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Coming out of the green closet: All you wanted to know about cannabis medicines

7/08/2018


Guest contributor Dr Jan Fizzell, public health physician for NSW Health and advisor to the NSW Chief Health Officer on medicinal cannabis, talks to the Your Room team about cannabis medicines – the state of play in Australia, what the evidence (and your doctor) says, and where next for NSW.

Bud, dope, grass, marijuana, mary jane, hash, weed – whatever you call it, there is no doubt that we are entering a historic time for cannabis.

In the last two months alone, a number of landmark developments have changed the global landscape for both recreational and medicinal cannabis.

On 19 June 2018, Canada's parliament voted to become the first G7 nation to fully legalise cannabis (legalisation comes into effect on 17 October 2018). Days later, on 25 June, the US Food and Drug Administration approved, for the first time, a drug derived from the cannabis plant. As recently as last month, the UK's Home Office announced, on 27 July, that medicinal cannabis will be available in the UK on prescription later this year.

Given Canada's recent legalisation announcement, recreational use of cannabis has been hot in the press. However, cannabis for medical purposes continues to drive public and political interest. 91 per cent of Australians support legalisation of cannabis for medicinal purposes (in comparison, only 32 per cent believe recreational cannabis use should be legal).

A range of countries worldwide have legalised medicinal cannabis, either through a largely unregulated general access model, such as the market in California, or as a form of registered medicine market, such as has been established in Israel. But where does this leave Australia?

From Perth to Sydney: Medicinal cannabis in Australia 

In 2016, Australia's Therapeutic Goods Administration (TGA) decriminalised supply and use of medicinal cannabis. The following year, the TGA rescheduled certain medicinal cannabis products to schedule 8 of the Poisons Standard, making the prescription of cannabis medicines legal in Australia.

Governments at both Commonwealth and State and Territory levels have implemented legislative and policy change to allow the cultivation, manufacture, prescribing and dispensing of medicinal cannabis products for patients in Australia. This has been driven partly by community and advocacy groups and the media and informed by the development of medicinal cannabis programs in other countries.

Cannabis medicines are now available on prescription in all Australian states and territories. In NSW specifically, doctors have been able to seek approval to prescribe medicinal cannabis for patients since 1 August 2016. This was a result of changes under the Poisons and Therapeutic Goods Amendment (Designated Non-ARTG Products) Regulation 2016 (under the Poisons and Therapeutic Goods Act 1966). Previously, NSW patients could only legally access cannabis-based medicines through clinical trials. 

The use of cannabis outside of regulated medicinal purposes for specific products remains illegal in Australia. If you use, personally cultivate, sell or supply cannabis (leaf, resin or oil) to someone else and get caught, you could face significant fines and other penalties, including a prison sentence.

Back to basics: What is a cannabis medicine and who can get it?

A cannabis medicine is a lawfully prescribed and dispensed pharmaceutical-grade, cannabis-derived product used specifically for human therapeutic (medical) purposes. All cannabis medicines in Australia need to meet a quality standard to ensure they are free from contaminants and are manufactured to a consistent standard. In Australia, cannabis medicines are regulated in the established medicines framework that applies to all drugs and poisons.

Only doctors can apply to prescribe a cannabis medicine – not patients or carers. NSW doctors apply for approval to prescribe cannabis medicines through a single application process when they consider it the appropriate treatment for their patients.  The doctor prescribing should consult with other doctors involved in the care of the patient. For some health conditions, a specialist in that treatment area is expected to lead or support prescribing. This is because those health conditions are usually managed by such a specialist.

There is no pre-determined list of conditions for which a cannabis medicine can be prescribed in Australia. Each application from a prescribing doctor will be considered on its merits.

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Blazing a trail: The NSW Government's approach to cannabis medicines

The NSW Government has committed $21 million to develop a better understanding of the therapeutic potential of cannabis medicines.

This includes $9 million over four years in clinical trials to evaluate the safety and effectiveness of cannabis medicine in providing relief from the symptoms of serious conditions: children with severe treatment-resistant epilepsy, adults with chemotherapy-induced nausea and vomiting unresponsive to standard treatments; and improving quality of life for adult palliative care patients. The NSW Clinical Trials program was established after advice from an expert advisory panel regarding the most important areas to understand the use of cannabis medicines.

The NSW Government has also invested up to $12 million over four years to establish and operate the NSW Centre for Medicinal Cannabis Research and Innovation. The Centre will draw on local and international researchers to advance our formal understanding of medicinal cannabis, monitor the NSW-funded clinical trials, educate the community, and help people navigate regulatory processes.

The NSW Centre for Medicinal Cannabis Research and Innovation has funded the $6 million Cannabis Medicines Access Program. The NSW Cannabis Medicines Advisory Service was opened in January 2018 to provide health practitioners anywhere in NSW with timely, high-quality clinical advice. It is Australia's first cannabis medicines 'hotline' and aims to simplify and speed up access for doctors whose patients may benefit from this type of treatment.

The NSW Government has also provided funding support for the Australian Centre for Cannabinoid Clinical Research and Excellence (ACRE). ACRE will develop prescribing protocols for the use of cannabis medicines and provide blood monitoring for patients and data collection tools for their health care professionals to collect more information on the safety and efficacy of these medicines.

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Is cannabis a medical miracle? The jury is still out

Cannabis is a complex plant and we are still learning about the hundreds of compounds that make up the plant; how they interact with each other and how they affect organs and systems in the human body.

Although medicinal cannabis has been introduced in a number of countries, it is still an emerging field. Little high-quality clinical research has been conducted into its therapeutic use and the strength and quality of scientific evidence from the research that has been conducted varies, as does the evidence of safety and effectiveness for many products currently available.

Doctors rely on high quality evidence from clinical trials to help make prescribing decisions. While positive stories of treatment from patients help us understand where to investigate further, we know that success sometimes comes from other treatments they are on at the same time, sometimes from a positive mental disposition towards the treatment working (a "placebo" effect), and sometimes only work in certain circumstances. Clinical trials help us.

We also often see work done in the laboratory or in mice promote cannabis as a miracle cure. However, sadly, "miracle" drugs in the laboratory don't always translate to successful treatments in humans. For example, in general, nine out of ten drugs for cancer that were promising in the laboratory or in animal models of disease don't work in clinical trials in humans.

Some new cannabis medicines will expose patients to much higher doses of cannabinoids (the chemical compounds of cannabis) than they would have been exposed to. Cannabinoids work all over the body. As such, we need a degree of caution in ensuring that they do not have unexpected adverse effects. For example, we know that some cannabinoids interact with the immune system. If we are trying to treat a cancer with a different medicine that needs the immune system to function, giving a cannabis medicine that might interfere with the immune system might do more harm than good.

Some uses of cannabis medicines have had significant amounts of research. The Commonwealth Department of Health through the Therapeutic Goods Administration (TGA), and with the support of the NSW, Victorian and Queensland state governments, commissioned a team to review the available scientific evidence for the use of cannabis medicines in five areas: palliative care, nausea and vomiting, epilepsy, multiple sclerosis and pain. The resulting guidance reveals that currently there is limited evidence about the effectiveness of medicinal cannabis for use in different medical conditions. There is also little known about the most suitable doses of individual cannabis products.

Currently, only one product has been fully assessed for safety, quality and efficacy and is registered on the Australian Register of Therapeutic Goods (ARTG). All other cannabis medicines are experimental and their effects on different people are still being studied.

Straight from the horse's mouth: What does your doctor think?  

On 2 March 2018, the NSW and Commonwealth governments introduced a streamlined application process for doctors to prescribe unregistered cannabis medicines. On 30 July 2018, this was supplemented by an online system which enables medical practitioners to submit Special Access Scheme (SAS) applications and notifications electronically. Previously, physical application forms had to be emailed or faxed to the TGA for review.

As of 17 July 2018, NSW Health has received three times as many applications (335) from doctors in the 4.5 months since streamlined arrangements were introduced on 2 March 2018, than the 113 applications received in the preceding 18-month period (from 1 August 2016 when changes to NSW legislation came into effect, up until 1 March 2018).

The NSW Government is working to support appropriately qualified medical practitioners to access legal, safe and effective pharmaceutical-grade cannabis products where they consider this to be an appropriate treatment option for their patients. However, a doctor's first duty of care is to ensure their patient's safety. To feel confident prescribing any new medicine, a doctor requires evidence – high quality clinical research, where carefully designed studies are conducted in humans – showing that the medicine is safe and effective.

Despite widespread anecdotal claims that cannabis is a natural, benign product, a cannabis medicine, like any experimental medicine, offers potential risks in the way it interacts with other medicines as well as uncertainty in what side effects it may cause. For a doctor, anecdotes do not equal evidence. It is ultimately the decision of the patient's doctor as to whether they prescribe, or not.

NSW doctors can access the NSW Cannabis Medicines Advisory Service to access up-to-date information about the use of cannabis medicines; formulations, dosing regimens and potential interactions with other drugs.

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Cannabis medicines: Where to next

Australia is proceeding towards a registered medicine model for cannabis. Legislation passed last year allowing cannabis to be prescribed as a Schedule 8 drug (a category that includes a varied range of addictive drugs such as morphine and codeine) reflects this.

However, although humans have been using cannabis products for thousands of years, we are still at the very beginning of the journey towards cannabis as medicine. High-quality clinical research, such as the three NSW Government-funded cannabis medicine trials, is vital to understand how cannabis products can contribute to patient outcomes.

Where it concerns cultivation, the Federal Parliament of Australia passed landmark legislation – the Narcotic Drugs Amendment Bill 2016 – on 29 February 2016 to allow the controlled cultivation of cannabis in Australia for medicinal and related scientific purposes. As of 11 July 2018, 18 Medicinal Cannabis Licences (cultivation and production), 10 Cannabis Research Licences (cultivation and production), and 13 Manufacture Licences have been granted.

The NSW Government has also funded $1 million for agronomic research undertaken by the NSW Department of Primary Industries to support the development of high quality cannabis products in NSW.

The data collected through the NSW Cannabis Medicines Advisory Service and clinical trials program will accelerate knowledge and understanding about the role of cannabis medicines and inform future practice. These investments in building the evidence base can help support applications for registration of cannabis medicines on the ARTG and listing on the Pharmaceutical Benefits Scheme (PBS) – the standard pathways for accessible and affordable quality medicines for Australian patients.

Cannabis as a medicine remains a topical, complex and emotionally-charged issue. It is also operating in a quickly changing public and political sphere. The NSW Government is committed to patients having access to cannabinoid products where they improve patient outcomes and this will remain a core focus in the months and years ahead.

Want to learn more about cannabis? Check out our cannabis drug page to get the facts.

Where can I find more information?

Visit the website of the Centre for Medicinal Cannabis Research and Innovation: www.medicinalcannabis.nsw.gov.au

Patients, their families and carers can also seek further information through:

  • Calling the cannabis medicines helpline: 1800 217 257
  • Emailing: cannabistrial@doh.health.nsw.gov.au
  • Writing to the Centre for Medicinal Cannabis Research and Innovation, NSW Ministry of Health, Locked Mail Bag 961, North Sydney, NSW 2059

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