Medicinal cannabis products in Australia
Medicinal cannabis products are pharmaceuticals derived from the cannabis plant. They may exist as a dried version of the cannabis plant or leverage compounds derived from the plant.
Medicinal cannabis products were legalised in Australia in 2016. The Australian Federal Government made changes to the Narcotic Drugs Act of 1967, which subsequently made medicinal cannabis available for prescription under strict guidelines and regulations. Various government agencies including the Therapeutic Goods Administration (TGA) and Office of Drug Control (ODC) have important roles in defining the regulation and oversight of activities involved in the cultivation, production and prescription of medicinal cannabis.
Healthcare professionals in Australia are able to prescribe medicinal cannabis under either the Special Access Scheme (SAS) or through the Authorised Prescriber Scheme. There is a broad range of medicinal cannabis formulations and formats available to healthcare professionals in Australia.
In Australia, there are four main modes of administration for medicinal cannabis products. These are inhalation, sublingual administration, oral administration and topical or suppository administration. There may be several different formats of product within a given administration method. As an example, oils, capsules and lozenges are all different product formats, but are administered orally.
Each administration method has its own unique pharmacokinetics, which is the absorption, distribution, metabolism and excretion of active ingredients, such as CBD (cannabidiol). Essentially, this means that each type of medicine has a difference in the onset of action (how long it takes for the medicine's effects to start) and duration of its effects. For example, vaporisation involves absorption through the lungs. This results in a faster onset of action than orally ingesting medicinal cannabis as absorption takes place in the digestive system. These differences may mean that different products are suitable for different use cases depending on the prescribers goal. A doctor will always prescribe a medicinal cannabis product that they determine is most suitable for a specific patient.
Beyond just format, medicinal cannabis products may be differentiated from one another through their composition. The main factors that encompass a medicinal cannabis product’s composition are its cannabinoid profile, potency, terpene profile, cultivar and type of extract.
A product’s cannabinoid profile is simply what cannabinoids are present in the medicine and in what concentration relative to one another. In general, medicines are classified as being CBD-dominant, balanced or THC-dominant. This is in line with the TGA’s medicinal cannabis classification system. Both dried cannabis flower medicines and medicines that use cannabis extracts such as oils, vaporiser cartridges and capsules can be differentiated on the basis of cannabinoid profiles.
Closely related to the cannabinoid profile is potency. This refers specifically to the concentration of the primary cannabinoids within the medicinal cannabis product. Medicinal cannabis products go through extensive testing to ensure different batches have the same potency for consistency.
A terpene profile outlines the terpenes present in the medicinal cannabis product and what concentrations they are present in. This is primarily a consideration for dried cannabis flower as opposed to extracts. Terpenes have the potential to impact a medicinal cannabis product through the entourage effect.
The species refers to the broad category of the cannabis plant. The commonly known species are indica, indica-dominant, hybrid, sativa-dominant and sativa. Cultivars are the specific strain of the cannabis plant, which may have unique cannabinoid and terpene profiles.
If the product is a cannabis extract, its type is an important consideration. On one end you have full spectrum extracts, which contain a broad array of phytocompounds including cannabinoids, terpenes and flavonoids. These pull as much of the plant product as possible with minimal distillation or filtering. After this you have distillate extracts, which feature single cannabinoids suspended in oils. Distillates have a higher purity level, but still have some minor cannabinoids and phytocompounds contained within them. Isolate powders have the highest level of purity. They are crystalline powders that aim to contain only one specific cannabinoid.
The term broad spectrum is also used when referring to CBD oil. It is similar to a full-spectrum product but refrains from deliberately including any THC.
Medicinal cannabis products are not available over the counter in Australia. This is because they hold the status of unapproved therapeutic goods according to the Therapeutic Goods Administration (TGA). However, the TGA can approve prescribers and reasons for prescription. When a doctor wishes to prescribe a product, they may need to submit an application for approval through the Special Access Scheme (SAS). This approval applies to a specific patient in the prescription. Alternatively, authorised prescribers can prescribe to a range of patients in their care without individual approval from the TGA. Included in the pool of potential products for prescription are cannabis oils, cannabis vapourisers, topical cannabis products and edible cannabis products.
The supply and production of medicinal cannabis products in Australia is highly regulated by the TGA and Office of Drug Control (ODC). One of the most important guidelines that suppliers and sponsors of medicinal cannabis must follow is the TGO 93. This is a Therapeutic Goods Order (TGO) applicable to medicinal cannabis products. It outlines the minimum quality requirements for these products and the ingredients used to manufacture them.
It is worth noting that while there currently no medicinal cannabis products available over-the-counter, this may change in the future. The TGA has down-scheduled low-dose CBD products to Schedule 3. This means they could be bought from a pharmacy without a prescription. Clinical trials are constantly being conducted, so we may see an over-the-counter be approved at some point.
Cannabis oil is a concentrated extract from the cannabis plant that is combined into a carrier oil. Cannabis oils can be administered in a number of different ways. One common method is sublingually, which involves placing drops of cannabis oil under the tongue. This method allows the oil to diffuse into the blood through a mucus membrane alongside the digestive system.
Cannabis oils may contain a combination of CBD and THC, depending on their composition. Traditionally, there are CBD oils, balanced oils and THC-dominant oils. Their effects and uses vary depending on their distribution of various phytocompounds. It’s important to know the differences between THC and CBD for the purposes of driving and workplace drug testing.
Cannabis vaporisation is an administration method that involves absorbing cannabis products through inhalation. A vaporiser is used to heat the medicinal cannabis product to an appropriate temperature. Once heated, it creates a vapour that the user inhales into their lungs. The vapour is then diffused through the lungs and absorbed into the bloodstream.
Cannabis vaporisers are available in two primary formats. Dry herb vaporisers use dried cannabis flower to create vapour. Extract vaporisers use cartridges that are filled with extracts made especially for the purpose of vaporisation.
Edible cannabis products are absorbed through the digestive system. They are consumed in a similar way to foods or oral medicines. After being swallowed they are digested and absorbed through the small intestine.
Being absorbed through the digestive system affects the onset of oral cannabis products. These products tend to take longer to take effect than other methods such as vaporisation or sublingual oil absorption. Additionally, the effects tend to last longer than other methods when they eventually do affect the user.
Oral cannabis products come in a range of different formats such as capsules, wafers, tablets, chewables and lozenges. While they all work by using digestive absorption, their compositions are unique and vary somewhat.
Topical cannabis products are absorbed through the skin. The skin has multiple layers and products achieve different levels of penetration depending on their composition. Many products do not penetrate beyond the initial layer of the skin. Other products affect deeper layers of the skin and can be absorbed by the bloodstream.
Topical cannabis products come in a range of different forms including creams, balms, patches and gels. While they have different consistencies and contents, these products are all applied by being gently massaged into the skin.
There are many important aspects surrounding medicinal cannabis oil. Learn about their manufacturing and the various types.