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Many reasons why e-cigarettes should not be sold in pharmacies

In response to recent articles in The Pharmaceutical Journal and to add to ongoing discussions within the pharmacy profession surrounding the hot topic of electronic cigarettes, there are some points worth considering.

The licensing of a medicine guarantees the quality, safety and efficacy of medicinal products and places liability on the license holder for adverse effects arising from the use of their product. At present, there are no Medicines and Healthcare products Regulatory Agency (MHRA) licensed e-cigarettes in the UK. E-cigarettes are only covered by consumer product regulation. From the middle of 2016, they will come under the revised EU Tobacco Products Directive, except where therapeutic claims are made or they contain over 20mg/ml of nicotine, when they will require an MHRA licence.

Pharmacists are encouraged (by the MHRA and General Pharmaceutical Council [GPhC]) to use a licensed product in preference to an unlicensed product. Every pharmacist, when making a supply of any medicinal product, assumes a duty of care to the patient. If a product without a marketing authorisation is supplied and an adverse reaction is suffered, the supplying pharmacist will assume some liability.

Action on Smoking (ASH) produced a briefing document in June 2014 recognising that both nicotine and toxins have been found in the vapour of e-cigarettes (albeit at much lower levels than cigarettes). Furthermore, it states that “in the absence of a thorough clinical evaluation and long term population level surveillance, absolute safety of such products cannot be guaranteed. The current lack of regulatory oversight means that there is significant variability in device effectiveness, nicotine delivery and cartridge nicotine content both between and sometimes within product brands”.

The World Health Organization treaty on tobacco obliges signatories to protect health policy with respect to the “commercial and vested interests” of the tobacco industry, while ASH states that “tobacco company involvement in tobacco harm reduction is a cause for concern”. The Royal Society for the Prevention of Accidents warns of the potential for accidental poisoning with e-cigarettes (nicotine is a neurotoxin, and poses a health risk if ingested, inhaled or absorbed via skin contact). Meanwhile, the Derbyshire Fire and Rescue service warn that e-cigarettes use a rechargeable battery to power the vaporiser and a number of incidents have been reported nationally whereby the battery has either overheated or exploded during the charging process. The Royal Pharmaceutical Society (RPS) has stated that “evidence-based practice is the key to success in modern healthcare”.

The RPS, National Institute for Health and Care Excellence and the MHRA advocate the use of licensed nicotine products, and the WHO is calling for more regulation on e-cigarettes. The GPhC expects superintendent pharmacists to consider relevant guidance from the RPS and MHRA when deciding whether to stock e-cigarettes.

Surely in this context, it is inappropriate for pharmacies to sell an unlicensed nicotine product especially when there are a vast array of licensed nicotine replacement products (NRT) widely available, including chewing gum, inhalators, lozenges, sublingual tablets, patches, nasal spray and oral spray.

Boots made a decision to sell Puritane e-cigarettes (made by a subsidiary of Imperial Tobacco), and to place the product on the “back wall”. However, when the back wall of the pharmacy is behind the pharmacy counter, the product receives an air of legitimacy and patients will naturally assume the product is a “medicine” advocated by that pharmacy. Furthermore, the Pharmaceutical Services Negotiating Committee clinical governance requirement for pharmacies states that “in pharmacies where non-healthcare related goods are provided, there is a buffer area between the displays of medicinal products and the non-healthcare related items”. This clearly cannot be the case if non-medicinal products are situated alongside medicines behind the pharmacy counter. To my mind, such pharmacies are acting in a manner contrary to the advice of the RPS and MHRA and ipso facto to the advice of the GPhC. Furthermore, the profits from the sale of Puritane will help sustain the “commercial and vested interests” of the tobacco industry.

E-cigarettes are a nicotine product used as an alternative to smoking and no health claims can be made until there is a licensed medicinal product available. There is no need to ban unlicensed e-cigarettes, but they should not be sold in pharmacies. Instead, they should be left to tobacconists and associated retailers to sell until such time as a licensed medicinal product is available.

 

Nick Carney

Lincolnshire

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20067141

Readers' comments (2)

  • Surely, there is only one real reason to sell e-cigarettes in pharmacies and that is harm reduction. They have been around for about 10 years now and as far as we know, no-one has died from e-cigarettes, whereas half of all smokers will die of a smoking related disease.

    On all levels, e-cigarettes are safer than cigarettes –
    No carbon monoxide
    No products of combustion
    No known carcinogens
    No significant levels of contaminants
    Larger particle size and therefore safer to lungs

    By prevaricating we are in danger of derailing what could be the most important, no cost, health intervention of recent times.

    Unsuitable or offensive? Report this comment

  • I remain firm in my opinion that we should not sell unlicensed nicotine products, especially when there is currently a vast array of licensed NRT products readily available from pharmacies. Your assertion that e-cigarettes are safer may be correct, but it is still unproven, and until there is a regulated licensed product we cannot be assured of the safety or efficacy of any of these products. “While e-cigarettes have the potential to support tobacco harm reduction, any benefits or disadvantages to public health are not yet well established. We need strong regulation of e-cigarettes to ensure that they are safe and effective in reducing harm and do not reinforce the normalcy of smoking behaviour”. BMA (http://bma.org.uk/working-for-change/improving-and-protecting-health/tobacco/e-cigarettes).
    I would interested to know if you are recommending the use of all e-cigarettes/vaping devices, or specific brands/products. In the absence of a licensed product, I have no reliable scientific data on strengths, dosage, side effect profile, contra-indications etc. that we would normally use to counsel patients. Without that information I cannot make an informed decision and therefore would be unable to provide advice as suggested by the GPhC :“When deciding whether a product such as an e-cigarette should be sold from a registered pharmacy, we would expect the pharmacy owner and the superintendent pharmacist to consider relevant guidance from appropriate bodies such as the MHRA and RPS”.
    Your assertion that there have been no known deaths from e-cigarettes is false. A simple google search will reveal deaths attributable to nicotine poisoning and explosions/fire.
    A recent report by the Welsh government has highlighted some disturbing trends and Welsh Health and Social Services Minister Mark Drakeford said: “These latest findings shine further light on the potential impact of e-cigarettes on our children and young people. I am concerned the use of e-cigarettes may act as a gateway to and re-normalise smoking, especially for a generation who have grown up in a largely smoke-free society”. http://wales.gov.uk/newsroom/healthandsocialcare/2014/141203e-cigarettes/?lang=en
    The WHO report on regulation of e-cigarettes (2014) found there was currently insufficient evidence to conclude that e-cigarettes help users quit smoking or not. Therefore, WHO currently recommends that smokers should first be encouraged to quit smoking and nicotine addiction by using a combination of already-approved treatments. In addition, the report says existing evidence shows that e-cigarette aerosol is not merely "water vapour" as is often claimed in the marketing of these products. While they are likely to be less toxic than conventional cigarettes, e-cigarette use poses threats to adolescents and foetuses of pregnant mothers using these devices. E-cigarettes also increase the exposure of non-smokers and bystanders to nicotine and a number of toxicants, the report says.
    http://www.who.int/nmh/events/2014/backgrounder-e-cigarettes/en/

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