Optimizing real-world benefit and risk of new psychedelic medications: the need for innovative postmarket surveillance
Nature Mental Health May 1, 2024 Joshua C. Black, Andrew A. Monte, Nabarun Dasgupta et al. 5 citations
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.