Psychedelics

Recent updates

• Community information sheet – Psychedelic therapy (April 2024)
• Training Framework - Psychedelic training framework for psychiatrists  (July 2023)
• Webinar recording - Psychedelic-assisted therapy: A clinician’s perspective (held 20 July 2023)
• Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression (June 2023)
• Clinical Memorandum: Therapeutic use of psychedelic substances (June 2023)
• FAQs (June 2023)
  
• Psych Matters podcast - Perspectives on psychedelic-assisted psychotherapy in clinical practice (23 June 2023)
• 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)

TGA decision

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).

Prescriber eligibility

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.

The RANZCP does not endorse any individual training program but has developed a framework to assist psychiatrists in ensuring they have undertaken appropriate and formal training, by self-assessing training courses against the criteria outlined in the framework.

Resources

RANZCP submissions to the TGA in March 2020 and May 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)

Recent media coverage

• Sydney Morning Herald: MDMA and magic mushrooms aren’t a ‘miracle cure’, psychiatrists warn ahead of new rules.
• RN – Life Matters – Talk back interview with Professor Richard Harvey and Dr Paul Liknaitzky.
• ABC Melbourne - Psychiatrists 'surprised' by TGA approval of 'experimental' drugs.
• ABC Current Affairs – PM - Australia to allow psychiatric treatment with psychedelics.
• Australian Doctor - Doctors offering psychedelic therapy should have prior experience and training, says psychiatry college.

Contact

policy@ranzcp.org