Pharmacists’ guide to vaping supply arrangements

When the Commonwealth’s legislated vaping reforms come into effect tomorrow, pharmacists need to adhere to a new set of regulations for Schedule 3 supply and Schedule 4 prescribing.

Ahead of the 1 October start date, PSA has updated their Professional Practice Guidelines for Pharmacists for Nicotine Dependence support.

Here’s what you need to know about changes to consultation guidelines and supply of nicotine containing vapes.

How are therapeutic vaping goods regulated and stocked?

Therapeutic vaping goods that are imported, manufactured or supplied in Australia must be notified to the TGA by the sponsor as complying with the applicable quality and safety standards, said Mandy Edlington, Assistant Secretary of the Vaping Legislative Reform Branch at the Therapeutic Goods Administration (TGA) in a webinar held on Thursday night.

‘Pharmacists and prescribers can refer to the TGA’s Notified vape list to determine what therapeutic vapes are available for supply in Australia, and the TGA is undertaking post-notification surveillance to ensure vapes included on that list are compliant with standards,’ said Ms Edlington. ‘Non-compliant vapes will be the subject of a determination and removed from the list.’

While the TGA’s Special Access Scheme does not normally allow for pre-ordering of stock, there is a difference when it comes to S3 or S4 vaping products, said PSA Victorian State Manager Jarrod McMaugh MPS.

‘Because it’s expected that we have stock available at the time the person deems appropriate, we can keep them [in stock],’ he said. ‘But we should limit how much we keep and they should be out of view.’

What are pharmacists’ obligations under the new S3 pathway?

S3 therapeutic vapes, prescribed under Special Access Scheme (SAS) Category C (SAS-C) are restricted to patients 18 years or over – subject to strict conditions and compliance with state and territory laws.

‘A prescription will continue to be needed for patients who are under 18 years of age, subject to state and territory requirements, and patients who require a higher nicotine concentration, of more than 20 mg per mL,’ said Ms Edlington.

Pharmacists must sight identification at every encounter to confirm patients’ identity and age.

‘[Even] if you know the person very well or have sold them vaping products 6 months in a row, you must still check their ID,’ added Mr McMaugh. 

It’s also essential to confirm the person prescribed or supplied the vape is who they say they are. 

‘From 1 October, provision of S3 or S4 vaping products is in-person to the person themselves,’ he said.

The legislation recognises that there may be circumstances where it’s necessary to provide  vaping products to the carer of the patient, said Ms Edlington.

‘We haven’t adopted social security legislation in order to confine what is precisely meant by “carer”, [but] it’s the responsibility of the person to demonstrate that they could be considered a carer,’ she said. 

Before prescribing an S3 vaping product, pharmacists must be satisfied that it is clinically appropriate for smoking cessation or the management of nicotine dependence, said Ms Edlington.

Pharmacists must also provide professional advice to the patient in relation to alternative registered therapies, appropriate dosage frequency, and interaction with other medicines.

‘[They must] ensure the quantity of goods supplied does not exceed more than 1 month supply at any one time,’ said Ms Edlington. 

If an S3 vaping consultation ends with a vaping product being provided, it should be considered as last line, with pharmacists obligated to talk to patients about all first-line options – whether nicotine replacement therapy (NRT), or prescription medicines, said Mr McMaugh.

Contact details about cessation support services should also be provided to the patient. ‘The therapeutic vape is not is not going to work in isolation,’ added Ms Edlington.

What paperwork is required?

SAS-C notifications must be made by pharmacists within 28 days for each instance of supply of a therapeutic vaping good substance – whether S3 or S4, said Ms Edlington.

PSA’s guidelines recommend that the SAS-C form is completed in real-time during the consultation.

‘If your workflow becomes disordered and you lose track of them, and then you get audited, the regulatory process can be quite severe and expensive,’ added Mr McMaugh.

PSA’s guidelines also recommend documenting S3 vaping consultations.

‘This helps you understand what was previously provided to this person, as far as advice and products,’ he said.

‘If you have the information about that person in your dispensing system, it may also upload to their My Health Record.’

Pharmacists will not have a mechanism from 1 October to determine if a person has visited another pharmacy for an S3 vaping product already, said Mr McMaugh.

[But] it is possible state-based governments might decide to include this in their real-time prescription monitoring,’ he said.

What is involved in S4 supply?

Pharmacists must have evidence of a prescriber’s Authorised Prescriber (AP) status to fill an S4 vaping script, and can use the TGA’s SAS and AP portal to validate this status online. 

Under the SAS-C and the SAS-B schemes, pharmacists must verify the SAS reference number by using the online validation tool. 

‘If pharmacists have any concerns in relation to the lawful supply of those goods under the Act using SAS-B or SAS-C pathways by a medical or nurse practitioner, they should contact the prescriber,’ said Ms Edlington.

If pharmacists receive a prescription for a S4 vaping product, they should check that the prescriber has filled in an SAS-B or SAS-C form before dispensing the product.

‘If it doesn’t exist, you should contact the prescriber. If they’ve got all the information, you can complete the form for them [but] you will be taking on extra paperwork for which you are not remunerated,’ he said. ‘[But] don’t complete an SAS-C form for a vaping prescription without speaking to the prescriber first.’

How should pharmacists tailor an S3 vaping consultation?

In all S3 vaping consultations, pharmacists need to understand why a person wants to quit vaping or smoking and what outcome they are seeking, said Mr McMaugh.

‘[For example] if they are looking to cut down or quit, we need to say “as you reduce your dose yourself, you need to allow yourself to have some withdrawal symptoms”,’ he said. 

‘Without experiencing some withdrawal symptoms, patients won’t experience receptor down regulation, and will still wind up with withdrawal symptoms in the future.’

It’s also important to help patients avoid relapse, which entails advising them against cutting down too quickly.

‘If withdrawal issues are a problem, they can increase the dose back up in response to that,’ said Mr McMaugh.

If a patient indicates they are running out of their 20 mg per mL supply before the month is up, they should be referred to their GP.

‘GPs have access to greater strengths and can provide [patients] with extra support,’ he added.

If a person presents for an S3 vaping consultation for vaping rather than smoking cessation, it’s important to keep in mind that existing NRT products are still off-label for this indication.

What does a behavioural intervention comprise?

Evidence-based behavioural intervention for smoking and/or vaping cessation includes four to six sessions over a month, or longer if required, said Dr Eileen Cole, GP lead at Victoria’s Quit Centre.

If pharmacists make a referral for a patient via the Quit Centre online referral process, the pre-quit call back model includes questions about patients’:

• vaping or smoking use
• previous use of pharmacotherapy
• current motivation and confidence. 

‘Counsellors will work with the patients to be able to develop a plan that will just work for them, including planning a quit day and strategies that they can use while they’re navigating those early challenges,’ said Dr Cole. 

For patients more interested in self-management, the My QuitBuddy app is another helpful resource.