Prescribing therapeutic vapes - overview of the regulatory changes

Speaker Key:

RL     Professor Robyn Langham AM

NZ    Professor Nick Zwar

EC     Dr Eileen Cole

NI    Nishi

RA   Rachel

ME    Mandy Edlington

00:00:00

NI               Ok, so today’s webinar will provide medical and nurse practitioners with the information you need when considering whether to prescribe therapeutic vapes to a patient for smoking cessation and/or nicotine dependence. 

                   Now, without further ado, I will pass over to Professor Robyn Langham to take us through an overview of the regulatory changes. Over to you, Robyn. 

00:00:28

RL              So, I guess this is why we’re here, the announcement, or the understanding and the recognition in Australia at least, that despite the regulatory reforms that were undertaken a couple of years ago now, that vape marketing and the use in Australia had increased particularly among the youth and the young Australian adults, and the growth in vaping and the unknown quality and the safety of the vapes that were being sold really represented an unacceptable population health risk. 

00:01:05

                   And this is just an excerpt from the proposed reforms Impact Analysis from the Office of Impact Analysis part of the Department of Prime Minister and Cabinet from late October last year. Next slide, please. 

                   So the rationale, as we’ve mentioned, was that the federal government was going to progressively ban all vapes within Australia unless they were therapeutic vapes that complied with the legislation that the TGA operates under, which is the Therapeutic Goods Act of 1989. 

                   Now, prior to these reforms, therapeutic vapes containing nicotine could only be legally purchased from pharmacies or through the Personal Importation Scheme by a patient with a valid prescription. And there was understanding, of course, that certain non-therapeutic vapes could be legally sold by non-pharmacy retailers to people without a prescription, which created opportunities for retailers to circumvent these rules. 

                   And what was becoming obvious was that there was not only highly attractive but also addictive products often marketed towards young people that became most readily available. And once these changes are complete that we’re about to talk about soon, tobacconists, vape shops, convenience stores will no longer be able to lawfully sell any type of vape, and also, the Personal Importation Scheme for vapes will be closed. 

00:02:37

                   And from Minister Butler’s announcement there, these changes will protect Australians, particularly young people, from the harms of vaping and nicotine dependence and, sorry, ensuring those with a legitimate need to access therapeutic vapes can continue to do so, where clinically appropriate. And that’s where the role of the prescriber comes into it. Next slide, please. 

                   So the timeline is here. As I’ve mentioned, the regulatory changes that were in October 2021, where a prescription was required to access nicotine vapes. In May of 2023, the Minister for Health and Aged Care announced the action on vaping. And then Minister for Health and Aged Care, Minister Butler, announced further enhanced controls on importation, manufacture, advertising, supply and commercial possession of vapes that are being implemented, as is the case now. 

                   The import restrictions commenced on disposable vapes in January, but because of the recognition of there being existing legal stock available in the country, there was a further period of time to allow for the selling of the existing legal supply of vapes until March of 2024, when further import restrictions will be imposed and further selling restrictions will be imposed. Next slide, please. 

                   So just a brief bit here, I guess, about the role of the TGA. The TGA administers the Therapeutic Goods Act which regulates the… It’s a legislation that regulates all the advertising, manufacture, import, export and supply of therapeutic goods in Australia. 

00:04:32

                   And we take very much a risk management approach to ensuring that therapeutic goods that are available for the Australia public meet acceptable standards of quality, safety and efficiency. And we work with key stakeholders, including health professionals, industry, State and Territory governments, community organisations, consumer groups, as well as the academic and research sector. 

                   The work of the TGA is really based on the principles of contemporary best practice regulator. We apply scientific and clinical expertise to decision making to ensure that the benefits to consumers outweigh the risk associated with the use of medicines, vaccines, medical devices and biologicals. 

                   We don’t regulate the clinician. We don’t provide clinical advice. We don’t have anything to do with the cost that’s set behind drugs and devices. But our role really is to ensure, as it says there, the quality, safety and efficacy of devices and drugs in the country. Next slide, please. 

                   So what are the role of vapes here in the clinical setting? Well, for those who smoke cigarettes, for those who have been using vapes containing nicotine, and sometimes this is unknown to them, as we’ve mentioned with the change, with the rapid increase in the amount of vapes that have been made available through non-medical retailers, that the addiction that comes from nicotine is a significant one. 

00:06:07

                   And for those patients who want to quit but have failed to achieve smoking cessation with the recognised nicotine replacement products and other avenues of quitting, then it may be reasonable to consider recommending vapes in conjunction with behavioural support. 

                   We’re going to hear from Nick Zwar soon about the guidelines from the Royal Australian College of GPs, and this includes new guidance on prescribing vapes, including for people under the age of 18 and also supporting vape cessation. So why prescribe vapes? Well, essentially, if you’ve tried everything else and then failed, then a therapeutic vape may be indicated. But as I said, we’ll hear more from Nick Zwar in a minute. Next slide, please. 

                   So this, I guess, is the most important thing that I think everyone should take away from tonight’s talk. And that is that vapes are unapproved goods. Now, for every other drug that is made available to patients on a prescription, they’re approved drugs, that is, they’ve been considered by the TGA for quality, safety and efficacy through a very well prescribed and robust process, to consider the behaviour and the performance of these agents. (Clarification: Every other prescription drug currently available for smoking cessation and the management of nicotine dependence in Australia is an approved drug. Vapes are the only unapproved therapeutic goods currently accessed under prescription for these indicators.)

                   Now, there are other nicotine replacement therapies that you’re more aware of and you’ve most likely used and also other prescription medicines which are registered, that are approved drugs. And they are all sitting in the Australian Register of Therapeutic Goods, the ARTG. Currently, however, there are no therapeutic vapes for either smoking cessation or management of nicotine dependence. There are no products that are included in the ARTG. 

00:08:16

                   And because they’re not registered, there is a need for us, and with the recognition of the need, that the therapeutic goods are made available through specific pathways. And these are called either the Special Access Scheme or the Authorised Prescriber process. They’re the two pathways. And for these therapeutic vapes, there is a need not only to prescribe them but also to notify the TGA or to gain approval from the TGA in the process of doing that prescription. 

                   So the stage one of the vaping reforms, which started on 1 January, does place stronger controls on the importation, manufacture and supply as well. So they ban importation of disposable and non-therapeutic vapes. There’s bans on importing therapeutic vapes without an import licence and a permit. And there is the closure of the Personal Importation Scheme as well as updated standards applied to those that are imported and manufactured with licences. 

                   I think it’s fair to say, and I speak as a clinician myself, that there’s a general lack of understanding of how best to use these Special… Or how the Special Access Scheme and Authorised Prescriber schemes work. And I think it’s true to say that not all patients who are prescribed unapproved or even off-label drugs are made fully aware of what that means. So I’m going to go through some of those Special Access Schemes and Authorised Prescriber schemes. My apologies if you are well aware of the processes that I’m about to describe.

                   One of the other things that I think we need to be mindful of, and that is that the nicotine replacement therapies that are registered on the ARTG are registered specifically for the indication of smoking cessation and not for nicotine withdrawal. (Clarification: The PBS restriction for nicotine replacement therapies aims to provide an affordable intervention to support nicotine cessation. Where clinically appropriate, a patient may be eligible for PBS subsidised NRTs provided they are nicotine dependent from the inhalation of any nicotine containing product.)

                   Technically, in prescribing these nicotine replacement therapies for someone who is addicted to nicotine through vaping, would be considered an off-label indication. Next slide, please. 

00:10:45

                   So there are, as I’ve mentioned, new product standards for unapproved vapes that have been introduced as well. And we are continually looking out towards further updates that are going to be available later this year. 

                   So the standard TGO 110 sets out minimum safety and quality requirements for all unapproved therapeutic vapes that have been allowed to be imported and supplied or exported from Australia. And from March of this year, all devices and vaping accessories for use with a therapeutic vaping substance will be covered by this Therapeutic Goods regulatory framework. 

                   So awareness about compliant vapes is anticipated to increase. There are a list of vapes that are considered compliant, and you, the prescriber, will become more aware of which ones they are and how best to prescribe them for your patients. At the moment, they are listed clearly on the TGA website on the nicotine hub. And by being able to utilise those websites and the information there, you’ll be able to familiarise yourself with the goods that are available for their patients, and also through ongoing contact with your pharmacies. 

                   We really acknowledge that we’re in a state of flux. As both prescribers and consumers and dispensers and industry, we’re all adapting to these changes. So I’m going to leave a lot of this detail to Nick’s talk later on, but I really want to welcome additional questions that you might have in this space. Next slide, please. 

00:12:44

                   So this is the very newly published list of notified unapproved vapes. As I’ve said, this list is published. It’s available on the TGA’s nicotine hub website. And there are certain other vapes containing nicotine that have been imported or manufactured prior to 1 March that can continue to be lawfully supplied. And this includes… You can’t read it. I can’t read it. You can’t read it. This includes a list not only of the vaping substances but also the accessories and the devices. Next slide, please. 

                   I’ve been talking about these schemes, these pathways to be able to prescribe so that your patients can access unapproved goods. This is the different pathways that exist, and these apply to all other processes for unapproved goods. 

                   Now, the first one, the first little box in blue there is for if you want to be able to prescribe to high numbers of patients, you can apply and be authorised as an Authorised Prescriber. And this means that you don’t need to notify the TGA every time you write a prescription, but you do need to report the numbers every six months, the numbers of prescriptions that you’ve written. 

                   Now, for the pharmacist to dispense, the pharmacist will need evidence of your Authorised Prescriber status to fulfil scripts for all unapproved goods. And I’m going to talk a little bit about that in a minute. But rather than what has been the case, which is patients have had to carry around both the prescription and a copy of your Authorised Prescriber status to the pharmacist, there’s now an online tool that will make that recognition and close what is often a very frustrating delay in the prescription process. 

00:14:39

                   The other box underneath that is if you just want to be able to prescribe to individual patients. So there’s two major pathways. Now, the SAS C pathway has been made available for nicotine vapes, because that’s really the most streamlined process. Now, for smoking cessation and treatment of nicotine addiction and to people, patients over the age of 16, the SAS C process is available. 

                   And you don’t need to notify the TGA for each patient. Sorry. You do need to notify the TGA for each patient, but it’s within a 28-day window for notifications. (Clarification: Pharmacists cannot dispense a script for therapeutic vapes under the SAS-C pathway without evidence of a notification being submitted in the portal.)

                   If your patient requires immediate access to the prescribed vapes, notification should be completed by the prescriber at the time the prescription is issued and the notification reference number included with the script. 

                   If the prescriber has not submitted a SAS-C notification, the pharmacist must contact the relevant practitioner to confirm that the supply is made under the SAS-C pathway. Supply cannot occur until the pharmacist has received confirmation.

                   And there is an online validation tool again that shows active notifications only. So you don’t need to notify the TGA before you issue the script, but you do need to notify the TGA for each patient. And the pharmacists, again, will need reference numbers to be able to use their online tool. 

                   The other bit down the bottom, which is the SAS B pathway, that’s what’s been implemented for people, for patients under the age of 16. And that’s really acknowledging the specific problems of nicotine with a young and developing brain, that indications… That really, the Therapeutic Goods Administration felt that this additional step of the pathway was warranted in order to ensure protection of young people as much as we can. 

00:16:25

                   So for a SAS B, you do need to apply to the TGA for each patient and you do need an approval letter before you issue the script. And that can be a 24-hour turnaround. So planning for your younger people through a SAS B pathway if you’re not an Authorised Prescriber is the important thing to notice here, to understand here. Next slide, please. 

                   So a very, hopefully, clear and straightforward pictorial pathway process for you here. The consultation phase is important in terms of making the decision to prescribe an unapproved drug is a clinical decision that’s made at the discretion of the prescriber, and before you do that, ensuring that all of the therapies that are already registered under the ARTG have been considered before you prescribe an unapproved good. 

                   The prescriber, though, is responsible for ensuring that the patient or the patient’s guardian has given their informed consent, because the TGA doesn’t have any oversight or doesn’t have any regulatory decision making around these products.

                   So the TGA notification or approval is the second step. And that’s either via the SAS system or becoming an Authorised Prescriber through the online system. The prescription should be written in accordance with your relevant state or territory legislation. 

                   And then the pharmacist that dispensed the prescription, again in accordance with their state or territory drugs and poisons legislation, understanding that the pharmacists now have access to an online tool, and provided that there is an authorisation number that you provide often with your script, that will make that process much easier as well. Next slide, please. 

00:18:20

                   So, again, I hate to say it, but again, this is probably the point of this evening from the TGA perspective. The requirements for the various nicotine vaping products and devices are really highlighted on this slide. 

                   So to provide a therapeutic vape, including a zero-nicotine vape, and I’m not sure that there’s a lot of those around at the moment being prescribed, and Nick might want to comment on that later, but a therapeutic vape or any packs or zero-nicotine vapes, you require an approval under the Authorised Prescriber or an approval and notification under SAS. 

                   The things that don’t require an approval are vaping devices without substances. But they must only be supplied by a registered pharmacist or a person that’s authorised under state or territory legislation to prescribe prescription medicines. (Clarification: Vaping devices can only be supplied to patients by pharmacists or someone licenced under state or territory law to supply prescription medicines.)

                   This slide, working with pharmacists, I think is also really, really important. I don’t think we can overemphasise the importance of communicating with our pharmacy colleagues in terms of being able to ensure that our patients are able to access their needs in a fairly straightforward and uncomplicated fashion. 

00:19:45

                   Pharmacists can only dispense therapeutic vapes that conform with TGA requirements. And that published list, that illegibly represented published list that I showed you before is where you’ll find which therapeutic vapes have been approved from a confirmational point of view. 

                   So there are transitional arrangements, as I’ve mentioned, that will allow pharmacists and other retailers and their wholesalers to sell out their existing lawful stock. So where they have been providing nicotine vapes for the purposes of smoking cessation, they’ll be able to still sell that existing stock. 

                   They can only dispense therapeutic vapes with evidence of either an Authorised Prescriber approval or a SAS B approval or in accordance with the SAS C pathway. And I’ve mentioned that new validation tool that’s been developed for pharmacists to confirm the validity of your approval status. 

                   But to be able to use that online tool, the pharmacists need to know your notification reference number. And if prescribers can include that number on their prescriptions, pharmacists can verify the notification without needing to be able to contact the prescriber.

                   I think it’s useful too if you are able to familiarise yourself with the products that are available at pharmacies in your area, and if you are issuing prescriptions that can be filled by different product lines, trying to reduce the pressure on pharmacists to carry multiple lines as well, but all the time making sure that those prescribed products conform to the TGA requirements. Next slide, please. 

00:21:30

                   This is really just a hotchpotch of questions, themes of questions, if you like, that have been coming to us from the general practice community and from other prescriber communities. So I guess I’m happy to go through these now, and you are certainly welcome to add any more questions as they might arise during the evening’s webinar. 

                   So the first one is, are medical appointments relating to the prescribing therapeutic vapes or supporting vape cessation included in the MBS? Absolutely, yes. Absolutely, the department recommends that patients discuss nicotine cessation with their usual GP or nurse practitioner and they use the range of non-specific MBS consultations that service providers may use to support their patients in seeking to cease or reduce nicotine dependence. 

                   The next question. Will therapeutic vaping goods be included in the Pharmaceutical Benefits Scheme? Hopefully, I’ve made it very, very clear that nicotine vaping products are not registered. They’re unapproved drugs. And at present, there are no therapeutic vaping products that are subsidised under the PBS, because they’re generally not made available to be subsidised on the PBS if they’re not registered on the ARTG. 

                   I’ve mentioned as well the question about other registered nicotine vaping products that are subsidised through the PBS. They are indicated for smoking cessation and not for nicotine withdrawal. 

                   (Clarification: The PBS restriction for nicotine replacement therapies aims to provide an affordable intervention to support nicotine cessation. Where clinically appropriate, a patient may be eligible for PBS subsidised NRTs provided they are nicotine dependent from the inhalation of any nicotine containing product.)

                   But they are available. Those other nicotine vaping products such as patches or Zyban or Champix or the other, Varenapix, are there for the use, though they will be used in an off-label fashion. 

00:23:54

                   That’s the second question, which is nicotine replacement product be used for vaping cessation. Absolutely, they can, but there is that technical requirement that they will be prescribed in an off-label fashion. And that’s because no form of nicotine replacement therapy has been evaluated specifically for vaping cessation. But NRTs are being used by some clinicians for this purpose, and that is consistent with the draft guidance that has been published by the RACGP. And Nick, you might want to talk a little bit more about that later. 

                   How do the State and Territory regulations apply when you’re prescribing therapeutic vapes? Look, this is really important, because there are variations governing the domestic supply of vaping products between the State and Territories. 

                   So the TGA’s requirements governing the supply do not override the State and Territory legislation. So it’s the responsibility of each prescribing practitioner to ensure that all of the State and Territory regulations and requirements are met. We are working in collaboration with the RACGP and the State and Territory health departments to provide further guidance in this area. 

                   The next question’s an interesting one. Can therapeutic vapes be used long term? I’ve mentioned they’ve not been evaluated for safety, quality and efficacy. The long-term health effects of vaping are unclear, and the guidelines that have been published do recommend three-monthly review, with a maximum 12 months of use, though I know that any of you who have dealt with anybody that’s trying to withdraw from nicotine through smoking will know that patients may require long-term use to avoid relapse. 

00:26:02

                   Can therapeutic vapes be prescribed to those under 18? Yes, but understand before you do this that there are clinical considerations that you need to be aware of. Firstly, there are regulatory settings that are specific to State and Territories, where there is some restrictions that apply to the supply of therapeutic vaping products to minors. 

                   And most States and Territories have legislation and regulations that prohibit or restrict the supply of vapes to people under the age of 18. So as I said, we’re working to provide more clarity there. I’d just encourage you to look at your own State or Territory jurisdiction regarding this. 

                   The new access pathways I’ve mentioned. To prescribe to patients under the age of 16, there will need to be a SAS B application pathway. And the major criteria for determining whether to approve supply relates to the patient, the product and the prescriber. The rain has set in in Melbourne. There you have it. Finally, we have a cool change. 

                   On the application, the prescriber would need to provide enough clinical justification to support the use, outlining the benefit versus the risk to assist the delegate in making decisions. And these requirements, as I’ve said, do not override State and Territory legislation. 

00:27:43

                   I know this is a really important area. The impact of the increasing number, rate of vaping activity in young people in Australia has really been driving these changes. So this is absolutely the people that it’s going to be able to affect most, and it’s so important that we develop some… We’re very clear on this. You can prescribe under the Authorised Prescriber pathway to those under 16, but you would require Human Research Ethics Committee approval prior to submitting an Authorised Prescriber application to the TGA. 

                   Next question. Do I need to obtain written consent from patients when prescribing therapeutic vapes? So this is something that we are working to try and modify in order that the whole process is going to become more streamlined at your end. But absolutely, you must be obtaining consent. You must be informing your patients and obtaining consent that what they are accessing is an unapproved therapeutic good, that is, the TGA has not evaluated them for safety, quality or efficacy. 

                   And this is consistent with the requirements for all unapproved therapeutic goods. What we are trying to emphasise here is that you must obtain and record informed consent, and that can be in the patient’s notes, clearly. And that is just in accordance with the good medical practice. You can ask your patients to provide written consent if that is your wish, or you can just record that in your medical files as evidence that you’ve obtained verbal consent. 

00:29:28

                   The last one, I guess, is the other piece of information that is written into the guidance around how you access unapproved goods, and that is that letting other healthcare providers know. And again, this is really just within accordance of the Medical Board of Australia’s good clinical practice code of conduct, that you do inform all other medical practitioners that are involved in the care of your patient of these important changes. 

RA              Eileen, if you’re all right to take over, we’ll just pass over to you. 

NI               Beautiful. Thanks, Rach. Over to you, Eileen. 

00:30:10

EC              Okay, thanks very much. So yes, my slides are going. That’s good. So since October 2021, the team at Quit Centre have been working to develop resources to support the work being done by clinicians who, every day, provide cessation care for people who smoke, and also, more recently, for people who vape. 

                   And health professionals within the Quit Centre team have been speaking with GPs, pharmacists and primary health care nurses to try and get a better understanding of their experiences and the challenges they’re facing in supporting people to quit, so that the resources, education and training that we develop to support this important work is relevant and useful. 

                   And it’s clear from our conversations that practices vary widely when it comes to cessation and that there’s a need to provide clinical support for clinicians to engage patients in conversations about cessation when there are many competing priorities and time is limited. 

                   And now that vaping’s been added into the mix in terms of our clinical consultations, an understanding of the latest evidence and guidelines and the regulatory environment will assist us in deciding when and if we will use nicotine vaping products in practice, and also, a working knowledge of the terminology relating to the products will bring confidence in having conversations. 

                   So in terms of what we know about smoking, multi-session behavioural intervention, such as that through Quitline, combined with pharmacotherapy for people who are nicotine dependent are effective evidence-based cessation treatments. And we can use brief advice, such as the three-step and the five-step approaches, to have short conversations with patients in our practice which will connect them to this care. 

00:31:57

                   So an example is Quit’s three steps of Ask, Advise, Help brief advice. And in these three steps, we ask all patients about their smoking status and document this in their medical record and then advise all patients who smoke to quit. And we need to make sure that we’re using language that’s not confrontational and that we present the message with messaging that’s salient or personally relevant to that patient, and then also advise them of the best way to quit. 

                   And it’s important then to follow this advice up with an offer of help for all patients who smoke, including an opt-out referral to multi-session behavioural intervention and by initiating pharmacotherapy if clinically appropriate. And I think it’s really important for us all to remember that even for people who refuse this offer of help or referral during the consultation, we’ve actually provided them with important information about quitting. 

                   And I think the value of adding multi-sessional behavioural intervention to our work of providing brief advice and pharmacotherapy shouldn’t be underestimated in terms of how effective it is in helping an individual to make a successful quit attempt. 

00:33:09

                   One study showed that compared to people who use no cessation support, those who received brief advice and pharmacotherapy were 59% more likely to quit, and those who also received behavioural intervention in addition to the brief advice and pharmacotherapy were more than twice as likely to quit compared to people using no cessation support.

                   And I think the value-add here is that while pharmacotherapy helps to reduce cravings and withdrawal symptoms, it’s the behavioural intervention that really helps people to identify their triggers for smoking and to develop their own practical strategies and shift their self-identity away from as being someone who smokes and/or vapes to someone who doesn’t. 

                   So while we have the evidence and guidelines about effective smoking cessation care, vaping’s added an additional layer of complexity into our cessation work as we navigate the use of nicotine vaping products to support people who’ve tried to quit and have been unsuccessful with first-line methods, and also as we seek to support people to stop vaping, including young people who may have never smoked and not experienced trying to quit. 

                   And in terms of the evidence, in addition to the evidence that Nick will, I’m sure, talk about, Quit Centre’s 2023 literature review also found that currently, there’s a lack of evidence about what are effective interventions for vaping cessation and that while research is underway to build this evidence base, it’s suggested that vaping cessation interventions align with evidence-based practices for smoking cessation. 

00:34:47

                   And I think we really need to recognise that we are in this evolving environment, that RACGP guidance is currently provisional and that the regulatory reforms will change over 2024, along with the available products. So we really need to watch this space. 

                   And I just wanted to add in this website. So if you can, to learn more about vaping products and become familiar with terminology, if you have a look at Tobacco in Australia, facts and issues, this website, you might find it really helpful. It’s an electronic publication. It’s authored by the team, including medical scientists, at Cancer Council Victoria. And chapter 18 is dedicated to e-cigarettes and other nicotine products. 

                   So when it comes to our patients, Quit Centre’s recent research with Quitline clients can provide some insight into the experiences and knowledge that patients bring with them into the consultation. And so themes that are identified in this qualitative research included that there’s no clarity for patients about who is an authoritative voice on vaping and who to turn to for vaping information, and also that awareness of the prescription requirements and access to vaping was highly variable. 

                   But in terms of vaping accessibility, vaping was really seen by clients as affordable and socially acceptable. And this was a key driver for continuing to vape, especially as it’s contrasted with the high cost and social unacceptability of smoking. 

00:36:30

                   And in terms of clients’ vaping experiences, a common experience was a rapid escalation of vaping, where participants, some were surprised by the addictiveness of the vape, and several people noted that their vaping habit, their vaping eclipsed their smoking not long after they started. And this was probably reinforced by the fact that vapes are allowed in places where smoking is not and that vaping is not finite. Unlike a cigarette, which has a beginning and an end, the ability to vape continuously presents a challenge. 

                   People reported some negative health aspects, ranging from mild discomfort to severe issues that required medical attention, in terms of respiratory symptoms but also shame about having a nicotine addiction, whereas some people reported benefits, including mood regulation and that they felt that it was safer or cleaner as an alternative to smoking. 

                   Many reported difficulty with reducing or quitting vaping, in particular, because they were worried about nicotine withdrawal, and some people felt that nicotine replacement therapy was relatively expensive compared to vaping. 

                   And generally, the experiences of phoning Quitline for cessation was seen as positive and that patients were able to access support to help with nicotine addiction and quitting. But like all or many other services, Quitline was seen to lack specific advice relating to vaping. And I think this just aligns with that lack of evidence at the moment.

00:38:08

                   So with all this information in mind, we come back to providing care according to the RACGP provisional guidelines, so if we go back to providing brief advice and pharmacotherapy for people who show signs of nicotine dependence, acknowledging that assessment of nicotine dependence is a bit more challenging in people who are vaping and vaping to quit smoking or potentially dual using, and then follow up with a referral for patients to multi-session behavioural intervention. 

                   So this is where Quitline can be really helpful, because Quitline’s a confidential, evidence-based telephone counselling service, and Quitline’s tailored to meet the needs of many people, including priority populations such as those living with mental illness, pregnant people and young people. And the Aboriginal Quitline is provided by counsellors who are Aboriginal and/or Torres Strait Islander. And Quitline can also support people who require an interpreter and those with hearing or speech impairment. 

                   But what about consultations with young people? As we know, I think we’re preparing for having more of these consultations in clinical practice. And we know from other areas of medicine that adolescents may not engage directly or present explicitly with a request for support with cessation or to report trouble with their vaping. And we may need to be alert to symptoms and signs that could be related to vaping, such as symptoms of nicotine withdrawal or new or worsening respiratory symptoms. 

00:39:47

                   And I think, like other areas in medicine, if we use an engagement approach that’s comprehensive, such as the HEADSSS psychosocial review, we’ll be able to do a holistic assessment. And then from there, we can provide brief advice, such as Ask, Advise, Help, the 5-As or other models such as the FRAMES model to allow us in the clinical setting, either as GPs or nurse practitioners, to provide support, and additionally, to link young people with a wider support team. 

                   And particularly in young people, multi-sessional and often multi-person behavioural support is vital. So Quitline or another local support service is really important in assessing the young person’s behaviours, and then building confidence and mobilising support for themselves. 

                   And then developing practical behavioural strategies which are contextualised for that individual patient, according to their age and their psychosocial context, such as encouraging their peers to recognise that they’re trying to quit, putting in individualised barriers to prevent them from accessing their vape, and looking at the types of behaviours they may substitute in for times when they’re thinking that they would vape. And as Robyn said earlier, for those with nicotine dependence, nicotine replacement therapy can be initiated. 

00:41:08

                   So when we talk about behavioural intervention, what do we actually mean? Behavioural intervention for smoking and vaping cessation is intensive counselling delivered by professional cessation counsellors in four to six sessions over a month. 

                   And it can be provided in Stop smoking clinics, courses or Quitline, which is a free clinical stop-smoking service delivered by telephone. Quitline provides multi-session behavioural counselling to help people make a quit attempt, manage nicotine withdrawal and adjust to life without smoking or vaping. And Quitline is readily accessed either by telephone or using the online referral form at Quit Centre. 

                   Quitline counsellors are counselling professionals, and they’re behaviour change experts. Over multiple calls, the Quitline counsellors use core counselling skills to engage the patient and guide them through each call, and working collaboratively in the call towards treatment goals. Quitline counsellors use established therapeutic approaches such as cognitive behavioural therapy and motivational interviewing to help people plan, make and sustain a quit attempt.

                   And within each call, Quitline counsellors assess the individual’s behaviours associated with smoking or vaping and provide tailored psychoeducation to support patients in understanding and managing their withdrawal experiences, including the potential for mood monitoring and information about the use of pharmacotherapy. 

                   And using individualised and tailored strategies, counsellors then work with the patients to enhance their motivation, build skills to manage triggers and cravings and to develop confidence to set and achieve goals and adopt a new self-image. 

00:43:00

                   Quitline’s call-back model means that when a clinician such a nurse practitioner or a GP and other clinicians in hospital settings make a referral, Quitline will then call the patient back within two business days. Then, after that initial call, the timing and the number of calls can be tailored to the individual, including up to two pre-quit calls, which can help the patient to build motivation to try and have a go at quitting. And then in the immediate post-quit period, calls are offered more frequently, when the risk of relapse is higher. 

                   And in particular for Aboriginal Quitline, there are dedicated counsellors that are available to continue to support the patient. And this applies to young people as well. And for all other callers, the counsellors use a team-based approach, supported by structured case notes to support continuity. 

                   So I think it would be great if everyone could bookmark Quit Centre in their browser as the simplest way to make a referral to Quitline. And if we make a referral to Quitline for a patient rather than asking them to call themselves, this really increases the likelihood that the patient will actually engage with the service and get the benefits of this free counselling. And for clinicians who refer in most States and Territories, once the treatment is complete, they will receive feedback from Quitline. 

                   And the Quit Centre team would love to hear from you. We welcome feedback and any questions that you have, please let us know about resources and educational events that we may be able to support you with. And if you see us around at conferences, please pop over and say hello and let us know about your challenging cases. That’s the end of my presentation. 

00:44:48

 NI              We will share a short video, demonstrating the SAS C and Authorised Prescriber scheme online systems. Although SAS B can be used to access therapeutic vapes in select circumstances, we won’t be covering it in this demo. This will show information using SAS B when prescribing unapproved therapeutic goods. It’s available on the TGA website.       (Clarification: This section of the webinar features a demonstration of the SAS & P prescriber portal. For the most up-to-date version of the demonstration please check the link in the description or visit TGA.gov.au )

00:45:22

NZ              So RACGP also acknowledges the traditional custodians of the land and waterways in which we work and live. We recognise their continuing connection to land, water and culture, and pay our respects to elders past, present and future. 

                   And what I’m going to talk about tonight, and I’ll try to get through the slides rapidly in the interests of time, relates to the RACGP’s smoking cessation guide. So just here’s the brief history of the guide. And we really focused on nicotine e-cigarettes since 2020, though we had mentioned them in earlier versions of the guide. But there were some particular literature reviews and focus as they have emerged in the smoking cessation landscape and become more and more prominent and needing to be considered. 

00:00:26

                   The Multidisciplinary Expert Advisory Group which I chair has a whole range of disciplines, which you can see there. And we have commissioned external reviews, meta analyses, evidence reviews to be done by the Joanna Briggs Institute in the past. And more recently, Hereco helped us to reanalyse the 2022 Cochrane review, which is relevant to tonight’s discussion, and there’s a process of consultation and feedback which the College goes through. 

                   So as has already been said, Australia has had a precautionary approach to vaping. We’ve been unsure about the health risks, and we are very worried about the risks of youth vaping. And it does contrast to some other countries, where there’s more of a consumer access model, not for youth though. To some extent, unfortunately, youth still get access, both here in Australia and overseas, whereas Australia has taken this different approach in trying to have a more medical access framework to nicotine vaping. 

                   Despite that, there has been an increase in vaping use in young people aged 14 and over. And you can see that rise, which has been really quite alarming. And Professor Langham referred to that in her presentation, and therefore the need for government to consider a stronger regulatory framework. 

                   Now, just a little bit of brief history about, I guess, the evidence on therapeutic vapes to support smoking cessation. And this has really emerged over time. In 2016, the Cochrane review ran two randomised controls of e-cigarettes. And that was comparing to placebo with cigarettes. And the evidence was really quite weak at that time. 

01:02:19

                   And then more recently, when the College (RACGP) got the Joanna Briggs Institute to look at the evidence and there was a comparison between nicotine e-cigarettes versus NRT, there were three more trials and nearly 1,500 participants. So the evidence did start to accumulate. 

                   And this is looking back at the JBI evidence summary. Even then, only three studies, the evidence favoured e-cigarettes as being more effective than nicotine replacement for supporting people to quit smoking. And I think it’d be fair to say that evidence has got stronger over time. 

                   The Cochrane review, published in 2022, had 17 new studies, so 78 studies in total. And as I said, with the assistance from Hereco, the College got that, the studies that were in the Cochrane review, reanalysed and looked at what we thought was the strength of the evidence, particularly in that comparison between nicotine e-cigarettes and nicotine replacement therapy. 

                   Because really, as a clinician, you’re not comparing this to placebo. What you’re thinking is, is this equally good or perhaps more effective form of nicotine replacement for the patient in front of me? And this is looking at that comparison that I mentioned, nicotine vaping versus nicotine replacement therapy. And there’s now, you can see, six studies there, and the odds ratio continues to favour nicotine e-cigarettes as being somewhat more effective than nicotine replacement. 

00:49:54

                   Now, it’s important to note that in some of these studies, nicotine replacement was monotherapy, perhaps with a patch or gum, rather than combination NRT, so the combination of a patch with a more rapid-acting form. And it could be still an open question, how much better, if at all better, nicotine e-cigarettes are in supporting smoking cessation if you’d make a comparison to combination NRT. 

                   This was the decision framework that Hereco produced for the College (RACGP) Expert Advisory Group and their rating of… Certainly, the evidence was moderate. And you would think that you would get, with nicotine replacement therapy, about 100 people per 1,000 treated quitting, and you’d get 62 more, and the range would be somewhere between 29 more to 104 more if you use nicotine vaping products, so are more effective on this evidence than standard NRT. Most of it was standard NRT. 

                   So this recommendation will be familiar to some of you, and it aligns with what Professor Langham was saying earlier, that the College’s view has been that nicotine therapeutic vaping does have a role in supporting smoking cessation, but it’s not first-line therapy. 

                   It’s for the smoker who hasn’t been able to quit using a combination of behavioural support of the sort that Dr Cole was talking about, along with approved pharmacotherapy, but would like to quit and would be interested to use this form of treatment. 

00:51:54

                   But you need an evidence-based discussion about the uncertainties. As has already been said, these are not registered therapeutic products, so we don’t know the safety and quality to the extent that we know for registered medicines. There’s a lack of uniformity in vaping devices, and the TGA is working on that with what was mentioned earlier. 

                   And the dual use, if people continue to smoke as well as use e-cigarettes, then they won’t get a benefit in terms of health outcomes. And the importance of regular review and regarding this as a stepping stone to getting off nicotine completely, not as something you would do in the long term. 

                   So then when to prescribe, I guess the why of prescribing. So why would you do this, and when would you do it? So if you have, as I said, people who’ve not succeeded, adults who’ve not succeeded with first-line pharmacotherapies, you might well consider nicotine therapeutic vapes. Also adult dual users who want to transition onto just vaping only and then transition off those in the longer term and stop any use of combustible tobacco. 

                   But as is noted on this slide, of course it’s up to medical or nurse practitioners to decide whether they wish to do this, whether it’s a form of therapy that they want to engage with and to understand and to become involved as using one of those pathways, as has been mentioned by Professor Langham. And obviously, the first-line pharmacotherapies remain the preferred option, but there are people who have tried that and not succeeded, or where this option might seem to be more likely to be efficacious. 

00:53:36

                   Now, in specific groups, yes, people with chronic illnesses, yes, Aboriginal-Torres Strait Islander people, yes, people with mental illness. Currently, we do not think there’s sufficient evidence of safety in pregnant or breastfeeding women. And in adolescents, this is what we currently say, it’s not to be used. 

                   Now, I think that’s an area for debate and discussion, but there isn’t evidence of safety and efficacy currently for using therapeutic vapes to support smoking cessation in people in adolescence. So it’s an evidence-free zone. It may be useful, but at the moment, we do not know about how effective that is. 

                   So when to prescribe? Another situation might be to support vaping cessation. And this is a challenge, because very much, we don’t know what the evidence is on this, because the work just hasn’t been done. And there’s a general lack of evidence on what helps for vaping cessation, though as already mentioned by Dr Cole, there has been some work looking at things like online support and peer group support, particularly in young people. 

                   So in the absence of evidence, what it seems reasonable to do in the vaping cessation landscape is to say, well, let’s apply to that, with caution, what works or has been shown to work for tobacco cessation, so behavioural support and pharmacotherapies. 

00:55:20

                   So first-line pharmacotherapies, I think in this situation, would probably be nicotine replacement therapy as the thing where there’s probably the most evidence, though it’s not a lot. There have been a very small number of studies on varenicline to support vaping cessation, so that may well be another option. Currently, there aren’t any studies that we’ve been able to find on use of bupropion for vaping cessation. And of course, accompanied by that behavioural support that we were mentioning. 

                   Now, having said all that, there may be a subgroup of people, including some that might be aged under 18, who’ve become very dependent on nicotine due to the vaping and where the approved pharmacotherapies, sorry about my spelling, may be less effective. 

                   Now, again, you’re weighing up the risks or benefit here and evidence-based discussion. It’s going to be a consultation that requires careful thought, and it will be a selected patient where people might feel that that is the best option to support that person, it might be a young person, for a period of time as they transition away from using nicotine. 

                   Now, there are a lot of unknowns. As we’ve said, long-term health effects are unknown. There’s a risk with poisoning, particularly with open systems, and that’s an issue about choice of the vaping device and the way the e-liquid is packaged. And that goes with acute nicotine toxicity. Some of the devices can deliver quite a lot of nicotine, and that can cause acute toxicity, and there have been instances of that in young people and in people going to emergency departments. 

                   We’ve mentioned dual use with continuing smoking, and a risk of greater long-term exposure to nicotine. Because there is evidence that people will continue to vape more than they’ll continue to use, say, a nicotine patch or nicotine gum. There has been this consideration about risk of diversion to non-smokers. I think the medical access model really reduces that risk very substantially. And there is a concern about nicotine exposure in adolescents in the brain development. And then there’s medicolegal risks for prescriber which always need to be considered. 

00:57:50

                   So just briefly on how to prescribe if people do decide to prescribe. Now, the amount of nicotine that someone will get from a nicotine vaping device or therapeutic vape will depend on the device itself, the electrical power of that device, the concentration of nicotine in the e-liquid and the way the person uses it, how often they puff on it, how deep they inhale the vapour. So it’s not an exact science, and it isn’t easy to know exactly how much a particular vaping device will deliver because of all those variables. 

                   There’s not a clear evidence at the moment about the effects of different doses, and there’s limited guidance about free-base nicotine concentrations and advise on how to prescribe and what would be the best choice of dosage. 

                   But it is important to note that people who use nicotine will self-titrate. They’re used to this drug, and they will vary their vaping technique, the same way smokers vary their smoking technique, to get the nicotine level that makes them comfortable. And that helps, I think, in terms of reducing the chances of overdose, because people will tend to titrate down and puff less often or less deeply if they’re getting too much of the drug. It doesn’t eliminate that, but it does help. 

00:59:20

                   So this is some suggestions about initial starting doses. For less dependent, if you’re using the salt pod devices, you might have 18 to 30 mg/mL. You might go above 30 in more dependent smokers. There’s 36 mg/mL ones available, and there’s also currently 59 mg/mL available as well. And if it’s a free-base liquid, you’re probably starting, for the less dependent smokers, at 6 to 12 mg, and the more dependent, around 18 to 20. And that’s very much a guide, and you may have to titrate up or titrate down after you review your patient. 

                   These are some examples of how you might prescribe a vaping pod, say, a 35 mg/mL pod, up to one pod daily, 30, and three repeats might be a reasonable amount, a three-month total supply or month’s supply. But of course, you would review perhaps sooner than that. You might want to see the patient before the end of that prescription. And similarly, with a vaping liquid, again, a starting dose and a quantity. 

                   And it is, as Professor Langham indicated earlier, important to also prescribe the device that people are going to use, because you do want them to be using a device that meets the TGO 110 standard. And now, we have a list of those that will be available from the TGA website. And that, there’s also efforts, I know, to get those into the prescribing software, which will help a lot, so that people will be able to see in their prescribing software ones that meet that standard. 

01:01:21

                   There are a number of current areas of uncertainty. As we’ve said, the prevalence of young people who vape and may never have been smokers has been really going up alarmingly. And we don’t have a lot of evidence on the effectiveness and safety of medicines for smoking cessation in that group. And that includes the approved medicines. 

                   And young people who are nicotine-dependent through vaping may benefit from using a therapeutic vape for a period of time, a limited period, but again, there’s a lack of research on effectiveness and safety. 

                   There’s differences across jurisdictions about the legality of supplying a young person with a therapeutic vape, even if it’s on prescription. And currently, information on this is not easily available and is likely to change over time. And I know that the department (Department of Health and Aged Care) and the jurisdictions are working on trying to collate that advice so that it will be more easily available for prescribers, I hope, in the near future. 

                   And just in terms of use of PBS-listed smoking cessation therapies to support vaping cessation, so things like nicotine replacement and varenicline and bupropion, that is also an area of a bit of uncertainty.

                   This is the streamlined authority for if you are writing, say, an NRT, a nicotine patch, for example. It does mention abstinence for smoking as the clinical criteria currently, but the Department of Health has put out a guidance in December last year, which has this interpretation. As you can see, the PBS restriction for NRT aims to provide an affordable intervention to support nicotine cessation. Where clinically appropriate, a patient may be eligible for PBS-prescribed NRTs, providing they are nicotine dependent from the inhalation of any nicotine-containing product. So that’s the Department’s view. It doesn’t say anything yet about other approved pharmacotherapies, such as varenicline. 

01:03:24

                   So I’ve gone through that rapidly because of the time and the technical difficulties, but I hope that’s been of some value.

NI               

                   I’m now going to hand over to our Q&A moderator, Mandy Edlington, Acting Principal Legal and Policy Advisor, with responsibility for the Regulatory Legal Services division, including vaping legislative reforms, to start off our Q&A session. Over to you, Mandy. 

01:03:51

ME             Thank you, Nishi. Look, thank you, everybody, for joining us today to listen to the webinar, and thank you very much to the speakers who have presented. Firstly, I’d like to let everybody know that the presentation that’s been delivered tonight will be available on the TGA website in due course. And we’ll send an email to all attendees once it is available. 

                   We’ve received quite a number of questions. Most of them appeared to be regulatory in nature. So please bear that in mind. I’ll try to get through as many as I possibly can. 

                   The first question relates to representatives of the e-cigarette industry doing the rounds of GP clinics. Are they allowed? This person asks, are they allowed to make therapeutic claims for their products, given that they aren’t TGA-approved? That’s a very good question. 

                   To whom are they making the claims is a relevant factor. If the claims are being made just simply to GPs during these visits, it doesn’t amount to advertising. If they’re making therapeutic claims elsewhere, that’s something that needs to be considered in accordance with the Therapeutic Goods Act. 

                   Importantly, goods that come into the country, imported, manufactured and supplied under the new exemptions that have been created under the Therapeutic Goods Act, are predicated on claims being confined to smoking cessation and the management of nicotine dependence. 

01:05:43

                   So as part of the process for notification, sponsors, either importers or domestic manufacturers, are required to actually declare or state to the TGA, in making a notification to us, that their products not only comply with the relevant product standards but are also only to be indicated for smoking cessation or the management of nicotine dependence. 

                   So if we’re talking about a product that is making use of certainly the SAS C pathway, those are the therapeutic claims for which vapes are limited. I would be really interested to know, however, whether or not there are any other therapeutic claims that are being touted by these representatives, if indeed that has occurred. Robyn Langham, I’m not sure whether you wanted to add anything further in relation to this particular question. 

RL              No, I think you’ve covered that pretty well, Mandy. It’s clear that advertising is not available, but direct communication and informing practitioners is not considered a form of advertising, as you said. 

ME             Thank you, Robyn. Next question. This attendee asks, do we follow the same process for vaping devices used for medicinal cannabis? Medicinal cannabis vapes, as in vaping devices used for the administration of medicinal cannabis, will not be obliged to provide the same or comply with the same requirements. For example, some of the controls that we’ve instituted with respect to therapeutic vapes require therapeutic vapes to actually be supplied within the pharmaceutical supply chain to persons who ordinarily deal with prescription medicines. 

01:07:44

                   Further to that, they’re to be supplied in pharmacy settings, either by registered pharmacists or by medical practitioners or nurse practitioners that are authorised to supply prescription medicines in the relevant State and Territory. 

                   Vaping devices that are supplied for medicinal cannabis in Australia will not be required to comply with those requirements. We will continue to review to the extent that it’s necessary to determine whether or not those vaping devices become or necessitate additional controls, given the controls that we’re now imposing on therapeutic vapes. So we’ll watch that space. 

                   The one exception that I’d like to say in terms of do we follow the same process, this is not related to prescribers but certainly for importers, importers are at the border needing to actually provide a notice to ODC and otherwise obtain import licences and permits in relation to vaping devices for medicinal cannabis.

                   So certainly at the border, there are additional controls that will apply in relation to medicinal cannabis. But domestically, the same arrangements that would apply in relation to prescribing presently vaping devices would apply. And when I say prescribing, I mean recommending for the use. 

                   Another question. A few people have asked for more clarity around devices and device accessories. Even though it was touched on during the presentation, can we make it totally clear for which a prescription is needed? And this is a very, very good question. 

01:09:26

                   Vaping devices and device accessories are able to be supplied in States and Territories in the absence of a prescription. A prescription is needed for an S4 substance. All of our reforms are predicated on seeking to ensure not that a vaping device or a vaping device accessory is supplied pursuant to a prescription, but rather that the ordinary controls and the supply chain associated with prescription medicines apply to therapeutic vapes. 

                   And by therapeutic vapes, I mean vaping substances, vaping accessories or vaping devices. So the idea, consistent with the Minister’s policy, is of course to ensure that these things are supplied to patients/customers in pharmacy settings. And this is somewhat unusual for medical devices and medical device accessories. 

                   Ordinarily, they’re not confined to be supplied in pharmacy settings. The requirements under the Poisons Standard dictate requirements in relation to S2, S3 and S4, relating to the way in which those substances are actually supplied into the market. The same doesn’t apply in relation to a vaping device or a vaping accessory that is absent of the vaping substance. 

                   But the reforms work in a way, and how we’ve sought to deal with this, is ensure that the same sort of oversight and the same supply chains necessarily apply, which means that there’s a medical practitioner or a nurse practitioner involved in the initial supply or recommendation or prescribing of the good to the patient. And the patient will, in the majority of situations, need to obtain those goods from a pharmacist. 

01:11:23

                   PBS aside, are there any products that we’re likely to see on the ARTG over the next 12 months? And this is a very interesting question. Of course, the TGA would be incredibly interested in an application coming forward and being evaluated by the TGA and, should it meet the relevant quality, safety and efficiency requirements, appear on the ARTG. Ultimately, that’s how all medicines should ultimately be dealt with. Unapproved medicines are ordinarily exceptions. 

                   We’re not necessarily holding our breath, however. Possibly, devices, we might. We could anticipate maybe to receive an application in relation to the vaping devices, but probably not the vaping substances. 

                   We are, the TGA, that is, working with a couple of sponsors who are keen to try. There have been representations made to the TGA about sponsors collating data, generating data, undertaking trials. But really, we think, at the moment, maybe the efficacy and safety bar is still too high for someone to be successful in terms of an evaluation by the TGA in the short term. 

                   I’m just going to run through and see whether or not there are any further questions. How will online prescribing companies be regulated? That’s a very good question and something that the TGA has been considering. Certainly, the TGA has experience with these sorts of vertical models in the context of medicinal cannabis, and it remains a subject of interest to us. Look, I think what I can say at this moment is watch this space, and I’ll hand over to Robyn Langham. 

01:13:52

RL              Thanks, Mandy. So the conduct of practitioners is not within the bounds of the Therapeutic Goods Act. We don’t regulate clinicians. The Medical Board though does, through AHPRA, regulate… Sorry, my husband’s sending me shopping questions for food on the way home. 

                   The Medical Board of Australia, through AHPRA, does however regulate practitioners. They have addressed what they see as best practice for telehealth processes. And they’ve made it very clear that they are interested in hearing of any online practitioner behaviour that steps outside of those telehealth guidelines that are available on their website, so that they can take the necessary action if something needs to be done. 

                   So yes, it’s concerning. AHPRA have addressed this with some guidance, and there is certainly appetite for them to be able to prosecute anybody that is not adhering to the guidelines. I hope that makes sense. 

ME             Last question. It’s a question for Nick actually, Nick, if you wouldn’t mind jumping back online, re. prescribing. How do we vary the dose relative to a patient’s typical daily cigarette use, e.g. what dose of nicotine would we prescribe for vapes for someone who smokes 20 cigarettes a day, mid-strength?

01:15:39

NZ              Yes. It’s a good question. And the answer is you cannot be… It’s very difficult to really equate the amount that people might get from tobacco use to the amount they might get from vaping. And in fact, there was quite a lot of discussion around this at the Ottawa Smoking Cessation Conference I was at in Canada a few weeks ago. And it basically came back to, well, you have to choose a starting dose that you think is reasonable, and then either titrate up or down in discussion with your patient. So it’s not possible to give an exact answer to that. 

                   I think, as I showed in the slides, if I was seeing a patient like that, I would be thinking… And I was prescribing a pod-type device, because pod-type devices don’t have the risks of open systems in terms of accidental ingestion or people adding other things to the mix, I would probably start with a 35 mg nicotine per mL pod and say roughly one pod a day would be about your starting dose. 

                   If the patient came back and said, oh, doctor, the pods are only… I’m only lasting… I’m going through more than a pod a day, I’d say, well, I’ve underdosed that patient. And if they said, I’m getting head buzzes and nausea, which doesn’t often happen, because they just would change their smoking technique, I might have given them slightly too high a dose.

                   And my clinical experience so far is I’ve started some people who are highly dependent on higher doses of nicotine pods than the 35s. I have used the 59 mg/mL one. And with those patients, sometimes a pod will last two or three days, which can offset some of the costs for them. And so there isn’t an exact answer to that question. But in the interim guidance, which is on the RACGP website, we do have those suggestions on starting doses which I rapidly went through in the presentation. 

01:18:09

ME             Thank you, Nick, very much for that. I think that probably brings the presentation to a close. And noting the time, 7:09, Nishi, I might hand back to you. Thank you very much. 

NI               You can stay connected and up to date with the regulatory changes, consultations and safety alerts by subscribing to our newsletter updates or following us on social media. Have a great evening, everyone. Thank you very much for joining with us. 

01:18:37