Table 2.
References | Year | Country | Type | Length | Setting | Sample size | ADR occurrence rate (%) | Detection method | ADR definition | Causality assessment | Fatal ADRs (%) |
---|---|---|---|---|---|---|---|---|---|---|---|
Jonville-Béra et al. [30] | 1998 | France | Single-center | 1 week | Emergency department; pediatric hospital | 260 | 1.5 | ICR | ADR | NR | 0 |
Buajordet et al. [31] | 1996 | Norway | Single-center | 5 months | University hospital; pediatric department | 919 | 5.8 | VR + ICR | ADR (WHO) | NR | NR |
Haffner et al. [32] | 2001 | Germany | Single-center | 13 weeks | Pediatric teaching hospital | 703 | 1.8 | ICR | ADR (WHO) | 71.3 % Probable or definite | NR |
Gallagher et al. [33] | 2008 | UK | Single-center | 2 weeks | Emergency department; pediatric hospital | 847 | 3.2 | ICR | ADR (WHO) | 63 % Probable, 37 % possible | 0 |
Posthumus et al. [34] | 2008 | The Netherlands | Single-center | 18 weeks | Emergency department; pediatric hospital | 683 | 6.9 | ICR | ADR (WHO) | NR | 0 |
Rashed et al. [35] | 2008–2009 | UK + Germany | Single-center | 3 months | Pediatric ward | 313 (UK) | 1.7 (both countries combined) | ICR | ADR (WHO) | NR | NR |
376 (Germany) | |||||||||||
Gallagher et al. [36] | 2009–2009 | UK | Single-center | 1 year | Tertiary pediatric hospital | 6821 | 2.6 | ICR | ADR (WHO) | NR | 0 |
Franceschi et al. [37] | 2004–2005 | Italy | Single-center | 2 months | Geriatic department | 1756 | 5.8 | ICR | ADR (WHO) | 6.8 % Definite, 91.2 % probable, 2 % possible | 0 |
Olivier et al. [38] | 2002–2003 | France | Single-center | 4 weeks | Emergency department; university hospital | 789 | 8.4 | ICR | ADR (WHO) | NR | 0.38 |
Conforti et al. [39] | 2009 | Italy | Single-center | 6 months | Geriatric ward | 909 | 28.2 | ICR | ADR (WHO) | NR | NR |
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, ICR intensive chart review, VR voluntary reporting, NR not reported