Exclusive: Medicinal cannabis could be available from chemists without a prescription from early next year in a controversial change pitting doctors against patient groups.
The nation’s medicines watchdog has opened a public consultation on the revolutionary change after pressure from a Senate inquiry, epilepsy groups, cancer patients, people with Crohn’s disease and those suffering chronic pain.
Singer and actress Olivia Newton-John has also called for Australia to loosen rules for medicinal cannabis after finding it helped with her pain and discomfort and sleep during treatment for breast cancer.
However, the Australian Medical Association will be opposing the move arguing there is not enough evidence it works and it is concerned it will normalise cannabis use and encourage people who wish to use the illegal form of the drug.
“It would be terrible if patients were of the view cannabis, with no evidence to support it, was better than an established therapy for a condition,” AMA vice president Dr Chris Zappala said.
Health Minister Greg Hunt said “any determinations regarding scheduling changes are a matter for the committee and the TGA in consultation with the States and Territories”.
The Therapeutic Goods Administration (TGA) has not yet registered any low dose cannabidiol (CBD) product as safe for use and before it could be sold without a prescription companies would have to apply to register their product with the TGA.
A recent safety review by the Therapeutic Goods Administration (TGA) found medical evidence supporting its use was flimsy and warned medicinal cannabis can double the effect of medications used to treat epilepsy and could interact with schizophrenia drugs.
However, the review cleared the way for making it available without a script finding “at low doses, CBD appears to have an acceptable safety and tolerability profile”.
Adverse effects such as mild drowsiness and fatigue could be managed by requiring a label that indicates it should not be used if driving or operating machinery, it said.
It has been legal to purchase medicinal cannabis if it is prescribed by a doctor under a special access scheme since a law change in March 2018, but many doctors refuse to make it available to patients and the approval process is complicated.
It is not subsidised by the nation’s drug subsidy scheme and at high doses can cost $40,000 a year.
To date, around 28,000 patients have applied to use medicinal cannabis and 45,000 scripts (around 4000 per month) have been issued, Associate Professor John Skerritt, head of the TGA, said.
There is evidence that when used in extremely high doses it is effective in some children with uncontrolled epilepsy.
There is evidence that when used in extremely high doses it is effective in some children with uncontrolled epilepsy, Professor Iain McGregor from the Lambert Initiative For Cannabinoid Therapeutics at Sydney University said.
The TGA has registered a high dose product Sativex for treating spasticity associated with multiple sclerosis.
Another high dose medicinal cannabis product Epidiolex used to treat uncontrolled epilepsy in children was granted orphan drugs status in Australia in November last year.
A major review of clinical studies on medicinal cannabis published last month found moderate evidence CBD could improve psychotic symptoms in schizophrenia patients but that further, large trials were needed to confirm the effect of CBD for the treatment of Crohn’s disease, ulcerative colitis, dyslipidemia and cannabis use disorders.
Professor McGregor said in low doses it might improve anxiety, relieve minor aches and pains, improve sleep and generally work to “degrumpify” a person’s mood.
His personal experience of medicinal cannabis while travelling in the UK where it is available without prescription was that it improved his tennis game by removing anxiety, he said.
Under the proposed changes chemists could supply doses of up to 60mg a day of CBD to adults and the consumer, not a doctor, would determine the symptoms they wanted to use it for.
The chemist would have to identify potential drug interactions before selling the product.
There are two main chemicals in cannabis cannabidiol (CBD) which has no psychoactive effects and Tetrahydrocannabinol (THC) the substance that gets you stoned.
The TGA is only proposing to open up low dose CBD to over the counter sales in chemists.
There have been 130 to 140 adverse events associated with high dose cannabis including nausea, sleepiness, extreme lethargy, vomiting, diarrhoea and problems with liver function and it could effectively double to dose effect of anti-epilepsy medications, Professor Skerritt said.
At lower doses the only adverse events were diarrhoea, a bit of fatigue and nauseas, he said.
While there was not a lot of evidence showing low dose cannabis had any measurable effect “that’s never stopped other (over the counter) medicines being sold” Professor Skerritt said.
Originally published as Medicinal cannabis could be available without a script