Psychedelics Application Form

Please ensure you have made payment prior to completing this form. Non-payment will result in your form not being considered.

Initial Check – Step 1 of 2

Guideline

It is suggested that you refer to the RANZCP Guideline,

Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression

when completing this application.

Please note:

When uploading files please name each file clearly as follows:

Applicant_surname-Applicant_firstname-title_of_document

The psychedelics authorized prescriber application is only open to current psychiatrists registered in Australia.

Fellowships listed: [mepr_college_fellowship] Your AHPRA Number is listed as: [mepr_ahpra_number]

If you are already a member of ANZCCP and your Fellowship or AHPRA Number is not listed correctly. Please go to your account to correct this first.

Go to My Account

Applicant Details

Fellowships listed: [mepr_college_fellowship] Your AHPRA Number is listed as: [mepr_ahpra_number]

Name

First

Last

Address

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

(Non Members Only) – My AHPRA Number is

I confirm I am a Fellow of RANZCP and I have provided my AHPRA Number

Please upload evidence of your RANZCP fellowship

Drag & Drop Files, Choose Files to Upload

Please upload evidence of your other HREC approval

Drag & Drop Files, Choose Files to Upload

Site Details

Site(s) at with the unapproved good will be prescribed.

List all addresses. List each new address on a separate line. Please provide a full street address.

Description of the facilities used to appropriately administer and monitor treatment.

Please provide a description of the facilities you are using that highlights their safety and appropriateness as settings for the medicine sessions. We expect you to touch upon the aesthetic, lighting, sound proofing and accessibility to toilets as a minimum.

Images of facilities.

Drag & Drop Files, Choose Files to Upload You can upload up to 6 files.

Pictures of facilities can be added. Please reduce file sizes prior to submitting.

Risk Management

How will risks associated with the use of the unapproved good be managed?

Process of obtaining informed consent from patients.

Please include details of all information that will be covered in the consent process.

Consent and Information Forms

Drag & Drop Files, Choose Files to Upload You can upload up to 6 files.

It is suggested that you upload any patient consent forms and information forms here.

How will consent and capacity be assessed on an ongoing basis, i.e. initially and before each treatment session?

What emergency medical equipment will be easily accessible and how will you manage a medical emergency?

Adequate equipment to provide basic life support should be available. i.e. blood pressure monitoring, oxygen saturation monitoring, oxygen and defibrillator. There should be specific processes for dealing with medical emergencies, including escalation protocols and means of accessing medical treatment not available onsite.

What are your processes for reporting, investigating, and managing adverse events?

Protocols may need to be developed for responding to non-routine circumstances that might be expected to arise, for example unwanted intrusion or building evacuation during dosing, or an attempt by a patient to leave the facility while still under the influence of the substance. Patients should be monitored post-dosing for adverse effects such as trauma provoked during dosing or trauma re-exposure, suicidality, flashbacks, and psychosis (RANZCP Guideline, 2023).

Data Collection

Will you be recording dosing sessions?

Recording of sessions is not considered required.

If recording sessions please provide further details.

It is often recommended that dosing sessions are video (or audio) recorded to enhance patient safety, although this will require patient consent, and may raise privacy issues. This may also place an onus on the health service in relation to storing and reviewing the recording in the case of any reported anomalies, which may be a time-consuming and costly process given the length of dosing sessions.

What central registry will you be uploading your data to?

Given the early stages of research in this area we consider it mandatory that all appropriate and de-identified data be available for research purposes.

Medications and Indications

Medications and Indications – approval is being sought for the following medication/s & indication/s

MDMA (3,4 methylenedioxy-methamphetamine) for Post Traumatic Stress Disorder
Psilocybin for Treatment Resistant Depression

Training and Experience

My role in the team will be

Solely a prescriber. And I have completed 40 hours of knowledge based training
Prescriber and secondary co-therapist with one other primary therapist. And I have completed at least 100 hours of knowledge-based training
Prescriber and primary therapist with one secondary co-therapist. And I have completed at least 100 hours of knowledge-based training and at least 40 hours of experiential training.

Co-therapists on the team have completed at least 100 hours of knowledge based training

Confirmed

Upload evidence of training and professional development

Drag & Drop Files, Choose Files to Upload You can upload up to 6 files.

Upload certificates for yourself and other team members as relevant.

Disclosure

I certify that I

Do not have a commercial interest in any of the products for which I am applying
Do have a commercial interest in one or more of the products for which I am applying

I certify that I

Have not applied for Authorised Prescriber approval of another Australian HREC (not ANZCCP) within the last 12 months
Have applied for Authorised Prescriber approval of another Australian HREC (not ANZCCP)) within the last 12 months

Upload prior application details.

Drag & Drop Files, Choose Files to Upload You can upload up to 2 files.

Final Check

Please ensure that you have uploaded with your application:

Check

Evidence of RANZCP fellowship
Evidence of additional professional education in psychedelic assisted therapy
Evidence of professional education in psychedelic assisted therapy of the other members of your PAT team
Patient Informed Consent Form
Evidence of other HREC AP approval (if appropriate)
Appropriate sources of evidence to support the use of the ‘unapproved’ good.

The sources of evidence for data, with the highest level of significance first, in decreasing order are: • product information documents (or equivalent) (if the good is approved by an overseas regulator) • randomised controlled trials • non-randomised controlled trials • individual case studies • consensus opinion of specialist colleges and societies

Signature

I will be fully compliant with the state laws within which I am prescribing and all conditions of any HREC approval.