Smoking cessation guidance

• Cornwall
  • Stop smoking service (01209 215666)
• Devon
  • Smokefree Devon Alliance (01884 836 024)
• Torbay
  • Torbay Stop Smoking Service (01803 299160)

Smoking Cessation Advisers recommend patches as first choice for most patients. The 16-hour patch (Nicorette®) is preferable as nicotine can cause sleep disturbances. However, if the patient has the first cigarette within 30 minutes of waking, the 24-hour patch (Nicotinell®) would be more appropriate.

Combination therapy should only be initiated by prescribers with specialist knowledge or upon specialist advice.

Although products are licensed for 10-12 weeks, smoking cessation advisers are encouraged to assess whether patients require therapy beyond 8 weeks. Titration of the dose is not considered necessary for the first 8 weeks.

It is suggested that prescriptions should be linked to an appointment with the smoking cessation adviser, who can check for continued abstinence.

Adverse drug reactions to NRT

NRT in general is associated with few adverse events. Withdrawal from nicotine and tobacco is often difficult to separate from the adverse reactions. Potential adverse reactions of NRT include: nausea, headache, cold and influenza-like symptoms, palpitations, dyspepsia, insomnia, vivid dreams and myalgia. Other side effects reported include chest pain, blood pressure changes, anxiety, irritability, somnolence, impaired concentration and dysmenorrhoea.

Patches have been particularly associated with skin reactions (discontinue if severe). Patches should be opened and then left for a minute before putting them on; this can help to prevent irritation.

Oral products have been associated with aphthous ulceration, cough, rhinitis and other local effects.

Fagerström test for nicotine dependence

Asking the following questions will help decide which NRT preparation to prescribe.

• How soon after you wake up do you smoke your first cigarette?
  • Within 5 minutes = 3
  • 6-30 minutes = 2
  • 31-60 minutes = 1
  • Longer than 60 minutes = 0
• Do you find it difficult to refrain from smoking in places where it is forbidden, e.g. restaurants?
  • Yes = 1
  • No = 0
• Which cigarette would you hate most to give up?
  • 1st of the day = 1
  • Other = 0
• How many cigarettes per day do you smoke?
  • 10 or fewer = 0
  • 11-20 = 1
  • 21-30 = 2
  • 31 or more = 3
• Do you smoke more frequently during the first few hours after waking than during the rest of the day?
  • Yes = 1
  • No = 0
• Do you smoke if you are so ill that you are in bed most of the day?
  • Yes = 1
  • No = 0

The answers to each question have a dependence score. Add up the total score to give that clients level of nicotine dependence.

• 1 - 3 inclusive - Low dependence
• 4 - 6 inclusive - Moderate dependence
• 7 - 10 inclusive - High dependence

The products have been placed in order of consideration.

Nicorette® Invisipatch 10mg

• Suggested daily quantity: One patch releases 10mg over 16 hours
• Suggested initial 14 day supply: 2 x 7 (£19.94)

This patch is recommended for people who do not smoke within an hour of waking.

Nicotinell® TTS 20 14mg patch

• Suggested daily quantity: One patch releases 14mg over 24 hours
• Suggested initial 14 day supply: 2 x 7 (£18.80)

Alternative patch if patient has first cigarette within 30 minutes of waking (24 hour nicotine therapy can adversely affect sleeping patterns)

NiQuitin® 2mg lozenge

• Suggested daily quantity: Ten - Fifteen 2mg lozenges
• Suggested initial 14 day supply: 2 – 3 x 72 (£19.94 - £29.91)

Nicorette® Cools 2mg lozenge

• Suggested daily quantity: Ten 2mg lozenges
• Suggested initial 14 day supply: 2 x 80 (£22.86)

Nicorette® chewing gum 2mg

• Suggested daily quantity: Ten - Fifteen 2mg pieces
• Suggested initial 14 day supply: 1 x 210 (£14.82)

Nicorette® inhalator

• Suggested daily quantity: Two - three 15mg cartridges
• Suggested initial 14 day supply: 1 x 36 (£23.33)

The products have been placed in order of consideration.

Nicorette® Invisipatch 15mg

• Suggested daily quantity: One patch releases 15mg over 16 hours
• Suggested initial 14 day supply: 2 x 7 (£19.94)

This patch is recommended for people who do not smoke within an hour of waking.

Nicotinell® TTS 30 21mg patch

• Suggested daily quantity: One patch releases 21mg over 24 hours
• Suggested initial 14 day supply: 2 x 7 (£19.94)

Alternative patch if patient has first cigarette within 30 minutes of waking (24 hour nicotine therapy can adversely affect sleeping patterns)

NiQuitin® 2mg or 4mg lozenge

• Suggested daily quantity: Ten - Fifteen lozenges
• Suggested initial 14 day supply: 2 – 3 x 72 (£19.94 - £29.91)

Nicorette® Cools 2mg or 4mg lozenge

• Suggested daily quantity: Ten – Fifteen lozenges
• Suggested initial 14 day supply: 2 – 3 x 80 (£22.86 - £34.44)

Nicorette® chewing gum 2mg or 4mg

• Suggested daily quantity: Ten - Fifteen pieces
• Suggested initial 14 day supply: 1 x 210 (£14.82 - £18.24)

Nicorette® inhalator

• Suggested daily quantity: Three - four 15mg cartridges
• Suggested initial 14 day supply: 1 x 36 plus 1 x 20 (£37.36)

Useful for patients who need “as required" craving control. It should be used with caution in patients with chronic throat disease or broncho-spastic disease. Patients with obstructive lung disease may find use of the Inhalator physically difficult.

Nicorette® QuickMist 1mg per spray

• Suggested daily quantity: 32 – 64 metered sprays
• Suggested initial 14 day supply: 2 x 13.2mL (£19.14)

The products have been placed in order of consideration.

Nicorette® Invisipatch 25mg

• Suggested daily quantity: One patch releases 25mg over 16 hours
• Suggested initial 14 day supply: 2 x 7 (£19.94)

This patch is recommended for people who do not smoke within an hour of waking.

Nicotinell® TTS 30 21mg patch

• Suggested daily quantity: One patch releases 21mg over 24 hours
• Suggested initial 14 day supply: 2 x 7 (£19.94)

Alternative patch if patient has first cigarette within 30 minutes of waking (24 hour nicotine therapy can adversely affect sleeping patterns)

Nicorette® QuickMist 1mg per spray

• Suggested daily quantity: 32 – 64 metered sprays
• Suggested initial 14 day supply: 2 x 13.2mL (£19.14)

NiQuitin® 4mg lozenge

• Suggested daily quantity: Ten - Fifteen lozenges
• Suggested initial 14 day supply: 2 – 3 x 72 (£19.94 - £29.91)

Nicorette® Cools 4mg lozenge

• Suggested daily quantity: Ten – Fifteen lozenges
• Suggested initial 14 day supply: 2 – 3 x 80 (£22.86 - £34.44)

Nicorette® chewing gum 4mg

• Suggested daily quantity: Ten - Fifteen pieces
• Suggested initial 14 day supply: 1 x 210 (£18.24)

Pregnancy

Nicotine freely crosses the placenta and has well described adverse effects on the developing foetus resulting in low birth weight and an increased risk of spontaneous abortion although it is not associated with congenital abnormalities.

Ideally, a pregnant woman should stop smoking using behavioural and motivational strategies. If this is not possible NRT may be recommended to assist a quit attempt as the risk to the foetus of using NRT is lower than that expected with smoking. However, as nicotine does pass to the foetus, the decision to use NRT should be made as early on in pregnancy as possible with the aim of discontinuing after two to three months use. It is beneficial to have finished an NRT course and quit smoking before the third trimester.

Mothers should be made aware that NRT is not harmless to the developing foetus and should be used for as short a time as possible.

24-hour patches should not be used in pregnancy to avoid the administration of nicotine overnight when the foetus would not normally be exposed to smoking-derived nicotine.

Liquorice flavoured gum should not be used in pregnancy.

Breast feeding

Nicotine passes freely into breast milk and exposure is best avoided during lactation. However, the risk associated is probably less than the infant inhaling second hand smoke. If smoking withdrawal cannot be achieved by behavioural means, NRT may be considered. The use of as required nicotine is preferable to patches as the mother can use this straight after feeding the infant and avoid using it in the 2 hours preceding the next feed, thus minimising the infant's exposure.

Cardiovascular disease

In stable cardiovascular disease the use of NRT represents a lower risk than continuing to smoke. In those hospitalised with a recent MI, dysrhythmia or cerebrovascular event who are considered to be haemodynamically unstable, the use of non-pharmacological means should be encouraged. If this fails, NRT may be considered but safety data in this group are limited; such use should be medically supervised.

Diabetes

Since nicotine affects both carbohydrate metabolism and insulin absorption, patients with diabetes should monitor their blood sugar more closely when quitting smoking.

Adolescents

All NRT products are licensed for use in adolescents (12 to 18 years). The MHRA advises that there is limited safety and efficacy data in this patient population and duration should be restricted to 12 weeks. Treatment should only be continued beyond this time on the advice of a healthcare professional.

Adolescent smokers differ from older smokers in that their motivation to stop smoking tends to be more unstable. It is sensible therefore, to attempt to establish that they are dependent at the outset and to check that they are fully committed to trying to stop smoking permanently before offering them NRT.

Renal or hepatic impairment

NRT should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment, as the clearance of nicotine or its metabolites may be decreased, with the potential for increased adverse effects.

Smoking cessation in secondary care

Patients' smoking status should be recorded upon admission to hospital and an offer made of referral to a stop smoking adviser. Patients expressing a desire to stop smoking during an admission may be offered patches or gum to manage acute withdrawal. A 7-day supply may be made on discharge and the patient should be strongly encouraged to access primary care smoking cessation services via their GP within a few days of discharge. The situation should be clearly stated on the patient's discharge summary. Patients who are admitted to hospital but who do not wish to quit may be offered NRT to help with nicotine cravings for the duration of their in-patient stay. Such therapy should not be continued on discharge unless the patient has indicated that they now wish to attempt to quit.

Patients admitted as an emergency: In normal circumstances patients would be required to be motivated to quit, however, these patients are likely to be experiencing withdrawal. It has been agreed locally that they should be offered NRT for their comfort and safety. They should also receive advice and support to encourage long-term abstinence.

Clozapine

For individuals prescribed clozapine switching to NRT from smoking can result in significant increases in plasma concentrations resulting in increased adverse effects, this may also occur with other antipsychotics.

Working in partnership with a clinician, varenicline should only be prescribed on the direct advice of a Smoking Cessation Specialist Advisor for a maximum of 12 weeks. Clinical trials have demonstrated efficacy in those receiving weekly support, so as far as possible varenicline should be prescribed to those receiving such support, either through the services or from a health professional. This will also enable prescribing to be contingent on continuing effort to quit smoking.

Locally it has been agreed that it is not appropriate to give an additional 12-week course to successful quitters. No data are available on the efficacy of an additional 12-week course of treatment for patients who do not succeed in stopping smoking during initial therapy or relapse after treatment.

Prescribing details:

• Varenicline is licensed for use with all smokers except those under 18 or pregnant, or with end stage renal disease. It is not advised for breast-feeding smokers and cautioned in severe renal impairment. To date there are no known drug interactions that need to be considered.
• Treatment with varenicline begins 1 week before the quit date. During this week the dose is titrated until it reaches the treatment dose of 1mg twice daily for a total of 12 weeks treatment. The titration schedule is days 1-3 0.5mg once a day, days 4-7 0.5mg twice daily, and day 8 onwards 1mg twice daily. There is a starter pack containing 11 x 0.5mg tablets and 14 x 1mg tablets.
• At the end of the treatment period, discontinuation of varenicline may be associated with irritability, an urge to smoke, depression and/or insomnia in up to 3% of patients. Because of this the SPC recommends that patients need to be informed and dose tapering considered.
• Combination with other smoking cessation therapies has not been adequately studied to be considered for use.
• Up to a third of patients may experience nausea. Other troublesome adverse effects include insomnia, abnormal dreams and headaches. The SPC suggests that varenicline be taken with a glass of water to help reduce nausea and taking the second pill at dinner or suppertime rather than bedtime may help reduce insomnia and disturbed dreams.
• Clinical trials excluded patients with significant co-morbidity that may be present in a population of smokers such as severe cardiovascular disease, uncontrolled hypertension and COPD. Patients with epilepsy were also excluded.
• Patients should be advised not to drive until it is known whether varenicline affects their ability to drive

Bupropion is included as second-line alternative to varenicline.

Patients should only be prescribed bupropion if they are motivated to stop and (ideally) are receiving support from a Smoking Cessation Adviser. GPs must assess the client's suitability for bupropion.

In order to promote compliance and prevent wastage, the following prescribing schedule is recommended:

• 2 weeks
• 2 weeks dependent on continued abstinence
• 3–5 weeks as appropriate (Total course = 7–9 weeks)

Prescriptions should be linked to an appointment with a Smoking Cessation Adviser to check for continued abstinence.

Bupropion is not recommended for smokers under the age of 18 years, as its safety and efficacy have not been evaluated in this group. Women who are pregnant or breastfeeding or those with a current or history of bipolar disorder should not be prescribed bupropion.

Insomnia is a very common adverse event which can be reduced by avoiding bedtime doses of bupropion (provided there is at least 8 hours between doses).

Patients should exercise caution before driving until they know whether bupropion affects their ability to drive.

Bupropion has considerable potential for interaction with other medicines. Further details can be found in the Summary of Product Characteristics (SPC). Details of other side effects associated with bupropion can also be found in the SPC. Doctors and pharmacists are asked to continue to report all suspected adverse reactions.