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Off-label drug use in pediatric patients: a comparative analysis with nationwide routine prescription data

Narin Akıcı1, N İpek Kırmızı2, Volkan Aydın2

  • 1Department of Pediatrics, Haydarpasa Numune Training and Research Hospital, İstanbul, Turkey.

The Turkish Journal of Pediatrics
|December 29, 2020
PubMed

Insights

This study analyzed pediatric off-label drug use (OLDU) in Turkey, finding correlations with socioeconomic factors and physician density. While demographics align with routine prescribing, significant differences exist in drug classes and diagnoses, highlighting areas for improved pediatric drug use.

Area of Science:

  • Pediatric Pharmacology
  • Drug Utilization Research
  • Public Health

Background:

  • Children are a vulnerable population for off-label drug use (OLDU).
  • Limited data exist on pediatric OLDU in clinical practice.
  • This study addresses this gap by investigating pediatric OLDU and comparing it to routine prescribing patterns.

Purpose of the Study:

  • To investigate pediatric off-label drug use (OLDU) practices in Turkey.
  • To compare pediatric OLDU with routine drug utilization patterns.
  • To identify demographic, socioeconomic, and drug-specific characteristics of pediatric OLDU.

Main Methods:

  • A cross-sectional study analyzing approved pediatric OLDU applications and electronic prescription data from Turkey in 2015.
  • Data were compared based on demographics, socioeconomic indices, drug details, and diagnoses.
  • Statistical analysis included correlation assessments.

Main Results:

  • 7,896 OLDU applications and over 7 million prescriptions were analyzed for children.
  • Pediatric OLDU and prescriptions correlated positively with socioeconomic development and physician density.
  • Antineoplastic/immunomodulating agents were most common in OLDU, while respiratory drugs were most common in routine prescribing.

Conclusions:

  • This is the first nationwide study detailing pediatric OLDU and prescribing practices.
  • Pediatric OLDU generally aligns with routine practice in demographics but varies in drug classes and diseases.
  • Findings aim to inform interventions for improving indicated pediatric drug use.
Abstract

Keywords:
antineoplasticchildrenimmunomodulatingoff-label drug useprescribing

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