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

• Main Authors: Iswinarno Doso Saputro, Iswinarno, Putra O.N, Putra, HARDIYONO, HARDIYONO, MUFIDAH, MUFIDAH
• Format: Article PeerReviewed
• Language: English; Indonesian; English; Indonesian; English
• Published: Mediterranean Council for Burns and Fire Disasters 2021
• Subjects: R Medicine (General); R5-920 Medicine (General)
• Online Access: https://repository.unair.ac.id/119374/1/Turnitin_compressed%20%281%29.pdf; https://repository.unair.ac.id/119374/4/6.Validasi%20Off%20Label....pdf; https://repository.unair.ac.id/119374/7/Off%20Label%20Medicine%20Burned%20Children%20%28Annals%20of%20Burns%20and%20Fire%20Disasters%29.pdf; https://repository.unair.ac.id/119374/8/3.%20Laik%20Etik%20%20%28%20Jurnal%20%20Off%20Label....%29.pdf; https://repository.unair.ac.id/119374/9/1%20artikel.pdf; https://repository.unair.ac.id/119374/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8126370/pdf/Ann-Burns-and-Fire-Disasters-34-18.pdf
• Institution: Universitas Airlangga

Abstract in English, French 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. Keywords: burns; children; off-label.