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
