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Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely

Elham Jaberi1, Inesse Boussaha2, Xavier Dode3

  • 1UMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, CEDEX 08, F-69376 Lyon, France.

Healthcare (Basel, Switzerland)
|January 23, 2024
PubMed

Insights

Nearly 40% of pediatric hospital discharge prescriptions in France were unlicensed or off-label (UL/OL). Younger children and those with more medications were more likely to receive UL/OL prescriptions, increasing drug-related problem risks.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety
  • Health Outcomes Research

Background:

  • Unlicensed and off-label (UL/OL) prescriptions are linked to increased drug-related problems.
  • Limited data exists on the prevalence of UL/OL drug use at hospital discharge.
  • This study addresses the gap in understanding UL/OL prescription patterns in pediatric patients upon discharge.

Purpose of the Study:

  • To determine the prevalence of unlicensed and off-label (UL/OL) drugs in outpatient prescriptions at pediatric hospital discharge.
  • To identify characteristics and predictors associated with UL/OL prescriptions in children.

Main Methods:

  • Retrospective analysis of routinely collected health data from pediatric hospital discharges (2014-2016).
  • Utilized French industry-independent formulary Thériaque (summaries of product characteristics) to define licensed labeling.
  • Described UL/OL prescription characteristics and analyzed predictors.

Main Results:

  • 2536 prescriptions from 479 children were analyzed.
  • Off-label (OL) prescriptions were 39.2% and unlicensed (UL) prescriptions were 2.3%, with 74% of children receiving at least one UL/OL drug.
  • Younger age and a higher number of prescribed drugs were significant predictors of UL/OL prescriptions.

Conclusions:

  • Approximately 40% of pediatric hospital discharge prescriptions in France involve unlicensed or off-label (UL/OL) medications.
  • The high prevalence highlights potential risks and the need for careful monitoring in pediatric pharmacotherapy.
  • Younger children and those with polypharmacy represent a vulnerable group for UL/OL prescribing.
Abstract

Keywords:
childrendischargedrug prescriptionoff-labelunlicensed

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