THE Australian Department of Health’s Therapeutic Goods Administration (TGA) has decided to down-schedule certain low-dose cannabidiol (CBD) products, allowing select medicinal cannabis products to be available over the counter.
This follows the UN decision at the start of December to remove cannabis and its derivatives from Schedule IV of the international treaty governing narcotic drugs, where it was listed among addictive opioids such as heroin.
While there are currently no approved low-dose medicinal cannabis products, this is expected to change as manufacturers produce medications that meet the TGA’s Schedule 3 criteria.
Medicinal cannabis has been legal in Australia at a federal level since 2016, however prescriptions required case-by-case approval from the TGA.
The availability of medicinal cannabis over the counter may enable those with symptoms that have proven difficult to treat to more easily seek relief.
What is medicinal cannabis?
With official restrictions around medicinal cannabis slowly relaxing, more Australians may be wondering how it’s different from illicit cannabis and what it’s used to treat.
Research has found that medicinal cannabis can be an effective treatment for a broad range of symptoms and conditions, particularly where traditional medicines have often proven ineffective.
There are two main active compounds (cannabinoids) found in cannabis:
- Tetrahydrocannabinol (THC) is the psychoactive compound most people associate with cannabis. While it may produce a euphoric “high”, THC can also be used as an analgesic for chronic pain, an appetite stimulant or to assist with sleep onset, nausea, glaucoma or muscle spasticity.
- Cannabidiol (CBD) is non-psychoactive and is believed to offset some of the negative side effects of THC, such as anxiety, paranoia or memory impairment and be used against seizures, inflammation, pain, nausea and vomiting, and migraines.
Medications may incorporate THC and CBD individually or in tandem. Whole cannabis products are believed by some to be more effective due to the “entourage effect”, by which the many organic compounds within cannabis support one another for a greater health outcome.
Medicinal cannabis products are available in a range of formats, and the absorption, potency and effects of the medication may vary according to the format and the individual patient. Formats include the dried flower, vape concentrate, oil, oral spray, soft gels, creams and lotions.
THC may impair a patient’s driving ability. A recent Australian study found that CBD does not impair a patient’s ability to drive, while THC can affect driving abilities for up to four hours. For this reason, CBD may be preferable for some patients. Nevertheless, the advice is that patients should not drive on medical cannabis.
How can patients in Australia access medicinal cannabis?
Until cannabis-based medications that meet the Schedule 3 requirements enter the market, patients must seek a prescription for medicinal cannabis through their doctor or medical team.
It’s also worth noting that higher dose CBD and THC-based products are not covered by the TGA’s decision and must still be accessed by prescription.
Patients seeking a prescription for medicinal cannabis must have a condition diagnosed by a doctor and experience symptoms that traditional treatment methods have failed to alleviate without unacceptable adverse side effects.
Where the patient’s doctor believes they may benefit from medicinal cannabis, the doctor must submit an SAS-B application to the TGA along with their clinical justification and the patient’s relevant medical history.
The TGA will then review applications on a case-by-case basis. While a successful application cannot be guaranteed, patients may have a greater chance of success where their symptoms match those for which the TGA has previously approved applications.
Up to December 31, 2020, the TGA had approved more than 85,000 SAS-B applications for unapproved medicinal cannabis products.
If you feel you may be eligible for medicinal cannabis through an SAS-B application, but your doctor is uncomfortable discussing or prescribing medical cannabis, Cannatrek Access links patients to qualified independent doctors. These doctors have experience with medicinal cannabis and will help the patient make an informed decision about the suitability of this treatment.
While research into the efficacy and effects of medicinal cannabis for certain treatments is increasing, it is in its early days. Patients should always talk to a health professional for advice on their unique requirements before making any decisions about their treatment options.
The latest and most accurate information on how to prescribe, and be prescribed medicinal cannabis, is at the TGA website.
- The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. The National Center for Biotechnology Information (NCBI).
- Medicinal Cannabis: The Role of the TGA. Australian Department of Health, Therapeutic Goods Administration, December 2020.
- The Promising Medicinal Benefits of Cannabis. “Hospital + Healthcare” magazine.