Preparing for vaping reforms on 1 October

Early next week (Tuesday 1 October), the next stage of the Commonwealth’s legislated vaping reforms comes into effect, including a Schedule 3 entry for nicotine-containing therapeutic vapes.

PSA’s updated guidelines for pharmacists providing nicotine dependence support are set to be released tomorrow (Thursday 26 September), followed by a national webinar on the same evening. 

Ahead of the release of these guidelines, Australian Pharmacist put some of your burning questions to Chris Campbell MPS, PSA General Manager Policy and Program Delivery. 

Here’s a sneak peek at what tomorrow night’s webinar will cover.

1. Vapes cannot be collected by third parties  – including a person’s husband or wife 

A change to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 means pharmacists are not permitted to provide third-party or distance supply of either Schedule 3 or Schedule 4 therapeutic vapes. 

All therapeutic vaping products must be handed to the individual who it is intended for, with even spouses precluded. This requirement is unique, and pharmacists will need to consider how to ensure this requirement is upheld.

‘The guidelines cover the circumstances where a carer may collect them, but it does need to be in person,’ said Mr Campbell. 

However, in most cases, a family member will not meet the definition of carer.

2. Pharmacists must refer people seeking care

Pharmacists who choose not to prescribe or dispense therapeutic vapes have an obligation to refer patients for care whether that be other nicotine dependence support or how they might access therapeutic vapes 

‘As health professionals, we have an obligation to support people who are legitimately seeking care said Mr Campbell

‘For some people, this could be a positive conversation around first-line therapies for smoking or nicotine cessation. For others, this may require referral to another health provider.’

Other options include referral to Quitline, a GP for a prescription or a participating pharmacy.

‘Because there are no published list of pharmacies, GPs or nurse practitioners that are participating, pharmacists may simply not know of any local pharmacies or local prescribers to refer to,’ said Mr Campbell.

‘But we still have a duty of care to make sure there are care options for that person, and that the patient is offered access to nicotine dependence advice, other treatment, first-line recommendations or a referral.’

3. All pharmacists need to be familiar with the updated guidelines, even in pharmacies and states which don’t have Schedule 3 therapeutic vapes

Updates to the guidelines highlight obligations not only for pharmacists providing Schedule 3 nicotine vaping products, but also those who choose to dispense on prescription only, or not stock them at all. 

‘Although there’s not much evidence in terms of cessation strategies for vaping, heat-not-burn tobacco or nicotine pouches, the guidelines will still support a pharmacist in having those discussions with patients,’ said Mr Campbell.

Schedule 3 therapeutic vaping products may also not be available in all jurisdictions, with both Western Australia and Tasmania planning to introduce legislation to prevent supply of vapes without a prescription from a doctor or nurse practitioner.

4. Prescribing Schedule 3 therapeutic vapes will take time to meet patient clinical needs and regulatory requirements

Prescribing vapes under Schedule 3 will take longer than most other Pharmacist Only medicines as the therapeutics and regulatory compliance obligations are more substantial.

During a Schedule 3 vaping consultation, pharmacists must:

• take a patient history
• sight photo identification (if a therapeutic vape is prescribed)
• discuss therapeutic options
• record patient details
• complete Special Access Scheme (SAS) notification (if a therapeutic vape is prescribed)
• offer a private area for the conversation and consultation to occur. 

‘The pharmacist should record relevant details of that consultation before making a recommendation and devising a management plan,’ said Mr Campbell.

Because therapeutic vapes are unapproved, prescribing of these products must take place under Special Access Scheme (SAS)  Category C (SAS-C).

‘Any pharmacy or pharmacist participating in the Schedule 3 provision of vapes will need to fill out that form at every occasion,’ he said.

Photo ID must be sighted at every occasion before prescribing therapeutic vapes, said Mr Campbell, even if the patient is well known to you.

‘Proof of ID is required in the Act for provision of Schedule 3 vapes,’ he said. ‘It is also a Therapeutic Goods Administration (TGA) requirement for pharmacists to record the date of birth and initials of patients on the SAS-C form.’

5. Therapeutic vapes cannot be prescribed or dispensed for recreational use

It is unlawful to supply therapeutic vaping products for recreational use, said Mr Campbell.

‘It is unlawful for any prescriber, be that a pharmacist, GP, or nurse practitioner, to prescribe a therapeutic vape for recreational use,’ he said.

6. Therapeutic vapes cannot be used as first-line treatment

The provision of therapeutic vapes is last line, said Mr Campbell. 

‘One of the requirements before initiating a therapeutic vape is that the person must have tried one or more of the first-line treatments,’ he said.

This includes:

• combination nicotine replacement therapy (NRT)
• nicotine replacement monotherapy
• varenicline
• bupropion.

7. Informed consent, including financial consent must be provided

Pharmacists must seek informed consent from patients before prescribing therapeutic vapes. This includes explaining to patients that:

• the products are unapproved and unregistered in Australia, meaning they are not tested for safety and efficacy 
• there is availability of first-line nicotine dependent products such as NRT, varenicline and bupropion. 

‘A pharmacy may charge a private consultation fee to support someone with nicotine dependence. We think this is fair and reasonable for the time this may take and very important patients are aware of any private fees upfront,’ said Mr Campbell. 

‘There also must be informed consent around the expected cost of vapes through the pharmacy. As private fees for nicotine dependence consultations are not subsidised by government and therapeutic vapes are not subsidised on the Pharmaceutical Benefits Scheme it’s important patients know this upfront.’

While subsidised consultations are not currently available through pharmacies, Medicare Benefits Schedule funded consultations are available via general practices for patients able to find and access a bulk billing practice. 

Eligible patients may also be able to access subsidised nicotine dependence treatments including NRT, on prescription, through general practice and dispensed in a pharmacy. This is something not currently available through pharmacist initiated treatments such as combined NRT. These subsidies are also not currently available through  pharmacists with authority to prescribe other first line treatments such as varenicline and bupropion. 

8. What else do pharmacists need to know?

All pharmacists are encouraged to attend PSA’s Navigating the new vaping regulation and what they mean for you webinar – held on Thursday 26 September from 7:30–9:00 pm AEST.

There will also be a series of in-person workshops around the country, with registration accessible via the PSA event page.