What is the current number of medicinal cannabis prescriptions in Australia so far?
The number of Medicinal Cannabis prescriptions in Australia is expected to reach 10,000 prescriptions by July 2019.
This is a significant increase from approximately 3,100 prescriptions for medicinal cannabis reported at the beginning of 2019.
- This figure represents less than 5% of the reported cannabis users in Australia
- 95% of cannabis use in Australia is still obtained and used illegally (via the ‘black market’)
Many Australian cannabis users are still buying and possessing cannabis illegally, for either recreational or medicinal purposes
- Possessing or growing cannabis in Australia without the proper ODC approvals, licences and permits, remains illegal and punishable by law
- Possessing or using cannabis as an individual, without a medical prescription, also remains illegal in Australia
Comparisons to other countries:
- In Canada, an estimated 71% of cannabis consumption is through illegal means
- said to relate to a lack of adequate legal supplies and
- higher costs of high-grade products
- California also struggles with a high degree of illicit marijuana sales
Medicinal Cannabis prescription trends | Changes in the number of SAS approvals for cannabis medications
The Table below illustrates changes in SAS Category B approval statistics for medicinal cannabis prescriptions in Australia.
- As of 31 May 2019, the TGA approved over 7,700 SAS Category B applications for unapproved medicinal cannabis products.
- A breakdown of the number of SAS Category B approvals by month (June 2018 to May 2019) is shown below
|Month||Number of SAS Category B approvals|
Number of medicinal cannabis prescriptions in June 2019: Yet to be reported.
It is expected that reports of the number of medicinal cannabis prescriptions (occurring in June 2019) will increase the total prescriptions to over 10,000 prescriptions for medicinal cannabis in Australia.
Please note: These figures are reported to represent the number of SAS Category B approvals only.
- The TGA received its first known medicinal cannabis SAS application in 1992.
- Most cannabis prescription approvals have occurred since 2016, with a nearly 200% increase in the past 6 months.
As of 30 June 2019, the total number of prescriptions for medicinal cannabis in Australia is expected have exceeded 10,000.
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Recreational vs Medicinal Use | An overview of GMP
Medicinal cannabis suppliers are subjected to strict cultivation and production licencing requirement, including secure record-keeping systems, regular testing and reporting, and frequent GMP auditing.
GMP helps ensure a quality, consistent product that is free from harmful contaminants that could seriously harm vulnerable individuals seeking these types of medications.
EU GMP / Australian GMP compliance for medicinal cannabis production is important because:
- Many individuals wanting to access medicinal cannabis may have compromised immune systems, e.g. cancer patients or people with HIV
- This compromised immunity means the purity of their cannabis medications is paramount to their safety; it is feasible that if a pharmaceutical product contained impurities, it could prove fatal to immune-compromised patients
Cannabis that is not GMP pharmaceutical-grade is of unproven purity, questionable quality, and varying strengths; substandard medicines could harm vulnerable patients with compromised immune systems.
This is one reason that EU/GMP must be followed at all steps of producing pharmaceutical cannabis products for domestic and international products.
Cannabis pharmaceuticals must meet TGO93 standards and/or EU/GMP.
The problem with the illegal use of cannabis by patients with serious health conditions:
- Illegally grown or imported cannabis products lack isolation of the medicinal components in cannabis plants
- They are a risky and inconsistent source of cannabinoids and/or THC
Online cannabis medication providers are already targeting individuals with fake cannabis medications, which are highly unlikely to have any valid therapeutic effects
- Illegal products are very unlikely to meet pharmaceutical standards (sterility, quality, strength consistency) as mandated by the Therapeutic Goods – Standard for Medicinal Cannabis (TGO 93) Order 2017.
- Users of illegal cannabis products also tend to inhale illegal cannabis and/or mix it with tobacco
- Inhalation of smoke particles and other toxins can cause significant harm to lung health and further compromise the health status of individuals, particularly those with serious conditions
Illegal cannabis also carries serious repercussions for importation, exportation, possession and use in Australia.
Pharmaceutical grade cannabis must meet TGO 93 standard. That noted, it remains an unapproved medication that is only available through Special Access Schemes (SAS).
Getting a prescription for medicinal cannabis in Australia
How easy — or how difficult — is it to get a prescription for medicinal cannabis?
Authorisation to prescribe unapproved cannabis medicines is monitored at the STATE level. This can vary from state to state.
- Gaining access for medicinal cannabis medications has reportedly been challenging for patients.
- They are encouraged to see their GP, who may — or may not — already applied for approval as an Authorised Prescriber or SAS prescriber.
- States are in charge of approving the prescribing medical provider (some applications can be done online, but this can take some time); AND
- Applications for Special Access for individual patients must also be submitted (said to take at least 2 days).
GPs and other medical professionals wanting to supply medicinal cannabis to patients need to apply one of two ways: either under the Special Access Scheme or by making an application under the Authorised Prescriber Scheme.
Many doctors remain hesitant to prescribe these medications and/or remain unfamiliar with their potential uses, dosage recommendations and effects.
Read more about the need for further clinical research studies for cannabis.
Which health conditions might benefit from medicinal cannabis?
TGA Special Access Schemes recognise that cannabis medications, while unapproved by the TGA due to insufficient efficacy and safety data, MIGHT have benefit for the following conditions:
- chemotherapy-induced nausea and vomiting
- refractory paediatric epilepsy
- palliative care indications
- cancer pain
- neuropathic pain
- spasticity from neurological conditions
- anorexia and wasting associated with chronic illness (such as cancer)
- others not listed above
Number of Medical Cannabis Prescribers in Australia
Nearly any Doctor can prescribe Medicinal Cannabis through the Special Access Scheme, once they’ve been approved as an Authorised Prescriber.
Many, however, remain reluctant to do so. This is partially due to unfamiliarity with the medications and a lack of consistent evidence in published trials.
- Many of the published cannabis-based research trials had low-quality evidence in relation to efficacy, dosing requirements and side effects.
- Inconsistent or inconclusive research findings hence remain a concern for prescribing Doctors, given these medicines are not yet TGA approved.
Inconclusive findings in systematic reviews are likely resulting from small study sizes or insufficiently rigorous trials.
That noted, worldwide prohibition of herbal medications prevented research from occurring for decades. Efficacy and safety research is expected to increase, in quality and quantity, with Federal legislation changing around the world. In fact, many top Universities – the latest being the University of Pennsylvania – are well into their research projects with new funding and study ethics approvals.
In Australia, NSW and Queensland both started research trials within 12 months after Federal Laws were changed, allowing easier access to cannabis-based medications.
There remains, however, a chasm between wanting to investigate innovative medicines and protecting the safety of study participants as well as research Sponsors in the face of contradicting, or insufficient, evidence.
There’s high excitement in Australia about the potential use of cannabinoid medications to treat various illnesses, including PTSD, opioid addictions and chronic pain.
However, HREC approvals in Australia have often been delayed, or turned down, to the frustration of medical researchers wanting to explore different applications for medicinal cannabis formulations. Attaining quality TGO93 cannabis medication supplies remains a challenge.
Doctors and patients have personal and professional liability for prescribing unapproved Medications
Another reason some GPs remain hesitant to prescribe medicinal cannabis arises from the fact that these medications, while available through Special Access Schemes, are not yet on the TGA approved medication list.
- Cannabis medications are not included in the Australian Register of Therapeutic Goods (ARTG).
- An unapproved medication status means that efficacy and safety, including potential side effects, have not been fully assessed.
Until further studies provide more evidence for the efficacy and safety of these medications, Doctors carry a degree of professional liability for prescribing the medications.
- There also remains a stigma about these medications.
- Most of the stigma persists due to a lack of exploration into the scientific differences in various cannabis-derived medications vs recreational use ‘pot’ or ‘weed.’
- Scientists and medical researchers are hoping to better educate patients, doctors, journalists and policy-makers about the differences between illegal vs highly-regulated, pharmaceutical-grade cannabis products produced using GMP (good manufacturing processes) and record-keeping systems
Additionally, Medical Professionals and prescribers simply lack adequate training in understanding specific conditions for which cannabinoid medications might have a positive effect.
The two main types of medical cannabis prescriptions are those that contain delta-9 tetrahydrocannabinol (THC), the psychoactive component; and those that contain non-psychoactive cannabinoids (CBD).
The level of THC determines if the cannabis medication is listed as a Schedule 8 or Schedule 4 medication.
Excerpt: In Victoria, for example, the CBD content of Schedule 4 medicinal cannabis products must be 98 per cent of the total cannabinoid content (e.g. A CBD to ‘other cannabinoid’ ratio of 49:1). This means other cannabinoids must be less than 2% of the medication content.
Cannabis medications with other components, such as over 2% THC, are classed as Schedule 8 controlled drugs.
Number of TGA Registered medicinal cannabis products
- Only one (1) medicinal cannabis product, Nabiximols (Sativex®), is listed on the ARTG as a Schedule 8 controlled drug (as of June 2019)
- The approved indication for Nabiximols (Sativex®) is: ‘treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.’
Cannabis-based medication permits and/or patient access approval processes, in relation to Schedule 8 drug prescriptions, vary from State to State.
Journal Publications and suggested reading
- Epilepsy – randomised controlled trials and other studies
- Multiple sclerosis – randomised controlled trials and other studies
- Nausea and vomiting – randomised controlled trials and other studies
- Pain – randomised controlled trials and other studies
- Palliation – randomised controlled trials and other studies
Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence
Authors: Emily Stockings, Dino Zagic, Gabrielle Campbell, Megan Weier, Wayne D Hall, Suzanne Nielsen, Geoffrey K Herkes, Michael Farrell, Louisa Degenhardt
The use of cannabis and cannabinoids in treating symptoms of multiple sclerosis: a systematic review of reviews
Authors: Suzanne Nielsen, Rada Germanos, Megan Weier, John Pollard, Louisa Degenhardt, Wayne Hall, Nicholas Buckley, Michael Farrell
Systematic review and meta-analysis of cannabinoids in palliative medicine
Authors: Martin Mücke, Megan Weier, Christopher Carter, Jan Copeland, Louisa Degenhardt, Henning Cuhls, Lukas Radbruch, Winfried Häuser, Rupert Conrad
Access to medicinal cannabis products for Consumers
Consumers, GPs, medical professionals and manufacturers can find more information on the Special Access Scheme (SAS) and Authorised Prescriber Scheme at: Access to medicinal cannabis products.
Page last updated: July 1, 2019.