The decision to make nicotine-containing e-cigarettes Prescription-Only from October places pharmacists at the frontline of counselling on a highly controversial product
In late December, the TGA confirmed its decision on nicotine for use in e-cigarettes: from 1 October 2021, consumers will need a doctor’s prescription to legally access nicotine e-cigarettes and liquid nicotine.
As well as confirming its September 2020 interim decision, the TGA amended it to include a provision for child resistant closures to be mandatory on nicotine preparations.
Pushing back the date
The starting date of October is later than originally proposed: the original date suggested was 1 June 2021.
“My final decision is to make certain nicotine-containing products, including e-cigarettes, only available with a prescription from an Australian medical practitioner,” said the TGA delegate.
“The basis on which I have made my final decision balances consumer demand for nicotine e-cigarettes to support smoking cessation and the public health need to reduce and prevent the initiation of nicotine addiction among non-smokers, in particular, in adolescents.”
In response to the final decision, Federal Health Minister Greg Hunt said that the government will take certain actions:
- The previously proposed Customs (Prohibited Imports) Regulations will not proceed due to the significant overlap with the TGA decision.
- In consultation with the RACGP, AMA and other medical experts, the government will develop a Telehealth Smoking Cessation item that will be available six months prior to the 1 October implementation date. As part of this work, the government will provide $1m for an education campaign focused on smoking cessation.
The TGA concluded that current available evidence does not support that e-cigarettes are a safer alternative to currently available smoking cessation aids, or to conclude if they are a useful quitting aid.
It also expressed concern that e-cigarettes could re-normalise smoking, and carried a risk of addiction for new or continuing users—and that the toxicity of long-term exposure to heated and inhaled chemicals is unknown.
The delegate also noted that exposure to nicotine in adolescents may have long-term consequences for brain development, potentially leading to learning and anxiety disorders.
The Minister’s response
“It is important to note that any doctor may currently prescribe nicotine-containing e-cigarettes that can be used by consumers for personal importation,” Mr Hunt said.
“This is not widely understood, and it is an important matter of public information that over 30,000 GPs may currently, and in the future, prescribe nicotine-based e-cigarettes for smoking cessation.
“Secondly, any of these GPs can also register with the TGA to become what is known as an ‘Authorised Prescriber’. A GP who is an Authorised Prescriber can issue prescriptions for e-cigarettes for dispensing at a local pharmacy as an alternate option to personal importation.
“Nicotine-containing e-cigarettes are currently illegal to sell in every state and territory, and possession in all jurisdictions (except South Australia) is also illegal without a valid medical prescription.
“That means that there is a current situation that legally imported materials are then illegally possessed under state law.
“This decision will both reduce the risk of an on ramp for teenagers as highlighted by the delegate, while rectifying the issue of legal importation but illegal possession.”
Mr Hunt also noted that there had been rapid growth of youth uptake of vaping internationally—and already in Australia.
“In Australia between 2016 and 2019, the number of current e-cigarette users aged 15–24 increased by approximately 72,000 (95.7% increase) for a total of approximately 147,000,” the Minister said.
“In addition, recent research from the Australian National University has found e-cigarette users are three times more likely to take up traditional cigarette products.”
Pharmaceutical Society of Australia national president Chris Freeman said that PSA supports smoking cessation therapies, “but we are cautious about promoting nicotine vaping products to Australians and echo the federal government’s concerns around protecting the health of children and young people and the importance of restricting and monitoring access to this vulnerable population”.
“Pharmacists have a vital role in supporting people who wish to quit smoking,” he said.
“There are a range of approved smoking cessation products available today in pharmacies around the country and pharmacists are available to support smoking cessation through evidence-based public health and harm minimisation activities.
“PSA acknowledges the need to develop a robust, real-world evidence base for the effectiveness of nicotine-containing e-cigarettes as a quit smoking aid and in harm reduction.
“As with all medications supplied though pharmacies in Australia, PSA supports registration through the Australian Register of Therapeutic Goods (ARTG). The sooner this can happen for nicotine liquid and associated devices the better.
“Pharmacists will respond accordingly when recommendations regarding access to e-cigarettes are finalised.
“We will take a harm minimisation approach, and will work with the government to enact access solutions that protect Australians from the harm associated with tobacco and other nicotine-containing products.”
Dr Freeman echoed the words of Anthony Tassone, Victorian branch president of the Pharmacy Guild, when Mr Tassone responded in September to the interim decision.
“Ideally, the products should be registered on the Australian Register of Therapeutic Goods,” Mr Tassone said in response to the interim decision.
“The Guild supports the interim decision under the proviso that nicotine liquid products are appropriately scheduled and controlled for therapeutic use to support smoking cessation.
“The requirement to have products registered on the ARTG will address concerns related to packaging, as well as safety and quality.
“The Guild believes this to be an extremely important measure to protect consumers, and to assure pharmacists that products being supplied have been assessed for safety and quality.”
An overview for pharmacists
In providing information on e-cigarettes for pharmacists, the TGA notes that shifting nicotine for vaping to S4 “will provide an opportunity for consumers to receive appropriate advice from a doctor and their pharmacist on the use of, and risks associated with, these products”.
“Certain other novel nicotine delivery products will also require a prescription, including heat-not-burn tobacco,” it notes.
At the time of writing there are currently no TGA-approved nicotine e-cigarettes on the ARTG.
“Pharmacists can dispense a prescription for nicotine e-cigarettes with evidence of a SAS or Authorised Prescriber approval,” says the TGA.
“Pharmacists can also extemporaneously compound as long as they meet Pharmacy Board of Australia requirements.”
Pharmacy wholesalers will be able to apply for an import permit under the Import Declaration (N10) pathway; or via a Self-Assessed Clearance (SAC) declaration.
The TGA is also encouraging pharmacists and their patients to report any suspected side-effects related to e-cigarettes, noting the TGA’s role in monitoring the safety of “unapproved” products.
This is an extract of an article from our February 2021 print magazine. Go to the magazine or e-magazine to see the full article – including a flowchart illustrating the process involved in dispensing a prescription for nicotine e-cigarettes.