Medicinal cannabis can now be prescribed by NSW GPs
New regulation means that from 1st August 2016, NSW doctors can seek approval to write up scripts of medicinal cannabis for patients who need it.
Previously, patients could only legally access cannabis-based medicines through clinical trials. However thanks to changes under the Poisons and Therapeutic Goods Amendment (Designated Non-ARTG Products) Regulation 2016 (under the Poisons and Therapeutic Goods Act 1966), the drugs can now be prescribed for patients who have exhausted their standard treatment options.
“People who are seriously ill should be able to access these medicines if they are the most appropriate next step in their treatment,” NSW Premier Mike Baird said on Sunday.
How do doctors get approval to prescribe?
In order to prescribe the drugs, doctors will need to get approval from both the Commonwealth Therapeutic Goods Administration and NSW Health.
According to NSW Health, in making their decision, the Commonwealth “will consider the prescriber’s expertise, the suitability of the product to treat the patient’s condition, and the quality of the product.”
A committee of medical experts from NSW Health will review the prescriber’s application, and will consider “whether the unregistered cannabis-based product is being appropriately prescribed for the patient’s condition.”
What can be prescribed?
Some cannabis-based products have already been assessed for quality, safety and efficacy by the medicines regulator. These include:
- Nabiximols (Sativex®) – registered in Australia with the Therapeutic Goods Administration for managing spasticity associated with multiple sclerosis.
- Dronabinol – registered by the US Food and Drug Administration for anorexia in patients with AIDS and chemotherapyinduced nausea and vomiting, where standard treatment has failed.
- Nabilone – registered by the US Food and Drug Administration for chemotherapyinduced nausea and vomiting.
Although applications aren’t limited to the above products, the products applied for must be legally produced and manufactured to appropriate quality standards. There must also be evidence that supports use for that product for the patient.
How do doctors apply?
For more information and to apply for authority to prescribe and supply cannabis products, visit NSW Health’s Pharmaceutical page. More information can also be found at their Cannabis and cannabis products information site.