Expert: Pharmacists Play Pivotal Role in Supporting Safe Consumption of Psychedelic Medicines Upon Their FDA Approval

Pharmacy Times interviewed Bia Labate, PhD, executive director of the Chacruna Institute and public education and culture specialist at the Multidisciplinary Association for Psychedelic Studies, and Kelan Thomas, PharmD, MS, associate professor of clinical sciences at Touro University California College of Pharmacy and board-certified psychiatric pharmacist, to discuss the psychedelic medicine market and the outlook for the field.

Thomas explained during the interview that the biggest point of focus in terms of the psychedelic medicine market in the United States today is the FDA approval process.

“This week is the American Society of Clinical Psychopharmacology annual meeting, and they're discussing medications like MDMA and psilocybin that have both gotten FDA breakthrough designation status,” Thomas said. “A recent data bridge report that looks at financial outlooks and markets estimated market growth in psychedelics in general from $2 billion in 2019 to $6.8 billion in 2027.”

Thomas noted that some companies may pursue varying avenues in providing these medications to the public following the FDA approval of psychedelic medicines, from the traditional pharmaceutical route for FDA approval to the dispensary route.

“Places potentially have different opportunities for use, such as the psilocybin initiative, which is going through the Oregon Health Authority,” Thomas said. “There could be all kinds of ways that the marketplace rolls out and all kinds of different uses.”

Upon the FDA approval of psychedelic medicine for psychiatric indications—such as MDMA for post-traumatic stress disorder or psilocybin for depression—psychiatric pharmacists in particular and all pharmacists generally, will play a pivotal role in the psychedelic medicine market in the United States, according to Thomas.

“If they become FDA-approved, there will be this risk evaluation and mitigation strategy (REMS) similar to what we've seen with medications like ketamine that will basically have rules around what the medical use in a clinic setting will look like,” Thomas said. “Pharmacists would be involved in the same ways that we think about adverse drug reactions, or drug interactions with any medication, as well as things like REMS. Specialty pharmacies will be the ones procuring, dispensing, and sending these medications to clinics for in-clinic use once these FDA REMS are set up.”

Labate noted that for the future, she hopes for more compassion, engagement, and support from the public and the US government to further research and more fully understand either the beneficial or deleterious effects of different psychedelic medicines on the body.

“We need research that is not just focused on showing the harms [of these drugs],” Labate said. “What about pouring research dollars into finding the potential therapeutic benefits of cannabis and all the other substances? That's also a problem with the research—official-funded research that we have had has stimulated much more focus on harms than benefits.”

Additionally, Labate said that tolerance of multiple models in the approach of the treatment of health concerns—especially mental health concerns—to advance our understanding of these areas and potential treatment options available would help to allow for an individualized approach to care.

“We're sitting on the top of this iceberg. We have a whole world underneath to be explored. We can, as a society, organize ourselves to help recognize that these substances can be very powerful, but they can also have negative effects,” Labate said. “It's in our best interest to gear this in a responsible, integrated, mature, open, and transparent conversation, since it's not by creating lies to our teenagers that we're going to keep them away from drugs.”