In January 2022, Health Canada broadened the scope of its Special Access Program (SAP) to encompass psilocybin and MDMA. Prior to this expansion, both substances were classified under Schedule I in the Canadian Drug and Substance Act (CDSA), classifying them to have no medicinal or health benefits. The changes repeal a 2013 amendment to the Food and Drug Regulations, which made certain drugs, listed in the schedule as “restricted drugs” of the of the Food and Drug Regulations, inaccessible through the SAP. A Class Exemption known as Section 56 were granted for licensed healthcare professionals who are authorized to prescribe in their respective provinces to be able to access psilocybin and MDMA through licensed manufacturers under the SAP guidelines.
Psilocybin and MDMA have not yet been approved for a drug label by Health Canada, the only way to access these drugs in Canada is through clinical trials or the SAP. To be eligible for these drugs through the SAP, prescribers must file an application and patients must suffer from a serious or life-threatening condition and have exhausted all conventional treatment options, which either failed, were unsuitable, or were not available in Canada.
Initially, only applications for psilocybin treatment to address end-of-life distress were approved, but in more recent months, the SAP has authorized practitioners to access psilocybin for treatment-resistant end-of-life distress and major depressive disorder (MDD), as well as 3,4-Methylenedioxymethamphetamine (MDMA) for treatment-resistant post-traumatic stress disorder (PTSD).
As a qualified prescriber requesting drugs through the SAP on behalf of their patients, certain responsibilities must be fulfilled. These include ensuring that patients are fully informed about the potential risks and benefits of the requested drug and its current development status. Additionally, physicians are required to submit a report to Health Canada detailing the outcomes of the drug’s usage, including any adverse reactions that may occur. It is crucial to maintain accurate and accessible records to account for the quantities of the drug received, as the drugs are not yet legal. Furthermore, the decision to prescribe the drug should be backed by credible evidence available in relevant medical literature or provided by the manufacturer.
Health Canada provides information on the SAP in the link below with associated forms and guidelines on how to apply for drug access. However, most prescribers will find the information insufficient to execute a successful application with what is provided, especially as it relates to psychedelic medicines and in this new and still exploratory field of medical therapy. As well it may be too time intensive for busy prescribers to figure out how Health Canada will evaluate and approve applications and have long drawn-out incomplete applications process.
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
Challenges in accessing psilocybin and MDMA for PaT under the SAP makes it an under-utilized avenue for much needed patients suffering from severe treatment-resistant mental illness who fit the eligibility criteria for the program.
The challenges are due to the functional nature of the program itself. The SAP is not meant or designed for broad accessibility and provides no drug label for administration, as the drugs accessible through it are not Health Canada approved or not available in Canada.
Canadian healthcare professionals will require substantial assistance if they have intentions to safely and effectively deliver psychedelic-assisted therapy (PaT) under the SAP using psilocybin and MDMA.
ATMA and Cenalife are collaborating to organize and structure components of PaT and the SAP so practitioners can feel supported in accessing these drugs. Even working within the narrow function and guidelines of the SAP, there is a lot ATMA/Cenalife can do to assist practitioners with success in both an SAP application approval and conducting PaT with it.
ATMA/Cenalife Collaborative Workshop & Services
ATMA/Cenalife will be facilitating workshops and developing administrative systems to provide physicians and practitioners with education, guidance, safety procedures, and protocols, as well as administrative support services to assist with the SAP applications and streamline treatment process upon approval.
Our workshops are provided through a team of multidisciplinary practitioners who are not only well-versed in healthcare but also in the field of PaT.
INSTRUCTORS
Live instructors include
Monika Hooper
Psychiatrist, Linden Medical Center
Ravi Bains
Psychiatrist and Clinical Trial Qualified Investigator for ATMA
Ben Malcolm
PharmD, MPH, Spirit Pharmacist - Founder
Rachel Dundas
Psychologist, RCC, Certified Play Therapist, Certified Trauma Practitioner
Jessica van der Hook
Advance Paramedic, Advisor for ATMA
Reverdi Darda
Registered Nurse, CEO Cenalife
What you will learn in the ATMA/Cenalife SAP workshop:
Health Canada SAP guidelines
Working with a team led by a physician or prescriber (plus a psychiatrist in Alberta)
Patient eligibility criteria and how to screen and assess
Drug accountability, suppliers, ordering and costs
Filling out an SAP application
Samples of SAP applications
Informed Consent Forms
PaT protocols for high standard of safety care
Documenting and reporting
Also learn about ATMA Services available post-workshop:
SAP application service
Patient/client pre-assessment services including Ketamine-Assisted Psychotherapy(KAP) as an option
Patient/client administrative handling
Network of independent practitioners to work with
Interdisciplinary team management
Accessibility to network of facilities for safe administration
Training on Safety protocol, Quality Assurance(QA) and Quality Management(QM) systems, as well as Standard Operating Procedures (SOPs)
Provide service accessibility on ATMA’s directory
Physicians are needed
This workshop is for any practitioner who has taken psychedelic-assisted therapy training and is interested in learning more about the SAP as a possible avenue for PaT for eligible patients; as well, those also wanting to learn about how legal regulations for PaT in Canada will likely roll-out upon legalization.
If you are a non-prescribing practitioner wishing to attend, we encourage you to network and encourage physician(s) and prescriber(s) to accompany you to the workshop. Physicians and prescribers are not just needed for the SAP and KAP, they will also play a crucial role in PaT when psilocybin and MDMA is legalized for therapy. Educating and getting physicians involved now is key to preparing this field for legalization.
Download this Physicians’ SAP Brochure as a tool to reach out to physicians.
Workshop Info
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- October 2nd & 3rd @ 6pm MST (2 x 2hrs on back-to-back evenings)
- October 19 @ 6pm MST (2hrs follow-up session)
- Earn 6 CE or CME Credits
- Additional workshops will be held based on demand
$249 CDN any practitioners with interests in the SAP and PaT
$149 CDN for all ATMA alumni
$69 CDN for ATMA Advanced PaT Certification Program graduates
