Psychedelic Care is Taking Shape

Why I signed the OPENurses letter to the FDA, and why nursing belongs at the center of safe, ethical, and equitable psychedelic care

I signed my name to a national letter from the Organization of Psychedelic and Entheogenic Nurses, known as OPENurses, asking the Food and Drug Administration to formally recognize registered nurses and advanced practice registered nurses as central members of future psychedelic care teams. I did not sign because nurses need another title or a ceremonial seat at the table. I signed because patients will need us there.

After 38 years as a registered nurse and a decade working in plant medicine, I have learned to look beyond the substance, device, or procedure in front of me. The treatment matters, but the care surrounding it often determines whether a patient feels informed or confused, safe or exposed, supported or abandoned. That truth becomes even more important when a therapy may temporarily alter perception, consciousness, emotional processing, and a person’s ability to advocate for themselves in the usual way.

The FDA has opened a rare policy window

On September 14, 2026, the FDA will hold a hybrid public hearing on the potential future therapeutic use of psychedelic drug products in supervised and supportive settings. The agency is specifically seeking input on provider training and credentialing, patient safety, access, and data collection and standardization. Requests to present oral comments are due August 21, 2026, and written comments may be submitted through October 5, 2026 (Food and Drug Administration [FDA], 2026a).

The scope is deliberately narrow. The FDA is not asking commenters to debate the safety or effectiveness of a particular product, federal scheduling, legalization or decriminalization, religious or ceremonial use, or individual disputes with practitioners. This hearing is about something more practical and, in many ways, more consequential: if psychedelic medicines enter wider clinical use, who will be trained to care for patients, what safeguards will be required, how will access be structured, and how will outcomes and adverse events be tracked?

Those are not side questions. They are the care model.

A psychedelic drug product is not a complete treatment system

A medication can be manufactured, tested, labeled, prescribed, and administered. It cannot sit beside a frightened patient for six hours. It cannot notice that a change in breathing, blood pressure, speech, orientation, or behavior is moving from expected to concerning. It cannot reconcile a complicated medication list, establish boundaries around therapeutic touch, recognize a trauma response, document an adverse event, arrange a safe discharge, or call the patient the next day when the experience has not resolved as neatly as the protocol suggested.

Nurses do those things. We assess. We educate. We monitor. We anticipate. We recognize patterns before they become crises. We translate clinical language into human language, coordinate across disciplines, and stay with people when the plan changes. In psychedelic care, where physiology, psychology, environment, relationship, and meaning may all affect the patient’s experience, nursing is not an accessory service. It is part of the safety infrastructure.

The FDA’s July 2026 final guidance for psychedelic clinical investigations already acknowledges a role for nursing. It recommends that an assistant monitor may have a nursing or bachelor’s degree plus at least one year of clinical experience in a licensed mental health care setting (FDA, 2026b). That is meaningful progress, especially because the wording does not automatically exclude associate-degree registered nurses. Still, it raises an important workforce question: should one year in a dedicated mental health setting be the only doorway into psychedelic nursing?

Psychedelic nursing cannot be reduced to psychiatric nursing

Psychiatric and mental health nurses bring indispensable expertise, including assessment of suicidality, psychosis, mania, trauma responses, de-escalation, and psychotherapeutic support. Their leadership will be essential. Yet psychedelic care will also need the clinical judgment of nurses from oncology, palliative and hospice care, emergency and critical care, anesthesia, addiction medicine, primary care, community health, and other specialties.

An oncology nurse knows how fear, mortality, family dynamics, medications, and meaning enter the room together. A palliative care nurse understands existential distress and the difference between eliminating symptoms and relieving suffering. An emergency nurse can identify a destabilizing situation quickly. A critical care or anesthesia nurse brings advanced physiological monitoring and crisis-response skills. A community health nurse understands what happens after the patient leaves the specialty clinic and returns to a real life shaped by transportation, housing, caregiving, cost, stigma, and fragmented follow-up.

The answer is not to lower standards. It is to build competency-based pathways that recognize relevant nursing experience, add psychedelic-specific education, require supervised clinical practice, and verify ongoing competence. A license alone is not enough. Enthusiasm is not training. But a narrow credentialing model that discards decades of transferable nursing expertise is not safer; it is simply wasteful, expensive, and likely to worsen access.

The evidence shows both readiness and a serious education gap

Nursing is the largest healthcare profession in the United States, with more than five million registered nurses working across hospitals, clinics, homes, schools, mental health agencies, hospices, public health systems, research, and underserved communities (American Association of Colleges of Nursing [AACN], 2026). That reach could make the difference between psychedelic care becoming a boutique service for people near wealthy urban centers and becoming a safe, scalable option within ordinary healthcare systems.

But we should not confuse workforce size with preparedness. In a 2024 survey of 1,133 nurses, 74.1% believed nurses have an important role in psychedelic healthcare and 80.7% expressed interest in observing psychedelic sessions. At the same time, only 26.5% felt confident in their knowledge of potential therapeutic benefits, and just 21.2% felt confident in their understanding of mechanisms of action (Porta et al., 2024). A separate statewide study found that only 12.7% of participating nurses reported any psychedelic content in their nursing education (Graefe et al., 2025).

That is the real mandate: include nurses and educate nurses. Recent nursing scholarship has called for psychedelic content to be integrated into undergraduate and graduate curricula, with emphasis on pharmacology, safety, ethics, clinical skills, and experiential learning appropriate to professional roles (Eshkevari et al., 2026). If policymakers expect nurses to protect patients in this emerging field, schools, employers, credentialing organizations, and professional associations must give nurses the education and supervised experience to do that work well.

This is not a new argument for me

Earlier this year, Elisabeth Mack and I wrote a book chapter titled “Microdosing Psilocybin as a Public Health Harm Reduction Practice: Registered Nurses in Trauma-Informed Psychedelic Care” for the forthcoming IGI Global volume Psychedelics for Clinical Practice: Scientific, Social, Legal, and Economic Pathways (Mack & Mack, 2026). The chapter is currently under peer review and the book is due to be published in early 2027. Our chapter placed nursing inside the public health and harm-reduction infrastructure surrounding psychedelic use. We examined medication safety, trauma-informed stabilization, community nursing engagement, scope of practice, health equity, structured competencies, and whole-person integration across the biological, mental, emotional, social, and spiritual domains of health.

Our point was not that every nurse should become a psychedelic facilitator. It was that nurses will encounter patients who are considering, using, or recovering from psychedelic experiences whether healthcare systems prepare us or not. Patients will bring questions to primary care. They will arrive in emergency departments. They will disclose use during medication reconciliation. They will seek support after a difficult experience. Some will receive psychedelic treatments in research or future medical settings. Nursing education and policy cannot wait until every regulatory question is settled before preparing the workforce to respond with skill instead of stigma.

The OPENurses letter brings that same argument directly to the FDA. Nurses must be included not only during administration, but across screening, preparation, physiological and psychological monitoring, informed consent, recovery, integration, adverse-event surveillance, care coordination, and long-term follow-up. We must also help design the standards that govern those responsibilities.

Patient vulnerability requires an independent clinical safeguard

Altered states can amplify trust, suggestibility, emotional openness, and power differences between patients and practitioners. That makes ethics concrete, not theoretical. Patients need clear advance agreements about who will be present, what forms of touch are permitted, how consent may be changed or withdrawn, what happens during psychological distress, and who can intervene when the person providing therapeutic support crosses a boundary.

A licensed nurse brings more than a comforting presence. Nurses carry an independent professional duty, a code of ethics, documentation responsibilities, mandatory reporting obligations, and accountability to a board of nursing. That does not make nurses incapable of harm, and it does not replace thoughtful team design. It does create another layer of oversight inside a setting where the patient may be unusually vulnerable and where a single-provider model can concentrate too much power in one person.

For that reason, the OPENurses letter supports clear informed-consent standards, defined monitoring and discharge criteria, protected reporting pathways, and the presence of independently licensed professionals with the authority and obligation to act. I strongly agree.

Access without safety is reckless. Safety without access is hollow.

There is a genuine tension here. Overly loose staffing and credentialing rules could expose patients to undertrained practitioners and inconsistent care. Overly restrictive rules could produce a small, expensive system clustered around scarce specialists and major academic centers. Either failure would harm patients.

The answer is not physician-only care, nurse-only care, or facilitator-only care. It is a multidisciplinary, scope-aware model that matches training and responsibility to each phase of care. APRNs may screen, diagnose, prescribe, and manage treatment within applicable state law. RNs may conduct assessments, reconcile medications, educate patients, monitor physiological and psychological status, administer medications under orders and protocols, coordinate emergency response, support recovery, document outcomes, and maintain continuity after the session. Psychotherapists, counselors, chaplains, peer specialists, and trained facilitators may contribute complementary expertise. Patients need a team, not a turf war.

Nurses also bring geographic reach. We already work in rural hospitals, federally qualified health centers, community mental health programs, home health, hospice, primary care, and public health. If future psychedelic therapies are designed only around the most specialized and expensive urban delivery models, health equity will become a promise written into policy and edited out of practice.

Build it with us, not around us

Nurses should not be invited in after psychedelic care models have already been built. We should be helping to decide what preparation looks like, what must be monitored, what constitutes safe discharge, how challenging experiences are followed, how adverse events are defined, how records move between providers, how consent is protected, and how care reaches communities beyond elite clinics.

This is the moment to get that architecture right. The FDA is asking about the workforce, safety, access, and data systems that may surround future psychedelic drug products. OPENurses has answered with a thoughtful, clinically grounded message: nurses are not peripheral to this work. We are part of its backbone.

How nurses and allies can act now

Nurses may add their names to the OPENurses sign-on letter and may also submit individual comments to the FDA docket. Comments should stay within the subjects the agency requested: training and credentialing, patient safety, access, and data collection. Written comments are due by 11:59 p.m. Eastern Time on October 5, 2026. Anyone who wishes to request an oral presentation at the September 14 hearing must register by 11:59 p.m. Eastern Time on August 21, 2026.

Read and support the OPENurses letter: OPENurses signatory form

Submit a public comment or review the hearing notice: Federal Register docket FDA-2026-N-7542

Register for the hearing or request to present: FDA public hearing page

If psychedelic medicine is going to enter healthcare, then healthcare must be ready for the whole person who walks through the door. Nurses know how to care for that person. Let us help build the system.

With you on the journey … Nurse Sherri Mack, BSN, RN - The Green Nurse

References

American Association of Colleges of Nursing. (2026, May). Nursing workforce fact sheet.

Eshkevari, L., Schimmels, J. E., Olenick, M., Porta, C. M., Glymph, D. C., & Ramirez,J. (2026). Integrating psychedelics into nursing education and practice: Historical, clinical, and educational perspectives. The Journal for Nurse Practitioners, 22(6), Article 105833.

https://doi.org/10.1016/j.nurpra.2026.105833

Food and Drug Administration. (2026a, July 14). Considerations for potential future therapeutic use of psychedelic drugs; Public hearing; request for comments. Federal Register, 91, 43095-43098.

Food and Drug Administration. (2026b, July). Psychedelic drugs: Considerations for clinical investigations [Final guidance for industry].

Graefe, A. C., Weirick, M. E., Harpin, S. B., Dorsen, C., & Porta, C. M. (2025). Registered nurses’ knowledge and attitudes towards psychedelics in healthcare: Statewide survey results. Journal of Psychiatric and Mental Health Nursing, 32(3), 634-642. https://doi.org/10.1111/jpm.13141

Mack, S., & Mack, E. (2026). Microdosing psilocybin as a public health harm reduction practice: Registered nurses in trauma-informed psychedelic care [Manuscript submitted for publication in Psychedelics for Clinical Practice: Scientific, Social, Legal, and Economic Pathways]. IGI Global.

Organization of Psychedelic and Entheogenic Nurses. (n.d.). The Organization of Psychedelic and Entheogenic Nurses.

Porta, C. M., Weirick, M. E., Graefe, A. C., Harpin, S. B., & Dorsen, C. (2024). Nurses’ perceptions of psychedelics to address mental health problems in the United States. Psychedelic Medicine, 2(3), 178-183. https://doi.org/10.1089/psymed.2023.0073

I had the opportunity to share what a statement to the Palm Springs City Council might sound like when advocating for the decriminalization of natural entheogenic plants and fungi. I briefly spoke at the Palm Springs Psychedelic Society event featuring Larry Norris, PhD, cofounder of Decriminalize Nature.

As a nurse with nearly 40 years of experience, I spoke from both my professional and personal perspectives. I believe psychedelics are powerful and are not appropriate for everyone. They deserve respect, education, preparation, harm reduction, ethical support, and honest conversations about their potential benefits and risks.

I do not believe criminalization creates safety. In my view, it drives use underground, reinforces stigma, and discourages people from seeking education, support, or help. I emphasize that we cannot punish our way into safer psychedelic use, and that safety is created by bringing these conversations into the light.

I believe decriminalization and safety are not opposing goals. When approached responsibly, they belong together.

Gratitude is extended to the Palm Springs Psychedelic Society and Larry Norris, PhD, for creating space for this important community conversation.

Some books are written about the medicine path. Others are born from walking it. Becoming Shamanka: Walking the Medicine Path carries decades of lived experience, spiritual inquiry, healing, and transformation. This one is personal for me. I have known Peter since my years of living in New England and have experienced his work as both a patient and a learner.

As psychedelics rush into the mainstream, this is the kind of hard-earned wisdom we cannot afford to leave behind. This is not a formal book review. It is a personal reflection on why I am honored to share the deeply lived work of Peter McSherry and his wife, Jayme MacNeil, at a moment when psychedelics are rapidly entering the mainstream.