To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries.
Prospective study of drugs administered to children in general paediatric medical wards over four weeks.
Children’s wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands).
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.
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.
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.
Key messagesMany drugs are not tested in children, which means that they are not specifically licensed for use in childrenLicensed drugs are often prescribed outside the terms of the product license (off label) in relation to age, indication, dose of frequency, route of administration, or formulationOver two thirds (67%) of 624 children admitted to wards in five European hospitals received drugs prescribed in an unlicensed or off label manner39% of the 2262 drug prescriptions given to children were off labelThe problem of off label and unlicensed drug prescribing in children is a European problem that requires European action