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Drug utilization pattern in children and off-label use of medicines in a pediatric intensive care unit

E Blanco-Reina1, A F Medina-Claros2, M A Vega-Jiménez3

  • 1Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España.

Medicina Intensiva
|January 14, 2015
PubMed

Insights

High rates of off-label drug prescriptions were observed in a Spanish neonatal and pediatric intensive care unit (NPICU). Most children received at least one off-label medication, highlighting a need for updated drug information.

Area of Science:

  • Pediatric Pharmacology
  • Neonatal Intensive Care
  • Drug Utilization Research

Background:

  • Neonatal and Pediatric Intensive Care Units (NPICUs) often manage critically ill children with complex medication needs.
  • Understanding drug prescription patterns and licensing status is crucial for patient safety and optimizing treatment.

Purpose of the Study:

  • To evaluate the prescription profile and licensing status of medications administered in a Spanish NPICU.
  • To identify the frequency and reasons for off-label and unlicensed drug use in this vulnerable patient population.

Main Methods:

  • A prospective observational study was conducted in a tertiary hospital's NPICU.
  • Prescriptions for 81 children were analyzed and classified as off-label or unlicensed based on the Summary of Product Characteristics (SPC).

Main Results:

  • Over 600 prescriptions were analyzed, with patients receiving an average of 7.4 drugs.
  • 52% of prescriptions were off-label, primarily due to dosage variations (79%) and different indications (13.5%).
  • Unlicensed drug use accounted for 5% of prescriptions, with 89% of children receiving at least one off-label prescription.

Conclusions:

  • Significant off-label and unlicensed drug use occurs in Spanish NPICUs, consistent with critical care settings.
  • While often protocol-driven, this highlights the need for evidence-based treatment and updated drug labeling.
  • The findings underscore the importance of monitoring and adapting drug use guidelines for pediatric intensive care.
Abstract

Keywords:
ChildrenCuidados intensivosFármacos no autorizadosIntensive careNeonatesNeonatosNiñosOff-label useUnlicensedUsos off-label

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