Osmont Marie-Noëlle, Degremont Adeline, Jantzem Hélène, Audouard-Marzin Youna, Lalanne Sébastien, Carlhant-Kowalski Dominique, Bellissant Eric, Oger Emmanuel, Polard Elisabeth
Pharmacovigilance and pharmacoepidemiology centre, Pharmacology Department, CHU, Rennes, France.
Univ Rennes, EA 7449 REPERES 'Pharmacoepidemiology and Health Services Research', Rennes, France.
Br J Clin Pharmacol. 2021 Feb;87(2):471-482. doi: 10.1111/bcp.14405. Epub 2020 Jun 18.
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.
为估算药物不良反应（ADR）的实际数量，我们除了使用法国药物警戒数据库（FPVDB）中自发报告的ADR外，还运用了法国医疗管理数据库（PMSI）。
对这两个数据源（PMSI和FPVDB）采用捕获 - 再捕获法，并通过第三个数据源检查它们的独立性。该研究于2014年7月1日至2016年6月30日在9家法国综合医院开展。从PMSI中，分析了所有出院小结，包括一系列与ADR相关的第十版国际疾病分类代码。此选择基于先前一项研究的结果。纳入了在FPVDB中自发报告的与这些代码对应的所有ADR。
在PMSI中，56.9%的住院与ADR相关（1104例中的628例）。在FPVDB中，我们保留了115例。两个数据库共有43例ADR。在两个数据源中，最常报告的ADR是皮肤性的（分别为33.1%和19.1%）和肾性的（分别为25.2%和11.6%）。在PMSI中最常怀疑的药物是抗感染药（31.1%），在FPVDB中是抗肿瘤药（30.4%）。使用捕获 - 再捕获法，ADR的估计数量为1657例[95%置信区间：1273至2040]。
使用PMSI可构成估算法国医院ADR实际数量的一种额外工具。在应用捕获 - 再捕获法之前，涉及第三个数据源的模型能够检查两个数据源（PMSI和FPVDB）的独立性。
