The decision to allow the distribution of nicotine e-cigarettes through Australian doctors and pharmacists has effectively legitimised these as yet unproven, unassessed, unregistered and potentially unsafe products as a health intervention.
From tomorrow, Australian-based doctors can prescribe and pharmacists can dispense nicotine e-cigarettes.
Australians have been able to import nicotine e-cigarettes with a prescription since 1 January this year. In August, and in advance of tomorrow's change, the TGA authorised pharmacists to promote their availability, albeit under strict conditions.
Documents seen by BioPharmaDispatch show nicotine e-cigarettes are being positioned to pharmacy as 'pharmaceuticals' and that their proponents are committed to seeking full TGA approval.
Why the need to authorise their distribution ahead of a full assessment and possible approval?
Political pressure?
In law, the TGA is independent of the health minister when it comes to exercising its legislated powers to make these changes on nicotine e-cigarettes.
However, during a Senate Estimates hearing in February 2019, South Australian Centre Alliance senator Stirling Griff revealed the extent of political advocacy in support of the products.
"Most of us - probably all of us around here now - are constantly bombarded by lobbyists claiming that vaping is a life-saving technology because it helps smokers quit," said Senator Griff.
The direct and very public political pressure applied to the TGA was on show during another Senate Estimates hearing in June this year. Government senators questioned TGA head John Skerritt on nicotine e-cigarettes. Senator Hollie Hughes questioned why general practitioners would not be compelled to prescribe the products. She described medical opposition to their availability as based on "very strange ideological grounds". Senator Eric Abetz suggested access to nicotine e-cigarettes should not even require a prescription and unsuccessfully sought Mr Skerritt's agreement to the assertion they are safer than tobacco smoking.
These products are readily and widely available
Earlier this year, Mr Skerritt acknowledged the reality that products for nicotine e-cigarettes are readily and widely available. In response to questions at a Senate Estimates hearing, he said, "It is very easy to obtain nicotine-containing e-liquids. A person in my block of units moved house recently, and I found on my doorstep, innocently and accidentally delivered, a very large bottle of nicotine-containing e-cigarette liquid. So it is very easy to purchase over the internet."
That will not change.
Since 1 January this year, these products have been lawfully available online from companies that can quickly and conveniently arrange a prescription and supply the products.
Completing one prescribing questionnaire, which asks very few questions, takes less than five minutes. The website says the information is reviewed by a doctor who can then issue a prescription. This all takes place within 24 hours. The prescription can then be uploaded to the website of the company promoting and supplying the vaping product.
This simple process has the obvious risk of product diversion, particularly amongst younger population groups, which has been a major issue in the US.
According to the US Centers for Disease Control and Prevention, in 2020 around one-in-five (19.6 per cent) American high school students reported they had used nicotine e-cigarettes in the past 30 days. Young people in the US are four times more likely to use nicotine e-cigarettes than adults.
The situation has led to FDA intervention, regulatory changes and a raft of lawsuits against one company over its promotional practices.
The quick, easy and ongoing online process to access nicotine e-cigarettes also raises questions about the practical impact of tomorrow's change.
How many people will go to the trouble of visiting a doctor and pharmacist when they can navigate a convenient five-minute process online? One website even co-opts potential users as product promoters with links to information they can provide a reluctant prescriber.
What is the real impact of tomorrow's change?
Does allowing the distribution of nicotine vaping products through traditional medicine channels only legitimise products that have not been approved or even assessed by the TGA as a health intervention?
In fact, the Department of Health website says the current evidence does not support the claim they assist in smoking cessation. It also says they cannot be considered safe.
Some might argue they are alternatives to nicotine replacement therapies.
There are significant differences.
Nicotine replacement therapies are TGA approved and reimbursed through the PBS, based on evidence. Nicotine e-cigarettes have not even been assessed by the TGA, let alone approved, and the research on their effectiveness is mixed, at best.
Also, how many people have developed a nicotine addiction from replacement therapies like gum and patches, compared to how many have been led to addiction by nicotine e-cigarettes?
Is this sector reluctant to be part of this?
Extensive lines of nicotine vaping products are being promoted to community pharmacies. Some are adopting a 'wait and see' approach to assess potential demand before committing to stock the products.
Materials distributed by one maker of nicotine e-cigarettes position the products as 'pharmaceuticals'. They are packaged as medicines and the company has also declared its intention to seek TGA approval for its product.
Information shared with BioPharmaDispatch also suggests some of the product suppliers are pre-empting this outcome by representing tomorrow's change as an effective TGA approval. They are doing this to push back against resistance by established service providers who are reluctant to support their promotion.
Tomorrow's change also almost certainly brings tobacco companies into the health system, given they are amongst the leading providers of nicotine vaping products.
How does an additional distribution channel protect younger people?
When it announced the change in December last year, the TGA said its "decision balances the need to prevent adolescents and young adults from taking-up nicotine e-cigarettes while allowing current smokers to access these products for smoking cessation with appropriate medical advice."
Yet how will the change prevent "adolescents and young adults" from accessing nicotine e-cigarettes? It simply creates a new distribution channel and the existing online websites are modifying their processes to accommodate the change.
