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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
Summary
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.
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