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The Unlicensed and Off-label Prescription of Medications in General Paediatric Ward: An Observational Study

Alícia Dorneles Dornelles1, Lisiane Hoff Calegari2,3, Lucian de Souza2,3

  • 1Postgraduate Program in Child and Adolescent Health, Department of Pediatrics, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Brazil.

Current Pediatric Reviews
|November 14, 2018
PubMed

Insights

Unlicensed and off-label medication use is frequent in pediatric patients, with nearly all children receiving at least one such prescription. This practice aligns with international findings, particularly concerning drug formulations.

Area of Science:

  • Pediatric pharmacology
  • Clinical pharmacy
  • Drug utilization studies

Background:

  • Unlicensed (UL) and off-label (OL) medication prescriptions are common in pediatric care.
  • This practice is often necessary due to the lack of FDA-approved alternatives.

Purpose of the Study:

  • To determine the frequency of UL and OL prescriptions in children aged one month to 12 years.
  • Focus on a Paediatric Inpatient Unit (PIU).

Main Methods:

  • Observational, prospective study design.
  • Prescriptions reviewed during one week in August 2014 and one week in January 2015.
  • Inclusion of 157 pediatric patients.

Main Results:

  • Nearly all patients (155/157) received UL or OL prescriptions.
  • High prevalence of UL (27-29.6%) and OL (44.6-45.1%) prescriptions.
  • Most frequent OL reason was drug formulation (15.8%).

Conclusions:

  • Off-label medication prescription in Brazilian children is consistent with global trends.
  • Discrepancies in OL prescriptions, especially formulation, are noted compared to FDA standards.
Abstract

Keywords:
Off-labelformulationhospital pharmacologypaediatric medicationpaediatric pharmacologyprescribingprescriptionunlicensed.

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