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Adverse Drug Reactions in Hospitalized Pediatric Patients: A Prospective Observational Study

J Kurian1, J Mathew1, K Sowjanya1

  • 1Department of Pharmacy Practice, JSS College of Pharmacy, JSS University, Mysore, Karnataka, 570015, India.

Indian Journal of Pediatrics
|February 27, 2016
PubMed

Insights

Adverse drug reactions (ADRs) occurred in 4.99% of pediatric patients, with infants, males, and those on multiple medications being most at risk. Continuous monitoring is crucial for pediatric drug safety.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety and Pharmacovigilance
  • Clinical Pharmacy

Background:

  • Adverse drug reactions (ADRs) pose a significant risk in pediatric populations.
  • Understanding the incidence, causality, and predictors of ADRs is crucial for improving patient safety.

Purpose of the Study:

  • To determine the incidence, pattern, causality, preventability, severity, and predictors of adverse drug reactions (ADRs) in pediatric patients.
  • To identify risk factors associated with ADRs in children.

Main Methods:

  • A prospective, observational study was conducted in a tertiary care hospital's pediatric wards.
  • Data on ADRs were collected and analyzed for incidence, causality (WHO Probability scale, Naranjo's algorithm), preventability (Modified Shumock and Thornton scale), severity (Modified Hartwig and Siegel scale), and predictors.

Main Results:

  • The incidence of ADRs was 4.99% among 1082 enrolled pediatric patients.
  • Gastrointestinal disorders were the most common ADRs, primarily associated with amoxicillin/clavulanate and ceftriaxone.
  • Infants, males, and patients receiving ≥4 medications showed a significant association with ADR occurrence.

Conclusions:

  • Infants, males, and children on multiple medications (≥4) are at higher risk for ADRs.
  • Continuous monitoring and vigilance are essential for managing drug safety in pediatric patients, particularly vulnerable groups.
Abstract

Keywords:
ADR monitoringAdverse drug reactionsPediatricsPharmacovigilance

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