| アブストラクト | AIMS: In order 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 two sources ("PMSI" and FPVDB), checking their independence via a third data source. The study ran from July 1st, 2014 to June 30th, 2016 in nine French general hospitals. From "PMSI", all discharge summaries including a selection of ICD10 codes (10th International Classification of Diseases) related to ADRs were analyzed. 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 1,104). In the FPVDB, we retained 115 cases. A total of 43 ADRs were common to the two 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 1,657 [95 % CI: 1,273 to 2,040]. CONCLUSIONS: 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 two 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,;35000, Rennes, France.;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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