AZA Allsop, MD, PhD, outlines what REMS-style safety monitoring could look like for psychedelic therapies and why top institutions are investing heavily.
In an interview with Pharmacy Times, AZA Allsop, MD, PhD, assistant professor of psychiatry at Yale and Howard University and head of research for Beckley Retreats, outlined what best-in-class safety monitoring for psychedelic therapies should look like for pharmacists. He pointed to a system similar to Risk Evaluation and Mitigation Strategies (REMS) that would track who administered a psychedelic intervention, when, and the corresponding integration window to prevent misuse such as repeat treatments across multiple centers.
Allsop also discussed heavy investment in psychedelic research from institutions like Stanford, Harvard, and Johns Hopkins, describing it as a sign that the field is regaining mainstream credibility after past setbacks, tempered by a risk-averse approach focused on maximizing benefit and minimizing harm. Closing the interview, Allsop reflected on psychedelics' potential to address converging crises, including the mental health crisis, the loneliness epidemic, and social polarization, while stressing the importance of equitable, accessible, and harm-reducing implementation as the field develops.
The discussion followed the
Pharmacy Times: For pharmacists who will eventually be involved in dispensing or counseling patients on these therapies, what should best-in-class safety monitoring look like in practice?
AZA Allsop, MD, PhD: I think this will be an ongoing process, particularly as we come to the implementation of these therapeutic modalities, but I think a system similar to the REMS system—where we can see what someone has been prescribed, when they were prescribed, and by whom—will be necessary. It allows us to make sure that medications aren't being misused or used in ways that aren't intended. I think a similar process will be necessary for psychedelics so that we know when someone has had a psychedelic intervention, who delivered it, and what the window of their integration period is. That way, we don't have, for instance, someone doing a psilocybin treatment at one center and then, a week later, going to another center—because that's not the way we've studied their actual development within the clinical setting. I think having that sort of monitoring program will be critical.
Pharmacy Times: Institutions like Stanford, Harvard, and Johns Hopkins are investing heavily in psychedelic research. What does that level of institutional commitment tell us about where the scientific consensus is heading?
Allsop: I think it shows that psychedelics have once again made their way back into the zeitgeist and the mainstream. We've been here before, though, and things didn't go as well as we would have liked. So I think it's a great sign that the institutions you named—and I'm at Yale—are all really excited about the potential, because there's such great potential for delivery and treatment within psychiatry. However, I think that has to be tempered by a very risk-averse approach that really tries to maximize the potential outcome and minimize the potential harm. I do think that at these institutions, that is the idea and the goal, and the infrastructure and resources are there to actually allow that to happen.
Pharmacy Times: Is there anything else that you would like to add, or anything that you think I missed before we end our discussion?
Allsop: I think we are right now in a very critical time in human history, where we have a convergence of multiple crises. We have the mental health crisis, the loneliness epidemic, and extreme polarization, both here locally in the United States and globally. I think psychedelics, embedded in very thoughtful ways into our clinical and cultural landscapes, can really help us combat all three of those epidemics. So again, I think there's a wonderful opportunity here, but there's also potential for harm, and we have to be very careful about making sure that as these become embedded into clinical and cultural spaces, we're doing so in a way that's accessible and equitable and that reduces and minimizes any potential harm.
