They complicate the process and don’t protect against harmful chemicals in similar unregulated products.
Doctors must prescribe nicotine vapes if Australians want to use them legally, but prescribers have labelled the regulations “kooky” and unrealistic.
Research also suggests the new TGA rules fall short of protecting Australians from potentially harmful non-nicotine e-liquids.
Although these national restrictions only came into effect on 1 October, it was already illegal to carry or use a disposable e-cigarette device or e-liquid containing nicotine without a valid prescription in every state and territory except South Australia.
However, people had been allowed to import disposable vapes and nicotine-containing e-liquids from overseas for personal use. It was that legal loophole that was recently pulled shut by the TGA.
Under these tighter regulations, consumers must have a valid prescription for nicotine-containing e-liquids from an Australian doctor. This allows them to import a three month supply for themselves, or purchase the smoking cessation tool from a pharmacy.
The products themselves must meet a new TGA standard for vaporiser nicotine, which includes minimum packaging, labelling and nicotine concentration requirements.
While all GPs are eligible to be able to write a script for nicotine vaping products, they need to apply to be a TGA authorised prescriber for their patient to obtain vaping products from an Australian pharmacy; otherwise, the patient will have to personally import it via an overseas website.
“It’s all a little bit kooky,” Sydney-based GP Dr Brad McKay told The Medical Republic.
According to the TGA website, GPs who are prescribing for the personal importation scheme are “encouraged to confirm” with overseas suppliers that the product meets the TGA’s standard.
“How many GPs are going to go online and write to some company or give them a call overseas in New Zealand, and then ask them if their nicotine solution is abiding by all of the TGA rules?” Dr McKay said.
Dr McKay said patients who had been vaping regularly for years had started to present to him with questions months before the new regulations came into effect.
“A lot of my patients are already quite savvy about it, they’ve been vaping for years, they’re really quite anxious about the rules and they’re wanting to do everything right,” he said.
“The vast majority of patients who are well versed in it already know what they’re doing and they’re already checking with the company and making sure that it’s abiding by the TGA rules.”
These patients, Dr McKay feels, are the ones who are primarily affected by the new regulations, while people who routinely purchase illicit vaping products are unlikely to be affected.
“It’s not actually changing the rules for the people that are just, ad hoc, getting it from the corner store and don’t have a clue what they’re doing,” he said.
While clinicians may be confused by the new regulations, patients are unlikely to struggle to find prescribers.
A simple internet search for prescription vapes reveals multiple telehealth providers dedicated to e-cigarettes and smoking cessation.
One clinic advertises a three-step process on its home page, advising potential clients that they can “complete a patient history form”, “get connected to a health professional in minutes” and then “receive [a] script and shop at a preferred supplier of TGO-110 compliant nicotine products”.
A button reading “get my prescription” then leads to a patient registration form.
Although vaping may have unknown consequences, Dr McKay said he felt it was important from a harm-minimisation standpoint that patients still be able to access the products.
“If I’ve got a patient who’s smoking 20 cigarettes a day, I know that’s going to do them pretty damn terrible harm over the next 20 years,” he said.
“But if they were to swap to vaping, then I know that the amount of chemical they’re going to be inhaling into their lungs will be minimal in comparison to smoking combustible cigarettes.”
Australian guidelines suggest prescribers attempt to wean patients off after three months, and consider transferring them to other nicotine replacement therapies. The RACGP advises 12 months use at most.
In 2019 there was a large outbreak across the US of what came to be known as e-cigarette/vaping-associated lung injury (EVALI), which was attributed largely to the vitamin E acetate used as an additive in THC vaping liquid.
Research into the potential harm of vaping is continuing, with a recent paper in the MJA revealing that even non-nicotine e-liquids, which are exempt from the new TGA regulations, commonly do contain nicotine and toxic chemicals.
The study, in which Perth-based researchers examined the ingredients of about 60 over-the-counter vaping liquids, found nicotine in 10% of the purportedly nicotine-free products.
Curtin University researcher Professor Ben Mullins, a co-author on the paper, said the most concerning finding was how extensive incorrect labelling was.
“One of the brands had their glycerol and propylene glycol ratios completely wrong; the labels were one way and the ratios in all their products that we examined were reversed,” he told TMR.
Another key finding was that e-liquid manufacturers appeared to be adding chemicals that are widely used as flavouring in food.
“[Being a safe food additive] doesn’t mean it’s been tested properly for inhalation toxicology, because inhaling something is very different to ingesting it,” Professor Mullins said.
This fear has already been realised, with many vapes previously found to contain diacetyl, a food additive which can cause popcorn lung if inhaled.
Professor Mullins also said that the newness of vaping made it hard to establish a level of risk.
“I think there’s a reasonable likelihood of adverse reactions in a lot of people,” he said.
“As for long term chronic use, we really don’t know the risks yet, because we don’t have enough of a body of epidemiological data.”