Medicinal cannabis

                               Medicinal cannabis, Patient access in South Australia

SA Health is committed to ensuring South Australian consumers have access to the optimal range of treatments and services to promote the best health outcomes for patients and the community.

Patients in South Australia can access medicinal cannabis medicines as a result of federal legislative changes which came into effect in November 2016 and the development of a patient access pathway.

Under the pathway, patients in South Australia can access medicinal cannabis on prescription from their authorised medical practitioner and dispense by a pharmacist.

The decision to consider medicinal cannabis as a treatment option is a matter for discussion between a medical practitioner and their patient, enabling consideration of the patient’s clinical information and the safety and efficacy of medicinal cannabis in the particular condition to be treated.

Importantly, medical practitioners must notify or apply for approval to the Commonwealth TGA to prescribe an unregistered medicinal cannabis product.

                                                   About the patient access pathway

A patient access pathway for medicinal cannabis (PDF 153KB) (opens in a new window) was developed following consultation with stakeholders, including medical professionals, health practitioner organisations, consumers and health consumer groups, and industry.  Under the pathway, legal requirements to prescribe medicinal cannabis products are aligned with those of other similarly scheduled medicines.  Both South Australian and Commonwealth requirements are addressed in the pathway.

                                               Legal requirements in SA

The South Australian Controlled Substances Act 1984 (opens in a new window) regulates the prescribing and supply of medicines in South Australia and applies to medicinal cannabis products.

A section 18A authority to prescribe a medicinal cannabis product that is a Schedule 8 controlled drug (drug of dependence) is required:

after 2 months of treatment or before commencing treatment where the person has  already been prescribed a Schedule 8 drug for a period exceeding 2 months
 before commencing treatment for any person the medical practitioner reasonably believes to be dependent on drugs.
Exemptions
A section 18A authority is not required for patients:

Patients aged 70 years or older
Notified Palliative Care Patients  (notification must be made to the Drugs of Dependence Unit)
Clinical evidence and guidance for health professionals and consumers
The medicinal use of cannabis in clinical treatment is subject to ongoing discussion and investigation by health professionals.  There is some clinical evidence for use of cannabis and derivatives in severe chronic conditions unresponsive to existing treatments, however, further research is progressing into the safety and efficacy of medicinal cannabis products, and to establish their role in clinical use.

The TGA has published guidance documents (opens in a new window) for health professionals and consumers to provide advice and further explanation about the evidence for use of medicinal cannabis products. A series of systematic reviews by the National Drug and Alcohol Research Centre informed the evidence-based guidance documents which assess the evidence for use in the following conditions:

Paediatric and adult epilepsies
Multiple sclerosis
Nausea and vomiting, resulting from chemotherapy and HIV/AIDS therapy
Various types of pain
Palliative care
The TGA has also published overarching guidance documents on the use of medicinal cannabis in Australia, for health professionals and consumers:

Guidance for the use of medicinal cannabis in Australia – Patient information (opens in a new window)
Guidance for the use of medicinal cannabis in Australia - Overview (opens in a new window)
Medicinal cannabis products: Patient information (opens in a new window)
Medicinal cannabis products
Medicinal cannabis products, with the exception of Sativex® ( nabiximols), are not included on the Australian Register of Therapeutic Goods (opens in a new window) (ARTG). This means they have not been subject to the same standards of safety and efficacy that apply to other prescription medicines in Australia. Unapproved therapeutic goods, including unregistered medicinal cannabis products, can be legally imported on authorisation from the Therapeutic Goods Administration (opens in a new window) (TGA) and Office of Drug Control (opens in a new window) (ODC). 

The ODC website lists licensed importers and suppliers who may supply medicinal cannabis products to pharmacies where doctors have obtained the necessary approval to prescribe the product for their patient.

Additional industry-sponsored websites to provide information about medicinal cannabis products, pricing and availability.  These include Cannabis Access Clinics and MCMP.

                                                  Cannabidiol (CBD)

One cannabis derivative, cannabidiol (in preparations for therapeutic use where cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation) is considered a Schedule 4 drug; the preparation must comply with the Poisons Standard (opens in a new window).

Cannabidiol products are currently unapproved (unregistered) therapeutic goods in Australia and require Commonwealth approval or notification (for example, approval under Special Access Scheme B) to prescribe. Supply of Schedule 4 cannabidiol medicines requires a prescription from a medical practitioner, and Commonwealth approval or notification.

An authority for purposes of South Australian Controlled Substances legislation is not required to prescribe Schedule 4 cannabidiol medicines.

Applying for approval to prescribe a medicinal cannabis product


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