Challenges of prescribing ‘unapproved’ medicinal cannabis

‘Unapproved’ medicinal cannabis products are therapeutic goods that have not yet been evaluated and included in the Australian Register of Therapeutic Goods (ARTG). They have not been assessed by the TGA for their quality, safety, or effectiveness.

There are currently two approved medicinal cannabis products listed on the ARTG: one for multiple sclerosis (Sativex) and one for two forms of severe epileptic encephalopathies (Epidyolex).

‘Unapproved’ medicinal cannabis for patients is generally accessed by either:

• Special Access Scheme (SAS) for individual patients on a case-by-case basis
• Authorised Prescriber (AP) for multiple patients with the same condition

Most research and evidence on medicinal cannabis products is based on five clinical conditions — multiple sclerosis, palliative care, epilepsy, nausea and vomiting, and chronic non-cancer pain.

Ahpra states that, with a few exceptions (such as the treatment of certain childhood epilepsies; muscle spasms and pain symptoms associated with multiple sclerosis; some neuropathic pain; and chemotherapy-induced nausea and vomiting in cancer), there is little evidence to support the use of medicinal cannabis.

The most common conditions for which medicinal cannabis is prescribed in Australia, according to Special Access Scheme data, are chronic pain and anxiety. Other conditions include sleep disturbance and insomnia, PTSD, depression, cancer pain, neuropathic pain, and ADHD.

Risks and side effects may include misuse, dependence, psychosis, asthenia, confusion, dizziness, increased heart rate, anxiety, hallucinations, memory problems, diarrhoea, dry mouth, drowsiness, fatigue, vomiting or nausea.

Contraindications include age, family history of psychosis, previous or current mental health condition, severe unstable cardiopulmonary disease, cardiovascular disease risk factors, kidney and liver disease, respiratory disease, pregnancy or breastfeeding. Consider other existing medications and their reactions with medicinal cannabis.

Key responsibilities when prescribing medicinal cannabis include:

• Understand the various forms of medicinal cannabis and their use and evidence.
• Perform and document a thorough patient assessment, including social, mental health, and substance use history; consider if further investigations are required before prescribing. Conventional, evidence-based treatments should have been tried and failed.
• Provide information on benefits, risks, and contraindications, and document.
• Obtain informed consent and document in the patient’s records.
• Advise the patient that it is illegal to drive while affected by products containing THC. Ensure this is documented in the patient’s records.
• Explain that, as an unapproved product, medicinal cannabis has not been assessed by the TGA for safety and efficacy.
• Obtain financial consent and document.
• Prepare a treatment/management plan with a trial period, document in the patient’s records, and conduct regular follow-up to monitor.
• Fulfil your obligation to ensure continuity of care, including communicating (with permission) with the patient’s usual treating practitioners.
• Use real-time prescription monitoring as required by State and Territory law (avoid asynchronous prescribing where a prescription is issued without a real-time consultation).
• If consulting and prescribing via telehealth, do so in accordance with the guidelines.
• Report any side effects to the TGA.

Prescribers must understand that they take on the medical and legal responsibility for the treatment outcome, including any adverse reactions. Other factors to consider include:

• It is an offence for a person to drive when impaired by a substance, including any detectable amount of THC in their system.
• Medicinal cannabis products are subject to State and Territory based regulations, including those for S8 medicines.
• You must report any adverse events or defects to the TGA and sponsor within 15 calendar days of becoming aware.
• Advertising medicinal cannabis to consumers is illegal.
• Check Real Time Prescription Monitoring (RTPM) in the jurisdiction patient resides.

Telehealth cannabis clinics which prescribe and dispense their own products raise significant conflicts of interest. Financial incentives to prescribe (e.g. paid per script) or to prescribe a particular product must be avoided. The Medical Board’s Code of Conduct – Good Medical Practice covers conflicts of interest (10.12) and financial and commercial dealings (10.13).

If working at a practice dedicated to medicinal cannabis prescribing, you must advise MDA National, and we will advise whether you are covered.

Prescribing medicinal cannabis without holding a fellowship or equivalent specialist qualifications, unless this is done as part of an accredited training position and supervised by a medicinal cannabis prescriber, is not covered.