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

Pharmaceutics. 2023 Nov 21;15(12):2652. doi: 10.3390/pharmaceutics15122652.

Abstract

Off-label prescribing is widespread among pediatricians, and it is unlikely that this trend will soon be bound by a uniform legal framework. This is necessitated by the fact that there are four variables: the patient's health condition, the physician's experience and knowledge, the legislative measures (laws, directives, guidelines, and recommendations), and finally, the pharmaceutical industry. There is considerable concern worldwide about the use of off-label medicines in children. We may call it an enormous global problem that is much talked about and written about; however, we should not forget that the goal around which everyone should unite is the patient's life. For healthcare providers, the most important thing will always be the health and preservation of the patient's life, particularly when it comes to children with life-threatening conditions in neonatal and pediatric intensive care units (NICU and PICU). The study aimed to examine the prevalence of off-label drug use in pediatrics. Literature research was conducted, and we included studies from 2012 to 2022 that evaluated off-label drug prevalence in various pediatric patient populations.

Keywords: children; legislation; neonates; off-label use; pediatrics; prescription; safety.

Publication types

  • Review

Grants and funding

The authors would like to acknowledge the financial support by the European Union-NextGenerationEU, through the National Recovery and Resilience Plan of the Republic of Bulgaria, project › BG-RRP-2.004-0004-C01.