Episode 29: Nicotine scheduling changes – Special episode #2

Voiceover:

Welcome to the NPS MedicineWise podcast, helping health professionals stay up to date with the latest news and evidence about medicines and medical tests.

Jill Thistlethwaite:

Hello, my name is Jill Thistlethwaite and I'm a GP and medical adviser at NPS MedicineWise. For this episode of the NPS MedicineWise podcast, from the Health Products Regulation Group including the TGA at the Australian Government Department of Health, I'd like to welcome Deputy Secretary Adjunct Professor John Skerritt, and joining him, Professor Nick Zwar, who is Executive Dean of the Health Sciences and Medicine Faculty at Bond University and also chair of the RACGP expert advisory group - smoking cessation clinical practice guidelines.

Today's episode is the second of two special episodes on upcoming scheduling changes for nicotine vaping products. In the first episode, which was hosted by NPS MedicineWise CEO Steve Morris a couple of weeks ago, John Skerritt was joined by Jenny Francis also from the TGA and they discussed the new prescribing process for nicotine vaping products that is coming into effect from the 1st of October this year, 2021. They also discussed why regulation is being changed and which products are being affected, In addition they talked about what prescribers need to do to prepare for this change.

So, John, for those who haven't had a chance to listen to that podcast, could you give us a top level recap of what the changes will entail?

John Skerritt:

Well, certainly, nicotine containing e-cigarettes are already unable to be sold within Australian states and territories and possession is illegal everywhere except for South Australia, but there's some ambiguity about individuals who import them for recreational use. And what we really want to achieve is that if the GP who is an absolutely central partner with an individual who is interested in giving up smoking, if an individual and their GP believe that e-cigarettes can contribute to smoking cessation, we want to formalise this requirement that that be done on the medical supervision. And we also want to close down this loophole, such that an increasing number of young people in particular teenagers and school children are accessing vaping. We don't want a new generation of nicotine dependent adolescents, especially given Australia in recent years has had such a tremendous success in reducing adolescence smoking numbers.

So from the 1st of October it will be unequivocal that in order to import or have access to nicotine containing e-cigarettes, it will be a prescription medicine, you'll require a prescription from your doctor, normally your GP and it will be dispensed either by an online or physical pharmacist.

Jill Thistlethwaite:

Thank you. I think that makes things a lot simpler for people. So Nick thinking about what GPs need to know at a top level about the scheduling changes, they are going to have some extra work to do. Is there anything else you'd like to add to what John has just told us?

Nick Zwar:

Yes, thanks. I think GPs need to understand I guess several things, one of which is that these are not approved medicines in the sense that we usually prescribe approved medicines. So no nicotine vaping product has been through a full assessment as a medicine for efficacy, safety, all of those things. So they're unapproved products which are going to be available on prescription. So that is an unusual situation and I think Australia's approach actually to this is unique around the world. So it's going to be an interesting journey that we're going on. So there are a number of uncertainties in that and you know, the evidence on nicotine containing e-cigarettes is still very much emerging.

We don't know a lot about their long-term safety, we know very little about their long-term safety. And though there is some evidence of efficacy for supporting smoking cessation and the RACGP guideline, which I've chaired has highlighted that. There's still a need, definitely a need for more research on how effective are they, and are there particular subgroups that they work particularly well for. So there's that, there's all of that. And then there's also understanding the pathways by which you could write a prescription, if you're a GP who chooses to become involved in prescribing nicotine e-cigarettes. And I don't know whether John might want to describe those, but there are several pathways to writing a prescription.

Jill Thistlethwaite:

So, for GPs do you see this as a way of GPs helping patients to quit smoking for those who've been trying to do that? Is this a pathway that can help in that process?

Nick Zwar:

Well, I certainly hope so. I mean, I think fundamentally nicotine containing e-cigarettes are another form of nicotine replacement. You know, we've had patches and gum and lozenge and other things for a long time, and there's lots of evidence about their efficacy and safety. But one of the things we know about nicotine replacement is that its effect is modest.

You know, you might get an increase of 15 or 20% in quit rates a year later compared to no pharmacotherapy. That's with psychosocial support as well. But none of our smoking cessation treatments are wonderfully effective. They all help. And the thing that's the advantage of nicotine containing e-cigarettes is people seem to keep using them for longer.

That's also one of their challenges as well, cause long-term use could be a problem. But where with nicotine gum or patch, people tend to stop using them after a few weeks and that's a challenge for doctors to encourage them, to use them for long enough to get the full benefit, people seem to use nicotine e-cigarettes longer and that may be to do with the amount of nicotine that's delivered, or it may be due to they're somewhat more closely mimicking the sensations of smoking combustible tobacco, a range of things. But that is a feature of nicotine e-cigarettes. But it raises the issue or concern about long-term use and there's also concern about dual-use. That's where people continue to smoke occasionally, but use nicotine e-cigarettes as well. And that's not going to have the health benefits of cessation of inhaled tobacco.

Jill Thistlethwaite:

That's quite a lot to think about, as a GP, if you're planning to get involved in prescribing. So John, the standards for the nicotine vaping products and the draft guidance to help explain the requirements was recently published. What do GPs need to know from the standard?

John Skerritt:

Well, Nick is quite right, but these are not approved medicines. Although we have had several companies engage in discussions with us to potentially bring products that to the market, that will likely be during 2022, the products will actually be on the market. We do have 150,000 prescriptions written in Australia every year for medicines that are not approved. Now, not approved means just that, but there are really, I guess, two or more safeguards. One of which is the doctor having to prescribe these products. The second thing that these products do have to meet certain quality standards, so we can talk about those quality standards in a minute.

It is true that, and we certainly don't want this to be a situation where people just add e-cigarettes to their smoking or that they take e-cigarettes on for years at a time. And this is why the supervision of the GP is so important. But I imagine that any GP having a discussion with a patient about smoking cessation will not necessarily jump straight to e-cigarettes. I may say, well, try these behavioral changes, try gum first of all. Or if you do have e-cigarettes, I'm going to put you on for two or three months and see how you go and monitor your compliance. There are ways to tell if people have been smoking, apart from smelling their breath. So I don't think many GPs would keep on prescribing for years at a time, and this is why the involvement with GPs is so important.

Now I can go on and talk a little bit about quality standards if you wish?

Jill Thistlethwaite:

Just a brief summary would be helpful.

John Skerritt:

Yeah, so we consulted publicly and as you can imagine, this is an area where there's many stakeholders and twice as many different opinions. We recognised that it was important for these products will have a range of standards, but that there was really two countervailing things also always present in our mind. That the first was that these are products which a GP will prescribe and so the GP holds the pin, for example, as far as whether or not a patient could have a menthol flavored version or not. And the GP is a gatekeeper also, as far as strength and other things they put on the prescription. The second thing is that it was important also to enable that there be products available for Australia from the 1st of October, we are such a small market that there will be very few companies that would manufacture locally, specifically just for the Australian market.

And so products that met the quality standards and came from countries such as the US or the UK or Germany, for example, we didn't want to put up unnecessary barriers providing they met the quality standards. So that was the thing we had to balance between being excessively prescriptive in quality standards. Now, just to summarise where we landed with the quality standards is that all ingredients have to be listed. And that's particularly important because there are some ingredients that aren't appropriate to be in these products, because of risks for safety.

On the other hand, we have not despite some clinical and other groups encouraging it, we have not said that flavours will be prohibited because we believe that that should be a discussion between the GP and the individual. We might have an individual who says, look, I really want to give this a go but I just can't stand a taste it leaves in my mouth, could I have a mint flavoured one? And again, that should be up to the GP to decide, not the deft hand of government. Nicotine concentrations have to be stated, in a consistent way, so that it's clear what people are getting. Now, the evidence from countries like New Zealand is that if you're a three pack a day smoker you do need either nicotine salt products or a higher concentration to help you potentially cease smoking than say an occasional smoker who wants to try this route.

We've required warning statements, such as keep out of reach of children and child resistant packaging. And also we are not allowing active ingredients other than nicotine. We didn't want this to be, for example, a way where there can be cannabis products mixed up with nicotine. And finally, we are limiting the concentration of nicotine to 100mg/mL, now that still enables people to have a range of concentrations available to them, but the rather dangerous practice of taking almost pure nicotine and mixing it up on your kitchen table will not be able to be done if there’s other concentrations. So there're some of the considerations of this new standard, but we do believe that enables quality products, that are already on the market globally to be imported into Australia and dispensed under a doctor's prescription by a pharmacist, but also it limits some of the questionable products coming into the country and being prescribed and dispensed.

Jill Thistlethwaite:

Thank you. It does sound quite complex, but I'm sure if people read the guidelines and follow it through, and we have some resources available on the NPS MedicineWise website as well, to help elucidate the pathway. It's just getting used to this as a change. Nick could you give us some information about the RACGP smoking cessation guideline update, which presumably includes some information about these changes as well?

Nick Zwar:

Yeah sure, we're just starting work on that, and we have a recommendation around nicotine e-cigarettes in our current guideline, which is available through the college website, and as John mentioned earlier, the way that the college thinks it's appropriate to position nicotine e-cigarettes is as a second line option. Particularly for people who may have tried established therapies, nicotine replacement of some kind or varenicline or bupropion and not succeeded in quitting. And there are quite a number of people who would fall into that category.

This is another option after an evidence-informed discussion about the uncertainties, which I mentioned earlier about long-term safety and the concerns about dual-use and extended use, et cetera, and understanding also the legalities as John mentioned about needing a prescription. So that's already there, but there's obviously quite a lot of practical guidance which is needed which John's already alluded to about what would be the type of nicotine, whether it's nicotine base or whether it's nicotine salts and there're issues once nicotine base gets above a certain concentration, it's quite irritant to the respiratory tract or the nasal pharynx or the pharynx rather. So there's dosage guidelines.

There's also, what about use in combination with other smoking cessation medicines, that already happens in the UK apparently in some instances. What about use in particular populations such as those with respiratory disease or with cardiovascular disease? What about in pregnancy or breastfeeding? So, there's a lot to think about, and also I think GPs need to understand the pathways, whether it's the accredited prescriber route, or the special access scheme or the personal importation route, which, and John may want to comment on this, I understand remains an option and understanding also what the standards cover and what they do not cover in terms of the specifications of what products meet the standard.

So there's a lot, a lot to know. I don't want to over-complicate it, but it actually is quite a lot of information for GPs to come to terms with in a fairly short period of time and make an assessment, whether they're comfortable to become, to prescribe this as an option for their patients. And there's also the issue, this is aimed at supporting a further option to help people stop smoking, which is great. And we definitely want to get people off combustible tobacco. I mean, the harms of that are very well known and are very serious. There's also the current vapers and how does this affect them as well? And, you know, you see different estimates, but there's something around 400,000 current vapers in Australia. And then there's the issue of making sure that this doesn't, and of course that is the aim, encourage non-smokers, including young people to take up use of nicotine. And maybe that could be a pathway to combustible tobacco in the long term and I know that's one of the major reasons for this approach, is to try to minimise the risk of that.

Jill Thistlethwaite:

Which is a really good aim, obviously. So the guidelines are available, the new guidelines are available on the RACGP website and the link is in the information about the podcast.

Nick Zwar:

Jill, the new guidelines aren't done yet. The current guidelines are available, but we're starting work on a module, particularly around all those issues I mentioned, and, and that will be available before the 1st of October. But there's a lot of work to do as I mentioned, to look at the experience from overseas and the literature and come up with, we hope that will be practical advice for GPs, but you know, the broad statements around where they fit in are already there in the current guidelines.

Jill Thistlethwaite:

Yep, and when the new guidelines are available that will be advertised to GPs.

Nick Zwar:

Yes, absolutely.

Jill Thistlethwaite:

So just as we come towards the end, could both of you give some idea about where we can find out more information? I've mentioned a few of the resources available, but some of the very specific things that you think GPs should access?

John Skerritt:

Well, the RACGP will have some very useful and is further developing, as Nick said, some very useful information, and there is some overseas experience. For example, a New Zealand, to draw on, on smoking cessation. Of course, we don't want this to be a pathway to people taking up nicotine and I think as for any area of prescribing, this will be a key area of responsible prescribing. And I know that one of the areas that we're also talking with the medical defence organisations is the issue of pressure on GPs by patients to write them prescriptions, especially if the GP might have a strong suspicion that the purpose isn't really for smoking cessation. And so there's quite a broad group of people in the medical area that who need to be aware and engaged, further than just prescribers, dispensers and regulators.

So the range of discussions is quite broad. There's also work going on now, the standards in place with the pharmaceutical supply chains, because we do want quality products that have been, for example, have certificates of analysis and so forth that come through the usual pharmacy supply chains. So there's a lot of work to be done.

As far as sources of information, we expect there'll be many. So apart from the RACGP, which will be tremendously useful, we also, on our department's website, on the TGA website, have a single place where for example, information about prescribing is available. We’re keen for as many GPs as possible to become authorised prescribers, because it's a very simple way, they can just, they're practice can just fill in a form. And all it has to say is to become an authorised for prescribing nicotine for smoking cessation and provide your practice details and AHPRA details.

So we're supporting all that, but again, there are other activities including through NPS MedicineWise and a range of other organisations and the general communication with the general public is another thing that we will step up in the coming months, including through social media and other forms of awareness raising.

Jill Thistlethwaite:

And Nick, any concluding remarks?

Nick Zwar:

Yeah, look, I think as John said, there's a lot still to be done ahead of this and I think the public understanding this, particularly people who currently use nicotine vaping products is going to be quite important for how it goes. And I think also, as we said GPs understanding those pathways, including the authorised prescriber pathway and the implications of using that pathway versus the personal importation pathway. Cause that makes quite a difference to what product they might access. And I think understanding those things is a challenge. I mean, I think it was shown that with medicinal cannabis that people can learn new pathways. And so that's kind of a model for in a way how these sorts of things can work. But I do think there's a lot left to be done in the months leading up and after October.

And there's also discussion about an MBS item as well, which we haven't touched on today and people will need to understand that as well.

Jill Thistlethwaite:

So, obviously people need to be aware of the changes and there will be further information available as we lead into October.

So I'd like to thank you both for joining me today and to our listeners and if there is anyone who'd like to have a look at some of the information we've discussed today, the links, resources and more can be found in the podcast notes.

So thank you to everybody.

Voiceover:

For more information about the safe and wise use of medicines, visit the NPS MedicineWise website at nps.org.au.