- 14 May 2021
- 14 min 30
- 14 May 2021
- 14 min 30
In this special edition of the NPS MedicineWise podcast about upcoming scheduling changes to nicotine vaping products, CEO Adj A/Prof Steve Morris talks with Adjunct Prof John Skerritt and Ms Jenny Francis from the Health Products Regulation Group (HPRG), including the Therapeutic Goods Administration at the Australian Government Department of Health. They discuss the new prescribing process for nicotine vaping products that is coming into effect from 1 October 2021, why the regulation is being changed, which products are being affected, and what prescribers need to do to prepare for this change.
This podcast was developed with funding from the Australian Government Department of Health.
NPS MedicineWise news article, access pathways flowchart and links to further information:
TGA: Nicotine e-cigarettes hub (for health professionals):
TGA: Nicotine e-cigarettes laws are changing (blog for consumers):
RACGP Guidelines: Supporting smoking cessation:
Welcome to the NPS MedicineWise podcast, helping health professionals stay up-to-date with the latest news and evidence about medicines and medical tests.
Hello, I'm Steve Morris, CEO of NPS MedicineWise, and welcome to another NPS MedicineWise podcast.
In this episode of the podcast, we hope to provide an opportunity for prescribers, for other health professionals, to understand more about an upcoming schedule change relating to nicotine vaping products.
With me today, I have two very knowledgeable guests to help us delve into this complex change from the Health Products Regulation Group, including the TGA at the Australian Government Department of Health, we have Deputy Secretary Adjunct Professor John Skerritt. Hello, John.
Hi. Hello there.
And Principal Legal and Policy Adviser, Jenny Francis.
Thanks very much, Steve.
We're going to jump right into the meat of some of the questions people might have.
So John, from the first of October, there'll be a new prescribing process for nicotine vaping products.
Can you just provide a top-line overview of the changes, and when these changes will be coming fully into effect?
Thanks. Well, in a way, it's actually a clarification of the status quo. Nicotine is already a prescription medicine when it's used for smoking cessation. There's a grey area, where nicotine is used for better or worse, recreational non smoking cessation uses.
We have a situation where the sale of nicotine is already illegal in every state or territory in Australia, and possession, even if you have bought nicotine-containing products unless if you have a prescription, it's currently illegal everywhere except in South Australia.
In reality, what these changes do is clarify, that for all purposes and smoking cessation is seen as the only valid purpose, you need to have a prescription. It actually clarifies the existing legal situation, rather than brings in sweeping changes.
There is confusion, of course, about the legal status of nicotine. If an individual is purchasing nicotine for vaping on Friday night and you get it by mail order from the US, currently our border force, because there are no Commonwealth laws relevant to it being a prescription medicine under all circumstances, currently our border and customs people can't intercept those shipments.
The bottom line is clarifying what's a grey area, it's making it quite clear that, for all purposes, nicotine is going to be a prescription medicine. But at the same time, we're simplifying and streamlining access to those who, in conjunction with their doctor, want to give the use of nicotine-containing e-cigarettes a go to help someone wean off smoking cigarettes.
Okay, thanks for that John.
Just picking up on a few things you mentioned there, what was the kind of forcing function for the regulation to be changed now, given these issues have been in place?
There was significant concern about increases in use of vaping by youth, because, even though many websites, and even if people are buying it illegally from vape stores and tobacconists, and it is illegal for Australian-based vape stores and tobacconists to sell nicotine products, but there's evidence that there was a lot of that going on.
The uptake by youth was significantly increasing, both in Australia and globally. For people 15 to 24, there was a doubling between 2016 and 2019. In the US, the word 'epidemic' was used, with a two and a half fold increase between 2017 and 2019, and similar results in Canada.
A number of studies have suggested that while there will always be youth who are higher risk takers, or try alcohol, may try illicit drugs and may try e-cigarettes, there are some who it creates a nicotine dependence and a potential gateway to smoking.
There's a lot of work about nicotine, whether it's from cigarette smoking or from vaping, having long-term consequences for the developing brain. The brain continues to develop until you're in your mid-20s. People 16, 17, 18, or even younger, exposed to nicotine, do have significant impacts on their brain development.
The first policy objective was to limit the access to youth of nicotine vaping products. The second policy objective was to make it quite clear that we wanted to support smoking cessation. The evidence for vaping and smoking cessation is mixed, there are some studies that show a significant relationship between vaping and reducing smoking, while others are inconclusive.
What this does do is allow individual prescribers, in conjunction with their patients who say, "Hey, I want to give up smoking", to actually try this approach if they feel other approaches haven't worked.
Yeah. Thanks for that, John. Just to really tease this out, so we're absolutely clear, which products are affected directly?
The product that's been focused on most are actually nicotine-containing vapes. These days they're both liquids that go into an e-cigarette, but increasingly there's integrated electronic devices that can be disposable, but might look more like a USB key, but they actually do the same thing. They heat the solution or a solvent of nicotine, more often, for vaping.
The change does also influence things like heat-not-burn tobacco, chewing tobacco and snuff. Not smoking tobacco, but other forms of tobacco and snuff. The greatest focus of both people who use vaping products, and also of potential use in smoking cessation, are really what we call nicotine vaping products.
I should emphasise that doesn't influence the range of current TGA-registered smoking cessation products, such as gums or sprays or patches.
Just to further tease out the difference between the prescribing process for nicotine vaping products, and the prescribing process for existing nicotine products..?
Okay. Most existing nicotine products used or all of it, existing nicotine products I should say, that are used for smoking cessation are actually available over the counter.
Some of them started life as prescription products, but through the TGA downscheduling process, are now available in pharmacies and in some cases are even available in supermarkets because they've been shown, for example, a gum has been shown to be safe and effective for general sale.
There are some prescription medicines, generally products that are also antidepressants, like varenicline and bupropion, that some prescribers have used as prescription medicines to assist with smoking cessation. They remain prescriptions, but the other nicotine-containing smoking cessation products that are on the market already are not prescription only. They're either pharmacy or they’re general sale.
Okay, thanks for that clarification. Given the changes you're describing John, the clarification and simplification, what do you think GPs need to do to prepare for this change when it comes into effect on the 1st of October?
We're working very closely on communications and education programs, we’re working with GP organisations like RACGP on prescribing guidelines. There are three ways by which a GP can prescribe this. Currently, and after the first of October, any Australian registered doctor can prescribe a product, and then the person can personally import it with a prescription.
But we're also working with the pharmacy supply chains, so that smoking cessation nicotine vaping products will be available from community pharmacies, and also with Australian based mail order pharmacies.
Mail order pharmacies are reasonably well established, you send your prescription and often with a discount, especially for private, non-PBS prescriptions. And you get your scripts sent back to you. Those pathways will require the prescriber to either be an authorised prescriber or under the special access scheme.
The authorised prescriber system for nicotine is extremely simple. They get a five-year approval, there's just a couple of fields, mainly name, AHPRA number, address of the practice. Then a prescriber can prescribe for any number of patients for smoking cessation, without having to come back to TGA for individual approvals.
All their medical receptionist has to do, every six months, is tell us how many patients they prescribe for.
It's a free of charge, very simple online process. We're communicating that process both through face-to-face meetings, through online education and also web and other formats, working closely with prescriber organisations.
Well, thank you for that John.
And Jenny, is there anything else that you'd like to add in terms of what people should be aware of in the space at the moment?
One thing that doctors did ask for during both the consultation process for the scheduling decision, as well as in their evidence before the Senate Committee on Tobacco Harm Reduction, was some sort of a safety standard that it would apply to these unapproved nicotine vaping products.
And so recently the TGA published a consultation paper on proposed content of such a product standard and invited submissions. The period for consultation has now closed, and consideration is now being given to the final contents of the proposed standard.
Generally, those contents will deal with labelling and packaging, nicotine content limits, and prohibiting the addition of other active ingredients and ingredients with known safety risks.
It will take account of the very extensive feedback that was received, both from medical practitioner organisations as well as others, and is anticipated to be made around the middle of May or so. So at least a period of a good four months before the decision will take effect on 1 October.
Okay. Thanks for that, Jenny. Just finally, John, is there any message you'd like to give to our audience around these changes?
As Jenny said, one of the things that prescriber groups, and even groups involved in vaping have expressed concerns about, is whether the products that they will have access to are of high quality.
There are a range of countries, both the well-established vaping product manufacturers in Europe, the UK, New Zealand, the US, but there's also a concern about products coming from other countries and also substandard products.
We have been consulting, as Jenny said, on a product standard. The challenge will be to provide a baseline for whether products for example don't contain substances that are known to be harmful when inhaled, that it's not a Trojan horse through to inhaling cannabis or other active pharmaceutical substances. If it's nicotine vaping, that's what the vaping should be about.
But at the same time, we don't want to excessively limit the choices out there in the marketplace. We realise that because of doctors involved, they're the one who will sit with a patient and say, 'Okay, I realise you're telling me, you find the pure nicotine unflavoured version harsh, we'll let you try it, we'll write a script for a menthol one.' It's the doctor who will be the gatekeeper here. Some may say, 'Look, unless if you have standards on every single requirement about flavouring and all that sort of stuff, kids will use them.'
The important thing here is that with appropriate education and communication and other materials, the GP is a gatekeeper. I don't know too many GPs that would be writing a prescription for a 14 year old for a nicotine vaping product. The focus here is on smoking cessation. These will be prescriptions tailored towards that purpose for adults.
Yeah. That's really clear, John. Thank you for that.
Look, we are planning another podcast episode on this topic to further delve into some of these scheduled changes and what they mean for clinical practice. So our audience can keep an eye out for that episode in near future.
In the meantime, John, Jenny, where should our listeners look for more information at the moment if they want to know more?
We have plenty of information on the TGA website. There is a nicotine e-cigarette hub on which we've posted information for health professionals, as well as for others including consumers and those who are going to be supplying them.
I think really that's where most of the information is that we're going to be producing, but over the next few months, in leading up to 1 October, there will also be other materials which will be available.
For example, in the last few days or last week, the TGA has published a blog for consumers, and will continue to supplement those materials including by distributing them through social media outlets.
There is other more targeted information for health professionals that will also become available as well as the RACGP revising its guidelines, in so far as they deal with nicotine vaping products.
Thanks for that, Jenny, that's really clear. Obviously, a fairly substantial amount of resources being produced to support this change.
Thank you, John and Jenny for your time today, much appreciated.
Thanks very much, Steve.
Not a problem.
Thanks you and thanks to our listeners for joining us today. If you'd like to have a look at some of the links and resources we discussed today, this can be found in the podcast notes. As I mentioned in the recording, there will be another podcast episode on this topic.
So if you have further questions or suggestions for what we should cover in this role or other upcoming episodes, we'd love to hear from you and you can get in touch by contacting NPS MedicineWise via Twitter or LinkedIn.
Thank you for listening. Goodbye.
For more information about the safe and wise use of medicines, visit the NPS MedicineWise website at nps.org.au.