Key messages

  • Any registered medical practitioner in Victoria can prescribe medicinal cannabis to any patient with any condition, if they believe it is clinically appropriate and have obtained the required approvals.
  • Medicinal cannabis products are classified as either Schedule 8 or Schedule 4 controlled substances, and in most cases are not listed on the ARTG.
  • Depending on the product being prescribed, approvals may be required from the Commonwealth and/or Victorian government prior to prescribing.

Overview

In Victoria, any registered medical practitioner is able to prescribe medicinal cannabis for any patient with any condition, if they believe it is clinically appropriate and have obtained the required Commonwealth and/or state approvals.

Prescribing medicinal cannabis follows the same process as for all other pharmaceutical medicines, with requirements dependent on 1) whether the product is registered on the Australian Register of Therapeutic Goods (ARTG), and 2) the Schedule of the product on the Australian Poisons Standard.

All products not registered on the ARTG require approval from the Therapeutic Goods Administration (TGA) to be prescribed. This approval can be obtained through the TGA's Special Access Scheme, or by becoming an Authorised Prescriber.

Irrespective of registration on the ARTG, most medicinal cannabis products (other than pure cannabidiol (CBD) will require a Victorian Schedule 8 treatment permit. Exemptions from the requirement for treatment permits exist if the patient is in hospital, an aged care service or prison, or the indication for treatment is palliative care.

Victorian (Schedule 8) and Commonwealth (TGA) approvals required to prescribe Schedule 8 medicinal cannabis products not listed on the ARTG can now be sought together via the TGA's single online application.

The above access pathways can be used by any medical practitioner, however the TGA may require evidence of specialist support for the proposed treatment.

Who can prescribe medicinal cannabis?

In Victoria, any medical practitioner can prescribe a medicinal cannabis product for their patient, if they believe it is clinically appropriate to do so. Medical practitioners do not need to gain accreditation, nor be specialists in a particular field.

Clinical evidence

Currently, the scientific literature supporting the use of medicinal cannabis to treat a range of conditions is limited, but there is some evidence suggesting it has potential beneficial effects. The role of medicinal cannabis in clinical settings will become clearer as additional research is published and the evidence base expands.

Recognising that many doctors know very little about medicinal cannabis, the Commonwealth, together with Victoria and other States, developed a series of clinical guidance documents to assist doctors and patients to understand the potential uses for medicinal cannabis.

These documents provide information on the available evidence and guidance on how to prescribe medicinal cannabis. Patients and doctors can use these documents to guide decisions on whether medicinal cannabis is appropriate for their condition.

These documents can be accessed via the TGA website.

For additional resources to assist prescribers in determining whether medicinal cannabis may be appropriate for their patient, visit the Office of Medicinal Cannabis data and resources section containing various clinical guidance documents and evidence reviews, and quarterly research updates.

Choosing a medicinal cannabis product

Product types

Medicinal cannabis refers to quality-assured pharmaceutical products that use the cannabis plant or chemicals contained within it to treat medical conditions, and are only available via prescription. There are over 100 cannabinoids in the cannabis plant. The two main cannabinoids that have been studied for potential therapeutic effects are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). As a result, medicinal cannabis products available in Australia tend to contain mostly THC, mostly CBD or a combination of both in their formulations. Some products also contain other chemical components from the cannabis plant including additional cannabinoids, terpenes and flavonoids.

Different cannabinoids or combinations of cannabinoids can have different therapeutic effects, as well as different side effects. Before deciding which medicinal cannabis product to prescribe, available clinical evidence should be reviewed to determine the product composition most likely to produce positive outcomes for the patient.

In addition to cannabinoid content, medicinal cannabis products vary in formulation (oils, tinctures, plant material, topical gels, etc.) and  routes of administration (inhalation, ingestion, etc.).

Medicinal cannabis does not include the recreational use of cannabis, which remains illegal in Victoria.

Scheduling

THC is classified as a Schedule 8 drug under the Australian Poisons Standard. Because most medicinal cannabis products contain varying amounts of THC, they are then classified as Schedule 8 products, and are controlled drugs in Victoria.

However, pure CBD preparations, containing two per cent or less of any other cannabinoids (including. THC) are classified as Schedule 4 prescription only medicines. The CBD content of Schedule 4 medicinal cannabis products must be 98 per cent of the total cannabinoid content (e.g. A CBD to 'other cannabinoid' ratio of 49:1).

Examples of medicinal cannabis products

Preparation Cannabinoid Composition Schedule
Oil capsule CBD10mg,
0mg other cannabinoids
Schedule 4
Plant material (floss) THC 18.3%-27.2% Schedule 8
Oral spray 2.7 mg THC and 2.5 mg CBD per 100 microlitre spray. Schedule 8

In Victoria, doctors need approval from the Department of Health and Human Services (DHHS) to prescribe Schedule 8 drugs. For Schedule 8 medicinal cannabis products, in most cases Victorian prescribers will need to first gain a Schedule 8 treatment permit. However, some exceptions apply (patients in hospitals, aged care facilities, prisons, or receiving palliative care).

Available products

The majority of medicinal cannabis products available in Australia have been imported from overseas, but more locally made products are expected to become available as the Australian medicinal cannabis industry becomes more established.

The Office of Drug Control (ODC) publishes an updated list of Australian importers and manufacturers of medicinal cannabis products on its website, which may assist in identifying products currently available in Australia. The suppliers of these products may be contacted directly for information relating to product composition and cost, and may have this information available on their website. Please note that this list is subject to change.

It is also possible to prescribe a medicinal cannabis product not already available in Australia, however, appropriate import permits issued by the ODC will also be required.

Only one medicinal cannabis product has been fully assessed for safety, quality and effectiveness and is registered on the ARTG. All other cannabis medicines are experimental. Information about their safety profile is not readily available. This includes appropriate formulations and dosing, possible side effects and how particular products may interact with other medicines a patient is receiving.

As with any medicine, before prescribing a medicinal cannabis product a medical practitioner will need to review and understand relevant and available product information to determine its appropriateness.

How to prescribe

Medicinal cannabis products generally require approval from the Commonwealth TGA and/or the Victorian DHHS before they can be prescribed. As described above, the types of approvals required will depend on how the product is scheduled, and whether it is listed on the ARTG.

If you are aware of what approvals you require, medical practitioners can now apply for both TGA Special Access Scheme approval and a Victorian Schedule 8 treatment permit using the TGA's single online application.

To apply for the necessary approvals, click on the button below that best describes the medicinal cannabis product you intend to prescribe.

A Schedule 8 or Schedule 4 medicinal cannabis product NOT registered on the ARTG

A Schedule 8 medicinal cannabis product registered on the ARTG, such as nabiximols (Sativex)

If you are unsure of what approvals you require, the following sections provide further information to assist you in determining the requirements for the medicinal cannabis product you are seeking to prescribe.

Unapproved medicinal cannabis products

Most medicinal cannabis products have not been assessed for safety and efficacy by the TGA and are not registered on the ARTG.

As with all unapproved medicines, to prescribe an unapproved medicinal cannabis product the prescriber will first need to gain approval from the Commonwealth TGA either through the Special Access Scheme or Authorised Prescriber Scheme.

Special Access Scheme

A medical practitioner can apply to prescribe an unapproved medicinal cannabis product to a single patient through the Special Access Scheme Category B (SAS B). In the application, the prescribing medical practitioner will need to provide information about:

  • The patient and their condition
  • Why it is clinically appropriate to prescribe an unapproved product
  • How the patient will be monitored for adverse events and their response to treatment

More information about the SAS B application process can be found on the TGA's website.

A doctor may also apply for SAS Category A approval to prescribe imported unapproved medicinal cannabis products, although they (or the dispensing pharmacist) will need to hold an import licence from the Commonwealth Office of Drug Control (ODC) and apply for import permission for each patient. More information on gaining an import licence can be found on the ODC's website.

Authorised Prescriber Scheme

If a doctor intends to prescribe the same medicinal cannabis product to a group of patients with the same condition (e.g. a purified CBD product for children with epilepsy), then they may apply to the TGA to become an Authorised Prescriber of that product.

Once a medical practitioner becomes an Authorised Prescriber, this means they do not need to notify the TGA each time they prescribe the cannabis product they are authorised to prescribe. Instead, they must report to the TGA the number of patients treated every 6 months.

To download the application form or to learn more about the Authorised Prescriber Scheme, visit the TGA's website.

Registered medicinal cannabis products

No Commonwealth approvals are required in order to prescribe medicinal cannabis products registered on the ARTG.

There is currently only one medicinal cannabis product, Nabiximols (Sativex®), listed on the ARTG as a schedule 8 controlled drug

The approved indication for Nabiximols (Sativex®) is:

'Treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.'

However, a Schedule 8 Treatment permit is required in order to prescribe Nabiximols (Sativex®) in Victoria.

Schedule 8 treatment permits

Irrespective of whether the medicinal cannabis product is registered on the ARTG or not, if the medicinal cannabis product is a Schedule 8 controlled drug then a Victorian Schedule 8 treatment permit is required, unless an exemption applies.

Exemptions to the Schedule 8 requirement exist for patients in the following circumstances:

  • Patients receiving palliative care.
    • To meet this exemption, the patient must be suffering an incurable, progressive, far-advanced disease with a prognosis of limited life expectancy; and the prescribing of the Schedule 8 poison is intended to provide palliative treatment.
  • Patients receiving inpatient treatment in a hospital
  • Patients receiving treatment in a hospital emergency department or a day procedure centre
  • Residents in aged care facilities
  • Patients in prison or police gaol.

No Victorian permit/approvals are required if a prescriber is seeking to prescribe a Schedule 4 medicinal cannabis product.

For Schedule 8 medicinal cannabis products that are registered on the ARTG (e.g. Sativex), DHHS requires the prescriber to sign a declaration if they will be prescribing the product for an 'off-label' condition before a treatment permit can be issued.

Departmental policy regarding the issuing of Schedule 8 treatment permits requires that, before the' application can be processed, applicants are required to sign and return a declaration acknowledging that they will be prescribing the product for an 'off-label' condition.

For unapproved products, the Victorian permit cannot be finalised until the prescriber has obtained the necessary Commonwealth approval. However, applications for both TGA Special Access Scheme approval and a Victorian Schedule 8 treatment permit can now be made concurrently using the TGA's single online application.

Summary of approvals required before prescribing a medicinal cannabis product

Product type Commonwealth approval (SAS or AP scheme) Victorian approval (S8 permit)
Unapproved S8 medicinal cannabis product
Registered S8 medicinal cannabis product
Unapproved S4 medicinal cannabis product
Registered S4 medicinal cannabis product (not yet available)

Cautionary advice

Adverse effects

Like all prescription drugs, medicinal cannabis can cause unwanted side effects, such as difficulty concentrating, dizziness, drowsiness, loss of balance and nausea, among others. The extent of these side effects can vary between individuals and be affected by the type of medicinal cannabis product being prescribed. In general, the side effects of high-CBD products are less than those for high-THC products.

More information on adverse effects and potential drug interactions can be found on the TGA's website.

Driving

THC is known to have impairing effects. As such, patients should be advised not to drive or operate machinery while being treated with medicinal cannabis products containing THC.

Furthermore, patients should be advised that driving with any detectable amount of THC in their system is a criminal offence in Victoria, even if a person has been prescribed a legal medicinal cannabis product. THC may be detected in saliva up to a number of days after administration.

Drug interactions

There is little evidence to provide clinical guidance on drug-drug interactions for cannabinoids. If cannabinoids are to be used in conjunction with other adjunctive therapies, clinicians and patients should be aware of common adverse events associated with cannabinoid use and consider whether these events are likely to interfere with quality of life beyond any therapeutic effects produced by the cannabinoid.

Dispensing

Once a medical practitioner has received the required approvals, they may issue a prescription for their patient. The patient may then take this prescription to any pharmacy to have their medicinal cannabis dispensed.

There are no additional requirements under Victorian law that a pharmacy must follow in order to dispense a medicinal cannabis product, aside from those that apply to all Schedule 4 or Schedule 8 drugs.

Once a prescription has been issued, the pharmacy will need to contact the supplier to organise supply of the product. Within an institution such as a hospital, supply may be arranged through the pharmacy department.

For unapproved medicinal cannabis products, the supplier will need to receive evidence confirming TGA approval, either through the SAS or Authorised Prescriber scheme, before they can release the product.

For products not available in Australia through a local supplier, the prescriber will need to hold a valid import permit (issued by the ODC) before importing the product from an overseas source. More information on importing medicinal cannabis can be found on the ODC's website.

It is illegal for a pharmacist to hold stock of any unapproved medicine which has not been authorised for supply to a patient. It is also illegal to advertise or promote any Schedule 8 or Schedule 4 medicine to the public, medical practitioners or anyone else.

* From April 2020, it will be mandatory for doctors and pharmacists to check SafeScript when writing or dispensing a prescription for schedule 8 medicines and certain schedule 4 medicines, including some medicinal cannabis products.