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All fired up

All fired up

Experts are divided – and pretty heated in their opinions – on the pros and cons of electronic cigarettes. So where should pharmacies stand when it comes to these increasingly popular products? 

The growing popularity of electronic cigarettes (e-cigarettes) has led to a heated debate as to their use and usefulness. Those on one side of the argument welcome them as a weapon in the battle against smoking, while others worry that they will ‘renormalise’ smoking and introduce non-smokers to nicotine. Those in favour argue that e-cigarettes have a positive role to play in reducing smoking rates. I

ndeed, December 2014 brought news that a new, highly respected, Cochrane Review of research had found evidence that smokers who use e-cigarettes can quit or reduce their habit. The review, which drew on two randomised trials, found that about nine per cent of smokers who had used e-cigarettes were able to stop smoking for up to one year, compared with about four per cent of smokers who used nicotine-free, placebo e-cigarettes.

Among smokers who had not quit, researchers found that 36 per cent of e-cigarette users reduced their consumption of tobacco cigarettes by half. This compared with 28 per cent of users who were given placebos.

The review authors added that the results needed to be expanded on by other studies, however. Deborah Arnott, chief executive of public health charity ASH believes that this ‘timely’ review indicates that these products have a role to play in helping smokers to quit. “It should stimulate more research,” she says, “which is just what is needed in this important area of public health, which has the potential to save so many lives.”

A useful role?

Also known as electronic nicotine delivery systems (ENDS), e-cigarettes are battery-powered nicotine delivery devices. The evidence that they can help smokers to quit their habit is, believes Robert West, Professor of Psychology at University College London and author of The SmokeFree Formula (published by Orion), ‘quite strong’.

“Our [recent] study of smokers in England suggests that they have been increasing the chances of stopping by about 50 per cent compared with stopping unaided,” he says. “It looks as if they are probably less effective than using the NHS stop smoking services, although we don’t have a direct comparison, but they are obviously a lot more popular.”

Professor West believes that e-cigarettes could substantially improve public health not only because of their widespread appeal, but also because of the huge health gains associated with stopping smoking. Smoking is the leading cause of preventable death in Great Britain. According to figures from the Office for National Statistics (ONS), in 2009, smoking caused nearly 80,000 deaths in England alone. Estimates from the Scottish and Welsh governments, says ONS, suggest that smoking is responsible for around 13,500 deaths per year in Scotland and 5,500 in Wales.

Or a gateway to harm?

Although using an e-cigarette may be better for health than smoking a normal cigarette, there are those who remain cautious about them. One major concern, for instance, is that e-cigarettes could provide a ‘gateway’ to smoking for non-smokers. Professor Peter Hajek, director of the Tobacco Dependence Research Unit at the Wolfson Institute of Preventive Medicine, Queen Mary University of London, says that there has been no sign, as yet, that this is happening.

“Young people who experiment with vaping [the term for using e-cigarettes] do not progress to regular use, unlike young people who experiment with conventional cigarettes, who do,” he says. “In fact, nonsmokers who become regular vapers are extremely rare.”

Professor West also reasons against this concern, pointing out that smoking prevalence is coming down as fast as ever among adults as well as young people. “The rate at which smokers are stopping was higher in 2014 than at any time since 2007 – when we started to track it monthly,” he says. Research conducted by the ONS and released in November 2014 was welcomed by many as it suggests that e-cigarettes are almost exclusively used by smokers and ex-smokers. 

The Adult Smoking Habits in Great Britain research found that almost no e-cigarette users had never previously smoked cigarettes. On the contrary, it found that e-cigarettes are used mainly as smoking cessation aids and for their perceived health benefits compared with smoking tobacco. More than half of e-cigarette users said that their main reason for using e-cigarettes was to stop smoking.

However, Dr John Middleton, vice president for policy at the Faculty of Public Health (FPH), remains cautious. “There will only be evidence of a ‘gateway effect’ if it happens, by which time it would be too late to prevent it,” he says. “The ONS data may be encouraging, but there are too many ‘known unknowns’ about the long-term effects of e-cigarettes for the FPH to fundamentally change its position on them at the moment.”

Explaining the FPH’s position, Dr Middleton adds: “It’s too early to know if the reduction in harm  from using e-cigarettes instead of smoking is greater than their potential risks. We don’t want to undermine efforts to help people quit smoking. What we really need is for electronic cigarettes to be subject to the same controls as tobacco, and e-cigarettes to be treated as a tobacco product, so they cannot be marketed or advertised.”

Dr Anthony Cox, lecturer in clinical pharmacy at the University of Birmingham and RPS English Pharmacy Board member, believes it is difficult to say for sure whether or not e-cigarettes could provide a gateway to smoking in the long run. “I don’t think that anyone can say hand on heart that this can’t or won’t happen,” he says. “We don’t want to be here in 20 years’ time saying ‘look, we have a real problem with nicotine addiction in this country’.”

Others in the ‘cautious’ camp point out that it is not yet certain what the long-term health effects of using e-cigarettes might be. On this point, Professor West says: “From the concentrations of toxins, the risk from long-term use is expected to be less than a twentieth that of cigarettes.” However, he adds: “It is extremely important to monitor this and ensure that rogue manufacturers do not let toxins get into their products.”

Professor Hajek points to the recent Cochrane review, which, he says, found no health concerns regarding e-cigarette use over the short- to mid-term – up to one and a half years. He concurs that use over longer periods of time may generate some health risks, but adds: “There is no doubt that switching from smoking to vaping reduces smoking-related risks dramatically.” Another argument – and one put forward by the FPH – is that if smokers use e-cigarettes in tandem with cigarettes, their health is still at risk from smoking cigarettes.

“For smokers who do not wish to or cannot otherwise quit, there may be health benefits to be realised by switching from smoking cigarettes to using e-cigarettes,” says Dr Middleton. “However, we have concerns that some people continue to smoke tobacco as well as using e-cigarettes. [In these cases] there may be benefits in terms of reducing their risk of lung cancer, but not heart disease.”

If we wait for the licenses to be granted before stocking the products, we will have missed the boat

What lies ahead?

Because the market for e-cigarettes has grown so rapidly and because there are so many products now available (there are nearly 500 different e-cigarettes), greater regulation has understandably been called for. In 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to license e-cigarettes as smoking cessation aids.

Professor Hajek predicts that within a year or two, it is likely that there will be at least one e-cigarette brand licensed by the MHRA. An MHRA spokesperson says: “Where electronic cigarettes make medicinal claims concerning smoking cessation and harm reduction, we continue to require regulation under medicines legislation as the correct route to marketing.

This ensures that these products, authorised as medicines, meet the appropriate standards of safety, quality and efficacy and as a result could be recommended under various NHS stop smoking schemes.” The European Tobacco Products Directive, meanwhile, will bring in alternative regulatory requirements for electronic cigarettes that do not make medicinal claims and contain less than 20mg/ml nicotine. The MHRA spokesperson explains: “By May 2016, e-cigarettes that do not make medicinal claims will be regulated under an alternative framework and the Department of Health is currently looking at how this will work.”

 

Pharmacy sales: for and against

For:

Graham Phillips, director and superintendent pharmacist at Manor Pharmacy Group in Hertfordshire, firmly believes that pharmacies should be stocking e-cigarettes. “I want pharmacy to be the ‘go-to’ place for quitting,” he says. “So while I’m 100 per cent in favour of licensing e-cigarettes, I believe that if we wait for the licenses to be granted before stocking the products, we will have missed the boat. Consumers will simply go elsewhere and we will have rendered ourselves irrelevant to their lives: we won’t just lose the sales, we will lose the opportunity to help people make healthy choices while they are still apparently well.”

Graham gave the pharmacists in his group the autonomy to choose whether or not to stock e-cigarettes, and all nine branches chose to stock them. “Having decided to stock them, we treat e-cigarettes identically to the way we treat any other NRT product and provide the same stop smoking advice with them as we would for a gum or a patch and so on,” he says. Feedback from customers has been ‘very positive’, he adds. In response to the argument that e-cigarettes may encourage new smokers, Graham says: “There is no evidence that this is the case – quite the reverse. It is simply another quitting option. I have spent my professional life crusading against smoking – the very last thing I would want to do is peddle something that encouraged new smokers.” And he adds: “As soon as they are licensed, we will only stock licensed e-cigarettes.”

Against:

Mike Hewitson, a pharmacy owner based in Dorset, won’t be swayed by the arguments in favour of e-cigarettes. “I’m not saying that I would prefer people to be smoking, but instead to give up their nicotine habit using an evidence-based method,” he says. “As far as I know, there is no evidence that people who use e-cigarettes get away from nicotine addiction… When we use NRT products as part of smoking cessation services, there is always a structured end point, with a gradual dose reduction and, hopefully – an end to smoking within 12 weeks. But with e-cigarettes, there is no structure or end-point, which is made worse because they so closely mimic the smoking habit.”

Mike worries that there are still lots of unknowns about e-cigarettes. “Nicotine is not completely risk free,” he says. “If you substitute one problem for another, you are not breaking the physical dependence on nicotine. Proponents of e-cigarettes always say that e-cigarettes are better than smoking, but I say they’re not better than people giving up. I don’t want someone to be reliant on perpetual intervention to keep them safe.” He says that even if licensed e-cigarettes emerge, he would not stock them. “The advice we give to our customers is that if you want to give up smoking, talk to a smoking cessation advisor. That way, you’re much more likely to give up. Whether it’s with support from a pharmacist or any trained adviser – you’re much more likely to quit if you have support.”

 

To stock, or not to stock

As to whether community pharmacies should stock e-cigarettes, this is another contentious issue. Dr Cox believes that e-cigarettes have ‘obvious advantages’ over normal cigarettes and are therefore of potentially great public health benefit. However, he also feels strongly that pharmacies should wait for e-cigarettes to be licensed before selling them. “Pharmacists are healthcare professionals and I feel they should be concerned with regulated medicinal products rather than recreational products,” he argues.

“We need licensed e-cigarettes. We don’t sell unlicensed headache tablets or any other unlicensed medicines, so why should it be different for e-cigarettes? If we don’t have a regulated product that has gone through licensing, how can we even know that it contains nicotine? There are also concerns being voiced about some of the flavourings contained in some e-cigarettes and whether these could potentially be dangerous when inhaled. These products, while safer than cigarettes, should be as safe as they can be and that requires regulation like every other medicine we sell.”

When licensed e-cigarettes do become available, Dr Cox hopes that pharmacies will offer them in smoking cessation services as one of the options available to people who are trying to quit smoking. Chief executive of Pharmacy Voice Rob Darracott says that while it is important that e-cigarettes are properly regulated to align with current nicotine replacement therapy (NRT) products, the choice as to whether to stock them is down to individual pharmacies.

“Pharmacists and community pharmacy teams play a key role in helping to reduce the considerable burden of harm that is associated with tobacco use,” he says. “So where a pharmacy owner decides to sell e-cigarettes, we believe pharmacists should be free to exercise their clinical judgment, as they would normally do in the exercise of their professional practice.”

Professor West isn’t against the idea of pharmacies selling e-cigarettes, but adds: “I think all pharmacies should do their best to get smokers to use the free NHS stop smoking service.” Dr Middleton agrees that it is for individual pharmacists to decide what products they sell. But, he says: “We believe that the evidence for the safety of e-cigarettes is unclear and would advise caution about their sale. The best advice a pharmacist can give to someone who wants to quit smoking is to use NHS cessation services. At the moment, the evidence shows that this is the most successful way for someone to quit.”

 

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