Previous psychedelic experience, overseeing administration and providing a suitable supervised environment feature in the Administration’s Authorised Prescriber recommendations.
The Therapeutic Goods Administration has released four recommendations for the authorised prescribing of MDMA and psilocybin by psychiatrists.
Psychiatrists granted specific authorisation under the Authorised Prescriber (AP) scheme have been allowed to prescribe 3, 4-methylenedioxy-methamphetamine (MDMA) for post-traumatic stress disorder and psilocybin for treatment-resistant depression since July 2023.
During this time, several procedural and practical challenges have been encountered by different stakeholders involved in the delivery of psychedelic-assisted psychotherapy, including psychiatrists applying to be part of the AP scheme, human research ethics committees (HRECs) and the TGA itself.
To address these challenges, the TGA undertook a review of the requirements to join the AP process, invited feedback from over 80 stakeholders including AP psychiatrists, peak professional bodies, HRECs as well as state and territory medicines and poisons units (29 responded) and held roundtable discussions and additional stakeholder meetings to gain feedback and help form the final recommendations.
“The final recommendations are intended to achieve a balance between facilitating appropriate access to the emerging unapproved psychedelics while ensuring strong safeguards are in place to protect patient safety,” the TGA said in a statement. “This is particularly important for therapeutic goods that are not registered by the TGA and involve treatment combining psychedelic medication with psychotherapy.”
Recommendation 1: Psychiatrist experience with psychedelics
Psychiatrists wanting to obtain AP status must show they have experience in psychedelic-assisted psychotherapy by either participating in relevant clinical trials or being supervised by an experienced AP.
“Stakeholders noted that few psychiatrists have participated in clinical trials, so requiring trial experience alone could restrict access. They also noted a need for clearly defined supervision criteria, training and continuing professional development (CPD), which fall outside the TGA’s regulatory scope,” the TGA’s recommendation read.
“The recommendations are expected to support safe and consistent clinical practice while maintaining patient access. Psychiatrists are encouraged to engage with professional guidance on psychedelic therapies to inform competency development, supervision, and ongoing professional development,” the TGA said.
Recommendation 2: Use of a therapy dyad
The TGA recommended that all psychedelic-assisted psychotherapy must be administered by a dyad involving the AP psychiatrist and at least one other healthcare practitioner registered with a National Board. Specifically, the TGA recommended an endorsed clinical psychologist, a physician with general medical registration, a nurse and/or midwife with mental health experience or an occupational therapist.
Importantly, all practitioners who form part of the therapy dyad must have a scope of practice that includes psychedelic-assisted psychotherapy as well as having the appropriate skills, training and competence to deliver said therapy.
The responsibility of determining the qualifications and experience of additional practitioners belongs to the AP psychiatrist.
“Consultation feedback supported broadening the range of therapists able to be involved in psychedelic‑assisted therapy to improve access, particularly in rural and regional areas, address workforce shortages and to better support culturally appropriate care. Stakeholders emphasised that professions involved with psychotherapy bring highly relevant, specialised skills, and that practical experience and competency should be prioritised over professional discipline alone,” the TGA said.
“[As] no National Board currently specifies a dedicated pathway for psychedelic‑assisted therapy, and that patients are likely to have complex and severe conditions, the TGA considers that oversight by at least one practitioner registered with a National Board remains essential.”
Recommendation 3: The AP psychiatrist must screen patients and obtain ongoing informed consent
“Prior to the consultation, there was a lack of clarity regarding the level of AP psychiatrist oversight, including on-site physical presence and requirements for screening and consent,” the TGA noted.
Given this lack of clarity and based on stakeholder feedback, the TGA has recommended that the AP psychiatrist is responsible for patient screening and ongoing informed consent and must be present in-person while the psychedelic is being administered to respond to any immediate issues or adverse events.
In a departure from the current system, the new recommendation does not require the AP psychiatrist to be on site for the full dosing day, a decision that the TGA claims “preserves a degree of flexibility to support service accessibility”. However, the recommendations clearly state that the AP psychiatrist is responsible for the patient and treating team if and when they leave the clinic.
The TGA acknowledged the feedback that the requirement for in-person screening and consent may make it harder for rural and regional patients to access psychedelic-assisted psychotherapy but felt that virtual screening and consent would not adequately meet the safety requirements for this group of patients.
“This recommendation aligns with state and territory regulatory frameworks for Schedule 8 psychedelic medicines (MDMA and psilocybin), which require that these medicines are not provided to patients for unsupervised use and are administered only within controlled clinical settings under the direct supervision and oversight of the AP psychiatrist,” the TGA said.
Related
Recommendation 4: Appropriate site location
The final recommendation provides greater clarity on what constitutes an appropriate site location for the administration of psychedelic-assisted psychotherapy.
Specifically, the site must, among other requirements:
- Have the appropriate equipment and trained staff to provide clinical care and monitoring, as well as being able to provide emergency resuscitation and respond to medical or behavioural emergencies
- Have secure storage and record keeping for Schedule 8 medicines in line with jurisdictional regulations
- Be located with 15 minutes of an accredited healthcare facility with an emergency department
“Stakeholder feedback strongly supported allowing treatment in settings beyond traditional hospital environments, noting that less overtly clinical, more therapeutic settings can improve patient comfort and outcomes. Such environments were also considered more culturally appropriate for First Nations people and more accessible for patients in rural and regional areas,” the TGA said in a statement.
“While formal accreditation, such as the National Safety and Quality Health Service Standards (NSQHS), were recognised as providing a high level of assurance, stakeholders raised significant concerns about its practicality. In particular, the costs, administrative burden, and indemnity risks associated with accreditation were seen as prohibitive for many providers, especially small, regional, and community‑based clinics. There were concerns that mandating accreditation could limit service availability, favour large metropolitan providers and reduce patient choice.”
The Australian has reported that the recommendations are subject to further approvals before they come into effect, and that the proposed changes will be criticised by certain doctors.
“One concern is that there is far too little evidence the therapies are effective yet they come with a huge price tag of around $30,000 and are targeted at vulnerable patients,” their article reads. “There are concerns too about possible side-effects, including psychosis, for patients.”
Advocates and individuals with a vested interest in psychedelic-assisted psychotherapies are (unsurprisingly) more positive about the recommendations.
“This will hopefully mean that the costs will come down if there’s less hours of psychiatry time and if there is more scope to use differently trained mental health professionals that may also reduce the cost,” Monica Schweickle, a clinical psychologist and director of a psychedelic clinic and consultancy, told The Australian.
“So I’m not sure how many of them would want to leave the site. But potentially, if you have a patient who has maybe done a number of dosing sessions already and they’ve been well screened, they’ve got a really good therapist team, then that would be a possibility to reduce the cost to someone.”
Further information on the recommendations can be obtained by contacting the Authorised Prescribers team via email.
