The use of off-label drugs in medicine: ethical and legal issues.


  • Alenka Boban Blagaić Department of Pharmacology, School of Medicine, University of Zagreb, Croatia
  • Vladimir Blagaić Department of Gynecology and Obstetrics, Clinical Hospital „Sveti Duh“, Zagreb, Croatia



off-label drug use, pharmaceuticals, prescribing


The term off-label drug describes the use of a particular drug outside its approved indication, dose, frequency and route of administration of that patient group for which it is registered. Despite the stated definition indicating a certain risk for their application, off-label application is part of everyday medical practice and is often the only treatment option for patients when no suitable approved drug is available. Possible legal-ethical-medical problems for a physician may arise if after such a therapy an adverse outcome occurs, not necessarily due to a given therapy. Drug Commission and Clinical Pharmacologists from the physician's institution could be the first instance to which a doctor might address if his intended treatment includes off-label medication.


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How to Cite

Boban Blagaić, A., & Blagaić, V. (2017). The use of off-label drugs in medicine: ethical and legal issues. BioMedicine and Surgery, 1(2), 84–87.