Medicinal cannabis black market worries TGA


cannabis medicinal

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.

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9 Comments

  1. Andrew
    23/08/2017

    I believe there may be an as-yet untested loophole for accessing medicinal cannabis in Australia;

    – Travel to US, acquire medicinal cannabis prescription from local authorised prescriber.
    – Purchase 3-months of product using said prescription
    – Return to Australia, declare imported prescription cannabis products at customs under Traveller’s Exemption, providing copy of US prescription as documentation.

    The travel may even be claimable as a tax or medical expenses deduction…

    Thanks to the family friend who clued me in to this loophole – he’s going to test it in the next few months and I’ll report back.

  2. Chris Cook
    25/08/2017

    Question for the TGA how many people have died from cannabis use also how does that figure compare to opiate deaths. How about we discuss the safety of cannabis after it actually does some harm people die everyday from opiates & everyone seams to think they are fine No one has ever died from cannabis use fact.

    • Andrew
      25/08/2017

      >>>No one has ever died from cannabis use fact.

      Not true. There’s a pretty well understood link between cannabis and acute coronary syndromes (ie. sudden death). Pretty rare, but absolutely causal.

      https://www.ncbi.nlm.nih.gov/pubmed/24783463

      • Deborah Taylor
        25/08/2017

        Show me a pharmacuetical drug that does not have one death attributed to it that can do what cannabis does.

      • Vickie
        25/08/2017

        Rubbish!

  3. Jamie
    25/08/2017

    Why does it have to be Australian trials only. There is a long history of use with Cannabis as well as many studies by many other countries other than Australia, why not use some of these other studies. I’m thinking they’re structuring it so only a limited few can supply the cannabis products, so when more doctors do prescribe it, only those limited suppliers will be making a fortune.

  4. Deborah Taylor
    25/08/2017

    And not having the doctors around that can prescribe is why the black market is still the easiest and best way for many patients.
    With doctors no longer providing adequate pain relief especially if you have a fast metabolism people are desperate. Be thankful alot turn to cannabis and not heroin etc.Plus its cheaper than a prescription IF you can get one. Still dont know one person who has been able to get a script.

  5. Deborah Taylor
    25/08/2017

    Not to mention alot of Doctors GP and specialists are telling paitents to source it on the black market as they cant prescribe it. Nor have the time to apply for licenses etc.
    The current system doesnt work. People are tired of believing the government will help and being dissapointed.
    My Grandmother and Uncle both took it before they died for pain relief and that was 10 years ago. It was the only thing helping in the end.

  6. kelly simpson
    25/08/2017

    The rates of prescription are low because it’s impossible to get in Australia!!! I have epilepsy and it took me forever to figure it out, thank god I found CannabisAccess, the whole process was so easy for me & my GP http://www.cannabisaccess.com.au

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