Change to classification of psilocybin and MDMA
6 Feb 2023
The Therapeutic Goods Administration has announced from 1 July 2023, psychiatrists who are specifically authorised under the TGA’s Authorised Prescriber scheme will be able to prescribe medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) for the treatment of certain mental health conditions.
Psychedelic substances psilocybin and MDMA are an emerging treatment for people experiencing post-traumatic stress disorder and treatment-resistant depression, where first-line therapies have failed.
The therapeutic use of psychedelic substances should only occur under rigorous conditions, overseen by an authorised psychiatrist, with careful oversight by an institutional research ethics committee, and careful monitoring and reporting of efficacy and safety outcomes.
For approval to prescribe, psychiatrists will need to demonstrate appropriate training, patient selection, evidence-based treatment protocols and patient monitoring.
Further, ongoing psychotherapeutic support remains an essential component of the psychedelic treatment model.
Over the coming month, the RANZCP will be working to develop further guidance for psychiatrists who apply to become TGA authorised prescribers.
RANZCP is guided by the best available evidence, and supports continued research to assess the efficacy, safety and effectiveness of psychedelic therapies in future practice. Research should be led by experts with appropriate psychiatric and psychotherapy training, including specific training in psychedelic psychotherapy, to ensure appropriate management of risks and side effects.
Please see RANZCP’s Clinical Memorandum on the therapeutic use of psychedelic substances for further information.
More information about the TGA’s announcement can be found here, including information on access to psilocybin and MDMA and next steps for healthcare professionals.
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The Royal Australian and New Zealand College of Psychiatrists is a membership organisation that prepares medical specialists in the field of psychiatry, supports and enhances clinical practice, advocates for people affected by mental illness and advises governments and other groups on mental health care. For information about our work, our members or our history, visit www.ranzcp.org.
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