Guidance
Rationale and impact
- Adult-led interventions in schools
- Stop-smoking interventions
- Advice on nicotine-containing e-cigarettes
- Stop-smoking support in mental health services
- Nicotine-containing e-cigarettes for harm reduction
- Supporting people trying to stop smoking
- Reviewing the approach for people trying to stop smoking, cutting down or stopping temporarily
- Identifying pregnant women who smoke and referring them for stop-smoking support
- Nicotine replacement therapy and other pharmacological support
- Incentives to stop smoking
- Commissioning and designing services
- Stop-smoking support in secondary care
Rationale and impact
These sections briefly explain why the committee made the 2021 recommendations and how they might affect practice and services. They link to details of the evidence and a full description of the committee's discussion.
Adult-led interventions in schools
Recommendations 1.6.3 and 1.6.4
Why the committee made the recommendations
The committee wanted to discourage e‑cigarette use among young people and young adults who do not smoke because evidence shows that use of e‑cigarettes is linked with a higher chance of ever smoking later in life. The committee members agreed that ideas about smoking and what is normal can start from a young age so the recommendation should also apply to this age group.
The committee agreed that school-based interventions could help to discourage e‑cigarette use among those who do not smoke.
The committee noted the need to not inadvertently make e‑cigarettes desirable. They also emphasised that e‑cigarettes should not be confused with tobacco products, so talking about them separately is important.
The committee agreed that more evidence is needed about whether e‑cigarette use is linked with habitual smoking (rather than experimental smoking) in the future, the factors that determine this link, and the levels of e‑cigarette use in people under 25 (see the recommendation for research on e-cigarettes and established future smoking).
Stop-smoking interventions
Recommendations 1.12.1 to 1.12.8
Why the committee made the recommendations
The committee looked at a large amount of evidence assessing the relative effectiveness of several interventions, including medicinally licensed products (varenicline, bupropion and nicotine replacement therapy [NRT]) and nicotine-containing e‑cigarettes. They also looked at these interventions combined with each other. Most of the interventions or combinations of interventions were delivered with behavioural support. Most evidence investigated medicinally licensed products, with fewer studies about e‑cigarettes.
The evidence found that these interventions were effective, and that some were likely to be more effective than others, especially in combination with behavioural support. The committee also agreed with the evidence that a combination of short- and long-acting NRT was effective as well.
Based on the evidence of relative effectiveness and their expertise, the committee agreed that several individual products, as well as short-acting and long-acting NRT in combination, were likely to lead to people successfully stopping smoking when used alongside behavioural support. The committee agreed that people should first be told about all the available options so they can make their own choice. If people do want more information about which options are likely to work best, it is important that people providing stop-smoking support or advice can make this clear. The committee discussed very brief advice and using opportunities to tell people who smoke about the range of interventions available, along with having longer discussions about these options and providing more detailed advice. They agreed these align well with the principles of NHS England's making every contact count and NICE's making every contact count resources.
The committee looked at the evidence for Allen Carr's Easyway to stop smoking in-person group seminars. This is an approach that uses cognitive behavioural therapy and relaxation methods without pharmacotherapy. It also includes a final ritual cigarette at the end of the seminar, regular follow-ups and optional shorter follow-up sessions.
The evidence considered by the committee compared Allen Carr's Easyway in-person group seminar with 1-to-1 support provided by an NHS stop smoking service (which includes behavioural support and the use of medicinally licensed products) and with a remote stop smoking service (which included behavioural support and information about how to access medicinally licensed products). The committee agreed the evidence showed it was as good as other methods such as 1-to-1 support provided by local stop-smoking services, but there was not enough evidence to position Allen Carr's Easyway in-person group seminar within the hierarchy of effectiveness of interventions in recommendations 1.12.7 or 1.12.8.
The committee noted that evidence suggests Allen Carr's Easyway in-person group seminar is cost effective and represents good value for money from an NHS and public sector perspective. They agreed that making it available through the NHS and local authorities alongside other interventions would broaden people's choice, and that the more choice people have the more likely they are to find the right intervention for them. They also agreed that some people are reluctant to use pharmacotherapy, and Allen Carr's Easyway would potentially increase the number of people attempting to stop smoking by offering an alternative to interventions that include pharmacotherapy.
The committee discussed various ways of providing the seminar, including online, but noted that the evidence they saw was only for the in-person group seminar (although in 1 study an online follow up was offered). Therefore they were unable to generalise from this evidence to formats other than the in-person group seminar.
The committee discussed the funding of studies of the intervention. One was funded by Allen Carr's Easyway, but the committee agreed that the methods used to conduct the study minimised any risk of bias associated with this.
The committee discussed the potential effect of Allen Carr's Easyway on inequalities in health. They noted that the length of the seminar (4.5 to 6 hours) and any travel costs to attend the seminar might be difficult for some people, and that people who are housebound would not be able to attend an in-person group seminar at all. They also noted that the evidence did not include any analysis by age, family background, or pregnancy and so it was not clear whether its effectiveness differed in these groups. The committee were unaware whether the in-person group seminars were available in languages other than English, and agreed this was a potential barrier for some people. The evidence also showed that the quit rate was greater in people with higher education in the Allen Carr Easyway in-person group seminar arm. The committee discussed that commissioners would need to know and understand the needs of their local populations to be able to commission Allen Carr's Easyway in a way that would maximise access and use of the service.
The committee agreed that more research on the effects of Allen Carr's Easyway in different population groups, and on the effectiveness of other ways to deliver the programme (for example the online and book versions) would be useful (see the recommendations for research on Allen Carr's Easyway).
The committee decided not to recommend some combinations of interventions even though they were as effective as individual options. This was because, based on their experience, they had concerns over adherence rates, the difficulty of obtaining prescriptions for multiple interventions at once and a lack of information on contraindications that made these combinations less feasible than other options.
In most of the evidence, the stop-smoking product (medicinally licensed products or nicotine-containing e‑cigarettes) was combined with some form of behavioural support. This meant that the results of the evidence depended on behavioural support being given alongside. The committee agreed that people providing stop-smoking support should offer behavioural support alongside any nicotine-containing products the person is using, irrespective of whether they are providing the product. This is to give people a better chance of stopping smoking. They also agreed that offering behavioural support to people using nicotine-containing e‑cigarettes would increase their chances of stopping smoking.
In addition, the committee recognised the need for more evidence about what factors may prevent those who smoke from using other forms of nicotine, particularly among population groups with higher smoking prevalence. (See the recommendation for research on factors that may influence the use of nicotine replacement therapy and e-cigarettes.)
How the recommendations might affect practice
Conversations guided by each person's preference are good practice and should already be taking place. However, extra time may be needed for people providing stop-smoking support or advice to discuss the intervention options with people who want to stop smoking, especially for the additional advice on e‑cigarettes. If these recommendations lead people to quit successfully with fewer unsuccessful attempts, this may mean fewer appointments per person.
Commissioning Allen Carr's Easyway in-person group seminar through the NHS or local authority would have resource implications for stop smoking services. But the intervention is cost effective and although the initial cost was higher than the comparator (Quit.ie or local stop smoking services group) this would be quickly offset (within 5 to 7 years) by the reduction in comorbidities and associated healthcare costs. The committee were also advised that the NHS or local authority is likely to be able to negotiate a discount for the intervention if enough people take up the offer.
The committee noted that some people living in rural areas may need help with travel costs if they need to travel long distances to attend the in-person seminar.
Advice on nicotine-containing e-cigarettes
Recommendations 1.12.13 to 1.12.17
Why the committee made the recommendations
Evidence showed that nicotine-containing e‑cigarettes can help people to stop smoking and are of similar effectiveness to other cessation options such as varenicline or long-acting and short-acting NRT.
Benefits and harms of e-cigarettes
The extensive harms of smoking are well known, and the committee agreed it is unlikely that e‑cigarettes could cause similar levels of harm. But they also agreed that for people who do not smoke, it is unlikely that inhaling vapour from an e‑cigarette is as low risk as not doing so, although the extent of that risk is not yet known. They discussed the potential benefits and risks of using nicotine-containing e‑cigarettes to stop smoking.
There was a small amount of evidence about short-term adverse events of e‑cigarettes that did not show that they caused any more adverse events than NRT, e‑cigarettes without nicotine or no treatment. The committee had low confidence in this evidence because studies were usually designed to investigate effectiveness and not adverse events, meaning they may not have been large enough to show an effect.
There were only 2 studies about the long-term harms of using nicotine-containing e‑cigarettes, and the committee discussed the uncertainty of the evidence and their concerns with these studies. A call for evidence did not produce any additional evidence in this area.
The committee agreed that there is insufficient evidence to tell whether e‑cigarettes cause long-term effects. E‑cigarettes are relatively new devices, and it is important to understand whether they cause any health harms or benefits aside from their potential to reduce smoking-related harm (see the recommendation for research on health effects of e-cigarettes).
The committee recognised the need for evidence about what factors may influence use of e‑cigarettes. So they made recommendations for research relating to any possible impacts of the amount of nicotine and frequency of use, and flavourings.
The committee discussed the outbreak of serious lung disease in the US in 2019, which US authorities identified was largely caused by vaping cannabis products containing vitamin E acetate. They also noted there has been a Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update highlighting serious lung injury with e‑cigarettes issued in January 2020 (E-cigarette use or vaping: reporting suspected adverse reactions, including lung injury). The committee discussed that the UK has well-established regulations for e‑cigarettes that restrict what they can contain.
Experts from the MHRA described to the committee the monitoring process for both short- and long-term harms of using e‑cigarettes. Monitoring is ongoing and the evidence may change in the future, but the committee was not aware of any major concerns being identified. Accurate information relies on adverse events being reported, so the committee recommended that people providing stop-smoking support or advice should actively report any suspected adverse events and encourage people to report any that they experience.
The committee used their knowledge and experience to supplement the very limited and uncertain evidence about harms. They agreed that because many of the harmful components of cigarettes are not present in e‑cigarettes, switching to nicotine-containing e‑cigarettes was likely to be significantly less harmful than continuing smoking. So, the committee agreed that people should be able to access them as part of the range of interventions they can choose to use (see the section on stop-smoking interventions). They also agreed that people should be given up-to-date information on what is known about e‑cigarettes to help them make an informed decision about whether to use them.
The committee agreed that with the limited data on effects of longer-term use, people should only use e‑cigarettes for as long as they help prevent them going back to smoking. They also agreed that people should be discouraged from continuing to smoke when using e‑cigarettes, even if they are smoking less, because there is no information on whether this will reduce their harm from smoking.
The committee discussed that it is more likely that people will not get enough nicotine to help them stop smoking, than get too much. They agreed that not getting enough nicotine is likely to increase the risk that the person will return to smoking, so they recommended that people should be encouraged to use as much as they need and told how to use the products effectively.
How the recommendations might affect practice
Extra time may be needed to discuss e‑cigarettes with people who are interested in using them. If these recommendations lead to more successful quit attempts, this may mean fewer appointments per person and substantial savings in downstream costs associated with smoking.
Stop-smoking support in mental health services
Why the committee made the recommendation
The committee agreed the importance of stop-smoking support being available to all, and that people with mental health conditions should not be treated differently in this. However, because those with mental health conditions have a higher prevalence of smoking, and are less likely to access standard smoking cessation services and have lower quit rates, it is important to look at whether additional support could be appropriate.
There was a small amount of evidence about tailored smoking cessation interventions for people with mental health conditions. The evidence of effectiveness identified was in populations with severe mental health conditions such as bipolar disorder, schizophrenia or post-traumatic stress disorder. However, the committee noted there was a lack of consensus of what constitutes a severe mental health condition. They heard from experts that people with other mental health conditions may need additional support as well. This applies both at an individual level and, for those in mental health settings, at a system level. The committee agreed that additional support should be offered to people with severe mental health conditions, and although it might be considered for other people with mental health conditions, there was insufficient evidence to make a wider recommendation. The committee noted that the recommended additional support would fit with current stop-smoking provision. Furthermore, the committee identified this as an important research gap that needs to be addressed to reduce health inequalities (see the recommendation for research on support for people with mental health conditions to stop smoking).
How the recommendation might affect practice
This potential additional support may need extra time and additional appointments. If these recommendations lead to more successful quit attempts, this may mean fewer appointments per person and substantial savings in downstream costs associated with smoking.
Nicotine-containing e-cigarettes for harm reduction
Why the committee made the recommendation for research
No evidence was found on the use of e‑cigarettes specifically for harm reduction for people who do not want, or are not ready, to stop smoking in one go. So, the committee chose not to make recommendations on using e‑cigarettes for harm reduction. They did discuss that e‑cigarettes may be used in this way and that there may be substantial dual use; that is, when someone is both smoking and using e‑cigarettes.
The committee agreed that more information is needed about the use of e‑cigarettes for those who may wish to reduce the amount they smoke.
Supporting people trying to stop smoking
Recommendations 1.17.1 and 1.17.2
Why the committee made the recommendations
The committee agreed that strategies to avoid relapsing are an important part of stop-smoking advice and support, and are likely to be most effective when introduced early in the process and regularly revisited.
Evidence about NRT for preventing relapse was mixed. Although there was evidence that they may be effective in people who had recently quit, using a single type of fast-acting NRT did not reduce relapse with any certainty when people had stopped smoking for longer. The committee discussed this evidence and noted that in their experience, using NRT for longer can stop people relapsing to smoking, particularly if more than 1 type of NRT is used (usually combining patches with a fast-acting form of NRT). They discussed that only offering NRT for 12 weeks could cause people to relapse.
Evidence showed that if people who have used varenicline and bupropion to stop smoking continue taking it for longer, this improves their chances of staying stopped. This included people diagnosed with serious mental illness. There were a small number of studies and they investigated different groups of people and used varenicline in different ways, so the committee had some uncertainty about the evidence.
The committee reflected on the mixed findings from the evidence. They agreed that, because preventing relapse is so important for people who have been able to stop smoking, offering longer-term pharmacotherapy to help prevent relapse was reasonable. The committee noted that bupropion was not licensed for relapse prevention. The studies that evaluated bupropion for this indication had different dosing regimens, so the committee did not specify what dose or duration of bupropion was most effective for preventing relapse.
The committee recognised the need for more evidence about which nicotine-containing products or combination of products are best at preventing relapse after a successful quit attempt (see the recommendations for research on relapse prevention and relapse prevention after enforced, temporary quit).
How the recommendations might affect practice
Stop-smoking advisers can use existing appointments to provide information about preventing relapse to people who want to stop smoking, so this is not expected to have a resource impact, though there may costs associated with prescribing additional pharmacotherapies.
Reviewing the approach for people trying to stop smoking, cutting down or stopping temporarily
Recommendations 1.17.6 and 1.17.7
Why the committee made the recommendations
The committee discussed that it is important to review any stop-smoking or harm-reduction approach taken so that any problems can be addressed. They agreed that it can take someone multiple attempts to stop smoking for good. Encouraging people who have relapsed to smoking and talking to them about trying again may mean that they stay in touch with the service and are more likely to stop smoking in the long term.
Identifying pregnant women who smoke and referring them for stop-smoking support
Recommendations 1.18.1 to 1.18.3
Why the committee made the recommendations
Stopping smoking in pregnancy is important for the health of both the woman and her baby.
Existing recommended practice, based on NICE's previous guideline on stopping smoking in pregnancy and after childbirth, is to offer opt-out provision for pregnant women. The evidence about opt-out referral systems was mixed, but the most recent evidence showed that it resulted in higher self-reported quit rates and more engagement with stop-smoking support.
Most current evidence uses carbon monoxide levels of 4 parts per million (ppm) as the cut-off for referral. Based on this and their expertise, the committee recommended that a carbon monoxide reading of 4 ppm or above would be an appropriate level to automatically refer women for stop-smoking support. This also aligns with the NHS Saving Babies' Lives Care Bundle.
The evidence about women's views on opt-out referral showed that giving women information on carbon monoxide testing and the automatic referral was an important factor in whether they accepted the referral and took up the support. The committee discussed whether there was a specific need for a recommendation on giving information, because all clinical treatment pathways should ensure that people are fully informed and take an active part in their care. They agreed that a recommendation would be helpful in this case, because they considered opt-out treatment is not common in most areas of care.
During development of this guideline, carbon monoxide monitoring was not being used because of COVID‑19 practice changes. The committee acknowledged that during the COVID‑19 pandemic referral decisions may need to be made without using carbon monoxide monitoring.
Nicotine replacement therapy and other pharmacological support
Recommendations 1.20.6 to 1.20.8 and 1.20.10
Why the committee made the recommendations
NICE's 2010 guideline on stopping smoking in pregnancy and after childbirth (replaced by this guideline) recommended nicotine replacement therapy (NRT) for pregnant women only if they are not able to stop smoking using a behavioural intervention without NRT, and once they have stopped smoking. New evidence showed that NRT may help women stop smoking in pregnancy when added to a behavioural intervention.
The committee discussed that women may stop smoking temporarily during pregnancy and relapse afterwards. There was no evidence about continuing NRT after pregnancy to prevent this but, based on their expert opinion, the committee agreed it may be useful.
Evidence showed that advice from healthcare professionals, particularly midwives, was valuable to pregnant women and contributed to their decisions about using NRT. The evidence also showed that consistent advice addressing the main concerns women tend to have about NRT during pregnancy (such as addictiveness, potential side effects and any pregnancy impacts) may help women to feel comfortable using NRT during and after pregnancy.
There is little evidence about the effectiveness or safety of using nicotine-containing e‑cigarettes to help women stop smoking in pregnancy. Many of the studies in the effectiveness meta-analysis for nicotine replacement therapies were over 10 years old and most used doses of nicotine that would now be considered to be low. The committee therefore made recommendations for research to help understand what type and dose of NRT is most effective and the views and concerns of pregnant women and their healthcare professionals about using nicotine-containing e-cigarettes in pregnancy.
Since the publication of this guideline, a National Institute for Health and Care Research trial on helping pregnant smokers quit has been published comparing e‑cigarettes and nicotine patches. NICE reviewed this trial with the help of topic experts (see the 2023 exceptional surveillance review). Although it provides some new data, there are still important gaps in the evidence - particularly for longer term outcomes. So NICE decided that more evidence on effectiveness and safety is still needed before it can update these recommendations.
How the recommendations might affect practice
The change in recommendations since NICE's previous guideline may increase prescriptions of NRT to pregnant women, and potentially increase how long it is prescribed for. If this leads to more cases of successful quitting, it will create considerable savings downstream.
Incentives to stop smoking
Recommendations 1.20.12 to 1.20.14
Why the committee made the recommendations
Evidence showed that offering financial incentives to help pregnant women stop smoking was both effective and cost effective. Voucher incentives were acceptable to many pregnant women and healthcare providers. The committee noted that these are already being used in some areas.
The committee discussed and agreed with the evidence that 'contingent rewards' (given only if biochemical tests prove the woman has stopped) were more effective than guaranteed payments given whether the woman has stopped or not.
More evidence is needed to find out what value of incentive works best. Evidence from the UK showed that schemes in which around £400 could be gained in vouchers staggered over time (with reductions for each relapse made) were effective and cost effective, so the committee included this amount as a guide.
Based on the evidence and their expertise, the committee agreed that incentive schemes that include both the pregnant woman and a significant other supporter could have a better chance of success.
They also agreed that some staff may be unfamiliar with incentive schemes and would benefit from training to help deliver them.
Although the guideline recommends that vouchers should be provided only to those with an abstinence validated by a biochemical method, the committee acknowledged that during the COVID‑19 pandemic carbon monoxide validation may not be being used. While this is the case, vouchers are recommended even if biochemical validation using carbon monoxide is not possible.
Commissioning and designing services
Recommendations 1.22.1 and 1.22.2
Why the committee made the recommendations
The committee looked at a large amount of evidence assessing the relative effectiveness of interventions for stopping smoking (medicinally licensed products and nicotine-containing e‑cigarettes, alone or in combination). Most of the interventions or combinations of interventions were delivered with behavioural support. The committee agreed which interventions should be accessible (see the rationale and impact section for stop-smoking interventions). They agreed that the recommendation from NICE's 2018 guideline on stop-smoking interventions and services (replaced by this guideline) to make stop-smoking interventions available through local plans and approaches to health and wellbeing was still relevant, so they drew on that to make a new recommendation.
The committee noted that not all medicinally licensed products are available in all stop-smoking services, and so local arrangements are in place to ensure that these are accessible when needed. Nicotine-containing e‑cigarettes are not licensed medicines so cannot currently be provided on prescription. However, there are ways of increasing their accessibility, for example by giving evidence-based advice about them and information on where people can access them. The committee were aware that some services use vouchers or starter pack schemes.
Based on evidence and their experience of the use of NRT for preventing relapse, the committee recommended it for longer-term use (see the rationale and impact section for supporting people trying to stop smoking) and agreed this needed to be reflected in service specifications to make sure it was made available.
The committee heard from experts that smoking prevalence is high in some population groups that may not be well served by existing stop-smoking provision (such as those with mental health conditions, or those who identify as LGBT+, or those with low income). And that although these groups may be motivated to stop smoking, they may experience additional challenges to successfully stopping (see the equality impact assessment).
We did not find any evidence on how to tailor effective and cost-effective interventions to ensure that they are engaging and accessible for under-served groups, or how acceptable those interventions may be for those groups. The committee identified this as an important gap that needs to be addressed to reduce health inequalities (see the recommendation for research on stop-smoking interventions for under-served groups).
How the recommendations might affect practice
The committee noted that schemes are already in place in some areas to support starting the use of nicotine-containing e‑cigarettes for stopping smoking.
NICE's 2013 guideline on smoking harm reduction already recommended that service specifications require providers of stop-smoking support to offer long-term NRT.
Stop-smoking support in secondary care
Why the committee made the recommendation
The committee agreed that nicotine-containing products should be available for sale in secondary care settings to help people stop smoking and to support temporary abstinence for patients, staff and visitors because hospital grounds are covered by smokefree legislation.