Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

OBJECTIVE To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries. DESIGN Prospective study of drugs administered to children in general paediatric medical wards over four weeks. SETTING Children's wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands). SUBJECTS Children aged 4 days to 16 years admitted to general paediatric medical wards. MAIN OUTCOME MEASURE Proportion of drugs that were used in an unlicensed or off label manner. RESULTS 2262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all drug prescriptions (1036; 46%) were either unlicensed or off label. Of these 1036, 872 were off label and 164 were unlicensed. Over half of the patients (421; 67%) received an unlicensed or off label drug prescription. CONCLUSIONS Use of off label or unlicensed drugs to treat children is widespread. This problem is likely to affect children throughout Europe and requires European action.