Prescribing Medical Cannabis in Australia

In 2016, the Australian Federal Government made medical cannabis lawful.

There are currently over 100 distinct cannabis products that can be prescribed. The majority are delta-9-tetrahydrocannabinol or cannabidiol-containing oral preparations (oils) or pills. There are other dried-flower goods available.

Prescriptions must be approved under the Therapeutic Goods Administration Special Access Scheme-B or Authorised Prescriber Scheme because most items are unregistered pharmaceuticals.

Applications for Special Access Scheme Category B can be submitted online, and approval is normally obtained within 24–48 hours. However, supply chain issues may cause the pharmacy to postpone dispensing.

Over 28,000 prescription permissions have been provided to patients by the end of 2019, involving over 1400 clinicians, the majority of whom were GPs. By the end of 2020, more than 70,000 approvals are expected.

Chronic non-cancer pain, anxiety, cancer-related symptoms, epilepsy, and other neurological illnesses account for the majority of prescriptions. However, there is a scarcity of evidence to back up some of the assertions.

Many doctors are hesitant to prescribe marijuana. While major side effects are uncommon, there are valid worries about driving, cognitive impairment, and drug dependency with delta-9-tetrahydrocannabinol-containing medicines. Cannabidiol-only products are less dangerous.

Is Cannabis Legal In Australia?

The availability of medical cannabis products is becoming more legal. In the face of growing public interest, product commercialisation, and significant patient demand for access, several countries are loosening their cannabis regulations. The great majority of Australians are in favour of medical marijuana use [1]. Media accounts of individuals with incurable diseases whose lives have been altered by cannabis-based therapies have fueled this support [2].

Medical professionals are naturally hesitant when it comes to medicinal marijuana. According to a poll of Australian GPs, they are unaware of the access methods, accessible products, and evidence basis supporting medical cannabis. 3 Patients frequently inquire about cannabis, but only a tiny percentage of doctors are comfortable discussing it with their patients. Overall, GPs are favourable about prescription medical cannabis, especially for serious diseases including cancer pain, chemotherapy-induced nausea and vomiting, epilepsy, and difficult-to-treat neurological disorders, if provided enough instruction [3]. With worries about the insufficient data from clinical studies and probable harmful effects, specialist colleges and the Australian Medical Association remain conservative voices in the medical cannabis discussion [4;5].

Defining Medical Cannabis

Hundreds of bioactive compounds have been discovered in the cannabis plant, the majority of which have yet to be identified. THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) are the two most researched cannabinoids (CBD).

Because of its activity on CB1 cannabinoid receptors, THC is responsible for the intoxicating effects of cannabis [6]. Despite intoxication effects at higher dosages, clinical trial data largely supports THC’s usefulness in treating chronic pain, multiple sclerosis spasticity, anorexia and cachexia, Tourette syndrome, and chemotherapy-induced nausea and vomiting [7;8]. Trials are under conducted to better characterise THC’s role as a treatment in these and other illnesses [910].

CBD has a wide spectrum of pharmacological effects but does not cause intoxication. CBD appears to have therapeutic effects at relatively large dosages (300–1500 mg) in the treatment of epilepsy, anxiety, and psychosis, according to preliminary research [11;12]. Other illnesses include neuropathic pain, drug and alcohol addiction, and neurodegenerative disorders are all undergoing clinical studies. CBD is widely accessible in over-the-counter nutraceutical ‘wellness’ products in various nations. These contain extremely low dosages (e.g., 5–25 mg) for which there is now minimal evidence of health benefits. CBD is not yet sold over-the-counter in Australia, however the Therapeutic Goods Administration (TGA) is investigating the feasibility of such streamlined access [13;14].

Past, Present, and Future

For many GPs who are unfamiliar with this developing field of clinical practice, prescribing medical cannabis may feel like a “jump in the dark.” Patients in Australia are inquiring about medical cannabis on a regular basis, therefore physicians should learn more about it whether or not they intend to prescribe it. 3 The Royal Australian College of General Practitioners hosts educational events, online courses, and certified seminars. Doctors who do not want to prescribe cannabis to their patients may refer them to one of the several cannabis access clinics that have sprung up in Australia’s major cities.

Despite the rapid increase of SAS-B approvals, polls show that many Australians continue to self-medicate using illegal cannabis [15;16]. Indeed, according to the National Drug Strategy Household Survey, 600,000 Australians use cannabis for therapeutic purposes, but only 3.9 percent get it through legal channels [17]. The high cost of unregistered cannabis-based products compared to illicit cannabis (which is often home-grown), the inability to find a doctor who will help with a TGA application, a lack of knowledge of official access pathways, and a reluctance to discuss cannabis use with a doctor could all be factors [15;16].

Illicit cannabis products are likely to be less effective as medicines. They are likely to contain a lot of THC and very little CBD [18], as well as pollutants including pesticides and heavy metals. The cannabinoid makeup of artisanal cannabis oils used in Australia to treat intractable children epilepsies varies significantly. In other situations, goods marketed as CBD-dominant were really high in THC [19]. The Australian standard TGO 93 for medical cannabis must be met by products purchased through authorised systems.

While the SAS-B and Authorised Prescriber programs are intended to provide access to quality-controlled pharmaceuticals, the existing framework is still being developed. It may still fall short of community expectations in terms of patient access. A recent Australian Senate Inquiry [20] made a number of suggestions aimed at enhancing patient access to goods and outlining measures to improve doctors’ education in this fast evolving and sometimes difficult field of clinical practice.

References

[1] National Drug Strategy Household Survey 2016: detailed findings

[2] Cannabis is the only thing easing their chronic pain. Now their father is facing jail

[3] Knowledge and attitudes of Australian general practitioners towards medicinal cannabis: a cross-sectional survey 

[4] Statement on “Medicinal Cannabis” with particular reference to its use in the management of patients with chronic noncancer pain

[5] Compassion and evidence in prescribing cannabinoids: a perspective from the Royal Australasian College of Physicians

[6] Dark Classics in Chemical Neuroscience: Δ9-Tetrahydrocannabinol

[7] The Health Effects of Cannabis and Cannabinoids

[8] Medicinal cannabis – guidance documents

[9] Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) for chronic insomnia disorder (‘CANSLEEP’ trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial

[10] Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV) 

[11] Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome

[12] Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test

[13] Current barriers to patient access to medicinal cannabis in Australia

[14] Notice of interim decisions on proposed amendments to the Poisons Standard – ACMS and Joint ACMS-ACCS meetings, June 2020

[15] Medicinal Cannabis for Inflammatory Bowel Disease: A Survey of Perspectives, Experiences, and Current Use in Australian Patients

[16] Medical cannabis use in the Australian community following introduction of legal access: the 2018–2019 Online Cross-Sectional Cannabis as Medicine Survey (CAMS-18)

[17] National Drug Strategy Household Survey 2019

[18] Analysis of Cannabis Seizures in NSW, Australia: Cannabis Potency and Cannabinoid Profile

[19] Composition and Use of Cannabis Extracts for Childhood Epilepsy in the Australian Community

[20] Current barriers to patient access to medicinal cannabis in Australia

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