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Unlicensed and Off-Label Medication Use in Pediatric and Neonatal Intensive Care Units: No Change Over a Decade

Hadar Nir-Neuman1, Ibrahim Abu-Kishk2, Michal Toledano3

  • 1Pediatric Division, Assaf Harofeh Medical Center, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Advances in Therapy
|June 28, 2018
PubMed

Insights

Pediatric intensive care units (PICU) and neonatal intensive care units (NICU) show high rates of off-label and unlicensed medication use. Despite regulatory efforts, unlicensed drug prescriptions in PICUs have increased since 2002.

Area of Science:

  • Pediatric Pharmacology
  • Neonatal Pharmacology
  • Drug Utilization Research

Background:

  • Many medications used in pediatric populations are not formally evaluated for this age group, leading to off-label and unlicensed prescriptions.
  • This practice poses potential risks due to a lack of age-specific pharmacokinetic and pharmacodynamic data.

Purpose of the Study:

  • To assess the current prevalence of unlicensed and off-label medication use in neonatal intensive care units (NICU) and pediatric intensive care units (PICU).
  • To compare current prescribing patterns with data from a similar study conducted in 2002.

Main Methods:

  • A 2-month prospective study recorded all drugs prescribed to patients in NICU (n=134) and PICU (n=56).
  • Medications were classified by patient age, license status, indication, and administration details.
  • Data were compared with a 2002 study from the same units.

Main Results:

  • In the NICU, 64.8% of prescriptions were off-label and 5.9% were unlicensed. 96.3% of neonates received at least one off-label medication.
  • In the PICU, 43.8% of prescriptions were off-label and 3.4% were unlicensed. 90.5% of PICU patients received at least one off-label or unlicensed medication.
  • While off-label use remained similar, unlicensed medication use decreased in NICU but increased significantly in PICU (0% in 2002 to 3.4% in 2016).

Conclusions:

  • The study confirms a high prevalence of off-label and unlicensed medication use in NICU and PICU settings.
  • Despite regulatory efforts, the use of unlicensed medications in PICUs has unexpectedly increased compared to 2002 data.
  • Continued monitoring and research are essential to ensure safe and effective medication use in critically ill children.
Abstract

Keywords:
Neonatal intensive careOff-label medicationsPediatric intensive careUnlicensed drugs

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