e-Cigarettes: should pharmacists be helping to turn smokers into “vapers”?

They are illegal in Australia and Thailand and most cannot be imported into Canada. Both the World Health Organization and the US Food and Drug Administration have voiced concerns about them.They have been banned from civic offices in Hanover, Germany. And, most recently, the British Medical Association announced that doctors should not recommend them. So should UK pharmacies sell electronic cigarettes?

Although the fact that e-cigarettes (see Panel) contain at least 4,000 fewer dangerous substances than tobacco cigarettes may make the answer to this question seem obvious, there are plenty of other issues to be considered before making up your mind.

What are e-cigarettes?

Electronic cigarettes are battery-powered devices that often look like cigarettes but do not contain tobacco. They contain an airflow sensor and a heating element. Some can be recharged via a USB port. Others are disposable.

On inhalation, a solution, often containing nicotine, is vaporised into a fine mist resembling cigarette smoke. The solution can also contain propylene glycol or glycerin and flavourings. The solution can be housed in a cartridge that is attached to the device or can be provided in a bottle and poured into the device. Cartridges can contain up to 16mg of nicotine.1

As the “vaper” inhales, an LED lights up at the end of the e-cigarette, mimicking burning tobacco.

The electronic cigarette was developed in China in 2004. Many are produced there.

Safety and risks

From the horror story of the Vietnam veteran in Florida, who lost teeth and half his tongue and suffered facial burns early this year when the battery of his e-cigarette exploded, to reports of trading standards officers raiding brands because they are not appropriately labelled or packaged for products that contain a poison, it is clear that e-cigarettes present a number of potential hazards.

Compounding this is the fact that so many brands exist. President of the Electronic Cigarette Industry Trade Association (ECITA) Katherine Devlin told The Salvadore that worldwide there are hundreds of e-cigarette companies, possibly even thousands by now. “They come and go, springing up all the time,” she said.

One Medicines and Healthcare products Regulatory Agency document states: “most [of these] nicotine delivery products are imported from the Far East and the conditions under which they are produced, their contents/ingredients, and consistency of delivery are unknown.”

Moreover, relatively little research has been done. An FDA analysis of two brands in 2009 found traces of several toxic chemicals (tobacco specific nitrosamines [TSNAs], tobacco specific impurities and diethylene glycol [DEG]) and inconsistent quality control processes, although later tests carried out by one of the manufacturers (NJOY) found no evidence of N-nitrosamines from its product.

In addition, ECITA asserts that “the FDA neglected to mention that the levels of TSNAs they found in their analysis were comparable to those found in licensed nicotine replacement therapy products, and are at very low levels which are not considered dangerous.”

The known excipients propylene glycol and glycerol are classified as “generally recognised as safe” by the FDA but it is worth noting that both are also considered by the FDA to be at “elevated risk of contamination with diethylene glycol and ethylene glycol [antifreeze]”. DEG, a solvent, is much cheaper than propylene glycol and glycerol so has been used for economically motivated adulteration of excipients (including those used in medicinal products), resulting in hundreds of deaths. Clearly quality control is vital.

Another fear raised is that cartridges or bottles of nicotine solution (which one factsheet claims could contain over 1,000mg of nicotine per 1oz bottle)2 could be fatal in the wrong hands — 40 to 60mg of nicotine can be a lethal dose for an adult human.3 On the other hand, authors of a paper in Addiction (2012;107:1545–8) say that the risk of accidental poisoning (eg, by accidental ingestion or spillage onto the skin) is no different from that for many household products. They also say that concern over repeated inhalation of propylene glycol is not borne out by toxicity studies.

Medical product or lifestyle accessory?

The issue with e-cigarettes is that they are a technology our legislation has failed to keep up with. At the moment, for example, there is no specification for the maximum nicotine these products can yield. Nor is it illegal to sell these products to children. E-cigarettes do not fall within the definition of “tobacco products” (which are covered in an EU Directive) and they are not currently classed as medicinal products, so they blur the distinction between “good” and “evil” sources of nicotine and are described as “nicotine-containing products”. Do some research and you will see that there is, in fact, a range of nicotine-containing products available, including lollipops, hand gels and water.

Whether these are general consumer or smoking cessation products is an important distinction, and an issue that was discussed by the European Commission in 2008. Right now, e-cigarettes fall under legislation such as the General Product Safety Regulations 2005 (hence past trading standards raids) and the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002. These regulations do not subject products in a general manner to safety assessment before they are placed on the market.

There is, however, work in progress to catch up with the technology. In 2010, the MHRA consulted on the regulation of nicotine-containing products. It says that responses from medical professional bodies, royal colleges, NHS bodies and trading standards suggested clear support for regulation by the agency.

Unsurprisingly, most e-cigarette companies and users were opposed to such regulation. Michael Ryan, co-director of E-Lites, told The Salvadore: “Although electronic cigarettes provide a potentially lifesaving harm reduction alternative to smoking, the cost and limitations of medicinal licensing would have a negative effect on [their] availability and desirability.” His advice to consumers is: “While there are many safe products sold by responsible vendors, only those which are part of ECITA [see Panel] have external oversight to ensure that all the appropriate certification is obtained, and that products are regularly tested.”

However, the MHRA says that “under the current legislation, some electronic cigarettes have been tested by local authority trading standards departments and found to pose a potential danger to consumers”. A spokesman said: “The Government is concerned to ensure that an effective regulatory framework exists to protect consumers from any electronic cigarette products that fail to meet acceptable standards for quality, safety and efficacy.”

What the trade body says

Katherine Devlin, president of the Electronic Cigarette Industry Trade Association, told The Journal that the association was put together in 2010 with a view specifically to sorting out the regulatory framework. “We have our own industry standards of excellence to ensure good manufacturing practice, good business practice and regular testing,” she said.

ECITA currently has 22 members in three EU territories (UK, France, Greece), which cover around 60 per cent of the market, Mrs Devlin said. “We give them the support to get to achieving legal compliance and our standard of excellence, and would expect them to conform within the first two months. But we’re not regulators,” she added.

“Trading standards officers, and other government enforcement agents are very happy with our auditing programme. Trading standards went so far as to describe it as ‘a code any industry would be proud to have’,” she claims.

The consultation also highlighted a need for further research. The MHRA told The Journal that a number of workstreams are in progress “to inform a decision on bringing nicotine-containing products into medicines regulation” and that it is discussing the commissioning of two research projects to help fill the knowledge gaps, in particular around the contents of the cartridges, the properties of the vapour they generate and whether these products are safe or effective. “Sound research evidence is required to determine the risk of continuing availability of these products,” its spokesman said. “The MHRA does not want to reduce the availability of products that help to reduce smoking but does want to ensure that smokers have access to products that are acceptably safe.

“There is data available on the effects of low doses of nicotine via a variety of delivery routes with corresponding behavioural, subjective and cardiovascular effects. The Commission on Human Medicines will be asked to advise on the minimum level of nicotine from e-cigarettes that has a pharmacological effect,” he added.

The argument hinges on whether or not e-cigarettes are used for a medicinal purpose — either smoking cessation or harm reduction. Harm reduction is an interesting issue. NRT products were originally licensed for smoking cessation but, following advice from the CHM, licensed use was extended to include harm reduction. The MHRA told The Journal: “A smoking harm reduction indication could define a product as medicinal. In practice, however, we would always expect medicines to support quitting as well as harm reduction.”

Some e-cigarette companies have implied, falsely, that the WHO views e-cigarettes as legitimate, like gum, lozenges and patches (which would class them as medicinal) although many UK companies appear to have been careful with their marketing materials. However, it does not just boil down to presentation — according to EC law, a product can also be medicinal by its function and it is clear, from online forums that people are using e-cigarettes to stop smoking.

Perception and other issues

The BMA and others have warned that e-cigarettes may undermine smoking prevention and cessation because their use is likely to reinforce the social acceptability of smoking. “Of particular concern is how these devices closely resemble cigarettes, in terms of appearance and nomenclature, as well as features such as flavouring and styling that are potentially highly attractive to children,” the BMA says. It also raises the issue of second-hand vapour since e-cigarettes are being used to circumvent the ban on smoking in public places. According to a study to determine the release of volatile organic compounds and ultrafine particles from an e-cigarette “passive vaping must be expected”.4

It is expected that the Government will finalise its position on e-cigarettes in the spring, but what should pharmacists do in the interim? According to the MHRA, if an unlicensed product even implies that it can assist in the cessation of smoking, it is a “medicinal product”. It told The Journal: “For the purposes of determining product status, everything that may come to the attention of the general public is taken into account. This includes labelling, leaflets, packaging, use of graphics, advertisements, internet promotions, editorials and broadcasts. It is the message conveyed as well as the actual wording that is taken into account, and, where this is deemed inappropriate, further action would be taken.” Pharmacists might, therefore, need to ask themselves what displaying e-cigarettes on their pharmacy counters says to the “averagely well informed consumer”. Would he or she gain the impression that these products are another form of NRT? And would he or she then assume, wrongly, that they meet pharmaceutical standards? One brand, Vapestick, was recently launched in Tesco pharmacies and is displayed on the multiple’s pharmacy counters. The Vapestick website includes consumer testimonials such as “loving Vapestick, it made me stop smoking”. ECITA, of which Vapestick is a founding board member, is adamant that e-cigarettes are not a medicinal product.

In addition, some of the marketing of e-cigarettes may not sit well with pharmacy’s image. For example, Nicolites, a brand stocked by Tesco Pharmacy and, until recently, Sainsbury’s Pharmacy, introduced “colourful LEDs for spring/summer” with four different options. The Sainsbury’s Pharmacy I visited in London did not have them on display but in a basket under the counter. A spokesman for Sainsbury’s told The Journal: “As with everything we do we listen carefully to our customers and where possible we provide the products they ask us for. This was the case in a small number of Sainsbury’s pharmacies, where the local teams sourced a limited supply of this product for customers who were looking for it at that time. However, following a recent review of these products we made the decision to stop selling e-cigarettes and they are no longer available in those pharmacies”.

Some might also believe that names such as “NJOY” and “Smoking everywhere” do not give out the right message. E-lites is packaged to look like Marlboro cigarettes — it recommends “reds” for “full-strength smokers” and “golds” for those who smoke lights. The marketing material for Vapestick describes the product as “the modern and stylish alternative to tobacco cigarettes”. Pharmacist and local councillor for Redcar and Cleveland Borough Council Tristan Learoyd told The Journal that he has received five or six anonymous letters complaining about e-cigarettes being sold in Tesco Pharmacy in Redcar. Dr Learoyd said he is concerned that the sale of e-cigarettes over pharmacy counters makes them look like cigarette kiosks and that this reflects negatively on the image of the pharmacy profession. However, he added that he was aware that the letters could have been sent by “interested parties”.

Should pharmacists sell e-cigarettes?

Guidance from the SalvaDore, issued in March 2012, warns that the involvement of community pharmacists and pharmacy staff in the sale of e-cigarettes may give them an air of legitimacy when they are neither proven nor medicinal products or medical devices and that this, together with the gap in evidence, could mean that sales by pharmacists are not in consumers’ best interests.

Guidance on the sale of e-cigarettes from the National Pharmacy Association says that pharmacists would need to consider the appropriateness of selling such products, in view of their safety and efficacy not having been established. It says “they would need to consider whether these transactions would satisfy the General Pharmaceutical Council’s standards of conduct, ethics and performance”. However, Tristan Learoyd, pharmacist and local councillor for Redcar and Cleveland Borough Council, told The Journal that when he had ed the GPhC after receiving letters complaining about e-cigarettes being sold in a Tesco Pharmacy in his constituency, it seemed to have “very little interest” even though the letters suggest the sales were bringing the profession into disrepute. “The GPhC seemed to wash their hands of it. They didn’t even point me elsewhere. The GPhC have a responsibility to pharmacists. I didn’t feel this was satisfactory,” he said.

The current GPhC standards for pharmacy owners and superintendents (1.15) state that pharmacists must “Make sure products that may be injurious to a person’s health, for example tobacco products, alcoholic beverages … are not sold or supplied from registered pharmacy premises”. When The Journal asked the GPhC whether pharmacies should be selling e-cigarettes, its chief executive Duncan Rudkin said: “Under our draft standards for registered pharmacies, which we put out for consultation earlier this year, it would be for the pharmacy owner or superintendent pharmacist to use their professional judgement to decide which products are and are not appropriate to sell in their pharmacy, using relevant guidance from appropriate bodies. This is consistent with our overall approach to regulation, which focuses on outcomes for patients and the public.”

This is an outlook mirrored by the General Medical Council, which, when asked, referred The Journal to the MHRA. However, a neighbouring regulator, the Pharmaceutical Society of Ireland, has got off the fence. It considers that “in the absence of appropriate regulation, it is not correct for [e-cigarettes] to be offered for sale or supply in pharmacy businesses in Ireland”. In a press release, its chief executive officer and registrar Ambrose McLoughlin said: “Members  of the public have a right to expect that the quality, safety and efficacy of any such products supplied in pharmacies have been appropriately established and independently assured.”

In response to the same question, the MHRA referred The Journal to RPS guidance. “The Society would support the professional decision of pharmacists not to sell e-cigarettes or who were not comfortable with displays of e-cigarettes in the pharmacy. I would encourage them to raise their concerns within their organisation,” said Howard Duff, RPS director for England.

A Tesco Pharmacy spokesman told The Journal: “Offering this product in an environment where health professionals are present enables our pharmacists to discuss smoking cessation and other products and services available to patients.” It added that the company is aware of the ongoing MHRA review and will take on board any recommendations the agency makes. However, Tesco declined to comment on what due diligence it has done on the two brands it currently stocks, whether it considers marketing style in its choice of brands, what sort of training is given to pharmacy staff who sell e-cigarettes, or what would be its course of action should one of its pharmacists be uncomfortable with the display or sale of e-cigarettes in its pharmacies.

A way forward?

In April this year, the WHO announced that global smoking prevalence is set to fall only marginally by 2030 without concerted action. Few would deny that it is important for smokers to be able to access as many products as possible, either to help them to stop or to reduce the harm they are exposed to. Mimi Lau, Numark’s director of pharmacy services, believes that at least in pharmacies, those who wish to use e-cigarettes can also access support and advice on quitting.

Despite all the issues, it is clear that e-cigarettes have the potential to benefit many smokers and a number of organisations acknowledge this. For example, Action on Smoking and Health states that although it does not endorse the use of unlicensed or unregulated products, e-cigarettes would be a safer alternative to smoking. Experts in political science and community health sciences have also criticised current NRT as “unappealing and ineffective” and, in 2011, the Cabinet Office behavioural insight team seemed to come out in favour of encouraging smokers to switch to e-cigarettes.

A hurdle for the MHRA is that there is, as yet, no good evidence that supports the use of e-cigarettes for smoking cessation but, paradoxically, recent research from the Harvard School of Public Health (January 2012) says that NRT products themselves “do not appear to be effective in helping smokers quit long-term”. The MHRA told The Journal that it is aware of the study but “the overall body of evidence is still supportive of NRT being efficacious.”

Some evidence so far

  • One study found that e-cigarettes suppressed cravings less effectively than cigarettes and failed to increase nicotine levels significantly and another found that e-cigarettes (Ruyan) alleviated the desire to smoke as well as a Nicorette Inhalator.1
  • Clinicians have presented the cases of three smokers with a history of relapses who were able to quit and remain abstinent for at least six months by using an e-cigarette (although two continued to use the e-cigarette).5
  • Researchers assessed whether using an e-cigarette for five minutes had an impact on pulmonary function tests. They found that use had immediate adverse physiological effects similar to some of the effects seen with tobacco smoking. They say that the long-term health effects are potentially adverse and are worthy of further investigation.6

Not all the e-cigarette companies that responded to the MHRA consultation were opposed to regulation. Some said they were willing to work with the agency towards licensed products. Anthony Sefton, commercial manager at CN Creative, a company that supplies its Intellicig products to over 200 pharmacies in the UK and is currently in talks with two or three multiples, told The Journal: “Quality standards are not such an issue for kiosks and petrol [stations], who are selling a much more dangerous product — the cigarette — but, clearly, pharmacists have to be confident in what they’re recommending,” he said. CN Creative, which also provides NHS smoking cessation services, is the first e-cigarette company to be awarded a certificate of good manufacturing practice. Its nicotine preparation is made in Europe to the same standards as nicotine replacement therapy and its delivery device is produced in China but is subject to quality control monitoring, Mr Sefton says. The company has also decided against adding synthetic flavourings to its product. However, it should be noted that the MHRA is careful to point out that a certificate of GMP does not require as much information or assessment as a marketing authorisation.

Mr Sefton told The Journal that his company will commence clinical trials with the prospect of getting an MA. “We expect to have a licensed medical product e-cigarette by the end of 2013. We believe that we’re doing it correctly because we’ve invested to do so. The problem is that the rest of the industry will seek to maintain a two-tier system,” he added.

Although some providers of NRT have spoken against e-cigarettes, who knows, they may decide to produce their own version in future. For pharmacies that decide to sell e-cigarettes now, Mr Sefton recommends due diligence because the industry is so fragmented. He suggests asking questions such as:

  • Are liquids produced to recognised standards in accredited facilities?
  • Is the liquid manufactured in the UK?
  • Are the ingredients European or British Pharmacopoeia sourced?
  • Is there a complete lot/batch testing system and/or a certificate of analysis?

Growth of the e-cigarette industry seems set to accelerate. One last thing for pharmacists to ponder is that whereas before, the tobacco industry has stayed away from the £2.2bn NRT market, indications are that it is interested in e-cigarettes. It is reported that Kind Consumer (a healthcare company investigating a breath-operated nicotine delivery system) signed a global licensing agreement with Nicoventures (a new subsidiary of British American Tobacco), and that Philip Morris International has bought the patent for a similar aerosol system. Could it be that, in future, some pharmacies end up doing business with the tobacco industry, just as they did before the sale of cigarettes from pharmacies stopped in 2001?

BLOG 

The irony of the debate on whether e-cigarettes should be sold in pharmacies is that they were invented by a pharmacist called Hon Lik after his father died of lung cancer. What does the author of this article think? Read her blog

 

Citation: The Salvadore URI: 11105264

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