Table 1.
References | Year | Country | Type | Length | Setting | Sample size | ADR occurrence rate (%) | Detection method | ADR definition | Causality assessment | Fatal ADRs (%) |
---|---|---|---|---|---|---|---|---|---|---|---|
Fattinger et al. [8] | 1996–1998 | Switzerland | Multicenter (2) | 2 years | Internal medicine department | 4431 | 3.3 | ICR | ADR | NR | 0.07 |
Pouyanne et al. [9] | 1998 | France | Multicenter (33) | 2 weeks | 62 Departments; 33 hospitals | 3137 | 3.2 | ICR | ADR (WHO) | NR | 0.13 |
Hardmeier et al. [10] | Up to 2000 | Switzerland | Multicenter (2) | Cross-sectional | 2 Hospitals, department of internal medicine | 6383 | 2.9 | ICR | ADE | NR | NR |
Pirmohamed et al. [11] | 2001–2002 | UK | Multicenter (2) | 6 months | Teaching + general hospital | 18,820 | 6.4 | ICR | ADR (WHO) | 0.7 % Definite, 69.5 % probable, 29.8 % possible | 0.15 |
Capuano et al. [12] | 2000 | Italy | Multicenter (2) | 20 days | Emergency departments | 1049 | 1.2 | ICR | ADE | NR | NR |
Trifirò et al. [13] | 2000 | Italy | Multicenter (22) | 20 days | Emergency department | 18,854 | 3.3 | ICR | ADE | NR | 0.01 |
Capuano et al. [14] | 2005 | Italy | Multicenter | 20 days | Emergency department | 7861 | 1.2 | ICR | ADE | NR | 0 |
Sánchez Muñoz-Torrero et al. [15] | 2009 | Spain | Multicenter (2) | 10 weeks | Internal medicine; teaching hospitals | 405 | 5.9 | ICR | ADR | NR | 0.49 |
Benard-Laribiere et al. [16] | 2006–2007 | France | Multicenter (61) | 2 weeks | Medical wards of teaching (25) and general (36) hospitals | 2692 | 3.6 | ICR | ADR | NR | 0.04 |
Lagnaoui et al. [17] | 1996–1997 | France | Single-center | 4 months | Internal medicine unit | 444 | 7.2 | ICR | ADR | NR | 0 |
Green et al. [18] | 1996 | UK | Cross-sectional random sample | Cross-sectional | University hospital | 200 | 7.5 | ICR | ADR (WHO) | 40 % Probable/likely, 53.3 % possible | 1 |
Bordet et al. [19] | NS | France | Single-center | 18 months | Cardiology hospital | 16,916 | 0.5 | VR | ADR (WHO) | NR | 0.11 |
Olivier et al. [20] | 1998 | France | Single-center | 4 weeks | Emergency department | 671 | 6.1 | ICR | ADR | NR | 0 |
Thuermann et al. [21] | 1999 | Germany | Single-center | 2 months | Department of neurology; teaching hospital | 600 | 0.8 | ICR | ADR (WHO) | 56.1 % Possible, 35.4 % probable, 4.8 % definite | 0.33 |
Dormann et al. [22] | 1998–1999 | Germany | Single-center | 13 months | Department of Medicine; university hospital | 915 | 8.5 | ICR | ADR (WHO) | 46.1 % Possible, 43.1 % probable, 10.8 % definite | 0.14 |
Bednall et al. [23] | 1999 | UK | Single-center | 2 weeks | Emergency department | 2636 | 1.3 | ICR | DRP | NR | NR |
Alexopoulou et al. [24] | 2005 | Greece | Single-center | 6 months | Department of medicine, university hospital | 548 | 12.8 | ICR | ADR (WHO) | 74.3 % Probable or definite, 25.7 % possible | NR |
Hopf et al. [25] | NS | UK | Single-center | 15 days | Teaching hospital | 2371 | 1.3 | ICR | ADR (WHO) | 43.3 % Possible, 53.7 % probable | 0.08 |
Schwake et al. [26] | 2003 | Germany | Single-center | 1 year | Intensive care unit; university hospital | 1554 | 6.4 | ICR | ADR (WHO) | NR | 0.13 |
Brvar et al. [27] | 2006 | Slovenia | Single-center, cross-sectional | 1 year | University hospital | 520 | 5.8 | ICR | ADR (WHO) | NR | 0 |
Farcas et al. [28] | 2009 | Romania | Single-center | 1 year | Internal medicine ward, university hospital | 1854 | 3.6 | VR | ADR (WHO) | NR | NR |
Hofer-Dueckelmann et al. [29] | 2007–2008 | Austria | Single-center | 6 months | Departments of gastroenterology, nephrology, cardiology | 3190 | 7.7 | ICR | ADR (WHO) | NR | 0.13 |
ADR occurrence was calculated by dividing the number of patients who experienced at least one ADR, or the number of admissions with at least one ADR, by the total number of patients or admissions included in the study. The ADR definition that was reported is stated, including whether the WHO definition was used in the study
ADR adverse drug reaction, WHO World Health Organization, DRP drug-related problem, ADE adverse drug event, ICR intensive chart review, VR voluntary reporting, NS not stated, NR not reported