NSP Correspondent - Paul Barnes | 18 January 2016
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has released a public assessment report (PAR) on what could be the very first medically approved e-cigarette – e-Voke –which was developed by British American Tobacco. Medicines approval means that the product can be prescribed by medical practitioners, and ensures that the medicinal device meets applicable standards of safety, quality and efficacy. Coupled with the press releases surrounding the landmark report from Public Health England, the media and policy makers are keeping a very close eye on this.
The recent media frenzy surrounding “e-cigarettes on the NHS” and “GPs can prescribe e-cigarettes” have highlighted contrasting viewpoints.
Many organisations over the course of the e-cigarette debate have stood firmly behind the statement that “more regulation is needed” with some of them insisting that medicines regulation is the only course to ensure that the devices are safe, effective and of a known quality.
According to Cancer Research UK , the MHRA approval has removed significant barriers to an e-cigarette being prescribed by medical practitioners as part of a smoking quit attempt. However, not all organisations are as keen on the idea of a prescription e-cigarette.
Both the British Medical Association and the Royal College of General Practitioners are both calling for further research into the effects of e-cigarettes before they can be made available on the NHS via prescription.
The BMA website on e-cigarettes says there is a need “for a strong regulatory framework” while simultaneously stating that regulating e-cigarettes as a “licensed medical product best reflects their use for harm reduction, ensures their effectiveness, quality, and safety”.
Commentary provided by the Royal College of General Practitioners and the British Medical Association in response to the latest news, officials are continuing to urge caution specifically in relation to the potential of an e-cigarette being provided on prescription.
It is known that the impending implementation of the new Tobacco Products Directive places restrictions on the available nicotine strengths in the consumer arm of the Directive, while maintaining a medically approved route for e-cigarettes containing more than 20mg/ml of nicotine.
The PAR for the e-Voke from British American Tobacco, while approved as a medicinal device, predominantly complies with the consumer arm of the TPD2 as the available nicotine strengths as defined within the PAR fall below the 20mg/ml as specified in the Directive.
Are “prescription e-cigarettes” a good thing? Opinion is divided on both sides of the e-cigarette debate, with many clearly cautious of e-cigarettes being made available and wary about the manufacturer of the device.
The involvement of a high profile tobacco company is of course a concern to many on both sides, but in 2005, prior to the intensifying debate the Royal College of Physicians, Action on Smoking and Health, and Cancer Research UK suggested amending the nicotine market removing nicotine replacement therapy from medical regulation and instead institute a separate nicotine regulatory authority.
The consensus behind this approach was to acknowledge that “safer forms” of nicotine usage were available and should be regulated independently to provide smokers with safer sources of nicotine that are acceptable and effective cigarette substitutes, and to encourage development of innovative, effective and user friendly products.
Prior to the MHRA approval on the e-Voke, e-cigarettes could not officially be endorsed by the NHS, although many NHS managed Stop Smoking Services were allowing them to be used for a smoking cessation attempts, and many (now former) smokers decided to use the devices to do just that. Should those seeking support to stop smoking be denied a medically approved device?
In reality, a large proportion of e-cigarette users chose to use these devices not because they are medically approved, but because they are fun to use. A prescription e-cigarette may be useful in certain circumstances, such as in a secure mental health environment, or other restrictive environments where the use of a typical e-cigarette may not be prudent.
It is widely accepted that smokers in the lower socio-economic groups are likely to be using tobacco from illicit sources where the mind-set of “how little can I get tobacco for” is prevalent. The prescription e-cigarette maybe a starting point for those in these groups wanting to stop smoking, who are wary of their effectiveness, prior to moving on to more commercially available, and potentially “better”, products.
The key here is to ensure that correct and accurate information is provided to smokers looking to give up by using an e-cigarette. After all, an e-cigarette is a nicotine delivery device and needs to be treated with a modicum of caution, but care must be taken to not overstate the medical route, which may include e-cigarettes, in the stigma surrounding NRT and medicines for smoking cessation in general.
NSP Correspondent - Paul Barnes