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23 Jun 2017


It seems hardly a week goes by without a news story on medicinal cannabis or a media interview request on the subject.

However,despite all of the information, the amount of misinformation in the general community is significant and at times is very concerning.  Many in the media believe that it is currently possible to go to your local GP and have medicinal cannabis prescribed for chronic pain. If not; why not? Presumably the patient would then go down to the local pharmacist and have it dispensed. Journalists are amazed when told that there are both State and Federal government laws and restrictions that still present significant barriers and that these restrictions need to be adhered to.

Medicinal cannabis certainly has had a very political and community driven introduction in this country. Things have been moving quickly, beginning with the passage of legislation in November 2016 involving the Therapeutic Goods Administration. Since that time, medicinal cannabis no longer falls under Australia's most stringent of schedules – reserved for dangerous drugs – thereby allowing for provisions to be put in place to use cannabis on medical grounds.

Just this month we have had a Senate vote to increase the ease of availability of all forms of medicinal cannabis for terminally ill patients. Some have described this as a political stunt and posturing. In essence, moves in this space are happening so quickly that it is quite likely opportunities and processes are evolving that render the recent Senate amendments potentially unnecessary.

More importantly and perhaps of more concern is that the usual guidelines and requirements for the introduction of new medications seem to have been forgotten in respect of medicinal cannabis. It seems that safety and concern for rigorous, clinically proven guidelines are dispensed with – all in the name of compassion for a patient population who are just as deserving of the same standard of care as the rest of the community when it comes to safety and harm minimisation. It seems that all the tenets of our world-class system have been forgotten and are suddenly archaic and of little value in the face of a voracious community perceived need. This is spurred on by numerous media stories featuring long-suffering patients and their families who are forced to access the illegal black market.

Under the TGA Special Access Scheme, some forms of medicinal cannabis are already available. This scheme provides for the import and supply of an unapproved therapeutic good to individual patients on a case-by-case basis.

What also has been forgotten in all of this is that there is a significant amount of State legislation to be complied with. The States and Territories will decide whether medical cannabis will be made available – and more importantly, which type of patients will be able to use it.  Some States and Territories have indicated they will list the conditions (e.g. QLD: Legal for specialists to prescribe for some patients; NSW: Available for adults with end-of-life illnesses; VIC: Available for children with epilepsy) The TGA is currently undertaking significant amount of education and information sharing with the medical community. This is especially necessary when a large portion of the media reporting is on access to prescribers and the relatively small numbers of prescribers or applications to prescribe. This is not surprising when clinical guidelines are in a state of evolution and there is uncertainty among many doctors about who should be eligible. Right from the beginning we have also maintained that there needs to be great clarity around how the medical cannabis system will operate.  There is a paucity of information from the Government, which is adding to the confusion.

The AMA has many other concerns.So much still remains to be clarified. Information about either the dosage or form of medicinal cannabis needs to be available to patients. In countries that have medical cannabis (Canada, Holland, Israel) there are only a few types of cannabis available and they are packaged and dispensed like any other pharmaceutical product, with information on strength, use, dosage etc. The different types of cannabis are prescribed for designated medical conditions.  It is not yet clear how medical cannabis will be dispensed. Is it to be dispensed through pharmacies, secure home delivery or from nominated GPs?  

It is also not yet clear who will be able to approve medical cannabis prescribing and whether doctors will need to undertake additional training to become an “approved” cannabis prescriber/dispenser.  The AMA has been told that modules are being created for doctors, but we don’t know exactly how or where this will be implemented.

There are some pharmaceutical cannabis products already approved by TGA (like Sativex) and controlled and standardised herbal cannabis, such as the products produced in the Netherlands. The system may be so convoluted and complicated for patients and prescribers that it won’t be able to fulfil the reason it was established and patients may continue to use the black market.

The recent Senate vote effectively means the Senate has supported an amendment to therapeutic goods laws to change category A of the Special Access Scheme for cannabis.  The effect of this will speed access to medicinal cannabis for people with a terminal illness. What this means is that from now on, a patient can go and see a doctor who can order medicinal cannabis for that patient if they have a terminal illness. If medicinal cannabis is not available in Australia, they can obtain it from overseas. This is most concerning in terms of guaranteeing safety and efficacy of the product imported. Doctors will only need to notify the TGA within a 28 day period.

What is needed is for the current consultative processes between TGA, Federal and State Governments with the appropriate stakeholders to continue. A lot has been achieved in a very short space of time. However, safety and reliability of product as well as clear clinical guidelines for use need to be firmly developed and supported by clear information sharing and training of doctors concerned. Politics should not be allowed to influence and certainly media and community information needs to be facilitated so that expectations do not exceed practicality. 

Published: 23 Jun 2017