Hospital databases for the identification of adverse drug reactions: A 2-year multicentre study in 9 French general hospitals.

Marie-Noëlle Osmont, Adeline Degremont, Hélène Jantzem, Youna Audouard-Marzin, Sébastien Lalanne, Dominique Carlhant-Kowalski, Eric Bellissant, Emmanuel Oger, Elisabeth Polard

British journal of clinical pharmacology 2021 Feb

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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). 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. 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]. 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. © 2020 The British Pharmacological Society.

Citation

Marie-Noëlle Osmont, Adeline Degremont, Hélène Jantzem, Youna Audouard-Marzin, Sébastien Lalanne, Dominique Carlhant-Kowalski, Eric Bellissant, Emmanuel Oger, Elisabeth Polard. Hospital databases for the identification of adverse drug reactions: A 2-year multicentre study in 9 French general hospitals. British journal of clinical pharmacology. 2021 Feb;87(2):471-482