Paediatric drug use with focus on off-label prescriptions at Swedish hospitals – a nationwide study

AIM To perform a nationwide investigation of paediatric drug use at Swedish hospitals, including an analysis of off-label drug use. METHODS All paediatric hospitals in Sweden were invited to register all prescriptions to children, aged between 0 and 18, during two separate 2-day-periods in 2008. Data were reported and analysed with respect to licence status and proportion of and reasons for off-label drug use. RESULTS Data on 11,294 prescriptions to 2947 paediatric patients were received. Drugs associated with pain relief, infection, prematurity, nutrition and surgery or anaesthesia were most commonly used. Paracetamol was the most frequently used drug on-label and also among the most commonly used off-label drugs. Nearly half (49%) of all administered prescriptions concerned unlicensed drugs, off-label drugs or extemporaneously prepared drugs. The corresponding rate among neonates was 69%. Lack of paediatric information in the Summary of Product Characteristics was the main reason for off-label classification. CONCLUSIONS Paediatric off-label drug use is common at Swedish hospitals, and nearly half of all prescriptions were not documented for use in children. The findings emphasize a need for paediatric clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in infants and neonates.