Use of medicinal cannabis products
Position Statement Dr Caroline Chin 7 January 2020
Medicinal cannabis preparations are not approved by the Australian Therapeutic Goods Administration but applications may be made for GPs to be eligible to prescribe medical cannabis which is a Schedule 8 drug controlled drug. To do this they must apply under the provisions of the legal and medical framework of the state. They must be accredited by the Australian Department of Health by applying for federal approval from the TGA as well as state approval from the WA Health Department. They can apply for this through a Special Access Scheme to become an Authorised Prescriber for an individual patient on a case by case basis.
These doctors are expected to have considered all clinically appropriate treatment options included in the Australian Register of Therapeutic Goods before applying to access an unapproved medicinal cannabis product under the SAS. They are expected to note that the TGA does not vouch for the quality, safety and effectiveness of unapproved products and the doctor and the patient must accept responsibility for any adverse consequences of treatment.
A doctor must provide a Treatment Justification Plan which includes both clinical justification and an intended monitoring plan. Prescribing criteria at this time include:
patients must have tried all first line conventional medications for the condition being treated and be refractory or unable to take due to adverse effects
an application must be notified to the TGA and WA Health Department
approved indications so far include chemotherapy induced nausea and vomiting, refractory paediatric epilepsy, palliative care indications, spasticity from neurological conditions. Even so these conditions do not guarantee TGA approval for all applications as evidence of the efficacy of medicinal cannabis is limited.
At this time my practice is as an advocate for evidence based medicine and at the moment from my reading, the evidence of the effectiveness and safety of medicinal cannabis is limited. I have not undertaken any specialist training in the use of these drug preparations and understand this is recommended by both the RACGP and medical indemnity companies before applying to becoming an authorised prescriber. It is not one of my special areas of interest nor do I have any post graduate additional qualification in this area. My position at this time is that I will not be applying to the TGA as an authorised prescriber and I apologise to my patients if this puts them in a difficult position of finding an alternative doctor. I can suggest a referral to a chronic pain specialist or provide a referral to Cannabis Access Clinic in Subiaco to assist with a patient’s medical history if a so requested and confidentiality waived. As with all new medicines, I am hesitant to be a pilot case and prefer to take a conscientious approach to prescribing. As evidence around the effectiveness and safety of medicinal cannabis products evolve, my position regarding my prescribing patterns may change and will reflect the emerging recognised clinical practice.