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[Justification of off-label antibiotics uses in hospitalized children]

Christelle Berthod1, Behrouz Kassaï2, Remy Boussageon3

  • 1Centre d'investigation clinique pédiatrique CIC 1407 Inserm-UMR 5558 CNRS Lyon, université et hospices civils de Lyon, 69003 Lyon, France.

Therapie
|June 26, 2017
PubMed

Insights

Unlicensed and off-label antibiotic use in children lacks strong evidence from randomized controlled trials (RCTs). While licensed antibiotics showed more evidence than off-label ones, no prescriptions met high-quality study standards.

Area of Science:

  • Pediatric Pharmacology
  • Evidence-Based Medicine
  • Drug Utilization Studies

Background:

  • Unlicensed and off-label (UL/OL) drug use, particularly antibiotics, is common in pediatric care.
  • The justification for this practice, especially concerning the quality of supporting evidence, remains unclear.

Purpose of the Study:

  • To compare the level of evidence supporting UL/OL antibiotic prescriptions in hospitalized children.
  • To determine if UL/OL antibiotic use is supported by high-quality randomized controlled trials (RCTs).

Main Methods:

  • An observational study analyzed antibiotic prescriptions in a pediatric hospital.
  • Prescriptions were categorized by license status (licensed, UL/OL) and level of evidence (sufficient, insufficient, no evidence).
  • The presence of RCTs was assessed for each antibiotic course.

Main Results:

  • Of 108 identified antibiotic courses, 34% were off-label; none were unlicensed.
  • No proof of efficacy was found for 76 analyzed courses.
  • RCTs supported 47% of courses, with licensed antibiotics significantly more likely to be supported (63%) than off-label (16%).

Conclusions:

  • High-quality RCTs are largely absent for justifying antibiotic prescriptions in pediatrics, irrespective of license status.
  • Licensed antibiotic prescriptions demonstrated more evidence of efficacy compared to off-label ones.
  • Further clinical trials are needed to meet pediatric patient needs for evidence-based antibiotic therapy.

Keywords:
Agents antibactérienAntibacterial agentsDrug prescriptionEvidence-based medicineMédecine basée sur les preuvesOff-label usePrescription médicamenteuseUtilisation hors-AMM

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