Frequently asked questions
Legalities
In 2016, The Therapeutic Goods Administration (TGA) reclassified medicinal cannabis products containing tetrahydrocannabinols (THC) from Schedule 9 (prohibited) to schedule 8 (controlled) of the Poisons Standard, making the prescription of medicinal cannabis containing THC legal in Australia. Cannabidiol (CBD) products (which have less than 2% of any other active component) remain at Schedule 4, and have much less restriction than Schedule 8 products.
A patient must receive an approval from the TGA and/or State Health Authority, and a prescription from a medical practitioner to legally possess and consume medicinal cannabis.
Recreational use remains illegal across all federal, state, and territories in Australia.
Federal legislation in Australia allows organisations to apply for a licence to cultivate medicinal cannabis with the Commonwealth Government’s Office of Drug Control. Currently, only one Australian company has medicinal cannabis for sale in the domestic market. A list of companies that are currently exporting/importing medicinal cannabis products to Australia is available on the Office of Drug Control website.
Medicinal cannabis products are dispensed through Pharmacies. Pharmacies are not authorised to stock medical cannabis products until they receive a legal prescription and TGA approval for a patient.
As of 30 July 2018 an online system was introduced to enable the lodgement of Special Access Scheme (SAS) applications and notifications. This TGA online system includes functionality that will now allow prescribers in certain States and Territories to submit an application and proper supporting documentation to both the Commonwealth and the relevant State/Territory Health Department simultaneously. Prior to the introduction of this system, prescribers of unapproved medicinal cannabis products were required to complete and separately submit paper forms to the TGA and relevant State Health Department.
Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at: Special Access Scheme online system
The current processing time for approval by the TGA is approximately 48 hours, but can take longer, pending Requests for Information on incomplete or incorrect applications.
There are a number of differences between illegal cannabis and legal, medicinal cannabis. The first being that medicinal cannabis products in Australia are upheld to quality and safety standards under the Therapeutic Goods Order No. 93. Things like cannabinoid content (THC and CBD), contamination, toxins, and pesticides are tested for, where illegal cannabis products may not contain the ingredients or accurate levels that they claim to, and could be full of harmful contaminants.
As a medical patient, it’s incredibly important to have access to consistent medicine that is made safely to ensure best outcomes for treatment success.
Treatment
The Endocannabinoid System is a complex regulatory system made up of receptors, molecules called endocannabinoids, and enzymes that either synthesize or metabolize those endocannabinoids. The main function of the endocannabinoid system is to regulate the human body by maintaining homeostasis.
The cannabis plant produces more than 500 different chemical compounds, including over 120 phytocannabinoids (like THC and CBD), 30 (known) terpenes (like linalool and myrcene), flavonoids and hundreds of other compounds; but fewer than 50 of these compounds are produced in significant amounts.
CB1 receptors are found primarily in the nervous system while CB2 receptors are found predominately the immune system, however both receptors can be found in various organs throughout the body. The mapping of these receptors fits well with the diverse range of symptoms and conditions that are found to respond positively to medicinal cannabis, and the synergistic effect (known as the Entourage Effect) of these different compounds working together in each unique strain/medicine is what causes such diverse effects.
Medicinal cannabis medicines in Australia are typically diluted in cannabis oil and administered via an oral spray, sublingually (drops under the tongue), capsules, or by vaporizing the dried flower. There are many other medical applications for medicinal cannabis that are not yet available legally in Australia, including suppositories, topicals and tinctures.
Although cannabis has a large safety profile, and there have been no recorded deaths attributed directly to cannabis use, cannabis can still produce notable side effects, especially in cannabis naive patients.
Side effects are very much dose-dependant, stemming from large doses of the cannabinoid, delta 9 Tetrahydrocannabinol (THC). Some users, especially novice ones, could experience psychoactive and other side effects associated with THC consumption:
- Tachycardia (rapid heartbeat) is common among novice users;
- Dry mouth (cottonmouth);
- Dizziness or light-headedness;
- Red, irritated eyes;
- Coughing caused by inhaled cannabis (combustion), or vaporized cannabis.
In many instances, the above side effects are short-term and more prevalent in novice users. CBD neuro-modulates THC at the CB1 receptor level, interfering with THC’s ability to activate the CB1 receptor. This causes CBD to eliminate some of THC’s negative side effects such as sedation, anxiety, and rapid heartbeat caused by THC. Though some early clinical data, it has been found that the combination of CBD and THC is a much more powerful application than THC just on its own; leading to the concept of the “Entourage Effect”.
Patients who are pregnant or breastfeeding, have liver disease, heart disease, lung disease, a family or personal history of mental health disorders such as bi-polar disease, schizophrenia, psychosis or substance use disorder are at greater risk for experiencing negative side effects, and should take further precautions and always consult with their doctor before using cannabis.
The first step is to be assessed by Tetra Health’s medical team to determine if medicinal cannabis could be a suitable treatment option for your symptoms or condition. Medicinal cannabis may not be appropriate in certain circumstances. Please book an appointment to discuss your medical history and condition with a medical professional.
Pricing
No, medicinal cannabis is not currently covered by the Pharmaceutical Benefits Scheme (PBS). To be included on the PBS, the medicine must be registered and approved by the TGA. To be approved, the medicine must be shown safe and effective through clinical trials. The current challenge is that until recently, cannabis has been a prohibited product, and has limitations of being patented as a new drug. Some medicinal cannabis trials are currently underway for various products, but it is unknown how long it will take for them to receive TGA approval.
The Department of Veteran Affairs, Work Cover and Private Health Funds will cover certain costs for eligible patients. Please enquire about these to the DVA or your health fund, or ask for more information during your Nurse Consultation and our team would be happy to assist.
Currently, medical cannabis products are quite costly in Australia. The high cost of product is largely because a number of medicines available in Australia are being imported. As more companies produce medicinal cannabis locally in Australia, we hope to see lower products become available.
The current cost of cannabis medication per patient varies greatly. Cost is dependant on the type of medicine that is prescribed (e.g. oil, flower, capsule), dosage and the indication being treated. A patient could expect to pay at least $200 per month.
In addition to the above variables, numerous studies have shown the enormous range of effects occurring when cannabis medicines are administered to different patients. This variance depends on several factors: cannabis use pattern, additional drugs being taken, genetic variations and how the cannabis is administered, etc. When administered orally, for example, the amount of THC that will make it into the bloodstream will vary between 4 and 20 percent.
In person consultations and follow-up appointments with a general practitioner or specialist for the purpose of are covered under Medicare. Telehealth consultations are generally not covered by Medicare.
