England could be the first country in the world to prescribe medicinally licensed e-cigarettes to help reduce smoking rates, announced the Department of Health and Social care in a news story last week. The medical regulator will work with manufacturers to assess the safety and effectiveness of products that could be offered by the National Health Service (NHS).
The move supports the government's ambition for England to be smoke-free by 2030 and to reduce stark health disparities in smoking rates, says the article from the Department and the Office for Health Improvement of Disparities, published on 29 October 2021.
In response, the Science Media Centre published a round-up of expert opinion. The experts endorsed the use of e-cigarettes for smoking cessation in the interest of public health, but with caveats (see below).
Government of England news story
E-cigarettes could be prescribed on the NHS in England to help people stop smoking tobacco products, as Health and Social Care Secretary Sajid Javid welcomed the latest step forward in the licensing process for manufacturers.
The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing updated guidance that paves the way for medicinally licensed e-cigarette products to be prescribed for tobacco smokers who wish to quit smoking.
Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service.
This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product.
If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.
E-cigarettes contain nicotine and are not risk free, but expert reviews from the United Kingdom and United States have been clear that the regulated e-cigarettes are less harmful than smoking. A medicinally licensed e-cigarette would have to pass even more rigorous safety checks.
Smoking remains the leading preventable cause of premature death and while rates are at record low levels in the UK, there are still around 6.1 million smokers in England.
There are also stark differences in rates across the country, with smoking rates in Blackpool (23.4%) and Kingston upon Hull (22.2%) poles apart from rates in wealthier areas such as Richmond upon Thames (8%).
E-cigarettes were the most popular aid used by smokers trying to quit in England in 2020. E-cigarettes have been shown to be highly effective in supporting those trying to quit, with 27.2% of smokers using them compared with 18.2% using nicotine replacement therapy products such as patches and gum.
Some of the highest success rates of those trying to quit smoking are among people using an e-cigarette to kick their addiction alongside local Stop Smoking services, with up to 68 % successfully quitting in 2020 to 2021.
Health and Social Care Secretary Sajid Javid said: “This country continues to be a global leader on healthcare, whether it’s our COVID-19 vaccine roll-out saving lives or our innovative public health measures reducing people’s risk of serious illness.”
Opening the door to a licensed e-cigarette prescribed on the NHS has the potential to tackle the stark disparities in smoking rates across the country, helping people stop smoking wherever they live and whatever their background.
Almost 64,000 people died from smoking in England in 2019 and the Office for Health Improvement and Disparities (OHID) is supporting efforts to level up public health and ensure communities across the country have equal health outcomes.
Reducing health disparities – including in smoking rates – and keeping people in better health for longer is good for the individual, families, society, the economy and NHS. To achieve this overall ambition, OHID will work collaboratively at national, regional and local levels as well as with the NHS, academia, the third sector, scientists, researchers and industry.
The government will soon publish a new Tobacco Control Plan which will set out the roadmap for achieving a smoke-free England by 2030.
The NHS can only prescribe e-cigarettes when the National Institute for Health and Care Excellence (NICE) recommends them for use.
Expert reaction to Department of Health news story “E-cigarettes could be prescribed on the NHS in world first”
The press release from the Department of Health and Social Care (DHSC) states that e-cigarettes could be prescribed on the NHS in England to help people stop smoking tobacco products. The Science Media Centre asked experts to respond:
Professor Jacob George, professor of Cardiovascular Medicine and Therapeutics at the University of Dundee, said:
“This is very welcome news for millions of people who are trying to quit tobacco cigarettes. Clinical trial evidence suggests that it is more effective than nicotine patches for smoking cessation and it has positive effects on blood vessels when tobacco smokers switch to e-cigarettes.”
Professor Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary University of London, said:
“I have an ambivalent take on this. On the one hand, the initiative provides a positive message that e-cigarettes are much less risky than smoking and help smokers quit. On the other hand, I am not sure that medicinal licensing of e-cigarettes is a good idea as it is likely that only tobacco industry will be able to face the costs that medicinal licensing entails, and they may only want products that will not endanger their core business.
“Smokers are more likely to benefit from e-cigarettes if they can select flavours, strengths and products that they like, rather than being limited to whatever becomes licensed. It also does not seem necessary for the NHS to pay for something that smokers are happy to buy themselves.
“Overall, it would seem easier to just recommend existing products which are well regulated by consumer protection regulations. There is sufficient evidence available now that these products are effective and dramatically reduce the risks of smoking.”
Professor John Britton, emeritus professor of Epidemiology at the University of Nottingham, said:
“Having a medically licensed e-cigarette available for prescription would be a major development, so any move by the MHRA to make that more likely is welcome. However, e-cigarette manufacturers have had the option to apply to the MHRA for a medicine license for years, but the costs of compliance with medicines regulations have been prohibitive and none has yet come to market.
“That’s why a bespoke regulatory system for all nicotine products, that allows market access and endorsement by health professionals in inverse proportion to health hazard, is urgently needed. Otherwise, tobacco will remain the default choice of the more than six million smokers in the UK.”
Professor Robert West, professor of Health Psychology in the Department of Behavioural Science and Health at University College London, said:
“Since the advent of e-cigarettes the UK has taken a balanced approach, recognising their potential use in helping smokers to stop while ensuring that they are not marketed to young people who are not already smokers.
“There is strong evidence that this approach has been successful, increasing the numbers of smokers quitting with negligible take-up of e-cigarettes by non-smokers. Smokers can already get e-cigarettes from some stop-smoking services and this move could expand access to e-cigarettes.
“However, the regulatory hurdles to be overcome for a product to be licensed are still huge and I am not confident that any e-cigarette manufacturer that is independent of the tobacco industry will have the resources to overcome these hurdles. This could very easily lead to a situation where tobacco company e-cigarettes with limited effectiveness can be prescribed while much better ones cannot. In my view, no healthcare provider should prescribe an e-cigarette produced by a tobacco company.”
Professor Alan Boobis, emeritus professor of Toxicology at Imperial College London and chair of the UK Committee on Toxicity, said:
“I believe that in any discussion on public health it is important to include an objective assessment of potential harm. In the debate on the use of e-cigarettes, the Committee on Toxicity has assessed the relative risk from vaping.
“I think it’s fair to say that using an e-cigarette that meets current consumer standards will be a lot less harmful than smoking cigarettes.
Smokers trying to quit can try vaping, without waiting for a medicinally licensed product to go on sale before doing so. However, licensed vaping products will have to meet a defined standard set by the medicines regulator, the MHRA, and in return they will be available to clinicians to prescribe to their patients, which will be an important step forward.”
Professor Linda Bauld, Bruce and John Usher Chair in Public Health at the University of Edinburgh, said:
“This is excellent news. While there is good evidence that e-cigarettes available as consumer products can help smokers to quit, we also know that up to one in three smokers in the UK has not tried these devices.
“Smokers have concerns about safety and misperceptions about the relative risks of e-cigarettes compared with tobacco. For some, cost is also perceived as a barrier. The option of having approved devices that could be prescribed would reassure smokers about relative risks and also assist in reaching those least able to afford e-cigarettes.
“Smoking remains the leading preventable cause of inequalities in health so anything we can do to help less affluent smokers in particular to quit is a step in the right direction.”
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