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.