Psychedelic drug treatment service provider licensing

Overview

Service providers who offer or provide treatment for a psychiatric disorder using one or more psychedelic drugs must meet quality and safety requirements under the Mental Health Services Protection Regulation.

Many of these service providers must also be licensed under the Mental Health Services Protection Act and Regulation and comply with mandatory quality and safety standards set out in the Psychedelic Drug Treatment Services Standards.

This regulatory framework provides government oversight and key protections for patients receiving psychedelic drug treatment services in Alberta.

The framework:

• requires licensing, except in the following cases:
  • approved clinical research trials
  • ketamine used outside of psychedelic-assisted psychotherapy
• outlines the conditions for prescribing, administering, dispensing or selling a designated psychedelic drug, and conditions for monitoring and caring for people while they are in an altered state of consciousness
• ensures clinical oversight of licensed psychedelic drug treatment services are provided by a psychiatrist
• sets out the qualifications for persons conducting psychedelic-assisted psychotherapy
• ensures service providers meet quality standards such as policies and procedures for:
  • safety and security
  • employee requirements, qualifications and training
  • record creation, maintenance and retention
  • facilities or other locations where services are offered or provided
• details requirements related to approved clinical research
• gives government authority to address complaints and concerns and to amend, suspend or cancel a service provider's licence

Apply for a licence

If you plan to start offering or providing psychedelic drug treatment services, contact us to begin the licensing process.

If you disagree with a decision made by Compliance and Monitoring regarding a psychedelic drug treatment services provider licence, you may be able to appeal it. Appeals are managed by the Appeals Secretariat, a neutral government office that operates separately from Compliance and Monitoring.

Find out how to appeal

File an approved clinical research trial report

If you are planning or have planned to conduct a clinical research trial involving a designated psychedelic drug, you:

• do not need to apply for a licence
• are required to file a report to the Alberta government of the clinical research trial once the trial has been approved by a research ethics board

Specific reporting requirements are laid out under section 47 of the Mental Health Services Protection Regulation. If you have any questions or concerns, reach us through the contact information below.

To begin the reporting process, complete and submit the Approved Clinical Research Trial Reporting form or contact us.

Forms

• Complete the Psychedelic Drug Treatment Services Licence Application form to apply for a licence.
• Use the Approved Clinical Research Trial Reporting form to advise the Ministry of Mental Health and Addiction of your clinical trials.

Incident reporting

Licensed psychedelic drug treatment service providers are required to report to the Ministry of Mental Health and Addiction any serious injury or death that occurs in relation to the provision of services. This includes any situation that may be injurious to the safety or health of patients or that may jeopardize the service provider’s ability to provide services.

To report an incident, follow these steps:

1. Use the Decision Process document to determine if an incident is reportable and whether it is a critical incident or a duty to notify.
2. Complete the Duty to Notify, Critical Incident Report form.

Complaints or concerns

All licensed psychedelic drug treatment service providers in the province are required to have a complaint process.

If you have concerns about the services you or someone else is receiving from a psychedelic drug treatment service provider, contact the service provider first.

If your concern or complaint is left unresolved, contact Compliance and Monitoring for assistance with:

• requirements within the Mental Health Services Protection Act, Mental Health Services Protection Regulation, or Psychedelic Drug Treatment Service Standards not being followed
• an unlicensed service provider providing psychedelic drug services

Complaint resolution process

When you contact Compliance and Monitoring:

• a complaints officer will collect the necessary details to follow up on your concern – so have as much of the following information available as possible:
  • name and address (including municipality) of the facility or service provider
  • a brief summary of your concern or complaint and when it occurred
  • names, titles and contact numbers of people you have spoken to about your concern or complaint (for example, the manager, senior manager or board member) and their involvement in trying to resolve it
• an assessment on the risks associated with your complaint will be completed:
  • it may result in an investigation or contacting other relevant authorities
  • a letter with the outcome of your complaint will be sent to you following the assessment
• personal and health information is managed in accordance with the Freedom of Information and Protection of Privacy Act and the Health Information Act.

Contact

Connect with Compliance and Monitoring:

Hours: 8:15 am to 4:30 pm (open Monday to Friday, closed statutory holidays)
Phone: 780-427-8740 for questions about provider licensing and clinical research trial reporting
Phone: 780-422-4703 to speak with a complaints officer about concerns regarding services
Toll free: 310-0000 before the phone number (in Alberta)
Email: [email protected]

Address:
Alberta Mental Health and Addiction
Attn: Compliance and Monitoring Unit
13th Floor, Telus House
10020 100 Street NW
Edmonton, Alberta  T5J 0N3

Service providers may use the following web portal to submit documents related to critical incidents, duty to notify and licensing:

Mental Health and Addiction – Submit Compliance and Monitoring Documents