Preparing Pharmacists for Psychedelic Medicine

Psychedelic medicines are moving closer to potential integration into clinical practice. Although much of the public discussion has previously focused on whether these therapies are effective, an equally important question is emerging: If psychedelic medicines receive FDA approval, how can they be implemented safely within the US health care system?

Recent clinical development and efficacy data have strengthened the rationale for considering this question seriously. Two phase 3 trials of 3,4-methylenedioxymethamphetamine (MDMA)–assisted therapy demonstrated significant improvements in posttraumatic stress disorder (PTSD) symptoms compared with therapy plus placebo.^1,2 However, the FDA declined to approve the initial application and requested an additional phase 3 study.³

More recently, two phase 3 trials of COMP360 synthetic psilocybin for treatment-resistant depression (TRD) met their primary efficacy endpoints, and a rolling new drug application submission and initial FDA review are underway.⁴ Other compounds continue to advance, such as BPL-003 (mebufotenin benzoate), an intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) also in development for TRD, with encouraging early-phase clinical data.⁵

In July 2026, Eli Lilly and Company announced an agreement to acquire AtaiBeckley, the developer of BPL-003, illustrating growing pharmaceutical-industry investment in this therapeutic area.⁶ None of these developments guarantee FDA approval. They do, however, create questions surrounding clinical implementation increasingly relevant.

As psychedelic drugs transition from substances historically associated with illicit use toward potential regulated therapeutics, clinical evidence is developing within a complex and unique cultural context. Psychedelic drugs and the people who use them continue to carry substantial stigma shaped, in part, by decades of prohibition. Stigma is increasingly recognized as an important determinant of health that can influence interactions within the health care system.⁷ Emerging evidence suggests that concerns about stigmatization and clinician knowledge can directly affect patients’ experiences and willingness to discuss psychedelic use with health care professionals.⁸

As evidence evolves, pharmacists should educate themselves on potential therapeutic applications and evaluate them objectively, without allowing either historical perceptions or contemporary enthusiasm to substitute for evidence.

Preparing for Safe Clinical Integration

Psychedelic therapies present implementation challenges different from those associated with most conventional psychiatric medications. Administration may occur episodically under supervision, potentially requiring prolonged monitoring, careful patient screening for interactions and contraindications, coordination of psychiatric medications before and after treatment, and systems for managing both psychological and physiologic adverse events.

These challenges are receiving increased attention from federal legislators, regulators, and agencies. In 2024, the bipartisan Congressional Psychedelics Advancing Therapies (PATH) Caucus issued a request for information (RFI) seeking stakeholder recommendations regarding the infrastructure, standards, and policies that could support safe implementation of psychedelic therapies.⁹ The Psychedelic Pharmacists Association (PPA), a professional organization focused on education, research, policy, and the pharmacist’s role in psychedelic medicine, responded with recommendations emphasizing multidisciplinary care, medication management, practitioner training, patient screening, pharmacovigilance, ethical safeguards, and pharmacist participation throughout the psychedelic continuum of care.

Federal engagement gained further momentum in 2026. The Health Resources and Services Administration (HRSA) requested stakeholder input on workforce training and care-delivery models for potential FDA-approved psychedelic therapies in ambulatory settings, including Federally Qualified Health Centers and Rural Health Clinics.¹⁰ PPA’s response emphasized roles pharmacists already perform across health care, including medication screening and consultation, mental health pharmacotherapy, Risk Evaluation and Mitigation Strategy (REMS) implementation, medication education, drug information, research, and controlled-substance management. The response also encouraged consideration of pharmacists with appropriate additional mental health and psychedelic-specific training for more direct roles in administration and monitoring.¹¹

Most recently, FDA finalized guidance addressing clinical investigations of psychedelic drugs and convened a September 2026 public hearing and request for comments regarding the potential future therapeutic use of psychedelic drugs in supervised and supportive settings.^12,13 PPA submitted written comments and participated in the public hearing, addressing FDA's four requested domains—provider training and credentialing, patient safety, access, and data collection and standardization—while continuing to emphasize appropriate pharmacist participation within multidisciplinary models of care.

Together, PPA’s engagement with the PATH Caucus, HRSA, and FDA reflects a broader point: pharmacists should participate in designing systems for psychedelic medicines before those systems are finalized, rather than attempting to define the pharmacist's role after implementation has already begun.

Many Required Competencies Are Already Familiar to Pharmacists

Psychedelic medicine is novel, but many of its medication-management challenges are not. Pharmacists routinely evaluate drug-drug and drug-disease interactions, conduct medication reconciliation, develop medication tapering strategies, educate patients, monitor adverse effects, manage controlled substances, and collaborate with other health care professionals. These competencies may be particularly important among patients with treatment-resistant psychiatric disorders, who frequently present with complex medication regimens.

Board-certified psychiatric pharmacists (BCPPs) represent an especially clear example. Their specialized training in psychiatric pharmacotherapy and experience practicing within interdisciplinary mental health teams make them well positioned to contribute to psychedelic care models; however, meaningful roles need not be limited exclusively to BCPPs. Pharmacists with appropriate mental health experience and additional role-specific training may contribute across screening, medication management, patient education, monitoring, drug information, research, pharmacovigilance, and policy.

This position is increasingly supported outside PPA. A 2026 Comment published in Nature Mental Health specifically examined current and future roles for psychiatric pharmacists in psychedelic therapy, concluding that integration of BCPPs could improve patient safety, address workforce shortages, and expand access while acknowledging unresolved questions involving training, regulation, and reimbursement.¹⁴

Importantly, possessing a PharmD alone should not be interpreted as sufficient preparation for every potential role. Direct participation in psychedelic administration or facilitation would require additional competency-based education, with requirements likely varying according to the drug, clinical setting, and responsibilities of the pharmacist. The appropriate scope of pharmacist involvement has not yet been established and will likely vary according to the therapy, treatment setting, regulatory requirements, and pharmacist competencies. Standards in this area remain under development.

REMS and Medication Safety May Provide a Familiar Framework

If the FDA determines that a psychedelic product requires a REMS or other restricted-distribution strategy, pharmacists would enter particularly familiar territory.

Esketamine (Spravato; Janssen Pharmaceuticals) provides an existing psychiatric example. Its REMS requires certified health care settings, administration under direct observation, post-administration monitoring, and specific dispensing requirements for certified pharmacies.¹⁵ Pharmacists already contribute to processes involving medication distribution, documentation, monitoring requirements, patient education, and regulatory compliance. Although the requirements for future psychedelic products cannot be assumed before FDA review, this experience provides a useful model for considering pharmacy's potential contribution.

Pharmacists may also support institutional protocols addressing medication reconciliation, storage and diversion prevention, adverse-event reporting, emergency procedures, and transitions on and off concomitant psychiatric medications. These functions are extensions of established clinical pharmacy practice rather than entirely new professional responsibilities. Integrating pharmacists to assist in monitoring administrations is a natural progression of that extension.

Workforce and Access Should Be Part of the Conversation

Safe implementation must also be feasible. HRSA’s RFI specifically asked how potential psychedelic therapies could eventually be delivered in medically underserved communities.¹⁰ The PPA response cautioned that credentialing requirements must protect patients without unnecessarily limiting the workforce available in rural and underserved settings.¹¹

Workforce demands could be substantial if these therapies are approved and widely adopted. One analysis projected that treating 1 million patients annually by 2031 could require around 55,000 to 100,000 additional psychedelic therapy clinicians, equivalent to roughly 10% to 17% of the US mental health workforce.¹⁶ These projections highlight the potential for workforce limitations to become an important barrier to equitable access.

Pharmacists could represent one component of a multidisciplinary solution. Psychiatric pharmacists may be particularly suited to direct clinical responsibilities; nonpsychiatric pharmacists may support screening, medication management, education, referral, safety monitoring, and continuity of care. The goal should not be to replace psychiatrists, psychologists, nurses, therapists, or other professionals. Rather, psychedelic care offers another opportunity to use multidisciplinary teams in which each profession practices according to its competencies to optimize patient outcomes.

FDA-Regulated Care Is Not the Only Emerging Setting

Federal approval remains the clearest pathway for incorporating psychedelic drugs into conventional medical practice, but it is not the only environment pharmacists will encounter. State-regulated programs in Oregon and Colorado established models of supervised psychedelic services outside traditional FDA drug approval pathways, while New Mexico is developing a regulated medical psilocybin program currently. Early real-world data from Oregon have begun to characterize outcomes, with a prospective cohort study reporting improvements in depression, anxiety, PTSD symptoms, mental well-being, and life satisfaction following state-regulated psilocybin services, while serious adverse reactions were uncommon.¹⁷ Pharmacists should be aware of state-run programs and be prepared to counsel patients accordingly.

Psychedelic use also occurs outside regulated medical systems. Pharmacists should acknowledge this reality and apply their medication expertise to harm reduction. A nonjudgmental approach may encourage patients to disclose psychedelic use, allowing pharmacists to identify potential interactions, contraindications, and other safety concerns. Medication-interaction screening, evidence-based education, and referral to appropriate medical care remain important patient-safety functions regardless of where exposure occurs.

Maintaining this distinction allows the profession to prioritize FDA-regulated, evidence-based care while remaining realistic about the broader environment in which pharmacists influence patient safety and provide support.

A Timely Opportunity for Pharmacy

The federal government is increasingly preparing for the potential entry of psychedelic medicines into clinical care. In 2026, federal actions have included finalized FDA guidance, an FDA public hearing and request for comments, an HRSA workforce and care-delivery RFI, and collaboration between the Department of Health and Human Services and Department of Veterans Affairs on research, workforce training, and potential future implementation.^10,12,13,18 Implementation questions are no longer purely theoretical.

Pharmacy has adapted repeatedly to new therapeutic frontiers. Psychedelic medicine may present another such challenge, requiring pharmacists to apply familiar principles of medication safety, patient education, interdisciplinary collaboration, and evidence-based practice in a new context. Preparation does not require predicting which drug will be approved or when. Pharmacists can begin by following the clinical evidence, understanding emerging pharmacology and drug-interaction data, learning from existing models such as esketamine, and participating in professional discussions about training, safety, and implementation.

Preparation also requires an evidence-based approach to communication with both patients and health care professionals. Pharmacists are well positioned to evaluate these therapies with the same objectivity applied to other emerging treatments, communicate without judgment, and help patients distinguish established evidence from both historical perceptions and contemporary hype.

For much of the past decade, conversations surrounding psychedelic medicine have centered on whether these therapies are effective. As evidence matures and regulatory decisions draw closer, the conversation is evolving. An equally important question is no longer whether psychedelic medicines may become part of clinical practice, but whether the health care system—and the pharmacy profession—will be prepared if they do.

REFERENCES

1. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27(6):1025-1033. doi:10.1038/s41591-021-01336-3
2. Mitchell JM, Ot’alora G M, van der Kolk B, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023;29(10):2473-2480. doi:10.1038/s41591-023-02565-4
3. Lykos Therapeutics announces complete response letter for midomafetamine capsules for PTSD. News release. Lykos Therapeutics. August 9, 2024. Accessed September 28, 2026. https://www.prnewswire.com/news-releases/lykos-therapeutics-announces-complete-response-letter-for-midomafetamine-capsules-for-ptsd-302219182.html
4. Compass Pathways announces second quarter and first half 2026 financial results and business highlights. News release. Compass Pathways. August 5, 2026. Accessed September 28, 2026. https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Announces-Second-Quarter-and-First-Half-2026-Financial-Results-and-Business-Highlights/default.aspx
5. Roberts C, Seynaeve M, Ermakova AO, et al. A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression. J Psychopharmacol. 2026;40(8):1247-1260. doi:10.1177/02698811261420087
6. Lilly to acquire AtaiBeckley to advance therapies for treatment-resistant depression and other mental health conditions. News release. Eli Lilly and Company. July 16, 2026. Accessed September 28, 2026. https://investor.lilly.com/news-releases/news-release-details/lilly-acquire-ataibeckley-advance-therapies-treatment-resistant
7. Hatzenbuehler ML, Phelan JC, Link BG. Stigma as a fundamental cause of population health inequalities. Am J Public Health. 2013;103(5):813-821. doi:10.2105/AJPH.2012.301069
8. St Pierre M, Standing L, Herman Y, Haden M, Walsh Z. Patients’ experiences discussing psychedelics for therapeutic purposes with physicians and other health care providers. Psychedelic Med. 2024;2(3):161-165. doi:10.1089/psymed.2023.0060
9. Congressional Psychedelics Advancing Therapies Caucus. Request for information on psychedelic medicine. 2024. https://www.congress.gov/118/crec/2024/08/09/170/129/modified/CREC-2024-08-09-pt1-PgE809-3.htm
10. Health Resources and Services Administration. Request for information: training and care delivery models for safe administration of potential FDA-approved psychedelic therapies in ambulatory clinical settings. Fed Regist. 2026;91:43103-43105. https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14146.pdf
11. Psychedelic Pharmacists Association. Comment on: Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings. Regulations.gov. 2026. Accessed September 28, 2026. https://www.regulations.gov/comment/HRSA-2026-0034-0049
12. Psychedelic Drugs: Considerations for Clinical Investigations. Final guidance. US Food and Drug Administration. July 2026. Accessed September 28, 2026. FDA guidance⁠. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations
13. US Food and Drug Administration. Considerations for potential future therapeutic use of psychedelic drugs; public hearing; request for comments. Fed Regist. 2026;91:43095-43098. https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14155.pdf
14. Jenkins J, Catanzano S, Vadiei N, et al. Psychedelic therapy and the current and future roles for psychiatric pharmacists in the USA. Nat Ment Health. Published online August 20, 2026. doi:10.1038/s44220-026-00709-2
15. Spravato (esketamine) nasal spray. Prescribing information. Janssen Pharmaceuticals, Inc; 2025. Accessed September 28, 2026. Spravato prescribing information⁠. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s016lbl.pdf
16. Marseille E, Bertozzi S, Kahn JG. The economics of psychedelic-assisted therapies: a research agenda. Front Psychiatry. 2022;13:1025726. doi:10.3389/fpsyt.2022.1025726
17. Korthuis PT, Cook RR, Gregoire D, et al. Safety and mental health outcomes of Oregon state-regulated psilocybin services. JAMA Netw Open. 2026;9(8):e2630608. doi:10.1001/jamanetworkopen.2026.30608
18. HHS & VA announce partnership to advance rapid-acting mental health treatments for veterans. News release. US Department of Health and Human Services. July 13, 2026. Accessed September 28, 2026. https://www.hhs.gov/press-room/hhs-va-partner-advance-psychedelic-therapies-veterans.html