EXPERT REACTION: E-cigarettes to be available on prescription

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The Therapeutic Goods Administration (TGA) has today announced its interim decision to amend the Poisons Standard to classify nicotine for human use as a prescription-only medication, rather than a dangerous poison. The proposed Schedule 4 entry will include nicotine for use in e-cigarettes, e-juice, heat-not-burn tobacco products, chewing tobacco, snuff and other novel nicotine products, even if no therapeutic claims are made. 

Organisation/s: James Cook University, The University of Melbourne, The University of Newcastle, University of South Australia, The University of Queensland, The University of Sydney, The University of Adelaide, Edith Cowan University, Australian Council on Smoking and Health

Funder: Federal Government

Media release

From: Therapeutic Goods Administration

Access to nicotine-containing e-cigarettes

Today the TGA announced an interim decision that, if made final, would clarify the regulation of e-cigarettes containing nicotine, and nicotine fluids for vaping. The proposed changes would mean that certain nicotine containing products could only be supplied with a doctor's prescription.

This is consistent with existing state and territory laws which make the sale of nicotine e-cigarettes / fluids (except for prescription medical use) illegal throughout Australia and its possession or use illegal everywhere but in South Australia. The main impact of the decision, if confirmed through a final decision, is that importing these products purchased from overseas internet sites without a valid prescription would be illegal, and subject to impounding by the Australian Border Force. Personal imports under the TGA Personal Importation Scheme, with a valid prescription, are permitted.

To support smoking cessation, the requirement for a prescription would provide an opportunity for patients to consult with their medical practitioner as to whether e-cigarettes or other products containing nicotine are right for you as an aid to stop smoking. Medical practitioners are well placed to support smoking cessation and advise on how to reduce the risks associated with nicotine use. It is anticipated that nicotine e-cigarette products for smoking cessation will be available from both community pharmacies and appropriate Australian online pharmacies.

The requirement for a prescription will also prevent the rapid growth of youth uptake in vaping seen in Australia and overseas, and a potential pathway to cigarette smoking by young people. Between 2015 and 2019, e-cigarette use by young people increased by 72% in the US, 150% in Canada and 96% in Australia.

The proposed changes would also not affect access to registered products to help smokers quit such as gums, sprays and patches.

The interim decision will be open for public consultation until 6 November 2020, with a final decision expected in mid-December, with an implementation date of either 1 April or 1 June 2021. The public can sign up to webinars explaining the interim decision on 8 and 9 October 2020.

Expert Reaction

These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.

Dr. Gary Chan is a NHMRC Emerging Leadership Fellow at the Centre for Youth Substance Abuse Research at the University of Queensland.

The most dangerous form of using nicotine is from smoking tobacco, not from vaping nicotine using e-cigarette. Requiring prescription for a nicotine vaping products while letting traditional tobacco products be widely available does not make any sense – In the debate of e-cigarette policy, it is essential to remember that that it is the harmful chemicals from burning cigarette that kill, not the nicotine per se.

From a public health perspective, a more reasonable policy is to ban combustible cigarettes while giving smokers easy access to nicotine vaping to relieve craving.

Last updated: 07 Oct 2020 2:57pm
Declared conflicts of interest:
None declared.
Professor Ron Borland is Deputy Director of the Melbourne Centre for Behaviour Change at The University of Melbourne

Too little, but welcome.  This appears to be an attempt to bow to the inevitable in as slow a way as possible.  There is now very strong evidence that vaping is superior to state of the art conventional therapies for smoking cessation, albeit dependent on persistent use of the vaping product. (the large RCTs of Hajek et al and Walker et al being the most important of which I am aware). 

Complementing this, is the fact that smoking rates are declining, in some cases at increased rates in countries allowing vaping (see Levy et al), so the myth of a gateway being a significant influence is disconfirmed for any serious scientist.   This was the main concern among tobacco control activists, and residual concern may explain the conservative approach. 

More likely also important is that vaping acts for many as a substitute for smoking, not as a cessation aid. It is more like digital camera replacing film.  Therapeutics goods legislation was never designed for such eventualities, so there is no model for regulators to apply.  This is  a tiny step in the right direction.

Hopefully, this is a first step to tobacco control policy that is based on realistic possibilities not on the naïve, though laudable in some respects, goal of eliminating all nicotine use. It will be interesting to see if those the tobacco control movement who have  opposed anything to do with vaping are  prepared to accept this science-grounded step forward.  

 In closing, I note that the Committee made it decision with what I believe to be an overly negative view of the health risks and risks of future tobacco dependence in youth.   The evidence base for some of the concerns is shaky, to say the least.

Last updated: 24 Sep 2020 12:17pm
Declared conflicts of interest:
Ron has no conflict of interest to declare
Simon Chapman AO is an Emeritus Professor in the Sydney School of Public Health at the University of Sydney

We made every conceivable regulatory error allowing tobacco to be sold anywhere, unregulated. E-cigarettes have unknown long-term health consequences and are powerfully addictive. If they are to be made available, prescription access makes perfect sense.

Last updated: 23 Sep 2020 4:53pm
Declared conflicts of interest:
Simon has declared he has no conflicts of interest.
Dr Stephen Bright is Senior Lecturer of Addiction within the School of Medical & Health Sciences at Edith Cowan University

Anything we can do to reduce tobacco smoking in society is a good thing. According to the British Medical Association, e-cigarettes are 95 percent less harmful than smoking. Vaping is a harm reduction strategy that is consistent with Australia’s national drug strategy. For vaping to be an effective harm reduction tool, it would be best for the product to be available over the counter in pharmacies, where health advice can be administered, without too much regulation. Pharmacies already stock nicotine products and are well placed to make sure nicotine for vaping is well regulated, though still easily available. There are concerns that if it is too hard to access vaping, then people may revert to smoking.

Last updated: 23 Sep 2020 4:42pm
Declared conflicts of interest:
None declared.
Dr Miranda Ween is from the Lung Research Lab at the Royal Adelaide Hospital and the University of Adelaide School of Medicine

Our recent systematic review published in CHEST was an update to the NASEM report noted by the TGA. This review provided additional evidence that nicotine alone can have health impacts beyond addiction, and my own research into the effects of vaped nicotine on lung immune cell function and lung cell toxicity supports this concept. Progression towards a prescription only model makes logical sense provided enough notice is given, which thankfully appears to be the case this time around.

This decision means that smokers or those that have switched to E-cigs will be able to discuss their E-cig use with a trained medical professional who will themselves be advised on the current health risks by RACGP. Studies have shown that smokers who discuss their quit goals and progress with a counsellor have a greater chance of success of quitting and not relapsing. This new regulation will also provide smokers with access to a legal, safe source of nicotine for their E-cigs, something the vaping industry has been asking for. It makes sense, that as a poison, that high concentration nicotine is only handled by qualified and trained professionals such as compounding pharmacists. I do believe that there needs to be a limit set on concentration, as heavily popular products overseas currently contain 59mg/ml of nicotine, far beyond what is in tobacco cigarettes.

Last updated: 23 Sep 2020 4:41pm
Declared conflicts of interest:
Miranda has declared she receives no funding from the tobacco, vaping, or nicotine replacement therapy industries and thus has no financial conflicts of interest.
Dr Aaron Drovandi is a Pharmacy Lecturer at James Cook University

Nicotine addiction has long posed a serious threat to public health in Australia and around the world. Conventional cigarettes in particular cause significant long-term damage to smokers, and assisting current smokers in quitting smoking is paramount for positive public health outcomes in Australia.

While e-cigarettes are by no means safe to use, and the exact health concerns relating to their use remaining unknown, they represent a less-harmful alternative for those who have previously or currently use conventional cigarettes.

The continued availability of e-cigarettes through regulated channels (such as by prescription) will ensure that those who use these products avoid the more harmful effects of conventional cigarettes. The interim decision by the TGA protects these users of e-cigarettes, though the ultimate goal in the fight against nicotine addiction and its consequences should be to phase out all harmful nicotine-containing products.

Last updated: 23 Sep 2020 4:20pm
Declared conflicts of interest:
None declared.
Dr Michelle Jongenelis is a Senior Research Fellow at the Melbourne Centre for Behaviour Change (Melbourne University)

The TGA’s decision to only allow the sale of e-cigarettes in chemists (and provided the purchaser has a prescription from their doctor) is an interim compromise and the consequences of this decision must be closely monitored prior to a final decision being made. It is important to recognise that e-cigarettes have yet to be be independently tested.

Furthermore, while this decision will minimise the risk of adolescents and non-smokers purchasing e-cigarettes and e-juice at brick and mortar vape shops, greater enforcement at the border is needed to ensure illegal importation via online stores is stamped out.

Last updated: 23 Sep 2020 4:19pm
Declared conflicts of interest:
None declared.
Associate Professor Gillian Gould is a GP researcher and Tobacco Treatment Specialist at the University of Newcastle

GPs as 'experts on life' are well-placed to help their patients who smoke make shared decisions on the best and most appropriate treatment for them to support quitting. Having smokers attend their GP, while being an additional barrier for some, can positively influence cessation.

E-cigarettes can be considered when other methods have failed or are not preferred. Evidence-based medicine should always incorporate the patient’s perspective. Best practice for smoking cessation should always include behaviour change techniques in addition to nicotine substitutes or pharmacotherapy.

This support can be provided by the GP and also a referral to the Quitline, which is a free service. Training should be available for GPs and other health professionals on on the correct way to prescribe e-cigarettes. Additionally, a reminder that GPs and health professionals should not only ask all patients about smoking, but other forms of tobacco use and about vaping.

Last updated: 23 Sep 2020 4:17pm
Declared conflicts of interest:
None declared.
Maurice Swanson OAM is Chief Executive of the Australian Council on Smoking and Health

We will want to look closely at the proposal before responding in detail. In the meantime, the TGA should be commended for maintaining its position that e-cigarettes are only available on a doctor’s prescription, and should continue to ignore noisy lobbying from organisations with commercial conflicts of interest. In responding to the TGA’s proposal, The Australian Council on Smoking and Health will be mindful that: The evidence that e-cigarettes are effective for population-wide smoking cessation is weak, the growing evidence that e-cigarettes cause harm to the heart, lungs, and the developing brain of adolescents and the growing evidence about high levels of e-cigarette use by young people in countries that have allowed them to be more freely available and promoted.

Last updated: 23 Sep 2020 4:15pm
Declared conflicts of interest:
None declared.
Associate Professor Kristin Carson-Chahhoud is an NHMRC ECR Fellow at the Australian Centre for Precision Health in the University of South Australia Cancer Research Institute

Australia needs to continue to focus on evidence-based policies, which includes ongoing review about long-term impacts of e-cigarettes and whether they do help with quitting. Reality is the evidence is not there yet to support e-cigarettes as a quitting aid but evidence-based gold standard care that we know is effective is getting overlooked.

We cannot have a regulatory framework that exposes a new generation of Australians to a nicotine addiction, as we see happening in New Zealand and Canada. The Government needs to focus on what we know works and invest in hard hitting mass media campaigns and existing severely underutilised services like Quitline. We know the existing services are highly effective in helping support people to break their nicotine addiction. What isn’t happening is investment desperately needed to link smokers back into gold standard and evidence-based quit smoking support.

Last updated: 23 Sep 2020 4:14pm
Declared conflicts of interest:
None declared.
Wayne Hall is an Emeritus Professor at the National Centre for Youth Substance Use Research at the University of Queensland

I cautiously welcome the proposed change to scheduling of nicotine that would allow it to be prescribed by medical practitioners for use in the form of e-cigarettes for smoking cessation or as an alternative to cigarettes. The effects of the change will critically depend on there being approved products available for prescription and on medical practitioners being prepared to prescribe them. If neither of these conditions are met, the policy will intensify the existing de facto prohibition of e-cigarettes.

Last updated: 23 Sep 2020 4:11pm
Declared conflicts of interest:
None declared.
Associate Professor Coral Gartner is from the School of Public Health at The University of Queensland

The scheduling decision clears up confusion about whether nicotine vaping products should be classed as dangerous poisons or as prescription medicines by state and territory health departments. Currently, these products are considered to be prescription medicines if intended for therapeutic use, such as for quitting smoking. But are classed as regulated dangerous poisons if intended for non-therapeutic use. There is a big difference between these two classifications because as a regulated dangerous poison, most states and territories do not allow people to obtain them, even with a medical prescription. This change makes it clearer that people who want to use these products to quit smoking can legally obtain them, if they have a prescription from a medical practitioner for them.

Currently, Australians who have a medical prescription for nicotine vaping products can import the products for their personal use. However, the Australian government announced an intention to ban the personal importation of nicotine vaping products from the 1st of January 2021. The intention to establish a streamlined pathway for access via the Special Access Scheme was announced, however there are still many questions about how practical this will be.

Last updated: 23 Sep 2020 4:09pm
Declared conflicts of interest:
None declared.
Professor Bruce Thompson is Dean of the School of Health Sciences at Swinburne University

Australia needs to continue to focus on evidence-based policies – this includes ongoing review of long term impacts of e-cigarettes and whether they do help with quitting. We cannot have a regulatory framework that  exposes a new generation to a nicotine addiction as we see happening in New Zealand and Canada. The government needs to focus on what we know works and invest in hard-hitting mass media campaigns and QUIT services that support people to break their nicotine addiction.

Last updated: 23 Sep 2020 4:05pm
Declared conflicts of interest:
None declared.

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