ADR EPIDEMIOLOGY IN PAEDIATRICS

Key words: ADR, Drug, Safety, Efficacy, Paediatrics

A meta-analysis of 8 prospective studies performed in the United States and Europe in the 2001-2007 period estimated that the incidence of ADRs in hospitalised children is 10.9% and in paediatric outpatients 1.0%. The contribution of ADRs to the hospitalisation of children was estimated at 1.8%. The skin and gastrointestinal system were the organs most commonly affected and antibiotics were the drugs most commonly associated with ADRs. During the same observation period, the international drug regulatory agencies issued safety alerts concerning the paediatric population for 28 drugs or drug classes, 5 of which were for psychotropic drugs and Food and Drug Administration issued safety alerts for 20 drugs. The Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA) issued warnings for 12 drugs: antidepressants, aspirin, cefaclor, ceftriaxone, codeine, desmopressin nasal spray, dolansetron, domperidone, lopinavir/ritonavir, metoclopramide, nasal decongestants and oseltamivir. For 3 medications (cefaclor, dolansetron, domperidone) measures were taken only in Italy. In some cases (e.g. nasal decongestants, domperidone) the decision was based on the scant evidence of efficacy in addition to the safety concerns. The drug safety issue is related to the rational use of drugs, and educational programmes for health professionals and parents are needed with the aim of improving the rational use of drugs and ensuring safe and effective medicines for children.