"Off-Label" Medicine Use In Burned Children: Three-Year Retrospective Study

I D Saputro1, O N Putra2, Hardiyono2

  • 1Faculty of Medicine, Airlangga University-General Hospital of Dr. Soetomo, Surabaya, Indonesia.

Insights

Off-label prescribing is common in burned children, with 35% of medications used inappropriately for age, indication, or dosage. Analgesics were most frequently prescribed off-label, highlighting a need for further research in pediatric burn care.

Area of Science:

  • Pediatric Burn Care
  • Pharmacology
  • Drug Utilization

Background:

  • Pediatric burn patients present unique physiological challenges impacting drug response.
  • Children are more likely to receive off-label prescriptions compared to adults due to altered pharmacokinetics.

Purpose of the Study:

  • To determine the incidence of off-label prescribing in hospitalized burned children.
  • To identify the types and reasons for off-label medication use in this population.

Main Methods:

  • Retrospective observational study analyzing medical records of burned children (under 18) from January 2017 to December 2019.
  • Inclusion criteria: hospitalized burn patients receiving at least one medication.
  • Data collection focused on prescribed medications and classification of off-label use.

Main Results:

  • 35% of 215 prescribed medications were off-label.
  • Off-label use for age range was most common (53%), followed by indication (30%), dosage (15%), and dosage form (2%).
  • Off-label prescribing was more prevalent in children aged 2-12 years compared to adolescents. Analgesics were the most common off-label therapeutic class.

Conclusions:

  • A significant proportion of medications administered to burned children are prescribed off-label, often with uncertain evidence.
  • Further research is crucial to address the safety and efficacy of off-label medications, particularly high-risk drugs, in pediatric burn patients.

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