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A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings
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A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings

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Off-label and unlicenced medicine administration to paediatric emergency department patients

David McD Taylor1,2, Paul Joffe3, Simone E Taylor4

  • 1Emergency Department, Austin Hospital, Melbourne, Victoria, Australia.

Emergency Medicine Australasia : EMA
|June 25, 2015
PubMed

Insights

Off-label and unlicenced medicine use is common in paediatric emergency departments, affecting over a third of young patients. A registry for these commonly used medicines is recommended to ensure safety and efficacy.

Area of Science:

  • Pediatric Emergency Medicine
  • Pharmacology
  • Drug Safety

Background:

  • Off-label and unlicenced medicine administration is a frequent practice in pediatric healthcare.
  • Understanding the prevalence and patterns of such use is crucial for patient safety.

Purpose of the Study:

  • To determine the prevalence and nature of off-label and unlicenced medicine administration in pediatric emergency departments (EDs).

Main Methods:

  • A retrospective, observational study was conducted across six EDs from July 2011 to June 2012.
  • Included were 3343 patients aged 0-17 years who received medication in the ED.
  • Medicines were classified as off-label/unlicenced based on Therapeutic Goods Administration approved categories.

Main Results:

  • Over a third of pediatric ED patients (36.3%) received off-label/unlicenced medicines.
  • Commonly administered off-label medications included salbutamol, ondansetron, ipratropium, fentanyl, and oxycodone.
  • Reasons for off-label use varied, including unapproved dose/frequency (44.0%), unapproved indication (28.6%), and unapproved route (7.6%).

Conclusions:

  • Off-label and unlicenced medicine administration is prevalent in pediatric EDs.
  • A registry of commonly used off-label medicines, supported by published evidence on safety and efficacy, is recommended.
Abstract

Keywords:
childemergency departmentmedicineoff labelpaediatric

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