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.
In a US population-based study, about 1 in 20 people who used psychedelics reported experiencing sexual or physical violence during their use. Younger age, female gender, and use of certain psychedelics like MDMA were associated with higher risk. The findings suggest that while most psychedelic experiences are safe, a minority involve violence, highlighting the need for harm reduction strategies.