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Medical use of cannabis

Medical use of cannabis

National position statement


A joint position statement with the Clinical Oncology Society of Australia


This is a position statement only and does not provide clinical advice about the use of medicinal cannabis in cancer.

The Therapeutic Goods Administration website has patient information and guidances to assist health professionals who choose to prescribe medicinal cannabis in Australia.


Key messages and recommendations

  • In Australia, medicinal cannabis refers to a range of quality assured, pharmaceutical cannabis preparations, for the relief of a medical condition and must be prescribed by a doctor. It should be taken as prescribed.
  • Existing published evidence does not support the use of medicinal cannabis for therapeutic indications relating to treatment or cure of cancer.
    • There is limited current evidence that medicinal cannabis or cannabinoids are effective at inhibiting tumour growth, or to treat or cure cancer in humans. In addition, there is no current evidence that medicinal cannabis or cannabinoids reduce risk or prevent cancer occurrence.
  • There is some limited low-level evidence that medicinal cannabis and cannabinoids in controlled delivery may benefit cancer patients where conventional treatments are unsuccessful in providing relief in the following areas:
    • for relieving nausea and vomiting in patients undergoing chemotherapy;
    • as an analgesic in patients experiencing pain;
    • as an appetite stimulant for patients experiencing weight loss and muscle wasting.
  • There are currently no cannabis and cannabinoids, natural or synthetic, based therapeutic products listed on the Australian Register of Therapeutic Goods indicated for use in cancer care in Australia. Products are available via the Special Access Scheme or an Authorised Prescriber. As of 1 February 2021, low-dose cannabidiol products listed on the Australian Register for Therapeutic Goods for use in adults can be supplied over-the-counter by pharmacists without a prescription.
  • There are currently several clinical trials underway at various phases to investigate the use of medicinal cannabis in cancer.
  • Community interest must be met with appropriate clinical evidence, best practice guidance and safety frameworks.
  • Currently there are no formal international or national supportive care guidelines for prescribing cannabis for the effective management of side effects of cancer or cancer treatment.
  • All patients presenting with side effects of cancer or cancer treatment must be supported to access appropriate management and relief options as early as possible, as a first line response.
  • Cancer Council and the Clinical Oncology Society of Australia strongly recommend reporting of the indication, safety, quality and other outcomes of interest, of unapproved cannabis-based therapeutic products prescribed through either an Authorised Prescriber or Special Access Scheme to enable the collection of real-world data to inform future availability and use of medicinal cannabis.
  • Evidence from controlled clinical trials is required to evaluate the impact of medicinal cannabis and cannabinoid products on cancer and side effects of cancer treatment. Cancer Council Australia and the Clinical Oncology Society of Australia welcome research into the potential benefits of cannabis and cannabinoids for cancer patients. Health professionals seeking to prescribe medicinal cannabis to patients should refer to the Therapeutic Goods Administration guidance documents.


Background

Managing conditions induced by cancer and cancer treatment, especially in patients with advanced cancer who have responded poorly to conventional relief options, is a significant concern for cancer patients and their doctors. There is increasing interest, both internationally and in Australia, in the opportunities to use cannabis in cancer care, particularly to relieve side effects of cancer treatment. However, there is currently limited evidence to support the quality, safety and efficacy for use of cannabis in standard care.

Cannabis, also known as marijuana (and colloquially as grass, pot, weed, hash etc.), is made from the dried flowers and leaves of the Cannabis sativa plant. Cannabinoids are chemical compounds found within cannabis which act upon cannabinoid receptors in the body. Cannabis contains over 500 distinct compounds, of which at least 144 are cannabinoids.[1].The two most abundant and researched cannabinoids are Tetrahydrocannabinol (THC) and Cannabidiol (CBD).

THC is the primary psychoactive component of cannabis, with the therapeutic use of THC complicated by its psychoactive side effects. In recent years, interest has increased in the potential use of non-psychoactive cannabinoid compounds such as CBD and other cannabinoids to alleviate chemotherapy induced illness.

In Australia, medicinal cannabis refers to a range of quality assured, pharmaceutical cannabis preparations, for the relief of a medical condition and must be prescribed by a doctor.[2][3] It should be taken as prescribed. Unregulated cannabis contains unknown concentrations of cannabinoids and may expose patients to harmful pesticides, fungicides and bacteria. Cannabinoids used in medicinal cannabis products can be derived naturally as extracts from the cannabis plant, such as nabiximol which is a chemically pure 50:50 mixture of THC and CBD; or produced synthetically in a laboratory to mimic or produce similar effects, such as dronabinol and nabilone which contain synthetic THC.[4] Several clinical trials are currently underway in Australia investigating the efficacy of cannabis in a medicinal form, and its use in specific cancer care indications, including symptom management for loss of appetite, nausea, insomnia and pain. Animal and human studies are currently being conducted to evaluate the potential for anti-cancer effect for some cancers.


Legal and regulatory implications

In Australia, cannabis and its products are regulated under various federal and state laws. Cannabis is encompassed by law under the Narcotics Drugs Act 1967,[5] and the Therapeutic Goods Act 1989,[6] and compliance is required with Customs (Prohibited Imports) Regulation 1956.[7] These controls ensure that practitioners prescribe according to current recommended indications using either the Special Access Scheme or as Authorised Prescribers or access via a clinical trial.[8] The Standard for the Uniform Scheduling of Medicines and Poisons is a Commonwealth legislative instrument consisting of decisions that classify different medicines and poisons into ‘schedules’. It is implemented through state and territory laws which may impose additional restrictions on the use of cannabis.

International agreements

Australia is a signatory to two United Nations international agreements relating to the use of cannabis for medical purposes: The Single Convention on Narcotic Drugs (1961);[9] and the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988).[10] The agreements aim to ensure the availability of controlled substances for medical and scientific purposes, and to combat drug misuse through coordinated international action, including drug trafficking. The Single Convention on Narcotic Drugs was implemented to limit possession, use, trade in, distribution, import, export, manufacture and production of drugs exclusively to medical and scientific purposes.[9] The Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances listed additional behaviour and mood-altering drugs to the Single Convention on Narcotic Drugs and distinguished between drugs which are totally prohibited and those, such as cannabis, which have the potential to be used for restricted medical purposes.[10] Australia must uphold its commitment to these agreements when considering the use of medicinal cannabis.


Evidence-base for medicinal use of cannabis

The purpose of this Position Statement on Medicinal Use of Cannabis in Cancer is to present the existing evidence of the effect and application of therapeutic preparations of cannabis in the human population. Therefore, it purposefully excludes evidence from pre-clinical trials, studies relating to cannabis and the endocannabinoid system, and research currently being conducted and therefore without results to publish. However, evidence from early phase studies, review papers utilising a wide range of research,[11] and pre-clinical studies,[12][13] indicate potential for medicinal cannabis to relieve effects of cancer and chemotherapy. Future evidence will be considered and incorporated into this Position Statement as available.

Existing published, peer-reviewed evidence does not support the therapeutic application of cannabis in cancer care. However, when symptoms are deemed refractory, a doctor on behalf of their patient, can request access to medicinal cannabis products to relieve pain associated with cancer symptoms and side effects of cancer treatment through the TGA Special Access Scheme or an Authorised Prescriber or an available clinical trial. This evidence to support this request is summarised below.

These conclusions were assessed against evidence summaries produced by the Commonwealth Department of Health to inform the Therapeutic Goods Administration (TGA) medicinal cannabis guidance documents for the use of medicinal cannabis approved via the Special Access Scheme in Guidance for the treatment of palliative care patients in Australia, and Guidance for the prevention or management of refractory chemotherapy induced nausea and vomiting in Australia.[14]

Evidence limitations

Historically, across the international research community, research into the use of cannabis in cancer and cancer care has been predominately conducted in vitro or in vivo using animal models. Studies using humans are entering the peer reviewed literature, however these remain limited. To date, and particularly reflected in the evidence available to inform this Position Statement, most human studies within existing published literature frequently compared medicinal cannabis prepared as a therapeutic product, either in its natural form or synthetic, with a placebo or used a comparator drug either not considered standard of care or indicated for the effect. The different comparator drugs used, and lack of significant results makes it difficult to draw conclusions from the evidence on the efficacy of medicinal cannabis. Additionally, many studies had high drop-out or non-completion rates by participants. The poor feasibility of the studies restricts accurate insights into effectiveness and potential population prescribing because, understanding the characteristics of who will benefit from the products are limited, resulting in inconclusiveness.

Prevention of cancer

There is no evidence that medicinal cannabis prevents cancer. Most studies investigated the role of cannabinoid receptors, CB1 and CB2 in cancer prevention, not the effect of cannabis itself.

Impact of cancer growth

There is limited, low quality evidence available on medicinal cannabis promoting or reducing cancer growth. One in vitro study investigated the impact of CBD and the synthetic cannabinoid WIN-55,212 in inhibiting prostate and colon cancer cells.[15] CBD was found to be more effective in inhibiting growth among both types of cancer cells, compared to WIN which only inhibited prostate cell proliferation.[15] This is a field of current research nationally and internationally with no results to report to support the use of medicinal cannabis in control or prevention of cancer.

There is also currently no evidence of the comparative effectiveness of medicinal cannabis, containing either natural or synthetic cannabinoids, compared to standard cancer treatment.

Curing cancer

There is currently no evidence that medicinal cannabis, containing either natural or synthetic cannabinoids, can treat or cure cancer or inhibit cancer growth.

Management of cancer symptoms and side effects from cancer treatment

Most of the research into the clinical application of medicinal cannabis has been in the management of common side effects induced by cancer treatment, usually chemotherapy. Evidence indicates that medicinal cannabis may provide a limited benefit for people affected by chemotherapy-induced nausea and vomiting, although the quality of these studies restricts the ability to translate this into practice.

Chemotherapy-induced nausea and vomiting

Several studies assessed the efficacy of medicinal cannabis on alleviating chemotherapy-induced nausea and vomiting as a single indicator.[16][17][18][18][19][20][21][22] All reported that synthetic THC based medicinal cannabis was more effective than either prochlorperazine (an antiemetic and antipsychotic drug which works by changing the actions of chemicals in the brain),[19][21][22] no treatment,[20] or non-concurrent comparison groups.[16][17][18] A statistically significant difference was found in one study, which compared dronabinol and prochlorperazine in combination to single agent (dronabinol or prochlorperazine). Study drop-out rates were greater than 10% and in five out of eight patients this was due to adverse events, compromising study validity.[19]

Chemotherapy-induced nausea

Most studies assessing the efficacy of medicinal cannabis in improving chemotherapy-induced nausea reported that synthetic THC based medicinal cannabis was more effective than a comparator drug,[23][24][25][26][27][28][29] or placebo treatment,[30][31] except for one which compared nabilone to prochloraperazine.[32] Another study reported that naturally extracted THC was more effective at improving chemotherapy-induced nausea compared to prochlorperzaine.[29] While these studies had relatively small sample sizes, five concluded that medicinal cannabis was significantly superior to a comparator. These were compared to oral procholorperazine,[23][24][26][27] and ondansetron, which blocks serotonin that causes vomiting.[28] A combination of small sample sizes and incomplete data in these studies possibly impacts the representativeness and conclusiveness of the findings.

Chemotherapy-induced vomiting

All studies which assessed the efficacy of medicinal cannabis in improving chemotherapy-induced vomiting concluded that synthetic THC based or naturally extracted THC based medicinal cannabis was more effective than a comparator drug,[23][24][25][26][27][28][32][33][34] or placebo treatment.[30][31][35] Although the majority reported that the results were statistically significant,[23][25][27][30][31][32][33][35] sample sizes were small, ranging from 19 to 114 participants with drop-out rates greater than 10%, often because of incomplete treatment. In addition, variations in the administration of drugs makes it difficult to compare studies and their effects.

Radiotherapy-induced nausea and vomiting

Only one study assessed the efficacy of medicinal cannabis (oral levonantradol) on radiotherapy-induced nausea and vomiting and found that levonantradol was no different to the drug oral chlorpromazine.[36]

Pain management

Four studies measured pain outcomes in patients who had cancer pain that was unalleviated by opioid therapy.[37][38][39][40] These studies concluded that Sativex, a commercially developed nabiximol containing a combination of THC:CBD and taken as a self-titrated spray was superior to a matched placebo or no treatment. However, an article that published two studies, found in the second study, that Sativex was no better than placebo at improving pain in patients who had previously responded to Sativex.[38] In a similar population, a study that assessed the effectiveness of nabiximol at improving pain, sleep and quality of life outcomes concluded that improvements were non-significant compared to a matched placebo.[41]

Among patients with chemotherapy-induced neuropathy pain, nabiximol, as a spray, appeared to be more effective than a placebo in improving neuropathy pain and quality of life outcomes.[42] Quality of life outcomes assessed included physical and emotional health problems (i.e. anxiety or depression), such as the ability to complete work and/or daily activities.[42]

Appetite

Five studies assessed appetite changes among cancer patients who had reported a loss of appetite or weight.[43][44][45][46][47] Of these studies, two found that synthetic THC medicinal cannabis products, oral nabilone,[46] or oral dronabinol,[45] were more effective in improving appetite compared to a matched placebo. Another study found that oral megestrol acetate, a non-cannabinoid comparator drug, was significantly more effective than oral dronabinol for improving appetite and promoting weight gain.[44] Four also assessed quality of life,[43][45][46][47] but only one concluded that medicinal cannabis (oral dronabinol) significantly improved quality of life compared to a matching placebo.[44] The measurement of quality of life differed across studies, some utilised scales and others questionnaires, which may have affected the comparability of results.


Best practice management of cancer symptoms and side effects of cancer treatment

To support doctors who wish to prescribe cannabis-based therapeutic products not approved, the TGA released a set of clinical guidance documents across a range of conditions to support informed decision making with their patients.[14] These guidance documents provide advice on the use of medicinal cannabis in the treatment of palliative care patients in Australia, and for the prevention or management of nausea and vomiting in Australia. In addition, the Australian Centre for Cannabinoid Clinical and Research Excellence have developed NSW Cannabis Medicines Prescribing Guidance 'to provide interim information to support NSW medical practitioners in prescribing cannabis medicines to patients for conditions where cannabinoids are perceived to have some benefit '.[48]

Medicinal cannabis is not a recommended treatment option in the Multinational Association for Supportive Care in Cancer (MASCC) and European Society for Medical Oncology consensus Guidelines on the Prevention of Chemotherapy and Radiotherapy Induced Nausea and Vomiting,[49] or the Australian eviQ clinical resources for the Prevention of chemotherapy induced nausea and vomiting,[50] and Management of radiotherapy induced nausea and vomiting.[49]


Access to therapeutic products in Australia

In 2016, the Australian Government amended the Narcotic Drugs Act 1967,[5] enabling the cultivation of cannabis for medical and research purposes. The Office of Drug Control, within the Commonwealth Department of Health, reviews applications and administers licences and permits for the cultivation, production and manufacture of medicinal cannabis therapeutic products. The Office of Drug Control does not have powers to authorise the prescription, administration of, and patient access to, cannabis. Patient access to cannabis for medicinal or research purposes requires both Commonwealth government review and state or territory health authority approval, as well as standard research ethics and governance review for use in human research.

In Australia, all authorised therapeutic substances are required to prove a high standard of safety, efficacy and quality, and demonstrate clinical effectiveness against standard treatment prior to use. Neither cannabis and cannabinoids, nor their synthetic forms have been approved by the TGA for a cancer-related therapeutic indication in Australia. The nabiximol, Sativex has been assessed as demonstrating safety, quality and efficacy for 'treatment, for symptom improvement in patients with spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medicine who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy '.[51] This efficacy does not as yet translate to other indications.

Cannabis, including seeds, extracts, resins and the plant, and any part of the plant , is typically a Schedule 8 controlled drug.[52] Schedule 8 controlled drugs are substances that ' should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical and psychological dependence '.[52] However, as the Standard for the Uniform Scheduling of Medicines and Poisons is implemented through individual state or territory drugs, poisons and controlled substances legislation, additional restrictions to access may be applied. Cannabis-based therapeutic products, dronabinol, nabilone and nabiximol are listed as Schedule 8 controlled substances.[52] Cannabidiol is listed as a Schedule 4 prescription-only medicine where it comprises 98% or more of the total cannabinoid content of the preparation and where other cannabinoids in the preparation are naturally found in cannabis and make up less than 2 percent of the preparation’s total cannabinoid content. Schedule 4 substances are 'substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription '.[52]

On 15 December 2020, the TGA announced that it would down-schedule certain low dose cannabidiol preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine) under the Poisons Standard. As of 1 February 2021, low-dose cannabidiol products containing up to a maximum of 150mg/day for use in adults will be allowed to be supplied over-the-counter by pharmacists without a prescription. Only low-dose cannabidiol products approved by the TGA and listed on the Australian Register of Therapeutic Goods that comply with specific packaging and dosage requirements under the Poisons Standard can be supplied.

Access to Schedule 8 substances unapproved in Australia can be sought through either the TGA’s Special Access Scheme, Authorised Prescriber initiative or through a clinical trial.[53] For the first two pathways, applications are assessed by the TGA on a case by case basis and require a doctor to agree to prescribe and monitor the use of the unapproved product. There is also an option for a product to be imported into Australia using Special Access Scheme Category A.[54] Cannabis and cannabis-based products are excluded from personal importation under the Therapeutic Goods Regulations 1990,[55] because cannabis is a prohibited substance under the Customs Act 1901.[6] A medical practitioner licensed under the Customs Act to import medicinal cannabis can do so on behalf of their patient through the Special Access Scheme. Patients must fund the cost of the product as no medicinal cannabis products are currently subsidised by the Pharmaceutical Benefits Scheme.


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