Oregon Psilocybin Advisory Board Approves Training and Products Recommendations

The Oregon Psilocybin Advisory Board recently approved a series of recommendations regarding psilocybin products and training requirements for psilocybin facilitators. These recommendations will be sent to the Oregon Health Authority (OHA) for consideration during formal rulemaking, with hearings scheduled from February 14 to February 25, 2022. Recommendations and rulemaking relating to training and products were placed on an expedited timeline to ensure that facilitators will be trained, and products will be ready for the January 2, 2023, launch of the first state-sponsored psilocybin therapy program in the United States.

The Training and Products subcommittees worked extensively with the Equity subcommittee to center these recommendations around cultural and health equity. All the proposed recommendations passed at the last Advisory Board meeting, subject to a few minor technical amendments. Below are the major takeaways from this first batch of approved recommendations.

Training Administration Recommendations

Under the approved recommendations, students applying for psilocybin training programs are required to provide a description of their educational background and a written statement explaining their commitment and interest in becoming a psilocybin facilitator. Applicants must also authorize their training program to conduct a criminal background check. Equity subcommittee members raised concerns regarding the background check requirement, expressing worry such a requirement will disparately impact individuals from communities disproportionately targeted by law enforcement. An amendment to drop the background check requirement was proposed but failed to pass.

Students under the approved recommendations must complete 120 hours of core training with at least 25% of those hours conducted in-person. At least 50% of the core training hours not conducted in-person would need to be completed through online synchronous learning (i.e., interactive, real-time online training with an instructor and fellow students). An amendment was proposed to suspend the in-person training requirement for the duration of the COVID-19 health emergency. The amendment failed to pass, with Advisory Board members who voted against the amendment expressing their opinion that in-person training will foster community amongst psilocybin facilitators.

Below is a breakdown of the topics core training covers and the minimum hours students would devote to each subject:

• Historical, Traditional, and Contemporary Plant Medicine Practices and Applications (12 Hours)
• Diversity, Cultural and Health Equity, and Racial Justice and Inclusion in relation to Psilocybin Services (12 Hours)
• Safety, Ethics and Responsibilities of a Psilocybin Facilitator (10 Hours)

• Psilocybin Pharmacology, Neuroscience, and Clinical Research (12 Hours)
• Core Psilocybin Facilitation Skills (16 Hours)
• Conducting a Psilocybin Preparation and Orientation Session (16 Hours)
• Conducting a Psilocybin Administration Session (20 Hours)
• Conducting Psilocybin Integration (14 Hours)

• Group Psilocybin Facilitation (8 Hours)

Practicum training is a major focus of the proposed training curriculum, and as the program matures, students will observe and facilitate psilocybin treatment sessions under the supervision of a Practicum Site Supervisor. The approved recommendations require students to complete at least 40 hours of practicum training, including at least 30 hours of direct practice and 10 hours of follow up consultation to review the student’s direct practice.

Accredited training programs will be classified as either “Comprehensive Training Programs” or “Partial Training Programs.” Comprehensive Training Programs are required to appoint a lead educator to provide core training and monitor student progress to ensure they are prepared to pass the state licensing exam. Comprehensive Training Programs must also train students in CPR and First Aid, or verify students are certified prior to completion of their program.

Partial Training Programs will offer only specific core training courses, and not all trainings required for licensure. Partial Training Programs are not subject to the practicum training requirements. Credits from Partial Training Programs are transferrable to any Comprehensive Training Program willing to accept them. The approved recommendations dictate that Comprehensive Training Programs must either categorically accept or categorically deny transfer hours.

Training Curriculum Recommendations

Training programs will educate students on the history of fungi and plant medicines, its use in indigenous and shamanic traditions, the pharmacology of psilocybin, the basic neuroscience relating to psilocybin, and psilocybin’s potential in treating depression, substance use, end-of-life issues, anxiety, trauma, and spirituality. The approved recommendations also address trainings for completing intake screenings, approving clients for treatment, and understanding various dosing strategies and considerations for individual clients.

Another major focus of the curriculum centers on training facilitators to positively connect with their clients. These trainings will educate students on the foundations of traumatic stress, skills needed to serve as an empathic presence for their clients, the optimal environmental components to employ during treatment, skills to facilitate group sessions, techniques for sympathizing and working compassionately with clients, and best practices for assisting clients with histories of trauma.

The Advisory Board also approved the following supplemental recommendations:

1. Programs shall train students on maintaining appropriate boundaries between facilitators and clients, the risk of emotional and sexual abuse, the potential harm to clients, and the consequences for facilitators.
2. Programs shall train students in professional ethics, including fraud, financial exploitation, the risks of financial conflicts of interest, and when and how to disclose those conflicts.
3. Programs shall train students on the importance of accurate record keeping and how to maintain appropriate client records including the importance of maintaining client privacy and data security.
4. Programs shall train students in the fiduciary duties that facilitators owe clients and the consequences of breaching those duties.
5. Programs shall train students to understand and explain all aspects of the client informed consent form and the appropriate timing and procedures for obtaining informed consent from clients.
6. Programs shall train students to understand and explain the client bill of rights and the related responsibilities of facilitators.
7. Programs shall train students in the legal requirements of Oregon’s Measure 109.
8. Programs shall train students on how to proactively make psilocybin services accessible to people with disabilities.
9. Programs shall train students on appropriate handling, storage, and dispensing of psilocybin products.
10. Programs shall train students in appropriate emergency procedures for obtaining medical assistance for clients and assisting vulnerable clients during emergencies.

Equity-Focused Training Recommendations

The Equity subcommittee proposed and successfully passed recommendations to orient psilocybin facilitators on the meanings of cultural equity and racial justice, how systematic inequity contributes to intergenerational trauma, and how facilitators can broaden their concepts of trauma to more compassionately relate and support clients from different cultures. The Advisory Board also passed an Equity subcommittee recommendation that OHA require training programs to measure student proficiency in cultural equity, racial justice, and the ethics of relational care and reciprocity.

Products Recommendations

Only two recommendations approved by the Advisory Board came directly from the Products subcommittee. The most controversial of which is allowing methanol as an allowable solvent in psilocybin production. Methanol is a Class II solvent, which the FDA classifies as a solvent that should be limited in pharmaceutical products due to their toxicity. Other allowable solvents under the approved recommendations, such as ethanol and acetic acid, are less dangerous and classified as Class III solvents. Methanol would allow for a more efficient extraction process, but Advisory Board members voicing dissent against its use maintain that increased production does not outweigh the risks to public health.

Equity-Focused Products Recommendations

Nearly all products recommendations approved at the last Advisory Board meeting came from the Equity subcommittee. OHA, under the approved recommendations, would maintain a list of prohibited additives and ingredients, but also adopt regulations allowing for the ethical examination of new additives that may improve psilocybin therapy outcomes. The approved recommendations also direct OHA to promulgate administrative rules allowing for exploration of formulation and delivery methods that improve accessibility for clients with disabilities who cannot orally ingest psilocybin.

An especially noteworthy recommendation is for the Products subcommittee and Psilocybin Advisory Board to further examine harm-reduction considerations in situations where a client uses other drugs prior to, during, or following psilocybin treatment. This consideration and future discussions are highly relevant as treating drug addiction is one of the most promising aspects of psilocybin therapy.

One of the bigger points of contention during the Advisory Board meeting was the issue of providing “remediation” pathways if there is an overproduction of psilocybin product. Despite the fact psilocybin production will be capped, Advisory Board members are predicting an overproduction of psilocybin product. The recommended remediation pathways allow for the transfer of excess psilocybin products to non-profit services centers and research studies.

Lastly, it was recommended that OHA and the Psilocybin Services Program evaluate psilocybin products every year beginning in 2024 and to report:

1. Its findings regarding the cultural, economic, safety, and social impacts of currently allowable psilocybin products;
2. Its response to an accompanying annual public comment period;
3. The announcement of newly allowed or newly excluded psilocybin products, foods, food ingredients, or other additives;
4. A review of completed, ongoing, and prospective clinical trials and FDA approval status for natural and/or synthetic psilocybin products, and their implications on the Oregon Psilocybin Services Program; and
5. An analysis of the opportunities and limitations of allowing or excluding chemical synthesis in the manufacture of psilocybin products in the Oregon Psilocybin Services Program, and the cultural, economic, safety, and social impacts of those opportunities and limitations.