Under the Public Health (Medicinal Cannabis) Act 2016 (PHMCA), a single patient prescriber is a medical specialist or general practitioner who has approval to prescribe a medicinal cannabis product to a particular patient.
To be a single-patient prescriber, you must:
- be a medical practitioner:
- either a specialist medical practitioner in the management of patients with the medical condition being treated with the product OR
- a general medical practitioner in consultation with a relevant medical specialist
- be registered (without undertakings on your registration) with the Australian Health Practitioners Regulation Agency
- have an established treating relationship with the patient, or the medical practitioner is in direct communication with another medical practitioner who has an established long-term treating relationship with the patient and both are in well-documented agreement with the application for medicinal cannabis approval for therapeutic purposes.
Guidance and regulations
- Guidance for the use of medicinal cannabis in Australia, December 2017 is a national guidance document covers the medical conditions, symptoms, and products to be used. The individual documents can be viewed on the TGA's website.
- Clinical guidance for the use of medicinal cannabis products, March 2018 (PDF 524 kB): covers the medical conditions/symptoms and products to be used.
- Standard for security of medicinal cannabis stock, January 2017 (PDF 326 kB) details how to secure and store medicinal cannabis products, under Part 8 of the regulation.
- Public Health (Medicinal Cannabis) Regulation 2017: describes patient-class prescribers, the class of patients to be treated, and the medicinal cannabis products to be prescribed.
- Read more on the Commonwealth's guidance for:
Forms and templates
- Application for medicinal cannabis approval (PDF 344 kB)
- Treatment report (PDF 105 kB)
- Notification of medicinal cannabis management plan (PDF 120 kB)
- Application for approval to dispense medicinal cannabis (PDF 287 kB)
- Medicinal cannabis management plan (PDF 133 kB)
Your legal obligations
The authorised single-patient prescriber must:
- ensure the medicinal cannabis product is stored in accordance with the manufacturers specifications and meets the requirements of the security standard if they are dispensing the medication from their practice
- prepare a medicinal cannabis management plan (if they are dispensing) under the medicinal cannabis approval
- notify Queensland Health when a medicinal cannabis management plan is made by submitting the notification form
- comply with the requirements of the medicinal cannabis approval (including but not limited to):
- not dispense medicinal cannabis for medicinal purposes to any unapproved patient.
- not exceed the approved maximum daily dose in accordance with that specified in the medicinal cannabis approval.
- not vary the approved route of administration.
- not vary the medicinal cannabis product without the relevant approvals.
- conduct a medication review prior to initiating medicinal cannabis for therapeutic purposes and in any reassessment of the patient(s) receiving medicinal cannabis.
- retain a copy of all the relevant documented approvals to prescribe medicinal cannabis in the patient's clinical record.
- report any adverse events to the TGA and to the State, as specified in their respective regulations and/or approvals
- include processes to identify any misuse/abuse/diversion by the patient in any reassessment of patient(s) receiving cannabis for medical purposes.
- clinically reassess the patient as to the appropriateness of treatment at least once every 3 months, or more frequently if required. Compare the outcome with the stated goal of treatment to determine whether treatment with medicinal cannabis should continue
- advise the patient that if their medicinal cannabis product contains THC then they cannot drive or operate heavy machinery.
- provide a treatment report to the chief executive on request
- comply with any conditions imposed on a TGA approval relating to the medicinal cannabis product(s) being used
Other conditions may apply, depending on individual cases.
Expert advisory panel
An expert advisory panel assists the chief executive to decide applications made under the single-patient prescriber pathway by providing:
- advice for each individual case under the single patient prescriber pathway
- recommendations about the conditions and symptoms for which an approval may be granted
- the medicinal cannabis products used, including type and form
- recommendations about current or proposed research related to medicinal cannabis.
The panel may also seek advice from other experts as required both nationally and internationally.
The panel are experts in the condition being reviewed; they will be able to advise that all reasonable treatment options for the disorder have been tried before using an unapproved product such as medicinal cannabis. The panel may seek a statement from patients via their treating doctor to assist in the review of an application. A consumer advocate is included in the membership of the panel.
The panel will only communicate with the applicant i.e. the doctor when more information is required to inform their advice to the Director-General. No direct communication with the patient will be entered into by the panel.