Frequently asked questions
Frequently Asked Questions about safe patient access to medicinal cannabis 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 dispensed 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.
Note, there is not a restricted list of medical conditions for which medicinal cannabis may be prescribed in South Australia.
Consistent with the requirements for Schedule 4 medicines in South Australia, there is no requirement for a medical practitioner to obtain State approval to prescribe a Schedule 4 cannabidiol (CBD) medicine.
A patient access pathway for medicinal cannabis (PDF 153KB) 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.
The South Australian Controlled Substances Act 1984 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:
A section 18A authority is not required for patients:
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 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:
The TGA has also published overarching guidance documents on the use of medicinal cannabis in Australia, for health professionals and consumers:
The Australian Centre for Cannabinoid Clinical and Research Excellence has also published a suite of six Prescribing Guidance documents to provide information to support medical practitioners in prescribing cannabis medicines.
NPS MedicineWise worked with the TGA, health professionals, member organisations and research and consumer organisations to gather the most up-to-date evidence for the use of medicinal cannabis in Australia. NPS has produced information and resources for both consumers and health professionals, including summaries on the latest evidence for medicinal cannabis and information to help explain the regulatory framework and process required to access medicinal cannabis.
To find out more go to www.nps.org.au/medicinal-cannabis
Medicinal cannabis products, with the exception of Sativex® (nabiximols), are not included on the Australian Register of Therapeutic Goods (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 (TGA) and Office of Drug Control (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.
One cannabis derivative, cannabidiol (in preparations for therapeutic use where cannabidiol comprises 98 per cent or more of the total cannabinioid content of the preparation) is considered a Schedule 4 drug; the preparation must comply with the Poisons Standard.
Cannabidiol products are currently unapproved (unregistered) therapeutic goods in Australia, with the exception of Epidyolex® (cannabidiol oral solution), 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 for unregistered products.
An authority for purposes of South Australian Controlled Substances legislation is not required to prescribe Schedule 4 cannabidiol medicines.
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