Before you consider prescribing an unapproved medicinal cannabis product, you should inform your patient:3-5
- that the product is not approved in Australia and (potentially) other countries
- that the quality, safety and efficacy have not been assessed by the TGA
- about the possible benefits of treatment
- about any known risks and side effects
- about available alternative treatments for their condition that use approved products.
Adequate knowledge of the condition being treated, the treatment options, the likelihood of recovery and long-term prognosis is necessary for your patient to be able to make an informed decision regarding treatment with an unapproved medicinal cannabis product.3,5
The use of unapproved medicinal cannabis products is considered experimental. You must obtain informed consent from the patient (or the patient’s legal guardian) before applying to the TGA to access a medicinal cannabis product. Informed consent should be freely given by the patient (or their legal guardian) and obtained in line with good medical practice.3,5
It is best practice to:4,5
- obtain informed consent in writing unless there are good reasons to the contrary
- provide a copy of the informed consent form template to the Human Research Ethics Committee (HREC) or specialist college, if required
- keep the signed informed consent form on the patient’s profile.
You should not submit informed consent forms to the TGA.3,4