The Australian Health Practitioner Regulation Agency (AHPRA) has cracked down on medicinal cannabis, with new guidance to tighten up the rules and put practitioners ‘on notice’.
Poor prescribing practices have placed patients at significant harm, with AHPRA stepping in to remind prescribers and dispensers that medicinal cannabis should be treated as any other Controlled Drug (Schedule 8 medicine).
‘We don’t prescribe opioids to every patient who asks for them, and medicinal cannabis is no different,’ said Medical Board of Australia Chair, Dr Susan O’Dwyer. ‘Patient demand is no indicator of clinical need.’
AHPRA has already taken action against 57 medical practitioners, pharmacists and nurses over medicinal cannabis prescribing practices, with AHPRA CEO Justin Untersteiner confirming that the regulator is currently investigating 60 more.
Australian Pharmacist investigates the issue and pharmacists’ obligations going forward.
Booming business, bad practice
Demand for medicinal cannabis has grown significantly in recent years. Australians spent approximately $402 million on medicinal cannabis in the first half of 2024, nearly matching the $448 million spent in all of 2023.
This surge in demand has led to a significant upswing in prescribing, with APHRA identifying eight practitioners who issued more than 10,000 scripts over a 6-month, and one who appears to have issued more than 17,000 scripts.
Nearly all medicinal cannabis products are unapproved Schedule 8 medicines, meaning prescribers must use the Special Access Scheme or Authorised Prescriber pathway to prescribe them.
But the development of closed loop arrangements, where medicinal cannabis is prescribed via telehealth appointments, has meant that the required level of scrutiny and investigation by prescribing doctors has perhaps not been conducted, said PSA National Vice President and Pharmacy Council of New South Wales Board Member Caroline Diamantis FPS.
‘Prescribers need to assess if there is a therapeutic need for the prescription and ensure they’ve developed appropriate management plans.’
AHPRA has said that poor professional standards have been applied, particularly around the volume of medicinal cannabis being prescribed and dispensed.
‘They are looking for stronger safeguards around prescribing, real-time prescription monitoring (RTPM) and S8 controls – prioritising therapeutic need over commercial convenience,’ Ms Diamantis said.
The other concern is around various business models that have been ‘conveniently’ created around the demand for medicinal cannabis.
‘AHPRA’s concern is that the prescriber and dispenser obligations for therapeutic suitability have been overlooked,’ she added.
Part and parcel of this new business model is the delivery service for medicinal cannabis adopted by some pharmacists.
‘The very real concern is there’s minimal human contact,’ she said. ‘The patient does not have an opportunity to speak with the dispensing pharmacist about any concerns or questions.’
A real danger for patients
Medicinal cannabis comes in various dosage formulations with various levels of activity including gummies, tinctures or vaporisers.
Patients can sometimes walk away with several different dose forms without prescribers investigating their:
- mental health
- medical history
- underlying illnesses.
‘Prescribers have to do their due diligence when they are selecting medicinal cannabis [products],’ Ms Diamantis said.
And because these medicines are often prescribed and dispensed via a standalone service, the patient’s regular GP and pharmacist may never know.
‘I’ve looked after vulnerable young patients, who are 16 and 18 years old and are being carefully monitored by their psychiatrists, GPs and pharmacists – yet without our knowledge, they have been accessing medicinal cannabis for a couple of years through third party online programs,’ she said.
‘The medicinal cannabis was prescribed online and sent through to partner pharmacies, who simply prepared the prescription and forwarded the medication – perhaps with minimal communication and not understanding the full [history] of that patient’s health. It’s fragmented healthcare at its worst.’
An investigation by the ABC revealed that some patients with a history of psychosis had been hospitalised after being prescribed medicinal cannabis – with one patient dying following inappropriate prescribing.
Your professional obligations
Pharmacists have a right to question prescribers, and an obligation to communicate with prescriber if they have concerns, Ms Diamantis said.
‘I have seen cases at the Pharmacy Council where volumes of medicinal cannabis have been provided to a single patient, with pharmacists not recognising that they have the final autonomy as the gatekeeper of the medication,’ she said.
Pharmacists should be accessing RTPM systems for every dispense event for medicinal cannabis, whether or not there is a legal compulsion upon them to do so.
RTPM allows pharmacists to identify that a person has been prescribed medicinal cannabis or that may not have been disclosed or on a pharmacy’s dispensing system. It also highlights medicinal cannabis supply patterns which indicate overuse or potential drug-drug interactions with other high-risk medicines such as opioids.
‘It’s illegal in NSW to dispense an S8 unregistered item on a fax or email. YOu either need a token or a real paper script.’
CAROLINE DIAMANTIS FPS
However, pharmacists should also be aware there may be gaps in these records. While all electronic prescriptions and computer-generated paper scripts with an eScript barcode will automatically be recorded in RTPM as unapproved therapeutic goods, human coding errors mean sometimes medicinal cannabis prescription or dispense events are not visible. Other reasons the script may not be visible include:
- forgery
- system glitch
- the script being from a state that does not allow the person’s history to be seen in the state where the script is presented.
Pharmacists should also be aware of the regulations in their state or territory around dispensing an unapproved Controlled Drug (S8).
‘[For example], it’s illegal in NSW to dispense an S8 unregistered item on a fax or email,’ Ms Diamantis said. ‘You either need a token or a real paper script.’
This is not something that many pharmacists know.
‘We have seen it time and time again at the Pharmacy Council where people have found themselves in trouble because they don’t know that,’ she said.
Time for a change
The use of loopholes and prioritising commercial interests over patient health and safety has created a ballooning public health challenge. The challenge for regulators will be maintaining access to medicinal cannabis to people with a therapeutic need, while cracking down on problematic prescribing practices.
‘We do need to keep the standard quite high,’ she said. ‘And if [individual patients] do have valid therapeutic reasons for it, there shouldn’t be a problem in the end – we just need everyone on the same page.’
Overall, it has been a learning process, Ms Diamantis believes.
‘As time has passed, I think AHPRA has realised that the regulation needs to be reviewed and that there has to be an increased awareness of the harm that could be inflicted on the public,’ she said. ‘There’s nothing wrong with reviewing the legislation, rules and guidelines to make sure that we are in alignment as prescribers and dispensers in keeping the public safe, because that is the ultimate goal for everyone.’
