- Webinar recording available - Psychedelic-assisted therapy: What psychiatrists need to know (held 27 April 2023)
- News item - Change to classification of psilocybin and MDMA (6 February 2023)
In Australia, the Therapeutic Goods Administration (TGA) has permitted the use of MDMA and psilocybin for the treatment of certain mental health conditions.
From 1 July 2023, authorised psychiatrists will be able prescribe MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.
For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances).
The changes to the scheduling of psilocybin and MDMA limits the prescribing of these substances to psychiatrists who are registered with the Australian Health Practitioner Regulation Agency (AHPRA) with a specialist registration in psychiatry and have completed a Fellowship with the RANZCP.
To prescribe MDMA and psilocybin psychiatrists must:
- have obtained approval for purposes of the Authorised Prescriber Scheme to use the substance for treating the conditions from a Human Research Ethics Committee (HREC) that is registered with the National Health and Medical Research Council (NHMRC), and subsequently
- have sought and obtained authorisation by the TGA under the Authorised Prescriber Scheme to prescribe these substances for patients under their care.
Psychiatrists should also consider and discuss with their patients the suitability of medical treatment options that are TGA approved (i.e. included on the Australian Register of Therapeutic Goods) before seeking to prescribe psilocybin or MDMA to them under the Authorised Prescriber scheme.
Role of the RANZCP
The priority for the RANZCP is to provide guidance for psychiatrists in relation to the rescheduling, including advice for psychiatrists who may wish to become TGA Authorised Prescribers.
The RANZCP will also provide relevant information for the broader community.
RANZCP Psychedelic-Assisted Therapy Steering Group
The Steering Group has now been established.
The group will:
- consider the appropriate level of information and support to provide to members
- provide guidance and recommendations for RANZCP media commentary
- provide relevant information about the prescribing pathway to members and the general public.
Psychedelic Assisted Therapy Steering Group Terms of Reference [PDF; 121 KB]
The Steering Group is continuing to progress resources for the RANZCP, including the development of a Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression and an update to the existing Clinical Memorandum: Therapeutic use of psychedelic substances.
The PAT Steering Group is also involved in ongoing advocacy around the monitoring and reporting of efficacy and safety outcomes from PAT. The College advocates that data, including on adverse events, must be collected systematically and longitudinally.
The names of the Steering Group members are listed below. Please direct any correspondence for the Steering Group to email@example.com with attention to the PAT Steering Group. Steering Group members will not reply to correspondence sent directly to them regarding PAT. All correspondence will be forwarded to firstname.lastname@example.org
- Prof Richard Harvey (Chair)
- A/Prof Shalini Arunogiri
- Dr George Blair-West
- Prof David Castle
- Dr Michael Daubney
- Prof Chris Davey
- Prof Steve Kisely
- Dr Cameron Lacey
- Prof Colleen Loo
- Dr Gabrielle Matta
- A/Prof Suresh Muthukumaraswamy
- Dr Nigel Strauss
- A member of the RANZCP Community Collaboration Committee with Lived Experience.
Milestones and timeline
|Establish Steering Group||March 2023|
|First Steering Group meeting and initial recommendations||April 2023|
|Advice and support for media (ongoing)||March-Dec 2023|
|Commence review of Clinical Memorandum||April 2023|
|Recommendations provided to Board||May 2023|
|Progress development and publication of the initial resources that will provide information and support to members||May-Jun 2023|
|Poisons Standard amendments effective from:||1 July 2023|
|Continue implementation of recommendations in terms of information and support for members||December 2023|
RANZCP submissions to the TGA in March 2020 and May 2022.
RANZCP Clinical Memorandum on the therapeutic use of psychedelic substances (July 2022)
TGA - Re-scheduling of psilocybin and MDMA in the Poisons Standard Q&A (3 February 2023)
TGA - information for psychiatrist prescribers (13 February 2023)
TGA - webinar presentation (1 March 2023)
RACGP - MDMA and psilocybin: What GPs need to know (22 March 2023)
TGA – Blog on understanding the changes to MDMA and psilocybin access (30 March 2023)