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Relationship between adverse drug reactions and unlicensed/off-label drug use in hospitalized children (EREMI): A

Kim An Nguyen1, Yanis Mimouni2, Elham Jaberi2

  • 1Neonatal Intensive Care Unit and Neonatology, hôpital Femme-Mère-Enfant, Hospices civils de Lyon, 69500 Bron, France; Department of Pharmacotoxicology, Hospices civils de Lyon, 69003 Lyon, France; UMR 5558, CRNS, LBBE, EMET, Université Lyon, 69008 Lyon, France.

Therapie
|February 17, 2021
PubMed

Insights

This study investigated the link between off-label drug use and adverse drug reactions (ADRs) in hospitalized children. Findings aim to improve pediatric prescribing practices and patient safety by identifying risk factors for ADRs.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety and Pharmacovigilance
  • Clinical Pharmacy Practice

Background:

  • Limited evidence exists on the association between off-label drug use and adverse drug reactions (ADRs).
  • Understanding prescribing practices and the impact of unlicensed or off-label drug use in pediatric inpatients is crucial.

Purpose of the Study:

  • To evaluate the relationship between adverse drug reactions (ADRs) and unlicensed or off-label drugs in hospitalized children.
  • To provide insights into prescribing practices, prevalence, and consequences of off-label drug use in pediatric inpatients.

Main Methods:

  • A multicenter prospective study utilizing the French summaries of product characteristics (Theriaque) for drug labeling.
  • Adverse drug reactions (ADRs) were detected through spontaneous reporting and active surveillance using trigger tools and electronic health records.
  • Causality assessment of suspected ADRs was performed independently by pharmacovigilance centers using Naranjo and French methods, with final validation by independent experts.

Main Results:

  • The study established a robust methodology for identifying and validating ADRs associated with off-label drug use in pediatric populations.
  • Identified risk factors associated with off-label drug use and subsequent ADRs in hospitalized children.
  • The research provides a comprehensive overview of the amplitude and consequences of off-label drug use in this demographic.

Conclusions:

  • This is the first large-scale, prospective study in France with active monitoring and independent validation of ADRs related to off-label drug use in children.
  • Findings can inform preventive strategies, guide future research, and enhance physician awareness regarding off-label prescribing and ADR detection/reporting.
  • While acknowledging potential under-reporting and confounders inherent in observational studies, the rigorous validation process ensures the reliability of confirmed ADRs.
Abstract

Keywords:
Adverse drug reactionsChildrenInpatientsOff-label drugsUnlicensed drugs

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