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Completeness of spontaneously reported adverse drug reactions in 4 databases

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dc.contributor.authorDedefo, M.G.
dc.contributor.authorKassie, G.M.
dc.contributor.authorGebreyohannes, E.A.
dc.contributor.authorLim, R.
dc.contributor.authorRoughead, E.
dc.contributor.authorKalisch Ellett, L.
dc.date.issued2025
dc.descriptionData source: Supplementary information, Available from the corresponding author upon reasonable request., https://doi.org/10.1002%2Fbcp.70182
dc.description.abstract<h4>Aims</h4>To assess the completeness of information provided in adverse drug reaction (ADR) reports in 4 spontaneous report databases.<h4>Methods</h4>The study was conducted using freely accessible ADR reports from the Canada Vigilance Adverse Reaction Online Database, the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, the UK Yellow Card Scheme and the Danish Medicines Agency ADR Database, covering the period 2014-2023. The variables used to evaluate the completeness of ADR reports were selected based on the vigiGrade completeness tool. Descriptive statistics were used to report the completeness of information in each ADR report, while chi-square tests were used to analyse differences in completeness by seriousness of report.<h4>Results</h4>In total, 290 079 individual case safety reports were analysed: 4289 from the Canadian database; 269 763 from the FAERS database; 13 624 from the UK Yellow Card Scheme; and 2403 from the Danish database. The most frequently completed information was the primary reporter, with nearly 100% completeness. The most frequently omitted information was the route of administration, with completion scores of 44% in the UK Yellow Card Scheme, 55% in the Danish database and 58% in the Canadian database. In FAERS, the event date was the most frequently omitted information with a completeness rate of 50%.<h4>Conclusion</h4>The completeness of information varied across different variables, with information frequently omitted for route of administration and event date. Enhancing awareness about providing complete information during ADR reporting is essential for collecting complete data and allowing signal detection.
dc.identifier.citationBritish Journal of Clinical Pharmacology, 2025; 91(12):3389-3400
dc.identifier.doi10.1002/bcp.70182
dc.identifier.issn0306-5251
dc.identifier.issn1365-2125
dc.identifier.orcidGebreyohannes, E.A. [0000-0002-0075-4553]
dc.identifier.orcidKalisch Ellett, L. [0000-0001-5063-6128]
dc.identifier.urihttps://hdl.handle.net/11541.2/45002
dc.language.isoen
dc.publisherWILEY
dc.relation.fundingUniversity of South Australia
dc.relation.fundingNational Health and Medical Research Council (NHMRC) APP1156368
dc.relation.fundingNHMRC APP2020626
dc.relation.fundingWiley - University of South Australia agreement via the Council of Australian University Librarians
dc.rightsCopyright 2025The Author(s). This is an open access article under the terms of the Creative Commons Attribution License. (http://creativecommons.org/licenses/by/4.0/)
dc.source.urihttps://doi.org/10.1002/bcp.70182
dc.subjectHumans
dc.subjectAdverse Drug Reaction Reporting Systems
dc.subjectUnited States Food and Drug Administration
dc.subjectDatabases, Factual
dc.subjectCanada
dc.subjectUnited States
dc.subjectDenmark
dc.subjectPharmacovigilance
dc.subjectDrug-Related Side Effects and Adverse Reactions
dc.subjectUnited Kingdom
dc.titleCompleteness of spontaneously reported adverse drug reactions in 4 databases
dc.typeJournal article
pubs.publication-statusPublished
ror.fileinfo12308676060001831 13308685990001831 Open Access Published Version
ror.mmsid9917059225901831

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