There has been a welcome breakthrough in the availability of medical cannabis products, which are increasingly being used to treat such conditions as epilepsy, anxiety, pain and insomnia.
The Therapeutic Goods Administration (TGA) has announced an interim decision to reclassify cannabidiol (CBD) products so they can be purchased over the counter at pharmacies.
CBD is a compound found in marijuana and hemp plants used to treat pain and seizures. It is “a naturally occurring substance that’s used in products to impart a feeling of relaxation and calm. Unlike its cousin, delta-9-tetrahydrocannabinol (THC), which is the major active ingredient in marijuana, CBD is not psychoactive”, according to WebMD.
New analysis, published this week in the International Journal of Drug Policy, shows that CBD-containing products are readily available online and in health food stores and pharmacies across the US, Canada, Britain and most European countries.
In Australia and New Zealand, however, CBD products are highly regulated and can only be accessed by a doctor applying on behalf of a patient through a complex and expensive “special access” process, says University of Sydney science media adviser Marcus Strom.
The TGA’s provisional ruling moves low dose CBD products from schedule 4 to schedule 3 of the Poisons Standard. This means companies can apply to register CBD products to be available through a pharmacist, without the need for a prescription.
Australian medicinal cannabis company Althea Group Holdings applauded the proposed change. Chief executive officer Josh Fegan described it as one of the biggest ever developments in the medical cannabis industry.
“The interim decision reflects the significant shift in community and government attitudes towards medicinal cannabis since it was legalised in Australia in late 2016, which has seen it move from a fringe alternative towards an accepted mainstream option,” he said.
Althea also noted the proposed amendment would “bring patient access into closer alignment with comparable international jurisdictions”.
Mr Fegan said Althea had closely monitored the proposed amendment and participated in the consultation process.
“We are excited by the TGA’s interim decision to down-schedule CBD products and see this development as a big step forward for prescription cannabis products already available in Australia.”
However, Mr Strom says analysis by the Lambert Initiative shows that the maximum doses permitted under the TGA proposal (60 milligrams (mg) a day) may not be high enough to benefit patients. “These are usually seen at higher CBD doses of between 300 and 1500mg a day,” he says.
In late 2019, health.com reported on the widespread take-up of CBD in the US: “There’s no question that CBD is the buzzy wellness product of the moment. If you live in a state where it’s currently legal, you might feel like CBD has gone from being sort of around to absolutely everywhere all at once. Coffee shops sell CBD lattes, spas offer CBD facials, beauty companies are rushing to release lotions with CBD or hemp oils in their formulas. And everyone from your anxious co-worker to your arthritis-suffering dad wants to get their hands on some CBD gummies.”
The TGA undertook public consultation and research before concluding that CBD at low dosages is safe. The TGA’s final decision on the scheduling of CBD is expected to be made in late November.
Stock market site smallcaps.com reports that cannabis market analyst FreshLeaf expects the over-the-counter CBD market in Australia to grow rapidly and potentially exceed $200 million in revenue.
Incannex Healthcare chief medical officer Dr Sud Agarwal says more than 60,000 patients in Australia have already been prescribed CBD via the Special Access Scheme or an Authorised Prescriber. This ‘clunky’ process often involved approval from the TGA for every prescription.
“The high costs of seeing a doctor each time for a prescription and also the relatively finite number of approvable indications will deter some patients getting CBD,” Dr Agarwal added.
To qualify as a Schedule 3 substance, CBD products must have a maximum recommended daily dose of 60mg and only a 30-day supply can be dispensed. It must be kept behind the counter at a pharmacy, requiring interaction with a pharmacist prior to the sale.
“Only oral, sublingual (dissolvable under the tongue) and oral mucosal (mouth sprays) products will be permitted under the schedule, thus excluding smoking, vaping and topical CBD products,” smallcaps.com reports.
It needs to have been strenuously tested in a “rigorous double-blinded, randomised, controlled clinical trial that shows statistically significant results pertaining to this therapeutic claim”.
And direct-to-consumer advertising of the product is banned.
Importantly, it is noted that low-dose CBD products may not work as well or for as many medical conditions as the prescribed version.
Those looking to CBD products as a sure-fire investment might be cooled by Dr Agarwal’s assessment of their production.
“Growing hemp or cannabis, extracting the oil and then formulating into final form and hoping for an identical product every time is a very challenging task,” Dr Agarwal said.
CBD questions answered by webmd.com
How do you take it?
You can take CBD oil by itself by mouth or use one of many products that has it as an ingredient. These include pills, chewable gels, ‘tinctures’ you drop under your tongue, vape cartridges you breathe in, creams on your skin, and foods like chocolate bars. The amount and quality of CBD in these products can be very different.
Does it make you high?
CBD doesn’t – another substance in marijuana called THC does that. If you use a CBD product, check the label and make sure that’s the only cannabinoid listed.
Is it addictive?
CBD oil by itself is not. But CBD products that also have THC can be. The key again is to know the source and check the ingredients and the amounts, so you know exactly what you’re using.
Can CBD help with seizures?
The US Food and Drugs Administration has approved only one CBD-based drug, and it’s used to treat two rare types of epilepsy – Lennox-Gastaut syndrome and Dravet syndrome – as well as seizures caused by tuberous sclerosis complex. It’s called Epidiolex, and it’s approved for adults and children over the age of one.
Can it ease pain?
Scientists are working to see if it might help with arthritis, and some people with HIV say it helps relieve nerve pain (also called neuropathy). There’s some evidence that it may help muscle spasms linked to multiple sclerosis, too. More research is needed to know for sure.
Does it help blood pressure?
In normal conditions, CBD doesn’t seem to affect this one way or the other. But researchers are studying whether it might help keep your blood pressure stable when you’re stressed. More work needs to be done before scientists fully understand its effects.
Does it help inflammation?
Early studies show that CBD might help with this, especially if it’s related to arthritis, MS, diabetes or Alzheimer’s. But scientists are still trying to prove that and figure out how it works.
Does CBD help cancer?
In studies done on lab mice, CBD oil showed promise at killing breast cancer cells and making chemotherapy drugs work better. But researchers have much more work to do to see if CBD can help people in that way.
Is it good for your skin?
There is evidence that CBD might be a treatment for acne. It seems to help with both the inflammation that can lead to break-outs and the amount of fatty acids in the blood, which can make them worse. It also may protect skin cells from damage.
Does it help psychosis?
One study showed it helped ease the symptoms of psychosis in people with schizophrenia, but more research is needed to know just how well it might work. Keep in mind that THC, which is found in several CBD products, can have the opposite effect, and product labels aren’t always accurate.
Does it help addiction?
Much more study is needed, but early studies show that CBD may help people who want to break their addiction to cigarettes as well as drugs like heroin, cocaine, and methamphetamine. This may be in part because it seems to help with anxiety and muscle tension.
Are there side-effects?
So far, CBD doesn’t seem to cause serious ones. When it’s used to treat epilepsy or psychotic disorders, people reported tiredness, diarrhoea, and changes in appetite. But CBD can affect how other medications work, so be sure to tell your doctor about everything you take, including vitamins and supplements.
Would you consider using CBD products? Does the reclassification make it more likely you will use CBD products?
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Disclaimer: This article contains general information about health issues and is not advice. For health advice, consult your medical practitioner.