Prescribing Guidelines for Smoking Cessation

PRESCRIBING NOTES: NICE recommends that NRT or varenicline should be prescribed as part of an abstinent contingent treatment, in which the smoker makes a commitment to stop smoking on or before a particular date (target stop date). A prescription for NRT or varenicline should be sufficient to last until 2 weeks after the target stop date. Normally, this will be after 2 weeks of NRT therapy, and 3–4 weeks for varenicline, to allow for the different methods of administration and mode of action. Subsequent prescriptions should be given only to people who have demonstrated, on re-assessment that their quit attempt is continuing.

NICE recommends that if a smokers attempt to quit is unsuccessful using NRT or varenicline, do not offer a repeat prescription within 6 months unless special circumstances have hampered the person’s initial attempt to stop, when it may be reasonable to try again sooner. Therefore, if a patient is repeatedly stop- starting nicotine replacement therapy, we would advise discussing the matter with the patient with the view to address any concerns and maximise self-motivation and adherence; hence achieve medicines optimisation.

NICOTINE REPLACEMENT THERAPY

There is no evidence of difference in efficacy between the different formulations of nicotine replacement therapy (NRT). When choosing a product, points to discuss with the smoker include:  Is the patient motivated to quit? The programme requires self-motivation for successful outcomes.  The number of cigarettes smoked per day and the time to the first cigarette of the day.  Speed of nicotine delivery of the different NRT products.  Ease of use of the product.  Contraindications and the potential for adverse effects  Amount of behavioural replacement provided.  Ability for the smoker to adjust and titrate the nicotine dose as required.  Prescriptions should be on an acute basis – patients should be reviewed to assess whether the chosen NRT is appropriate and being used correctly.  Use of intermittent formulations as required to relieve cravings.  NRT is licensed for use in children from the age of 12. N.B. Nicotinell ® lozenges should only be prescribed for children under the age of 18 on the recommendations of a doctor.  Consider offering a combination of nicotine patches and another form of NRT (such as gum, inhalator, lozenge or nasal spray) to people who show a high level of dependence on nicotine or who have found single forms of NRT inadequate in the past.

ADVANTAGES DISADVANTAGES Nicotine ▪Provides flexibility of 24 hours or 16 hour use. ▪Patients can not adjust dose Transdermal ▪Easy to use and conceal. ▪Allergic reactions to adhesive may occur. Patches ▪A low maintenance solution ▪People with dermatologic conditions should not use the patch. ▪Once-a-day application associated with fewer compliance problems. ▪24 hour patch may cause sleep disturbances but ideal for ▪Ideal for those who prefer not to take oral medication. those with strong cravings during early morning. Nicotine ▪Variety of flavours available. ▪Irritation of the throat Lozenges ▪Patients can adjust use to manage withdrawal symptoms. ▪Increased salivation ▪Allows control of nicotine intake in short bursts to help control cravings. ▪GI side effects (nausea, heartburn) might be bothersome. ▪Alternative for those who prefer not to or cannot chew gum ▪Treatment should not exceed 6 months ▪Practically an unnoticeable aid ▪Should not be used by people with mouth ulcers. Nicotine ▪Variety of flavours available. ▪Lozenges may cause the mouth or tongue to be slightly sore Mini ▪Portable and discreet pocket-size vial or irritated. May feel sick. Lozenges ▪Starts to relieve cravings in just 3 minutes. Mini-lozenge dissolves up ▪Treatment should not exceed 6 months to 3 times faster than other stop smoking lozenges. Nicotine ▪Mimics hand-to-mouth ritual of smoking. ▪Initial throat or mouth irritation can be bothersome. Inhalator ▪Patients can adjust use to manage withdrawal symptoms. ▪Up to 12 cartridges can be used daily for 8 weeks. ▪Works faster than gum and lozenges. Nicotine ▪Patients can adjust use to manage withdrawal symptoms. ▪Nasal/throat irritation may be bothersome. Nasal Spray ▪Works quicker than gum and lozenges. ▪In the first few days of use, the spray may irritate the nose ▪Each dose gives an amount of nicotine equivalent to one cigarette. causing sneezing or watery eyes. If this occurs do not drive or ▪Nicotine can enter the bloodstream, reaching the brain within 10 operate machinery until these unwanted effects have stopped. minutes. Strongest form of NRT – can be useful and effective form of ▪Should be used no more than 5 times an hours and no more medication for highly dependent heavy smokers. than 40 doses a day. Maximum treatment is 3 months. Nicotine ▪Discreet – no chewing or sucking is required. Designed to be dissolved Nicorette Microtab Lemon contains aspartame (a source of Sublingual under the tongue. phenylalanine) and may be harmful for people with Tablet phenylketonuria. Should not be chewed or swallowed – may cause unwanted side effects. Nicotine ▪ Available as sugar free - which would benefit diabetics. ▪Patients must use proper chewing techniques to minimize Chewing ▪ Variety of flavours available &fast-acting. Gives short bursts of adverse effects. Gum nicotine. ▪ increased salivation ▪Allows control of nicotine intake and the freedom to use an extra piece ▪some people dislike the taste and some may find it difficult to of gum within the hour. get used to having to ‘park’ the gum in their mouth.

Summary of NRT Preparation Strength Pack Size Trade Price Max/Day Nicotine Transdermal Patch Nicotinell Beige Patches TTS 30 21mg/24 hours 7 patches £9.40 1 patch Nicotinell Beige Patches TTS 20 14mg/24 hours 7 patches £9.40 Nicotinell Beige Patches TTS 10 7mg/24 hours 7 patches £9.12 Niquitin CQ Beige or Clear Patches Step1 21mg/24 hours 7 patches £9.97 1 patch Niquitin CQ Beige or Clear Patches Step2 14mg/24 hours 7 patches £9.97 Niquitin CQ Beige or Clear Patches Step3 7mg/24 hours 7 patches £9.97 Nicorette Invisi Range 25mg/16 hours 7 patches £10.37 1 patch 15mg/16 hours 7 patches £10.37 10mg/16 hours 7 patches £10.37 Nicotine Lozenges Nicotinell 1mg 36 £4.27 30 96 £9.12 2mg 36 £4.95 15 96 £10.60 NiQuitin CQ 2mg OR 4mg 36 £5.12 15 72 £9.97 Nicorette Cools 2mg 20 £3.18 15 80 £11.48 4mg 80 £11.48 15 Nicotine Mini Lozenges 1.5mg OR 4mg 20 £3.50 Niquitin Minis 60 £9.57 15 Nicotine Inhalator Nicorette (with inhalator) 15mg/cartridge 20 cartridge £15.11 6 [N.B. 10mg/cartridge is no longer 36 cartridge £24.03 available.] Nicotine Nasal Spray Nicorette Nasal Spray (64 sprays) 0.5mg/metered 200 sprays audit £13.80 spray Nicotine Sublingual Tablet Nicorette Microtab (with dispenser) 2mg 2x15 tablet disc £4.83 40 Nicorette Microtab (with refill) 2mg 7x15 tablet disc £12.12 40 Nicotine Chewing Gum Nicorette 2mg 30 £3.25 15 105 £9.55 4mg 30 £3.99 15 105 £11.63 NiQuitin CQ 2mg 12 or 24 or 96 NiQuitin - (£1.71, £2.85, £8.55) 15 OR Nicotinell (12= n/a, £3.01, £8.26) Nicotinell - 25 Nicotinell 4mg 12 or 24 or 96 NiQuitin - (£1.71, £2.85, £8.55) 15 Nicotinell (12= n/a, £3.30, £10.26) Nicotine Mouth Spray Nicorette Quick Mist 1mg per spray Single or Duo Pack £12.12 (single) £19.14 (duo pack) 64 sprays 24 hours

SIGNPOSTING TO LOCAL STOP SMOKING SERVICE (offered by Provide)

Provide are offering an Essex Lifestyle Service, which incorporates a stop smoking service. They can be contacted by telephone on 0300 303 9988 Monday to Friday 8am-8pm or by email at: [email protected] . Alternatively, a referral form for the service can be accessed by clicking here

This programme is for available to anyone who is registered with a GP in West Essex

Please note: the list of NRT Preparations above has been produced in conjunction with the local stop smoking service in order to maintain equity of treatment available to the patient. In exceptional cases, patients may be given different NRT products than those listed above but this would be on an individual need.

Licensed dose, duration, and brief usage instruction of nicotine replacement therapy products. Formulation and usage instructions of NRT No. of cigarettes smoked per day Licensed dose and duration 16-hour Patch (Nicorette Invisi Range) 10 or more per day Use 25 mg/16 hours patch daily for 6 to 8 weeks, then Use Apply patch each morning to dry, non-hairy skin on 15 mg/16 hours patch daily for 2 weeks, then Use the hip, trunk, or upper arm and hold in position for 10 mg/16 hours patch daily for 2 weeks. 10–20 seconds to ensure adhesion. Place new patch Less than 10 per day Use 15 mg/16 hours patch daily for 6 to 8 weeks, then Use on a different skin site. Do not reuse skin sites for 10 mg/16 hours patch daily for 4 weeks. several days. Note: Remove the patch at night. 24-hour Patch (Nicotinell®) 20 or more per day Use 21 mg/24 hours patch daily for 3 to 4 weeks, then Use Usage instruction is the same as above. Suitable for 14 mg/24 hours patch daily for 3 to 4 weeks, then Use those who experience strong cravings for cigarettes on 7 mg/24 hours patch daily for 3 to 4 weeks. waking. Less than 20 per day Use 14 mg/24 hours patch daily for 3 to 4 weeks, then Use 7 mg/24 hours patch daily for 3 to 4 weeks. 24-hour Patch (NiQuitin CQ®, NiQuitin® Clear) 10 or more per day Use 21 mg/24 hours patch daily for 6 weeks, then Use Usage instruction is the same as above. Suitable for 14 mg/24 hours patch daily for 2 weeks, then Use those who experience strong cravings for cigarettes on 7 mg/24 hours patch daily for 2 weeks. waking. Less than 10 per day Use 14 mg patch for 6 weeks, then Use 7 mg patch for 2 weeks. Nasal spray (Nicorette®) Any Use one spray in each nostril as required, up to twice Use one spray in each nostril as required. every hour for 16 hours daily (maximum of 64 sprays daily)

Inhalator (Nicorette®) Any Inhale when there is an urge to smoke. Initially use a Insert the cartridge into the device and draw in air maximum of 6 of the 15 mg cartridges daily for up to 8 weeks, through the mouthpiece. then reduce gradually over the next 4 weeks. Gum (Nicorette®, Nicotinell®, Niquitin CQ®) More than 20 per day Chew one piece of 4 mg gum slowly for about 30 minutes Chew the gum until the taste becomes strong, then rest when there is an urge to smoke. Sufficient gum should be it between the cheek and gum; when the taste starts to used, usually 8 to12 pieces up to maximum of 15 pieces fade, repeat this process. a day. Reduce gradually over 3 months; when daily use is 1 to 2 pieces of gum, stop. 20 or less per day Chew one piece of 2 mg gum slowly for about 30 minutes when there is an urge to smoke. (Sufficient gum should be used, usually 8 to 12 pieces up to maximum of 15 pieces a day. People needing more than 15 pieces per day should use 4 mg gum). Reduce gradually over 3 months; when daily use is 1to 2 pieces of gum, stop. Lozenge (Nicorette®, Nicotinell®, Niquitin CQ®) Smoke <20 cigarettes a day - use Suck 1 lozenge every 1to 2 hours when the urge to smoke Suck one lozonge until the taste becomes strong, then lower-strength lozenges (i.e. 1mg). occurs. Treatment should continue for 6 to 12 weeks before rest it between the cheek and gum; when the taste attempting to reduce the dose. starts to fade, repeat this process. Occasionally move Smoke >20 cigarettes a day AND for Maximum 15 lozenges daily. lozenge from one side of the mouth to the other. those who fail to stop smoking with the Lozenges last for 10 to 30 minutes depending on their lower-strength - use higher strength size. lozenges. Sublingual tablet (Nicorette Microtab®) More than 20 per day Use 2 tablets (4 mg) sublingually each hour (maximum 40 Place each tablet under the tongue and allowed to tablets/day). Continue for at least 3 months then gradually dissolve. reduce; when daily use is 1to 2 tablets, stop. Maximum 40 tablets daily. 20 or less per day Use 1 tablet (2 mg) sublingually each hour. Continue for at least 3 months then gradually reduce; when daily use is 1to 2 tablets, stop. Maximum 40 tablets daily. Oromucosal spray (Nicorette QuickMist®) Any Use 1to 2 sprays in the mouth as required (maximum of 64 Use 1to 2 sprays in the mouth as required. If using the sprays daily) for up to 8 weeks, then reduce gradually over oral spray for the first time, or if unit not used for 2 or the next 4 weeks. Do not exceed 2 sprays per episode (up more days, prime the unit before administration by to 4 sprays every hour for 16 hours a day). pressing the top of the spray with the index finger 3 times until a fine spray appears.

VARENICLINE (CHAMPIX)  Recommended course of treatment = 12 weeks

 For people who have stopped smoking at the end of the 12 weeks, an additional course of 12 weeks treatment with varenicline at 1mg twice-daily may be considered to help maintain abstinence.  Recommend treatment with varenicline is started while the person is still smoking. Advise the person to stop smoking 7 to 14 days after starting varenicline.  Do not prescribe in children ≤ 18 years, pregnant or breast-feeding adults or with people with end-stage renal disease.  The combination of nicotine replacement therapy with varenicline is not recommended.

MHRA/CHM ADVICE – Patients should be advised to discontinue treatment and seek prompt medical advice if they develop agitation, depressed mood or suicidal thoughts. Patients with a history of psychiatric illness should be monitored closely while taking varenicline.

Bupropion (Zyban) is contraindicated in patients with previous or current seizure disorder and should not be prescribed in patients with other risk factors for seizures unless there is compelling clinical justification for which the potential benefit outweighs the increased risk of seizure. Such risk factors include concomitant use of any drug known to lower the seizure threshold (including antipsychotics, antidepressants, antimalarials, theophylline, systemic steroids, tramadol, quinolones and sedating antihistamines), alcohol abuse, a history of head trauma, diabetes treated with hypoglycaemics or insulin and use of stimulants or anorectic products.

Electronic Cigarettes

Electronic cigarettes are not listed in the Drug Tariff; therefore, not available on the NHS.

Stop Smoking Service on your mobile phone If you have an iPhone, iPad or iPod touch you can download the free NHS Stop Smoking app from the iTunes App store. The app provides (i) provides daily support and instant tips (ii) keeps track of how much money you're saving (iii) shows how many days you've been smoke free (iv) includes a direct line to the NHS Smoking helpline and (v) provides links to local NHS Smoking Services. Refer to http://www.nhs.uk/Tools/Pages/iphonesmoking.aspx

Other Support Groups 1) The National NHS Stop Smoking Helpline (0800 022 4 332) is a free service for smokers who wish to stop smoking but do not require the more intensive support offered by the Stop Smoking Services. In addition to this, some NHS Stop Smoking Services will provide psychological support over the telephone for smokers who are mobility impaired or unable to attend face to face services.

2) SMOKEFREE – www.smokefree.nhs.uk

A public health campaign initiated and supported by Public Health England providing free information, advice and support to people who are giving up smoking, and those who have given up smoking and do not want to start again. 3) Find a support service using NHS choices: http://www.nhs.uk/Service-Search/Stop-smoking-services/LocationSearch/1846

References 1. NICE Clinical Guideline - http://guidance.nice.org.uk/PH10/Guidance/pdf/English 2. CKS summaries for Smoking Cessation - http://cks.nice.org.uk/smoking-cessation#!background 3. Varenicline MHRA alert- http://webarchive.nationalarchives.gov.uk/20150110161501/http:/www.mhra.gov.uk/home/groups/pl- p/documents/publication/con020567.pdf 4. Patient.co.uk - http://www.patient.co.uk/support/smokefree-nhs-choices 5. BNF (October 2016) https://www.evidence.nhs.uk/formulary/bnf/current/4-central-nervous-system/410-drugs-used-in-substance- dependence/4102-nicotine-dependence/nicotine-replacement-therapy 6. Niquitin - http://www.niquitin.co.uk/ ; Nicotinell - http://nicotinell.co.uk/ ; Nicorette - http://www.nicorette.co.uk/ 7. Ash Fact Sheet – Action on smoking and health - http://www.ash.org.uk/files/documents/ASH_116.pdf 8. www.provide .org.uk and nhs.uk/smokefree

Guidance Written by: Hinal Patel – Prescribing Support Pharmacist (WECCG) Date Produced –June 2014 Review Date – June 2016

Guidance reviewed by Tracey Gulliford – Prescribing Support Pharmacy Technician (WECCG) Date Reviewed – November 2016 Review Date – November 2018