Background The use of drugs in children presents several problems of safety and tolerability, mainly due to lack of information about the risk-benefit profile in real conditions of use. Pharmacovigilance could make drug treatment safer especially in the most vulnerable groups such as children and the over-65s.

Purpose To assess the effect of adverse drug reactions (ADRs) on paediatric patients visited in emergency departments (ED).

Materials and methods In this study we consider ADRs reported in the MEREAFaPS project database (epidemiological monitoring of adverse drug reactions in ED) collected in 16 hospitals of Lombardy from 1 July 2009 to 31 December 2011. The ADRs were coded according to the MedDRA Dictionary. All the potential ADRs among patients <18 years were reported and analysed by seriousness, suspected drugs, resolution, preventability and type of adverse reactions.

Results During the observation period we collected 10885 reports: over-65s patients represented 40.78% of the total ADRs and paediatric population (<18) accounted for 8.60%. 43.37% of paediatric ADRs concerned patients aged less than 2 with a clear prevalence of non-serious reactions over severe ones. The incidence of ADRs evaluated on ED access was 1.5/1000 ED paediatric visits. The System Organ Classification (SOC) most frequently reported was skin and subcutaneous reactions (59.74%), while the SOC with the highest proportion of severe reactions were psychiatric disorders (73.33% of ADRs were serious) and nervous system diseases (53.73% of ADRs were serious). The most frequently reported drug was amoxicillin/clavulanic acid (21.80%), followed by amoxicillin alone and acetaminophen. Adverse vaccine reactions represented 12.18% of cases overall: the hexavalent vaccine was the most reported (4.65% of ADRs).

Conclusions This study underlines the importance of pharmacovigilance in the paediatric population and the need for more careful drug use especially in early childhood. Moreover the attention of specialists to these issues should be increased with training initiatives on problems related to drug treatment and, above all, encouragement to report spontaneously.

No conflict of interest.