| アブストラクト | INTRODUCTION: Adverse drug reactions (ADRs) can be reported by Health Care Professionals (HCPs; e.g., physicians, pharmacists) and non-Health Care Professionals (non-HCPs; e.g., consumers). Previous studies investigating differences between reports from HCPs and non-HCPs rarely considered the completeness of information provided. In addition, they mostly did not distinguish between physicians and pharmacists or were performed years ago. The aim of our study was to analyse and compare the completeness of information provided in reports from physicians, pharmacists and consumers from Germany in a more recent dataset. MATERIALS AND METHODS: We analysed all spontaneous reports from Germany received between 2018 and 2021 in the ADR database EudraVigilance exclusively reported by physicians (n = 69,976), pharmacists (n = 42,396) or consumers (n = 121,144). Demographical parameters of the patients were analysed descriptively. Completeness of reports was evaluated applying an established score (vigiGrade). Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using logistic regression analysis in order to identify report, patient, drug or ADR-specific information provided more often in reports from physicians, pharmacists or consumers. RESULTS: Within the study period the number of reports per year by physicians and pharmacists decreased steadily, while an opposite trend was observed for consumer reports. The proportion of female patients was higher in reports from pharmacists (64.4%) and consumers (64.8%) compared to those from physicians (55.3%). On average, patients in reports from pharmacists (58.7) were older compared to those from physicians (53.5) and consumers (52.6). As an example for the presence of specific information, the time to onset of the ADR could be calculated more often in consumer compared to physician (OR 1.9 [1.8-1.9]) and pharmacist reports (OR 1.7 [1.6-1.7]). In contrast, pharmacist (OR 0.5 [0.4-0.5]) and consumer (OR 0.5 [0.5-0.5]) reports included the indication of the suspected drug less often than physician reports. Physician reports on average (mean = 0.5) were slightly more complete according to the vigiGrade score compared to reports from consumers (mean = 0.4) and pharmacists (mean = 0.4). CONCLUSION: The ADR reports from consumers were comparable with regard to the completeness score with those from physicians and pharmacists underlining their value. Differences in completeness of specific information between the reporter types were found, suggesting that a common reporting of interactions between the three reporters may further improve the completeness of ADR reports. Furthermore, stratified analysis of ADR reports per reporter type may be helpful for certain objectives in scientific research. |
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| ジャーナル名 | Drug safety |
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| 投稿日 | 2023/11/21 |
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| 投稿者 | Christ, Patrick; Dubrall, Diana; Schmid, Matthias; Sachs, Bernhardt |
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| 組織名 | Research Division, Federal Institute for Drugs and Medical Devices, Bonn,;Germany.;Institute for Medical Biometry, Informatics and Epidemiology, University Hospital;of Bonn, Bonn, Germany.;Germany. Bernhardt.Sachs@bfarm.de.;Department for Dermatology and Allergy, University Hospital RWTH Aachen, Aachen, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37987966/ |
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