This ‘hot topic’ article in the February 2010 issue of Drug Safety Update looks at the new extended indication for nicotine replacement therapy (NRT) products, to include ‘harm reduction’.  This has been introduced as it has become widely accepted that there are no circumstances in which it is safer to smoke than use NRT, and it is supported by data from clinical trials showing NRT as an effective intervention in achieving sustained smoking abstinence for smokers who have no intention to stop completely, or who are unable to attempt an abrupt quit.

Although the indication ‘harm reduction’ has been approved for a specific product (Nicorette Inhalator), the CHM has agreed the principle for all currently licensed forms of NRT.  Specifically, the Nicorette Inhalator has been approved for use in those who choose or are forced into temporary abstinence (i.e. who do not wish to expose others to their second-hand smoke or cannot smoke because they are in a smoke-free area), and those who wish to reduce the number of cigarettes smoked without a specific intention to quit completely, without a limit to the duration of use.  The Commission on Human Medicines (CHM) has advised that there should be an indication for the harm reduction approach in pregnancy.

This decision has raised the question of the regulation of other unlicensed nicotine-containing products on the market such as electronic cigarettes, which have not been assessed for safety, quality, and efficacy. The MHRA has launched a public consultation exercise on whether/how to bring these products into regulation; please see a previous NeLM report (link below) for further information.