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[Off-label and unlicensed drug use: Results from a pilot study in a pediatric intensive care unit]

Isabel García-López1, Javier Ezequiel Fuentes-Ríos2, Silvia Manrique-Rodríguez2

  • 1Servicio de Farmacia, Hospital Infantil Universitario Niño Jesús, Madrid, España.

Anales De Pediatria (Barcelona, Spain : 2003)
|May 7, 2016
PubMed

Insights

Pediatric intensive care units frequently use off-label and unlicensed drugs in children. This study highlights the high prevalence of these prescriptions, emphasizing the need for more pediatric drug utilization research.

Area of Science:

  • Pediatric Intensive Care
  • Pharmacology
  • Drug Utilization

Background:

  • Off-label and unlicensed drug use in pediatric populations is a significant concern.
  • Limited data exists on drug safety and efficacy in critically ill children.

Purpose of the Study:

  • To determine the prevalence of off-label and unlicensed drug prescriptions in a pediatric intensive care unit (PICU).
  • To analyze the patterns and reasons for non-approved drug use in pediatric patients.

Main Methods:

  • A prospective, observational pilot study conducted over six weeks in a PICU.
  • Inclusion of hospitalized patients aged 0-18 years.
  • Classification of 696 drug prescriptions using European Medicines Agency guidelines.

Main Results:

  • All 42 included patients received at least one off-label prescription (median 8.9 per patient).
  • 53.9% of prescriptions were off-label, and 8.6% were unlicensed.
  • Off-label use was most common due to indication, age, and dose, increasing with younger patients.

Conclusions:

  • PICUs exhibit a high rate of off-label and unlicensed drug use in pediatric patients.
  • The lack of pediatric-specific drug data necessitates further research into drug utilization practices.
  • Studies documenting pediatric drug use are crucial for improving patient safety and treatment efficacy.
Abstract

Keywords:
Drug approvalDrug utilizationIndicación fuera de ficha técnicaIntensive care units pediatricOff-label prescriptionsOff-label usePediatricsPediatríaPrescripciones en condiciones off-labelUnidad de cuidados intensivos pediátricosUnlabeled indicationUso aprobado de medicamentosUso off-labelUtilización de medicamentos

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