The legalisation and supply of Medicinal Cannabis in Australia and elsewhere is making rapid strides despite a relative lack of evidence for its benefits.
With the Federal Government easing supply and Victoria harvesting the nation’s first legal crop of Medicinal Cannabis, state governments are racing to conduct clinical trials and smooth the way for patient access, which until now has been hindered by high costs and opaque approval procedures.
Medical Cannabis in it's various forms has been legalised by countries including Canada, Israel, the UK, Denmark, Czech Republic, Austria, Sweden, Germany, Spain and more than half of the US, although much of the legislation remains complex and ever-changing.1
Cannabis products have not had a regular place in pharmacies since the mid-1940s, when they were available by prescription and over-the-counter. A gradual shift in drug regulation and public sentiment led to cannabis becoming a controlled substance, and the most widely used illicit drug in the world.
In Australia, Lucy and Lou Haslam generated much of the recent debate around Medicinal Plant Based Herbs when they ran a public campaign about their son Daniel, a cancer patient from Tamworth, NSW who found relief in using Medicinal Cannabis to treat his symptoms before he died last year.
Now that Cannabis returning to Australian pharmacies in the wake of growing awareness of its potential benefits, it will be up to pharmacists, in collaboration with other health professionals, to ensure patients receive safe, evidence-based products and advice.
A quickly changing landscape
In February the Turnbull Government announced a more efficient supply of Medicinal Plant Based Herbs products to patients with the relevant approvals. This followed on the heels of legislation allowing for domestic production that came into effect in October 2016, which in turn followed the TGA’s decision in August to down-schedule Medicinal Plant Based Herbs from Schedule 9 of the Poisons Standard (prohibited substance) to Schedule 8 (controlled drug).2
Until domestic production meets demand, the government has authorised commercial importers to source an interim supply from reputable suppliers overseas for secure storage in Australia. Patients are expected to have access to these products as early as May 2017. The use of Medicinal Plant Based Herbs for non-medicinal purposes will remain illegal, in line with the Single Convention.3
Soon doctors will be able to prescribe – and pharmacists dispense – Medicinal Cannabis products cultivated and produced by Australian companies. The Federal Health Minister Greg Hunt suggested on ABC Radio’s AM program in February that local production in Victoria may meet demand by mid-2017.
Why can’t Australia keep importing Medicinal Cannabis? For one thing, global supplies are scarce and relatively expensive. Australian production will generate a safe, legal and sustainable supply, supporting more local opportunities for research and development. This could also make way for a new Australian agricultural industry similar to Tasmanian opium poppies, but unlike poppies, Medicinal Cannabis is grown in glasshouses for security.4
Minister Hunt said the Government’s Medicinal Plant Based Herbs scheme will place these products ‘under standard medical care where dose responses and adverse events can be properly monitored and responded to – just as happens with other medications.’
Unlike other medicines, however, Medicinal Cannabis has not been entered into the TGA’s Australian Register of Therapeutic Goods (ARTG), pending further evidence from clinical trials. 5 In the meantime patients can access it through the TGA’s Special Access Scheme or Authorised Prescriber Scheme (via their GP).
Associate Professor David Allsop, Associate Director the Lambert Initiative at the University of Sydney, said the issue with this arrangement is that medicinal cannabis is the only scheduled drug excluded from the Category A route of the Special Access Scheme, which means ‘terminally ill patients cannot gain ready access in the timeframes appropriate to their dire situation.’
Assoc Prof Allsop also said the new legislation ‘doesn’t change the fact that in order to gain access, a doctor still needs to make the application, but most doctors either do not know how to apply, do not have the required training or expertise to apply, or are politically or philosophically against supporting a Medicinal Plant Based Herbs application.’
What will it look like?
A recent study assessing Australian pharmacists’ views on Medicinal Plant Based Herbs found all participating pharmacists were concerned about ‘public stigma’ around the drug, particularly because of its illicit use.1 Many pharmacists wanted public awareness campaigns or discussions to increase the public’s knowledge of Medicinal Plant Based Herbs, so the stigma wouldn’t affect their patients (as some of them had seen with patients accessing methadone). One pharmacist said, ‘I don’t want my patients to think that we are a “cannabis pharmacy” it might give us (franchise) a bad look in the community.’1
The drug cannabis is created from the dried leaves and flowering heads of the Medicinal Plant Based sativa plant, which contains approximately 60 bioactive constituents, among the most potent of which are delta-9-tetrahydrocannabinol (THC) and cannabidiol.6 Medicinal Plant Based Herb products include pharmaceutical preparations such as oils, tinctures, sprays, tablets and extracts. They contain specific amounts of specific chemicals to maximise therapeutic effects and reduce side-effects.
Dr Scott Smid, a Senior Lecturer in Pharmacology at the University of Adelaide, said ‘I would envisage the most common forms of Medicinal Plant Based Herbs to be primarily pharmaceutical-grade formulations in a variety of forms produced in accredited GMP facilities.’
The European Medicine Agency’s (EMA) Good Manufacturing Practice (GMP) certification is the world’s most rigorous standard for the production of pharmaceutical products.
‘This would include oromucosal sprays like the nabiximols (Sativex) or encapsulated oils and tinctures containing standardised cannabis extracts or pure cannabinoids.’
What do experts say?
While many medical professionals have embraced the new legislation as a welcome step forward, they have raised concerns about its implementation and the relative lack of evidence for cannabis’s therapeutic effects.
Assoc Prof Allsop said the legislation would make the process for patients to access Medicinal Plant Based Herbs more streamlined and cost-effective: ‘Prior to this change, patients have faced a lengthy process of navigating federal and state level permissions and import permits, and overseas suppliers needing to organise export permits.’ On the other hand, he questioned whether allowing importation of medicinal cannabis from overseas would make it difficult for Australian growers and manufacturers to establish themselves.
Dr Smid said, ‘there is a strong advocacy from patient and community groups for improved access and the Government has responded to this… This is not without reason, for there is building anecdotal evidence of the effectiveness of Medicinal Plant Based Herbs for various conditions.’
However, Dr Smid pointed out that more clinical studies are needed: ‘To ensure that the use of Medicinal Plant Based Herbs is safe and effectively targeted in the community, it will need acceptance within the medical community and their benchmark reference point will be the evidence from clinical trials.’
Much more research could be done on the make-up of the plant itself: ‘This is exciting, as cannabinoids may reveal new insights into the biological basis of disease, for example some types of epilepsy,’ said Dr Smid.
Dr David Caldicott, an Emergency Consultant and Senior Clinical Lecturer in Medicine at the Australian National University, said: ‘There have been many promises made to patients and loved ones about Medicinal Plant Based Herbs in Australia – most have been broken.’
While he indicated the new legislation could improve patients’ quality of life, he added that the medical profession largely remained in the dark about what strains and formulations of cannabis were being produced. He agreed with Assoc Prof Allsop that ‘the special access schemes in place to allow prescribing remain opaque and cumbersome. We are regularly advised by the (Australian) authorities that Australia is evolving as the best practice leader in this space. The global evidence remains overwhelmingly to the contrary.’
What about the evidence?
The National Academy of Sciences in the US recently released a comprehensive review of the literature on the therapeutic use of cannabis.7 The report concluded that, while there has been a significant increase in scientific literature on cannabis in recent years, accompanied by extensive policy changes and increased rates of medicinal and recreational usage, ‘conclusive evidence regarding the short- and long-term health effects (harms and benefits) of cannabis use remains elusive.’7
This lack of conclusive research is a ‘significant public health concern for vulnerable populations such as adolescents and pregnant women,’ because ‘no accepted standards exist to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely.’
A recent development that may help change this is the global standards organisation ASTM International’s plans to create a committee focusing on standards and guidance materials for medicinal cannabis products and processes. The organisation is well placed to develop the standards, as it currently draws on the expertise of 30,000 members and industry representatives to operate more than 12,000 global standards.
The report stated that for more conclusive research to be conducted, there was a need for more diverse funding, improved and standardised research methodologies, and access to the necessary amounts of cannabis.
Given the barriers to research on the therapeutic use of cannabis, it may not be surprising that plenty of evidence exists for the harmful effects of recreational use. Among the report’s findings were substantial evidence of an association between cannabis smoking and respiratory symptoms, increased risk of car crashes and the development of schizophrenia and other psychoses. The potential side effects of medicinal use are not yet clear.
State by State
Now the Federal Government has allowed domestic production of medicinal cannabis, state and territory governments are legalising the cultivation and possession of cannabis for approved patients within their jurisdiction. It is up to the state governments to decide which criminal or civil penalties apply to cannabis, although federal offences also apply.4
Victoria is leading the charge with a number of recent Australia-firsts.
The first crop of medicinal marijuana has been harvested in Victoria and is being tested to treat children with severe epilepsy. In another major stride forward, a world-class cultivation and manufacturing facility has been constructed to support the supply of medicinal cannabis in Victoria.
Under the Narcotic Drugs Act 1967, the Office of Drug Control also granted the first cannabis research and commercial cultivation licences to Melbourne-based Cann Group in February and March. Cann Group Chairman Mr Allan McCallum said, ‘we are putting in place the building blocks to ensure we have industry-leading research, cultivation and manufacturing capabilities. This will position us to eventually provide Australians with access to innovative and high quality medicinal cannabis treatments.’
The Victorian Budget 2016-17 included $28.5 million to establish the Office of Medicinal Cannabis and the Independent Medical Advisory Committee to map out the steps required to roll out this treatment, which will be the first locally produced medicinal cannabis to be legally available in Australia.
In March Premier Daniel Andrews announced 29 children with severe epilepsy would become the first patients in Victoria to be legally treated with medicinal cannabis, in the form of cannabidiol oral solution fast-tracked from Canada. The product was exported by Tilray, the first medicinal cannabis research and production company in North America to be GMP-certified in December 2016, and is also available to other Australian states and territories as well as New Zealand under the special access pathways.
The Queensland Government enabled legal access to medicinal cannabis in December 2015 and facilitated clinical trials investigating its use to treat children with drug-resistant epilepsy in July 2016.8 As of March 2017, palliative care, oncology and neurology patients in Queensland can legally access medicinal cannabis through the relevant specialists. Doctors can more easily gain approval for their patients through the Public Health (Medicinal Cannabis) Act 2016. Dispensing pharmacists must complete a Medicinal Cannabis Management Plan detailing how the risks associated with the product will be managed.
New South Wales
State Opposition Leader Luke Foley has introduced legislation to the NSW Parliament to decriminalise cannabis possession for the terminally ill. Medically certified patients and their carers would be able to use small amounts of cannabis (up to 15 grams) to ease the pain of chronic or serious medical conditions. Mr Foley said, ‘seeking respite from relentless and unwavering illness should not be a criminal offence. It should be met with sympathy and support.’
Over the next five years the state will also invest $9 million in clinical trials,9 including a partnership between the University of Sydney and Tilray to investigate the potential for medicinal cannabis to treat chemotherapy-induced vomiting and nausea.
In April 2016 the Tasmanian Government announced the Controlled Access Scheme (CAS), enabling specialist doctors to prescribe medicinal cannabis to patients with serious medical conditions that have not responded to conventional treatments. The scheme aims to allow broader access than other state legislation because it does not specify particular conditions.10 An expert panel under the Department of Health and Human Services will assess applications.
Australian Capital Territory
In August 2016 the ACT Government announced plans to establish a Medicinal Cannabis Scheme, including evidence-based guidelines and education resources to support medical practitioners in how to best prescribe medicinal cannabis.11 Although the government highlighted that the ACT’s ability to cultivate was limited by the small size of its jurisdiction, it was optimistic about the Territory’s potential for research, including a $1 million research project at the University of Canberra on the use of cannabis to treat melanoma.
As of 1 November 2016, certain medicinal cannabis products can be prescribed by doctors after they apply to the ACT Chief Health Officer. The ACT Minister of Health has also sought expressions of interest for the ACT Medicinal Cannabis Medical Advisory Panel.12
From 1 November 2016 specialist doctors can legally prescribe and pharmacists can legally dispense medicinal cannabis products. Doctors must first gain approval from the TGA and the Western Australian Department of Health.13
The state introduced zero-tolerance drug-driving laws in February 2016, with no leniency for users of medicinal cannabis. The Northern Territory election took place in August 2016, shortly before the new medicinal cannabis legislation came into effect, with neither major party taking a stance on the issue.
In February the South Australian Government moved to legalise industrial hemp. The legislation limits the level of THC in any crops grown in South Australia and subjects growers to a fit and proper person test and regulatory checks.
In March MPs from all major parties hosted a forum with health professionals, consumers and the medicinal cannabis industry, addressing the fact that for many patients, access to medicinal cannabis was still only a ‘mirage’ because, even though it was technically legal, South Australia did not yet have a single authorised prescriber.
What role will pharmacists play?
To ensure Quality Use of Medicines, pharmacists need to be aware of changes in legislation and how they play out at a state level.
Dr Smid said he expected pharmacists to play an important role in the safe dispensing of medicinal cannabis in Australia. ‘This may cover many facets of the pharmacist’s existing role between the community and health profession, including education, monitoring and vigilance.’
He noted that, although most medicinal cannabis products will need to be both refrigerated and secure, for example in lockable or code-protected fridges, ‘I can’t see them requiring any further security arrangements beyond other prescription drugs with an abuse potential.’
The pharmacy profession has already advocated for and established similar public health services such as pharmacist-delivered vaccinations, which are now successfully offered in every state and territory in Australia. Pharmacists, who will be the ones supplying and dispensing medicinal cannabis, should therefore play a role in the ongoing debate around its legalisation.
In May 2016, researchers at the University of Sydney released a study exploring pharmacists’ views on medicinal cannabis, based on interviews with 34 registered Australian pharmacists. The study’s motive was the fact that ‘pharmacists are the gatekeepers of medicines and future administrators/ dispensers of cannabis to the public, however very little has been heard about pharmacists’ perspectives.’1
The study found that, ‘overall, the majority of participants expressed support and encouragement for the legalisation of medicinal cannabis with a sense of duty of care to their patients.’ Most of them supported its legislation as a Schedule 8 medicine although some thought it could be more appropriately classified as a Schedule 4.
Most of the pharmacists said community pharmacy would be the most appropriate setting for patients to obtain medicinal cannabis because it was the most accessible, particularly for chronic and palliative patients.
The study also brought to light potential barriers to supply, as well as some ethical and professional concerns. The pharmacists suggested the development of comprehensive guidelines, quality assurance protocols and/or recording systems, even a nationalised framework.
‘Pharmacists’ support for a nationalised framework was to ensure a level of consistency, uniformity and standardisation across the country (i.e. to avoid inter-state variations).’
Some pharmacists were concerned about an increased risk of security issues such as break-ins, suggesting that pharmacists had the right to conscientiously object. One pharmacist put it this way: ‘I don’t think we can dictate that all pharmacists dispense it, because individuals may have their preferences and that is something we may have to accept. I just think we should encourage all pharmacists to be part of it and participate in it as they have a responsibility here to dispense these particular products.’
Overall, the study concluded that, ‘pharmacists would be responsible for the stocking, handling, ethical supply, counselling and overseeing the safe use of medicinal cannabis. This makes their professional support, opinion and perspective a fundamental aspect to be explored in order to ensure medicinal cannabis is implemented successfully.’
Article Name: The legalisation and supply of medicinal cannabis in Australia and elsewhere is making rapid strides despite a relative lack of evidence for its benefits.