Three Guardrails For Safe Psychedelic Therapy
When it comes to access to psychedelic medicine, the central question decision-makers ask is: How do we administer this treatment safely?
Oregon became the first state to comprehensively address the question when it released its final regulations for psilocybin-assisted treatment late last year, after more than two years of study and deliberation. While the full regulatory framework is worth a read (the document swells to over 100 pages and makes clear how serious and thorough regulators have been in addressing safety), here are three of the most critical guardrails that lawmakers and regulators everywhere should consider:
1. Product Safety and Testing.
Rules make it clear that psilocybin administered during treatment must be procured from a state-licensed manufacturer, and those manufacturers must comply with a raft of quality and safety standards. For example, manufacturers are responsible for ensuring the consistent potency of the psilocybin that they produce, which is critical for accurate dosing. Thus, if a batch “exceeds 20 percent relative standard deviation between sample increments,” the product cannot be used. Proper dosage is a core component of effective therapy, and the state has worked hard to monitor this in support of client safety and program efficacy.
The rules also require rigorous testing to verify the species of mushroom from which the psilocybin is derived (i.e. psilocybe cubensis) and ensure the absence of harmful chemicals (e.g. pesticides) or metals.
2. Facilitator Training Standards.
In Oregon, facilitators must be state-licensed, and to be eligible for licensing, facilitators are required to graduate from a state-certified training school. Facilitators must also pass an exam and obtain the endorsement of the training program director, or one of the lead educators at the program, before they can even apply for a license.
And the state requires that the training itself be extremely rigorous, mandating components such as: “pharmacology, neuroscience, pharmacodynamics, pharmacokinetics of psilocybin”, “drug and supplement interaction”, “concentration of psilocybin and psilocin in available psilocybin products”, “effects and mechanisms of action of psilocybin on the brain”, “models of substance use, addiction, and recovery”, “dosing strategies and considerations”, “physical reactions and side effects of psilocybin”, and a survey of the latest clinical research on psilocybin.
3. Safety Screening.
Like any transformative medical intervention, psychedelic treatment is not for everyone. That’s why the Oregon Health Authority erected a safety screening process before any psilocybin treatment session can begin.
Certain medications or pre-existing conditions increase the risk profile for psilocybin treatment and therefore may exclude a person from psilocybin treatment. For example, a person who has taken lithium within the last 30 days is not eligible because psilocybin can interact with lithium to produce “a significant seizure risk.” In other instances, the screening operates not to render a person ineligible for treatment, but rather to ensure that the facilitator provides the necessary context for the client to make an informed decision about undergoing treatment.
