| アブストラクト | The objective of this study is to examine the potential association between drug use and adverse event reporting in France. A number of drug users and cases reported were extracted from the French Health Care Insurance database (Open Medic) and the French pharmacovigilance database. We performed two separate mixed-effect models (with a drug used or reporting rate as dependent variables) with a random intercept for drug classes. We selected 62 drugs from 10 drug classes, for which 177 364 cases were reported in the French pharmacovigilance database in 2020. The results showed a strong association between drug users and the number of reported cases in France among each drug class (P < 0.01). Within a drug class, the number of reported cases is, therefore, a proxy for the exposure to a given drug in the population. This finding could be useful to approximate and compare drug exposure from pharmacovigilance databases. |
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| ジャーナル名 | Fundamental & clinical pharmacology |
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| 投稿日 | 2023/3/14 |
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| 投稿者 | Orhon, Pauline; Robert, Marion; Morand, Thomas; Cracowski, Jean-Luc; Khouri, Charles |
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| 組織名 | Pharmacovigilance Unit, Grenoble Alpes University Hospital, 38000, Grenoble,;France.;Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, Grenoble, France.;Clinical Pharmacology Department INSERM CIC1406, Grenoble Alpes University;Hospital, 38000, Grenoble, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36908067/ |
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