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


CONCLUSIONS
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.
Department of Paediatrics, University Hospital Rijeka, Rijeka, Croatia.
Goran
G
Palčevski
Nataša
N
Skočibušić
Vera
V
Vlahović-Palčevski
D000293:Adolescent; D000298:Adolescent, Hospitalized / Q000706:statistics & numerical data; D002648:Child; D002673:Child, Hospitalized / Q000706:statistics & numerical data; D002675:Child, Preschool; D015331:Cohort Studies; D017523:Croatia; D003430:Cross-Sectional Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D017723:Drug Utilization Review / Q000706:statistics & numerical data*; D057286:Electronic Health Records; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data; D006785:Hospitals, University / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D056687:Off-Label Use / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D011446:Prospective Studies; D055815:Young Adult