Off-Label Medicine Use in Pediatric Anesthesia—Recommendations of the World Federation of Societies of Anaesthesiologists (WFSA) Paediatric Committee

Abstract

Background Off-label medicine use is the administration of a medication in any manner that is not included in the approved package insert for that medication. The off label use of medicines is common in pediatric anesthesia due to the limited number of drugs that are specifically approved for use in children. This is due to the lack of clinical drug trials involving children, resulting in the absence of safety and efficacy data for this population of patients. This may lead to an increased risk of adverse events when these medicines are used in pediatric patients and expose anesthesia practitioners to the risk of litigation. Aims This paper describes an approach and principles for decision making for anesthesia practitioners around use of medicines in pediatric patients undergoing anesthesia. Conclusion The decision to use a medication off label should be rational, clinically appropriate and based on a balance of benefit versus risk.