By Geoff Bloom, Partner, Dr. Teresa Nicoletti, Partner and Meghan Carruthers, Special Counsel

Prescribers in Queensland account for close to 45% of Special Access Scheme B (SAS-B) applications nationally. Further, between 2020 and 2024, SAS-B applications grew nationally, demonstrating an almost 3-fold increase over four years.[1]

In October 2024, Queensland Health (Qld Health) released a factsheet clarifying the expectations of health practitioners in Queensland when prescribing and dispensing unapproved medicinal cannabis products. This follows the report of a survey in May 2024 of health practitioners, patients, peak bodies and professional organisations regarding their prescribing and dispensing practices for medicinal cannabis. Despite making specific reference to Queensland legislation, the concerns highlighted by Qld Health are relevant across Australia and health practitioners are strongly encouraged to review their state-specific equivalent requirements.

At a time when prescribing practitioners in medicinal cannabis clinics are under particular scrutiny from AHPRA, practitioners and clinics should incorporate the concerns of the factsheet into the way that they practice. Mills Oakley’s Health & Life Sciences Team has been conducting compliance audits on businesses combining a medicinal cannabis clinic, a preferred pharmacy business and a wholesaler supplying “own brand” medicinal cannabis, to assist those businesses to comply with the myriad of regulations, guidelines and, yes, factsheets, applying in this area.

Survey

The Survey questioned health practitioners, patients and health organisations.

Regarding health practitioners, including 111 medical practitioners and 111 pharmacists:

• 87% hold concerns about current prescribing/dispensing practices for medicinal cannabis in Queensland.
• 41% reported feeling confident or very confident in knowledge of the legislative requirements for prescribing/dispensing medicinal cannabis in Queensland – suggesting that 59% do not.
• 41% reported feeling confident or very confident in actually prescribing/dispensing medicinal cannabis in Qld – suggesting that 59% do not.
• 47% always or regularly observe prescribing or dispensing of medicinal cannabis where there is a clear lack of clinical evidence, yet only 6% responded as having reported the activities of another health practitioner to a government agency in the previous 12 months.
• 31% of dispensers reported always or regularly observing unlawful prescriptions.

Prescribing in Queensland, including checks of QScript and for patients on opioids

Any health practitioner wishing to prescribe unapproved medicinal cannabis products to patients must first obtain approval via the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathways under the Therapeutic Goods Act 1989 (Cth), administered by the Therapeutic Goods Administration (TGA).  Even where the TGA has approved supply via the SAS or AP pathway, a prescriber must still comply with any requirements imposed by the state or territory in which they practise.

Under section 50 of the Medicines and Poisons Act 2019 (Qld) (MPA), medical practitioners and nurse practitioners holding an SAS or AP approval may prescribe unapproved medicinal cannabis products if they do so in accordance with their approval. No further Queensland approval is required.

However, prior to prescribing an unapproved Schedule 8 medicinal cannabis product, a prescriber must check QScript (the monitored medicines database) as part of their assessment of the patient and comply with the Monitored Medicines Standard (MM Standard).  The MM Standard provides that, in the ordinary course, a monitored medicine can only be prescribed to a patient on the Queensland Opioid Treatment Program (QOTP) if the prescriber is the patient’s QOTP provider or has the QOTP provider’s explicit agreement.

Prescribers should also ensure that they obtain a patient’s informed consent before prescribing, as well as informing the patient about any restrictions on driving and operating machinery.  Qld Health suggests consent should be in writing unless “there are good reasons to the contrary.”

Content of a written prescription

All prescriptions must comply with the standard requirements for prescriptions including, where applicable, containing additional information for Schedule 8 medicines. In Queensland, prescriptions must include:

• the name, form and strength of the medicine;
• the form and strength of the medicine:
  • writing a category on a prescription (for example based on the TGA-approved category) does not comply; and
  • writing a strength range of the medicine (e.g. THC 19-24%) also does not comply;
• how much may be dispensed or given, including repeats;
• the intervals at which medicine may be dispensed; and
• instructions for using the medicine.

Qld Health cautions prescribers to consider the cost of medicinal cannabis. Some patients may not be able to afford to purchase multiple units at a time.  Prescribers may wish to prescribe lower volumes consistent with a patient’s capacity to pay.  Likewise, prescribers should not authorise dispensing intervals which would allow patients to obtain a large volume of medicinal cannabis in a short time frame, unless necessary for a therapeutic purpose.

Monthly limits

Qld Health discourages prescribers from stating on a prescription the monthly total limit of medicinal cannabis a patient may be supplied. Referring to a monthly limit is potentially unclear and confusing for pharmacists. For example, does the limit apply to what can be used within a calendar month or a month from the date of first dispensing, or can the “monthly” limit be used over consecutive months?

Qld Health also notes that it may be difficult for dispensers to work out whether a patient has exceeded their monthly limit if, for example, they have multiple scripts and use different pharmacies (including interstate pharmacies) such that the data on QScript may not be accurate.  Qld Health states that dispensers are not legally obliged to check whether a patient has exceeded the monthly limit stated on a prescription but do still need to determine that it is safe and clinically appropriate to dispense the medicine.

Brand substitution

In theory, a prescription for a single “type” of a schedule 8 medicine, such as medicinal cannabis, can authorise a pharmacist to dispense several specific products that fit that type, thereby allowing a pharmacist to substitute different brands that fit that type. However, Qld Health’s view is that it is unclear which different medicinal cannabis products can be considered the same “type” of medicinal cannabis medicine. Presumably, that is because medicinal cannabis is derived from different plants which may have varying cannabinoid and terpene content, not to mention formulations and routes of administration, such that different medicinal cannabis products that each have, for example, THC 19-24% may well have different therapeutic effects because the content of other cannabinoids, terpenes and other compounds that may be present varies.

Accordingly, Qld Health’s guidance is that only one medicinal cannabis product should be written on a prescription. Multiple prescriptions are required if a patient is prescribed more than one medicinal cannabis product.

Medicinal cannabis prescriptions which refer to potential substitutes for the prescribed product are non-compliant. If the named product is unavailable and an alternative brand is required, a dispenser must contact the prescriber for a new prescription and the original prescription (for the unavailable product) must be cancelled. Qld Health suggests that a prescriber may wish to contact a dispenser to ensure a product is available before issuing the prescription.

Amending prescriptions

A prescriber may amend an original prescription for supply in one of the following ways:

• For a handwritten prescription, the prescriber must sign and date the amendment in a way that does not obscure the content of the original prescription.
• For a computer-generated prescription, the prescription must be amended on the computer and printed again.
• For an electronic prescription made in an electronic prescription management system, the prescription must be cancelled and reissued. It cannot be amended.

Reporting requirements

The Factsheet reminds health practitioners of their reporting obligations in a range of circumstances relating to diversion-risk medicines, such as:

• stolen or lost diversion-risk medicines;
• failure to send the paper prescription for a diversion-risk medicine to the dispenser after sending a digital copy of a paper prescription;
• reporting and preventing use of unlawful (e.g. false or fraudulent) documents;
• reporting supply on false prescription; and
• reporting a lost, stolen or destroyed paper or electronic register for a Schedule 8 safe or approved store.

 Compliance audits for medicinal cannabis businesses

If you would like to find out more about Mills Oakley’s compliance audits for medicinal cannabis businesses, please get in contact.

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[1] https://dashboard-data.health.gov.au/single/?appid=1066afbe-2b37-427d-8c47-2caa5082cccc&sheet=088f611b-10de-4d72-be68-ccf8d12c54e9&select=clearall