“Off-label” medicine use in burned children: three-year retrospective study

SUMMARY. Burn patients, especially children, experience many problems during their hospitalization. Because of their unique physiologic and altered pharmacokinetic profile, children receive more off-label prescribing than adults. The aim of this study was to analyze the incidence of off-label prescribing in burned children. This was a retrospective observational study conducted in the Dr. Soetomo General Hospital from December 2019 to March 2020. Data were collected from the medical records of burned children hospitalized over a 3-year period, from January 2017 to December 2019. Burn patients under 18 years old who received at least one prescribing medication were enrolled in this study. Twenty-six burned children met the inclusion criteria. A total of 215 medications were prescribed during this study and 35% of them were classified as off-label. The term off-label for age range was the highest among the off-label prescribing medicines, as much as 53%, with 30% classified for an unapproved indication, 15% for an unapproved dosage, and 2% for an unapproved dosage form. The prevalence of off-label prescribing was higher in children from 2 to 12 years old than in adolescents. Analgesics were the therapeutic classes most often prescribed as off-label in burned children. Most burned children are administered off-label medication with uncertain evidence. Further research is needed in this population to focus on several medications with high risk potential.