European Journal of Clinical Pharmacology

, Volume 68, Issue 7, pp 1073–1077

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

  • Goran Palčevski
  • Nataša Skočibušić
  • Vera Vlahović-Palčevski
Pharmacoepidemiology and Prescription



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.


Children Drug prescribing Unlicensed Off-label 


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Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Goran Palčevski
    • 1
  • Nataša Skočibušić
    • 2
  • Vera Vlahović-Palčevski
    • 3
  1. 1.Department of PaediatricsUniversity Hospital RijekaRijekaCroatia
  2. 2.University of Rijeka Medical SchoolRijekaCroatia
  3. 3.Unit for Clinical PharmacologyUniversity Hospital RijekaRijekaCroatia

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