Medicinal cannabis information for health professionals

Overview

In Victoria, any registered medical practitioner or nurse practitioner can prescribe medicinal cannabis for any patient with any condition, if they believe it is clinically appropriate and have obtained any 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 Commonwealth Therapeutic Goods Administration (TGA) to be prescribed. This approval can be obtained through either the TGA's Special Access Scheme, or by becoming an Authorised Prescriber. To assist prescribers, a list of available unapproved medicinal cannabis products has been published on the TGA’s website.

Irrespective of registration on the ARTG, medicinal cannabis products containing over 2 per-cent tetrahydrocannabinol (THC) are Schedule 8 drugs of dependence. Prescribers are required to apply for and hold a Victorian Schedule 8 treatment permit when prescribing a Schedule 8 medicinal cannabis product to a patient with a history of drug-dependence. For non-drug dependent patients, no Victorian treatment permit is required.

Victorian (Schedule 8) and Commonwealth (TGA) approvals can now be sought together via the TGA's single online application.

Prescribers and pharmacists are also required to check SafeScript, Victoria’s real-time prescription monitoring system, prior to prescribing and dispensing Schedule 8 medicinal cannabis products to any patient.

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. Nurse practitioners are also able to prescribe both Schedule 4 and Schedule 8 medicinal cannabis products, if doing so is within their scope of practice.

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 to support its use for patients suffering from chronic or terminal illnesses who don’t get relief from other medicines. Currently, most research and evidence on medicinal cannabis products have come from five clinical conditions – multiple sclerosis, palliative care, epilepsy, nausea and vomiting, and chronic non-cancer pain.

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.

Additional resources to assist prescribers in determining whether medicinal cannabis may be appropriate for their patient can be found in the data and resources section.

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.). Smoking medicinal cannabis should not be supported as it is difficult to estimate dosage, and due to the well-documented evidence that smoking in general is harmful.

Medicinal cannabis does not include the recreational or self-described medical use of cannabis without a prescription, both of which remain 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

In Victoria, doctors need approval from the Department of Health to prescribe Schedule 8 medicinal cannabis products to patients with a history of drug-dependence. Prescribers and pharmacists are also required to check SafeScript prior to prescribing and dispensing Schedule 8 medicinal cannabis products to any patient.

How to prescribe

Medicinal cannabis products generally require approval from the Commonwealth TGA and, in some circumstances, the Victorian Department of Health before they can be prescribed. What approvals are 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 and nurse 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.

If the product you are seeking to prescribe is a Schedule 4 cannabidiol (CBD) product that has been entered on the ARTG, no approvals are required prior to issuing a prescription.

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.

The TGA now accepts applications to prescribe medicinal cannabis products through the Special Access and Authorised Prescriber Scheme by active ingredient category (e.g. high THC, low CBD), rather than by trade name. This allows for flexibility at the point of prescription, with prescribers able to issue a script for any product within the approved category. Products are categorised by cannabinoid content as follows:

• Category 1 CBD medicinal cannabis product (CBD ≥98%)
• Category 2 CBD dominant medicinal cannabis product (CBD ≥60% and <98%)
• Category 3 Balanced medicinal cannabis product (CBD <60% and ≥40%)
• Category 4 THC dominant medicinal cannabis product (THC 60-98%)
• Category 5 THC medicinal cannabis product (THC >98%)

To support health care professionals in prescribing and supplying unapproved medicinal cannabis products the TGA has published a list of available products and sponsor details under each of these categories.

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 category of medicinal cannabis product to a group of patients with the same condition (e.g. Category 1 CBD products for children with epilepsy), then they may apply to the TGA to become an Authorised Prescriber of that product type.

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 are currently only two medicinal cannabis products entered on the ARTG:

• Nabiximols(Sativex^®), a schedule 8 controlled drug approved for the treatment of spasticity due to multiple sclerosis.
• Epidyolex (Cannabidiol), a Schedule 4 prescription only medicine approved as an adjunctive therapy of seizures associated with Lennox-Gastaut or Dravet syndrome for patients 2 years of age and older.

Schedule 8 treatment permits

For patients with a history of drug-dependence, Victorian prescribers are required to apply for and hold a Victorian treatment permit before prescribing Schedule 8 medicinal cannabis products.

Victorian medical and nurse practitioners do not require a treatment permit from the Victorian Department of Health when prescribing Schedule 8 medicinal cannabis products to non-drug dependent patients. However, prescribers are still required to check SafeScript each time before prescribing a Schedule 8 medicinal cannabis products, to any patient.

When applying for a permit to prescribe S8 medicinal cannabis to a drug-dependent patient, the following must be specified:

1. Name of the proprietary product you intend to prescribe (e.g. Beacon Medical THC Flower 25%); note that the TGA category of the medicinal cannabis productalone is insufficient
2. Strength(s) or concentration(s) of the active S8 ingredient (e.g. 25% THC)
3. The precise maximum daily dose of the active S8 ingredient (e.g. 250mg THC inhaled daily)

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

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.

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.

Writing a prescription

Once a medical or nurse practitioner has received any required approvals and reviewed recent dispensing records for their patient on SafeScript, they may issue a prescription.

As with other medicines, prescribers are required to include the ‘full particulars’ of the medicinal cannabis product on the prescription, which must include:

1. The active ingredient(s) (generic name) of the medicine (e.g. THC).
2. Strength(s) or concentration(s) of the active ingredient(s) (e.g. THC 10mg/mL : CBD 15mg/mL)
3. Directions for the precise dose and frequency of administration (e.g. 1mL po tds)
4. Quantity to be supplied (written in both words and figures) (e.g. 50mL (Fifty mL))
5. All other components of a prescription, as specified in Regulation 24 of the Drugs Poisons and Controlled Substances Regulations 2017.
6. While not specified in the regulations, it is strongly recommended that the name of the proprietary product is included in order to minimise uncertainty and the likelihood that a pharmacist will need to contact the prescriber, to seek clarification, before supply can be made to the patient.

Including only the TGA category of the medicinal cannabis product is insufficient and does not comply with the requirement to include the ‘full particulars’ of a medicine.

If the medicine is to be supplied only once, a statement (using words and not just figures) that there is to be no repeat supply; or the maximum number of times the medicine may be supplied (written in both words and figures) should also be included.

Dispensing

Patients may take their 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. Pharmacists must also check SafeScript prior to dispensing Schedule 8 medicinal cannabis products containing THC.

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.

It is an offence for a pharmacist to supply a Schedule 4 or Schedule 8 medicine contrary to the instructions written on a prescription - other than in exceptional circumstances. Pharmacists are therefore only able to substitute medicinal cannabis products provided the active ingredients, concentration, quantity and any other specifications (e.g., dosage form) are the same, and the prescriber has not indicated that brand substitution is not permitted.

If a substitution is required due to stock issues or other reasons, pharmacists are required to contact the prescriber to receive a verbal or written instruction from them to dispense a product with different active ingredient ratios, concentrations, etc.

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.