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Off-Label Use of Drugs and Adverse Drug Reactions in Pediatric Units: A Prospective, Multicenter Study

Andrea D Pratico1,2, Laura Longo3, Silvana Mansueto3

  • 1Clinical Neuroscience Institute, Kings College London, London, United Kingdom.

Current Drug Safety
|June 21, 2018
PubMed

Insights

Off-label drug use in children, especially newborns, increases adverse drug reaction risk. Pharmacovigilance programs are crucial for monitoring these risks in pediatric and neonatal care.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety
  • Clinical Pharmacy

Background:

  • Increasing use of off-label medications in pediatric practice necessitates robust pharmacovigilance.
  • Monitoring adverse drug reactions (ADRs) from off-label prescriptions in children is critical.

Purpose of the Study:

  • To present the results of a one-year pharmacovigilance program in the Sicilian Region, Italy.
  • To analyze the incidence and characteristics of off-label drug use and associated ADRs in pediatric patients.

Main Methods:

  • Prospective review of 14,916 prescriptions for 5,060 pediatric patients across 6 centers.
  • Patients stratified by age: newborn, infant, child, and adolescent.
  • Identification of off-label prescriptions and recording of adverse drug reactions.

Main Results:

  • 8.97% of patients received at least one off-label drug, with newborns being the most frequent recipients (56.2%).
  • Anti-infectives were the most common off-label drug class.
  • 90 adverse drug reactions (1.78%) were recorded; 36.7% were associated with off-label use.
  • Off-label drug use significantly increased the risk of ADRs (7.3% vs. 1.2%, p <0.01).

Conclusions:

  • Children in neonatal intensive care units (NICUs) are highly likely to receive off-label medications.
  • Off-label medication use is associated with polypharmacy in pediatric patients.
  • ADRs are more frequent with off-label than on-label drug use in pediatric and neonatal units.
Abstract

Keywords:
Drug safetyadverse drug reactionsclinical trialsdrug regulationoff-label prescriptionpharmacovigilance.

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