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

Nature Mental Health volume 2, pages 469–477 (2024)Cite this article

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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.

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Fig. 1: The continuum of psychedelic drug use.
Fig. 2: Evolving research needs as the market expands.

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Authors and Affiliations

  1. Rocky Mountain Poison & Drug Safety, Denver Health and Hospital Authority, Denver, CO, USA

    Joshua C. Black, Andrew A. Monte, Jennifer S. Jewell, Karilynn M. Rockhill, Richard A. Olson & Richard C. Dart

  2. Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA

    Andrew A. Monte & Richard C. Dart

  3. University of North Carolina, Chapel Hill, NC, USA

    Nabarun Dasgupta

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Contributions

J.C.B., A.A.M., N.D., J.S.J., K.M.R., R.A.O. and R.C.D. substantially contributed to the conception and design of the work. J.C.B., A.A.M., J.S.J., K.M.R. and R.C.D. wrote the initial draft. J.C.B., A.A.M., N.D., J.S.J., K.M.R., R.A.O. and R.C.D. critically reviewed for intellectual content. J.C.B. led the writing and editing process.

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Correspondence to Joshua C. Black.

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This research was conducted by Rocky Mountain Poison and Drug Safety (RMPDS). Outside of this work, RMPDS is supported by subscriptions from pharmaceutical manufacturers, government and non-government agencies for surveillance, research and reporting services. RMPDS is a division of the nonprofit Denver Health and Hospital Authority (DHHA), a political subdivision of the state of Colorado, USA. No subscriber participated in the development of these viewpoints.

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Black, J.C., Monte, A.A., Dasgupta, N. et al. Optimizing real-world benefit and risk of new psychedelic medications: the need for innovative postmarket surveillance. Nat. Mental Health 2, 469–477 (2024). https://doi.org/10.1038/s44220-024-00233-1

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