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

  • Pharmacoepidemiology and Prescription
  • Published:
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Abstract

Purpose

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.

Methods

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

Results

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.

Conclusion

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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Acknowledgments

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.

Competing interests

None

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Authors and Affiliations

  1. Department of Paediatrics, University Hospital Rijeka, Rijeka, Croatia

    Goran Palčevski

  2. University of Rijeka Medical School, Rijeka, Croatia

    Nataša Skočibušić

  3. Unit for Clinical Pharmacology, University Hospital Rijeka, Krešimirova 42, 51000, Rijeka, Croatia

    Vera Vlahović-Palčevski

Authors
  1. Goran Palčevski
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  2. Nataša Skočibušić
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  3. Vera Vlahović-Palčevski
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Corresponding author

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). https://doi.org/10.1007/s00228-012-1221-x

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  • DOI: https://doi.org/10.1007/s00228-012-1221-x

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