S8 esketamine, MDMA and psilocybine

Part 5 of the Monitored Medicines Prescribing Code (the Code) outlines the prescribing conditions and requirements for esketamine, including:

• when prescribers may prescribe esketamine without authorisation of the CEO
• when prescribers require written authorisation from the CEO before prescribing esketamine.

It also details how to apply for authorisation from the CEO.

Part 5 of the Code also outlines the method of application and requirements to be met when applying for authorisation to prescribe MDMA [N, α -dimethyl-3,4-(methylenedioxy) phenylethylamine] and psilocybine, which are listed as S8 medicines for specific uses only (post-traumatic stress disorder and treatment-resistant depression, respectively).

Authorisation of the CEO

When is prior authorisation of the CEO required?

All prescribing must be in accordance with Part 1 and Part 5 of the Code.

MDMA and psilocybine always require written authorisation from the CEO prior to prescribing. 

Esketamine for treatment-resistant depression is restricted by the Australian sponsor to psychiatrists treating patients in particular clinics. 

Applying for authorisation to prescribe

Applications must be on the application form, which must be completed in full and, where required, be accompanied by supporting documentation as specified on the form.

Application form

Where authorisation of the CEO is required to prescribe esketamine, applications need to be submitted by a medical practitioner who holds specialist registration on the AHPRA register of practitioners in the Speciality of ‘Psychiatry’.

Applications for authorisation of the CEO to prescribe and administer MDMA or psilocybine, must be submitted by a medical practitioner who:

• holds specialist registration on the AHPRA register of practitioners in the Speciality of ‘Psychiatry’ and is approved as an Authorised Prescriber of the product by the TGA; or
• is prescribing MDMA or psilocybine, for the indications specified in the Poisons Standard, within clinical trials that have been approved by or notified to the TGA.

General conditions for prescribing esketamine, MDMA, and psilocybine

Esketamine, MDMA, and psilocybine must be administered in a clinic by an authorised health professional.

Community pharmacies dispensing esketamine, MDMA and psilocybine

Esketamine, MDMA and psilocybine must never be provided directly to a patient or agent and should be administered in a clinic by an authorised health professional.

When a clinic is sourcing from a community pharmacy by prescription (for each patient), the dispensed product must be delivered to the clinic address. Prescriptions must be endorsed with supply to the clinic only.