| アブストラクト | AIMS: To estimate the actual number of adverse drug reactions (ADRs), we used the French medical administrative database (PMSI) in addition to ADRs spontaneously reported in the French Pharmacovigilance Database (FPVDB). METHODS: Capture-recapture method was applied to these 2 sources (PMSI and FPVDB), checking their independence via a third data source. The study ran from 1 July 2014 to 30 June 2016 in 9 French general hospitals. From PMSI, all discharge summaries including a selection of 10th International Classification of Diseases codes related to ADRs were analysed. This selection was based on the results of a previous study. All ADRs corresponding to these codes, spontaneously reported in the FPVDB, were included. RESULTS: In PMSI, 56.9% of hospital stays were related to an ADR (628 out of 1104). In the FPVDB, we retained 115 cases. A total of 43 ADRs were common to the 2 databases. In both sources, the most frequently reported ADRs were cutaneous (33.1 and 19.1%) and renal (25.2% and 11.6%). The most frequently suspected drugs were anti-infectives in PMSI (31.1%) and antineoplastic drugs in the FPVDB (30.4%). Using the capture-recapture method, the estimated number of ADRs was 1657 [95% CI: 1273 to 2040]. CONCLUSION: The use of the PMSI could constitute an additional tool for the estimation of the actual number of ADRs in French hospitals. A model involving a third data source enabled the independence of the 2 sources (PMSI and FPVDB) to be checked before applying the capture-recapture method. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2020/6/3 |
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| 投稿者 | Osmont, Marie-Noelle; Degremont, Adeline; Jantzem, Helene; Audouard-Marzin, Youna; Lalanne, Sebastien; Carlhant-Kowalski, Dominique; Bellissant, Eric; Oger, Emmanuel; Polard, Elisabeth |
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| 組織名 | Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU,;Rennes, France.;Univ Rennes, EA 7449 REPERES 'Pharmacoepidemiology and Health Services Research',;Pharmacovigilance centre, CHRU, Brest, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32484575/ |
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