1 Recommendations

The Programme Development Group (PDG) considers that the recommended approaches are cost effective.

The evidence underpinning the recommendations is listed in The evidence.

See also What evidence is the guidance based on? for the evidence reviews, economic modelling report and expert papers.

For the research recommendations and gaps in research see Recommendations for research and Gaps in the evidence.

Context

Stop smoking services provide highly cost-effective interventions to help people stop smoking[1] and any investment in the harm-reduction approaches covered by this guidance should not detract from their provision. Rather, the recommendations in this guidance are intended to support and extend the reach and impact of existing services.

Although existing evidence is not clear about the health benefits of smoking reduction, those who reduce the amount they smoke are more likely to stop smoking eventually, particularly if they are using licensed nicotine-containing products.

Definitions

The recommendations use the phrase 'licensed nicotine-containing products' to cover products containing nicotine that have 'marketing authorisation' for use as a smoking cessation aid and for tobacco harm-reduction[2] from the Medicines and Healthcare products Regulatory Agency (MHRA). Authorisation by the MHRA ensures they are effective, deliver nicotine safely and are manufactured to a consistent quality.

Using these products can make it easier for people to cut down before stopping, reduce their smoking or abstain. They can also help reduce compensatory smoking behaviour, such as inhaling smoke more deeply to compensate for smoking fewer cigarettes.

Box 1 Harm reduction approaches covered by the guidance

  • Stopping smoking, but using one or more licensed nicotine-containing products as long as needed to prevent relapse

  • Cutting down prior to stopping smoking (cutting down to quit)

    • with the help of one or more licensed nicotine-containing products (the products may be used as long as needed to prevent relapse)

    • without using licensed nicotine-containing products.

  • Smoking reduction

    • with the help of one or more licensed nicotine-containing products (the products may be used as long as needed to prevent relapse)

    • without using licensed nicotine-containing products.

  • Temporary abstinence from smoking

    • with the help of one or more licensed nicotine-containing products

    • without using licensed nicotine-containing products.

Whose health will benefit?

The approaches covered by this guidance are aimed at people who:

  • may not be able (or do not want) to stop smoking in one step

  • may want to stop smoking, without necessarily giving up nicotine

  • may not be ready to stop smoking, but want to reduce the amount they smoke.

The recommendations are particularly relevant to people who are highly dependent on nicotine and groups where smoking prevalence is higher than average. Examples include: people with mental illness, people from lower socioeconomic groups and people from lesbian, gay and bisexual and trans-gendered groups. They are also relevant to people who are less likely to use services focusing on abrupt cessation.

Recommendation 1 Raising awareness of licensed nicotine-containing products

Who should take action?

  • National, subnational and local organisations responsible for public health and tackling tobacco use. This includes:

    • professional bodies with a healthcare or public health responsibility

    • subnational tobacco control organisations

    • stop smoking services

    • statutory agencies such as health and wellbeing boards and local authorities

    • voluntary and community sector organisations.

What action should they take?

  • Raise public awareness of the harm caused by smoking and secondhand smoke. Provide information on how people who smoke can reduce the risk of illness and death (to themselves and others) by using one or more licensed nicotine-containing products. Explain that they could be used as a partial or complete substitute for tobacco, either temporarily or in the long-term.

  • Provide this information in a range of formats and languages for different target groups.

  • Ensure it includes the following information:

    • smoking causes a range of diseases and conditions including cancer, chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD)

    • most health problems are caused by other components in tobacco smoke, not by the nicotine

    • smoking is highly addictive largely because it delivers nicotine very quickly to the brain and this makes stopping smoking difficult

    • nicotine levels in licensed nicotine-containing products are much lower than in tobacco, and the way these products deliver nicotine makes them less addictive than smoking tobacco

    • licensed nicotine-containing products are an effective way of reducing the harm from tobacco for both the person smoking and those around them

    • it is safer to use licensed nicotine-containing products than to smoke

    • nicotine replacement therapy (NRT) products [3] have been demonstrated in trials to be safe to use for at least 5 years

    • there is reason to believe that lifetime use of licensed nicotine-containing products will be considerably less harmful than smoking

    • little direct evidence is available on the effectiveness, quality and safety of nicotine-containing products that are not regulated by the MHRA[3]. However, they are expected to be less harmful than tobacco.

  • Provide information on how to obtain and use licensed nicotine-containing products including:

    • what forms they take

    • how to use them effectively when trying to stop or reduce smoking (either as a partial or complete substitute for smoking)

    • long-term use to reduce the risk of relapsing

    • where to obtain them (including from GPs)

    • the cost compared with smoking.

Recommendation 2 Self-help materials

Who should take action?

  • National, subnational and local organisations responsible for public health and tackling tobacco use. This includes:

    • professional bodies with a public health responsibility

    • subnational tobacco control organisations

    • stop smoking services

    • statutory agencies such as health and wellbeing boards and local authorities

    • voluntary and community sector organisations.

  • Organisations providing practitioners with training in reducing the harm caused by smoking, such as the National Centre for Smoking Cessation and Training (NCSCT).

  • Telephone helplines and Internet support sites aimed at helping people to stop smoking.

  • Manufacturers of licensed nicotine-containing products.

  • Retailers.

What action should they take?

  • Provide self-help materials in a range of formats and languages, tailored to meet the needs of groups where smoking prevalence and tobacco dependency is high. For example, these may include people with a mental illness, people from lower socioeconomic groups and people from lesbian, gay and bisexual and trans-gendered groups. Also target groups that are less likely to access services focusing on abrupt cessation.

  • Self-help materials should include:

    • details about the harm-reduction approaches outlined in box 1

    • an emphasis on the fact that stopping smoking will improve health far more than continuing to smoke, even at a reduced rate

    • advice on how to plan a schedule (see recommendation 4)

    • advice on strategies to cut down and gradually stop or reduce the amount they smoke (see recommendation 4)

    • benefits of using licensed nicotine-containing products to reduce the harm from smoking (see recommendation 1)

    • type of licensed nicotine-containing products available (the MHRA website is the most up-to-date source)

    • how to use licensed nicotine-containing products effectively to manage the cravings, mood swings and other effects of nicotine dependency and to prevent relapse

    • where licensed nicotine-containing products can be purchased and who is able to supply or prescribe them

    • where to get further help and support.

  • Use social media websites as a means of promoting self-help materials.

Recommendation 3 Choosing a harm-reduction approach

Who should take action?

  • Stop smoking advisers.

  • Health and social care practitioners and others with a public health responsibility, in particular those working in:

    • primary and secondary healthcare

    • pharmacies

    • local authorities

    • residential and domiciliary care.

  • Community and voluntary organisations.

  • Telephone helplines and Internet support sites aimed at helping people to stop smoking.

What action should they take?

  • Identify people who smoke and advise them to stop smoking in one step as the best approach. See NICE guidance on smoking cessation services and brief interventions and referral for smoking cessation and the Department of Health's Stop smoking service delivery and monitoring guidance 2011/12.

  • If someone does not want, is not ready or is unable to stop smoking in one step, ask if they would like to consider a harm-reduction approach. If they agree, help them to identify why they smoke, their smoking triggers and their smoking behaviour. Use this information to work through the harm-reduction approaches outlined in box 1.

  • Use professional judgement to suggest which approach(es) might be most suitable, based on the person's smoking behaviour, experience of previous quit attempts and their health and social circumstances. Briefly discuss the merits of each approach to help them choose.

  • Ensure people know that licensed nicotine-containing products (such as nicotine patches, gum, or spray) make it easier to cut down prior to stopping, or to reduce the amount they smoke. Explain that using these products also helps avoid compensatory smoking and increases the chances of stopping in the longer term.

  • Recommend one or more licensed nicotine-containing products. If possible, supply or prescribe these products. Otherwise, encourage people to ask their GP or pharmacist for them, or tell them where they can buy the products themselves (see recommendation 6).

  • Advise people that they can continue to use licensed nicotine-containing products in the long term, rather than risk relapsing after they have stopped, or reduced their smoking.

  • If more intensive support is required, offer a referral to stop smoking services. These services provide pharmacotherapies and more comprehensive support and advice about harm reduction and stopping smoking in the longer term (see recommendations 4–7).

Recommendation 4 Behavioural support

Who should take action?

  • Stop smoking advisers.

  • Health and social care practitioners and others with a public health responsibility who are trained to provide behavioural support to help people stop smoking.

  • Telephone helplines and Internet support sites aimed at helping people to stop smoking.

What action should they take?

  • Find out about the person's smoking behaviour and level of nicotine dependence by asking how many cigarettes they smoke – and how soon after waking. (See the Department of Health's Stop smoking service delivery and monitoring guidance 2011/12.)

  • Use the information gathered to help people set goals and discuss reduction strategies. This may include increasing the time interval between cigarettes, delaying the first cigarette of the day or choosing periods during the day, or specific occasions, when they will not smoke.

  • Help people who are cutting down prior to stopping smoking to set a specific quit date. The quit date should normally be within 6 weeks from the start of receiving behavioural support, although the sooner the better. Help them to develop a schedule detailing how much they aim to cut down (and when) in the lead up to that date.

  • Help people who are aiming to reduce the amount they smoke (but not intending to stop) to set a date when they will have achieved their goal. Help them to develop a schedule for this or to identify specific periods of time (or specific events) when they will not smoke.

  • Tell people who are not prepared to stop smoking that the health benefits from smoking reduction are unclear. However, advise them that if they reduce their smoking now they are more likely to stop smoking in the future. Explain that this is particularly true if they use licensed nicotine-containing products to help reduce the amount they smoke.

  • Where necessary, advise people how to use licensed nicotine-containing products effectively.

  • Offer follow-up appointments to review progress and support people who have adopted a harm-reduction approach (see recommendation 7).

Recommendation 5 Advising on licensed nicotine-containing products

Who should take action?

  • Stop smoking advisers.

  • Health and social care practitioners and others with a public health responsibility, in particular those working in:

    • primary and secondary healthcare

    • pharmacies

    • local authorities

    • residential and domiciliary care.

  • Community and voluntary organisations.

  • Telephone helplines and Internet support sites aimed at helping people to stop smoking.

What action should they take?

  • Reassure people who smoke that licensed nicotine-containing products are a safe and effective way of reducing the amount they smoke. Advise that they can be used as a complete or partial substitute for tobacco, either in the short or long term. Reassure them that it is better to use these products and reduce the amount they smoke than to continue smoking at their current level.

  • Explain how to use licensed nicotine-containing products correctly. This includes ensuring people know how to achieve a sufficiently high dose to control cravings, prevent compensatory smoking and achieve their goals on stopping or reducing the amount they smoke.

  • Explain that people can use one product on its own or a combination of different ones. Advise them that using more than one product is more likely to be successful, particularly for more dependent smokers. (Some products are fast acting and deal better with immediate cravings, whereas others are long acting and provide a steadier supply of nicotine.)

  • Advise people to replace each cigarette with a licensed nicotine-containing product, for example, a lozenge or piece of gum. Ideally they should use this before the usual time they would have had the cigarette, to allow for the slower nicotine release from these products.

  • Advise people that licensed nicotine-containing products can be used for as long as they help reduce the desire to smoke – and for the long term, if necessary, to prevent relapse.

  • Tell people that some nicotine-containing products are not regulated by the MHRA[4] and, therefore, their effectiveness, safety and quality cannot be assured. Also advise them that these products are likely to be less harmful than cigarettes.

Recommendation 6 Supplying licensed nicotine-containing products

Who should take action?

  • Stop smoking advisers.

  • GPs and other healthcare professionals with prescribing rights.

  • Practitioners named by patient group directives.

  • Prison health service staff.

  • Custody officers, police force medical examiners and related healthcare professionals.

What action should they take?

  • Offer all types of licensed nicotine-containing products to people who smoke, as part of a harm-reduction strategy (either singly or in combination). Take into account their preference and level of dependence. As an example, patches could be offered with gum or lozenges.

  • Offer licensed nicotine-containing products, as necessary, to help prevent a relapse among people who have stopped smoking or reduced the amount they smoke. (This includes people who have stopped smoking in one step or by cutting down prior to stopping.)

Recommendation 7 Follow-up appointments

Who should take action?

  • Stop smoking advisers.

  • Health and social care practitioners who are trained to provide behavioural support to help people stop smoking.

What action should they take?

  • Follow people up to see whether they have achieved their goal(s). If those who set out to reduce the amount they smoke (or to abstain temporarily) have been successful, assess their motivation to maintain that level, to further reduce the amount they smoke or to stop smoking.

  • Use professional judgement about the number, timing and frequency of appointments offered.

  • At appropriate intervals, measure exhaled carbon monoxide level to gauge people's progress and help motivate them. Ask them whether daily activities, for example climbing the stairs or walking uphill, have become easier. Use this feedback to prompt discussion about the benefits of reducing their smoking and, where appropriate, to encourage a further reduction or stopping completely.

  • Encourage people who have not achieved their goals to try again. Also discuss whether they would like to continue using the same licensed nicotine-containing product or try a different one (or a different combination of products).

Recommendation 8 Supporting temporary abstinence

Who should take action?

  • Stop smoking advisers.

  • Health and social care practitioners and others with a public health responsibility, in particular those working in:

    • primary and secondary healthcare

    • pharmacies

    • local authorities

    • residential and domiciliary care.

  • Community and voluntary organisations.

  • Telephone helplines and Internet support sites that help people to stop smoking.

What action should they take?

  • Offer people who want (or need) to abstain temporarily on a short-, medium- or longer-term basis advice on how to do this[5]. Include information about the different types of licensed nicotine-containing products and how to use them (see recommendation 5). Where possible, prescribe them (see recommendation 6).

  • Offer behavioural support to people who want (or need) to abstain temporarily. Support may be provided in one-to-one or group sessions by specialist services (see recommendation 4). It could include discussing why it is important to reduce the harm caused by smoking (to others as well as themselves). It could also include encouraging people to consider other times or situations when they could abstain.

  • Offer follow-up appointments (see recommendation 7).

Recommendation 9 People in closed institutions

Who should take action?

Managers of services where smoking is not permitted such as:

  • secure mental health units

  • immigration retention centres

  • custodial sites such as prisons and police stations.

What action should they take?

  • Incorporate management of smoking in the care plan of people in closed institutions who smoke.

  • Ensure those giving harm-reduction advice in situations where smoking is not permitted are trained to the same standard as the level required for the National Centre for Smoking Cessation and Training stage 2 assessment (or the equivalent). This includes people working in mental health and prison health services.

  • Ensure staff recognise that some people perceive smoking as an integral part of their lives. Also ensure staff recognise the issues arising from enforced, as opposed to voluntary, abstinence.

  • Ensure staff recognise how the closed environment may restrict the techniques and coping mechanisms that people would normally use to stop smoking or reduce the amount they smoke. Provide the support required for their circumstances (see recommendations 3–7). This includes prescribing or supplying licensed nicotine-containing products.

  • Ensure staff understand that, if someone reduces the amount they smoke (or stops completely), this can impact on their need for psychotropic and some other medications (see UK Medicines information for further details). Ensure arrangements are in place to adjust their medication accordingly.

Recommendation 10 Staff working in closed institutions

Who should take action?

Managers of services where smoking is not permitted such as:

  • secure mental health units

  • immigration retention centres

  • custodial sites such as prisons and police stations.

What action should they take?

  • Ensure staff with health and social care or custodial responsibilities do not smoke during working hours in locations where the people in their care are not allowed to smoke.

  • Ensure systems are in place for staff who smoke to receive advice and guidance on how to stop smoking in one step (see recommendation 3, also see NICE guidance on workplace interventions to promote smoking cessation). If, after discussion, the person does not want (or does not feel able) to do this, ask them if they would like to consider a harm-reduction approach, as outlined in box 1.

  • Encourage staff to use stop smoking services to stop or reduce the amount they smoke.

  • Encourage staff who do not want to stop smoking to use licensed nicotine-containing products to help them abstain immediately before and while on duty.

Recommendation 11 Commissioning stop smoking services

Who should take action?

Commissioners of stop smoking services.

What action should they take?

  • Ensure investment in harm-reduction approaches does not detract from, but supports and extends the reach and impact of, existing stop smoking services. (The latter provide highly cost-effective interventions to help people stop smoking in one step[1].)

  • Develop smoking cessation referral and treatment pathways to ensure a range of approaches and interventions are available to support people who opt for a harm-reduction approach (see box 1).

  • Ensure the providers of stop smoking and other behaviour-change services offer people who smoke the harm-reduction approaches outlined in box 1. Ensure services are available in the community, as part of primary and secondary healthcare and on offer from local authorities.

  • Develop activity and outcome measures to assess the performance of service providers involved in supporting people who are using harm-reduction approaches. Measures of activity could include:

    • numbers attending the services (to allow comparison with the numbers attending before harm-reductions options were offered)

    • classifying the harm-reduction approaches used (see box 1)

    • client characteristics (such as demographic data, cigarette usage, level of dependency and previous quit attempts)

    • type and amount of licensed nicotine-containing products supplied or prescribed, and over-the-counter sales of these products

    • number of people setting a quit date.

  • Ensure service specifications include a requirement that providers of stop smoking services offer licensed nicotine-containing products on a long-term basis to help prevent a relapse among people who have stopped smoking. Long-term use should also be available to help people maintain a lower level of consumption.

  • Ensure service specifications include a requirement that staff working in stop smoking services are trained to the National Centre for Smoking Cessation and Training stage 2 assessment level (or the equivalent).

Recommendation 12 Education and training for practitioners

Who should take action?

  • Health Education England and local education and training boards.

  • Royal medical and nursing colleges and other professional bodies.

  • Organisations providing training on the harm caused by smoking, such as the National Centre for Smoking Cessation and Training.

  • Commissioners, providers and managers of stop smoking services.

What action should they take?

  • Include the principles and practice of tobacco harm reduction, as outlined in this guidance, within all relevant curricula.

  • Ensure service specifications and service-level agreements state that staff are trained to National Centre for Smoking Cessation and Training stage 2 assessment level (or the equivalent). Staff should also undertake continuing professional development on a regular basis.

Recommendation 13 Point-of-sale promotion of licensed nicotine-containing products

Who should take action?

Manufacturers and retailers of licensed nicotine-containing products, including tobacco retailers.

What action should they take?

  • Encourage people who smoke to consider the harm-reduction approaches outlined in box 1.

  • Display licensed nicotine-containing products in shops and supermarkets, and on websites selling cigarettes and tobacco products.

Recommendation 14 Manufacturer information on licensed nicotine-containing products

Who should take action?

Manufacturers of licensed nicotine-containing products.

What action should they take?

  • Provide clear, unambiguous and accurate information to the consumer on the health risks of any licensed nicotine-containing product, as compared to continuing to smoke and not smoking. This should include details on long-term use.

  • Provide simple, clear instructions on how to use licensed nicotine-containing products to support the harm-reduction approaches outlined in box 1.

  • Consider providing information on the outer packaging as well as in the enclosed leaflet.

  • Package products in a way that makes it as easy as possible for people to take the recommended dose for the right amount of time.



[1] See NICE guidance on smoking cessation services.

[2] At the time of publication (June 2013), only nicotine replacement therapy (NRT) products were licensed by the Medicines and Healthcare products Regulatory Agency (MHRA). A decision from the MHRA on the regulation of other nicotine-containing products (for example, electronic cigarettes and topical gels) was pending. The MHRA has since issued a decision that all nicotine-containing products should be regulated once the European Commission's revised Tobacco Products Directive comes into effect in the UK (this is expected to be in 2016). In the meantime, the UK government will encourage applications for medicines licences for nicotine-containing products and will make best use of the flexibilities within the existing framework to enable licensed products to be available. For further details, see the MHRA website.

[3] At the time of publication (June 2013), NRT products were the only licensed nicotine-containing products. The MHRA has since issued a decision that all nicotine-containing products should be regulated once the European Commission's revised Tobacco Products Directive comes into effect in the UK (this is expected to be in 2016). In the meantime, the UK government will encourage applications for medicines licences for nicotine-containing products and will make best use of the flexibilities within the existing framework to enable licensed products to be available. For further details, see the MHRA website.

[4] Unlicensed products that are currently being marketed, such as electronic cigarettes, and products new to the market will need a medicines licence once the European Commission's revised Tobacco Products Directive comes into effect in the UK (this is expected to be in 2016). In the meantime, the UK government will encourage applications for medicines licences for nicotine-containing products and will make best use of the flexibilities within the existing framework to enable licensed products to be available. For further details, see the MHRA website.

[5] People might temporarily abstain in the short-term to comply with smokefree policies, for example, at work. Medium-term temporary abstinence may occur when admitted to hospital. Long-term temporary abstinence might occur during a custodial sentence.

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