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Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey



The aim of this study was to determine the prevalence and pattern of unlicensed and off-label drugs prescribed to hospitalized children at the Department of Paediatrics, University Hospital Rijeka, Croatia.


A prospective cross-sectional study was performed on 1 day each month during a 12 month period and included all hospitalized children and adolescents.


A total of 1,643 prescriptions for 198 different drugs were prescribed to 531 out of 691 (77%) hospitalized patients. Forty-six percent of the different drugs were prescribed in an unlicensed or off-label manner. Of all drug prescriptions, 25% were either unlicensed or off-label. Forty-eight percent of the patients received either an unlicensed or off-label drug. The most frequently prescribed off-label drugs were proton pump inhibitors.


Unlicensed and off-label drug use is common. It is not illegal and may be clinically appropriate but is associated with a number of clinical, safety, and ethical issues. Regulatory authorities should use existing clinical evidence on the use of off-label and unlicensed drugs in decision making. Marketing authorization holders and national regulatory authorities should monitor for any safety concerns associated with unlicensed and off-label drug use and take appropriate measures as well as identify research priorities and mandate clinical studies to resolve important questions.

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The authors would like to thank Vesna Rosović-Bazijanac, hospital pharmacist, for the assistance in determiningf the licensing status of drugs by reviewing SPCs and Davorka Gudac Mađarević, MD, for assistance in data collection.

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Correspondence to Vera Vlahović-Palčevski.

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Palčevski, G., Skočibušić, N. & Vlahović-Palčevski, V. Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey. Eur J Clin Pharmacol 68, 1073–1077 (2012).

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  • Children
  • Drug prescribing
  • Unlicensed
  • Off-label