In Fall of 2022, HAF convened a Safety Committee to help support the successful and responsible rollout of the Oregon Psilocybin Services program. The Safety Committee engages community stakeholders, identifies potential issues related to client and program safety, and proposes solutions.  During a Committee meeting on May 11th, 2023, one such issue arose regarding product potency and dosing. 

As manufacturers begin to receive their first potency testing results, the Safety Committee was presented with information that led us to believe that the potency of mushroom products may be unintentionally underrepresented on product labels, and as a result actual effective potency of psilocybin products as currently labeled may be higher, even much higher, than most would assume from the label. This issue has come to light because of the exemplary diligence and transparency of manufacturers and testing labs. 

The current potency issue is twofold: 

1. Labeling: Current OHA rules require that licensed laboratories test for psilocybin and psilocin, but the rules do not require that manufacturers state the psilocin content or “approximate psilocybin-equivalent” weight on psilocybin product labels. This could render current dosage tables and administration rules significantly off-base, possibly resulting in a session longer and far more intense than expected. For example, if a serving is labeled as having 10 mg of psilocybin yet it also contains 8 mg of psilocin not stated on the label, then the psilocybin-equivalent potency would be about 21 mg. (Psilocin is approximately 1.4 times more potent than psilocybin, a ratio that should be confirmed with the labs and/or a chemist familiar with the labs’ procedures.) In this hypothetical example, the facilitator and client would be under the impression that the client will consume 10 mg of psilocybin analyte, but the actual delivered “psilocybin-equivalent” could be over twice the intended amount.
2. Dosage Allowance:  In contemporary research trials using psilocybin, 25 mg to 30 mg is usually considered a “high dose,” meaning a dose likely in most recipients to occasion ego-dissolution aka mystical-type experience (also with an apparently unavoidable chance of periods of extreme anxiety/fear). With the exceptions of a study on psilocybin-assisted therapy for the treatment of Alcohol Use Disorder and a pharmacokinetics study that deliberately pushed the envelope by testing even higher doses, we are not aware of research trials that give more than 30 mg (or 30 mg per 70 kg of body weight) of psilocybin.

In light of that, service centers may be well advised to give more than 30 mg only in exceptional cases, understanding that they would be giving an “extremely high dose.” OHA may wish to revisit its rule that currently allows up to 50 mg to be given. We currently take no position on this, other than that all parties should be well educated on dosing.

Note that the dose amounts in the current rules were apparently based on an assumption that 5 grams of dried P.cubensis, a common “high dose” in the underground, gives about 50 mg of psilocybin-equivalent. But there is evidence that that is an overestimate, perhaps by roughly a factor of two. Because the conversion factor varies so much from strain to strain and even specimen to specimen, it is better to learn to think in terms of milligrams of psilocybin and psilocin, relying on testing, without trying to translate to and from grams of mushroom material.

Proposed Best Practices for Manufacturers:

1. Include psilocin content on all product labels immediately. 
2. Include “approximate total psilocybin equivalent” on product packaging. It is recommended that labs describe and include this calculation in their reports.

Proposed Best Practices for Service Centers: 

1. Manufacturers: Work with manufacturers to understand the full lab test results and the actual, effective potency of the products taking into account both psilocybin and psilocin.
2. Labels: Only purchase and distribute servings labeled with both psilocybin and psilocin content.
3. Staff Education: Educate the entire team, including the people dispensing the product and facilitators, that dosing is not an exact science. First, we don’t yet know how repeatable or accurate the testing is. No test in chemistry or medicine is perfectly repeatable and 100% accurate. Second, there are surely individual differences among people: given the same dose, some people will react much more sensitively and some much less so. 
4. Dose: Consider the total approximate psilocybin equivalent when determining dose and consider limiting the dose to 30 mg or less, in the absence of compelling reason to go higher.
5. Client Education: Early on in the process, educate clients about what milligram weights constitute microdoses (sub perceptual) or very low doses, medium doses, and high doses – all  in terms of milligrams of approximate psilocybin equivalent (25 to 30 mg being considered a high dose). Inform clients if you’re setting a dose limit lower than what the OHA allows for and why. 
6. Time: Considering increasing the required duration of an administration session higher than what is listed in the current OHA rules (section 333-333-5250). 

Possible OHA Rule Changes in the Future:

Based on the information above, the HAF Safety Committee is considering a request for the following rule changes: 

1. Amend the OHA rules on dosage to require that both psilocybin and psilocin potency be calculated together as “total psilocybin equivalent.” 
2. Amend the OHA rules to require manufacturers to label all psilocybin products with psilocybin weight, psilocin weight, and “approximate total psilocybin equivalent” weight, and require that service centers only sell psilocybin products so labeled.
3. Review the minimum time requirements by dosage in light of the fact that recent research studies use 25 mg as a high dose and currently someone in Oregon receiving 24 mg only needs to stay for 4 hours. 

Thank you for your support and partnership as we prepare to launch this program together. 

Sincerely,

Members of the Healing Advocacy Fund Safety Committee & Community Partners

Benjamin Brubaker, Founder/Director Subtle Winds Psilocybin Facilitator Training Program

Bruce Goldberg, M.D., Former Director of the Oregon Health Authority

Elizabeth Nielson, PhD, Fluence 

Gared Hansen, Uptown Fungus, Licensed Manufacturer

Hadas Alterman, American Psychedelic Practitioners Association

Hannah McLane, SoundMind Institute

Josiah Laughlin, RN, BSN

Matthew Hicks, ND, MS, CPTR, Founder & CEO of Synaptic Institute 

Melanie Velez, DNP, PMHNP, Subtle Winds

Dennis McKenna, Ph.D., McKenna Academy of Natural Philosophy

Dee Lafferty, Inner Guidance Services Inc., Licensed Service Center Operator

Ryan Reid, Aboveground Services LLC, Oregon Psilocybin Licensed Facilitator and Service Center

Robert Jesse, researcher and advisor to Johns Hopkins and UC Berkeley

Aryan Sarparast, M.D., Oregon Health & Science University

Dr. Olivia Giguere, ND, Synaptic Institute

Seth Mehr, M.D., Cascade Psychedelic Medicine

Steve Elfrink, OmTerra Corporation

Michael Hauty, M.D., Subtle Winds, Pending Facilitator 

Bethany Griffin-Shetler, CBD, PPD, CBE, CLC, Health Educator

Holly Platt Marstall, BSN, RN

William Barry Reeves, M.D., Buddhists Responding - Corvallis

Sam Chapman, Executive Director, Healing Advocacy Fund

Heidi Pendergast, Oregon Director, Healing Advocacy Fund

Eric von Borstel, M.D., Santiam Hospital

Heath McAllister, ND, Pure Vitality

Joshua Pritikin, Ph.D. Quantitative Psychology

Brad Huit, RN, Private Individual

Emily Ross-Johnson, LPCA, Private Practice

Amy Terebesi, Medical Psilocybin Supporter

Markee Moon, RN, St. Charles Hospital

Jeffrey Hayes, M.D., Retired

Carol Wagner, MS

Beth Smith, MS, RD, Beth Smith Nutrition

Meg McCauley, InnerTrek

Brett Fritts, Investor

Dennis Trembly, Individual

Amaya Urzaa, Facilitator (in training)

Rolla Lewis, EdD, NCC, John Cobb Institute 

Mike Grudzien, M.S., The Eugene Guest House

T. Leppold, LMFT Retired

Hugh Studebaker, Retired public school counselor  

Karrie Johnson, PA-C, Private Practice

Alain Pire, PhD, APEX

Jennifer Hare, Academic Advisor, Academic Advisor

Jeremy Russel, Community Member

Evan Weger, M.S. in Experimental Psychology

Alexander Lopez, Engineer, Semiconductor Manufacturing

Danielle Somerville, Organic farmer, Paralegal, Naturopath

Richard Swain, Master's Degree - Psychology Emphasis

Allison Coleman, Founder, Axisflip Cryptofinancial

Cynthia Birney, Movement Specialist GCFP, Feldenkrais Guild of America

Josiah Barber, Interested party

Jennifer Scribner, Individual

Mary Chesnut, Retired

Michelle McDaniel, Patient

Adam Hagenbach, Journeyman Craftsman, Wildething Woodworking

Del Potter, Ph.D., Spiritus Bioscience Inc.

Bruce Grobman, Concerned Retiree

Victor Cummings, Educator/Advocate, Mending Mindcelium

Haylie Gonzalez, Mending Mindcelium

David Gordon, Researcher, GordoTEK

Harry Rinehart, M.D., Retired, The Rinehart Clinic

Kathleen Ruiz, Individual

Dianne Buoncristiani, Individual

Gary McCuen, Individual

Nicole Thornton, Individual

Gary Crays, Individual

Elliott Varnum, Individual

Elaine Holcomb, Individual

Wendi Myers, Individual

Michael Gandsey, Individual

Robert Carroll, Individual

Tyler Russell, Individual

Jeff Hibbard, Individual

Bruce Grobman, Individual

Michelle McDaniel, Individual

Alexander Lopez, Individual

Evan Weger, Individual

Meg McCauley, Individual

Lorena Huerta-Brambila, Individual

Jacqueline Danos, Individual

Allen Schill, Individual

Chapin Hawkins, Individual

Jerome Comeau, Individual

J. Kunko, RN

Tracey Tiret, Clinical Herbalist and Oregon Psilocybin Licensed Facilitator

Emanuel Sferios, M.A.

Annie McCuen, Individual

Natalie Malone, Individual

Terry Dalsemer, Retired Psychotherapist

Marcel Liberge, Individual

Emily Roussard, Mental Health Counselor

Brett Orr, Individual

Sara Valade, Individual

Jason Polen, Fortify Law PLLC

Coyote Marten, B.S.

Jacob Hunt, LCSW

Tom Downs, Manager and Founder of the CO Healing House

Sera Miller, Oregon Psilocybin Licensed Facilitator and Healthcare Improvement & Compliance Professional

Cathy Schuler, BSN

Daniel Golletz, Ph.D., Psychologist

Johnny Dwork, Oregon Psilocybin Licensed Facilitator

Val Adell, Individual

Ana Holub, Individual

Brad Purfeerst, Individual

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