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Hospital databases for the identification of adverse drug reactions: A 2‐year multicentre study in 9 French general hospitals
Author(s) -
Osmont MarieNoëlle,
Degremont Adeline,
Jantzem Hélène,
AudouardMarzin Youna,
Lalanne Sébastien,
CarlhantKowalski Dominique,
Bellissant Eric,
Oger Emmanuel,
Polard Elisabeth
Publication year - 2021
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14405
Subject(s) - pharmacovigilance , medicine , database , drug reaction , emergency medicine , adverse effect , drug , pharmacology , computer science
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.