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The first novel nicotine delivery device has gained a medicinal licence, but what place do these products have in public health and community pharmacy?

The popularity of electronic cigarettes has surged in recent years with the UK market now estimated to be worth around £200m. A YouGov survey for Action on Smoking and Health (ASH) released in April this year revealed that usage of electronic cigarettes among adults in Britain has tripled over the past two years from an estimated 700,000 users in 2012 to 2.1m in 2014.

Also known as vapourisers or electronic nicotine delivery systems (ENDS), e-cigarettes are battery-operated devices, which heat and vaporize a nicotine solution, known as 'e-liquid'. Using them is known as 'vaping'.

First developed over 10 years ago, e-cigarettes today vary widely in appearance and nicotine delivery, with those known as 'cigalikes' designed to look like regular cigarettes, while others bear little resemblance to their tobacco-containing forerunners. Some are disposable while newer, rechargeable varieties contain replaceable pre-filled cartridges or refillable tanks.

Less harmful than smoking

E-cigarettes are marketed as less harmful alternatives to smoking, and the current evidence, although limited, suggests that this is the case. In fact, a recent analysis of the constituents of e-cigarette vapour, published in the journal Addiction, found that popular e-cigarette brands are at least 20 times safer than tobacco cigarettes in terms of long-term health risks. Furthermore, the vapour, which consists mainly of water and propylene glycol/ glycerine, is considered unlikely to cause an acute adverse reaction in the user or pose a risk to bystanders.

Nevertheless, with nearly 500 products on the market, there is a wide variation in safety and quality, and cases of accidental poisoning, although rare, have been reported. In a recent report, the World Health Organization (WHO) pointed out that most ENDS have not been tested by independent scientists, while chronic inhalation of nicotine vapour could still cause adverse health effects.

Professor Robert West from University College London's department of epidemiology & public health, who is conducting ongoing research into the benefits and risks of ENDS, concedes that €it is not clear whether long-term use of e-cigarettes carries health risks€, but believes that €from what is known about the contents of the vapour, [the risks] will be much less than from smoking€.

Smoking cessation aids

While e-cigarettes are currently regulated as consumer rather than medicinal products, there is growing evidence to support their potential role in harm reduction and smoking cessation. Over half of current and ex-smokers in the ASH study reported having tried electronic cigarettes, with nearly two-thirds of users made up of current smokers and one-third consisting of ex-smokers. The majority of former smokers had used e-cigarettes to help 'keep off tobacco' or 'stop smoking entirely', while many current smokers were turning to the devices as an aid to cutting down or quitting.

The ongoing Smoking Toolkit Study led by Professor West has shown that ENDS have now overtaken NRT as the quitting aid of choice in England. While the growth in e-cigarette prevalence has coincided with a small increase in the rate at which smokers are making quit attempts, other factors may be involved.

These findings were backed up by a large UCL survey of smokers published in Addiction in May. This found that people attempting to quit smoking without professional help are approximately 60 per cent more likely to succeed if they use e-cigarettes rather than willpower alone or OTC NRT products.

€E-cigarettes could substantially improve public health because of their widespread appeal and the huge health gains associated with stopping smoking,€ concludes Professor West. €However we should also recognise that the strongest evidence remains for use of the NHS stop smoking services.€

Rob Darracott, chief executive of Pharmacy Voice, says that while €there is lots of anecdotal evidence that electronic cigarettes can help people cut down or quit, we don't yet know where they fit on the continuum from cold turkey through to a NHS stop smoking service, which is still the gold standard in helping people to quit€.

While the benefits of electronic cigarettes as smoking cessation aids remain unconfirmed, many experts believe that these devices could help improve public health by promoting harm reduction. In its guidance on a harm reduction approach to smoking, the National Institute for Health and Care Excellence (NICE) supports the use of licensed nicotine-containing products (NCPs) €to help smokers cut down for temporary abstinence and as a substitute for smoking, possibly indefinitely€. Although NICE does not recommend unlicensed NCPs, the guidance is clear that using an electronic cigarette is safer than smoking.

Regulation

The rapid growth of the e-cigarette market, coupled with the increasing involvement of the tobacco industry and the variation in safety and nicotine levels between products, has prompted calls for greater regulation and standardisation of products.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced its plans to license e-cigarettes as smoking cessation aids back in June 2013, but has been slow to implement the regulatory processes.

Meanwhile, the European Commission has amended the EU Tobacco Products Directive (TPD) to include legislation to regulate e-cigarettes containing a certain level of nicotine as medicines alongside other nicotine-containing products. Once the TPD comes into effect in May 2016, e-cigarettes will be regulated either as licensed medicinal products if they are marketed as a quit aid, or alternatively as consumer products. In the latter case, they must adhere to certain quality and safety standards, have a maximum nicotine strength of 20mg/ml and will be subject to the same advertising restrictions as tobacco products.

Some experts, including Professor Peter Hajek, director of the tobacco dependence research unit at Barts and The London School of Medicine and Dentistry, Queen Mary, have expressed concern that regulation will reduce the public health potential of e-cigarettes by limiting their availability. However both ASH and pharmacy's representative bodies are in favour of medical regulation of high strength products.

As yet, just one novel nicotine delivery system has secured a medicines licence. Not strictly an electronic cigarette, Voke uses non-electronic, miniaturised breath-operated valve technology to deliver nicotine without heat or combustion. Developed by Kind Consumer, the device will be exclusively distributed by Nicoventures, a wholly owned subsidiary of British American Tobacco.

Place in pharmacy

Despite the fact that ENDS currently remain regulated solely as consumer products, and Voke has yet to come onto the market, the sale of electronic cigarettes through community pharmacies is becoming increasingly prevalent.

The Royal Pharmaceutical Society still advises pharmacies against the sale of these devices so long as they are not licensed medicines, but some pharmacists, including Graham Phillips, owner of Manor Pharmacy Group in Hertfordshire, are adamant that pharmacies should not miss out on the business and public health opportunities presented by e-cigarettes because of the slow response of regulatory bodies.

€I want pharmacy to be the 'go to' place for quitting, so while I'm 100 per cent in favour of licensing e-cigs, I believe that if we wait for the licences we will have missed the boat. We won't just lose the sales, we will lose the opportunity to help people make healthy choices while they are still apparently well,€ he says.

However, RPS English Pharmacy Board member and MPharm lecturer at the University of Birmingham, Dr Anthony Cox, argues that while e-cigarettes may soon have a place in smoking cessation services, supplying them before they are licensed as such is purely €commercially driven€.

€Pharmacy should be associated with healthcare and some of these products are entirely inappropriate for pharmacies,€ he says. €We should be in the business of selling licensed products, which have an evidence base for their effectiveness and safety. Why should we lower the bar for electronic cigarettes?€

Rob Darracott acknowledges that the choice is not quite so clear-cut because, unlike unlicensed medicines, electronic cigarettes are already available on the mass market.

While Pharmacy Voice cannot advise pharmacists on whether or not the sale of these products is appropriate, he recognises that, €if someone is interested in buying the product they could also be interested in having a conversation about stopping smoking€ and urges those considering supplying ENDS to do some research and look at how they could fit into their existing services.

€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.€

Tobacco industry involvement

Concerns have been expressed about the growing association between electronic cigarettes and the tobacco industry, with some questioning the appropriateness of a licensed aid to smoking cessation distributed by a tobacco company. While initially slow to recognise the potential of these products, tobacco companies have since been acquiring e-cigarette manufacturers, with all large tobacco multinationals now active in the sector.

In its report on e-cigarettes, the WHO suspects that the tobacco industry's involvement is driven by an interest in €maintaining the status quo in favour of cigarettes for as long as possible, while simultaneously providing a longer-term source of profit should the cigarette model prove unsustainable€.

Despite these concerns, other experts argue that the association is of minor importance as long as e-cigarettes lead to a reduction in smoking. €The same arguments could be made in relation to the food industry and the obesity and diabetes epidemics,€ points out Graham Phillips, €but we are not going to stop shopping at Tesco and Sainsbury's because you can buy healthy options there too.€

Protecting young people

Another concern is that the growing popularity of ENDS could undo the progress of the smoke-free legislation by 're-normalising' smoking behaviour and/or acting as a gateway to smoking for children and young people. However, current evidence suggests that usage among non-smokers, including youngsters, is very low. According to the ASH YouGov survey, only a tiny proportion (0.1 per cent) of vapers are non-smokers and just 1 per cent of 'never smokers' have experimented with electronic cigarettes.

In addition, ASH research analysed by Public Health England in September found that while there has been an increase in electronic cigarette usage among adolescents between 2013 and 2014, only 1.8 per cent of children are regular users, the majority of whom are already smokers or ex-smokers. Encouragingly, 98 per cent of children who have never smoked have never tried an e-cigarette, although 80 per cent of children are aware of these products.

There is currently no legal age restriction on the sale of ecigarettes but the majority of these products carry a voluntary age warning advising that they should not be sold to under-18s, while the Children and Families Act 2014 has created a provision to raise the age of sale for e-cigarettes to 18 years.

Despite low use among youngsters, some e-cig advertising has been criticised as being attractive to young people. Currently, ENDS are heavily marketed by online advertising, social media, sports sponsorship and celebrity endorsements. In addition, e-cigarettes often come in brightly coloured packaging and are available in a wide variety of flavours.

Advertising will be restricted from 2016 when the TPD comes into force. In the meantime, a UK public consultation launched by the Committees of Advertising Practice in February has made several proposals including a ban on advertisements appealing to under-18s or showing anyone under 25 years using the products. Chief executive of ASH, Deborah Arnott, says that while it supports stricter advertising controls and a sale age of 18 years, €our survey results should reassure the public that e-cigarettes are not currently widely used by young people, nor are they interested in taking them up€.

Smoke-free legislation

Concerns that ENDS will re-normalise smoking behaviour and undermine the core messages of tobacco control have led WHO to call for a ban on their use in public spaces. Currently, electronic cigarettes are not regulated under smoke-free laws in the UK and users are free to use them in most public places.

ASH has spoken out against bringing e-cigarettes under smokefree legislation on the basis that there is no evidence of any harm to bystanders from e-cigarette vapour, while Rob Darracott says that he feels €sympathetic to users who don't want to end up outside on the street with the smokers whom they are trying to avoid€. In a YouGov Poll commissioned by the Sunday Times, 60 per cent of Britons said they would support a ban in public spaces.

The e-cigarette phenomena has placed pharmacists on the horns of a complex professional and commercial dilemma. There are no signs that the debate will quieten any time soon.

For

€While I'm 100 per cent in favour of licensing e-cigs, I believe that if we wait for the licences we will have missed the boat.€ Graham Phillips, owner of Manor Pharmacy Group in Hertfordshire

Against

€We should be in the business of selling licensed products, which have an evidence base for their effectiveness and safety. Why should we lower the bar for electronic cigarettes?€ Dr Anthony Cox, RPS English Pharmacy Board member and MPharm lecturer at the University of Birmingham

Up to you

€We believe pharmacists should be free to exercise their clinical judgment [on whether to supply ecigarettes] as they would normally do in the exercise of their professional practice.€ Rob Darracott, chief executive of Pharmacy Voice