It is well documented that Utah is in the midst of a mental health crisis. Having recognized this, the Utah Legislature created the Utah Mental Illness and Psychotherapy Task Force in early 2022. The task force was charged with examining the evidence regarding psychotherapeutics and making recommendations on whether they can be safely used and, if so, how.
The task force concluded, following months of study, that MDMA and psilocybin (“magic mushrooms”) can offer significant benefits to those with mental illness.
Below are the top ten takeaways from the task force’s findings:
- MDMA is safe and effective: MDMA is effective at treating PTSD and is safe when administered in therapeutic settings. When taken as directed, it does not lead to addiction or dependence. A compassionate use board should consider administration for additional conditions such as OCD, eating disorders, alcohol abuse, and chronic pain. Report pages, 13, 19-21, 26.
- Psilocybin is safe and effective: Psilocybin is an effective therapy for treatment resistant depression and depression and anxiety associated with life-threatening diagnoses. Psilocybin is safe with no risk of dependence and no confirmed cases of overdose. A compassionate use board should consider administration for additional conditions such as OCD, eating disorders, alcohol abuse, and chronic pain. Report pages 15, 20, 27.
- Production Safety: Manufacturers should be licensed by the state. This regulatory agency will create reporting requirements and safety standards to include. Product should be tracked from production through ingestion. Report page 28.
- Patient Safety: Patients must be over 18 and should be prescreened for contraindications. In-person supervision should be required during sessions and patients should be discharged to a responsible party. Report page 17.
- Multidisciplinary Approach: Only MDs and DOs should be authorized to recommend psilocybin or MDMA. However, they should work closely with established mental health providers such as therapists to determine when a recommendation is appropriate and to ensure patients receive sufficient preparation, supervision, and integration. Paraprofessional patient supervision during treatment should be considered. Report pages 16-17, 23.
- Licensure and Training: A Psychotherapeutic Drug Board should be created within DHHS. This board will create training and certification requirements for anyone administering or recommending psychotherapeutic treatment. Report pages 29-30.
- Ethical Considerations: Sessions should be video recorded absent informed consent from the patient. Patients and providers should not co-ingest. Providers should disclose risks and patients should give written, informed consent. Report page 31
- Legality: Patients and providers who comply with legislation and administrative rules should be immune from any state, administrative, or criminal action. Report page 30.
- Continuous Improvement: A review board should be created to stay abreast of research in the field and to make recommendations accordingly. This may include expanding which drugs are available and/or which indications can be treated with psychotherapeutics. Report page 30.
- Access: Everyone should benefit from medical advancements. Any psychotherapeutic program should consider costs and how treatment can be financially available for everyone. Report page 31-32.
Proposed Psilocybin Framework
1️⃣ = Corresponding takeaway/recommendation from the task force
✅ = Additional restriction beyond what the task force recommended
1. Recommended Psychotherapy Drug
- Psilocybin only 2️⃣ ✅
2. Qualifying conditions
- Depression 2️⃣
- PTSD and anxiety if a patient has not responded adequately to other treatment.
- Compassionate use board may give approval to use for other conditions. This is similar to what is currently done with cannabis. See Utah Code §26-61a-105. 2️⃣
3. Production
- The Utah Department of Agriculture provides production oversight. This will be similar to the oversight provided for cannabis production and will include facility inspections, product quality control measures, and security measures. See Utah Code Title 4, Chapter 41a. 3️⃣
- Life cycle monitoring: Psilocybin producers will be responsible for tracking their product until it is administered to a patient or returned to them for disposal if it is not used. This will help prevent diversion and make it easier for the Department of Agriculture to monitor compliance. This is similar to the cannabis inventory control system. See Utah Code §4-41a-103. ✅
4. Distribution
- Pharmacists distribute psilocybin only to qualified medical providers who will then administer to patients. ✅
- Pharmacists wishing to distribute psilocybin must register with the Department of Health and complete initial and continuing education requirements. This is similar to the current requirements for cannabis distribution. See Utah Code Title 26, Chapter 61a, Part 4. ✅
- Pharmacists must store psilocybin as they do other controlled substances.
- Psilocybin may only be transported by producers, clinicians, or pharmacists. During transport it must be kept in a tamper-proof container. A log must be kept in the transportation vehicle. ✅
5. Recommendation
- Medical practitioners who already prescribe medication under Utah law (physicians, advance practice nurse practitioners, physician assistants, and psychiatrists) may take a two-day course to become qualified to recommend psilocybin. 5️⃣ 6️⃣
- Psilocybin may only be recommended to patients age 21 and older. 4️⃣ ✅
- Psilocybin can only be recommended for a qualifying condition.
6. Administration and Patient Safety
- Psilocybin may only be administered in a provider’s office.
- Providers must provide patients with a safety data sheet and patients must give written, informed consent before treatment. 7️⃣
- Providers shall enter psilocybin recommendations in a database to allow themselves and other providers to check for history and drug interactions.
- Patients must be continuously monitored during sessions either in-person or via live video feed which is monitored by someone on site. 4️⃣
- Additionally, all sessions must be video recorded and a recording preserved for one year to prevent any inappropriate contact between providers and patients. A patient may waive this monitoring. 7️⃣
- All providers must have an emergency transport protocol in place. ✅
- Providers must have appropriate rescue medications, as determined by administrative rule, on site.
- At the conclusion of a session, a patient may only be released to a responsible party. 4️⃣
7. Community Protections
- Any advertising will be regulated to not appeal to children and shall promote medical rather than recreational use. This is similar to what is done with cannabis. See Utah Code §26-61a-116.
- A regulatory review board will continue to monitor scientific research on psychotherapeutic substances and make recommendations about best practices, additional conditions for which psilocybin should be prescribed, and additional psychotherapeutics which should be available to patients. 9️⃣