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Off-label drug use remains common in pediatric patients, with 28.1% of visits involving at least one medication not aligned with Food and Drug Administration (FDA) age indications. This highlights ongoing challenges in pediatric pharmacotherapy despite declining trends.

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Area of Science:

  • Pediatric Pharmacology
  • Drug Utilization Research
  • Health Services Research

Background:

  • Off-label drug use in pediatric populations is a persistent concern, often necessitated by a lack of age-appropriate formulations or FDA-approved indications.
  • Understanding the prevalence and patterns of off-label prescribing is crucial for ensuring patient safety and optimizing therapeutic outcomes in children.

Purpose of the Study:

  • To quantify the frequency of off-label drug use in pediatric patients (≤18 years) in 2014 based on Food and Drug Administration (FDA)-approved age ranges.
  • To analyze off-label drug use rates by drug classification and compare current rates with historical data.
  • To identify factors associated with off-label medication prescribing in pediatric inpatient settings.

Main Methods:

  • A retrospective cohort study utilizing an administrative database of inpatient resource use from January 1 to December 31, 2014.
  • Inclusion criteria: Patients ≤18 years receiving one of 76 commonly prescribed medications.
  • Off-label use defined as administration outside FDA-approved age ranges or dosage forms.

Main Results:

  • Approximately 28.1% (779,270/2,773,770) of pediatric patient visits involved at least one off-label medication.
  • Higher rates of off-label prescribing were associated with younger patient age, longer hospital stays, and increased mortality.
  • Off-label medication use varied significantly by care setting, with rates of 45.5% in observational, 53.9% in inpatient, and 54.2% in ambulatory settings.

Conclusions:

  • Despite a declining trend, one in four medications prescribed to pediatric patients in major US pediatric hospitals in 2014 were used off-label regarding age indications.
  • Significant variability in off-label drug use exists across different drug categories and healthcare encounter types.
  • Ongoing research into the safety, efficacy, pharmacokinetics, and optimal dosing of commonly prescribed medications in pediatric subpopulations is essential.