Evidence map›Paper›PMID 39317875›Full record

ArticleTherapeutic innovation & regulatory science2024

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

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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Article in Therapeutic innovation & regulatory science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

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8 authors.

Augustus Chukwuebuka EzeodimegwuDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria. augustus.ezeodimegwu@gmail.com.
Francis Chibuike IloabuchiDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.
Ifunanya Mary-Ann OnyiaDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.
Cynthia Chidubem EzeDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.
Gabriel EzenriDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.
Princess Chidimma OnyekwuoDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.
Chukwuebuka Vincent IhemegbulamDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.
Abdulmuminu IsahDepartment of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.

Funding

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6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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.

resultsOf 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.

conclusionThe 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.

Indexed as

PharmacovigilanceWorld Health OrganizationAdverse Drug Reaction Reporting SystemsCross-Sectional StudiesDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleNigeriaSecondary Care CentersSurveys and Questionnaires

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PMID39317875

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.