Therapeutic vapes for smoking cessation and nicotine dependence

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Recent legislative reforms in Australia have changed the way people can access e-cigarettes or vapes. Now available through some pharmacies, therapeutic vapes may be considered as a support for patients on their smoking cessation journeys.

I'm Jo Cheah, a hospital pharmacist in Melbourne, and your host for this episode of the Australian Prescriber Podcast. It's my pleasure to welcome Eileen Cole, the GP lead and Jennifer Kyi, pharmacist advisor at Quit. Eileen, Jennifer, and their co-authors have written the article, Therapeutic Vapes for Smoking Cessation and Nicotine Dependence for the Australian Prescriber. Thank you both for being here.

EC: Thanks very much.

Jennifer, could you please outline the recent legislative reforms in Australia regarding the supply of vapes?

JK: Yes. So the reforms were announced by the Australian government to regulate vaping products. So as of the 1st of July 2024, vapes for the management of smoking cessation and nicotine dependence can only be sold at participating pharmacies and not through other retail outlets.

And this applies to all vapes, including those that do not contain nicotine. And this means that vapes are now available as a prescription item Schedule 4, or as a pharmacist-only Schedule 3 item provided it meets certain conditions and subject to state and territory law.

From the 1st of October 2024, pharmacists may now supply vapes with nicotine concentration of 20 mg per mL or less to adults 18 years and over without prescription. And again, this is subject to conditions as well as state and territory law. Specific legislation relating to the control of therapeutic vapes also differs within each state and territory. There is also more information through the PSA regulation hub.

Jennifer, could you please outline the current status of smoking and vaping within the Australian population?

JK: The National Drug Strategy Household survey showed there was a decrease in tobacco use in 2022 to 2023. However, smoking rates still remain high for people over the age of 60, people living with mental illness, Aboriginal and Torres Strait Islander people, and people living in rural and remote areas.

Of concern is the increased rates of e-cigarettes use, also known as vapes. And the current use of vapes has nearly tripled to 7% where the largest increase in vapes were particularly in the younger population. So this includes people aged 14 to 17 years where the use of vapes increased from 1.8% to 9% and people aged 18 to 24 years where the use of vapes increased from 5.3% to 21%.

Those are quite alarming figures, especially in the younger populations. Eileen, can you please run through the current first line recommendations for smoking cessation and include a refresher on how you would assess nicotine dependency?

EC: Thanks, Jo. So I think it's important for us to remember that vaping and the use of vapes for smoking cessation, these are not first line management options for smoking cessation. And the RACGP recommends that for people who've tried to achieve smoking cessation with first-line pharmacotherapy, that is a combination of behavioural support and TGA-approved pharmacotherapy, but haven't been able to succeed in quitting smoking and they're still motivated to quit, that vapes may then be a reasonable intervention to recommend, ensuring that there's associated behavioural support.

So these first line options are registered, which means that they've been tested by the TGA, are nicotine replacement therapy [NRT], and there's multiple forms. There's shorter acting formulations [of NRT] and the longer acting [NRT] formulations in patch. And then there's oral [smoking] cessation medications, which are varenicline and bupropion.

So nicotine replacement therapy can be used, the formulations can be used individually, but best results from that form of medication can be achieved if there's the combination of the shorter acting and the longer acting forms used together. And they're accessible over-the-counter through pharmacies and through supermarkets.

If oral medications are considered more suitable for patients, then pharmacotherapy through varenicline or bupropion requires a prescription for the medications. And so pharmacotherapy really will help people who experience nicotine dependence and therefore experience cravings and withdrawal symptoms when they try to stop smoking.

And an assessment of nicotine dependence can be done by a clinician through some simple questions. So asking a person the time that they have their first cigarette in the morning and also asking them how many cigarettes they smoke in a day. And this information can help to determine the level of nicotine dependence in a patient. So someone who is smoking within 30 minutes of waking and smoking more than 10 cigarettes a day could be assessed as being nicotine dependent. And this will help clinicians to choose the most appropriate pharmacotherapy for that patient.

And the RACGP clinical guidelines has a great algorithm on guiding patients according to their level of nicotine dependence in the use of nicotine replacement therapy and other pharmacotherapies.

Thank you, Eileen. And Eileen, whilst I've got you, I did want to know if you had any comment on the current evidence for vaping for smoking cessation, and whether there were any clinical trials that you're aware of that are assessing safety and effectiveness in this indication?

EC: I think this is where we really look to the RACGP to guide us. And in their most recent guidelines, which were updated in October [2024] in alignment with the regulatory reform, they make comment and step out the evidence that they reviewed when making their guidelines and recommendations. And so they really recommend that because of the evidence that they cite in their guidelines that if any health professionals are using vapes as an intervention for smoking cessation, then there really should be an evidence informed shared decision-making process that health professionals follow, so that patients are aware of the following caveats that due to the lack of available evidence of the long-term health effects of vapes, which are currently unknown, that they should be used for no longer than 12 months in supporting smoking cessation, if possible, that vapes are not registered therapeutic goods and therefore their safety, efficacy and quality have not yet been established.

Also, that there's a lack of uniformity in vaping devices and vapes, which increases the uncertainties associated with their use. And then particularly important, I think, to maximise the possible benefits and minimise the risk of harm, dual use (that is that vaping and smoking together) should be avoided, and that it's really important for health professionals to encourage patients to return regularly for review and monitoring.

And again, just another question with the dual use between cigarettes and vaping, is that inclusive of therapeutic vapes or non-therapeutic vapes?

EC: It's challenging, isn't it? Because people come to vaping for a number of reasons. They may be using it for smoking cessation or be vaping outright and then take up smoking as well. So I think this is another area for further research and exploration as there’s a lot of questions that remain.

Definitely. Thanks, Eileen. And although this article is focused on smoking cessation, can you briefly discuss vaping cessation?

EC: Yes. And this is another area for which there's very little evidence to inform cessation practise at the moment. And so while we're waiting for evidence to emerge, expert recommendation is that we use approaches that we currently use for smoking cessation, that it's what I described earlier, the combination of behavioural support, with pharmacotherapy if that's clinically appropriate.

And again, mentioning the RACGP guidelines, they've got some fantastic links and resources in the therefore clinicians who are supporting young people in particular who can really struggle with vaping and quitting vaping, some practical strategies and some information about the use of pharmacotherapy and behavioural supports in young people. And then when we think about people who are using therapeutic vapes for smoking cessation, it's really important for us as clinicians to have a conversation at the beginning of treatment about the plans and how we're going to approach together stopping vaping, noting that we don't want to use vapes as a long-term option for smoking cessation.

Strategies that the RACGP currently suggests include weaning vapes from 12 weeks or transitioning to nicotine replacement therapy. They also suggest that transitioning to oral pharmacotherapies, in particular varenicline, may be considered, but further research is needed before these can be formally recommended.

As you've already previously mentioned, there is a lack of uniformity in the products available through this scheme or market. So how are doctors and nurse practitioners and pharmacists choosing which products might be suitable for their patients?

EC: So any vapes that are supplied must come from the TGA's notified vape list. So this is a list of vapes that sponsors, which have notified the TGA that are compliant with relevant standards for both the vaping products and device standards. So it's important that anyone who's using a vape with their patients or prescribing or supplying a vape ensures that the product is from the list of notified vapes. For people who are already vaping, taking a history and understanding the device that is currently being used by the patient, and also the nicotine substances that they're currently using as well.

So I guess to summarise, our goal is obviously to help patients with smoking cessation, but we definitely want to prevent long-term use of vapes as well.

EC: That's right, yes.

And if required, if we are recommending or supplying vaping products, we need to refer to the notified list as that lists products that meet certain criteria set by the TGA. Is that correct?

EC: That's correct.

Thanks, Eileen. And Jennifer, what are the different pathways through which vapes can be accessed from pharmacies for smoking cessation and what considerations and record keeping are required by the pharmacist when supplying?

JK: Sure. So let's take a step back. Currently, all therapeutic vapes are unapproved products, and unapproved products are not listed under Australian Register of Therapeutic Goods. That's the ARTG. So they have not been tested by the TGA for safety, quality and efficacy. There are different pathways for the access of unapproved vapes and the prescribing and supply of vapes must be under the Special Access Scheme, that's the SAS, or Authorised Prescriber, the AP pathways. Medical practitioners can apply to become an Authorised Prescriber if they want to regularly prescribe for multiple patients [without requiring individual approvals]. Otherwise, practitioners can also use the SAS category B or C pathways for each individual patients.

Pharmacists must use the SAS category C pathway and meet Schedule 3 requirements to supply vapes without prescription. All pathways can be accessed through the SAS and AP online system. And this can be found on the TGA vaping hub.

So for a pharmacist to meet regulatory as well as guideline requirements, supplying Schedule 3 vapes by a pharmacist needs to include: being satisfied that supply is clinically appropriate for smoking cessation or the management of nicotine dependence; sighting evidence of the patient's identity and age (they need to be over the age of 18); as well as inform the patient that the vapes are not listed on the ARTG. And importantly to obtain informed consent, and the PSA [Pharmaceutical Society of Australia] guidelines to have a template for written consent in Appendix 4; provide professional counselling on alternative registered therapies as well as contact details for cessation support services; as well as supply of vaping product from the TGA notified list of vapes, with concentration of 20 mg per mL or less.

Pharmacists also need to ensure that the supply of vapes does not exceed one month supply, so that's within the one month period. Pharmacists also need to supply vapes in accordance with state and territory registrations as well as good pharmacy practise. The pharmacist supplying vapes as Schedule 3 products must use the SAS category C notification pathway each time you supply it to a patient. So for record keeping, pharmacists should also document the consultation with patients in their medical records including informed consent and also communicate to the patient's regular GP or medical practise. Additionally, it's also important to report any adverse effects to the TGA. And more information about this can be found within the PSA guidelines.

So relating to prescription vapes, a referral to a medical practitioner for a script may be required if the person is under 18 years of age, for vapes with concentration higher than 20 mg per mL, or if a patient is assessed as having complex medical needs and requires additional support or advice from medical practitioners. And when dispensing the prescribed vapes, pharmacists need to confirm a valid SAS or authorised prescriber submission using the TGA online validation tool or by contacting the prescriber for the notification number. And all notifications, applications and validation searches is accessible for all community pharmacists and prescribers, through the TGA vaping hub using the SAS or AP online system.

If a pharmacist was to supply via prescription or through their Schedule 3 pharmacist-only schedule, will that be recorded anyway, for example, in My Health Record? Or is there any other way for other prescribers or clinicians to track whether these things have been prescribed or supplied?

EC: No, they're not currently listed in any of the other SafeScript or online portals. So the SAS and AP online tool is the only online mechanism that we have.

Sure. So the idea is that the TGA will be tracking if there's any excessive applications or supply for a particular patient.

EC: Yeah. We have no knowledge of how that's being done.

Thank you. Sorry, that was just a side thought there.

EC: Yeah. It's another topic of discussion.

Yeah, of course.

And Jennifer and also Eileen, I'll put the question out to both of you. What are some non-pharmacological recommendations for smoking cessation?

JK: Well, acknowledging that pharmacists and GP has a limit of amount of time. Some strategies used within a clinical setting can include setting and planning a quit day, telling families or friends of plans to stop smoking or vaping and how that can help, identifying situations and triggers that might make the patient want to smoke. So for example, in association with coffee or certain routine. The 4Ds can also deal with craving, and that's delay, deep breath, drink water, and do something else to keep their hands busy.

It's also important to recommend the use of behavioural intervention, and that's to increase the patient's smoking cessation rates as well. Eileen, did you want to jump through here?

EC: Yeah. I think this is where we want to highlight the importance of multi-session behavioural intervention. Multi-session behavioural intervention can increase the success of a quit attempt, and this is readily available through Quitline in Australia. So Quitline is free and it's available in all states and territories, and it can help patients in the early days by supporting their quit attempt, helping them to plan, make, and sustain a quit attempt and learn to become a person who lives without smoking or vaping.

In addition to Quitline, face-to-face and in-person support can be offered by stop smoking counsellors. And also we list in the article a list of apps and online resources for information and for support.

I'm sure doctors, nurses and pharmacists might feel certain ways about the use of therapeutic vapes in their practise. So, do they have any resources or support that they can lean on when they're dealing with a smoking cessation query which involves therapeutic vapes in their practise?

EC: Absolutely. So, I think the TGA website for a start is really important so that you can become familiar with your obligations and then accessing information, training and further resources on smoking and smoking cessation through quitcentre.org.au is available for all health professionals in Australia. And patient information related to smoking cessation is available at quit.org.au. And for health professionals to access Quitline for their patients, go to quitcentre.org.au and you'll find links to referral forms from that web page.

And if a practitioner makes a referral directly, rather than asking the patient to call, this increases their patient success through increasing their enrolment in the Quitline services.

Excellent. That brings us to the end of the episode. Thank you both for your time.

EC: Thanks very much, Jo. It's been a pleasure.

JK: Thanks, Jo.

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Eileen and Jennifer's article is available on the Australian Prescriber website. All of the authors work for Quit, Cancer Council Victoria, which operates the Australian government-funded websites Quit and Quit Centre. Quitline is a state-based service funded by each jurisdiction. The views of the host and the guests on the podcast are their own and may not represent Australian Prescriber or Therapeutic Guidelines. I'm Jo Cheah, and thanks again for joining us on the Australian Prescriber Podcast.