2021 is giving us over-the-counter medical cannabis (low-dose CBD)
Low-dose CBD cannabis oil can be sold in pharmacies from next year. Image: Stephen Stockwell
From early 2021 you'll technically be allowed to buy low-dose cannabis oil from pharmacies without a prescription.
Firstly, these products won't get you high. This is only low-dose CBD oil we're talking about and products won’t be allowed to have more than 1 per cent THC (which is the psychoactive part of the plant).
When the changes come in on February 1 next year, the maximum dose for adults will be limited to 150mg per day, which is why it's considered low-dose. It's expected patients would use this to help them sleep, reduce anxiety or depression and treat pain, although there's currently not much evidence the oil is effective at this strength.
The decision from the Therapeutic Goods Administration (TGA) changes low-dose CBD oil from a schedule four drug, which doctors have to prescribe, to a schedule three drug, which chemists can hand out over-the-counter without a prescription.
Cassandra Hunt, the managing director of cannabis industry consultancy, Fresh Leaf Analytics, told Hack the change is significant.
"It's the biggest milestone since legalisation in 2016 and it's going to dramatically change access for patients in Australia."
She says this will make life much easier for people who want to use this drug.
"Previously, they've had to go to a GP and they've had to talk to the GP about what they're trying to treat, and then the GP has had to get special permission in order for them to be able to access a prescription."
There will be a wait for products
While the changes will come into effect in early 2021, it could be years before there's actually a product to buy.
Cassandra Hunt from Fresh Leaf Analytics told Hack that it's unlikely anything will be on the shelves in February.
"In order for companies to get these products registered or available over-the-counter in pharmacies, they have to be registered as an S3 medicine," she said.
"What that requires is quite significant data about the safety and efficacy and quality of the products."
According to Cassandra, because the Australian cannabis industry is still so new, they don't know how effective their low-dose CBD products are and it could take years to get that data.
She says it's not clear what info the TGA wants, but if it's expecting companies to run clinical trials then it could be a five-year wait for products.
"That data, given the industry is so young, isn't easy to come by."
Medical Association “surprised” by down-scheduling
The Australian Medical Association (AMA) doesn't support the TGA's decision to down-schedule low-dose CBD oil.
In a statement to Hack, the AMA said it isn't confident pharmacists have the education to properly advise patients, and that side effects could go unchecked.
"Medical practitioners have only been prescribing CBD products for a few years, the evidence is still emerging, more education around its use is required," the AMA said.
When it comes to possible side effects, the medical association fears doctors won't be able to properly monitor patients when the CBD oil is sold through pharmacies.
"There is a risk that patient conditions that are associated with CBD use (e.g. anxiety, psychosis, chronic non-cancer pain, and epilepsy) will go unchecked and cause further harm to the patient," the AMA told Hack.
The TGA told Hack the decision to make low-dose CBD oil available over the counter wasn't based on how well it works, just that it isn't harmful.
"The scheduling decision was made on the basis of the safety profile of CBD at this dose," a TGA spokesperson said.
Cassandra from Fresh Leaf Analytics admits evidence of how well these products work is hard to come by but agrees they're not harmful.
"There is good safety data to show that at the types of doses we're talking about CBD is very safe."
The illicit silver lining
According to Cassandra Hunt from Fresh Leaf Analytics, the TGA could also be trying to move CBD users away from the black market.
"I think one of the other motivations of the TGA is to make it easier for people to access these products where they might otherwise be using illicit channels," she told Hack.
"The problem with some of the illicit channels is that the quality of the products is not always good."
"Sometimes those products say they have something in them and that's not in there, so you can't really rely on the fact that you're getting a good product."
She also says that for the first time, as the cost of medical cannabis production comes down, legal products are reaching price parity with the illegal market.
"If you couple that with making it more easily accessible through pharmacies, that should hopefully make a big difference for people who've been getting relief through those channels, but maybe can't rely on those products being good quality."
Originally published here: https://www.abc.net.au/triplej/programs/hack/cbd-oil-available-from-pharmacies/12997370