| アブストラクト | The aim of this study was to identify factors associated with the completeness of spontaneous reports of adverse drug reactions (ADR) from different reporter types. We analysed 69,976 spontaneous ADR reports from physicians, 42,396 from pharmacists and 121,144 from consumers. The adjusted vigiGrade completeness score for ADR reports from EudraVigilance was used to evaluate the completeness of information provided in the structured format of each ADR report. Mean values of the vigiGrade completeness scores were calculated for various factors such as age, sex, receive year, seriousness and causal relationship. For all three reporters, the completeness of the ADR reports referring to older patients and children/ adolescents was lower than for middle-aged patients. Furthermore, generally poorly documented reports often included more than one suspected/interacting drug or no information on the patients' sex. Additionally, ADR reports with an at least possible causal relationship were more completely documented than those with a not assessable causal relationship in a subset of 479 ADR individually assessed reports. Differences between the reporters were only observed regarding seriousness criteria and receive year. The missing of certain information parameters in ADR reports from all three reporter types may serve as indicators for a poorer overall completeness of documentation. |
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| 組織名 | Institute for Medical Biometry, Informatics and Epidemiology, University Hospital;Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Diana.Dubrall@bfarm.de.;Research Division, Federal Institute for Drugs and Medical Devices (BfArM),;Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany. Diana.Dubrall@bfarm.de.;Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.;Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.;Department for Dermatology and Allergy, University Hospital RWTH Aachen,;Morillenhang 27, 52074, Aachen, Germany. |
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