Medicinal cannabis: an overview

Commonwealth legislation and regulations

The Therapeutic Goods (Poisons Standard – February 2024) Instrument 2024 (SUSMP) regulates the classification of medications. Cannabis medicines are typically classified as Schedule 4 or Schedule 8 depending on cannabinoid content. In accordance with the SUSMP and in broad terms, a cannabis medicine with 2 per cent or less of THC is classified as Schedule 4, whereas other cannabis medicines are classified as Schedule 8. 

The Therapeutic Goods Administration (TGA) is responsible for regulating access to and the quality of therapeutic goods. Ordinarily, therapeutic goods must be approved and entered on the Australian Register of Therapeutic Goods (ARTG) to be lawfully supplied in Australia. However, some exemptions do apply that allow for the supply of unregistered therapeutic goods, including:

• Authorised Prescriber Scheme (AP) – whereby prescribers apply for approval to prescribe a specified cannabis medicine for a particular indication for a class of patients in their immediate care. This is the most commonly used exemption.
• Special Access Scheme (SAS) – which allows for cannabis medicines to be prescribed for a single patient on a case-by-case basis. There are two SAS pathways.
  • Pathway A: requires an application for approval to prescribe cannabis medicines to a seriously ill patient, but the prescriber must import the medicinal cannabis product on a patient-by-patient basis. 
  • Pathway B: more commonly used, requires an application for approval to prescribe cannabis medicines to a specific patient and a suitable clinical justification including why products in the ARTG are not suitable. 

At present, the only cannabis medicines currently registered on the ARTG are Epidyolex (cannabidiol) (Schedule 4) and Sativex® (nabiximols) (Schedule 8). The vast majority of cannabis medicines in Australia are therefore unregistered, meaning they have not been assessed by the TGA for safety, quality, or effectiveness. All unregistered cannabis medications are classified as Schedule 8. 

In addition to the approvals noted above, prescribers require additional approvals to prescribe unregistered cannabis medication to patients including those receiving opioid replacement therapy, or who may be drug dependent, or who are under the age of 16 years. 

Pharmacists do not require accreditation or additional licences to dispense cannabis medicines (registered or unregistered). Of course, pharmacists must hold valid authorities to dispense Schedule 4 and/or Schedule 8 medicines in order to dispense cannabis medicines falling within those schedules.

State/Territory legislation and regulations

Each State and Territory has its own laws governing the manufacture, possession, supply, storage, recording and use of scheduled medicines. In NSW, the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW) are the relevant legislative instruments. 

A pharmacist must take the usual steps to confirm the prescription meets relevant legislative and regulatory requirements (which differ between Schedule 4 and Schedule 8 medications) in the State in which the dispensing is to occur. 

In order to order and dispense, the pharmacist must be in receipt of a valid prescription. 

After satisfying themselves a prescription for cannabis medicines meets relevant legislative and regulatory requirements (ie that it is valid), a pharmacist ought to:

• verify the prescriber, including seeking specific verification the prescriber is properly approved to prescribe (under either the AP or SAS). Pharmacists should always seek copies of approvals provided to prescribers;
• use SafeScript to assist in identifying if a patient is on OTP or is likely to be drug dependent. If a pharmacist identifies a patient as being on OTP or likely to be drug dependent, the prescriber should be informed, and the pharmacist should seek further verification of the prescriber’s approval to prescribe; and
• exercise independent clinical judgment as to the appropriateness of the cannabis medicine for the patient. This should include at least speaking with the patient and prescriber as to the condition being treated, the nature of previous treatment and why that treatment was ineffective or inappropriate. An unregistered cannabis medicine ought to be prescribed and approved as a ‘last resort’ after registered treatment options have been exhausted. 

Dosage

Given the evolving nature of treatment using cannabis medicines, particularly in relation to inhaled products, there is limited guidance available for pharmacists as to appropriate therapeutic and maximum dosage ranges. New guidance material is released from time to time, and it is important for pharmacists to always remain up to date with the best and latest guidance material. 

In exercising clinical judgment as to the appropriateness of prescribed cannabis medicine, pharmacists are reminded that the fact a medication has been prescribed is not sufficient. Independent judgment must always be exercised. 

In the absence of firm guidance, pharmacists ought to employ safeguards to reduce the risk of oversupply of cannabis medicines, including:

• setting maximum monthly limits for each patient, with a view to progressively lowering those limits over time;
• setting maximum limits on the number of unregistered cannabis medicines a patient can be prescribed at one time; and 
• requiring patients to always attend the same pharmacy for cannabis treatment. This affords a pharmacist the opportunity to regularly discuss and assess the effectiveness of treatment, counsel the patient, and to more accurately consider the appropriate dosage levels required to achieve therapeutic effect.

Recordkeeping

As with all dispensing, recordkeeping is of primary importance. 

Pharmacists are recommended to record notes in patient dispensing profiles in relation to prescriber and patient interaction, maximum limits, any red flags and discussions in relation to dosage reduction. 

Those notes ought to provide sufficient detail that they can be understood at a later date, and ought to reflect and support the outcome of a pharmacist exercising independent clinical judgment as to the appropriateness of a prescribed cannabis medicine.

Other key issues 

It is important for pharmacists to remember that unregistered cannabis medicines cannot be provided on emergency supply. Those medications must only be dispensed following receipt of a valid prescription. 

Pharmacists are also not entitled to substitute any unregistered cannabis product. While stock availability issues (particularly with dried flower products) can be a concern, there is no ability to substitute one unregistered cannabis product with another. 

Pharmacists must always remember that unregistered cannabis medicines cannot be held in stock.  Pharmacists are only permitted to order an unregistered cannabis medicine on receipt of a valid prescription. 

Registered cannabis medications can be held in stock like any other registered Schedule 4 or Schedule 8 medicine.

Storage requirements for both registered and unregistered cannabis medications are similar to other medications falling in the same Schedule. Unregistered cannabis medicines (Schedule 8) must be stored separately from other schedule medication in a steel, compliant safe affixed to the building. That safe is required to be locked when the medications are not in immediate use. 

In practice, given unregistered cannabis medicines cannot be held in stock, those products will only be held in a safe for a short period. 

Unregistered cannabis medicines are, for the purposes of drug registers, to be treated like any other Schedule 8 medicine. Pharmacists are reminded that:

• receipt and supply must be recorded in the drug register on the date of those transactions;
• separate pages of the register must be used for each brand name and strength; and
• mandatory six-month auditing requirements apply. 

Pharmacists are recommended to conduct additional and more frequent audits of high-risk drugs, including cannabis medicines.