A guided framework for assessing off-label medication use in psychiatry

Abstract

Objective The objective of this article is to present a decision aid in the form of a flowchart, designed to assist psychiatrists in navigating the challenges of off-label medication use. This tool is believed to be the only one currently available that combines guidance from medical indemnity insurers, RANZCP guidelines, CATG frameworks, and relevant legislation to provide a practical guide for everyday psychiatric practice. Conclusions There are clinical, legal, ethical, and financial considerations to take into account each time an off-label prescription is ordered. There is no legal barrier to prevent psychiatrists from prescribing off-label in Australia and New Zealand. The medication should be utilised if it is in the best interests of the patient. However, practitioners must be able to defend the rationale for their off-label medication use with evidence of sound quality. Off-label use medication use can lead to improved patient outcomes and quality of life. On the other hand, poor practice in off-label prescribing can result in adverse events, patient harm, legal implications, and damage to professional reputation. By evaluating available evidence, considering patient characteristics, obtaining informed consent, and documenting the rationale for off-label use, clinical decision-making can be enhanced whilst mitigating the risks associated with off-label prescribing.