Therapeutic vapes for smoking cessation and nicotine dependence

SUMMARY

The Australian Government has enacted laws restricting the supply of electronic cigarettes (vapes) to people requiring them for smoking cessation or the treatment of nicotine dependence, under the care of a medical practitioner, nurse practitioner or pharmacist.

Currently no vapes are included on the Australian Register of Therapeutic Goods, meaning that the prescription and supply of therapeutic vapes must be through the Special Access Scheme or Authorised Prescriber pathways.

Clinical guidelines state that therapeutic vapes may be considered for supporting people who have been unable to quit smoking using first-line therapies (a combination of behavioural support and registered nicotine replacement therapies or oral smoking cessation medicines).

Clinical review should occur 1 week after vape initiation, with additional follow-up according to an individualised management plan, to monitor progress, review adverse effects (e.g. cough, irritated throat, headache or nausea), encourage the use of behavioural smoking cessation supports, and discourage dual use of vapes and conventional cigarettes.

An attempt to wean or stop vaping after 12 weeks is recommended, with a possible transition to registered smoking cessation medicines if required (in addition to ongoing behavioural support). The maximum recommended duration of vape use is 12 months.

 

Introduction

In the 2022–23 Australian National Drug Strategy Household Survey, 8.3% of people aged 14 years and over reported smoking tobacco daily, which was fewer than ever before.¹ Despite the overall decline, smoking rates remain high in some populations, including people aged over 60 years, Aboriginal and Torres Strait Islander people, people living with mental illness, and people living in rural and remote areas.¹

In contrast to tobacco smoking, current use of electronic cigarettes (e-cigarettes, also known as vaporisers or vapes), either regularly or intermittently, nearly tripled since the previous survey 3 years earlier, from 2.5 to 7.0%.¹ The largest increases in vape use were in people aged 14 to 17 years (from 1.8 to 9.7%) and 18 to 24 years (from 5.3 to 21%).¹ Rates of dual use (both smoking tobacco and using vapes) increased from 0.7 to 2.3%.¹

Vaping can be harmful to health and may lead to nicotine addiction.² Commonwealth legislative and regulatory reforms in 2024 were designed to reduce availability of non-therapeutic vapes, by limiting supply of vapes to pharmacies only, for smoking cessation and the treatment of nicotine dependence.³ As a result of these reforms, more people may seek information from health professionals about vapes, and ask for support to stop smoking or vaping.

There are currently no vapes included on the Australian Register of Therapeutic Goods, which means that therapeutic vapes must be prescribed and supplied via the Special Access Scheme or Authorised Prescriber pathways for ‘unapproved’ therapeutic goods.

General practitioners (GPs), nurse practitioners and pharmacists play important and complementary roles in supporting patients to plan, make and sustain attempts to quit.⁴ Low levels of confidence in discussing vapes for smoking cessation have been reported by GPs⁵ and pharmacists,⁶ and there is limited evidence to inform vaping cessation practice.⁷

The purpose of this article is to inform health professionals about the use of therapeutic vapes to support people who are smoking or vaping, in the context of the recent legislative reforms and updated clinical guidelines.

 

Assessment of suitability for therapeutic vapes

Nicotine dependence can be considered a chronic relapsing condition.⁷ Health professionals should use every clinically appropriate opportunity to offer cessation care to people who smoke or vape. Help may be especially important in people from populations where smoking rates remain high, and in those with higher levels of nicotine dependence (e.g. see case study about ‘Drako’ in Box 1). Users of non-therapeutic vapes obtained from unregulated sources, which may be incorrectly labelled as ‘nicotine free’, may also require assistance with cessation.⁸

For patients like Drako (Box 1), who are highly nicotine dependent and seeking advice about vaping for smoking cessation, it is important to first explore previous smoking cessation experiences.⁷ Clinical practice guidelines from The Royal Australian College of General Practitioners (RACGP) and the Pharmaceutical Society of Australia (PSA) state that vapes may be considered for supporting people to quit smoking completely when they have been unable to quit with first-line therapies (a combination of behavioural support and registered smoking cessation medicines such as nicotine replacement therapies (NRT), varenicline or bupropion).^7,9

An evidence-informed, shared decision-making approach is essential for guiding treatment decisions. When vapes are being considered, it is important to ensure that the patient understands that vapes are currently not registered therapeutic goods, and therefore their quality, safety and efficacy have not been established; and that the long-term health effects of vaping are unknown.⁷

GPs, nurse practitioners and pharmacists are under no obligation to provide vapes as part of smoking cessation treatment when there are registered medicines that are suitable for the patient. As with any unapproved or off-label medicine, the prescriber is responsible for clinical outcomes, including adverse events.^10,11

The Quit Centre website provides health professionals with information, resources and links to guidelines on smoking and vaping cessation.

 

Initiating therapeutic vapes: practical considerations

Initiating treatment with a vape requires consideration of the patient’s age, their medical and medication history, smoking and vaping history including dual use, and their level of nicotine dependence. Nicotine dependence may be assessed by asking about the time to first cigarette or vape (within 30 minutes of waking suggests a high level of dependence) or by using tools such as the Hooked On Nicotine Checklist (HONC) for people who smoke or the modified HONC for people who vape.^7,9,12,13

Patient preferences based on current vape use (if applicable), and factors such as cost and stock availability, should also be considered. As vapes are unapproved therapeutic goods, informed consent should be obtained.^7,9,12 Clinical consultation details and consent should be documented in the patient’s clinical record.^7,12

Vaping devices and systems vary. Closed systems use vaping substances contained in non-refillable pods or cartridges, while open systems allow for substance filling and re-filling. The pros and cons of the different devices have been described elsewhere,¹⁴ but when selecting for a patient, closed systems are recommended to reduce the risks of nicotine ingestion or cutaneous exposure that may result in poisoning, especially in young children (the potentially lethal dose of nicotine via oral exposure is 5 mg/kg body weight).¹⁵

Guidance on nicotine concentration at therapeutic vape initiation is included in both the RACGP and PSA guidelines, and summarised in Table 1.^7,9 Nicotine is available in freebase and salt forms. The salt forms have a lower pH than the freebase form and therefore cause less throat irritation at higher concentrations (above 20 mg/mL).⁷ The salt and freebase forms are not directly interchangeable, even at equivalent nicotine concentrations,^7,12 so cautious dosing is required if the patient is switching forms.⁹ Potential advantages and disadvantages of salt forms are summarised in the RACGP guideline.⁷

Table 1 Suggested nicotine concentrations for therapeutic vape initiation^7,9

	New vape users		Current vape users
	Lower nicotine dependence (smokes more than 30 min after waking and smokes 10 or fewer cigarettes a day)	Higher nicotine dependence (smokes within 30 min of waking or smokes more than 10 cigarettes a day)
Suggested nicotine concentration [NB1]	6 to 12 mg/mL nicotine freebase 18 to 30 mg/mL nicotine salt	18 to 20 mg/mL nicotine freebase more than 30 mg/mL nicotine salt	base dose on patient preference and current usage reduce risk of poisoning by recommending a closed system or reducing nicotine concentration where appropriate
NB1: The nicotine salt concentrations listed in the table are expressed as the equivalent nicotine freebase concentration.16

Initial dosing must be individualised because clear evidence of the effect of different doses is not currently available.⁷ The dose of nicotine a patient receives with each puff depends on the nicotine form and concentration in the vaping substance, the composition of the vaping substance (e-liquid), the power of the vaping device and the vaping technique used.^17,18 Self-titration enables people who use nicotine to achieve their desired nicotine level.⁷

Clinical review 1 week after initiation is recommended.^7,9 Ongoing follow-up should be arranged according to an individualised management plan, to monitor progress, review any acute adverse effects (e.g. cough, dry or irritated mouth and throat, headache or nausea), encourage the use of behavioural supports and discourage dual use.⁹ Adverse events related to vaping (including device-related injuries, such as burns) must be reported to the Therapeutic Goods Administration (TGA).¹⁰

 

Access to therapeutic vapes

Information for prescribers, pharmacists and patients is regularly updated on the TGA’s Vaping hub.¹² The TGA maintains a Notified vape list which includes all vaping substances and devices that have been notified by a product sponsor (manufacturer or importer) as complying with TGA standards and that can be legally supplied in Australia from a pharmacy.^12,16

Legislation relating to the control of therapeutic vaping goods differs in each state and territory. Information specific to each state and territory is available at the PSA Regulation hub.¹⁹

Since 1 October 2024, pharmacists in most Australian jurisdictions can supply therapeutic vapes with a freebase-equivalent nicotine concentration of 20 mg/mL or less, to patients aged 18 years or over, without a prescription for management of smoking or nicotine addiction.³

Patients who are under 18 years of age or require a higher concentration of nicotine, and those who have complex medical needs, require a prescription from a medical or nurse practitioner, as do patients living in jurisdictions where the prescription requirement remains for all nicotine concentrations and age groups.³

Access pathways

As all vaping products are unapproved therapeutic goods, prescribing and supply of vapes must be under the Special Access Scheme (SAS) and Authorised Prescriber pathways.

Medical practitioners and nurse practitioners need to use the SAS Category B or C pathways, or a medical practitioner can apply to become an Authorised Prescriber (Table 2); pharmacists dispensing prescribed vapes must confirm validity of prescriptions using the TGA’s validation search tool or by contacting the prescriber.⁹ Applications, notification and validation searches are made through the Special Access Scheme & Authorised Prescriber Scheme Online System.²⁰

Table 2 Access pathways for therapeutic vaping products (subject to state and territory regulations)¹² [NB1]

Pathway	Explanation
SAS Category B (application pathway)	for medical practitioners and nurse practitioners to prescribe vaping products for patients aged under 16 years prior approval from TGA required for each patient
SAS Category C (notification pathway)	for medical practitioners and nurse practitioners to prescribe vaping products for patients aged 16 years and over for pharmacists to supply vaping products (nicotine 20 mg/mL or less, including nicotine-free vapes) for patients aged 18 years and over TGA must be notified about each patient within 28 days after issuing a prescription or supplying a vaping product
Authorised Prescriber	for medical practitioners only approval as an Authorised Prescriber required prior to prescribing allows medical practitioner to prescribe vapes for more than one patient without obtaining individual approvals 6-monthly TGA reporting of patient numbers to TGA there are 2 Authorised Prescriber pathways: established history of use pathway for patients aged 16 years and over standard pathway for patients aged under 16 years (requires endorsement or approval from a human research ethics committee)
SAS = Special Access Scheme; TGA = Therapeutic Goods Administration NB1: Vaping devices that do not contain, and are not packaged with, a vaping substance do not need to be prescribed or authorised for supply under the SAS or by an Authorised Prescriber; however, a pharmacist can only supply a vaping device if satisfied it will be for use for smoking cessation or the management of nicotine dependence.

Prescribing practitioners must issue a prescription for a vape product from the TGA’s Notified vape list¹², and should include the following information on the prescription:⁷

• vape brand and product (not essential but good clinical practice)
• nicotine concentration in mg/mL
• recommended daily dose
• initial quantity, and number of repeats if applicable (maximum 3 months supply recommended)
• Authorised Prescriber or SAS submission or reference number (see below).

Flavourings may be specified (permitted flavours are mint, menthol and tobacco). Further details and prescribing information are available in the RACGP guidelines.⁷

Pharmacists must use the SAS Category C pathway, and meet Schedule 3 (pharmacist-only) supply requirements, to supply vapes without a prescription (Box 2).

 

Vaping cessation

Prior to prescribing a therapeutic vape for those vaping to quit smoking, it is recommended that a strategy for down-titrating is discussed, noting that the maximum recommended duration of vape use is 12 months.⁷ Suggested strategies include attempting to wean or stop vaping after 12 weeks, and transitioning to NRT. Transitioning to oral smoking cessation medicines may be considered, however further research is needed before these can be recommended.⁷

For people who want to stop vaping, approaches similar to those used for smoking cessation are recommended.^7,9,21 Young people, who may struggle to stop or cut down use of vapes despite wanting to, may benefit from holistic assessment²² and using practical strategies such as finding behavioural substitutions to vaping, increasing barriers to obtaining vapes and accessing social supports.^23,24

There is currently no evidence about effective cessation strategies for people who are both smoking and vaping (dual use), and a stepwise approach that prioritises smoking cessation has been suggested.^7,18

Smoking cessation pharmacotherapies including NRT, bupropion and varenicline may increase the likelihood of successfully quitting vaping.²⁵ NRT is approved for use (for smoking cessation) from 12 years of age.^13,25

 

Behavioural support

Brief interventions delivered in general practice increase patient smoking cessation rates,²⁶ but many patients require more intensive assistance.

Multi-session counselling programs delivered either individually or in groups (e.g. cessation clinics, quit courses, Quitline) are designed to help people make a quit attempt, manage nicotine withdrawal and adjust to life without smoking or vaping.

One accessible service is Quitline’s free telephone counselling service, funded by each state and territory within its own jurisdiction.²⁷ Health professionals can organise a counselling call for their patient using the Quitline referral form. Use of Quitline increases smoking cessation rates and is even more effective when combined with pharmacotherapy.²⁸ Quitline can support people using vaping to quit smoking and people wanting to quit vaping, including young people with no smoking history. Quitline offers all people who identify as an Aboriginal or Torres Strait Islander person the option to speak with a First Nations counsellor. It has tailored protocols for priority groups including people disclosing mental health conditions or alcohol and other drug issues, pregnant people and their partners, people with chronic diseases, young people under 18 years, and sexually or gender diverse people.

Other behavioural support resources include the My QuitBuddy app (recently updated to support vaping cessation as well as smoking cessation), cessation websites, automated text messaging and online tools (Table 3).^28,29

 Table 3 Behavioural support resources for smoking and vaping cessation

Service	Description	Links	Developer or provider	Cost	Evidence
Quitline (137 848)	multi-session behavioural counselling for smoking and vaping cessation	Quitline Quitline referral form	state-funded services following National Minimum Quitline Standards27	free if you refer patient; otherwise cost of local call for first call-in	Cochrane review28
QuitCoach [NB1]	interactive web-based automated expert system	QuitCoach	Cancer Council Victoria	free	randomised clinical trial29
QuitTxt [NB1] [NB2]	interactive text-messaging program	QuitTxt	Cancer Council Victoria	free	randomised clinical trial29
My QuitBuddy mobile phone app (Android and iOS)	information and motivational tracking app for smoking and vaping cessation	My QuitBuddy app	Australian Government	free	no efficacy evaluation undertaken
Websites	information, planning and motivational tools	Quit	Cancer Council Victoria and Australian Government	free	no efficacy evaluation undertaken
		iCanQuit	New South Wales Government
		QUiT HQ	Queensland Government
		Make Smoking History	Cancer Council Western Australian and Western Australian Government
NB1: QuitCoach and QuitTxt are for smoking cessation only. NB2: QuitTxt is only available in Victoria, South Australia, Western Australia and Northern Territory.

 

Conclusion

Legislative reforms have restricted access to vaping products in Australia. Prescribers and pharmacists may prescribe or supply vapes to people who have not been able to quit smoking or vaping using registered medicines and behavioural support. The TGA’s Vaping hub, and updated guidelines from the RACGP and the PSA are key resources to support health practitioners during this period of regulatory reform.

This article was finalised on 11 November 2024.

Conflicts of interest: 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. Cancer Council Victoria owns the Quitline trademark, having established the world’s first Quitline service in Victoria in the 1980s. Catherine Segan is also a chief investigator on government-funded research trials (including the National Health and Medical Research Council) on the effectiveness of behavioural interventions and pharmacotherapy for smoking cessation.

This article is peer reviewed.

 

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