AusDoc special report: Is medicinal cannabis prescribing out of control?
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“The script for medicinal cannabis comes in, then things start to fall apart for them,” says Dr Stephen Parker.
“They become dramatically unwell and don’t return to their previous functioning.”
Dr Parker continues: “The thing that makes me anxious is that we are seeing young people develop psychosis who were performing well in school or university.”
Dr Parker is a psychiatrist at the Metro North Health early-onset psychosis service in Brisbane who is among the growing number of doctors alarmed at Australia’s dramatic embrace of medicinal cannabis as a new mass prescription wonder cure.
He’s aware that there have always been people who use cannabis who develop psychosis — that is part of the bread and butter of any psychosis service.
“The difference here is that we are being referred patients who have been been prescribed this medicinally by other doctors.
“It is becoming more and more the picture of presentations in our youth population — and I know my colleagues in adult psychiatry are seeing it too.”
As you will see, for many within the medical profession, the politicians and regulators who engineered the explosion in prescribing failed to include the usual checks and balances used with drug therapies.
At the time of writing, there are more than 5000 prescribers.
But as AMA president Professor Steve Robson said recently: “It is not clear who is using it, why they are using it, what it is being used for, and whether it actually works or not.
“We are certainly hearing stories about quality issues and adverse responses. And that should trigger concern in the community; it certainly does among the medical fraternity.”
Regulators have been panicked at the spectacle of what has happened. Officials from the Department of Health and Aged Care, along with AHPRA, the TGA, the Medical Board of Australia and a string of other regulators held a rare joint meeting in February to discuss how to protect patients.
The question they will face is whether they are prepared to curb an industry worth around $350 million.
The rise of medicinal cannabis
The story starts 10 years ago at a time when future profits were speculative, based largely on the commercial opportunities offered by various clinical trials suggesting medicinal cannabis had a therapeutic use.
At a national level, one of the loudest voices was that of former Greens senator, and former GP, Dr Richard Di Natale.
In 2014, he introduced a private member’s bill to the Senate that called for the formation of a new regulator to oversee the growing and distribution of medicinal cannabis.
The evidence that the drug was safe and effective was “crystal clear” he told the newspapers.
“This is a reform whose time has come,” he said.
“We need national laws on the issue. I’m confident that federally we’ll get some movement on it.”
A year later, the Victorian Government announced its plans to legalise medicinal marijuana, with the idea that it could be used to treat severe epilepsy, cancer pain and chemotherapy-related nausea, and had a potential role in palliative care.
Then-premier Daniel Andrews fronted the ABC where he spoke of “450 beautiful little people”.
“They’re going to get legally for the first time the medicine that they need to transform their lives, and indeed to save their lives,” he said.
The “beautiful little people” was a reference to children with severe epilepsy.
One high-profile case that featured in the media around this time was that of Barry and Joy Lambert, whose three-year-old granddaughter Katelyn had Dravet syndrome and experienced hundreds of seizures a day.
The couple donated $34 million to the University of Sydney in 2015 to fund medicinal cannabis research, after international findings suggested Katelyn might benefit.
There was also Daniel Haslam, who spoke widely of finding relief from chemotherapy side effects by using the drug. He died aged 25 after a five-year battle with bowel cancer.
NSW premier Mike Baird wrote in The Daily Telegraph: “Dan’s own dreams of a family and a farm will never be realised.
“But his legacy lives on, and this week I am proud to launch Australia’s first medical cannabis trial for terminally ill patients.”
Professor Jennifer Martin, a physician and clinical pharmacologist at the University of Newcastle, was the clinician who led the first stage of that trial.
“When it came to the debate on the legality of cannabis in Australia, the Federal Government always said they were only prepared to go down the standard drug development pathway via the TGA, and so needed a lot of research to actually tell us how to use this drug safety,” she told AusDoc last month.
At the time, Professor Martin was concerned that there needed to be more data on safety, indications, efficacy and dose before it was widely rolled out as a mainstream medical therapy.
She says she got a lot of negative flack.
“I had people writing to my email, sending me notes in my letterbox; I was told that I was blocking people’s access to this life-saving treatment,” she says.
“We weren’t blocking it; we were just clear we needed to ensure we didn’t harm anyone by using it appropriately, and we needed research for that.
“But it seemed apparent that research was going to take three or four years, which it has. And people were saying all these doctors doing clinical trials are delaying us access to it now.”
The key changes came quickly. By October 2015, the then-federal health minister Sussan Ley announced the government would change the law so medicinal cannabis could be cultivated and grown in Australia.
Six months later, the amendments to the Narcotic Drugs Act 1967 passed through Federal Parliament, allowing growers to compete in trade that was becoming global in reach.
At this time, the TGA was already canvassing the idea of down-scheduling medicinal cannabis from a Schedule 9 product to Schedule 8.
The change was made in August 2016.
There was an issue, however.
Given that no medicinal cannabis product had been registered as a therapeutic good, there were only two routes available for clinicians wanting to prescribe the drug: the Authorised Prescriber (AP) pathway and the Special Access Scheme (SAS A and SAS B).
In the two years that followed, there were just 293 approvals.
“It was very tightly governed,” recalls Professor Martin.
“In NSW, we had a health committee that reviewed all applications, and all doctors submitted to that committee every time they wanted to prescribe cannabis.
“Then they would have to advise us what was happening with the patient and whether it was helping, harming or no effect.”
In NSW, the applications were turned around in several days.
But patient groups started to complain that it was taking too long to get the drug to people in need.
Even doctors said the red tape was onerous.
“It’s a basket case,” then-RACGP president Dr Bastian Seidel told the ABC.
“It’s almost impossible [to get a prescription], and it’s impossible because of political reasons,” he added, a reference to what he considered the convoluted and different processes in each state and territory.
So the TGA acted again, this time introducing what seemed a relatively minor bureaucratic tweak: an online system to enable doctors to submit their applications electronically.
Along with this, the watchdog also struck an agreement with the states and territories that this system be amended to require just a single application for both the TGA and the relevant state.
From that point on, prescribing mushroomed.
The number of SAS B approvals jumped from about 2500 in 2018 to 25,000 a year later.
Last year, some 131,910 approvals were made* [see footnote].
“It’s just like an AI tool now,” Professor Martin says.
“In the past when you had an SAS B drug, a pharmacist would ring you from the TGA, you would discuss it with them, and then it would be sent to someone else within the organisation, and they would approve it or not and request governance and oversight.
“But none of that is happening with cannabis — it’s basically just getting automatic approval without having medical oversight.”
Patient harm?
The experiences of the staff at the early-onset psychosis service, given the volume of prescribing, can be seen as worst-case scenario rarities.
Dr Parker and his colleagues wrote in a letter to Australasian Psychiatry last year that five of the 67 patients referred to the clinic between Nov 2022 and July 2023 had been using high concentrate THC in the proceeding three months which had been prescribed to them by doctors.
Two patients continued to obtain prescriptions after the onset of psychosis.
They said four additional patients at the clinic also managed to obtain de novo scripts for high concentrated THC after psychosis onset.
Most patients had obtained their scripts from online clinics — and in all cases, the indication was “anxiety” — but Dr Parker says he hasn’t been able to get in touch with any of the prescribers.
“As a practitioner, I have struggled to communicate with them, I’ve struggled to correspond with them, I’ve struggled to get them on the telephone,” he says.
“I’ve found that to be a real challenge.”
Chair of the RANZCP Queensland branch Professor Brett Emmerson told AusDoc the problem is happening “all along the Queensland coast”.
“The unit that seems to be the most vocal about it, certainly over the last six months, has been the Cairns Mental Health Unit,” he says.
“They estimate there are one or two admissions to hospital every week due to medicinal cannabis.”
He adds: “This industry is causing harm, and it is being widely, inappropriately used.”
In terms of widespread harm, given the scale of prescribing, that is far less clear.
FOI documents on the TGA website show just 126 adverse event reports between March 2023 to March 2024, ranging from psychotic disorders, suicidal ideation, paranoia to nausea, vertigo and eye swelling.
AHPRA has also released figures on notifications against prescribing doctors which show there have been 309 complaints against just over 200 practitioners to date.
Many of these complaints were less about bad outcomes and more about the high costs of scripts, along with claims by patients that the doses prescribed were too weak to have an effect.
However, doctors have also been reported for overprescribing, prescribing without authority, and inadequate or inappropriate history-taking or examination.
As a result, conditions or cautions have been imposed on 26 practitioners, according to AHPRA.
It is important to note that the larger operators stress the care they provide is safe and that their doctors will inform the patient’s usual GP. The health care model is built around the patient, they state.
There are clinics operated by cannabis suppliers where they employ their own in-house doctors – and for critics, these “vertically integrated” models pose serious conflicts of interest.
Running alongside this are those concerns about the care model, specifically the explosion of telehealth cannabis clinics, with their promises of a one-stop service operating detached from general practice.
“The expectation is that when we write a script for our patient, it’s tailored to them and what product is best for them,” says RACGP vice-president Associate Professor Michael Clements.
“That’s easiest to do when you have no financial relationship with the people that profit from the script.
“But in cases where a doctor’s working for a particular company that sells a particular cannabis product, you can already see that there’s a very, very high risk of potential for conflict of interest where that doctor may feel obliged to [prescribe their product], even if not contractually.”
He adds: “Where we have single disease clinic models or single prescription product services that people access online or through their phones, the sole purpose of the entity is to sell cannabis.”
He also points to the the medical board’s code of practice which makes explicit that doctors should not take into account commercial reasons when prescribing.
“All I can say is that none of my patients have ever described being refused a cannabis product,” he continues.
“They tell me, ‘Oh, this Facebook ad came up, I called them saying I wanted to try it, and they asked me a couple of key questions, I gave the right answers, and I got the script mailed to my house’.”
He adds: “I [as their regular GP] wasn’t asked or consulted on their comorbidities or their mental health history … or their opioid or drug addiction history and risk factors.”
One company, Cannatrek, was recently accused of dubious practices by the media, with A Current Affair claiming it has been paying doctors to prescribe its products.
The program alleged a Sydney GP was taking an “educational fee” from cannabis companies in exchange for prescribing their products.
The company was one of the first to receive a medicinal cannabis license in Australia — and more than doubled its revenue to $90 million in 2022-23.
A spokesperson denied paying doctors directly to prescribe the products.
“Cannatrek does however, pay medical clinics as part of our Education and Support Services Program.
“This type of program is designed to facilitate the education of prescribers and other healthcare professionals on the benefits of legal medicinal cannabis products.”
They added: “Cannatrek is aware of its legal and regulatory obligations and is satisfied that its arrangements comply with all applicable laws.”
NSW Health has said it taking “regulatory action” against the Sydney GP, and she has been banned from prescribing Schedule 8 medicines, including medicinal cannabis.
She has not responded to AusDoc questions.
So what of the costs patients face?
Among the major providers, the cost of an initial consultation ranges from $59 to $129.
According to one analysis, the typical cost of medicinal cannabis prescribed, given it’s strictly a non-PBS private script, is between $250 to $300 a month.
Some smaller outfits, like Queensland-based Cann I Help, are also offering a rapid turnaround service, promising a nurse assessment and GP consult in 60 minutes, and a script that same day if the doctor deems it appropriate.
The company recently announced it is now giving free consultations.
“Offering complimentary initial consultations underscores our dedication to making a tangible difference in the lives of those in need,” its media release stated.
It told AusDoc that all patients seen through its rapid access clinic are subject to “the same comprehensive assessment” as patients accessing its standard service, before a prescribing decision is made.
Where is medicinal cannabis coming from?
It’s also worth stressing the other point raised by Professor Robson: his concerns about the products being prescribed as therapies.
Since 2021, the TGA has split medicinal cannabis products into five categories based on how much cannabidiol (CBD) or delta-9-tetrahydrocannabinol (THC) they contain.
Category 5 is for products containing more than 98% THC — products that may give the user a high or euphoria if used inappropriately.
Under the SAS B scheme, Category 5 products are the most commonly prescribed: over 140,000 approvals since 2021, compared to 58,490 for Category 1, which is a high-concentrate dominant CBD product.
Significantly, about a third (45,684) of the Category 5 THC approvals were for the treatment of anxiety.
“When medicinal cannabis was first allowed onto the market, it was only supposed to have CBD in it; it wasn’t supposed to have THC,” Professor Emmerson says.
“The fact that it’s being prescribed for insomnia, and more importantly anxiety, is just wrong — there’s no evidence that it actually works.”
In fact, the TGA’s own guidance says that medicinal cannabis products containing THC are “generally not appropriate” for patients who have a “previous psychotic or concurrent active mood or anxiety disorder”.
Associate Professor Vicki Kotsirilos, the first authorised GP prescriber of medicinal cannabis, says: “It concerns me that there is such a rapid rise in high THC-dominant medicinal cannabis products being prescribed by doctors, and I would literally call these doctors ‘cowboy doctors’.”
She adds that there are some “exceptional circumstances” where research shows a THC-dominant product might be appropriate, such as in palliative care or for severe cancer-related symptoms or neuropathic pain.
However, it is not appropriate for mental health conditions.
“For the treatment of anxiety, or sleep disorder, I would only consider a CBD-dominant product and that would be after all other treatments have been explored.
“What the studies have shown is doses of greater than 30 or 40mg of THC per day may trigger anxiety and psychosis and, in some cases, even beyond the period of intoxication a month after exposure.”
Lack of oversight?
Then comes the concerns about the quality of the products themselves.
Three years ago, amid the global ructions of the COVID-19 pandemic, the TGA made a change it said was designed to “ease the regulatory burden on the medicinal cannabis industry”.
It was that product sponsors would no longer need to submit a declaration of compliance with Therapeutic Goods Order (TGO) 93 — its standards for quality manufacturing of medicinal cannabis.
The regulator’s caveat was that it would still conduct random and targeted monitoring of products.
The most recent testing happened in 2022-23, when it checked whether a number of cannabis oil products had been adulterated with delta-8 THC.
But since then, there has been no testing of imported products.
Of the 500 products that doctors have prescribed, only two — Sativex and Epidyolex — are listed on the Australian Register of Therapeutic Goods, where they are subject to the TGA’s normal pharmacovigilance processes.
Medicinal cannabis is meant to be a treatment of last resort, which is why it’s mainly available through the TGA’s special access schemes.
The TGA has also repeatedly stressed where the buck ultimately stops.
“The decision to use a particular medicine is the responsibility of the prescribing health practitioner,” it has said.
“The prescriber is required to consider the available evidence to support the use of the medicine and any potential risks for the individual patient.”
And it adds that the use of an unapproved therapeutic good is a clinical decision made by the medical practitioner “in consultation with their patient”, which includes obtaining consent.
Where do we go from here?
The TGA has not been blind to the failings of its own system.
In an interview with AusDoc last year, its exiting boss Professor John Skerritt acknowledged that the watchdog had been distracted, given it was dealing with a global pandemic.
A 2022 briefing paper dug out from the TGA’s FOI log admits there is “little scrutiny on whether the risk-benefit ratio remains favourable to patients” use the products.
“This concern is especially relevant when it comes to long-term use of THC-containing products, especially in children, who are more vulnerable to the deleterious effects of this cannabinoid.”
It also questions the “appropriateness” of continuing to place the risk of prescribing with the medical profession, “whilst an unregulated industry continues to grow”.
The joint meeting held by regulators in February, a meeting that included the TGA, federal health department, state and territory health department and various health complaints commissions, has yet to announce any action plan.
In a statement, AHPRA said that protecting patients from harm and inappropriate prescribing without stifling legitimate access to cannabis was a “key priority”.
Given the prescribers are the mechanisms for the industry to operate, the TGA could make the decision to restrict prescriber numbers in the same way it has attempted to do with a product like risperidone.
Confine it to specific specialists, tie it to practitioners with a proven ongoing relationship with the patient?
But you also wonder about the politics.
As mentioned at the top of this article, the TGA risks dismantling a business worth more than $300 million, a business that to its supporters is providing a plant-based therapy that works and in a way that is not triggering mass adverse events.
“My hope is that the regulation around the prescribing of medicinal cannabis can change towards a tightening up of the indications for which it can be prescribed,” Dr Parker says.
“The perception of many public sector psychiatrists is that this is an increasing problem and an increasing challenge.
“But I’m also aware that this may sit contrary to the view of many people who may perceive benefit is obtained from the use of medicinal cannabis products.
“It’s difficult to weigh, and I work at the very pointy end, in a service with people who are severely unwell … but certainly with the people I see, it makes me feel anxious to see these prescribing patterns.”
*Approval numbers do not equate the actual number of patients receiving the medicines. The TGA says it does not hold prescription data and is not able to provide accurate figures on the number of patients accessing medicinal cannabis.
More information: Impacts of medicinal cannabis on an early psychosis service. Australasian Psychiatry 2023: online 21 December
