Using a capture–recapture method to assess the frequency of adverse drug reactions in a French university hospital

Abstract

AimsThere is evidence that different methods used to identify and quantify adverse drug reactions (ADR) in hospitals are not exhaustive (spontaneous repor ting or computerized medical databases). The combination of these different sources of data could improve knowledge about ADR frequency in hospitals. The aim of this study was to estimate the incidence of serious ADRs handled in medical wards of a French university hospital using data from the Programme de Medicalization des Systemes d'Information (PMSI) and spontaneous reports recorded in the French Pharmacovigilance Database. MethodsThe study period was the first semester of 2001. From PMSI, all hospitalization summaries including an ICD-10th code related to a potential ADR were selected. From the French Pharmacovigilance Database, all serious ADRs which occurred during the study period and were reported by physicians working in the University Hospital were collected. After identification of common cases, the capture-recapture method was applied in order to estimate the real number of ADRs occurring during the fi rst semester of 2001. ResultsFrom PMSI, we identified 274 different hospital stays related to an ADR. Out of 241 reports selected from the French Pharmacovigilance Database, we retained 151 ADRs for analysis. Fifty-two ADRs were common in the two databases, g iving an estimated number of serious ADRs of 796 [95% confidence interval (CI) 638, 954], corresponding to 2.9% of inpatients (95% CI 2.3, 3.5).

Adverse drug events in hospitals: a systematic review

“…Interestingly, 62.1% of the studies (18/29) 6,7,8,9,12,13,15,16,19,20,21,22,25,26,27,31,33,34 involved university, academic, or teaching hospitals, i.e., presumably large-scale, high-complexity hospital units.…”

“…Forty-eight percent of the studies (14/29) 6,8,9,14,18,19,22,23,24,25,28,29,30,31 used a retrospective approach, i.e., the presence of ADEs was analyzed after the patient was discharged; 48.3% of the studies (14/29) 7,11,12,13,15,16,17,20,21,26,27,32,33,34 used a prospective approach, whereby the ADEs were identified during the hospital stay; and one study 10 was cross-sectional, where ADEs were identified using a survey. Among the studies with a prospective approach, two used retrospective strategies to complement the evaluation, based on an analysis of hospital discharge forms 16,21 .…”

“…Twenty-eight articles remained 6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33 for evaluation, plus one more article retrieved by manual search 34 . Table 1 describes the studies, conducted in 13 countries from North America, Europe, South America, and Asia.…”

“…Only 41.4% (12/29) 6,7,10,11,12,20,21,26,27,28,29,33 provided information about age, and 24.1% (7/29) 6,7,10,20,26,27,33 on gender. As for the unit of analysis, 62.1% (18/29) 6,7,10,11,12,15,18,20,21,24,25,26,27,30,31,32,33,34 used the number of patients or patient charts, 48.3% (14/29) 6,8,9,12,14,16,17,20,22,23,25,28,29,33 the number of admissions or discharges, and 24.1% (7/29) 13,16,17,19,31,…”

“…Most of the studies were performed in one hospital (19/29) 7,8,12,13,15,16,17,18,19,20,21,25,26,27,28,31,32,33,34 . Six were multi-center 6,9,22,23,24,29 and Figure 1 Flowchart of systematic article search and selection on in-hospital adverse drug events.…”