• Advise people who smoke of the benefits of quitting and ask if they want help to quit.
• For people who want to stop smoking refer to an intensive support service, such as NHS Stop Smoking Services.
• For adults who do not want referral:
• Offer practical advice and follow up to help them stop smoking.
• Offer drug treatment with nicotine replacement therapy (NRT), bupropion, or varenicline to reduce withdrawal symptoms.
• For pregnant or breastfeeding women who do not want referral:
• Offer practical advice and follow up to help them stop smoking.
• Advise stopping without using any drug treatment for women who feel confident they can manage without.
• Advise stopping smoking with NRT for women who cannot manage without.
• For children over the age of 12 years who do not want referral:
• Offer practical advice and follow up to help them stop smoking.
• Advise stopping smoking completely, supported by the use of NRT.
• For someone who does not want to stop smoking:
• Record their smoking status and review once a year, where possible.

• Record the smoking status of all people of smoking age.
• Discuss conditions that are adversely affected by smoking, such as heart disease, peripheral vascular disease, chronic obstructive pulmonary disease, and pregnancy.
• Advise people who smoke of the benefits of quitting and ask if they want help to quit.
• Advice about the benefits of stopping should be clear, strong, and relevant to any health problems they have.
• For people who want to stop smoking:
• Ask about circumstances that could adversely affect their ability to stop smoking:
• Do they live with people who smoke?
• Are they under stress at home or work?
• Do they have any mental health problems?
• Assess their level of nicotine dependency:
• People are generally considered heavily dependent smokers if they smoke 20 cigarettes or more a day, or smoke within 30 minutes of waking.
• People are generally considered less heavily dependent smokers if they smoke less than 20 cigarettes a day and do not smoke within 30 minutes of waking.
• Assume people who are borderline to be heavily dependent for the purposes of drug treatment.

• These recommendations are based on pragmatic advice from experts [Srivastava et al, 2006].

• The preferred management is referral to an intensive support service, such as the NHS Stop Smoking Services.
• For people who do not want referral:
• Offer practical advice and follow-up to help them stop smoking.
• Offer drug treatment to reduce withdrawal symptoms.

• Local NHS Stop Smoking Services can be found:
• Online: www.gosmokefree.nhs.uk
• Via the NHS Smoking Helpline: 0800 169 0 169 (England)

• These recommendations are consistent with guidance issued by the National Institute for Health and Clinical Excellence [NICE, 2006].

• It is strongly recommended that people who want to stop smoking quit abruptly, supported by drug treatment whenever possible.
• For people who are willing and feel able to quit abruptly, reduce the risk of relapse by prescribing nicotine replacement therapy, bupropion, or varenicline. The choice of treatment should be made on an individual basis, taking into account:
• The individual's previous experience of smoking cessation drugs and their preference for treatment.
• Contraindications, cautions, and risk of adverse effects (see Table 1).
• For people who want to quit but are clearly unwilling or unable to quit abruptly, some experts recommend offering nicotine replacement therapy to help them to reduce the amount they smoke before quitting. However the National Institute for Health and Clinical Excellence does not recommend this approach. Instead it states that this strategy should only be used as part of a properly designed and conducted research study of people who have repeatedly tried and failed to quit and those who are adamant that they do not want to quit abruptly. This approach is therefore not recommended as part of routine clinical practice.

• See Prescribing information for details on prescribing the individual treatments.

Basis for the recommendation to stop abruptly, supported by drug treatment:

• There is good evidence summarized by National Institute for Health and Clinical Excellence, to support the use of nicotine replacement therapy (NRT), bupropion, and varenicline for people who are trying to stop smoking [NICE, 2002; NICE, 2007]. This evidence shows that drug treatment increases a person's chances of stopping smoking and of staying stopped after 6–12 months compared with not using drug treatment.
• Nicotine replacement therapy (NRT):
• Good evidence indicates that NRT is significantly more effective than placebo at maintaining continuous abstinence from smoking after at least 6 months [NICE, 2002; Stead et al, 2008]. Evidence suggests that bupropion and NRT do not significantly differ in efficacy [NICE, 2002; Hughes et al, 2007].
• NRT has been in use for many years and has a very good safety profile. For these reasons, many regard it as the pharmacological treatment of choice in smoking cessation [BNF 54, 2007].
• Bupropion:
• Good evidence indicates that bupropion is significantly more effective than placebo at maintaining continuous abstinence from smoking after at least 6 months [NICE, 2002; Hughes et al, 2007]. Evidence suggests bupropion and NRT do not differ in efficacy [NICE, 2002; Hughes et al, 2007].
• Bupropion has been in use in the UK as an aid to smoking cessation since June 2000. Bupropion is associated with a dose-dependent risk of seizure, with an estimated risk of approximately 0.1% (1 in 1000) [CSM, 2001a; CSM, 2001b].
• Varenicline
• Good evidence indicates that varenicline is significantly more effective than placebo at maintaining continuous abstinence from smoking after at least 6 months [Cahill et al, 2007]. Evidence suggests that varenicline has greater efficacy in maintaining continuous abstinence than bupropion [Cahill et al, 2007; Hughes et al, 2007]. CKS found no published studies comparing varenicline with NRT.
• Varenicline has been in use in the UK since December 2006. It is still under intensive surveillance for adverse effects (black triangle).

Basis for using NRT to reduce the amount smoked before quitting:

• There is difference of opinion among experts as to the value of nicotine-assisted reduction to stop.
• Evidence from a systematic review found that compared to placebo [Wang et al, 2008]:
• For people who declare an unwillingness or inability to quit smoking in the short term, NRT is effective in reducing their smoking.
• A small but statistically significant proportion of people treated with NRT quit smoking completely even though they had declared no interest in quitting.
• In this population of recalcitrant smokers, NRT generates abstinence success rates less than half of those reported for smokers willing to attempt an abrupt quit with NRT.
• The National Institute for Health and Clinical Excellence (NICE) recommends that until further evidence becomes available nicotine-assisted reduction to stop only be used in properly designed and conducted research studies [NICE, 2008]. NICE recommend further research is required to establish:
• How to make nicotine-assisted reduction to stop available without deterring people who want to stop from attempting to quit abruptly.
• Which health care professionals can best support this strategy.
• How this strategy would fit in with existing services.
• Other experts support the use of nicotine-assisted reduction to stop, based upon this evidence [McEwen et al, 2006].

Advise people who want to stop smoking to:

• Prepare mentally to stop by:
• Making a list of reasons why they want to stop.
• Explaining that most of the pleasure of smoking comes from the relief of nicotine withdrawal symptoms.
• Expecting stopping to be difficult but progressively easier after the third or fourth day. Modest weight gain may occur but is less likely while using drug treatments to help stop smoking.
• Involving family and friends by telling people about their intention to stop and, if possible, stopping with someone else.
• Set a date to stop smoking when they feel well and under the least amount of stress possible. Advise people to stop immediately if they are ready to do so.
• Avoid relapses by:
• Using drug treatments to relieve the symptoms of nicotine withdrawal (e.g. nicotine replacement therapy).
• Avoiding situations associated with smoking until they can comfortably resist the impulse to smoke (e.g. remove smoking paraphernalia from the home, avoid alcohol in the early stages of stopping).
• Replacing smoking with other activities, such as chewing gum, drinking water or tea, or taking glucose tablets relieve nicotine cravings.
• Setting targets for remaining smoke free and rewarding themselves for reaching these targets.
• Try again if they relapse. Most people who successfully stop smoking long term need several attempts before they finally stop completely.

• These are pragmatic recommendations based on expert opinion [ASH, 2005a; Srivastava et al, 2006].

• For people quitting abruptly supported by drug treatment, review within 2 weeks of their stop date:
• For people who continue to smoke, reassess their readiness to quit. If they demonstrate a continuing attempt to quit:
• Encourage them to quit abruptly. If they can quit abruptly, continue treatment.
• For people who want to quit but are clearly unwilling or unable to quit abruptly, some experts recommend offering nicotine replacement therapy to help them to reduce the amount they smoke before quitting. However the National Institute for Health and Clinical Excellence does not recommend this approach. Instead it states that this strategy should only be used as part of a properly designed and conducted research study of people who have repeatedly tried and failed to quit and those who are adamant that they do not want to quit abruptly. This approach is therefore not recommended as part of routine clinical practice.
• For people with adverse effects from treatment, consider reducing the dose of current treatment, or trying an alternative treatment (or formulation in the case of NRT).
• For people with significant nicotine withdrawal symptoms on treatment, the options include:
• Increasing the dose (up to the maximum licensed dose that is tolerated).
• For people using NRT patches, consider combining with a rapid-release NRT product to relieve breakthrough symptoms.
• Changing formulation of NRT e.g. people who experience withdrawal symptoms first thing in the morning after removing NRT patch at night could consider using a 24-hour patch.
• For people remaining smoke free and managing well, review each month and prescribe further medication.
• For people using NRT to assist a reduction in smoking before quitting, review within 1 month of starting NRT and assess their level of smoking. The goal is to reduce smoking by at least 50% within a month of starting NRT and to have stopped smoking completely within 6 months. Continue NRT for 3 months after stopping completely.

• The recommended duration of treatment is:
• Nicotine replacement therapy — 12 weeks.
• Varenicline — 12 weeks followed by a further 12 weeks if it is thought necessary to prevent relapse.
• Bupropion — 7–9 weeks.

Basis for recommending continued treatment only if the person demonstrates a continued attempt to stop:

• This is pragmatic advice that is consistent with recommendations made by the National Institute for Health and Clinical Excellence [NICE, 2008].

• The preferred management is referral to an intensive support service, such as the NHS Stop Smoking Services.
• For women who do not want referral:
• Offer practical advice and follow up to help them stop smoking.
• Advise stopping without using any drug treatment for women who feel confident they can manage without.
• For women who feel able to stop smoking but who are likely to relapse without treatment, offer drug treatment (nicotine replacement therapy).

• Local NHS Stop Smoking Services can be found:
• Online: www.gosmokefree.nhs.uk
• Via the NHS Smoking Helpline: 0800 169 0 169 (England)

• These recommendations are consistent with guidance issued by the National Institute for Health and Clinical Excellence [NICE, 2006].

• Nicotine replacement therapy is recommended for pregnant or breastfeeding women who feel unable or are unlikely to stop smoking without drug treatment.
• Bupropion and varenicline are not recommended for use in women who are pregnant or breastfeeding.

• Basis for using nicotine replacement therapy (NRT) in pregnancy:
• There is a lack of trial data on the benefits and risks of NRT in pregnancy. To eliminate all possible risks from nicotine a women would ideally stop smoking without using NRT.
• There is expert consensus that replacing smoking with NRT to prevent relapse is justifiable in pregnant women in whom non-pharmacological interventions, such as behavioural counselling, have been unsuccessful because [MHRA, 2005a]:
• Although there is no direct evidence for it, it is assumed that evidence for the effectiveness for NRT in smoking cessation in the general population is applicable to pregnant women.
• The risk to the fetus of continued smoking is likely to be greater than any potential risks from NRT because cigarette smoking, in general, delivers more nicotine than does NRT, and it exposes both mother and fetus to many other toxins.
• Basis for using NRT when breastfeeding:
• There is a lack of trial data on the benefits and risks of NRT in breastfeeding women. The amount of nicotine the infant is exposed to from breast milk is relatively small and is less hazardous than the second-hand smoke the infant would otherwise be exposed to if the mother continued to smoke [MHRA, 2005a].

Advise women who are pregnant or breastfeeding who want to stop smoking to:

• Prepare mentally to stop by:
• Making a list of reasons why they want to stop.
• Explaining that most of the pleasure of smoking comes from the relief of nicotine withdrawal symptoms.
• Expecting stopping to be difficult but progressively easier after the third or fourth day.
• Involving family and friends by telling people about their intention to stop and, if possible, stopping with someone else.
• Set a date to stop smoking when they feel well and under the least amount of stress possible. Advise women to stop immediately if they are ready to do so.
• Avoid relapses by:
• Using nicotine replacement therapy to relieve the symptoms of nicotine withdrawal.
• Avoiding situations associated with smoking until they can comfortably resist the impulse to smoke (e.g. remove smoking paraphernalia from the home).
• Replacing smoking with other activities, such as chewing gum, drinking water or tea, or taking glucose tablets relieve nicotine cravings.
• Setting targets for remaining smoke free and rewarding themselves for reaching these targets.
• Try again if they relapse. Most people who successfully stop smoking long term need several attempts before they finally stop completely.

• These are pragmatic recommendations based on expert opinion [ASH, 2005b; Srivastava et al, 2006].

• For women stopping smoking without nicotine replacement therapy (NRT), review within 7 days of the stop date and offer NRT to those who have not stopped smoking or who are having difficulty not smoking.
• For women stopping smoking completely with NRT, review within 2 weeks of their stop date:
• For those who continue to smoke, reassess their readiness to quit by asking them whether they would like help to continue with their quit attempt. Continue treatment if they demonstrate a continuing attempt to stop.
• For those with adverse effects from treatment, consider reducing their dose, or changing the formulation.
• For those with significant nicotine withdrawal symptoms on treatment, consider increasing the dose of NRT (up to the maximum licensed dose that is tolerated).
• For people remaining smoke free and managing well review each month and prescribe further NRT for up to 12 weeks.

• These recommendations are consistent with guidance issued by the National Institute for Health and Clinical Excellence [NICE, 2006].

• The preferred management is referral to an intensive support service, such as the NHS Stop Smoking Services.
• For people who do not want referral:
• Offer practical advice and follow up to help them stop smoking.
• Advise stopping smoking completely and offer drug treatment (nicotine replacement therapy) to reduce the risk of relapse.

• Local NHS Stop Smoking Services can be found:
• Online: www.gosmokefree.nhs.uk
• Via the NHS Smoking Helpline: 0800 169 0 169 (England)

• These recommendations are consistent with guidance issued by the National Institute for Health and Clinical Excellence [NICE, 2006].

• For children over the age of 12 years, offer nicotine replacement therapy to reduce the risk of relapse.
• Treatment should be limited to 12 weeks where possible.
• See Prescribing information for details on prescribing the individual treatments.

• The recommendation to use nicotine replacement therapy (NRT) in children over 12 years of age is in line with advice issued by the Commission on Human Medicines (CHM) [MHRA, 2005a]. The CHM advises that, because data on safety and efficacy are limited, duration should be restricted to 12 weeks. Treatment may be continued longer than 12 weeks under the supervision of a healthcare professional.
• NRT to assist smoking reduction before quitting is not recommended in this age group because treatment is likely to exceed the recommended duration of 12 weeks.
• Bupropion and varenicline are not recommended because they are not licensed for use in people younger than 18 years of age.

Advise children who want to stop smoking to:

• Prepare mentally to stop by:
• Making a list of reasons why they want to stop.
• Explaining that most of the pleasure of smoking comes from the relief of nicotine withdrawal symptoms.
• Expecting stopping to be difficult but progressively easier after the third or fourth day. Modest weight gain may occur but is less likely while using NRT to help stop smoking.
• Involving family and friends by telling people about their intention to stop and, if possible, stopping with someone else.
• Set a date to stop smoking when they feel well and under the least amount of stress possible. Advise children to stop immediately if they are ready to do so.
• Avoid relapses by:
• Using nicotine replacement therapy to relieve the symptoms of nicotine withdrawal.
• Avoiding situations associated with smoking until they can comfortably resist the impulse to smoke. Remove smoking paraphernalia and avoid alcohol in the early stages of stopping.
• Replacing smoking with other activities, such as chewing gum, drinking water or tea, or taking glucose tablets relieve nicotine cravings.
• Setting targets for remaining smoke free and rewarding themselves for reaching these targets.
• Try again if they relapse. Most people who successfully stop smoking long term need several attempts before they finally stop completely.

• These are pragmatic recommendations based on expert opinion [ASH, 2005b; Srivastava et al, 2006].

• Review children over 12 years of age using nicotine replacement therapy (NRT) within 2 weeks of their stop date:
• For those who continue to smoke, reassess their readiness to quit by asking them whether they would like help to continue with their quit attempt. Continue treatment if they demonstrate a continuing attempt to stop.
• For those with adverse effects from treatment, consider reducing the dose or changing the formulation.
• For those with significant nicotine withdrawal symptoms on treatment, the options include:
• Increasing the dose (up to the maximum licensed dose that is tolerated).
• For people using NRT patches, consider combining with a rapid-release NRT product to relieve breakthrough symptoms.
• Changing formulation of NRT e.g. people who experience withdrawal symptoms first thing in the morning after removing NRT at night could consider using a 24-hour patch.
• For those remaining smoke free and managing well, review each month and prescribe further medication for up to 12 weeks.

• These are pragmatic recommendations that are consistent with guidance issued by the National Institute for Health and Clinical Excellence [NICE, 2008].

• Record the smoking status of individuals who are not ready to stop and review this with the individual once a year, where possible.

• This recommendation is consistent with guidance issued by the National Institute for Health and Clinical Excellence [NICE, 2006].