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The smoking gun?

Clinical The jury's still out on e-cigarettes: are they a useful addition to the NRT arsenal or just another habit to kick?

The MHRA's plans to license all electronic cigarettes by 2016 presents pharmacists with a challenging dilemma. The medicines watchdog's finding that none of the devices already on the market that it has tested would meet licensing requirements only adds to the controversy surrounding their safety. So is it time for pharmacists to clear their shelves of unlicensed e-cigarettes or are they as important as ever in the push to get smokers to quit?

The arguments

In the blue corner, the MHRA says there is UK consensus that we should work to ensure that the EU Tobacco Products Directive, likely to be in force in 2016, should bring e-cigarettes – indeed, all nicotine-containing products – into medicines regulation across the continent.

Europe can be unpredictable, so the MHRA's announcement – though strongly supported by the British Medical Association (BMA) and Royal Pharmaceutical Society (RPS) – may not prove an infallible guide to what will happen in practice. The MHRA has, however, decided that it will regulate e-cigarettes as medicines in the UK and has called on manufacturers with unlicensed products currently on sale to apply for a licence by 2016.  

The RPS has issued guidance suggesting sales by pharmacies may not be compatible with GPhC standards because customers may get the wrong impression that e-cigarettes are medicinal products. The Pharmaceutical Society of Northern Ireland (PSNI) went even further by "strongly" recommending pharmacists consider withdrawing e-cigarettes from sale.

However, in the red corner, the Electronic Cigarette Industry Trade Association (ECITA) says its members will refuse to apply for licences because regulators will insist on changes to their products that will make them less appealing to consumers. The result, the ECITA says, could be a public health disaster, as e-cigarette users return to smoking tobacco or use black market e-cigarettes.

The wild card in the e-cigarette pack is Nice, which earlier this month issued guidance saying licensed nicotine-replacement therapy (NRT) should be recommended and that, while unlicensed NRT products such as e-cigarettes may be an unknown quantity, the public could be told that they are likely to be less harmful than tobacco.

The implications

The row has important implications for public health. On one side, e-cigarettes are still a relatively new product and there are understandable concerns about the as-yet undefined and unpredictable long-term effects of regularly inhaling e-cigarette contents, including the mist-making material propylene glycol.

There are also the well-known effects of nicotine, including anxiety and mood changes, and some say there is evidence that it contributes to circulatory disease.

There are fears, too, that widespread use of e-cigarettes could lead to greater tobacco dependence and even to a new generation of young people becoming nicotine-addicted – though it is worth noting that recent research by the anti-smoking organisation Ash shows limited regular e-cigarette use by young people.

However, on the other side, e-cigarettes are used by large numbers of people, with ASH estimating their numbers at 1.3 million. E-cigarette defenders add that, as both electronic and chemical devices, they are regulated by a string of EU directives that enforce a variety of measures relating to purity and safety.

Whether you are for or against e-cigarettes, the variation in nicotine doses individuals receive from today's devices means it is difficult to see how they could be used to reliably taper from a high dose to medium and then low doses in the same way as traditional NRT products.

E-cigarettes are therefore a harm-reduction option, rather than a traditional NRT-style product aimed at weaning individuals off nicotine forever.

Pharmacists' choice

With e-cigarettes on sale all around them, pharmacies are faced with a difficult choice. One option is to follow the RPS/PSNI advice and refuse to stock unlicensed e-cigarettes. Another option would be to sell e-cigarettes in the open shop in the same way as tobacconists, supermarkets and garages – but that would conflict with many pharmacists' sense of professional obligation.

Several Northern Ireland pharmacists contacted by C+D said they had withdrawn e-cigarettes from sale following PSNI's advice, while others claimed to have taken them off their shelves months ago.

Pharmacies in England also suggested they were taking a cautious approach. Rakesh Patel, pharmacy manager at Mr Pickford's Pharmacy, Leicester, suggests only selling e-cigarettes to certain customers.

For a long time he would not have anything to do with e-cigarettes. However, Mr Patel has changed his mind in the past year.

"Now we do stock one line and sell it only to adults over 18 who are smokers and who are trying to reduce their smoking," he says.

"I've noticed customers don't just use the e-cigarettes as an alternative," he told C+D. "They are actually trying to reduce their use of nicotine – so it seems to work for older people in that way."

Mr Patel adds that sales of e-cigarettes can lead to an opportunity for a conversation about smoking cessation and a possible referral to a smoking-cessation service.

The mixed reaction from pharmacists and representatives suggests there needs to be more clarity on the safety of e-cigarettes prior to regulation in 2016.

Without consistent guidance, not only will the sale of e-cigarettes remain patchy as pharmacists make their own decisions about their worth, but the current drive toward a harm-reduction approach to help smokers quit could be stubbed out before it has ignited.

The story of the e-cigarette

The first e-cigarette was patented in 1963 by an American, Herbert E Gilbert, who patented a cigarette-shaped device containing a tiny battery-powered heater that vapourised a flavoured nicotine-bearing liquid.

Mr Gilbert's device passed into obscurity sometime in the late 1960s and the modern e-cigarette was invented by Chinese pharmacist Hon Lik. It delivered a nicotine-containing vapour that could be inhaled much like cigarette smoke.

Hon Lik's device uses a small lithium battery to power a vibrating piezoelectric element at ultrasonic frequencies: a mix of propylene glycol and nicotine is vapourised by this vibration, producing a mist that looks and behaves very much like smoke.

Hon Lik patented the device in 2003, and his employers introduced it onto the Chinese market in 2004 – it then spread to the rest of the world.

The latest evidence on e-cigarettes

Nice says in guidance issued this month that there is no evidence on the long-term safety of e-cigarettes, whether they are used alone or alongside cigarette smoking. It says there are no firm cases of harm that are directly attributable to e-cigarette use.

However, last year a University of Athens study of 32 people suggested that e-cigarettes could be harmful to the lungs, finding that there was an immediate airway resistance among non-smokers and smokers with normal spirometry.

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