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. 2006 Apr 1;136(13-14):218-22.
doi: 10.4414/smw.2006.11275.

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

Ermindo R Di Paolo  1 , Hans Stoetter, Jacques Cotting, Peter Frey, Mario Gehri, Maja Beck-Popovic, Jean-François Tolsa, Sergio Fanconi, André Pannatier
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Free article

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

Ermindo R Di Paolo et al. Swiss Med Wkly. .
Free article

Abstract

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".

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