Articles and Case Studies

Prescribing Medicinal Cannabis

01 Jun 2017

John Vijayaraj 110x137

by Mr John Vijayaraj

medicinal cannabis

On 1 November 2016, following a decision by the Therapeutic Goods Administration (TGA), medicinal cannabis became a controlled drug (Schedule 8) in the Poisons Standard.

As a result, medicinal cannabis can be prescribed. However, the reality is that prescribing cannabis is no easy feat, and medical practitioners will need to be guided by legislative requirements at a state or territory and federal level.

[This article was last updated on 3 May 2018]

All states and territories have adopted the national scheduling changes. At a federal level, medical practitioners will need to obtain TGA approval before prescribing medicinal cannabis in addition to complying with the prescribing requirements of their state or territory.

Medical practitioners will have to present clinical evidence in support of their applications to prescribe medicinal cannabis. Queensland’s clinical guidelines shed some light on possible clinical indications for use that might be approved.1 These include drug-resistant epilepsy, symptom control in palliative care, symptoms associated with multiple sclerosis, chemotherapy-induced nausea, and vomiting and pain management.

Here is a step by step guide to apply for approval to prescribe medicinal cannabis.

Step 1: Determine your state or territory prescribing requirements

Medicinal cannabis – state and territory prescribing requirements

New South Wales

 

To prescribe medicinal cannabis, the medical practitioner must hold an authority issued by both the Secretary NSW Health to prescribe that product for that particular patient and the Secretary, Commonwealth Department of Health to import and/or supply that particular product under the Commonwealth’s Special Access Scheme, Authorised Prescriber Scheme or Clinical Trial Scheme.

Queensland

The pathways by which a medical practitioner may access medicinal cannabis to facilitate treatment include the following:

  • clinical trials – a medical practitioner can be an investigator on a clinical trial using a specific medicinal cannabis product
  • a single-patient prescriber, on a case-by-case basis – the medical specialist  applies to Queensland Health for approval to prescribe
  • a patient-class prescriber pathway is still being developed – a specific class of specialist medical practitioners authorised to prescribe a specified medicinal cannabis product.

In addition to the state pathways, TGA approval is required to authorise the supply of a specific medicinal cannabis product to be used for treatment. This is actioned through the Special Access Scheme (Category B) or the Authorised Prescriber Scheme administered by the TGA.

Victoria

If a medicinal cannabis product is registered on the Australian Register of Therapeutic Goods (ARTG), then it can be prescribed as per usual prescribing processes.

Irrespective of whether the medicinal cannabis product is registered with the ARTG or not, if the medicinal cannabis product is S8, then a Victorian S8 treatment permit is required.

If the medicinal cannabis product is not an approved product, then approval from the TGA is required (Special Access Scheme or Authorised Prescriber Scheme).

Australian Capital Territory

In order to prescribe cannabis as a controlled medicine, medical practitioners should obtain authority from the ACT Chief Health Officer (CHO) under the same process which currently applies for other controlled medicines, such as opiates and amphetamines. Only registered medical practitioners can apply for an authority to prescribe a controlled medicine for one of their patients.

Prescribers should also obtain approval from the TGA before applying to the CHO for authority to prescribe medicinal cannabis.

Northern Territory

A patient living in the Northern Territory must access medicines containing cannabinoids through a Northern Territory doctor who is authorised under the Special Access or Authorised Prescriber Schemes administered by the TGA.

Western Australia

The Schedule 8 Medicines Prescribing Code governs the prescribing of Schedule 8 medicines in WA.

To prescribe medicinal cannabis, a practitioner must apply to the WA Department of Health to become an approved prescriber. Prescribers authorised for cannabis-based products may prescribe without seeking individual authorisation as long as prescribing is in accordance with the Code.

Prescribing authorised within the Code includes:

  • products registered with the TGA
  • prescribing for the approved TGA indication (see below)
  • prescribing by a specialist in the relevant field.

South Australia

Authorised medical practitioners can legally prescribe medicinal cannabis products with Commonwealth approval. State approval is only required for treatment longer than two months, or before commencing treatment where the patient is already prescribed a Schedule 8 drug (for a period exceeding two months) and for any patient the medical practitioner reasonably believes to be drug dependent. A specialist medical practitioner may apply for approval to prescribe medicinal cannabis when the patient has tried conventional treatments and these have failed, and there is some clinical evidence that the benefits of using medicinal cannabis outweigh the risks.

Tasmania

The Controlled Access Scheme (CAS) will allow authorised medical specialists to prescribe medicinal cannabis products to their patients in certain circumstances. The CAS will impose conditions to ensure safety, including review of applications by a skilled panel of specialist medical practitioners.

Step 2: Apply for TGA approval

Australian registered medical practitioners can apply to the TGA to access cannabis products in the following ways:2

  • Access for individual patients – through either the Authorised Prescriber Scheme or Special Access Scheme (Part B)
  • Access as part of a clinical trial.

TGA approval is not required for category A patients through the Special Access Scheme (see our section on the Special Access Scheme below for further information).

Authorised Prescriber Scheme

To be 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; and
  • be able to monitor the outcome of therapy.

An Authorised Prescriber is allowed to supply the product directly to specified patients under their immediate care and not to other practitioners who prescribe or administer the product. Once a medical practitioner becomes an Authorised Prescriber, they do not need to notify the TGA when prescribing the unapproved product. However, they must report to the TGA the number of patients treated on a six-monthly basis.

Special Access Scheme (SAS)

The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case-by-case basis. Patients are grouped into two categories under the scheme:

  • Category A patients are defined as “persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment”.
  • Category B patients are all other patients who do not fit the Category A definition.

Medical practitioners can supply cannabis to Category A patients without the approval of the TGA as long as the medical practitioner notifies the TGA within 28 days of completing the Category A form. The TGA does not send out a letter of approval or acknowledgment. The medical practitioner completes the Category A form and sends it to the supplier of the product and a copy to the TGA. This provides the supplier with the legal authority to supply the product. Category A is a notification only.

TGA approval is required for Category B patients.

Clinical trial

The state or territory legislation and the TGA Act apply to clinical trials of medicinal cannabis. If you wish to conduct a clinical trial using medicinal cannabis:

  • make sure that medicinal cannabis is not a prohibited substance in your state or territory
  • obtain approval from a Human Research Ethical Committee
  • notify the TGA (clinical trial notification scheme) or apply for approval (clinical trial exemption scheme).

Step 3: Apply for a licence and permission to import, if necessary

Once an Australian registered medical practitioner has obtained approval (under the applicable state or territory laws) to prescribe a medicinal cannabis product to a particular patient, the medical practitioner can apply on the patient’s behalf for approval to import and supply these products through the SAS. Alternatively, the medical practitioner can apply to the TGA to become an Authorised Prescriber, and approval or authorisation is granted on a case-by-case basis.

Once approved, the medical practitioner wishing to import the product will then need to obtain import permits from the Office of Drug Control (ODC).

As a result of recent changes, patients can also access medicinal cannabis through the personal importation scheme. However, the personal importation of medicinal cannabis products is still subject to tight controls including import permit requirements from the ODC and applicable state and territory requirements. At present, the ODC is only providing permits to medical practitioners to import medicinal cannabis on behalf of patients through the personal importation scheme.

Step 4: Comply with conditions of approval or authorisation and ongoing regulatory requirements

Each state and territory has its own ongoing prescribing requirements. Members can contact our Medico-legal Advisory Service for further information regarding ongoing regulatory requirements.


Doctors can call the TGA on 1800 020 653 during weekdays, 9.00am–5.00pm (AEST), to speak to the TGA about access to medicinal cannabis including information about licensed suppliers.


John Vijayaraj
Medico-legal Adviser
MDA National


References

  1. Vijayaraj, John. Queensland Releases Australia’s First Medicinal Cannabis Guidelines.
  2. Medicinal Cannabis Products: Overview of Regulation. Available at: tga.gov.au/access-medicinal-cannabis-products-1
Clinical, Anaesthesia, Dermatology, Emergency Medicine, General Practice, Intensive Care Medicine, Obstetrics and Gynaecology, Ophthalmology, Pathology, Psychiatry, Radiology, Sports Medicine, Surgery, Physician, Geriatric Medicine, Cardiology, Plastic And Reconstructive Surgery, Radiation Oncology, Paediatrics, Independent Medical Assessor - IME
 

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