MAPS Canada is pleased to be undertaking its first research study: Examining the Special Access Program (SAP) for Therapeutic Access to Psychedelics in Canada Nationally – An Exploratory Study of the Determinants Impacting Access (EXPAND Study).
About the EXPAND Study
Psychedelics are currently illegal in Canada and cannot be obtained by doctors or given to patients without special permission from Health Canada. One avenue for permission is the Special Access Program (SAP). Through this program, licensed prescribers can apply for permission to treat their patients with psychedelics. To do so, they have to show that their patient has a serious life-threatening illness, and that they know how to provide psychedelic-assisted therapy. Permission is granted by Health Canada on a case-by-case basis.
Psilocybin has been accessed to date through the SAP. Psilocybin is the active psychedelic -related chemical found in Psilocybe cubensis, commonly known as magic mushrooms. Psilocybin has shown efficacy in treating fear of end of life in terminally ill cancer patients, smoking cessation, and decreasing depression/anxiety.
To date, not many SAP applications have been successful. In addition, many prescribers who are eligible to apply through the SAP do not apply, either because they are unaware of the program, hesitant to use it, or face other barriers.
The EXPAND Study will address these issues by engaging with prescribers in order to gain a better understanding of the barriers and facilitators to submitting an SAP application.
The study will collect data from:
- Prescribers who are interested in making an SAP application but have not yet done so.
- Prescribers who have made an SAP application and have received a response from Health Canada.
In this study we will try to answer the following research questions:
- What are prescribers’ perceptions of the barriers and facilitators in making an application to the Special Access Program (SAP) for their patients?
- What are the factors in SAP applications that are more likely to lead to acceptance or rejection by Health Canada/the Minister of Health?
The goal of this research is to help prescribers make more effective applications to the SAP for psychedelics for their patients, and ultimately to increase access to psychedelic medicines for everyone who wants them within the current Canadian legal context. The research will also help create a knowledge base that can drive evidence-informed policies for access.
Study results and outputs will be posted here as the study progresses.
For more information about the study, to participate, or to learn more about the community of practice, contact us at research@MAPSCanada.org
- We want to understand the factors that make it more or less likely for a prescriber to apply to the SAP for psychedelic medication.
- We also want to learn which elements of an application tend to be successful or unsuccessful.
- This knowledge will allow us to help prescribers manage barriers, make stronger applications, and potentially help inform drug policy pertaining to psychedelics.
- This study will have all of its relevant documents (i.e. study protocol, surveys, social media posts, emails) submitted to the Research Ethics Board (REB) for approval. The researchers will work with the REB to ensure that the study is up to REB standards. The study will not proceed without the approval of the REB.
- Read MAPS Canada’s Research Ethics Statement
- Participants will be given an explanation of the study purpose, risks, and benefits, and will be able to ask questions and talk about any concerns with the investigators.
- If they agree to participate, participants will be given a standardized consent form before beginning the study. This is confidential and will be protected to ensure the safety of prescribers and individuals involved with this study.
- Participants may withdraw consent at any time for any reason.
Survey data will be collected using PHIPA-compliant survey software designed specifically for research involving medical personnel. PHIPA, or the Personal Health Information Protection Act (PHIPA) is Ontario’s health- specific privacy legislation which ensures the privacy of all healthcare information. PHIPA is substantially similar to PIPEDA, the Personal Information Protection and Electronic Documents Act, a federal act pertaining to information privacy. Find out more about PHIPA and PIPEDA.
Data will be stored on a password-protected drive, only accessible by the research team.
- Data will be analyzed for trends and common themes across responses. Preliminary themes will also be shared with participants to ensure the themes collected reflect their responses.
- We will also collect demographic data (age, gender, location, etc.) to look for differences in different subgroups.
- Data will be shared in a confidential manner, using encrypted software to ensure that there are no specific identifiers such as prescriber registration number and date of birth. However, the collection of demographic data will be used within the study to determine which categorical subsets may be correlated most with SAP approval or denial.
- We will publish an academic paper and present the findings at academic conferences as applicable.
- We also hope to use these findings to inform the creation of resources that prescribers can use to make stronger SAP applications for their patients (i.e. templates, infographics, flow charts, communities of practice).