Do your patients know the risks of unapproved medicinal cannabis products?

Medicinal cannabis prescribing in Australia has increased significantly in recent years. 

However, many patients are unaware that most medicinal cannabis products are unapproved goods. Unapproved medicinal cannabis must be accessed via the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathways. This means they have not been assessed by the Therapeutic Good Administration (TGA) for quality, safety or efficacy. 

As a prescriber, you play a critical role in ensuring patients are informed, protected and supported when these products are being considered for their clinical situation.

Understanding your responsibilities

Prescribing an unapproved medicinal cannabis product carries important clinical and regulatory obligations. As a prescriber, you should ensure that:

• prescribing decisions are based on sound clinical judgement and available evidence
• you have first considered or trialled approved therapeutic goods in the Australian Register of Therapeutic Goods (ARTG) 
• prescribing complies with the requirements of SAS and AP, as well as applicable state and territory legislation
• patients are appropriately monitored throughout and following treatment.

Ongoing clinical oversight is particularly important given the variability in product composition and the evolving evidence base.

Informed consent is essential

Before prescribing, you must ensure meaningful, documented informed consent is obtained.

Patients should clearly understand:

• that there could be approved alternative treatment options 
• the product is unapproved and not included in the ARTG
• the safety, quality and efficacy of the unapproved good may not be well established for their condition
• known and potential risks, side effects and interactions with other medicines 
• possible impacts on cognition and daily activities
• that medicinal cannabis may impact their ability to drive and that there are applicable state and territory laws 
• the costs, access arrangements and implications for ongoing treatment.

Patients should be given the opportunity to ask questions and withdraw consent at any time.

Importantly, the responsibility to ensure consent is well informed rests with you as the prescriber, even where information is also provided by clinics or suppliers.

Supporting safe and responsible use

Medicinal cannabis may be appropriate for some patients, but like all unapproved medicines, it requires careful consideration, clear communication and ongoing oversight.

By ensuring patients are well informed and appropriately monitored, prescribers play a vital role in supporting safe and responsible use which contributes to strengthening confidence in Australia’s regulatory framework.

Monitoring safety and reporting adverse events

Active monitoring is essential when prescribing unapproved products.

You should:

• monitor for adverse events, including potential impacts on cognition, mental health, and functional capacity (such as driving or work safety)
• consider possible interactions with other medicines
• report suspected adverse events to the TGA, especially those that are serious or unexpected

Adverse events must be reported to the TGA within 15 calendar days of you being made aware of an issue. Timely reporting contributes to stronger post‑market surveillance and helps build the evidence base for these products. The preferred reporting route is via the online portal. 

Documenting decisions and discussions

Clear documentation supports both patient care and professional accountability.

You should ensure that:

• informed consent discussions are recorded in the patient’s clinical record
• records reflect that the patient understands the unapproved status and associated risks with the product
• prescribing decisions and follow‑up arrangements are documented and reviewed
• other healthcare practitioners involved in the patient’s care are informed of medicinal cannabis being prescribed