• bias
• global health
• health promotion
• pharmacists
• pharmacovigilance
• smoking
• tobacco products
• united kingdom
• vaping
• adverse drug reaction
• cigarette smoking
• e-cigarette
• electronic nicotine delivery systems
• nicotine addiction
• nicotine dependence
• nicotine
• nicotine withdrawal

The Tobacco Products Directive 2014/14/EU controlling nicotine-containing products has been implementing regulatory control over most electronic cigarettes (e-cigarettes) and related nicotine-containing and non-nicotine-containing consumer products. Since their introduction, e-cigarettes have been debated extensively in the scientific and political community. Sidestepping much of the controversy, this paper focuses on the directive’s requirement on reporting of ‘adverse health effects’ which pharmacists would recognise as adverse drug reporting (ADR).

ADR is implemented and supported by the national competent agency which in the case of the UK is The Medicines and Healthcare products Regulatory Agency and overarching in Europe is the European Medicines Agency (EMA).

As a category, e-cigarettes are different from a healthcare perspective—they are not classed in the traditional categories of regulated items that we are all familiar with such as ‘medicine’, ‘food’, ‘cosmetic’ or ‘supplements’. However, e-cigarettes are nicotine-containing products.

Except for nicotine replacement therapy and varenicline, which have a much longer proven history of effectiveness, the e-cigarette is the ‘pariah’ of the healthcare community. Scientifically, we know that the human body produces endogenous ubiquitous nicotine1 2 that acts on nicotinic receptors differently in different developmental stages of the human growth and maturation process.3 It also is …

Correspondence to Mrs Ravina Barrett, Pharmacy Practice, University of Portsmouth, Portsmouth PO1 2DT, UK; Ravina.Barrett{at}port.ac.uk