The president of the Australian Medical Association has claimed “most” medicinal cannabis manufacturers are exploiting the Special Access and Authorised Prescriber schemes and said patient care is “often non-existent” in vertically integrated telehealth models, as the medical body continued its broadside against the industry.
In possibly the most sweeping attack on the sector so far, Dr Danielle McMullen said continuity of care is being “disregarded” with few consequences for “irresponsible telehealth companies”.
Writing on LinkedIn, she said regulators “must act now to restore trust”.
Dr McMullen said regulatory gaps must be closed and manufacturers made to demonstrate the efficacy and safety of their products. All telehealth services — including those prescribing medicinal cannabis — must be held to the same clinical and ethical standards as traditional care, she added.
But again, the AMA did not disclose any figures to back up its oft-cited claim that serious patient harm was on the rise.
“This is a matter of urgency, as AMA members are increasingly reporting serious patient harm,” Dr McMullen wrote on AMA Insider. “Emergency department doctors across Australia are seeing a rise in cases linked to high-THC medicinal cannabis products, including cannabis-induced psychosis and problematic substance dependence.
“Alarmingly, some patients with pre-existing psychotic conditions are being prescribed these products, and cases of cannabis hyperemesis syndrome are also increasing.
“Due to inadequate reporting systems and limited regulatory oversight, we don’t know the true number of adverse events related to medicinal cannabis. While the TGA has recorded more than 600 in the past three years, the sector considers this a gross underestimation.”
Of the 615 reports referred to by Dr McMullen, headache, nausea and coughing were responsible for 29% of adverse events and anxiety 12%. There were 54 cases of psychotic disorder and 14 of suicidal ideation or behaviour.
Dr McMullen said the pathways for accessing medicinal cannabis were intended for complex conditions, and to ensure patients who need new or uncommon medicines from overseas can obtain them.
Yet “most” medicinal cannabis manufacturers are “exploiting these schemes”, she said.
“Essentially, they are using this as a loophole to avoid proper efficacy, safety and quality testing of their products in Australia through the TGA. We welcome the TGA’s commitment to addressing these issues.”
While telehealth has become a permanent fixture in delivering patient care, it has become “vulnerable to exploitation”, Dr McMullen added, “particularly in the prescribing of medicinal cannabis, where concerning prescribing practices are putting patient safety at risk”.
Vertically integrated, single-issue telehealth providers “stormed onto the scene”, the AMA president said, “many offering same-day prescriptions for medicinal cannabis and other products… that bypass patients’ regular GPs and other specialists”.
“Medicinal cannabis is increasingly being prescribed for conditions where its use is either contraindicated or requires close, ongoing supervision,” she said. “Yet in vertically controlled, direct-to-consumer telehealth models, that oversight is often non-existent. These providers rarely communicate with a patient’s regular doctor, undermining the core principle of continuity of care in the pursuit of profit.
“Reform is needed to ensure gaps in our current regulatory framework are addressed. In-person assessments, the safety check of separate prescribing and dispensing, and continuity of care are being disregarded — with few consequences for irresponsible telehealth companies. We acknowledge AHPRA recently updated its prescribing guidance to address poor prescribing practices, and while we welcome this action, more must be done.
“Urgent intervention is needed to ensure medicinal cannabis is prescribed, dispensed, and regulated in the same manner as other registered drugs of dependence.”
Dr McMullen concluded by saying the message “seems to have finally gotten through” after health ministers agreed at a joint meeting in September that “further work is needed to strengthen governance, oversight, and regulatory frameworks to address inappropriate prescribing of medicinal cannabis”.
“The AMA is keen to work with health ministers and regulatory bodies to arrive at an evidence-based framework that is built around safety and quality,” she said.