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

Autor: Osmont MN; Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France., Degremont A; Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France.; Univ Rennes, EA 7449 REPERES 'Pharmacoepidemiology and Health Services Research', Rennes, France., Jantzem H; Pharmacovigilance centre, CHRU, Brest, France., Audouard-Marzin Y; Pharmacovigilance centre, CHRU, Brest, France., Lalanne S; Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France., Carlhant-Kowalski D; Pharmacovigilance centre, CHRU, Brest, France., Bellissant E; Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France., Oger E; Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France.; Univ Rennes, EA 7449 REPERES 'Pharmacoepidemiology and Health Services Research', Rennes, France., Polard E; Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France.; Univ Rennes, EA 7449 REPERES 'Pharmacoepidemiology and Health Services Research', Rennes, France.
Jazyk: angličtina
Zdroj: British journal of clinical pharmacology [Br J Clin Pharmacol] 2021 Feb; Vol. 87 (2), pp. 471-482. Date of Electronic Publication: 2020 Jun 18.
DOI: 10.1111/bcp.14405
Abstrakt: 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.
(© 2020 The British Pharmacological Society.)
Databáze: MEDLINE
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