Prescribing medicinal cannabis in Australia

Any medical doctor can prescribe medicinal cannabis in Australia to eligible patients after obtaining the required approvals from the Therapeutic Goods Administration (TGA) and the relevant State or Territory’s Health Department.

 

How to prescribe medicinal cannabis

Any medical doctor can prescribe medicinal cannabis in Australia and there are several pathways available:

  1. The Special Access Scheme (SAS) for prescribing to an individual patient.
  2. Becoming an Authorised Prescriber for prescribing to many patients. 
  3. Referring patient to a doctor experienced in prescribing medicinal cannabis (‘shared-care’).
  4. Enlist patient in a clinical trial.

At the end of this page are links to some useful resources.

Determine if your patient is suitable for medicinal cannabis

Medicinal cannabis can be prescribed after first-line and second-line clinically appropriate treatment options that are included in the ARTG have been considered, and if there is sufficient evidence to support that medicinal cannabis may help patients achieve better health outcomes for a medical condition.

Considerations for prescribing medicinal cannabis:

  • Does the patient have a chronic, life-impacting conditions?
  • Is the patient’s condition treatable with medicinal cannabis? (We have compiled scientific literature for common conditions that can be found here).
  • Have first- and second-line treatment options been trialed?
  • Is there a potential for drug-drug interactions?
  • Have other patient-specific factors been considered? (risk factors, genetic and familial predispositions, driving, cardiac disease, drug and alcohol abuse, mental health).
  • Finding the best treatment option for the patient. Not all cannabis medicines are the same.

Special Access Scheme

Unapproved medicinal cannabis products can be prescribed to an individual patient through the TGA’s Special Access Scheme (SAS).

    1. Applications can be lodged for the TGA and relevant state health authority via the SAS Online system. Note: In Tasmania, separate approval must be sought from the Tasmanian Department of Health and Human Services.
    2. A response from the TGA will be received in 48 hrs.

Applications require the relevant clinical evidence to support using a medicinal cannabis product for your patient’s medical condition. The application also requires information on a specific cannabis product (trade name, formulation, route of administration and dose).

More information on Special Access Schemes can be found on the TGA website: https://www.tga.gov.au/form/special-access-scheme

Doctors who have any questions about prescribing medical cannabis through the Special Access Scheme or Authorised Prescriber Scheme can ring the special TGA hotline:
TGA Medicinal Cannabis Hotline for GPs
Phone: 1800 020 653
Monday – Friday (9-5pm)
Email: medicinal.cannabis@health.gov.au

 

Authorised Prescriber Scheme

Doctors can apply to the TGA to become an Authorised Prescriber, which allows them to prescribe an unregistered medicine to a whole class of patients.
To become an Authorised Prescriber the medical practitioner must:

  • Have the training and expertise appropriate for the condition being treated and the proposed use of the product
  • Be able to best determine the needs of the patient
  • Be able to monitor the outcome of therapy


More information on how to become and Authorised Prescriber can be found on the TGA website: https://www.tga.gov.au/form/authorised-prescribers
The process involves:

  1. Applying to become an Authorised Prescriber (Authorised Prescriber form)
  2. Obtaining endorsement from an Ethics Committee in the form of a letter
  3. Determining state/territory regulatory requirements.
  4. One approval is obtained, the product can be prescribed and ordered through a pharmacy.

Note that this process also requires determining which specific medicinal cannabis product will be used.

The Office of Drug Control has a list of manufacturers and suppliers of medicinal cannabis products that may assist prescribers with medicinal cannabis product selection: https://www.odc.gov.au/manufacturers-and-suppliers-medicinal-cannabis-products

Information on Bod’s cananbis medicines can be found here.

 

Clinical trials

Doctors may also consider their patient’s eligibility for a clinical trial.

More information on clinical trials being conducted by Bod can be found here.

A list of all Australian medicinal cannabis clinical trials can be found here (Applied Cannabis Research).

Shared-care clinics

Some doctors choose to share the patient’s care (‘shared-care’) with a doctor that is experienced with prescribing medicinal cannabis. There are several shared-care clinics in Australia that specialise in prescribing medicinal cannabis. Click here for more information on shared care clinics.

 

Some useful resources

  1. Supporting clinical evidence for numerous conditions (pain management, neurology, oncology, psychology): https://bodpharmaceuticals.com/clinical-evidence-hcp/
  2. Information on our medicines: https://bodpharmaceuticals.com/medicines-hcp/
  3. Clinical resources (dosing guidelines, patient diaries, usage instructions, drug-drug interactions): https://bodpharmaceuticals.com/clinical-resources-hcp/ 
  4. A list of manufacturers and suppliers of medicinal cannabis products that may assist prescribers with medicinal cannabis product selection (Office of Drug Control): https://www.odc.gov.au/manufacturers-and-suppliers-medicinal-cannabis-products
  5. More detailed information on prescribing medicinal cannabis in Australia by NPS’ Australian Prescriber: https://www.nps.org.au/australian-prescriber/articles/prescribing-medicinal-cannabis
  6. NPS Medicinal cannabis: process for prescribers https://www.nps.org.au/assets/Medicinal-cannabis-process-for-prescribers.pdf