) had 9 years of experience in pharmacovigilance. For the core structural indicators, 7 (63.6%) of the facilities had a pharmacovigilance center while only 4 (36.4%) had a copy of the Nigerian pharmacovigilance policy. Regarding financial provisions, 10 (90.9%) hospitals reported that there was no regular financial provision for the center while 10 (90.9%) centers had a standard adverse drug reaction reporting form. For the core process indicators, the mean ± SD of the nine core process indicators ranged from 0.9 ± 3.0 to 75.6 ± 38.6 and the total number of reports in the local database, therapeutic ineffectiveness, and medication error were limited.

Conclusion: The assessment of pharmacovigilance activities in the Federal Capital Territory of Nigeria revealed significant gaps in infrastructure, financial support, and process implementation. Despite the presence of pharmacovigilance centers in the majority of facilities, the lack of consistent financial support and limited adherence to core process indicators highlight the need for enhanced training, resources, and policy enforcement to improve ADR reporting and overall drug safety monitoring. Strengthening these areas is crucial for advancing pharmacovigilance practices and ensuring patient safety in Nigeria.

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使用世界卫生组织药物警戒指标评估尼日利亚联邦首都地区二级医院的药物警戒状况。
背景:药物警戒 (PV) 在确保药物安全,特别是在检测和预防药物不良反应 (ADR) 方面至关重要。然而,尼日利亚的药物警戒活动仍面临许多挑战,如自发报告率非常低、培训和资金不足等。本研究采用世界卫生组织的药物警戒指标,对尼日利亚联邦首都区(FCT)的药物警戒状况进行了评估:方法:在联邦首都区的二级医疗机构中开展了一项横向问卷调查。世卫组织药物警戒指标调查表包括结构、过程和结果三方面的衡量指标,调查表用于向所有同意调查的医疗机构的药物警戒协调人收集数据。所有变量均采用描述性统计方法进行总结。研究结果已获得联邦首都直辖区发展局伦理审查委员会的伦理批准:在联邦首都直辖区的 14 家二级医疗机构中,有 11 家同意参与研究(回复率 = 84.6%)。受访者中有 4 位女性(占 36.4%),2 位(占 18.2%)拥有 9 年药物警戒经验。在核心结构指标方面,7 家机构(63.6%)设有药物警戒中心,只有 4 家机构(36.4%)拥有尼日利亚药物警戒政策。在财政拨款方面,10 家(90.9%)医院表示没有为中心提供定期财政拨款,而 10 家(90.9%)中心拥有标准的药物不良反应报告表。在核心流程指标方面,9项核心流程指标的平均值(±SD)从0.9±3.0到75.6±38.6不等,本地数据库中的报告总数、治疗无效和用药错误的报告数量有限:对尼日利亚联邦首都区药物警戒活动的评估显示,该地区在基础设施、财政支持和流程实施方面存在巨大差距。尽管大多数机构都设有药物警戒中心,但由于缺乏持续的财政支持以及对核心流程指标的遵守有限,突出表明需要加强培训、资源和政策执行,以改善药物不良反应报告和整体药物安全监测。加强这些方面的工作对于尼日利亚推进药物警戒实践和确保患者安全至关重要。
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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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