Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework
Publication year
2021Source
Clinical Pharmacology and Therapeutics, 110, 4, (2021), pp. 952-965ISSN
Publication type
Article / Letter to editor

Display more detailsDisplay less details
Organization
Pharmacology-Toxicology
Intensive Care
Journal title
Clinical Pharmacology and Therapeutics
Volume
vol. 110
Issue
iss. 4
Page start
p. 952
Page end
p. 965
Subject
Radboudumc 11: Renal disorders RIHS: Radboud Institute for Health SciencesAbstract
A drug is granted a license for use after a thorough assessment of risks and benefits based on high-quality scientific proof of its efficacy and safety. Many drugs that are relevant to children are not licensed for use in this population implying that a thorough assessment of risks and benefits in the pediatric population has not been made at all, implying a negative risk-benefit balance in children, or implying insufficient information to establish the risk-benefit balance. Use of drugs without positive assessment of risks and benefits exposes children to potential lack of efficacy, unknown toxicity, and harm. To aid guideline committees and individual prescribers, we here present a tutorial of the Benefit and Risk Assessment for Off-label use (BRAvO) decision framework. This pragmatic framework offers a structured assessment of benefits and risks of off-label drug use, including a clinical pharmacological based approach to age-appropriate dose selection. As proof of concept and to illustrate the practical use, we have applied the framework to assess benefits and risks of off-label use of ondansetron for gastroenteritis-induced nausea and vomiting. The framework could also guide decisions on off-label use in other special populations (e.g., pregnant women, elderly, obese, or critically ill patients) where off-label drug use is frequent, thereby contributing to effective and safe pharmacotherapy.
This item appears in the following Collection(s)
- Academic publications [227881]
- Electronic publications [107344]
- Faculty of Medical Sciences [86219]
- Open Access publications [76465]
Upload full text
Use your RU credentials (u/z-number and password) to log in with SURFconext to upload a file for processing by the repository team.