Prescribing
Medicinal Cannabis
The evidence for Medicinal Cannabis
While showing therapeutic potential, cannabis is a highly complex plant and significant gaps remain in our knowledge. We don’t fully understand the hundreds of chemical compounds that make up the plant or the intricacies of the human endocannabinoid system.
Currently, most cannabis medicines available in Australia are unregistered, meaning they haven’t been fully assessed by the Australian Government’s Therapeutic Goods Administration (TGA) for safety and efficacy, although they do need to meet a quality standard. As with all medicines, the potential benefits and harms need to be rigorously investigated and assessed against established treatment options.
The TGA, with the support of the NSW, Victorian and Queensland state governments, commissioned a team to review the available scientific evidence for the use of cannabis medicines in five areas: palliative care, nausea and vomiting, epilepsy, multiple sclerosis and pain. The documents have been endorsed by the Australian Advisory Council on the Medicinal Use of Cannabis. These guidance documents are available updated by the TGA as new evidence emerges.
Prescribing Medicinal Cannabis
Since 2016, the Commonwealth and State and Territory governments have undertaken a number reforms to allow for the legal prescribing of cannabis for medicinal purposes. However, further research is necessary to obtain evidence about the effectiveness and most suitable doses of medicinal cannabis products for use in different medical conditions. To enable legal access to medicinal cannabis until further research is completed, the TGA allows for registered medical practitioners to apply for access to unregistered (non-ARTG) medicinal cannabis products on a case-by-case basis via Special Access Scheme Category B (SAS-B) or the Authorised Prescriber (AP) Scheme.
The Therapeutic Goods Administration does not place any limitation on the conditions for which a healthcare practitioner can prescribe medicinal cannabis. Therefore, if the practitioner feels that medicinal cannabis products are a viable treatment option for their patients – they may prescribe appropriate unregistered medicinal cannabis products in accordance with the current regulatory framework.
INDICATIONS AND CLINICAL JUSTIFICATION
Indications and clinical justification
To enable an approval for access to medicinal cannabis, a clinical justification for the use of medicinal cannabis for the patient’s specific medical condition must be documented. The clinical justification should include:
- A summary of the patient’s unmet medical need(s).
- The clinical justification sources indicating the potential benefit of a medicinal cannabis therapy for the patient.
- A proposed therapeutic treatment plan outlining the terms of the therapy period, including dosing strategy and monitoring and evaluation arrangements.
MEDICAL ASSESSMENT
MONITORING
INITIAL TRIAL TREATMENT PLAN
DOSING AND TITRATION
CONTRAINDICATIONS
SPECIAL PRECAUTIONS