The Pharmacist brings e-cigarette sceptics and optimists for a lively debate about the future of the devices and to decide whether they are here to stay in pharmacy. The round table looks at the role e-cigarettes can play in smoking cessation, issues surrounding marketing strategies, regulation going forward and instead of helping people stop smoking, it encourages the habit in those who wouldn’t otherwise.
LN: According to Ash data, there are 2.1 million e-cigarette users in the UK as of April 2014.
The e-cigarette industry was given a massive boost following the airing of the first UK TV adverts featuring members of the public vaping but it has also had to contend with the devices being linked to at least 100 fires in the past two years, including one death, not to mention what is most probably its biggest barrier of all – regulation.
So what does this all mean for the backing of e-cigarettes from healthcare professionals? This confusing and complex web of good news and bad news means health professionals are reluctant to recommend the use of e-cigarettes to their patients as a way of giving up smoking completely, cutting down on the number of cigarettes they smoke, or as a safer alternative to tobacco.
The question I want to put to you all is: “E-cigarettes, friend or foe?” What is the RPS’ position, Ash?
AS: As the market is currently unregulated, it is inappropriate for pharmacists – if they feel in any way compromised – to make the sale of e-cigarettes. However, our statement says if people are using them, pharmacists should support them as an aid to quit smoking, advising them to move towards a regulated product because of the guaranteed quality. That’s the position we took and is the position we still hold.
As far as we’re concerned, as soon as there is a regulated product, we will completely support the use of e-cigarettes as an alternative form of helping people to quit smoking, because there is absolutely no doubt about the potential value they have.
It is just a question of having something you have confidence in from a professional point of view, that will meet a consistent standard and will meet the needs of the public.
PH: There are going to be two levels of regulation following the implementation of the public directive. We already have the scope for medicines regulation but there will also be the option of Tobacco Product Directive (TPD) regulated. Would TPD regulated products be sufficient?
AS: No, devices will have to be MHRA regulated.
MR: Just to add to Ash’s point there, to able to make a medical claim that says that you are a product that helps smoking cessation, you need to have an MHRA licence and you need to be a licensed medicine. That’s just a very simple thing. So I don’t think any e-cigarette should be allowed to make a claim that they help patients to stop smoking without having gone through an appropriate regulatory process.
LN: Isn’t the point that e-cigarettes could be used as an alternative to smoking and not necessarily wholly just in smoking cessation?
MR: That’s fine. I’ve no objection to e-cigarettes being out there and people selecting them for whatever reason they choose. But if you’re a pharmacist and you want to recommend an e-cigarette for a medicinal purpose then you should be able to select an e-cigarette that has an appropriate medicinal license.
MD: We have a situation where our initial success in the Advertising Standards Authority regulation of these products was to stop manufacturers making claims about e-cigarette effectiveness in smoking cessation or in the products being less harmful than smoking.
The two things we know about e-cigarettes is that: one, they’re a great deal less harmful than smoking and the second is they appear to be effective in helping smokers stop. So we have these very good rules, which are stopping manufacturers from making true claims.
MR: If they are true claims then they can get a license?
MD: No, not quite. The claim is true first and then you get licensed, right? So if you have the evidence of effectiveness for that product and you go through the whole license regulation framework then you get a license. That’s not the same as whether this class of products appear to be effective in smoking cessation, and I have to say the evidence is fairly impressive in that they do appear to be at least as successful as nicotine replacement therapy, and that they deliver higher levels of nicotine than nicotine replacement therapy.
MR: This to me really is just a general principle, and I’m actually fighting this principle on a number of fronts. If you’re going to make a medicinal claim you should be a medicine, you should be regulated by the MHRA, you should provide your evidence, and your manufacturing should be inspected and supervised by the MHRA, so when any patient uses one of those medicines they should be reassured they have the quality behind it.
MD: It’s a very good principle, which Public Health England completely supports. I’m pointing out the unintended consequence that it stops people making evidence-based assertions.
There are a small number of pharmaceutical companies who specialise in e-cigarettes that have been taken over by the tobacco industry – these will get through MHRA regulation in time. But for the small independent providers whose products appear to be just as good, it seems less certain.
LN: Is the regulatory question mark holding up the reach of e-cigarettes?
PH: To some degree it is but without any regulatory drive, products have evolved massively over the past two to three years. The evolution of our devices have taken place over two years, we’ve gone from a disposable to a vaporiser. If you had to go through a regulatory process for all of that, it might’ve taken 20 years.
Certainly, we would have to consider taking some of our products through MHRA regulation, depending on the rules. But the TPD is a good step in the right direction. The only concern I have with the TPD, at the moment, is the upper limit of the 20mg per millilitre.That potentially excludes people who could get the greatest benefit from this product, those who are using roll your own tobacco and who have traditionally wanted extra nicotine.
If they’re limited at 20 as the upper threshold, those people might not be able to get the craving reduction they need.
AS: I feel it is important to qualify that the RPS has not at any point said pharmacies should stop selling e-cigarettes. We’ve said there is a need to have a regulated product, ideally, but it must be a professional decision by a pharmacist, within the pharmacy setting, to make the decision as to whether they stock the devices.
When we spoke to a number of companies, we were told the best one out there was the one that Boots stocked; the one that Lloyds stocked; or the one that Numark stocked – and they were all different. I’m an independent pharmacist; I have no mechanism to test which one of the three really is the best. Why is it that there isn’t an agreement between the major retailers where they stock them all because they’re all just as effective?
I have been very clear that if somebody is using e-cigarettes and asks for the support and advice of a pharmacist, I would expect that pharmacist to support and help them. Advise they are not regulated, that they may not be a consistent dose and try and move them onto a regulated product, but do not say: “Don’t use it.”
PH: A lot of your members believe you’ve said pharmacists shouldn’t support people using nicotine e-cigarettes.
JDA: It is Ash, that’s exactly the impression everybody has.
AS: We’ve been out and twice repeated that the message isn’t that. There is a place for these products, the only issue I have is regulation and that I have confidence in what I’m supplying. I have taken a personal decision that my pharmacy doesn’t stock e-cigarettes, but I also tell my pharmacists and my staff who provide smoking cessation support that if somebody comes in using e-cigarettes to support them and not to turn around and say “just because you’re using e-cigarettes go away”. It’s actually the reverse, it’s about saying “how do we help you as part of that? If that’s where you’re going and it helps you to quit smoking that’s great.”
SH: Having been King Canute with this particular subject for many years and saying: “no, no, never ever on my watch will this happen”, over a period of time, and I think colleagues of mine have come to the same position – admittedly some later than others – that I felt pharmacy had something to say on this subject and a place to play.
It was a very difficult decision and involved several months of debate, but we got to a position where we looked at whether we could stock e-cigarettes as a useful harm reduction strategy within a total smoking category within Lloyds pharmacies. We decided this would give pharmacy an opportunity to engage with patients and consumers about the relative merits of these unlicensed products in harm reduction if they were not yet ready to make a quit attempt. If they were ready to make a quit attempt then we could easily move them into a licensed NRT product.
In stocking e-cigarette device, we made sure we carried out due diligence. We audited the factory where they were made in the Far East and we have lots of data about not only what goes in e-cigarettes but also what comes out the other end, because that’s equally important.
Our whole smoking category has grown, but e-cigarettes are only a very small part of it. Licensed NRT products have grown substantially more, which tends to suggest, and we know this through audit, that those conversations are definitely happening.
I felt it better pharmacists were at least able to engage customers in a debate on e-cigarettes, rather than they buy the products from eBay, a garage forecourt or a car boot sale of variable and dubious quality.
DS: The discussion so far has revolved around the use of e-cigarettes by smokers, and it’s also revolved around patients getting their advice from pharmacists, but that’s not necessarily the real world.
We’re seeing e-cigarettes sold in retailers and your local corner shop with the devices positioned next to candy bars.
We see that as irresponsible and we’re quite concerned about the growing youth appeal of e-cigarettes, particularly to non-smokers.
US data shows between 2011 and 2013, the number of young people aged 6-12 that tried e-cigarettes doubled from about 3.3 per cent to 6.8 per cent.
E-cigarettes, while in the safety of a pharmacy as a smoking cessation aid is something we would support, we are concerned about their growing appeal to non-smokers and the presentation of them as a lifestyle choice and something that’s cool and sexy.
MR: There are e-cigarette shops popping up all over the place, which are veritable Aladdin’s caves and are fast becoming a magnet for young people.
MD: UK data shows e-cigarette use among young people that have never smoked is extremely rare, even experimentation is quite rare – I think it was four per cent who’d ever even tried using the products.
Sustained use of e-cigarettes is overwhelmingly among established smokers. So what we’re seeing is young people who have already started smoking cigarettes trying these products.
MR: But public health professionals have demonstrated some pushback on that data, claiming what they were seeing wasn’t matching up to the figures that were being presented by Public Health England.
MD: I know of a chain of vape shops that are having all staff trained as level one stop smoking advisors because they want to give the best standard of help to their customers in quitting smoking.
JDA: Mark and Steve’s teams have got to provide returns to their clinical commissioning groups on the number of patients who are successful quitters at four weeks and at 12 weeks. If the vaping shops do exactly the same thing; fantastic.
DS: I don’t know the evidence base in terms of whether or not e-cigarettes encourage people to stop smoking –but there are a lot of people who still use dual usage – is it still too early in an e-cigarette’s life to actually say that it stops people smoking?
MD: A third of e-cigarette users – 700,000 – have completely stopped smoking tobacco. Of the remainder, about half are trying to stop smoking. The other half say they have no intention to stop smoking.
NM: Regulation should come into this market to reduce the concerns of e-cigarettes being sold to under-18s. We are clear these products are intended for adult smokers only, that is why all Nicocigs packaging holds over- 18 stickers. We’ve been selling our product in Tesco, Asda and Morrisons Pharmacy for some time and we’ve always given support/training to make sure products are not sold to under- 18s.
LN: Do you think there is a place for bubblegum and strawberry flavours in e-cigarettes?
NM: We acknowledge this is a valid concern, which is why we do not market flavours that could be seen as being exclusively attractive to minors. Certain flavours, which can be seen as attracting children to e-cigarettes, should be removed and manufacturers need to be more responsible. However, our adult customers tell us that flavours are important to them. We have in some cases; found those who do like the various flavours are using them because it makes it more difficult for them to go back to the traditional flavouring of tobacco cigarettes.
JDA: If we listen to the story of e-cigarettes in terms of using them as a harm reduction strategy, what we’re hearing is actually very compelling evidence in favour of helping people quit smoking and switching over.
There’s a bit of a debate around whether it attracts the young, but the evidence I’ve seen – and I’m no expert on this – seems to suggest there isn’t much evidence for it.
On balance you’d say that in terms of harm reduction, friend or foe, they have to be friend.
MR: I’m very impressed with Steve’s comment about the way he looked at the products. It gives me a lot of confidence.
SH: It’s the only way I can sleep.
MR: Which I think is a very professional way of handling it. I commend you. It’s very good and I’m very impressed. At least it means while there isn’t regulation, at least someone has looked into the quality and the data behind the devices – I think that’s the bit that we need to do to give people confidence.
LN: Some of you have expressed disappointment that people don’t have all the information they need to be able to make an appropriate decision on e-cigarettes. Does that come down to education from pharmacists and the advice they give to patients, highlighting the need for them to be educated about e-cigarettes, completely and appropriately, to pass on that message?
MR: I appreciate there are some manufacturers in this marketplace trying their best to do the right thing, and there are pharmacists in this marketplace that are trying to make a professional assessment.
If a patient knew which ones would be safe and appropriate for them then I think there’s a way that they can make reasonable decisions on the way they run their life.
MD: I agree absolutely wholeheartedly that smokers and vapours have a right to products, which they know are safe and effective. Part of that deal is that we have to be able to tell them these products are safe and effective or how can they know that?
SH: I think two things – public education is clearly important, but there’s also education of the profession and appropriate positioning within the pharmacy. The approach that we, and others, have taken is as responsible as it can be given the vagaries around regulation.
I do think there is a real gap in public knowledge about how all things are not created equal. There are some very responsible manufacturers out there who are doing their level best to ensure the quality, integrity and safety of their products. There are others who clearly are not and are in it for the very short-term.
PH: Pharmacists and consumers should be able to see an ingredient declaration on all of these products. Ideally, if it was a food product in a major retailer it would have a full traceability record, so if there was a consumer complaint we could get right back to the source of the problem and nip it in the bud.
We already declare our ingredients. Every product has a batch code on the side and at the back of all our brochures there is an ingredient declaration telling you what the USP additives are, and the food grade additives.
JDA: Where is the due diligence? If a pharmacist decides to stock e-cigarettes – as a lot do – where are they getting them from?
A pharmacist needs to be ready to answer when a patient asks “where did you get that? What do you know about the company who makes that?” If you bought it from some swag guy who walked in, that’s not really going to put you in a good position when something goes wrong.
On the other hand, if you’ve done research, you’ve had meetings and you can point to some kind of audit trail and some kind of pedigree, you’re on the way. The big companies will do this and big companies follow these kinds of procedures because they want longevity in the marketplace, you want to protect your reputation and you want repeat business. So are you dealing with somebody who’s in that zone or somebody who’s a fly-by-night trying to make a quick buck?
LN: So do you think there should be interim standardised guidance on choosing an e-cigarette manufacturer?
JDA: I think there should be. It is quite an easy view to say that as e-cigarettes are not licensed, we won’t get involved in it. In terms of educational material for pharmacists on e-cigarettes, I’m still a bit on the fence about it because some want it and some not.
What this is actually about, and this is when I think a debate like this is useful, is whether we are we accepting e-cigarettes as mainstream or are we not?
NM: We’ve been working with Morrison’s to give them confidence and understanding of the product, as well as the current do’s and don’ts that we have because we see ourselves as a responsible manufacturer.
We are trying, as part of this industry, to give as much information to the public, be it through consumer leaflets, be it through our pharmacy guides that we give to the pharmacies that we approach, and all the certificates we can’t show to the public, we do show to the superintendents.
MR: If we’re saying the MHRA process it too laborious and too expensive, then they need to change because we need some regulation in this area so that we have confidence. We can’t all go through the process that Steve’s been through of visiting factories because we should have a regulatory body that will do that for us.
NM: We continue to monitor closely existing consumer products regulations, the upcoming Tobacco Products Directive (which include e-cigarettes for the first time) and the voluntary medicinal licensing scheme, across both our Nicolites and Vivid brands. In particular we continue to engage with the MHRA.
AS: It staggers me the MHRA have made this so difficult given that there is such a need to do something now. It strikes me as being really poor given the fact that it would make this a much more accepted product in helping people to cease smoking than it currently is.
DS: I’d like to see the regulation or confidence in this process brought forward so we quickly get some view on who the good guys are and where the quality products in this marketplace are.