Psychedelics FAQs

What are psychedelic drugs?

Psychedelics are a class of drug, also called hallucinogens, that can induce states of altered perception and thinking. Drugs in this class include psilocybin and LSD (lysergic acid diethylamide). 

In the context of psychedelic-assisted therapy, MDMA (methylenedioxymethamphetamine) is often described as a psychedelic drug. While this isn’t technically true – MDMA is in a class of drugs called empathogens or entactogens – it’s simpler to refer to MDMA as a psychedelic drug in this context.

While most of the current attention in the media is on MDMA and psilocybin, early research into the potential usefulness of other psychedelics, such as ayahuasca and LSD, is also being conducted. However only MDMA to assist in treating post-traumatic stress disorder (PTSD) and psilocybin to assist in treating treatment resistant depression (TRD) will be available outside of research settings in Australia.

What is psychedelic-assisted therapy or PAT?

Psychedelic-assisted therapy is a treatment focused on a series of psychotherapy sessions, at least one of which includes the use of a psychedelic drug as a tool or adjunct to help and facilitate the psychotherapy.* A treatment series will usually involve: 

• preparation sessions that encourage trust help strengthen the relationship between the patient and their treatment team, including discussing expectations about the therapy and preparing the patient for the often profound effects of the psychedelic drug.
• active dosing session(s) with the psychedelic drug during which significant cognitive, perceptual and emotional experiences may encourage significant and new insights about self and the way one sees the world (sometimes known as weltanschauung)
• integration sessions that help the patient and their treatment team process what was discussed and/or experienced during the active dosing session, and what those discussions and/or experiences mean for the patient’s treatment goals

*What is psychotherapy?

Psychotherapy, also called talk therapy, focuses on building a trusting relationship between the patient and their practitioner and exploring the patient’s thoughts, experiences, and behaviours, to help achieve their treatment goals. There are different forms of psychotherapy. Please see the RANZCP Position Statement: Psychotherapy conducted by psychiatrists for more information.

What are the TGA amendments to the Poisons Standard?

In Australia from 1 July 2023, the Therapeutic Goods Administration (TGA) will amend the Poisons Standard to permit MDMA to be used as a controlled drug in the treatment of treatment resistant PTSD and psilocybin to be used as a controlled drug in the treatment of TRD. 

The use of MDMA and psilocybin to treat any conditions other than PTSD and TRD, respectively, remains restricted to clinical trials.

Only registered psychiatrists are authorized to prescribe after they have obtained approval from a HREC and received TGA approval under the Authorised Prescriber Scheme. The product to be prescribed must be specified, and must be manufactured according to principles of Good Manufacturing Practice (GMP). Psychiatrists are required to comply with all legislation of the State or Territory in which they practice.

Refer to TGA: Information for Psychiatrist Prescribers.

What is that going to look like in practice?

This is a new, experimental treatment that is restricted to specific conditions, and only psychiatrists who have been approved by an HREC and been approved by the TGA as an Authorised Prescriber can prescribe these drugs.

The way psychedelics are used in psychedelic-assisted therapy is very different to the way other drugs, such as anti-depressants, are used. With a drug like an anti-depressant, a patient takes that drug regularly for an extended period of time.

In PAT, the psychedelic drug is used only on a very limited number of times. In some research protocols, the psychedelic drug is only used once. The psychedelic drug is only taken under supervision in a clinical setting with the support of a treatment team. It is a tool to assist the psychotherapy. It is not the treatment itself.

The clinical setting where the psychedelic-assisted therapy takes place needs to be in a comfortable and safe environment where adequate medical and psychological assistance is always available so that if problems arise they can be managed quickly and effectively. Hence the importance of well-trained and experienced treaters. The PAT model is resource intensive, and existing challenges around funding and psychiatry workforce shortages, particularly outside of major cities, are likely to be barriers to access at least in the initial stages of the rollout of this novel treatment.

Will many psychiatrists be involved in PAT?

The TGA amendments to the Poisons Standard are recent and it is unclear how many psychiatrists will be involved in PAT. It will require an investment of time and resources from potential psychiatric prescribers so that they can be permitted to prescribe these medicines (e.g., complete the research and paperwork required to apply to an HREC and the TGA; ensure they are meeting State and territory legal requirements; and have access to a suitable treatment environment in order to be able to provide the treatment as part of an appropriate multidisciplinary team).

Initially it is anticipated that only a small number of psychiatrists will be involved in PAT considering the onerous requirements for licensing as detailed above. Depending on how effective or not the treatment proves to be, the number of psychiatrists involved in prescribing will probably increase over time. 

What is the RANZCP’s position on the amendments to the Poisons Standard?

In May 2022, the RANZCP made a submission to the TGA in response to the application to reschedule MDMA and psilocybin.

In this submission, the RANZCP did not support amending the Poisons Standard for psilocybin or MDMA. The submission shared the RANZCP’s position on the promising, but limited, evidence available for psychedelic-assisted therapy, and advised a cautious approach led by evidence and informed by further research.  

The RANZCP was not further consulted on the additional controls that the TGA has now approved which will add psilocybin and MDMA to Schedule 8 under the Poisons Standard, permitting their use by authorised psychiatrists as controlled drugs only for treatment resistant depression and PTSD, following HREC approval and TGA approval under the Authorised Prescriber Scheme. 

The RANZCP accepts that the additional controls allow for narrower access than was originally proposed in the rescheduling application, and supports that prescribing be limited to authorised psychiatrists only. 

However, the RANZCP believes that patient safety is the primary concern. These treatments are experimental, and a cautious initial approach is merited to help prevent potential serious adverse outcomes for patients. This field is developing and the position of the RANZCP will be reviewed and updated as more data becomes available, and the experiences of practitioners and patients involved in these treatments outside of clinical trial settings becomes known.

What is the RANZCP position on the TGA loosening restrictions further to include other conditions? 

There is currently insufficient clinical evidence to support down scheduling psychedelic-assisted therapies for other conditions. The RANZCP’s position will continue to be informed by the evidence base.

Are there any implications of this TGA decision for New Zealand? 

Regulations in New Zealand remain unchanged. 

In New Zealand, the prescription of controlled substances is regulated by Section 8 of the Misuse of Drugs Act 1975, while the specific restrictions on Schedule 1 substances (including psilocybin and MDMA) are governed by Section 22(1)(a) of Misuse of Drugs Act Regulations 1977, which requires Ministerial approval. Under Section 29 of the Medicines Act a medical practitioner may apply to obtain an unapproved medicine in line with Medsafe guidelines. 

Guidance issued by the RANZCP is bi-national and therefore would apply across Australia and New Zealand. 

What do the changes mean for potential patients, family and carers?

There has been significant hype in the media around psychedelic-assisted therapy, and many people for whom established therapies have not been successful may be understandably hopeful about the potential of PAT. It is important to recognise that these are experimental treatments that will not be suitable, or desirable, for everyone who may be eligible.

Patient safety is the most important consideration, and the RANZCP advocates for a cautious approach informed by the best available evidence in order to minimise the risk of harm. The delivery of PAT using either MDMA or psilocybin must occur under highly controlled conditions and include the careful monitoring and reporting of efficacy and safety outcomes to protect patients.

Patients must be able to understand the potential risks and benefits of PAT using either MDMA or psilocybin and be able to provide informed consent.

During the consent process, psychiatrists must ensure patients understand that therapeutic outcomes cannot be guaranteed, and that unwanted side-effects may occur. They must also carefully explain the costs of treatment. It would usually be appropriate for whānau, families and carers to be involved in this process depending on the patient’s preference.

What is the cost of psychedelic-assisted therapy? 

The out-of-pocket costs of psychedelic-assisted therapy are unknown. As unapproved medicines, MDMA and psilocybin containing products are not eligible for listing on the Pharmaceutical Benefits Scheme. 

Standard psychiatry consultations that are undertaken as part of provision of care can be billed under the MBS in line with the MBS legislation. Given the resource-intensive nature of the therapy, and the cost of the medications, patients can expect to have significant out-of-pocket expenses.  

Are psychedelic drugs still illegal for the public to possess?

Yes. 

The illicit use of psychedelics, even when intended to be therapeutic, poses significant risk to the community and is illegal in Australia and New Zealand. Unlike pharmaceutical-grade psychedelics, illicitly-accessed MDMA and psilocybin are of unknown composition. Improperly screened patients may suffer adverse physical and/or mental health effects with limited or no support from medical practitioners. There is no oversight of the credentials, training, or ethical behaviour of unregulated ‘practitioners’. 

What do the changes mean for psychiatrists?

Only interested psychiatrists who choose to follow the prescribing pathway, which includes HREC approval and TGA approval as an Authorised Prescriber, can prescribe these drugs.

The RANZCP has developed a Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression to provide information and guidance, including considerations for use of psychedelic-assisted therapy. The TGA also provides Information for Psychiatrist Prescribers.

What kind of training is expected for psychiatrists interested in prescribing?

The RANZCP is currently considering what level of training would be appropriate and has not developed or endorsed any training programs.  The RANZCP will develop a guidance document for potential prescribers, including principles for identifying quality training opportunities. 

Many patients are asking for this therapy and I’d like to offer it, how should I start?  

The RANZCP has released a new Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression provide guidance around the TGA amendments to the Poisons Standard and the delivery of PAT. 

Information about the prescribing pathway is available from the TGA’s webpage, Access to MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin for therapeutic purposes – information for psychiatrist prescribers.

Some patients may be eligible to enrol in a current clinical trial. Information about current clinical trials can be found through the Australian New Zealand Clinical Trials Registry. 

Who can deliver the psychotherapy component of PAT?

The RANZCP position is that psychotherapy is delivered by a treating dyad of health professionals, one of whom is a medical practitioner. Both practitioners must have undertaken comprehensive training in PAT (see Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression). The medical practitioner is someone currently registered with AHPRA with relevant qualifications and experience in psychiatry and psychotherapy, for example, a psychiatrist or a psychiatry trainee. The second therapist must have current registration with AHPRA or their equivalent governing body, with primary qualifications in their field of practice, for example, a clinical Master's degree relevant to psychotherapy.*

* The TGA have stated that they expect “It is likely that a minimum standard of training of others involved in patient oversight would be that of clinical psychologists.”

What are the regulations for legal supply and storage? 

To import products that contain a controlled substance (this includes MDMA and psilocybin), the importer requires both an exemption, approval or authority under the TGA Act, and a licence and/or permit to import from the Office of Drug Control under the Customs (Prohibited Imports) Regulations 1956. Further information is available in TGA guidelines Information for Psychiatrist Prescribers

What about indemnity insurance?

Consistent with the prescription of all medications or treatments, psychiatrists should ensure that they have appropriate indemnity insurance either as an individual or under their organisation’s policy prior to prescription. Psychiatrists are advised to check with their indemnity provider that they are covered for the use of MDMA and psilocybin as unapproved medicines. 

Are there any restrictions on settings in which psychedelic-assisted therapy can be offered e.g., public or private?

Under the TGA pathway, the expectation is that psychedelic-assisted therapy would be conducted in an appropriate setting – such as a day hospital or inpatient setting – to facilitate the ongoing assessment and management of the patient.

There are no restrictions on whether this be undertaken in private or public healthcare settings, but the same TGA pathway will need to be followed. 

Services will also need to be confident that they have appropriate infrastructure to administer PAT. All services providing PAT should have clear practice policies and guidelines, overseen by an appropriate clinical governance committee. This includes outlining appropriate use of a multidisciplinary team, processes for monitoring and management of acute and severe side-effects and escalation mechanisms in the treatment of adverse events.

How can registrars (trainees) improve their skills in this area?

Under the TGA pathway, prescription of psilocybin and MDMA is only permitted by psychiatrists who are registered with the Australian Health Practitioner Regulation Agency (AHPRA) with a specialist registration in psychiatry and have completed Fellowship with the RANZCP.

Trainees interested in contributing to research in this area can work with supervisors or research institutions to identify opportunities. Keeping up to date with RANZCP guidance and published literature is also suggested.