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

Summary

Late-phase clinical trials indicate that psychedelic-assisted psychotherapy may soon receive FDA approval in the USA. However, without effective postmarket surveillance to monitor its use, there is a risk that the potential benefits will not be realized. Poorly designed surveillance could lead to misattributing adverse events to illicit substances. A comprehensive program is needed to ensure patient safety and equitable access while monitoring various factors affecting treatment outcomes.

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.