Frequently asked questions on medicinal cannabis

What is cannabis?

The term cannabis is widely used to refer to any plant in the genus Cannabis including dried flowers and leaves (marijuana), seeds, extracts and resins. Between 60 and 100 chemicals called cannabinoids and some 300 non-cannabinoid chemicals are produced by the cannabis plant.

Delta-9 tetrahydrocannabinol (THC) is the main cannabinoid responsible for the ‘high’ and psychoactive effects produced by cannabis, and the reason for recreational use as an illicit drug.

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What is medicinal cannabis?

The main cannabinoids studied and currently thought to be the most important for medical use are THC and cannabidiol (CBD). Many other cannabinoids exist and a number are being researched for possible medical use.

The term ‘medicinal cannabis products’ covers a range of approved, quality assured cannabis preparations intended for human therapeutic use, including pharmaceutical cannabis preparations such as tablets, oils, tinctures and other extracts.

Crude cannabis is difficult for doctors to prescribe because the specific components (chemicals known as cannabinoids), the dose and potency in each plant is not tested or known.

Pharmaceutical preparations of cannabis contain specific active components in known amounts and mixtures, which optimise the therapeutic benefit and minimise side effects. The dose and strength of the preparation can be controlled and standardised, making it safer for patients to use.

The Commonwealth Department of Health regulates medicinal cannabis products through the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).

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What are the benefits of medicinal cannabis?

There is little high quality research on the benefits of medicinal cannabis and the clinical evidence for its role is still under discussion and being investigated.

Medicinal cannabis preparations have been used with some reported success to relieve symptoms in some specific conditions, such as reducing spasticity and muscle pain in people with multiple sclerosis.

There is also some evidence that medicinal cannabis may be useful in treating seizures, nausea and vomiting due to chemotherapy, and also as an appetite stimulant for people living with human immunodeficiency virus (HIV) infection or cancer.

The Commonwealth TGA has published guidance materials for doctors to support them in determining whether prescribing medicinal cannabis is appropriate and beneficial.Refer to the TGA for information.

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What are the side effects of medicinal cannabis?

It is important that medicinal cannabis is only used under medical supervision because it may interact with other medicines a patient is taking or cause adverse reactions.

The known side-effects from medicinal cannabis treatment (both CBD and THC) include fatigue and sedation, vertigo, nausea and vomiting, fever, decreased or increased appetite, dry mouth, and diarrhoea.

THC (and products high in THC) have been associated with feeling high or feeling dissatisfied, depression, confusion, hallucinations, paranoid delusions, psychosis, and cognitive distortion (having thoughts that are not true).

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What is the current legal status of medicinal cannabis?

Amendments to the Narcotics Drugs Act 1967 to allow the controlled cultivation of cannabis for medicinal or scientific purposes under a national licensing scheme came into operation on 30 October 2016. The Commonwealth Government is responsible for issuing licences and permits under this scheme.

These amendments do not legalise the growing or use of cannabis for non-medical purposes nor do they legalise the cultivation of cannabis or its use outside of regulated medicinal purposes. They also do not make cannabis products available over the counter without a prescription from an authorised specialist medical practitioner.

Commonwealth scheduling changes to medicinal cannabis in effect from 1 November 2016, mean certain cannabis products are Schedule 8 medicines (controlled drugs) when used for medicinal purposes, in accordance with the Narcotics Drugs Act 1967 and the Therapeutic Goods Act 1989. These medicinal cannabis products are prescription only medicines in the same schedule as medicines such as morphine and oxycodone.

South Australia adopts the Commonwealth scheduling and from 1 November 2016, medical practitioners in South Australia can legally prescribe medicinal cannabis products with Commonwealth approval and relevant State approval for purposes of South Australian Controlled Substances legislation.

The State Government released a patient access pathway to clarify access in South Australia.

Medicinal cannabis is lawful when the cultivation, manufacture, prescribing, and supply complies with all applicable Commonwealth and State laws.

All other types of cannabis remain prohibited.

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What about cannabidiol?

One cannabis derivative, cannabidiol (also known as CBD), in products for therapeutic use containing 2% or less of other cannabinoids found in cannabis, is a Schedule 4 medicine. The total cannabinoids in the product must be at least 98% cannabidiol to be in Schedule 4.

There are no registered cannabidiol medicines in Australia. Supply of unregistered 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.

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Does legislation that deals with medicinal cannabis mean that it is now legal to smoke cannabis?

No, cannabis remains a highly regulated drug in Australia and its use and supply is controlled by a number of Commonwealth, State and Territory laws. Patients will not be able to access medicinal cannabis products for smoking.

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Do the legislative changes mean I can now grow my own medicinal cannabis legally?

No, people cannot legally grow their own cannabis for medicinal use; even it has been prescribed for them by an authorised medical practitioner.

Throughout Australia, it remains illegal to cultivate cannabis or manufacture cannabis products. The only exception will be where cultivation and manufacture is done under a licence and a permit granted under the Commonwealth licensing scheme for medicinal use.

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Who can prescribe medicinal cannabis?

The conditions for which medicinal cannabis might be considered will likely be complex medical conditions and as such, prescribing of medicinal cannabis is restricted in South Australia to specialist medical practitioners with expertise in the management of the disease being treated. In certain circumstances, authority may be granted to a general practitioner where written support for treatment is provided by the patient’s treating specialist.

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What approvals or notifications are required to prescribe medicinal cannabis?

To prescribe or supply an unregistered medicinal cannabis product requires Commonwealth approval or notification under the applicable Commonwealth schemes. These are the TGA Special Access Scheme, Authorised Prescriber Scheme or Clinical Trials Schemes.

Approval under South Australian Controlled Substances legislation is also required to prescribe a Schedule 8 medicinal cannabis product where it is being prescribed for longer than 2 months, or to patient 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.

Exemptions apply in South Australia for patients aged over 70 years of age, and terminally ill patients whose doctors have notified the Drugs of Dependence Unit (Notified Palliative Care Patients).

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How will patients obtain medicinal cannabis products?

How patients are supplied medicinal cannabis on prescription depends on the Commonwealth pathway for approval that the medical practitioner chooses.

Supply of medicinal cannabis products under the TGA Special Access Scheme

Category B (SAS B), TGA Authorised Prescriber Scheme or Clinical Trials Schemes

The Commonwealth Office of Drug Control has licensed certain sponsors/importers

Under their interim sponsored import policy to hold medicinal cannabis stock in

Australia for timely supply to patients on prescription under the TGA’s Special Access

Scheme (Category B only), Authorised Prescriber Scheme and Clinical Trials Scheme. It is envisaged that these imports will provide a temporary solution to improve the timeliness of supply while the domestic cultivation and manufacture scheme comes into effect.

Medicinal cannabis products for therapeutic use that meet Therapeutic Goods Administration (TGA) standards can be supplied on prescription in South Australia when prescribed by a medical practitioner with the required approvals or notifications, and dispensed by a pharmacist.

Medicinal cannabis products will not be available over the counter and patients will not be able to access medicinal cannabis products for smoking or for recreational use.

Medicinal cannabis products cultivated and manufactured under the national licensing scheme will soon be available however currently there is no medicinal cannabis product lawfully manufactured in Australia. Some products lawfully made overseas may be approved for import. For more information about medicinal cannabis products refer to the Medicinal Cannabis Products fact sheet (PDF 421KB).

Information on products is also available from the TGA - Phone 1800 220 007.

Supply of medicinal cannabis products under the TGA Special Access Scheme Category A (SAS A)

Medical practitioners can prescribe medicinal cannabis products to very seriously ill patients without the approval of the TGA as long as the medical practitioner notifies the TGA under the conditions of SAS A. State approval may also be required to prescribe Schedule 8 medicinal cannabis products.

Only products imported for individual patient use can be supplied under SAS A. The doctor or pharmacist must apply for import permission to import a product for supply to the particular patient from the Commonwealth Office of Drug Control. Approval from the exporting country may also be required.

Medicinal cannabis products available in Australia under the Commonwealth’s interim sponsored import policy cannot be supplied under SAS A.

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What is the Government of South Australia doing?

The South Australian Government is committed to ensuring South Australian consumers have access to the optimal range of safe and effective treatments and services to promote the best health outcomes for patients and the community.South Australia is contributing to a national approach that is based on evidence and clinical assessment.

South Australia adopts the Commonwealth scheduling and since 1 November 2016, medical practitioners in South Australia can legally prescribe medicinal cannabis products with the required Commonwealth and State approvals.

A consultation process was undertaken with medical practitioners and key interested parties to develop the details of an access pathway in South Australia that is evidence‑based and gives patients safe and legal access to high quality medicinal cannabis products.

The State Government has released a patient access pathway to clarify access.

The Government of South Australia does not have a role in issuing licences or permits for the cultivation of medicinal cannabis.

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Will medicinal cannabis products be subsidised under the Commonwealth Government’s Pharmaceutical Benefits Scheme?

Medicinal cannabis products are not currently subsidised under the Pharmaceutical Benefits Scheme (PBS).Medicines must be registered products, listed on the Australian Register of Therapeutic Goods (ARTG) before they can be considered for PBS subsidy.

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Where can I find more information about access to medicinal cannabis?

For more information about the Commonwealth licensing scheme for licences and permits, visit the Office of Drug Control website.

For more information about access to medicinal cannabis products and Commonwealth approval necessary to prescribe unregistered medicinal cannabis products, visit the Therapeutic Goods Administration website.

To apply for an authority to prescribe medicinal cannabis in South Australia, medical practitioners can complete the application form. For more information about requirements under the South Australian Controlled Substances legislation, contact the Drugs of
Dependence Unit on 1300 652 584.

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Is there a list of doctors who can prescribe medicinal cannabis?

Australia doctors are not allowed to advertise to the public that they are able to prescribe a particular medicine. This is related to the Therapeutic Goods legislation, and to the standards upheld by the Australian Health Practitioner Regulation Agency and the Medical Board of Australia and goes to matters of medical ethics and good medical practice. Furthermore, for privacy reasons we do not publish or provide the names of doctors who prescribe medicinal cannabis products.

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Can I drive while being treated with medicinal cannabis?

Patients should not drive or operate machinery while being treated with medicinal cannabis. In addition measurable concentrations of THC (tetrahydrocannabinol – the main psychoactive substance in cannabis) can be detected in urine many days after the last dose. It may take up to five days for 80 to 90 per cent of the dose to be excreted. Drug-driving is a criminal offence, and patients should discuss the implications for safe and legal driving with their doctor.

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Can I import a product over the internet or by post?

Personal import of medicinal cannabis products is not permitted other than through the traveller’s exemption process.Please refer to the TGA for information.

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