Unlicensed and off-label drug use in a Swiss paediatric university hospital.

BACKGROUND

Many medicines used in newborns, infants, children and adolescents are not licensed ("unlicensed") or are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various healthcare settings in the USA, Europe and Australia, but data are scarce in Switzerland.

OBJECTIVES

The aim of our prospective study was to determine the proportion of unlicensed or off-label prescriptions in paediatric patients.

METHODS

This pilot study was conducted prospectively over a six month period in the department of paediatrics of a university hospital.

RESULTS

Sixty patients aged from three days to 14 years were included in the study. A total of 483 prescriptions were written for the patients. More than half of all prescriptions (247; 51%) followed the terms of the marketing authorization. 114 (24%) were unlicensed and 122 (25%) off-label. All patients received at least one unlicensed or offlabel medicine.

CONCLUSION

The use of unlicensed or off-label medicines to treat children was found to be common. Co-operation between the pharmaceutical industry, national regulatory authorities, clinical researchers, healthcare professionals and parents is required in order to ensure that children do not remain "therapeutic orphans".