Pharmacist hub

Dispensing low concentration NVPs

Pharmacists in Australia have been dispensing unlicensed NVPs under prescription since October 2021, when the framework for therapeutic vaping was implemented. In June 2024, the Government implemented changes to the framework focused on preventing access by never-smokers, particularly among the young, while refining the access pathway for those who may benefit therapeutically from using NVPs.

Key among those changes, from 1st October 2024, low-nicotine-concentration NVPs (20 mg/mL or less) will be rescheduled to S3, and pharmacists may dispense them to patients without a prescription. S4 NVPs, with higher nicotine concentrations, will continue to be available under prescription for those who have tried and failed to quit in the past.

This guide will help you prepare for the changes.

Background

This year marks the 20th anniversary since a Chinese pharmacist, Hon Lik, first marketed an electronic cigarette. Since then, vaping technology has established itself with millions of users worldwide.

Vaping is increasingly understood to have real promise as a smoking cessation tool, with new-generation vapes (low-powered devices that contain nicotine in salt form) substantially reproducing the behavioural and pharmacological experience of smoking.

However, NVP technology has proven extremely polarising. While most people who vape are smokers or ex-smokers, more and more young never-smokers are vaping and frequently becoming dependent.

Globally, regulators continue to struggle to find a balance between giving smokers access to NVPs and preventing a new large-scale emergence of nicotine addiction.

The updated NVP regulations

The rules governing NVPs have been updated, most recently in June this year, with changes to the primary legislation, standards, and other regulations. In particular, the changes:

  • Prohibit the sale of “disposable” NVPs.
  • Ban the import of recreational vapes and increase enforcement powers to reduce the illicit market.
  • Give the TGA powers to approve limited marketing.
  • From 1 October 2024, create a new class of S3 pharmacist-only low-concentration NVPs.

The TGA has prefaced additional changes to its standard for NVPs, TGO 110, to be introduced in due course. These changes will introduce further product standards, limiting flavours and other characteristics.

How will the role of pharmacists change for therapeutic vaping?

One of the main concerns with the original framework was that while there are more than 3,000 prescribers, people wishing to discuss whether NVPs were appropriate for them had no idea where to go to start that discussion.

The new legislation makes pharmacists the starting point for those seeking access to, or advice on, NVPs.

What can pharmacists dispense?

The Government considers low-concentration NVPs to be sufficiently low-risk. From 1 October 2024, pharmacists can (but are not required to) dispense vapes containing a nicotine concentration of 20 mg/mL or less to adults aged 18 and over without a prescription.

[Pharmacists will not be required (or permitted) to record patient data during these transactions.]

Pharmacists will also stock and dispense higher-concentration NVPs to patients with a prescription.

What’s the difference between low-concentration vapes and prescribed vapes?

Nicotine delivery from NVPs is primarily determined by the nicotine concentration and device characteristics, principally the device’s power.

Therapeutic NVPs are new-generation, closed-system NVPs that operate at low power to minimise overheating. This helps avoid the creation of toxic by-products in the resulting aerosol.

In these products, as a rule of thumb the amount of nicotine delivered from:

  • NVPs with 20 mg/mL or less deliver nicotine approximately equivalent to that provided by nicotine replacement therapy (NRT).
  • NVPs with between 40 and 60 mg/mL deliver nicotine in a manner comparable to cigarettes.

It is unlikely that low-concentration NVPs will be the optimal intervention for most patients. However, they will act as an important tool for pharmacists when they first discuss therapeutic vaping with their patients.

What is the pharmacist’s new role in the therapeutic model?

Pharmacists regularly act as the central access point in a holistic healthcare model. They evaluate patients, dispense S3 medicines where appropriate, and refer patients to doctors when required.

Pharmacists will increasingly see patients inquiring about NVPs, but their role in providing access to NVPs will remain consistent.

Pharmacists will provide initial information about therapeutic vaping and when it may be appropriate for a patient. In most cases, their principal role will be to act as a conduit between the patient and specialist prescribers, either in person or through an appropriate telehealth prescriber.

Guidance for pharmacists when a patient presents seeking access to NVPs

This module contains practical guidance to ensure that pharmacists counsel patients seeking access to NVPs in accordance with good pharmacy practice and in accordance with the new regulatory framework.

When considering whether to dispense low-concentration NVPs to patients, it is critical for pharmacists to recognise that in many patients, these products will not exert their full therapeutic potential.

Pharmacists should consider prescribing low-concentration NVPs in the following circumstances:

  • Where a patient needs access to an NVP until such time as they can speak to a smoking cessation prescriber; or
  • Where a patient has been dispensed low-concentration NVPs previously and has maintained exclusive use without also using cigarettes and/or illicit vapes and is not using more of the low-concentration vape than the manufacturer recommends. For Nicovape® Q, this is one Nicovape® Q Cartridge per day.

Where a pharmacist chooses to prescribe low-concentration NVPs, the regulations oblige them to direct patients towards a smoking cessation service / prescriber.

This is a crucial stipulation that de-risks the pharmacist by ensuring patients can access a full range of support in using NVPs therapeutically.

Specialist prescribers can fully assess a patient’s cessation needs, establish a cessation strategy and consider prescribing a range of treatments, including higher concentration NVPs, which pharmacies will continue to dispense.

Will low-concentration S3 vapes be suitable for all patients?

No. The major therapeutic advance of NVPs is that they can act as a complete smoking substitution, substantially reproducing the pharmacological, pharmacokinetic, sensory, and behavioural characteristics of cigarettes.

When this occurs, these products promote adherence and prevent relapse, both of which are critical factors in treating patients who have historically failed to quit.

Historically, approximately 90% of all Nicovape® Q NVPs prescribed have been at concentrations of more than 20 mg/mL.

Many patients will require continued access to higher-concentration NVPs to remain smoke-free or to ensure they do not seek illicit vapes.

Good Pharmacy Practice in dispensing low-concentration vapes

When presented with a patient, the pharmacist should ask whether the patient has previously been dispensed NVPs, and if so, whether they have a valid script.

Depending on the patient’s response:

Patient has never been dispensed NVPs

The pharmacist may:

  • Provide them with a fact sheet on therapeutic vaping; and
  • Recommend where they may see a specialist prescriber if they have further questions. (See “Counselling patients about seeing a specialist prescriber.”)

The pharmacist may also discuss dispensing a short-term supply of low-concentration NVPs until such time as they can see a specialist prescriber. (See “Counselling a patient when prescribing low concentration NVPs.”)

Patient (i) has been dispensed NVPs (ii) does not have a valid script and (iii) has not been dispensed low-concentration NVPs

The pharmacist may discuss with the patient why they no longer have a valid script, and recommend that they return to discuss their cessation needs with their existing specialist prescriber.

If the patient does not want to, or cannot see, their former prescriber, the pharmacist may recommend an alternative specialist prescriber.

The pharmacist may also discuss dispensing a short-term supply of low-concentration NVPs until such time as they can see a specialist prescriber. The pharmacist may advise the patient that they should see a specialist prescriber.

Patient does not have a valid script, but has been dispensed low-concentration NVPs

The pharmacist should determine whether, when the patient uses low-concentration NVPs, they are either:

  • Still smoking;
  • Using illicit vapes alongside dispensed vapes; and/or
  • Using more than one cartridge per day.

If the answer is yes to any question, the pharmacist should counsel the patient that:

  • It is unlikely that low-concentration NVPs are an appropriate intervention for the patient; and
  • Smoking, even at a very low amount or infrequently, is a high-risk activity and that they should aim to stop smoking at the earliest possible opportunity.

Patient has been dispensed NVPs and has a valid script

The pharmacist may dispense that script in the normal course.

Initial assessment of patients

When a customer approaches a pharmacist about prescribed vapes, pharmacists should first determine whether the customer is a current smoker, (illicit market) vaper, or dual-user.

If they are none of those, there is unlikely to be a reason to consider dispensing low-concentration NVPs, unless they are a former smoker or illicit vaper who is considering relapsing.

Pharmacists may provide interested customers with a fact sheet on therapeutic vaping and recommend where they may see a specialist prescriber if they have further questions.

(Sample fact sheet: Click to view PDF on)

If the customer is a smoker and/or user of illicit vapes, they may benefit from access to NVPs and should be treated as a patient.

Counselling a patient about low-concentration NVPs

When a pharmacist chooses to prescribe a low-concentration NVP, they may advise the patient that:

  • They should use the NVP only when they crave nicotine, and as often as required to remain completely cigarette or illicit vape-free.
  • A key advantage of using a vape is that they can have a single puff when they need it to satisfy cravings for nicotine.
  • Patients should try to have no more than 15 puffs per hour, which will result in most patients consuming a single Nicovape® Q Cartridge per day.

When a pharmacist dispenses low-concentration NVPs, they must direct patients to a specialist prescriber.

About specialist prescribers

Helping patients access a specialist prescriber who is able to assess their smoking cessation needs is key to giving patients the best chance of a positive outcome.

Importantly, for the pharmacist, it is a significant step to mitigate risks involved in prescribing NVPs as specialist prescribers can:

  • Make a more comprehensive assessment of patients than pharmacists.
  • Prescribe a broader range of treatments, including higher-concentration NVPs.
  • Implement a comprehensive cessation strategy, in accordance with RACGP Guidelines.

Finding local specialist prescribers

While there are more than 3,000 prescribers of NVPs across Australia, it is important that pharmacists are able to direct patients to specialist prescribers located nearby.

If pharmacists are not aware of any local specialist prescribers, they may recommend that the patient seek an assessment from a specialist telehealth provider. Pharmacists should identify telehealth platforms that will assess patients and return them to the pharmacy with a script for NVPs or other therapies. 

If you are unaware of which specialist prescribers are near your pharmacy or which telehealth platform may be appropriate for your patients, Liber can help.

Explaining the Importance of Specialist Prescribers

When a pharmacist suggests that a patient see a specialist prescriber, they may explain to patients that:

  • NVPs are one of a number of smoking cessation options that may be appropriate for them.
  • There are specialists who can better assess their needs, and you would be happy to refer them to such a specialist.
  • You can dispense a low-concentration vape immediately—this may be appropriate for them, but if it isn’t, an assessment will allow them access to a wider range of therapies than you can offer.

Other obligations when dispensing

When dispensing NVPs, pharmacists must:

  • No Licensed NVPs: Inform the patient that while the NVP being dispensed is compliant with TGO 110, it is not ARTG-listed and has not been assessed by the TGA for safety or efficacy.
  • Obtain Informed Consent: Obtain informed consent before dispensing the NVP.
  • [Record Keeping: While the regulations prevent you from taking any personally identifying patient information for your records, you should make a record each time you prescribe to a patient, stating the time and date and confirming that you informed the patient and that they consented.]
  • Advise Patient on Product Use: Refer the patient to the manufacturer’s usage instructions and CMI.
  • Report Adverse Events and Product Defects: If the pharmacist becomes aware of any adverse events or product defects, they must report these to the TGA and sponsor in accordance with SAS Guidance within 15 days.
Pharmacist hub modules
Pharmacy programs

Liber:Onboard

Onboard your pharmacy with Liber’s medical liaison team today

Whitney Kabel

Head of Medical Liaison

Find an appointment time
  • external link (hubspot.com)

Liber:Activate

Establish your local GPs as activated authorised prescribers
Learn more
  • external link (liber.com.au)

This content is gated for Australian healthcare professionals only

This website is a source of educational content for Australian-registered healthcare professionals only. You must not use the content for any other purpose. If you are a patient seeking medical advice please see your healthcare professional. By accessing this website you are agreeing that you are an Australian-registered healthcare professional with a current AHPRA registration and are entitled to access this content. Your use of this content is also subject to our Terms of Use and Privacy Policy.

It is an offence to falsely claim to be a registered practitioner, to use a protected title, and/or to use symbols or language that may lead a reasonable person to believe that you are a registered health practitioner or are qualified to practice in a health profession.

Healthcare professional?
Register now for full access

By registering you accept the Terms of Use and Privacy Policy
Already registered?