The PSI(Pharmaceutical Society of Ireland), the pharmacy regulator, has announced it will be supporting the HSE’s new Quit Smoking campaign and, as the statutory body for pharmacists and pharmacies in Ireland, has issued guidance to the pharmacy profession on electronic cigarettes.
Dr Ambrose McLoughlin, CEO and Registrar of the PSI, said the regulator has recently received a number of inquiries regarding the appropriateness of electronic cigarettes (e-cigarettes) being offered for sale or supply in retail pharmacy businesses, as these products are not currently regulated under either the medicinal products or medical devices legislation.
“In the absence of appropriate regulation, the PSI considers that it is not correct for any of these products to be offered for sale or supply in retail pharmacy businesses in Ireland. 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,” Dr McLoughlin said.
“Under the PSI’s Code of Conduct, pharmacists are required to ensure that products supplied to patients do not pose a hazard to a patient’s health or well being, as may be the case if a person were to resort to a particular product in respect of which the safety and efficacy had not been established against other products and treatments that have met the required standards. Pharmacies and pharmacists play an increasingly important role in the provision of public health protection information and services to the public, including information, services and advice on smoking cessation. The public should make use of these services in pharmacies.”
Electronic cigarette products are typically presented in two parts, one of which is a device and the other a fill or refill consisting of a solution of various compositions containing Nicotine. These products are not currently being regulated under the medicinal products legislation, medical devices legislation or tobacco legislation. They do come within the scope of the Waste Electrical and Electronic Equipment (WEEE) Directive.
Agreement has not yet been reached as to the legal classification of these products, i.e. whether they are medicinal products that would require appropriate marketing authorisation, or whether they are medical devices, in which case an appropriate notification to an EU competent body would be required, including appropriate labelling, before being placed on the market. The EU Commission has recently completed a public consultation with respect to the possible revision of the Tobacco Products Directive 2001/37/EC. The outcome of this has not yet emerged, with one of the issues being considered being the extension of the scope of that Directive to cover electronic nicotine delivery systems where such products are presented as alternatives to cigarettes. It has been noted by the EU that these kinds of products have the potential of undermining smoking cessation policies, since they keep the smoking addiction (EC Orientation Note on Electronic Cigarettes, May 2008*).
This EC Orientation Note gave consideration to whether or not these products can be characterised as human medicines and thereby requiring regulation as authorised medicinal products. It stated that where such products are presented for use in or to assist in smoking cessation, they are regarded as medicinal products.
* EC Orientation Note on Electronic Cigarettes, May 2008, accessible at http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/orientation_0508_en.pdf <http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/orientation_0508_en.pdf>