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Off-label drug use in children

Surabhi S Jain1, S B Bavdekar, Nithya J Gogtay

  • 1Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India.

Indian Journal of Pediatrics
|September 24, 2008
PubMed

Insights

Off-label drug use is common in Indian pediatric wards, with over half of prescriptions being unapproved. Altered dosages were the most frequent reason for this widespread practice in children.

Area of Science:

  • Pediatric Pharmacology
  • Drug Utilization Studies
  • Clinical Pharmacy

Background:

  • Off-label drug use in children is a significant concern due to potential safety and efficacy issues.
  • Pediatric populations often require specialized dosing and indications not covered by standard drug approvals.

Purpose of the Study:

  • To investigate the prevalence and characteristics of off-label medication use in children admitted to a pediatric general ward.
  • To identify common off-label drug categories and reasons for their use in a tertiary care setting.

Main Methods:

  • Prospective enrollment of 600 pediatric patients (1 month to 12 years) over two months.
  • Utilized British National Formulary (BNF) version 2005 to define and categorize off-label drug use.
  • Analyzed 2000 prescriptions, assessing dose, frequency, indication, age appropriateness, and route of administration.

Main Results:

  • Over half (50.62%) of the 2000 prescriptions analyzed were for off-label drug use.
  • The average rate of off-label prescriptions per patient was 1.74, highest in infants (2.33/patient).
  • Common reasons included alteration in dosage (most frequent), age, and indication; furosemide, diazepam, and cefotaxime were frequently used off-label.

Conclusions:

  • Off-label drug prescribing is highly prevalent in pediatric general wards within Indian tertiary care hospitals.
  • The findings highlight a critical need for improved guidelines and monitoring of medication use in pediatric patients.
Abstract

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