Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2018

Medicinal cannabis – regulation, access and efficacy (#11)

John Skerritt 1
  1. Commonwealth Department of Health, Woden, ACT, Australia

A national scheme to enable patient access to medicinal cannabis products, including locally grown and manufactured ones, was introduced in 2016. The Commonwealth Department of Health has oversight of schemes for cultivation and manufacture of medicinal cannabis products and for product quality and scheduling and patient access.  

Cannabis products are treated as medicines made available through a doctor’s prescription. Clinical trials of products are encouraged and where their efficacy and safety is adequately demonstrated they could be submitted for potential TGA registration. In the interim, products that met certain quality standards (under Therapeutic Goods Order 93) could be provided through “unapproved product” pathways. These include the Authorised prescriber scheme, the Special Access Scheme A (notification) and B (application) pathways. A new SAS portal was launched on 30 July to enable simultaneous submission of applications to meet requirements of TGA and major state health departments. Along with other conditions, approvals have been made for chemotherapy-induced nausea and vomiting, chronic cancer pain and in palliative care. Products with various THC and CBD compositions and dosage forms have been approved, including raw bud, oils, tinctures, extracts and pharmaceuticals for over 1000 patients.

We commissioned reviews of the published observational and RCT clinical evidence for cannabis products in several conditions. Reasonable evidence of efficacy was found in certain paediatric epilepsies, MS and neuropathic pain studies. In chemotherapy induced nausea and vomiting in adults, THC/ analogues were as effective as prochlorperazine, but in cancer patients, there were no differences between cannabinoids and placebo for improving caloric intake, appetite, nausea/vomiting, pain, dizziness, mental health or sleep.  Clinical guidance documents for cannabinoids have been developed with the input of many clinicians and patient groups.