Medical Marijuana Products Will Now Be Prescribed on The Basis of Active Ingredient Content; Not Brand Name   As of the 22nd of November, The Therapeutic Goods Administration (TGA) has made changes to the process of applying for approval to prescribe medical cannabis - both via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways. These changes have been introduced with the aim of reducing the administrative burden for prescribers who determine that an unapproved medicinal cannabis product is clinically suitable for their patient. This article will highlight some of these changes as we discuss their implications on medical cannabis prescribers, pharmacists, and consumers.

1. Active Ingredients to Be the Basis Under Which Cannabis Products Will Be Grouped for Prescriber Approval

In a move that aims to reduce the regulatory burden on prescribers, the TGA has announced that active ingredients, rather than specific trade names, will now be used for the purpose of prescriber approval. The current process for approval has often been described as long and arduous, with prescribers being required to wait up to 48 hours for the paperwork to be assessed & approval to be given to prescribe medicinal cannabis. Of course, this means that very few doctors were willing to undertake this time-consuming process. With the new changes, any unapproved cannabis products will be grouped together based on their cannabinoid content. Prior to these changes, General Practitioners were required to apply for a specific trade name and had to seek fresh TGA approval in the case of product discontinuation, name changes, or unavailability. With the new amendments, however, GP’s using the Special Access Scheme (SAS) will now be required to seek the TGA approval using one of the five categories of medicinal cannabis. This means that if you get approval for medicines in one category, you can switch between products with similar active ingredients without seeking approval from the TGA whenever there is a need. “The change means that prescribers can obtain approval for a category and then issue prescriptions for any product within that category without the need to reapply for TGA approval each time. And ultimately, our goal is to improve patient access for appropriate patients,” says TGA in a presentation. Here are the 5 general categories that the TGA will use to grant approval going forward:

• Category 1- CBD products where CBD concentration is greater than or equal to 98%.
• Category 2- CBD dominant products with a CBD concentration of between 60 and 98%.
• Category 3- Balanced products, with CBD levels between 40 and 60%.
• Category 4- THC concentration between 60-98%.
• Category 5- Products with a THC concentration of more than 98%.

“We are also publishing on the TGA website a list of products which are available under each of those categories, just in recognition of the fact that there is some complexity there. So, sponsors will be declaring to us what category their products fall in, and we'll be publishing those products on the TGA website to assist prescribers and pharmacists,” says TGA representative Petra Bismire.

2. Certain Medicinal Cannabis Products Have Been Included in The Authorised Prescriber Established History of Use List

Following these changes, certain medicinal cannabis products have been included in a list titled the ‘Established history of use’ pathway with reference to active ingredient categories, dosage forms, and indications. This list features products up to Category 3 and suggests the use of oils and capsules only for people with chronic pain and anxiety.

3. TGA Has Published a List of Medical Cannabis Products on Their Website

The TGA, in a bid to make the new information available to everyone, has posted a list of licensed cannabis medicines on their websites. They’ve also highlighted what these 5 different active ingredient categories are and the prerequisites a product must fulfil to be placed under each category. Prescribers, pharmacists, and medical cannabis users are advised to go through this information and acquaint themselves with the new categories.

A Quick Summary of What This Means

• Medical cannabis products will now be prescribed based on the active cannabinoid present rather than brand name.
• Products with varying CBD and THC content grouped into 5 categories.
• This move removes the burden on prescribers and medical practitioners to seek approval from TGA every time they need to switch brands.
• Substitution between products is now permissible for products that fall under the same category.
• This makes it easier to deal with product shortages and discontinuation without having to involve TGA on a case-by-case basis.
• Pharmacists should continue to dispense prescriptions according to their relevant state or territory legislation.
• Oils and capsules are mainly for patients with chronic respiratory pain or anxiety.
• TGA requires prescribers to provide a 6-month report based on the number of patients they prescribe marijuana to.
• For patients to receive these medicines, they will need to present their prescription plus a copy of the TGA approval letter.