The TGA has criticised claims that red tape turns patients to black market cannabis
And one medicinal cannabis stakeholder says that doctors are unready when it comes to prescribing the drug.
The TGA has responded to claims made on the Lateline program that patients are turning to the black market for medicinal cannabis products because of excessive red tape, principally in seeking approvals under the Special Access Scheme Category B.
“This scheme has operated for many years and the TGA provides over 20,000 approvals per year for doctors to prescribe a range of unregistered medicines,” the TGA said in a statement.
“Clearly, it can and does work efficiently to meet the needs of patients.
“Why are prescription levels for medicinal cannabis products relatively low? The Lateline story itself provided the answer. One of the interviewees, Justin Sinclair, stated, ‘There is a great paucity of evidence in the literature, at least when it comes to human trials’.”
The TGA says that Australia’s evidence-based system of medicine provides for the best possible care and protection of patients.
“Mr Sinclair is correct and the very fact that there is a great paucity of evidence, including that of safety, means that it would be inappropriate to allow access without appropriate clinical oversight and would risk the health and safety of patients,” it explains.
“Doctors that have educated themselves on the available evidence and present their clinical justification can, and are, receiving rapid approvals (often within two working days) under SAS Cat B.”
The TGA warns that medicinal cannabis products are not treatments of first choice because they have not yet been assessed for safety, quality and efficacy.
“Until they are, it is appropriate to protect patient safety to ensure that doctors using these products are making an appropriate clinical decision based on sound evidence,” it says.
The TGA says it is working with states and territories to make it easier for doctors to assess evidence on medicinal cannabis products, bringing together clinical guidances to assist in prescribing decisions.
The first of these, on epilepsy and palliative care, will be available before the end of the year.
It says it is also working to streamline necessary state based approval processes.
“The TGA is responsible for the supply of the product, while the states retain responsibility for approving doctors to handle schedule 8 substances. This is no different to any other schedule 8 medicine.
“The TGA is very concerned about patients deciding to use black market products. Testing of these products has revealed in the past that they are not always as advertised and can contain dangerous levels of contaminants and other substances.
“Patients should always work with their doctor to determine the best possible, legal treatment regime.”
Meanwhile, many eligible patients may believe accessing medicinal cannabis is easier than it really is, according to one stakeholder.
A spokesperson for Cannabis Access, a new online portal and resource for doctors, says that few health care initiatives are attracting as much attention as the changing regulatory environment governing the prescription of medicinal cannabis in Australia.
The hype would give those suffering severe conditions the impression that it is easier for them to access medicinal cannabis than it actually is, the spokesperson says.
In reality, doctors face two key issues when responding to patients who may benefit from medicinal cannabis:
- few doctors were taught about the endocannabinoid system while qualifying, and there is no central depository of reference material for those wishing to get up to speed now; and
- before doctors are able to prescribe medicinal cannabis, certain approvals and authorisations need to be sought at both federal and state levels.
Cannabis Access lists the products that have been approved by the Office of Drug Control for legal import and provides comprehensive reviews of clinical studies that have been conducted.
Trials are underway in Australia examining different cannabis-based medicines.
Medlab Clinical Limited is trialing a cannabidiol and tetrahydrocannabinol compound for the treatment of advanced stage cancer patients with intractable pain, as well as a marijuana-derived cannabidiol indicated for chemotherapy-induced nausea and vomiting, with a secondary endpoint in patients suffering seizures.
Zelda Therapeutics recently announced that it has expanded its breast cancer research to study the effects of medicinal cannabis on reoccurring tumours.
The upcoming Pharmacy Connect conference’s education program will include an overview of medicinal cannabis, including the current market in Australia.
Conference Convenor Kos Sclavos said in June that he was “alarmed and somewhat embarrassed when patients report to me that some pharmacists could not assist them at all, on how to access product and clinical information about medicinal cannabis”.
“Even if pharmacists are not willing to go through the arduous Special Access Scheme (SAS) through the TGA, they need to be informed about the products so they can assist both their patients and where relevant, their carer,” Mr Sclavos said at the time.