Updated 3 March 2018
Do you know what to do if a patient brings up the idea of using medicinal cannabis to treat their condition?
While the use of cannabis-derived products for therapeutic purposes has been debated for some time, interest in medicinal cannabis has recently gained significant momentum in Australia. On 30 October 2016, federal legislation was introduced which enables the legal cultivation, production and manufacturing of medicinal cannabis products in Australia.
See our medicinal cannabis prescribing considerations flowchart.
Is it legal to prescribe cannabis?
Medicinal cannabis was down-scheduled by the Therapeutic Goods Administration (TGA) from a prohibited substance (Schedule 9) to a controlled drug (Schedule 8) effective from 1 November 2016. Some states also introduced legislation providing a framework for medicinal cannabis to be prescribed for patients, subject to appropriate state and territory authorities and Commonwealth approval. However, cannabis remains illegal in Australia in all other forms.
As well as considering whether it’s appropriate to prescribe a medicinal cannabis product, you need to check what legal steps are required to prescribe medicinal cannabis in your state or territory.
When is it appropriate to consider prescribing medicinal cannabis?
The existing duty to exercise reasonable care and skill in prescribing a medication applies. In addition, with the exception of one product, medicinal cannabis products in Australia are still unapproved therapeutic goods. In prescribing an unapproved therapeutic good, you therefore take responsibility for the patient’s use of that product as with any other unapproved product.
In order to comply with the legal approval processes, you should consider the following preliminary questions before deciding whether to prescribe medicinal cannabis:
Is a medicinal cannabis product appropriate for your patient’s condition?
Clinical evidence to support the use of medicinal cannabis for a specific condition is required as part of the various approval processes. According to the TGA, “…the less critical the clinical need for the proposed product, the higher the degree of evidence needed to support the use of that product”. This is likely to limit its use to areas where early research and clinical trials suggest there is some therapeutic benefit such as palliative care (nausea, vomiting and pain) multiple sclerosis (severe spasticity), chemotherapy-induced nausea and vomiting, and drug-resistant epilepsy (Dravet and Lennox-Gastaut syndromes).
Have you considered other treatments and any drug interactions?
Medicinal cannabis is not a first line therapy for any condition and must be considered in the context of the patient's condition, other medications and side effects from more conventional treatments.
Are there any contra-indications?
For example, a history of hyper-sensitivity to any cannabinoid, pregnancy, personal or family history of schizophrenia or other psychotic illness, severe and unstable cardio-pulmonary disease.
Is specialist involvement required in the approval processes?
Some schemes allow only specialists to prescribe medicinal cannabis (check your state regulatory framework listed below). Further, if you are not a specialist in the condition to be treated with medicinal cannabis the TGA says it would expect a specialist report to be included with the Special Access Scheme application (see below for details about this scheme).
More information and guidance
Commonwealth guidance documents were released in December 2017 addressing five conditions for which medicinal cannabis has been considered for treatment: palliative care, multiple sclerosis, chemotherapy-induced nausea and vomiting, chronic non-cancer pain, and epilepsy. The guidance documents are the result of a project involving federal and state health departments and researchers from multiple universities, research and advisory bodies. They are intended to “provide information about the current state of clinical evidence and raise awareness of how to prescribe medicinal cannabis in Australia under current access scheme”.
Queensland is the only state that has published clinical guidance on the use of medicinal cannabis. Together with the Commonwealth guidance, these provide a useful resource for doctors in all jurisdictions when evaluating the appropriateness of medicinal cannabis for their patients.
NSW has taken a different approach in establishing a NSW Cannabis Medicines Advisory Service which is intended to provide expert advice on “when a cannabis medicine might be an appropriate treatment option, which medicines are available and how to administer them.” This service also references the Commonwealth guidance documents.
If you are unclear about your ethical, professional or legal obligations, visit our Medico-legal Advisory Service (MLAS) webpage or for immediate advice, call our MLAS on 1800 128 268, 24/7 in emergencies.
You will need to take particular care around the issue of informed consent. Some states require specific issues to be covered (see State or Territory requirements – below). The TGA suggests obtaining informed consent in writing, and that in addition to general advice about the condition and its consequences, treatment options, the likelihood of recovery and long-term prognosis, patients should also be informed:
- that medicinal cannabis products have not been approved by the TGA and therefore individual or other specific arrangements for access need to be made;
- that the quality, safety and efficacy has not been assessed by the TGA;
- about the possible benefits of treatment and any risks and side effects that are known;
- about the possibility of unknown risks and late side effects;
- about any alternative treatments using approved products which are available.
A particular consideration for patients may be the effect of treatment on their ability to drive. The Commonwealth and Queensland clinical resources state that patients should be advised that they cannot drive or operate machinery while undergoing treatment with medicinal cannabis containing THC (tetrahydrocannabinol). Research has shown a patient may test positive to a random drug test while being treated with medicinal cannabis if it contains THC.
In the case of an application under the Special Access Scheme (see below for details about this scheme), consent should be obtained before the application is made.
Legal pathways to prescribing medicinal cannabis
The National Health and Medical Research Council maintains a list of current available clinical trials and further information may be available through your state or territory health department.
It is important to be aware that most if not all of these trials require a patient to have never taken any medicinal cannabis product previously. Therefore if a patient has previously been sourcing and using medicinal cannabis they will not meet the trial criteria.
State or territory requirements
Depending on where you are practising, you may need to satisfy both state or territory and Commonwealth approval processes.
State and territory regulatory frameworks for access to medicinal cannabis
Tel: 02 6205 0998 Email: firstname.lastname@example.org
Registered medical practitioners have to obtain an authority from the ACT Chief Health Officer (CHO) to prescribe medicinal cannabis under the same process for other controlled medicine
Tel: 02 9391 9944 Email: email@example.com
In March 2018 NSW announced it will remove the additional state-based approval process and rely on the TGA assessment. This change is due to take place ‘within weeks’. More detail is to be provided.
The NSW Government’s Centre for Medicinal Cannabis Research and Innovation has information about clinical trials, access and research in NSW Medical practitioners can apply to prescribe by submitting an application form to the email address listed. A Medicinal Cannabis Compassionate Use Scheme also exists.
NSW has also established the NSW Cannabis Medicines Advisory Service, which provides clinical guidance and support to NSW doctors considering prescribing a cannabis medicine for their patient.
Tel (02) 4923 6200 Email HNELHD-CMAS@hnehealth.nsw.gov.au
Tel: 08 8999 2633 Email: chiefhealthofficer.DoH@nt.gov.au
NT doctors must be authorised to prescribe medicinal cannabis products under the schemes administered by the TGA.
Tel: 07 3708 5283 Email: MCTeam@health.qld.gov.au
Clinical guidance and process guidance is available on the Queensland Health website outlining the different prescriber pathways.
Tel: 1300 652 584 Email: HealthDrugsofDependenceUnit@sa.gov.au
A factsheet on prescribing medicinal cannabis is available on the SA Health website. A section 18A authority may be required from the Drugs of Dependence Unit for some patients.
Tel: 03 6166 0400 Email: firstname.lastname@example.org
Controlled access scheme is now in place to enable specialist doctors to prescribe medicinal cannabis in certain circumstances.
Tel: 03 9096 7768 Email: email@example.com
Legislation establishes the Victorian Access to Medicinal Cannabis Scheme which enables certain specialist doctors to prescribe medicinal cannabis in certain circumstances.
Tel: 08 9222 6883 Email: firstname.lastname@example.org
See also Part 5 of the Schedule 8 Medicines Prescribing Code and the quick guide for health professionals (both available on the Department of Health website).
Prescribing an unapproved therapeutic good – Commonwealth requirements
As Medicinal cannabis products are unregistered medicines (except for Sativex), approval is also needed from the TGA to obtain supply of a product.
Prescribing unapproved therapeutic goods
Authorised Prescriber Scheme
- Generally used for approval to supply medicinal cannabis to a specific class of patients based on their medical condition
- Application forms are available on the TGA website.
- Details including endorsement from a Human Research Ethics Committee or from your specialist college.
Special Access Scheme (Category A)*
- Generally used for notification to the TGA only available for terminally ill patients.
- If a doctor determines their patient is terminally ill, they can prescribe medicinal cannabis under Category A and notify the TGA within 28 days but do not require prior authorisation from the TGA.
Special Access Scheme (Category B)
- Generally used for approval to import and/or supply a medicinal cannabis product for a specific patient, with decisions made on an individual basis.
- Application forms for this scheme are also available on the TGA website.
- Efficacy and safety data, along with details about the seriousness of the condition. If you are not a specialist in the condition, the TGA may expect a report from an appropriate specialist on the use and suitability of the medicinal cannabis product for the person and/or condition.
* Initially, medicinal cannabis was removed from access under Category A of the Special Access Scheme; however, this was reversed by a Senate decision in June 2017.
Accessing medicinal cannabis products
Once authorisation has been obtained, as the prescribing doctor, you are required to identify and arrange the supply of the product.
There are several types of medicinal cannabis products available, including oil, vapour, balm, capsule and pill forms. You should review the evidence for potential products in the context of your patient’s condition and let this guide product selection.
If stock is available in Australia, you can contact a supplier, provide the supplier with the necessary approvals and authorisations you have obtained and the supplier can then provide you with the product.
If there is no stock in Australia, you would then need to apply for a licence and permit to import the product yourself or contact an importer who can liaise with overseas suppliers and arrange an importation of the product you wish to prescribe. The overseas company will require an export permit from its home country.
A list of manufacturers and importers is available on the website of The Office of Drug Control.
Treatment plan and reporting requirements
An approval under the Authorised Prescriber or Special Access Schemes will include conditions relating to the approval with which you must comply. There may be ongoing obligations set out in the conditions relating to the approval.
An Authorised Prescriber must provide a report to the TGA on a six-monthly basis, listing each of the medicinal cannabis products supplied during this period.
There are also some state-specific timeframes on monitoring and reporting, which you need to check when you seek state approval to prescribe.
Given that these cannabis products are unapproved medicines, you should review patients regularly to ensure the treatment’s efficacy and manage any adverse events. If there is an adverse event, you must provide a report to the TGA within the timeframe set out in the relevant guide: Access to unapproved therapeutic goods via the Special Access Scheme or Access to unapproved therapeutic goods: Authorised prescribers.
1 From 1 June 2015, cannabidiol was included under Schedule 4 “prescription only” medicines when preparations for therapeutic use contain 2% or less of other cannabinoids found in cannabis (TGA website)
2 Nabiximols (Sativex) is registered with the TGA for managing spasticity with multiple sclerosis.
Avant policy cover
Avant provides cover under its Practitioner Indemnity Insurance Policy for civil liability claims, in addition to legal defence costs, which relates to healthcare that is provided to a patient. As a medical practitioner has to apply to become a registered prescriber of medicinal cannabis, it is no different to any other drug which is accessed through the TGA’s authorised prescriber scheme or special access scheme and is therefore covered under the Avant practitioner policy. Avant’s Practitioner Indemnity Insurance Policy also provides cover for clinical trials unless the trial involves pregnant women, gene therapy, use of stem cells or children under the age of 16 years. All cover is subject to the terms, conditions and exclusions in the policy.
The TGA has introduced a medicinal cannabis hotline for doctors which may also be a useful resource: 1800 020 653.
Importers and manufacturers of medicinal cannabis products
Access to medicinal cannabis products: questions and answers
Access to medicinal cannabis products: steps to using access schemes
Centre for medicinal cannabis research and innovation
NSW Cannabis Medicines Advisory Service.
Prescribing medicinal cannabis
Medicinal cannabis clinical guidance
Medicinal cannabis access and use
Medicinal cannabis, Patient access in South Australia
Approvals to prescribe medicinal cannabis in South Australia factsheet
Schedule 8 medicines prescribing code
Medicinal Cannabis: Quick guide for health professionals
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