Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies

Aims To explore the usefulness of data derived from observational studies o n adverse drug reactions (ADRs) in defining and preventing the risk of phar macological interventions in children in different health care settings. Methods A systematic review of studies on ADRs in hospitalized children, in outpatient children, and on ADRs causing paediatric hospital admissions wa s performed. Studies were identified through a search of the MEDLINE and EM BASE databases. The inclusion criteria required that the population was not selected for particular conditions or drug exposure and prospective monito ring was used for identifying ADRs. Data were analysed by a random-effects model. Results Seventeen prospective studies were included. In hospitalized childr en, the overall incidence of ADRs was 9.53% (95% confidence interval [CI], 6.81,12.26); severe reactions accounted for 12.29% (95%CI, 8.43,16.17) of t he total. The overall rate of paediatric hospital admissions due to ADRs wa s 2.09% (95%CI, 1.02,3.77); 39.3% (95%CI, 30.7,47.9) of the ADRs causing ho spital admissions were life threatening reactions. For outpatient children the overall incidence of ADRs was 1.46% (95%CI, 0.7,3.03). Conclusions The results show that ADRs in children are a significant public health issue. The completeness and accuracy of prescription reporting as w ell as clinical information from studies was a rarity, making it difficult for health practitioners to implement evidence based preventive strategies. Further, methodologically sound drug surveillance studies are necessary fo r an effective promotion of a safer use of drugs in children.