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Webinar presentation: Nicotine vaping products, the NZ smoking cessation experience, 15 October 2021

19 October 2021

Disclaimer

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The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by:
    • Adj Professor John Skerritt, Therapeutic Goods Administration, Department of Health
    • Dr Natalie Walker, Associate Professor in Population Health, NZ
    • Dr George Laking, Medical oncologist at Auckland and Northland District Health Boards, NZ
    • Dr Hayden McRobbie, Consultant in Lifestyle Medicine, Lakes District Health Board, Rotorua, NZ
  • Presented at: Online webinar
  • Presentation date: Thursday 15 October 2021
  • Presentation summary: Adj Professor Skerritt, from the Department of Health's Therapeutic Goods Administration, chaired this event, joined by three eminent New Zealanders with practical and clinical experience in the practice of smoking cessation treatments in New Zealand, particularly in the role nicotine vaping products can play in a person's journey to quit.

Recording of online webinar presentation

Transcript

Adj. Professor John Skerritt

Good evening, everyone. And thank you for joining our webinar on what we're going to call the New Zealand experience with vaping. And there's still a number of people still joining us. And I realise people are often a little bit late at the end of a busy day, where we've currently got about 60 people online and I know the numbers will increase. And we're absolutely delighted that we had three excellent colleagues from New Zealand join us.

The aim of today's exercise was really to look at the New Zealand smoking cessation experience and the role of nicotine vaping products. It isn't so much to explore differences in the regulatory framework. New Zealand has also introduced a comprehensive regulatory framework. It's different from the Australian prescription-only model, but it certainly has a number of controls, especially around the quality of products.

Instead, the experience is a practical experience for those who are healthcare professionals working with individuals who want to try vaping as a means of potential smoking cessation. And without much further ado, I'm going to introduce our three colleagues. The first speaker tonight's going to be Dr Natalie Walker. She's an associate professor at University of Auckland and director of the Centre for Addiction Research.

Natalie's going to talk about some of her experience in the conduct of community-based clinical trials, you could call them real-world clinical trials, on smoking cessation, including the role of nicotine vaping products. Then we're pleased to have Dr George Laking. And George is a medical oncologist. You could argue he probably sees the end of the effects of smoking through treatment of lung cancer. He does definitely.

But George is the chair of End Smoking New Zealand and has a particular involvement and connection with the Māori people and indeed, Māori Medical Practitioners Association. And again, some of that experience, as we know in Māori populations as well as in Aboriginal and Torres Strait Islanders in Australia, we have higher rates of smoking. And we're even more interested in whether they're first New Zealanders or first Australians to assist with smoking cessation.

And last, but not least, we're going to be honoured to have a presentation from Professor Hayden McRobbie. Hayden does work in both Sydney and in New Zealand. He's currently broadcasting from New Zealand. And he's originally trained in Otago. And Hayden has a key role in tobacco control in New Zealand. And he will be providing, as a medical doctor, some of his very practical, real-world experience in the role of nicotine vaping products and also the interaction between nicotine vaping and smoking indeed in other long-term health conditions.

And I should just say the speakers will talk for about ten minutes each. And then that will give time for us to have some questions and answers. And again, I'd just remind you that we're really here to learn from what our colleagues in New Zealand have learnt themselves over recent years. There is a lot of information on the Australian regulatory and other systems on the TGA website. And we're always happy to take other questions directly.

But I'd encourage people asking questions to focus on some of the real-world issues of the use of nicotine vaping products in smoking cessation. Over to you, Professor Walker.

Dr Natalie Walker

Hello, everybody. Thank you. It's nice to speak today. I'm just going to give you a very quick summary of some of the pivotal New Zealand trials on e-cigarettes and how we came to run them and how they have influenced New Zealand's position on e-cigarettes. First of all, this is the smoking prevalence in New Zealand. The red line indicates the current prevalence, which is 13%. And the blue line represents New Zealand's smoke-free goal, which is 5% of the population by 2025 will be smoking.

The key thing that you'll notice here is that we're probably not going to reach our goal because the goal includes everyone. We're not going to leave any smokers behind. But you can see that there's a clear equity issue, a major equity issue. And I imagine that the Australian data, which I haven't seen, was probably going to be really similar. Both can countries have very strong tobacco policy and we have the full range of smoking cessation products and services available.

And yet, this is the picture that no one talks about. When we undertake research in New Zealand, it's always trying to address these equity issues. What else do we have to offer? And I personally believe that we have to move to looking at reduced harm products. Importantly, here's our NRT, nicotine replacement therapy. It's a low addictive potential and low potential of harm. When e-cigarettes first came into the market, they were sitting around the same level as NRT in terms of addiction, potential and harm.

But over time, the e-cigarettes have become much better at delivering nicotine. And now potentially, some of them are more at the high addiction potential, but the harm is very low. I don't know what has happened in Australia, but in New Zealand, we've had some oral nicotine products that had come into the market and the heat-not-burn products. These tobacco products up here still reduced harm.

Over here, we have reduced nicotine tobacco, which New Zealand government is currently looking at as another option. High risk of harm, but low addiction potential. No point using it. There's a third arm to this graph, which is about acceptability of these products. And that's where e-cigarettes come in. I'm going to talk to you about three different trials that we've run. The Wide [?] study, the ASCEND study, the ASCEND-II trial and the Cessation study, I'm not going to talk about.

This is our new one. The first trial we undertook used the Cigalikes. These were the very first e-cigarettes that came into the market. And then our two subsequent trials used the second-generation e-cigarettes, each one slightly more improved quality-wise. And the new trial, we're looking at these nicotine pod-type e-cigarettes. When e-cigarettes first arrived into the country, everyone was going, what are these things?

Everyone's really interested and the smokers are really interested in them. But the government's saying, what's in them? How do we regulate them? Should they be regulated as drug paraphernalia or do they have potential to help people to quit? And we're working very closely with the government in developing some research to answer some of these questions, particularly, what's in them? Do they help people with cravings?

And do people actually like them? The first study we did was a crossover study. And after an overnight fast from smoking, we asked people to come in and use these Cigalike e-cigarettes, who were randomised to different orders. And compared them to the nicotine inhalator, which is an NRT product, and a cigarette. This graph shows you that the nicotine e-cigarette actually had very similar findings to the nicotine inhalator in terms of addressing changes in desire to smoke from baseline.

We also asked whether they found them acceptable and our participants said they found that e-cigarettes were much more pleasant than the NRT product. Less mouth and throat irritation than NRT product. And the PK, we did some PK work and they were very, very similar to the [unclear] too. Then from this information, we thought we need to do some more definitive stuff, bigger trials. We need to have a look. What do we need to do?

We need to answer some more questions about whether e-cigarettes help people to quit. And we designed two studies. One that is called ASCEND. And these are large, pragmatic clinical trials. We wanted to know if someone went and brought an e-cigarette from a shop, a vape shop or a supermarket, what are the quit rates? Compared to an efficacy study which will be in a clinic where you might pay someone to turn up.

And the findings from that study are not very generalisable. The government wanted to know what is happening out in the general population. As you can see, the two studies are very large because quit rates are generally quite low. And you need large numbers to get a big enough look at effect sizes. And importantly, this is very open eligibility. Hardly any exclusion criteria. People are literally provided with a product and no further contact until we ring them up for some to ask if they're still smoking.

But we were able to reach our Māori population, which was super important. When the first trial was published, the ASCEND trial, at the same time, there was a study published from Italy. And these two studies were the first two trials of e-cigarettes and both were very similar. The only difference was one was in the population of unmotivated to quit and one were motivated to quit. One was clinic-based. One was a national sample, very light touch and slightly different nicotine content in the products.

And what did these studies find? Basically, the quit rates were generally fairly low in both studies and similar to what you would get with a national quitline or a telephone counselling service or a text message smoking cessation service. Although there were differences in our verified quit rates at six months in each treatment group, it was a non-significant finding. There were no statistically different findings.

However, there were statistically significant findings in terms of cigarettes per day in favour of the nicotine e-cigarettes. And also, the nicotine e-cigarettes are really good at helping prevent relapse back to smoking. It's like, I'm not having a cigarette. But am I going to have a craving for a cigarette? I'm going to reach for that e-cigarette. And there was no difference in the frequency of adverse events between the two groups or the different groups or the two trials.

And those two trials immediately went into a Cochrane review. And there, they stayed. They were the only two trials for a very long time that had any information about whether these Cigalikes, these old types of devices and then just starting to… The new devices were happening, but there was no trials of them yet, because it takes time, one, to get the money, but also to run them. Each trial's about three years to run, because it lacks the sample size.

Then our second trial happened. And this was with the newer devices. And this is really looking at combination treatment. Should we consider a nicotine e-cigarette a bit like an NRT product, so you can combine it with a patch and this is the oral product? And that's what we looked at. And this is one of the problems with pragmatic trials. They're real world and we ran into a few problems. And that's to do with the fact that when people come into the trial, there's equal poise.

They're happy to accept whatever medication they are provided and they acknowledge that. But that wasn't always true. Because they came in saying that. But as soon as they weren't randomised to the e-cigarettes, they left. And this is this withdrawal rate in the people that were given the NRT. Often, smokers have tried repeatedly and repeatedly to quit with NRT and they have failed. And all of a sudden, something new comes along, it's very interesting.

If you think about your own behaviour, you keep repeating something and it fails. Is that the definition of stupidity? You would then go and try something new. And this is why e-cigarettes is something that's appealing. And we also found that the follow-up in this group was much higher in those allocated patch and some of them actually crossed over. They got allocated into the patch group and they went, I don't want this.

I'm going to go buy my own e-cigarette. And that's exactly what they did. And even those that received the placebo e-cigarette, some of them were able to figure out that it was a placebo and went off and got themselves a nicotine e-cigarette. Very hard to do these real-world studies where you're trying to be very light touch and not manipulate or change anything. And this is what happens. Despite that and after adjusting for those issues in the analysis, this is what we found in the second trial.

Is that combination treatment works better than a single treatment. It's exactly the same finding for NRT combination. NRT is better than single-product use. The difference here is this is self-reported. It's not verified abstinence. If you verified, it would drop slightly. When the second trial was published, another study came out at the same time. This is from the UK. And these are the comparison of the quit rates.

And the main thing to notice here is the UK study was in a clinic. And it really highlights quit rates are higher. It's because clinic-based smoking cessation services offer much more of a wraparound service. It's much more intensive. And we would expect the more contact, the more intensive support, you're going to get higher quit rates. Compared to just buying it from a shop and never talking to anyone else about it.

And again, our safety findings was similar as before. No alarms raised here. Quickly just talking about the ASCEND-II trial, the second one, about dual use. And what we found is in those people that were allocated the e-cigarettes and the NRT, actually, their dual use was more common with the NRT than with e-cigarettes. Which was consistent with some data we had from the UK. But at the end of six months, very few people were dual users.

They'd either gone completely back to cigarettes or they had quit or they were using just one other product. And then our dual users were much more cigarette-dependent. Which means that we're really not managing the nicotine replacement. If you're dealing with somebody that's a dual user, you might be saying, we need to increase maybe your NRT or we might give a stronger dose e-cigarette. Or look at some other cessation medication like varenicline or something like that.

Important thing to note is dual use is transient. People are completely shifting in and out of that state constantly. And here's an example here. This is the treatment group that received everything, a patch plus the nicotine e-cigarettes. And the colour ones are the dual users. And you can see over time, they're constantly trying, constantly switching their products, constantly trying to stop smoking. And this is really about we have to be supporting our smokers on this journey.

It is a journey. It's very rarely an instant, I'm no longer smoking. And it's very rarely a straight line. And this just highlights that. And what has happened with these trials that we've undertaken in New Zealand? They've gone into the Cochrane review. And the Cochrane review is a living review now. Every new study that comes in, the review immediately gets updated. And to date, they have found 61 studies and almost 17,000 people have been in these studies.

But interestingly, of all those studies, between only four and six have actually been of any use to go in and inform our policy around whether e-cigarettes help people quit smoking. When people say, we need more research, we do need more research, but we need better quality research that's actually going to make a difference and be informative. And that's why we always design our trials to go into the Cochrane review and we're very careful about our design.

Just quickly around side effects. The Cochrane review has also set the side effects around nicotine e-cigarettes, usually throat and mouth irritation. That's about three in every ten people may have that. Or a dry cough, again, about three in every ten. And over time, once they're using the device, that those side effects are self-limiting. And some people experience headache, but headache can also be a symptom of withdrawal as part of quitting.

And some nausea. I'm going to stop there. And I think we're going to pass over to George.

Dr George Laking

Just to make a declaration, I work as a medical oncologist in Auckland. I chair End Smoking New Zealand. I've been a collaborator with Natalie in her recent trials. And I've accepted money from GSK once, which I'll declare forever and a day now. If we go to the next slide, please. I've called this vaping in context. The context in particular being smoking and the context of societies. The context of smoking in the context of society.

And if we're talking about New Zealand, it's good to think about what happened over the last decade since the Māori Affairs Parliamentary Committee commissioned an inquiry into the tobacco industry in Aotearoa and the consequences of tobacco use for Māori. Of course, tobacco are unknown in these lands until the arrival of Europeans. Same goes in Australia, of course. In 2011, springing from the Māori initiative, because really, tobacco has been very heavily used proportionately by Māori people.

Māori women really amongst the highest smoking rates for any population in the world, with consequent extremely bad results for health. We embarked on a project a decade ago with the goal of becoming essentially a smoke-free nation by 2025. And that's been understood as a 5% prevalence of daily smoking. And because we're big on equity, that 5% prevalence has got to be the maximum for every cohort within society.

5% for Māori as well as for non-Māori. And this slide shows the challenge, because we worked really hard over the last decade. We ramped up tobacco excise tax by 10% a year. We denormalised smoking. We followed your lead with introducing standardised packaging in 2018. And we adopted pharmacotherapies as pathways out of tobacco addiction for smokers, with public funding of nicotine patches and gum and buprenorphine and varenicline.

And I have to say I felt a lot of optimism at the start of the decade as to the potential for what could be done with pharmacotherapy. But by the end of the decade, we are seriously off-track for this target of achieving 5% prevalence of smoking. That's what the graph is showing. The green line in the middle is all adults in the New Zealand population. The dotted segment is the story so far. If you look at the slope of that line, it's not going to intersect with the smoke-free goal of 5% prevalence.

The slope has to become a lot steeper downwards. And then if you then cast your eye up to the purple line, that's the Māori situation, which is even worse. We achieved a 23% relative fall in prevalence over the decade. We now need an 83% fall in prevalence of Māori to smoke to achieve this goal of 5% prevalence that the government so solemnly committed to a decade ago. And we're here in a situation now, based on very stringent measures over the last decade that have been at best partially successful.

We need change. We need something new to get us over the line, so long as we continue to believe in this goal. And from my own area of work, I continue to believe that this is a worthy goal to try to achieve. This has been a part of the appeal of the arrival of new technologies, such as electronic cigarettes as a form of nicotine replacement for people. And the next slides, if we go to the next slide, thanks, what I've done is I've put a health technology assessment lens over electronic cigarettes.

You must understand the situation in New Zealand is that nicotine-containing electronic cigarettes are on the market as a consumer product. They are over-the-counter, readily available product. And I'm aware that you have the situation of nicotine has to be prescribed. Which I think is a reasonably challenging situation for a medical person to be in. Because when we prescribe, we're used to having data sheets for the products that we prescribe.

And feel a bit uncomfortable about writing prescriptions for products that don't quite exist in that registered pharmaceutical world. But anyhow, vaping certainly has a very great public health significance. And it's reasonable to consider it through the lens of health technology assessment. And I've applied one of these five-point HTA lenses here, starting with acceptability. Vaping's acceptable to people.

And my own view is the reason for the acceptability is the rapid-onset nicotine pharmacokinetics that it displays. To me, I think that explains the appeal a lot more than the stories you hear about hand action and the ritual of smoking and so forth. Basically, you get a hit from vaping, especially from the newer technologies. That's what this slide here is showing. I've sometimes thought of vaping as nicotine replacement therapy that is scarily effective, after the disappointment with what the registered, the gum and patches and inhalator could achieve.

This can achieve in terms of acceptability. Could we have the next slide? Thanks. Next slide, four more points in a health technology assessment lens. Effectiveness, having looked at the Cochrane report, which I understand to translate in absolute terms to, in the clinical trials, nicotine-containing electronic cigarettes in absolute terms generated for extra successful quarters out of 100. When looked at purely in terms of efficacy, I'd have to describe those results as about the minimum level of significance to warrant a change in practice.

And as Natalie said, we've winnowed it down to about four to six studies. And again, I would say the strength of evidence at present is at best moderate. And the absolute effect size is only 4%. However, my own reading is that these results confirm in principle that for some people, vaping reliably replaces smoking. I don't see these data as saying that vaping replaces NRT. Although NRT is still a lot less effective than I would like, nicotine replacement therapy has got its place.

It's a proven pharmacotherapy on the medicines list. What I hope about vaping is that with the right regulatory environment and with further technical development, it might become more effective in helping people to quit. Because it's a product that has got potential for product improvement, as we have seen with the successive generations of technology. In terms of efficiency, we could say it's cost-effective because, at least in our country, people are self-funding.

It's about ten times cheaper than smoking in this country. In terms of equity, that first chart with the difference between the ethnicities reveals the very great iniquity associated with tobacco smoking. And vaping has potential to mitigate this to the extent that it reduces tobacco smoking. In terms of timeliness, it's here. It's available on demand here and now. And in our country, you don't have to book an appointment with a health provider.

You just go down to the shop or you can order it online, even in time of COVID. Could we have the next slide? Thanks. But I've left the major issue from the HTA perspective till last. How safe are these things? And it certainly polarises expert opinion around the heading of safety. To start with, what I would invite you to do is to consider the meaning of the term electronic cigarette. At a basic level, in my view, the electronic cigarette is not a medicine.

It's better described as a presentation. A battery heats a coil that converts a liquid to an aerosol that's inhaled. The coil is between 200 and 250 degrees Celsius. The user internalises the pharmaceutical via an intrapulmonary route. Depending on what is internalised, this could be harmless or this could be lethal. But I'd like to submit that in itself, the electronic cigarette is neutral. It's a way of getting a pharmaceutical into a person's body.

If we could have the next slide? Thanks. And if we're thinking in terms of safety… EVALI, this was a major issue in the e-cigarette or vaping use associated lung injury outbreak that happened in the United States of America in 2019 and 2020. Some thousands of people were affected. There were at least seven fatalities. It appears to have been penned down to adulteration of cannabis-containing liquids with vitamin E acetate.

And there's reports such as this one by Blount that found vitamin E acetate in 94% of bronchoalveolar lavage samples of EVALI patients and 0% in healthy controls. The vitamin E was being used to thicken up the cannabis oil that people were using vapes for. There's no such thickener that's used for nicotine-containing e-liquids. You don't need that type of thickener. They're not oils like cannabis. And although there remain many unanswered questions about EVALI, it is clear that the main effect of that was due to vitamin E acetate.

Unrelated to nicotine vaping preparations that we're talking about for smoking cessation. Also in support of the idea of EVALI as a distinct episode of product degradation, you can consider its epidemiological trajectory. There was an abrupt spike of severe illness localised in space and time to the Americas in 2019 and 2020. It's been said the key risk factor for EVALI is use of an e-cigarette or similar product.

Although that's true, that's about as informative as saying the key risk factor for drug-induced liver failure is use of a tablet or a similar product. Because we're talking about a presentation here. It's the actual pharmaceutical, of course, that you have to focus in on as the culprit for the toxicity. Be that as it may, this EVALI must still raise medical concern. E-cigarettes are pharmaceuticals. We don't have a consensus way to describe them more precisely in this country.

There aren't data sheets. People use them without supervision. And now you're being asked to prescribe them. If things go wrong, medicine will have to pick up the pieces. This could be perhaps intimidating. Could we have the next slide? Thanks. Can we make the uncertainty tolerable? I come back to the word context. And the context is the known danger of smoking, which I sometimes think people lose some focus on.

Tobacco smoke, an excess of 7,000 chemicals, at least 69 of which are known to be carcinogens, the chemistry is very different. They're made by pyrolysis and oxidation of a complex organic substrate at about 900 degrees. Not 200 to 250, 900 degrees. That's much more activating nastier chemistry than you have with an e-cigarette coil. Of course, e-cigarette aerosols have been shown to contain carcinogens and toxicants like acid aldehyde, acrolein, diacetyl, formaldehyde.

The point is that the levels in cigarette smoke as far as we can tell are much higher than in vaping under realistic conditions. And Farsalinos is notable for having done a lot of work on this topic. Could I have the next slide? Thanks. One avenue of understanding the safety dimension is biomarker studies. The United States Food and Drug Administration is commissioning biomarker studies as a means of understanding and registering e-liquids with the FDA.

This slide from Shahab and colleagues shows nicotine carcinogen toxicant exposure in long-term e-cigarettes and nicotine replacement therapy users, compared to people who smoke. The e-cigarettes are on the right. The smoking is on the left. The biomarker levels are much higher in people who smoke. Still detectable for many of them, in people who use e-cigarettes, but much higher in people who smoke.

Which I think reasonably implies that there is a gradient of risk exposure being seen here. Could we have the next slide? Thanks. Just about there with my comments tonight. And really, I encourage you to think about the regulatory environment that this technology exists in. And of course, there is a good deal of literature drawing attention to potential health hazards associated with vaping nicotine.

I think for this reason, as doctors, we'd be hard-pressed to recommend that a person adopt vaping nicotine for a different reason than trying to quit smoking. But certainly for the purpose of quitting smoking, vaping nicotine takes them on a movement towards something that's less harmful. There's been talk about the gateway concept or the gateway hypothesis with vaped nicotine. And I'd like to develop that idea to consider a gateway where it's possible to move in two directions.

You can move from vaped nicotine to tobacco, smoked, or you can move from smoked tobacco back to vaped nicotine. And my own contention is the direction and rate of movement through that gateway is primarily a result of the regulatory and social environment in which that gateway exists. If vaping is demonised and made hard to obtain, then movement will tend to be into the arms of tobacco cigarettes.

It'd be very bad indeed because all the indicators are suggesting that tobacco cigarettes remain as poisonous and as dangerous as ever and will be very great surprise indeed if vaping turned out to be anywhere near as dangerous as that. I also feel optimistic about the potential for vaping to be subjected to regulation. It's a new technology. It's free of the deadweight of history. It has a product improvement pathway.

We must also think about people who do not smoke and who are not addicted to nicotine, especially children and young people. And I express support for where the government and our country landed on this with the Smokefree Environments and Regulated Products Act. Which if you refer to that, part 3A states the purposes of the act. And it's quite explicit in saying the purposes of the act are about reducing to help to support smokers to switch to regulated products that are significantly less harmful than smoking.

At the same time as preventing people from taking up these products who don't smoke.

Adj. Professor John Skerritt

Thanks, George.

Dr George Laking

That's it for me. Thanks.

Adj. Professor John Skerritt

Thanks very much. And our last speaker is Hayden, who's going to give some practical tips. Over to Hayden.

Dr Hayden McRobbie

Thanks very much, John. And thanks for asking me to speak. I'm going to go through these slides pretty quickly to try and save some time for some questions at the end. These slides, I'm happy to share them afterwards and they may even be available through the TGA. The previous speakers have done a great job in covering off these topics. And I'm not going to dwell on them too much. But George showed you some data that electronic cigarettes have become very good at delivering nicotine to the user.

And you're just here, as Natalie pointed out earlier, also, is that some products… This is the dual, for example, which is a pod device. In the hands of the experienced user can almost achieve the same blood nicotine levels as a combustible cigarette. But I just want to point out as well that nicotine delivery is not all about how much nicotine is in the e-liquid or the pod. And this is something that people sometimes get a little bit concerned about.

And they see these very high levels of nicotine and they try and push people to the lower levels. But concentration of nicotine in the liquid is just one of the various factors. The other constituents of the e-liquid, the heating of the e-liquid and the technique of the user or the puffing topography, all play a role in how well nicotine is absorbed. In terms of nicotine itself, you'll see liquids that either have freebase nicotine or nicotine salts.

The freebase nicotine is the bioactive form. The salts, the form that's present in the tobacco leaf, these are typically less harsh and it also allows for higher concentrations to be used. This has some advantages, in a way, because you use less volume of e-liquid. And that means that there's potentially less exposure to toxicants. But as I pointed out earlier, it's not always as clear-cut. What we do know is practice is important.

And what this means for your patients is that they're probably not going to switch straight away. I know some that do. But most of the people that I would support and in switching to vaping take a little bit of time to make that full switch. But that's their goal, aim to quit smoking completely, but it may take some time. And that's just what's demonstrated here. It just takes some time for people to get used to it. And over time, they learn to extract more of the nicotine out of the devices.

I'm lucky in New Zealand. I don't have to write a prescription for e-cigarettes. As George has pointed out, these are consumer products. I still give advice on them. It's not that I say, not my problem, not a medicine, see you later. And I'll talk about what I say at the end. But for you in Australia, you're going to have to write a prescription for people that want to use these. And you'll need to consider a little bit about what people want to use, whether they're buying premixed or concentrated nicotine.

And importantly, for consumers or patients, they'll need to have that prescription with them. And in most cases, arrange for a copy of the prescription to be enclosed with the packaging that's sent in. There are some very specific rules and regulations around that. In terms of dosing… And I know a number of questions that have come through have asked about that. I'm not going to go into the details here because you can download these from the TGA website.

These are some guidelines. They're just guidance. It's not hard and fast rules about this, about what you might like to prescribe based on cigarette consumption. And also the suggested supply. One thing is the concentration. The second thing is how much you actually prescribe. The folks from University of Wollongong have also come up with some guidance for new users. And again, I'm not going to take you through this just in the interest of time. And some guidance for existing users.

Again, these are available on the TGA website. But what I do want to point out is that don't be too quick to think that just putting people on the lowest concentration of nicotine is going to be the best thing for them. Remember, especially with quite highly dependent smokers, they're used to very high levels of nicotine over a long period of time. And people tend to try and extract the same amount of nicotine out of these vaping devices as they would out of their conventional cigarettes.

This study took smokers or they were ex-smokers and they got them to use a high-dose nicotine e-cigarette. And then they switched them to using a low-dose nicotine cigarette. And what they found in this study is actually, when you switch them to the lower concentration of nicotine, they had to puff more on their e-cigarette device to get the same blood levels of nicotine out of it. But in doing so, they were increasing their exposure to some of these aldehydes.

It's not all as straightforward as we'd like to think it is. I personally like to suggest that people use somewhere around 12 to 18 milligrammes per mil when they're starting out, if they're using the freebase and probably around 50 milligrammes per mil if they're using the salts. Bearing in mind that I see mostly quite highly dependent smokers. You might argue that's probably most of the smokers that are left.

Don't be afraid of using or suggesting a slightly higher dose here in smokers that are used to quite high levels of nicotine. But there's going to be some patient variability. Natalie's covered the adverse effects. Most of them are mild to moderate and disappear over time. In terms of writing a prescription for you, and thanks to Colin Mendelsohn for this. As a non-PBS, some things you must include, the nicotine concentration, the volume of the liquid or the number of pods for a three-month supply.

And you can give up to three repeats. There is some examples there of what you might like to prescribe. Of course, if you've got people using nicotine concentrate, it's a little bit more difficult. But if someone knows what they're using and these are typically the experienced users and they'll tell you exactly what volume and what strength that you need to prescribe. Most of the time, with new people, it's going to be either the pods or the premix.

Terms of flavours, you can specify if you want. I personally wouldn't. There are so many different flavours out there. Flavours are important to people. And they typically change flavours over time. And some of the studies Natalie talked about earlier, we started everyone off on a tobacco-flavoured product. And actually, most of them switched to fruit flavour or something similar over time. I said, what would I say to people who smoke?

And these are most of the people that I'd be seeing. And I always start off by talking about what I can offer. In New Zealand, I can't prescribe electronic cigarettes. They're a consumer product. It's a little bit outside of my realm of offering and I don't have a stash of them in my drawer either to pull out and offer people. I always start off by explaining what I can offer, which is a combination of stop smoking medications, your NRT, bupropion varenicline, for example, and behavioural support.

For those that want to use an e-cigarette, I usually ask them if I can tell them what I know. Because we can't assume that people know everything about these products. A few key messages I try and get across. First, they can help people quit smoking, but they're certainly no magic cure. And you saw that from the data that George was presenting. Vaping poses lower health risks than smoked tobacco. And there's definitely a benefit from smokers switching from smoked tobacco to vaping.

But we don't know the health risks associated with long-term use. Only that they're likely to be many times less than smoking. Another key message, because I'm not quite sure that everyone quite appreciates this, is that vaping of any kind should not be used by people who do not smoke, even vaping without nicotine in. In general, daily vaping is more effective for quitting than intermittent use. Trying to encourage people to use their device frequently.

This is a bit like getting people to use nicotine chewing gum. It takes some time and it takes some practice. The more advanced models generally deliver nicotine a little bit more efficiently. I advise people to carefully read and understand the manufacturer's recommendation. Don't use your phone charger to charge an e-cigarette device, for example. It may take practice to learn how to use it. And importantly, stop the use of combustible cigarettes as soon as possible.

And my advice as well, as soon as you're comfortable that you're not going to go back to smoking, aim to stop vaping as well. I can't give an exact timeframe on that, because everyone's a little bit different. There are some safety tips that you might want to give as well, some of these we've covered. But I'll leave those up on those slides for later. One final point, screening for vaping and documentation. Firstly, vaping is not smoking.

A person who's switched completely from cigarettes to vaping should be categorised as an ex-smoker. Don't categorise them as a current smoker if they're only exclusively vaping. If they're dual-using, then I think you can still code as a current smoker. And occasionally, I think we're starting to see now some people that are vaping who have never smoked. They can be coded as a non-smoker. But somewhere within the clinical record, we really need to be recording vaping status.

I'm aware that not all practice management systems allow that. Look, quick things in conclusion, not a magic cure. I hope you all can appreciate that. There may be some long-term adverse events associated with long-term vaping. I think some concern's warranted, but it has to be balanced against the risks of them continuing to smoke. And I'll finish there. Thanks, John.

Adj. Professor John Skerritt

Thanks so much, Hayden, for some very practical advice. I've been looking at all the questions coming in. And we might take some of the questions that are coming through the chat or emailed to us beforehand first. And then if time permits, we'll take live questions. The question for the various panel members, one of the things that was very controversial here is whether or not flavoured vapes should be permitted.

And there's two sides to that. Some people will say it will encourage them to vape rather than continue smoking. Others say it encourages children and adolescents and so forth. I'd be interested, maybe Hayden and George, in your views, about the use of flavoured vapes.

Dr Hayden McRobbie

Shall I start off? Look, I think flavours are really important and is part of the appeal of switching. And it's one thing we haven't really had in nicotine replacement therapies as they're not exactly appealing to use. I think flavours are important. In New Zealand, there has been some restriction around flavours. For example, at gas stations, you can't buy all manner of flavours and they're restricted to mint tobacco and menthol.

Adj. Professor John Skerritt

George, did you have anything to add?

Dr George Laking

Yes. I support a range of flavours. There are some flavours that are undesirable, clearly because of the diacetyl buttery popcorn flavour. You never want to have that. But I don't think it should necessarily be assumed that adults would dislike bubblegum flavour and that bubblegum flavour is something that's purely directed at young people. Many adults might enjoy bubblegum flavour.

And the bigger point is that for a person who's trying to get away from smoking tobacco, actually it's desirable to have an experience that's somewhat different from smoking tobacco. And to not have a tobacco-associated flavour in the vape.

Adj. Professor John Skerritt

Thanks for that. The next question that's been rather popular is… And I don't know if this comes from Natalie in her trials or of her practical experience or both. Is about ceasing vaping. We've talked about getting people from smoking combustible cigarettes to vaping. But how do you stop them vaping once they're hooked? And it may be in the follow-up to the trials. I could start with you, Natalie. Was that part of the follow-up of any of the work you've done on looking at people just moving from being a vaper to being an entire non-nicotine user?

Dr Natalie Walker

No, we haven't, although they're starting to come through now. These new trials that are being developed are looking at how to support people to stop vaping. I think Hayden's messaging around when you're talking to patients, say, when you're ready, once you fully switch, the first thing is to get you to fully switch away from the tobacco. And then ideally, you should try and phase out the vaping as well, slowly wean yourself off that.

And I think that's a consistent message. How you do that, it's under discussion probably with the patient at the moment. It's around, did they want to try a different form of NRT to start that reduction? Some of the trials I've seen that are in development are using things like text messaging services. It's really probably in discussion with the patient about what they've tried before, what they want to do. Some are quite happy to be a long-term vaper and just they take that risk and they're happy with it. But it's just a discussion at the moment.

Adj. Professor John Skerritt

Anything to add, Hayden or George? I'm getting off…

Dr George Laking

Yes. Nicotine, of course, is the principal addictive component of tobacco smoke, but there's a good deal of evidence to suggest it's not the only addictive component of tobacco smoke. This is still a topic under research. I feel a bit conscious of delving into an area that says, topic of active scientific investigation. But there appeared to also be monoamine oxidase inhibitory components of tobacco smoke. They're involved in interacting with nicotine to sustain the addiction.

This leads to a more theoretical argument that it might be easier to get off just nicotine on its own compared to nicotine and smoke.

Adj. Professor John Skerritt

And another pragmatic one in terms of advice to people. Do you tend to recommend the newer pods or do you still recommend liquids? Or does that depend on the type of person you're trying to counsel for smoking cessation? I guess it's the salts versus freebase question too.

Dr Hayden McRobbie

Look, I think it does depend upon who you're dealing with. I know that some people really like the tank systems, the refillable systems, and they really get into using these. Other people don't want the hassle of using these devices and would rather just something that's nice and simple and easy to use. There are some discussions that actually some of the newer technology in the pods may be a bit less harmful than some of the older technologies in terms of safety mechanisms within it and overheating.

Although I think the evidence around that is fairly slim at the moment. I think very much patient preference.

Dr George Laking

This is the product improvement aspect of vaping. Because as the successive iterations on the technology, it must be feasible to regulate out the older, inferior versions. It was never possible to improve on a smoked tobacco combustible cigarette. But there is an improvement pathway for vaping. One of the issues in choice of device also is the waste aspect. Because over time, especially the pods can generate quite a bit of waste. And that brings in the whole recycling dimension.

Adj. Professor John Skerritt

But is there also a big concern with some of the pods and the salt products that their concentrations are high? One of the things that was controversial here is that we didn't put an upper limit. Some people argued that we should have banned anything above 20 milligrammes per mil.

Dr George Laking

Support of having a higher nicotine concentration is that it means that there's proportionately more nicotine in the mix compared to all the other stuff that goes into the mix that you might not necessarily want to inhale. That's an argument in support of a higher level of nicotine. The argument against is probably getting into this realm of scarily effective nicotine replacement therapy.

Dr Hayden McRobbie

Just one more thing to add, John. The EU Tobacco Products Directive, of course, set the limit to 20 milligrammes per mil, which was somewhat arbitrary. And I'm not aware of any strong evidence that suggests that is the level that it should have been at.

Adj. Professor John Skerritt

It's been quite controversial here. How would you select particular patients for initiating them on both patches and nicotine vaping products? Are there particular patients that you'd start on both or would you recommend they, say, try patches first or?

Dr Hayden McRobbie

I'll take that one, then. Look, my typical approach with supporting people to quit smoking is to talk about what I can talk about and recommend, which is typically the smoking cessation pharmacotherapy. Often though, patients have tried all of these things and they're very determined or have a strong desire to try something that's new. I think we've got to be open to that. And I think it's our role to try and help people make decisions through informed choice and giving them some information about these.

I do have some people that do choose to use both NRT and vaping products. And as Natalie showed you, there is some evidence for that.

Adj. Professor John Skerritt

I could see George nodding. But do you feel that… I know we're only talking… And some people have criticised this, that you might only get an extra four or six patients out of 100 to give up smoking. But I still would argue that's four or six people who are going to be a lot healthier. George, are you more of a view that it's not a bad place to start with combining them?

Dr George Laking

Yes. I think we're now getting into the real expertise of primary care, to be honest. A general practitioner is the expert on the person in front of them and finding the combination that works for that person. If the goal is to quit smoking, then I think pharmacologically, we might feel very comfortable about combining multiple presentations in vehicles of nicotine replacement.

Adj. Professor John Skerritt

And talking about pharmacology, when you have the discussion with someone who wants to quit smoking and as a prescriber, what things would you look at for someone who you might want to say, patches and gum haven't worked, they're a varenicline candidate as opposed to nicotine vaping candidate?

Dr George Laking

Again, this is the difference in our country compared to your country. I support vaping with nicotine for smoking cessation, but I'm also a doctor. People come and see me as a doctor. And I feel a responsibility to work through the list of stuff that's got the evidence behind it and the data sheets and the sanctions and go through those things. And when I get to the point where I say, look, I've gone through the proper list and now we're onto this. At that point.

Adj. Professor John Skerritt

But would you more generally point someone to varenicline first, all other things being equal or?

Dr George Laking

I'm going to confess. With vaping as a consumer product in this country, I say to people, have you tried vaping? Because it's just so simple when it's a consumer product and they can go down to the shop and try it out. And it's a different…

Adj. Professor John Skerritt

And you tend to ask them at first?

Dr George Laking

Yes. It's a different realm and a different commitment from having to do a prescription. It's still in the realm of consumer activity for New Zealanders. I'll say…

Adj. Professor John Skerritt

Although you've got the prescription pad in Australia. It's what you're writing out varenicline or a nicotine vaping product. Sorry, Natalie. You had a comment?

Dr Natalie Walker

I was just going to say, you have to remember, I've seen some data from Australia recently which has shown that even though you might write a prescription for varenicline, not everyone is going to actually fill that prescription or have the full prescription and use it appropriately. Like any medication, that's just thinking about that as well, the fact that it's the vapes that are a little bit easier to access in that sense.

Because you can get it from New Zealand from a corner shop or a supermarket or a vape shop very easily. Whereas varenicline requires going to the pharmacist and maybe repeatedly… In New Zealand, we have to go multiple times to get the full course. It's about understanding the access issues for the person that's sitting in front of you.

Adj. Professor John Skerritt

And look, time for just a couple more questions coming in. Cessation of vaping. Two related questions or maybe unrelated. Advice that is given in New Zealand on vaping during pregnancy, number one. And about ceasing vaping or not ceasing vaping, say, prior to different types of surgery.

Dr Natalie Walker

The New Zealand smoking cessation guidelines have just been updated and they are accessible if you just google them. And they do have a little section on vaping and pregnancy. I'm just remembering what it says. It says that if they have tried everything and you've had a full explanation of potential risks versus continued smoking, that in New Zealand, that's at the discretion of the doctor to have that discussion about vaping as an option.

Adj. Professor John Skerritt

And I realise we're two minutes past seven. I've got one final question that's come in and I know it was touched on. Do you use rule of thumb advice in vaping? For example, depending on how heavy a smoker is. Most people will describe themselves as social, five cigarettes a day, pack a day, two packs a day sort of people. Do you use that as a rule of thumb to recommend what product and what strength they should start on?

And maybe if we could finish with a bit of a discussion on that. I know you touched on that in your presentations.

Dr Hayden McRobbie

But just number of cigarettes smoked per day is certainly an indicator of how dependent someone is. I quite like to also use time to first cigarette in the morning or after waking. Certainly people that are smoking within half an hour of waking would be your really highly dependent smokers. Number of cigarettes smoked per day in New Zealand, and I dare say the same with Australia, has become a different indicator. Because there are so many restrictions now.

Dr Hayden McRobbie

Price of tobacco. People have tried to cut down perhaps without suddenly reducing their dependence. Time to first cigarette is really the helpful goal there.

Adj. Professor John Skerritt

And if someone got out of bed and 15 minutes later, they're smoking, you tend to the higher dose?

Dr Hayden McRobbie

I tend to go for the higher doses, yes.

Adj. Professor John Skerritt

Any other thoughts, George, or you'd be along the same lines?

Dr George Laking

Yes. And this is pharmacological. The vape strengths are more likely to bring side effects of nicotine in people who aren't accustomed to that level of nicotine.

Adj. Professor John Skerritt

And I guess the final question… I said that was going to be the final, but we've had one more that's quite of interest to this group. Is, what happens in New Zealand, say, if people are admitted in hospital? Is there a general view they let them… And that was related a bit to my prior to surgery question. But if you're admitted to hospital, even for a non-surgical procedure, is there general acceptance of vaping areas where people can continue to vape?

Dr George Laking

Yes, still out on the doorstep, which is unsatisfactory, in my view. And actually coming from the Māori perspective, we're supposed to be looking after people. We shunt them out onto the doorstep to engage in their habit. And it's not really all that. It's not really an example of care in my book.

Adj. Professor John Skerritt

I think, given we're now five past seven, I'd just like to thank our friends who pro bono offered, with a little bit of encouragement, but you came forward tremendously. And it's been fantastically educational. And I think speaking on behalf of my Australian colleagues, we've got a lot to learn from your experience. And thanks so much for offering up your time and your wisdom tonight, especially given it's later at night for you.

And seeing a peak. We had 109 people online. And I'd like to thank all the Australians who are online. We particularly ask questions around the New Zealand experience. And as some of you have questions about the Australian experience, we've captured them. We will point you towards our website. But if there's other particular questions that we will review that we may not have answered, we'll add them to our Q&As.

But thanks so much, everyone, for your participation this evening. Have a good night. And I know I learnt something and I'm sure the rest of you did too. Thanks very much.