‘Unapproved’ medicinal cannabis: changes to prescribing pathway

Changes to the prescribing pathway allow a more streamlined process for prescribing ‘unapproved’ medicinal cannabis for your patients. Find out more.

‘Unapproved’ medicinal cannabis: changes to prescribing pathway

Key points

  • Authorised Prescriber (AP) and Special Access Scheme (SAS) applications for ‘unapproved’ medicinal cannabis products are now made by active ingredient rather than brand name.
  • Five new categories stratify medicinal cannabis products by cannabinoid content.
  • Prescribers no longer need to submit a separate application to the Therapeutics Goods Administration (TGA) each time they change the product prescribed. This allows greater flexibility when substituting products within the active ingredient category and dosage form for which approval has been granted.
  • A published list of medicinal cannabis products is available on the TGA website.
  • From 28 April 2022, extemporaneous compounding of medicinal cannabis products can only occur with a prescription with AP or SAS approval.

Abbreviations

AP – Authorised Prescriber

ARTG – Australian Register of Therapeutic Goods

CBD – cannabidiol

HREC – Human Research Ethics Committee

SAS – Special Access Scheme

TGA – Therapeutic Goods Administration

THC – tetrahydrocannabinol

 

What's changed?

As of 22 November 2021, AP and SAS applications for ‘unapproved’ medicinal cannabis products are made by active ingredient rather than brand (trade) name. Each product falls under one of five categories based on cannabinoid content.1

Certain medicinal cannabis products are included in the AP ‘Established history of use’ pathway by reference to active ingredient categories, dosage forms and indications. When using this pathway, prescribers do not require Human Research Ethics Committee (HREC) approval or specialist college endorsement before applying to the TGA to become an AP.1

From 28 April 2022, extemporaneous compounding of medicinal cannabis products can only occur with a prescription based on approvals under either the SAS or AP pathway. Prescribers are required to make SAS or AP submissions on the basis of the active ingredient category of cannabinoid content and the dosage form of the final extemporaneously compounded product.2

What are ‘unapproved’ therapeutic goods?

‘Unapproved’ therapeutic goods are not registered on the Australian Register of Therapeutic Goods (ARTG). Most medicinal cannabis products are ‘unapproved’ therapeutic goods. This means they have not been assessed by the TGA for safety, quality or effectiveness.3

This excludes Sativex (nabiximols) and Epidyolex (cannabidiol [CBD]), which are included in the ARTG for specific indications.4,5

 

Why were the changes made?

Changes to the prescribing pathway, requiring SAS and AP application by active ingredient, aimed to:2,6

  • reduce administrative burden for prescribers
  • allow flexibility in brand substitution when needed, such as in the event of a product shortage or discontinuation
  • further improve patient access by enabling continuation of therapy in the event of a product shortage or discontinuation, or when a decision is made to switch to another equivalent product for other reasons such as cost.

Prior to the change, the TGA required prescribers to submit a separate application each time they changed the product prescribed.

Clarifying the existing requirements for extemporaneously compounded medicinal cannabis to bring it in line with other ‘unapproved’ medicinal cannabis products.7

 

New categories of medicinal cannabis products

The CBD content of a medicinal cannabis product determines the category it falls under:2

  • Category 1: CBD medicinal cannabis product (CBD ≥ 98%).
  • Category 2: CBD-dominant medicinal cannabis product (CBD ≥ 60% and < 98%).
  • Category 3: Balanced medicinal cannabis product (CBD < 60% and ≥ 40%).
  • Category 4: Tetrahydrocannabinol (THC)-dominant medicinal cannabis product (THC/other non-CBD cannabinoids 60–98%).
  • Category 5: THC medicinal cannabis product (THC/other non-CBD cannabinoids > 98%).

Under the AP scheme, medicinal cannabis products in Categories 1–3 are included in the TGA’s List of medicinal cannabis medicines with established history of use. These products are indicated for treatment of certain conditions in adult patients (refractory chronic pain and/or refractory anxiety) and have certain dosage forms (oral liquid and capsule).8

For more information, see the TGA’s Active ingredient categories for medicinal cannabis products.

A published list of medicinal cannabis products under each category is available on the TGA website.

 

Pathways to prescribe medicinal cannabis products

After considering appropriate treatment options on the ARTG for the condition, prescribers may decide that a medicinal cannabis product is clinically appropriate for their patient.9

Before prescribers can provide a prescription, they will need to notify or apply to the TGA for approval to supply the product through either the SAS or AP pathway.9

Prescribers may wish to refer to the TGA’s published list of medicinal cannabis products, stratified by the five active ingredient categories, to select a clinically suitable medicine for their patient.

An infographic showing the pathways for accessing medicinal cannabis products is available for download or print.

Authorised Prescriber (AP) Scheme

  • Any Australian registered medical practitioner can become an AP by applying through the SAS & AP Online System.9
  • APs can prescribe medicinal cannabis products directly to their patients, without requiring clinical justification or separate approval for individual patients.10
  • Prescribers do not need HREC approval or specialist college endorsement if the selected medicine’s active ingredient category, dosage form and indication is included in the TGA’s List of medicinal cannabis medicines with established history of use.9
  • APs do not need to notify the TGA each time they prescribe medicinal cannabis products during the approval period (up to 5 years).
  • APs must report the number of patients they treat every 6 months, even if the number is zero.10

Special Access Scheme (SAS)

  • The SAS allows prescribers (including nurse practitioners) to prescribe medicinal cannabis products for a single patient on a case-by-case basis.9
  • Prescribers must complete the SAS Category B application and SAS Category A notification using the SAS & AP Online System.9
  • Under the SAS Category B pathway, prescribers must provide clinical justification for the use of the product. The TGA may request supporting evidence for some novel indications or evidence of specialist support from a practitioner with appropriate expertise.9
  • Under the SAS Category A pathway, prescribers must import medicinal cannabis products on a patient-by-patient basis via application to the Office of Drug Control.9
 

Considerations for clinical practice

The changes to the medicinal cannabis prescribing pathway allow flexibility in switching products within the approved active ingredient category and dosage form as the clinical need of the patient changes. Prescribers do not need to apply for a new approval each time.11

Prescribers are responsible for providing prescriptions in accordance with relevant state and territory legislation, and the TGA approval. Prescriptions for medicinal cannabis products:9

  • must include active ingredient name(s), strength, dosing amount and frequency
  • include quantity and number of repeats if necessary
  • may include brand (trade) name if clinically necessary
  • should include details regarding the preparation of the extemporaneously compounded product if relevant
  • may include any other formulation details if clinically necessary.

Pharmacists are responsible for complying with all legislation in the jurisdiction where the pharmacy practice occurs. When dispensing a prescription for a medicinal cannabis product, pharmacists:2

  • must ensure dispensing is done in accordance with the prescriber’s intentions
  • must ensure there is AP or SAS approval for all ‘unapproved’ medicinal cannabis products by sighting a copy of the approval letter in accordance with best practice
  • substitute brands in accordance with regular practice (see Pharmacy Board of Australia Guidelines for dispensing of medicines)
  • should not dispense a prescription without satisfying themselves that it is safe, appropriate and lawful to supply the medicine
  • meet the professional standards determined by the Pharmacy Board of Australia.

Pharmacists should also consider the Pharmacy Board of Australia Guidelines on compounding of medicines. These guidelines include detailed guidance on when it is appropriate for a medicine to be extemporaneously compounded, and the requirements to be complied when compounding medicines.

Prescribers and pharmacists are responsible for continually monitoring the use of the medicinal cannabis product prescribed. The preferred reporting route for side effects is via the TGA website.6

 
 

References

  1. Therapeutic Goods Administration (TGA). New streamlined process for medicinal cannabis applications. Canberra: Australian Government Department of Health, 2021 (accessed 16 May 2022).
  2. Therapeutic Goods Administration (TGA). Applications and reporting. Canberra: Australian Government Department of Health, 2021 (accessed 16 May 2022).
  3. Therapeutic Goods Administration (TGA). Medicinal cannabis. Canberra: Australian Government Department of Health, 2022 (accessed 16 May 2022).
  4. Chiesi Australia Pty Ltd. Nabiximols (Sativex) product information. 29 July 2021 (accessed 16 May 2021).
  5. Chiesi Australia Pty Ltd. Cannabidiol (Epidyolex) product information. 8 December 2020 (accessed 16 May 2021).
  6. Therapeutic Goods Administration (TGA). Webinar presentation: Medicinal cannabis - changes to Special Access Scheme (SAS) and Authorised Prescriber applications. Canberra: Australian Government Department of Health, 2021 (accessed 16 May 2022).
  7. Therapeutic Goods Administration (TGA). Webinar: Medicinal cannabis reforms. Canberra: Australian Government Department of Health, 2022 (accessed 16 May 2022).
  8. Therapeutic Goods Administration (TGA). List of medicinal cannabis medicines with established history of use. Canberra: Australian Government Department of Health, 2022 (accessed 16 May 2022).
  9. Therapeutic Goods Administration (TGA). Accessing medicinal cannabis for a patient. Canberra: Australian Government Department of Health, 2021 (accessed 16 May 2022).
  10. Therapeutic Goods Administration (TGA). Authorised Prescribers. Canberra: Australian Government Department of Health, 2022 (accessed 16 May 2022)
  11. Tsirtsakis A. Changes to medicinal cannabis prescribing pathways. East Melbourne, VIC: RACGP, 2021 (accessed 16 May 2022).