Psychedelic drug treatment service provider licensing

Overview

Service providers may also need 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, complete the Psychedelic Drug Treatment Services Licence Application form and 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.

Critical incident reporting and duty to notify

Licensed psychedelic drug treatment service providers are required to report to the Ministry of Mental Health and Addiction of critical incidents that have caused or threatens to cause serious injury or death. In addition, service providers have a duty to notify or report on situations that may jeopardize the service provider’s ability to provide services and/or situations that may be injurious to the safety or health of patients.

To report a critical incident or on a duty to notify, 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. Download the Critical Incident Reporting and Duty to Notify Form.
3. Open the form from the download folder, complete the form, and save the form on your computer.
4. Open the following web portal and fill out the required information: Mental Health and Addiction – Submit Compliance and Monitoring Documents.
5. Upload the completed form on the portal and click Submit.

Complaints or concerns

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

It is recommended that service providers post the below complaints hotline poster in a visible location in each facility where the service is provided.

Download the Compliance and Monitoring Complaints Hotline poster

If you have concerns about the services you or someone else is receiving from a psychedelic drug treatment service provider, start by raising it with your service provider first.

If your concern or complaint is still unresolved, contact us if it is about:

• treatment or services received from a licensed service provider
• suspected non-compliance with the Mental Health Services Protection Act, Mental Health Services Protection Regulation, or Standards
• suspicion that a service provider is offering or providing psychedelic drug services without a licence under the Mental Health Services Protection Act

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
• we will assess the risks associated with your complaint, and may conduct an investigation or contact other relevant authorities, or both, as required
• you will receive a follow up letter with the outcome of your complaint
• we will make every effort to protect your identity
  • personal and health information is managed in accordance with the Health Information Act and Freedom of Information and Protection of Privacy 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