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Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022

Valentina Petkova1, Dilyana Georgieva2, Milen Dimitrov2

  • 1Department of Social Pharmacy, Faculty of Pharmacy, Medical University of Sofia, 1000 Sofia, Bulgaria.

Pharmaceutics
|December 23, 2023
PubMed

Insights

Off-label prescribing in pediatrics is a significant global issue. This study reviewed literature from 2012-2022 to understand the prevalence of using medications outside their approved indications for children.

Area of Science:

  • Pediatric Pharmacology
  • Drug Utilization Research
  • Clinical Pharmacy

Background:

  • Off-label prescribing is common in pediatrics, posing global health concerns.
  • The practice is influenced by patient condition, physician expertise, regulations, and the pharmaceutical industry.
  • Ensuring patient safety, especially for critically ill children, is paramount.

Purpose of the Study:

  • To investigate the prevalence of off-label drug use in pediatric populations.
  • To synthesize current data on pediatric off-label prescribing trends.

Main Methods:

  • Conducted a literature review.
  • Included studies published between 2012 and 2022.
  • Focused on research evaluating off-label drug prevalence in diverse pediatric groups.

Main Results:

  • Off-label medication use is widespread among pediatricians.
  • Significant global concern exists regarding the use of unapproved medicines in children.
  • Data from 2012-2022 indicates ongoing prevalence across various pediatric patient groups.

Conclusions:

  • Off-label prescribing in children remains a complex and prevalent issue.
  • A unified legal framework is unlikely in the near future.
  • Prioritizing patient well-being, particularly for those in neonatal and pediatric intensive care units, is essential.

Keywords:
childrenlegislationneonatesoff-label usepediatricsprescriptionsafety

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