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