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

Marie-Noëlle Osmont (1) , Adeline Degremont (1, 2) , Hélène Jantzem (3) , Youna Audouard-Marzin (3) , Sébastien Lalanne (1) , Dominique Carlhant-Kowalski (3) , Eric Bellissant (1) , Emmanuel Oger (1, 2) , Elisabeth Polard (1, 2)

1 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
2 REPERES - Recherche en Pharmaco-épidémiologie et Recours aux Soins
3 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest

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.

Mots clés: adverse drug reaction reporting systems; pharmacovigilance; databases; 10th International Classification of Diseases

Domaines: Pharmacologie; Santé publique et épidémiologie

Marie-Noëlle Osmont, Adeline Degremont, Hélène Jantzem, Youna Audouard-Marzin, Sébastien Lalanne, et al.. 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, 87 (2), pp.471-482. ⟨10.1111/bcp.14405⟩. ⟨hal-02887186⟩