Optimizing real-world benefit and risk of new psychedelic medications: the need for innovative postmarket surveillance

As psychedelic-assisted psychotherapy nears FDA approval and broader use in the USA, current postmarket surveillance systems are ill-suited to monitor its real-world safety and effectiveness. Without a fit-for-purpose program, risks include misattributing adverse events to illicit psychedelics and failing to achieve equitable patient access. A successful surveillance mosaic should incorporate environmental, personal, and outcome domains to ensure safe, appropriate, and equitable care. The authors argue for intentionally designed data systems to proactively monitor utilization and inform reasonable limitations.

Study at a glance

Abstract

The encouraging results of late-phase clinical trials investigating psychedelic-assisted psychotherapy suggests that US Food and Drug Administration approval and subsequent expansion of use is imminent in the USA. Without fit-for-purpose postmarket surveillance to proactively monitor utilization by patients and providers, there is a risk that the real-world benefits of psychedelic-assisted psychotherapy will not be realized. Incorrect conclusions, such as misattribution of adverse events to illicit psychedelics, may result from ill-designed surveillance programs. A successful surveillance program should monitor appropriate, equitable access for patients and inform reasonable limitations to improve patient safety. Multiple domains, including environmental factors, personal factors and relevant effectiveness and safety outcomes, should be incorporated. Current data systems that monitor drug use are generally ill-suited to address the unique needs for psychedelic surveillance. An intentionally designed mosaic of data systems is required to monitor the safety and effectiveness of psychedelic surveillance. In this Perspective, authors argue for a more robust and comprehensive postmarket surveillance program of psychedelic-assisted psychotherapy to better ensure safe, appropriate and equitable care for patients.