Pharmacist Hub

Pharmacist questions and answers

The following questions have been submitted by pharmacists during previous education webinars – answers provided by Richard Lee (Liber Pharmaceuticals Ltd).

What information needs to be reported to the TGA for each patient?

The TGA requires that supply of S3 vapes is reported as an SAS-C notification.

If a prescribing doctor (who is not an authorised prescriber), or a nurse practitioner were to prescribe a vaping product, that would also require an SAS-C notification.

Liber has detailed exactly how to file an SAS-C notification – see How to file an SAS-C notification.

Any information submitted is anonymized. You are only required to submit information about the product supplied and certain patient details (date of birth, age and patient’s initials).

The notification process itself takes about two minutes.

We are hoping to automate this process for you and are working with both the prescribing software providers and the TGA to accomplish this.

We’ll have to update you as soon as we hear from the TGA on that. 

What we do know is that that notification doesn’t need to be immediate. The requirement is within 28 days of supply, although we have no clarity on whether pharmacists may provide a consolidated report. 

What we do know is that the TGA refined the AP reporting requirements for wholesalers and sponsors to reduce their burden when it came to vaping products. 

I hope that we end up with a pragmatic and sensible solution in this case as well.

You can visit our Pharmacist Resources section to download or order physical copies – you can also book a meeting with our Head of Medical Liaison, Whitney Kabel. 

Whitney can talk you through all of the collaterals that we have prepared over the last 3 ½ years – not only patient collaterals, but also our comprehensive suite of pharmacy information to assist you with supplying and dispensing.

We’d love to talk to you directly about what you and your pharmacists may need in the coming months.

Practice standards around supplying any form of medicine, whether it be an S4 or pharmacist-only medicine, requires the pharmacist to validate and confirm who the medicine is actually being supplied to. 

In a circumstance such as this, pharmacists should speak to the patient face-to-face before supplying and dispensing any therapeutic vaping products.

Yes, the minimum age is 18. If patients present at below the age of 18, then they must be assessed by a specialist prescriber.

If a pharmacist is not comfortable supplying a patient with S3 vapes, the easiest solution is to point the patient to a specialist prescriber. 

When deciding whether to supply any vapes for therapeutic purposes, pharmacists must consider that if a patient is nicotine dependent, or if a patient is smoking, then the immediate concern is to stop them smoking. 

At the end of the day, a pharmacist, in a similar manner to any other medical practitioner, will ultimately have the discretion to treat the patient in front of them as they most see fit, including choosing not to supply S3 vapes.

We’re going to have to wait for the PSA guidance on that.

If we look at the RACGP’s guidance, which has been in existence for far longer, the therapeutic use of vapes is recommended as a second-line treatment.

Remember, this is guidance to a prescriber, so at the end of the day, the prescriber must look at the patient’s needs and make their own clinical assessment.

The worst outcome when a patient enquires about therapeutic vaping is that they leave the pharmacy and revert to smoking.

From Liber’s perspective, using a low-concentration vape is a better outcome for a patient than smoking.

If the patient refuses NRT, then in that situation, you may choose to provide an interim supply (say up to a week of S3 vapes), while recommending that they go to a prescriber.

Yes, please reach out to us and we will direct you to responsible operators that are trained and ready to prescribe suitable therapeutic vaping products to your patients for in-pharmacy dispensing. We can also supply you with POS materials, including patient hand-outs.

IMPORTANT: Most ‘nicotine vaping’ telehealth services operate under a vertical supply model, i.e., their prescriptions lock patients into their own online store, effectively bypassing the pharmacy channel. Many products sold via these platforms are also untested and uninsured consumer/recreational goods.

Yes, they do. 

The Nicovape® Q device is rechargeable and retails at $29.95 – paired with two Nicovape® Q cartridges that retail at $10-$12/ea, this costs about the same as a packet of cigarettes in total. 

Once a patient has a Nicovape® Q device, it will typically last for up to a year. Lots of patients also choose to buy a second device as a back up.

Nicovape® Q cartridges are removable and separate to the device – once empty, they are discarded and replaced with a new cartridge.

It’s a simple question with a complicated answer. The amount of nicotine that gets into your bloodstream is a factor of three things:

  1. The power of the device;
  2. The concentration of the nicotine; and
  3. How hard you draw or puff on the device. 

Most pack-a-day smokers can use a 2 mL cartridge at a 50 mg/mL concentration in a day, which is 100 milligrams of nicotine. For a 20 mg/mL cartridge it would be 40 milligrams of nicotine – at this concentration, nicotine-dependent people may exceed a cartridge a day, perhaps up to 2 or 2.5 cartridges to maintain satiation. 

If the patient is using more than a cartridge a day regularly, that is when you advise them that this is not the appropriate intervention for them. 

Consider that, when a smoker lights a cigarette, they typically take 10 to 12 puffs to get through the cigarette. Once a cigarette is lit, a smoker (typically) smokes the entire cigarette, but that does not mean that they need all of those puffs to achieve satiation. 

If we think of this in terms of nicotine, if a patient were satiated a third of the way through their cigarette, then it may well be that a 20 mg/mL cartridge is sufficient for them. The question you need to ask a patient who has been prescribed a 20 mg/mL cartridge is, how long is it lasting? 

The nicotine a patient needs is the amount required to satisfy their craving when they’re using the product appropriately. If that is more than a cartridge per day, then we need to get them to a doctor to be assessed and likely be prescribed a higher-concentration product, or a combination of a low-concentration product with a patch. 

This is where the specialist prescribers should come into play, and is not a decision that a pharmacist supplying an S3 product should be required to make.

At this stage, no.  

The initial reasoning behind that was because a zero nicotine product was not considered to be therapeutic before implementation of the new regulations and would have rendered our entire range non-therapeutic. 

However, we are considering whether prescribers require a zero nicotine product as part of their cessation toolkit. It’s certainly something that we are able to do. If you are aware of prescribers or patients who are requesting vaping products with zero nicotine, we’d be happy to have a conversation to see how best we can look after that patient.

Supply is limited to one month at a time.

However, there is no clarity at this stage as to what a month’s supply of S3 vapes means. The TGA, the PSA and the RACGP have yet to provide guidance on what restrictions, if any, there are when determining that number.

With the Nicovape® Q range, Liber’s maximum recommended dosage is one Nicovape® Q cartridge per day, regardless of concentration.

Liber’s highest concentration vape, Nicovape® Q50, is 50 mg/mL, and is the product that most closely replicates the smoking experience. Most patients initiating use of Nicovape® Q will do so with Nicovape® Q50. Our maximum recommended dosage of Nicovape® Q50 is up to a pod a day, which is 100 milligrams in total.

If we drop down to the Nicovape® Q20 product range, 100 milligrams is the total nicotine equivalent of two and a half Nicovape® Q20 cartridges. This is why S3 vapes will not be appropriate for most patients.

The amount of nicotine that a patient needs is the amount that will stop them from smoking. That is why regular assessment of the amount that the patient is consuming is so important. The problem we have seen with the rise of recreational vapes, particularly amongst people who’ve never smoked before, is that when people start to vape, having never smoked, they don’t learn how to titrate nicotine. Because of this many patients don’t know what satiation feels like and over consume.

This is why we are seeing many (previously nicotine-naive) people getting through 1000, 1200, or 1500 puffs per day using illicit disposables.

It is important that when the patient starts using an S3 vape, they understand how to use a vape effectively, with the goal of cessation in mind. In this regard, the proper use of a vape is a single dose, i.e., a single puff of up to two seconds, and then the patient should wait for 20 or 30 seconds to assess whether they are still craving nicotine before having a second puff, with a recommendation of no more than 15 puffs an hour.

For patients who are more frequent users and thus more dependent, a single pod of a 20 mg/mL concentration product may be insufficient for their needs. A higher concentration product is recommended for these patients to ensure their usage is kept below one pod per day.

Nicovape® Q devices are rechargeable and a fully charged device will last just over a single cartridge. We are finding that a device’s total lifespan is between nine and 12 months (dependent upon the number of recharge cycles the battery undergoes).

A lot of patients like to keep a spare device, in case the battery runs out in their first device. The retail price of a device is $29.95, so a cartridge retailing at between $10-12 together with the device will cost around $40 for the initial purchase, which is less than a packet of cigarettes.

From then on, a cartridge-a-day user, if they were previously a pack-a-day smoker, will be saving about 75% against their original outlay on tobacco.

I spoke to a patient the other week who was a 50-a-day smoker. She has switched to Nicovape® Q for about six months now. She’s gone from 50 cigarettes a day to 1/6 of a cartridge a day, so a cartridge lasts her six days. She has saved $8,000 in those six months. She currently anticipates being at fresh air and entirely nicotine abstinent within the next three months.

The short answer is, we don’t yet know the answer to that question. 

The question has a couple of different facets to it. One of the big concerns to be addressed is diversion, i.e., people buying lots of vapes and selling them to kids. 

The supply and access to the illicit market has diminished significantly, but there will always be a black market. However, if a presenting patient is used to an illicit, recreational vape, and wants to continue to vape recreationally, a low-concentration S3 therapeutic vape is not going to be the product they are looking for. 

The Government’s aim was to make vaping products no longer the easiest form of illicit product to access, and I think they’ve done a good job in that. I also think we’re going to see enforcement against the stores increasing in the next two to three months. 

Secondly, for personal use, is someone likely to go and buy lots of S3 vapes? For someone who is nicotine dependent, that is a really expensive way to address your nicotine need or habit. Most illicit vapes have nicotine concentrations of 50 mg/mL or higher. The low-concentration vapes that can be supplied without a script are not the type of product that those people want. As mentioned in the chat, a red flag for diversion is more likely to be the purchase of multiple devices, rather than multiple cartridges.

Script shopping and diversion are issues that the PSA, the TGA and the Government are looking at closely. They have to balance the political compromise that no data be collected, with the genuine need to stop diversion and ensure that people are not abusing the pharmacy system.

The TGA has developed a validation tool as part of their SAS dashboard that allows you, if you’re presented with a script, to input the special access number and validate the pathway by which the prescriber has prescribed the product. 

You can also dispense S4 products against a script that has not been written correctly, or which doesn’t contain an AP’s number, by filing the SAS-C notification on behalf of the prescriber. We have developed collaterals to support this, and we have collaterals addressing most questions with flow charts and processes for the more complicated aspects of prescribing vapes. 

The TGA historically published a list of authorised prescribers of nicotine, although that list was a fraction of the actual prescribers.

The issue is that many prescribers are concerned that they will be deluged with a series of thousands of recreational vapers seeking access to vapes.

We have a good idea where the authorised prescribers are, and we’re happy to work with individual pharmacies who wish to work with those prescribers, or more broadly, at a banner group level.

Yes. Our head of Medical Liaison, Whitney Kabel, will be able to facilitate that for you.

We are happy to conduct training face to face or virtually. We also have a series of written collaterals that set out, in simple terms, what you need as a pharmacist, as a pharmacy, and as a banner. 

We’ve spent three years developing the most comprehensive library of training resources available and we’re ready to put it to work for you in the manner that best works for you. 

We would love to. What we are hoping is that the TGA will have a tool available, but there are challenges to doing this based upon some of the amendments to the Bill in the Senate.

Senator Steele-John was adamant that no data would be collected when S3 vapes were dispensed. Mark Butler spoke about Project Stop in the Parliament, and we’ve heard SafeScript mentioned, and also Medadvisor.

There are lots of ways to track usage, but also ensuring that you as pharmacists, have proper record keeping to ensure your clinical governance around any supply issues. My view is that the simplest way to do this may be to tailor the SAS-C notification process and incorporate the ability to check a patient’s history against SAS-C notifications, but that will be something that will be driven by the TGA. 

It may be possible for us, with the myNicovapeQ portal, to allow some sort of record-keeping in there, but that is something that we will need to work on over the next couple of months. There is no question in our mind, that monitoring usage is important. We don’t want to see people ‘pharmacy shopping’ for this. We would like to see continuity of care and stable script management. 

We want to see patients out of S3 products and into S4, even if it’s for low-concentration vapes, as quickly as possible. Primarily because, under prescribed access, the RACGP’s Guidelines are very clear that 12-month usage is an appropriate time for patients to attempt and achieve abstinence. What we don’t want is people accepting lifetime use in the majority of cases, simply because there is no set end point at which we achieve absence.

I’ve been talking about Liber’s commitment to seeking admission to the ARTG for three and a half years now. 

The simple fact of the matter is we need to agree an appropriate pathway to licensing with the TGA. 

We have already been in discussions with the regulators in the UK, the MHRA, who are the only people who have published guidance on how to seek medical licensing. We have held what they call ‘scientific advisory meetings’ with them, and have agreed the appropriate pathway for us to achieve licensing in the UK. 

As the final version of TGO 110 comes out, we will look to sit down with the TGA and work out what they will require for admission to the ARTG.

I anticipate that once agreed, the licensing process will take from 18 months to two years. 

Supplying and Dispensing Therapeutic Vapes

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Liber:Activate

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Important links

Therapeutic Goods Administration

Pharmaceutical Society of Australia

References

  1. PSA Professional Practice Standard 1: https://www.psa.org.au/practice-support-industry/pps/
Nicovape Q products are TGA notified therapeutic vaping goods indicated for smoking cessation or the management of nicotine dependence. TGA Notification ID numbers: VG-2024-NTF-00234, VG-2024-NTF-00241, VG-2024-NTF-00240, VG-2024-NTF-00235, VG-2024-NTF-00242, VG-2024-NTF-00239, VG-2024-NTF-00237, VG-2024-NTF-00243, VG-2024-NTF-00238, VG-2024-NTF-00236.

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