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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.

To consider whether medicinal cannabis is an appropriate treatment option, a specialist medical practitioner, in discussion with their patient, considers the clinical information and evidence for medicinal cannabis in the condition to be treated.

Importantly, medical practitioners must notify or apply for approval to the Commonwealth Department of Health (PDF 201KB) to supply and where necessary import, an unregistered medicinal cannabis product.

About the patient access pathway

A patient access pathway (PDF 153KB) for medicinal cannabis has been developed following consultation with stakeholders, including medical professionals, health practitioner organisations, consumers and health consumer groups, and industry.Under the pathway, patients in South Australia can be supplied medicinal cannabis products prescribed by their medical specialist and dispensed by a pharmacist.

Existing South Australian Controlled Substances legislation that regulates the prescribing and supply of Schedule 8 medicines in South Australia applies to Schedule 8 medicinal cannabis drugs.

A section 18A authority is only required for treatment longer than 2 months, or before commencing treatment where the person is already prescribed a Schedule 8 drug (for a period exceeding 2 months) and for any person the medical practitioner reasonably believes to be dependent on drugs.

A specialist medical practitioner is recognised by AHPRA as a specialist in the management of the disease being treated.

Exemptions

A section 18A authority is not required for patients:

  • aged 70 years or older
  • who are Notified Palliative Care Patients
  • who are not drug dependent, for regular use for a period of less than 2 months.

Applications for authority to prescribe Schedule 8 medicinal cannabis products may be referred to an expert clinical panel within SA Health for advice on a case by case basis.

One cannabis derivative, cannabidiol in preparations for therapeutic use containing 2% or less of other cannabinoids found in cannabis, is a Schedule 4 medicine. This means the total cannabinoids in the product must be at least 98% cannabidiol to be in Schedule 4. 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.

Approval to prescribe

To apply for approval to prescribe a Schedule 8 medicinal cannabis drug or to discuss authority requirements and exemptions in South Australia contact:

Drugs of Dependence Unit

Phone: 1300 652 584
Fax: 1300 658 447
Email: HealthDrugsofDependenceUnit@sa.gov.au

Therapeutic Goods Administration (TGA)

Phone: 1800 020 653
Email: info@tga.gov.au

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 (PDF 168KB) for use of cannabis and derivatives in severe chronic conditions unresponsive to existing treatments, however further research and development 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 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 look at the following areas:

  • 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:

Medicinal cannabis products

Cannabis for medical use is regulated as a medicine in Australia. Medicinal cannabis products, with the exception of Sativex®, are not included on the Australian Register of Therapeutic Goods (ARTG) which means they have not been subject to the same standards of safety and efficacy that apply to other prescription medicines in Australia. Unregistered medicines, including unregistered medicinal cannabis products can be legally imported on authorisation from the Therapeutic Goods Administration (TGA) and Office of Drug Control (ODC).

The ODC website lists licensed importers who may import medicinal cannabis products Several of these licensed importers have medicinal cannabis products available in Australia for supply where doctors have obtained approval to prescribe a product for their patient under the Special Access Scheme (Category B) or the Authorised Prescriber Scheme.

Additional industry sponsored websites provide information about medicinal cannabis products, pricing and availability.  These include cannabisaccess.com.au and mcmp.com.au.

Cannabidiol (CBD)

One cannabis derivative, cannabidiol in preparations for therapeutic use containing 2% or less of other cannabinoids found in cannabis, is a Schedule 4 medicine. To be considered a Schedule 4 medicine, the total cannabinoids in the product must be at least 98% cannabidiol.. Products that contain both CBD and THC will likely be Schedule 8 controlled drugs.

Cannabidiol products are currently unregistered therapeutic goods in Australia and require Commonwealth approval or notification (for example, approval under Special Access Scheme B).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

To apply for approval to prescribe a Schedule 8 medicinal cannabis product or to discuss authority requirements and exemptions in South Australia contact:

Drugs of Dependence Unit
Phone:  1300 652 584
Fax: 1300 658 447
Email: HealthDrugsofDependenceUnit@sa.gov.au

Therapeutic Goods Administration (TGA)
Phone: 1800 020 653
Email: info@tga.gov.au

More information

For more information about the patient access pathway to medicinal cannabis in South Australia:

Medicines and Technology Programs
Department of Health and Ageing
Email: medicinal.cannabis@sa.gov.au
Phone: (08) 8226 6169

For information about industry development support in South Australia:

Office of Industrial Hemp and Medicinal Cannabis
Email: officeihmc@sa.gov.au
Phone: (08) 8463 5630

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