Completeness of spontaneously reported adverse drug reactions in 4 databases.
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| Název: | Completeness of spontaneously reported adverse drug reactions in 4 databases. |
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| Autoři: | Dedefo MG; Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia., Kassie GM; Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.; South Australian Health and Medical Research Institute, Adelaide, SA, Australia.; College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia., Gebreyohannes EA; Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.; Centre for Optimisation of Medicines, School of Allied Health, The University of Western Australia, Perth, WA, Australia., Lim R; Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia., Roughead E; Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia., Kalisch Ellett L; Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia. |
| Zdroj: | British journal of clinical pharmacology [Br J Clin Pharmacol] 2025 Dec; Vol. 91 (12), pp. 3389-3400. Date of Electronic Publication: 2025 Jul 28. |
| Způsob vydávání: | Journal Article |
| Jazyk: | English |
| Informace o časopise: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Oxford : Wiley-Blackwell Original Publication: London, Macmillan Journals Ltd. |
| Výrazy ze slovníku MeSH: | Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Adverse Drug Reaction Reporting Systems*/standards , Databases, Factual*/statistics & numerical data , Databases, Factual*/standards , Drug-Related Side Effects and Adverse Reactions*/epidemiology, Humans ; Denmark/epidemiology ; Canada/epidemiology ; Pharmacovigilance ; United States/epidemiology ; United Kingdom/epidemiology ; United States Food and Drug Administration |
| Abstrakt: | Aims: To assess the completeness of information provided in adverse drug reaction (ADR) reports in 4 spontaneous report databases. Methods: 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. Results: 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%. Conclusion: 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. (© 2025 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.) |
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| Grant Information: | University of South Australia; APP1156368 National Health and Medical Research Council (NHMRC); APP2020626 National Health and Medical Research Council (NHMRC) |
| Contributed Indexing: | Keywords: adverse drug reaction reporting systems; drug safety; drug‐related side effects and adverse reactions; pharmacovigilance; postmarketing surveillance |
| Entry Date(s): | Date Created: 20250728 Date Completed: 20251126 Latest Revision: 20251128 |
| Update Code: | 20251128 |
| PubMed Central ID: | PMC12648374 |
| DOI: | 10.1002/bcp.70182 |
| PMID: | 40717560 |
| Databáze: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Aims: To assess the completeness of information provided in adverse drug reaction (ADR) reports in 4 spontaneous report databases.<br />Methods: 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.<br />Results: 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%.<br />Conclusion: 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.<br /> (© 2025 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.) |
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| ISSN: | 1365-2125 |
| DOI: | 10.1002/bcp.70182 |