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The use of unlicensed and off-label medicines in the neonate

Sharon Conroy1, John McIntyre

  • 1Academic Division of Child Health (University of Nottingham), The Medical School, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK. sharon.conroy@nottingham.ac.uk

Seminars in Fetal & Neonatal Medicine
|February 11, 2005
PubMed

Insights

Neonatal intensive care often involves using unlicensed and off-label medicines, with up to 93% of infants receiving them. This practice, while common, poses risks due to limited data and formulations, necessitating urgent improvements for safe infant therapy.

Area of Science:

  • Neonatal medicine
  • Pediatric pharmacology
  • Drug safety

Background:

  • Unlicensed and off-label medicine use is prevalent in neonatal intensive care units (NICUs).
  • Up to 93% of neonates receive at least one unlicensed or off-label medication during their NICU stay.
  • This practice is critical for neonatal care but lacks sufficient evidence and appropriate formulations.

Purpose of the Study:

  • To highlight the widespread issue of unlicensed and off-label drug use in neonates.
  • To identify the challenges and risks associated with this practice.
  • To advocate for urgent improvements in neonatal medication safety and regulation.

Main Methods:

  • Review of current practices in neonatal intensive care.
  • Analysis of the extent of unlicensed and off-label medicine use.
  • Identification of associated problems including dosing, administration, and medication errors.

Main Results:

  • High prevalence of unlicensed/off-label medicine use in neonates (up to 93%).
  • Significant challenges exist due to lack of appropriate information and licensed formulations.
  • Increased risk of medication errors and suboptimal therapy.

Conclusions:

  • Urgent action is needed to address the risks of unlicensed and off-label medicines in neonates.
  • Initiatives in the US and Europe are acknowledged but insufficient.
  • Ensuring safe, effective, and high-quality therapy for neonates is a fundamental right that is currently compromised.

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