Guidance for the Management of Smoking Cessation within Sirona Care & Health and Providers in the Community

Transcription

1 Guidance for the Management of Smoking Cessation within Sirona Care & Health and Providers in the Community This guidance should be used in close conjunction with the referenced guidelines, in particular NICE PH10 - Smoking Cessation Services in Primary Care and NICE PH45 Tobacco Harm Reduction and the E-cigarette Briefing by the National Centre for Smoking Cessation and Training (NCSCT). This guidance is for use by the Specialist Stop Smoking Team and ALL Community Stop Smoking Advisors in GP Practices, Pharmacies, Dental Practices and other organisations where those Advisors have been trained by Sirona in order to provide a stop smoking service. The information in this guidance and the relevant documents listed above will make recommendations that will include the use of Nicotine Replacement Therapy (NRT), Varenicline, Harm Reduction and how to approach and react to the growing use of E-cigarettes. The Sirona Specialist Stop Smoking Service does not recommend to clients the use of Zyban anymore so stop smoking advisors are advised to recommend Varenicline instead. Staff characteristics The Stop Smoking Service consists of the Specialist Stop Smoking Team and Community Stop Smoking Advisors All Specialist and Community Stop Smoking Advisors will need to be assessed as competent to work in these roles having undertaken training to provide the advice and support to smokers wishing to quit abruptly or follow a harm reduction model To use care in the recommendation of appropriate treatments to support smokers to either stop smoking abruptly or follow a Harm Reduction model Sirona Care & Health Specialist Stop Smoking Advisors do not supply medication but will make recommendations to the community pharmacist or the GP for supply / prescription of the appropriate products All Stop Smoking Advisors should keep up to date with changes to recommendations. It is the responsibility of the individual to keep up-to-date through being mentored, (Community Advisors only) attendance at quarterly Refresher and Network Training and receiving communications from the Specialist Stop Smoking Service Stop Smoking Service client consultation Clients can be seen through either one to one or in groups in a variety of settings that include: GP Practices Pharmacies Dentists 1

2 Specialist Stop Smoking Service run drop in clinics Other recognised agencies A smoker will be offered, on average, stop smoking support for between six and eight weeks if they opt to use Nicotine Replacement Therapy or a minimum of twelve weeks if they use Varenicline. (For Harm Reduction and E-cigarettes please see the appropriate section in this guidance). The following is the procedure to follow at the first face-to face session with a smoker: Introduction and review of starter pack Ask about smoking habit Ask about previous attempts and known reasons for relapse Ask about previous medications used Explain the treatment options available and their use Issue prescription /recommendation Expectations of advisor and client Complete Individual Record Sheet (IRS form) (Pharmacies complete IRS Form on PharmOutcomes) Take CO reading and record/discuss Discuss coping strategies/difficult situations Set quit date Summarise and book next appointment For subsequent sessions: Ascertain progress towards quit attempt Review medication suitability, frequency of use and technique Issue further script /recommendation if required Address any problems and /or risky situations where relapse may occur CO monitor and update IRS Form Discuss coping strategies Book next appointment Recommendations for Abrupt Smoking Cessation This service promotes the use of NRT and Varenicline as an aid to treating tobacco dependence and for relieving nicotine withdrawal symptoms. See appendix 1 for information about each NRT product and appendix 3 for Varenicline including contraindications This service is for tobacco users identified as sufficiently motivated to quit, receiving specialist advice and support from trained Stop Smoking Service Advisors - the term 'sufficiently motivated to quit' normally refers to a client's willingness to set a quit date and receive weekly support for the first four weeks of treatment See appendix 2 for advice around special client groups 2

3 The maximum treatment with NRT or Varenicline for any one assessment is normally 12 weeks. A client using Varenicline can be prescribed a further twelve weeks supply after the initial twelve week period if required If the client has been smoke free for four weeks (as per carbon monoxide validation) the client is then a non-smoker. If the client is still abstaining from smoking at weeks after the quit date then in negotiation with the client, treatment should be gradually withdrawn. If there is concern that the client might relapse if NRT is withdrawn after this point then NRT may be prescribed for an indefinite period in order to stop the client relapsing, although efforts should be made again in time to wean the client off Nicotine Containing Products (NCPs). A combination of NRT products is recommended. The combination of two different NRT formulations is more effective than a single NRT product. Possible combinations of NRT include the patch (a slow release form of NRT) with a faster-acting NRT such as the gum or nicotine mouthspray (to allow good control over the nicotine dose during cravings) If the smoker is unsuccessful in staying stopped at 4 weeks then discontinue treatment and suggest they make a fresh start when they are ready again Do not recommend NRT if the client has previous serious reactions to NRT or any of the other ingredients contained within the products Follow up Patients should be followed up by the Stop Smoking Advisor between 4-6 weeks following their quit date. Ideally this follow up should be face to face but can be done via telephone if there is no other option. Every effort must be made to take a CO reading at the start of the support and at weeks 4-6. Harm Reduction Harm reduction is an appropriate offer for: Smokers not yet able or willing to quit Smokers who need to temporarily abstain from smoking People who are highly dependent on nicotine Smokers who wish to protect their families from second hand smoke Harm reduction approaches may or may not include temporary or long term use of licensed nicotine containing products. It is safer to use licensed nicotine containing products than to smoke. Long term use of licensed nicotine containing products is safe. Key elements of NICE Guidance PH45 Stopping smoking in one step (an abrupt quit) is the most effective method of ensuring lasting abstinence. Evidence suggests that providing licensed nicotine containing products for long term use (up to 5 years) is a cost effective use of NHS resources and does not pose a significant health risk. 3

4 There is strong evidence that nicotine replacement therapy is effective in reducing cigarette consumption and in eventual abstinence in smokers not looking to quit. Evidence suggests that using behavioural support (with or without NRT) in cutting down to quit reduces the number of cigarettes smoked prior to quitting and increases the likelihood of quitting itself. Harm Reduction approaches recommended by this guidance: Front line professionals working with smokers should raise awareness of the safety and effectiveness of licensed nicotine containing products. All professionals should promote their effective use to smokers who are trying to stop, cut down smoking, or temporarily abstain and advise on their long-term use to reduce the risk of relapsing. Stopping Smoking Advise all smokers that stopping smoking in one step is the most effective way of achieving lasting success The use of pharmacotherapy (including nicotine replacement therapy and Varenicline) and behavioural support together increases the chances of a successful quit attempt The use of licensed nicotine containing products as long as needed is recommended to prevent relapse, supported by regular follow up appointments Cutting down to quit Smokers not ready to set a quit date should be offered the cut down to quit model (see Appendix 4) which involves a staged approach to quitting and the use of pharmacotherapy and behavioural support As the Cut down to quit model requires additional support, these clients should be referred directly to the Specialist Stop Smoking service who have the resources to work with this client group The use of licensed nicotine containing products as long as needed is recommended to prevent relapse, supported by regular follow up appointments Temporary Abstinence Advice should be given to all smokers who want (or need) to abstain temporarily on a short, medium or long term basis on how to do this This advice should include information about the different types of licensed-nicotine containing products and how to use them Behavioural support including follow up appointments should also be offered to those who want to temporarily abstain. Licensed nicotine containing products can be prescribed for temporary abstinence when combined with behavioural support Referral to the Specialist Stop Smoking Support service is also appropriate for this group of smokers if necessary This approach is particularly recommended for those in secondary care (including mental health settings) or pre-operative patients, pregnant women, those in closed institutions, 4

5 shift workers, those who wish to abstain for other reasons such as holidays, religious reasons etc. Reducing smoking Whilst NICE guidance does recommend smoking reduction, with or without the help of licensed nicotine containing products, more evidence is needed on the health benefits of smoking reduction, rates of relapse and progression to stopping smoking among people who have opted to reduce the amount they smoke If smokers say they are not interested in quitting they should be given information on the benefits of stopping smoking and brief advice. They should also be advised that it could still be worthwhile them cutting down with the aid of a licensed nicotine product. Make a note in the client s record to ask about this again next time the opportunity arises, as they may be ready to make a quit attempt in the future and should be encouraged to do so Unlicensed Nicotine Containing Products (including electronic cigarettes) Products that contain nicotine but do not contain tobacco and so deliver nicotine without the harmful toxins found in tobacco are referred to as nicotine containing products. Some such as nicotine replacement therapy are regulated by MHRA, others such as electronic cigarettes and topical gels are currently not covered by MHRA regulation and therefore cannot be recommended due to uncertainty over their safety, quality and effectiveness. However it is recognised that these products are likely to be less harmful than cigarettes and are being considered for regulation in the future. When they are regulated NICE has agreed to use them as part of harm reduction strategy. Electronic cigarettes are devices that deliver nicotine by heating and vaporising a solution that typically contains nicotine, propylene glycol and/or glycerol, and flavourings. Short-term exposure to electronic cigarettes appears to be associated with few serious risks. Low levels of toxicants and carcinogens have been detected in electronic cigarette liquid and vapour although these are much lower than those found in conventional cigarette smoke. B&NES Tobacco Action Network is concerned that electronic cigarettes, and similar products without regulation, could be marketed in a way that may promote smoking and be attractive to children and young people. Some e-cigarettes have been reported to have technical flaws e.g. leaking cartridges or exploding charging devices which have caused fire damage and the amount of nicotine contained in the product is often unclear due to poor labelling. According to figures from the National Poisoning Information Service, the number of people poisoned by swallowing e- cigarette liquids containing nicotine rose sharply in the UK last year, with 139 calls from healthcare professionals seeking expert advice on treatment (compared to 29 in 2012). Therefore B&NES Tobacco Action Network fully supports regulation of these products to control their marketing, sale to children and young people and to improve safety and quality of the product. 5

6 Recommendations for practice: It is acknowledged that a growing proportion of the smoking population are using e-cigarettes as a method of cutting down or stopping smoking. Where this is the case, clients should be advised of the above and given the following information: Short-term exposure to electronic cigarettes appears to be associated with few serious risks. Low levels of toxicants and carcinogens have been detected in electronic cigarette liquid and vapour although these are much lower than those found in conventional cigarette smoke Mouth and throat irritation are the most commonly reported symptoms of electronic cigarette use and appear to subside over time Behavioural support, as provided by a trained stop smoking practitioner, is likely to improve the efficacy of electronic cigarettes in the same way such support markedly increases the efficacy of NRT As with other unlicensed products the Stop Smoking Service cannot recommend, provide or prescribe electronic cigarettes until such time as there are licensed options available If a client is being supported by a stop smoking service and is using electronic cigarettes and also wants to use NRT then it is ok for them to use both in conjunction. They do not need to have stopped using the electronic cigarette before they can use NRT The above recommendations for practice are not applicable for working with children and young people. Please refer to the Working with Children and Young People section (below)for recommended approach While there is currently no restriction placed on the sale of electronic cigarettes to children, the majority carry a voluntary age warning that they are not for sale to under 18s. New powers in the Children and Families Act 2014 allow for the introduction of a ban on selling electronic cigarettes to under 18's Working with Children and Young People The NICE PH10 guidance on smoking cessation recommends the following approach to working with children aged years: Offer young people aged information, advice and support on how to stop smoking. Encourage use of local NHS Stop Smoking Services by providing details on when, where and how to access them Use professional judgement to decide whether or not to offer NRT to young people over 12 years who show clear evidence of nicotine dependence. If NRT is prescribed, offer it as part of a supervised regime NICE guidance on harm reduction does not differentiate approach by the age of client. Therefore we would only recommend using the above harm reduction approaches to working with year olds as part of a supervised regime. 6

7 Advice to clients includes: Patient information leaflet on each product supplied; also new indications information if relevant Follow-up appointments Advice on obtaining further supplies of NRT The client should be informed that information relating to the supply of NRT is passed to other health service organisations, to the GP if necessary and the Sirona Specialist Stop Smoking Service Withdrawal symptoms Possible changes in the body on stopping smoking, e.g. weight gain The effects of smoking tobacco whilst using NRT Diabetics monitor blood glucose levels more closely than usual when NRT is started Self-help leaflets Where to obtain more information. Records kept Records of the consultation must be kept for at least two years including the following documents in particular: Individual Report Sheet (IRS Form) The letter of recommendation to supply, or a copy, should be kept with the client s IRS Form (See Appendix 5) Details of the product(s) recommended must be recorded as required for audit purposes on the IRS Form Please note: In time, paper IRS Forms will be replaced by electronic versions. The latter can be archived as required in your patient management systems (e.g. SystmOne and EMIS). 7

8 APPENDIX 1 ADMINISTRATION DIRECTIONS FOR NICOTINE REPLACEMENT THERAPY FORMULATIONS This section should be used in conjunction with the individual product summary of product characteristics (SPCs), for the most up-to-date information see (search on the products name) and NICE Public Health Guideline 10 Smoking Cessation Service Prescribing and Advising on Pharmacotherapies A) GUM Dose and method of administration Oral administration (as resin) Smoking Cessation Adults (over 18 years of age) 2mg gum (Nicorette/Boots NicAssist; Nicotinell; NiQuitin CQ) For individuals smoking 20 cigarettes or less daily Use 2mg gum for smokers who have their first cigarette of the day more than 30 minutes after waking. One 2mg piece chewed slowly for 30 minutes taken regularly before the urge to smoke. Maximum of 15 pieces daily Individuals needing more than 15 pieces of 2mg gum a day should consider the 4mg gum instead. Treatment should be continued for at least 3 months followed by a gradual reduction in dosage 4mg gum (Nicorette/Boots NicAssist; Nicotinell; NiQuitin CQ) For individuals smoking more than 20 cigarettes a day Use 4mg gum for smoker who have their first cigarette of the day within 30 minutes of waking up. One 4mg piece chewed slowly for 30 minutes taken regularly before the urge to smoke. Maximum 15 pieces daily of 4mg gum. Treatment should be continued for at least 3 months followed by a gradual reduction in dosage. Side effects Specific advice to client Common: Throat or mouth irritation, increased salivation, jaw ache. Gum should be chewed until the taste becomes strong and then parked between the gum and cheek until the taste fades. Recommence chewing 8

9 once the taste has faded. This chew-rest-chew technique should be applied for 30 minutes. Avoid chewing gum at the same time as acidic drinks e.g. coffee or soda because these may interfere with the buccal absorption of nicotine. Avoid these drinks for 15 minutes before chewing the gum. Gum may stick to and in rare cases damage dentures or dental appliances. B) INHALATOR Dose and method of administration Oral administration of nicotine via nicotine-impregnated plug in inhalator mouthpiece 15mg nicotine (Nicorette/Boots NicAssist Inhalator) Smoking Cessation Adults (over 18 years of age) Use when the urge to smoke occurs. When taken regularly aim to use before the urge develops. Deep drawing or short sucks on the mouthpiece are effective but client will soon find the best technique. Shallow or deep puffing for eight 5-minute sessions, each cartridge lasts approximately 20 minutes of intense use. Advise using 3-6 cartridges (15mg/cartridge) daily for up to 8 weeks. Then reduce the dose by half over the next 2 weeks, then reduce to zero by the last day. Maximum usage of 6 cartridges per day. Side effects Specific advice to client Throat irritation, cough, rhinitis, pharyngitis, stomatitis, sinusitis, dry mouth. Air should be drawn into the mouth through the mouthpiece. Clients should be warned that the inhalator requires more effort to inhale than a cigarette and that less nicotine is delivered per inhalation. Therefore the client may need to inhale for longer (than with a cigarette). The inhalator is best used at room temperature as nicotine delivery is affected by temperature. Used cartridges will contain residual nicotine and should be disposed of safely. Advise the client to keep them in the case and dispose of them in household rubbish. N.B: Patients with obstructive lung disease may find use of the inhaler difficult. Nicotine Gum, Patch Nasal Spray or Sublingual tablet may be preferred in such cases. 9

10 C) LOZENGE Dose and method of administration Oral administration Smoking Cessation Nicotinell 1mg lozenge Nicotinell lozenges are not for under 18 years of age Suitable for smokers with a low-moderate dependency (less than 20 cigarettes a day) Initially one lozenge (1mg) every 1-2 hours when the urge to smoke occurs. The usual dose is 8-12 lozenges per day to a maximum dosage of 30 lozenges per day. Treatment to continue for at least three months and after three months the user should gradually reduce the number of lozenges per day. Discontinue treatment when use is 1-2 lozenges per day. Maximum treatment period 6 months. Nicotinell 2mg lozenge Nicotinell lozenges are not for under 18 years of age For individuals smoking more than 30 cigarettes a day, strong or very strong nicotine dependency. Initially 1 lozenge every 1-2 hours. Suck when feel the urge to smoke. The usual dose is 8-12 lozenges per day to a maximum dosage of 15 lozenges per day. Treatment to continue for at least three months and after three months the user should gradually reduce the number of lozenges per day. Discontinue treatment when use is 1-2 lozenges per day. Maximum treatment period 6 months. NiQuitin 2mg and 4mg lozenges Use 2mg lozenges for smokers who have their first cigarette of the day more than 30 minutes after waking. Use 4mg lozenges for smoker who have their first cigarette of the day within 30 minutes of waking up. Weeks 1-6: 1 lozenge every 1-2 hours. Users should take AT LEAST 9 10

11 lozenges per day, but should not exceed 15 lozenges a day Weeks 7-9: 1 lozenge every 2-4 hours Weeks 10 12: 1 lozenge every 4-8 hours Beyond 12 weeks, users may take 1-2 lozenges per day only on occasions when they are strongly tempted to smoke. Maximum period of treatment: 6 months. NiQuitin Minis 1.5mg Suitable for smokers who smoke 20 cigarettes or less a day. Use whenever there is an urge to smoke. The usual dose is 8-12 lozenges per day to a maximum dosage of 15 lozenges per day. Continue for up to six weeks to break the habit of smoking, then gradually reduce lozenge use. When daily use is 1-2 lozenges, use should be stopped. To help stay smoke free after treatment, users may take a lozenge in situations when they are strongly tempted to smoke. NiQuitin Minis 4mg Suitable for smokers who smoke more than 20 cigarettes a day. Use whenever there is an urge to smoke. The usual dose is 8-12 lozenges per day to a maximum dosage of 15 lozenges per day. Continue for up to six weeks to break the habit of smoking, then gradually reduce lozenge use. When daily use is 1-2 lozenges, use should be stopped. To help stay smoke free after treatment, users may take a lozenge in situations when they are strongly tempted to smoke. Nicorette Cools Lozenge (2mg) (Adults and children over 12) Suitable for smokers who smoke 20 cigarettes or less a day. Use whenever there is an urge to smoke. The usual dose is 8-12 lozenges per day to a maximum dosage of 15 lozenges per day. Nicorette Cools Lozenge (4mg) (Adults and children over 12) Suitable for smokers who smoke more than 20 cigarettes a day. Use whenever there is an urge to smoke. The usual dose is 8-12 lozenges per day to a maximum dosage of 15 lozenges per day. Side effects Throat and mouth irritation, increased salivation, hiccups, dyspepsia - especially at the start of treatment. Slower sucking should overcome this. Less commonly gingival bleeding. 11

12 Specific advice to client Clients should not eat or drink while a lozenge is in the mouth. Not to be given to clients with phenylketonuria or fructose intolerance. Nicotinell Lozenge: Lozenge should be sucked until the taste is strong and then parked between the gum and the cheek until the taste fades. Once faded then sucking should recommence. Continue until lozenge dissolved (approximately 30 minutes) Simultaneous use of coffee, acid drinks and soft drinks may decrease absorption of nicotine and should be avoided for 15 minutes before sucking lozenge. NiQuitin Lozenge: One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately minutes). The lozenge should not be chewed or swallowed whole. Users should not eat or drink while a lozenge is in the mouth. Nicorette Cools Lozenge One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately minutes). The lozenge should not be chewed or swallowed whole. Users should not eat or drink while a lozenge is in the mouth. D) NASAL SPRAY /MOUTH SPRAY Dose and method of administration Nasal administration (Nicorette / NicAssist nasal spray 500 micrograms/ metered spray). Smoking Cessation Adults (over 18 years of age) Frequency of use depends on the previous smoking habit of the individual and their level of nicotine dependence. On commencing treatment the patient uses the spray to treat cravings as required Apply one spray into each nostril as required (Nasal spray), spray one spray onto the buccal mucosa up to a maximum of twice per hour, over a 16 hour period for a period of 8 weeks THEN reduce dosage gradually over next 4 weeks achieving half the dose reduction required. THEN continue to reduce dosage to zero over next 2 weeks. Maximum of 64 sprays daily, Maximum period of treatment 9 months. 12

13 Mouth spray (Nicorette Quickmist mouth spray 1mg/spray) Smoking Cessation Adults and children (over 12 years of age) Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after the first spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. Client may use up to 4 sprays per hour. Do not exceed 2 sprays per dosing episode and 64 sprays (4 sprays per hour over 16 hours) in any 24-hour period. Each mouth spray contains at least 150 sprays Side effects Nasal Spray: Nose and throat irritation, sneezing, sore or running nose, nosebleeds, watering eyes, ear sensations. Also tingling or burning sensation in the head, increased urination. Mouth Spray: May initially cause mouth or throat irritation. Dysgeusia, headache, hiccups, nausea, and vomiting symptoms, dyspepsia, oral soft tissue pain, and paraesthesia, stomatitis, salivary hypersecretion, burning lips, dry mouth Specific advice to client Advise on correct use of nasal or mouth spray as per the Patient Information Leaflet. Warn of possible local effects but also that these tend to lessen within a few days. CAUTION the nasal spray should not be used whilst driving or operating machinery as side effects could cause an accident. Nasal spray must not be given to clients with chronic nasal disorders such as polyposis, vasomotor rhinitis and perennial rhinitis. E) PATCHES Dose and method of administration Skin patch (transdermal) administration. Smoking Cessation Adults (over 18 years of age) Apply on waking to clean, dry, intact, non-hairy skin on hip, chest or upper arm. Remove after time specified. Avoid 24 hr patch in pregnancy; 13

14 formulations other than patch usually preferred during pregnancy. New patch should be placed on a different area, avoiding used sites for several days afterwards. If successful then gradually reduce dosage with time. Nicorette Invisipatch / Boots NicAssist Translucent 16 hour patch For individuals smoking 10 or more cigarettes a day 25mg patch for 16 hours daily for 8 weeks THEN 15mg patch for 16 hours daily for 2 weeks THEN 10mg patch for 16 hours daily for 2 weeks THEN review treatment For individuals smoking less then 10 cigarettes a day 15mg patch for 16 hours daily for 8 weeks THEN 10mg patch for 16 hours daily for 4 weeks THEN review treatment Nicotinell TTS patches (24 hours) Nicotinell TTS 30 patch For individuals smoking more than 20 cigarettes per day one patch (21mg) daily. Nicotinell TTS 20 patch For individuals smoking 20 cigarettes or less per day one patch (14mg) daily. Nicotinell TTS 10 patch For individuals smoking 10 cigarettes or less per day one patch (7mg) daily. Withdraw treatment gradually reducing the dose every 3-4 weeks. Doses can be maintained or increased if abstinence is not achieved after 3 months or if withdrawal symptoms are experienced. NiQuitin patches (24 hours) For individuals smoking 10 or more cigarettes daily: 21mg patch daily for 6 weeks THEN 14mg patch daily for 2 weeks THEN 7mg patch daily for 2 weeks THEN review treatment Individuals who experience persistent side effects with the 21mg patch should switch to the 14mg for the remainder of the 6 weeks followed by the 7mg patch for 2 weeks as above. For individuals smoking less than 10 cigarettes per day: 14mg patch daily for 6 weeks THEN 14

15 7mg patch daily for 2 weeks THEN review treatment For optimum results the 10 week course (8 weeks for light smokers) should be completed in full. Treatment with NiQuitin patch may be continued beyond 10 weeks if needed to stay cigarette free, however, those who have quit smoking but are having difficulty discontinuing using the patches recommended to seek additional help and advice from a healthcare professional. Side effects Specific advice to client Skin reactions, such as erythema and itching. Discontinue patch use if severe. Myalgia, vivid dreams with 24 hour patch. Patches must not be given to clients with chronic generalised skin disease such as psoriasis, chronic dermatitis and urticarial; clients who have had a previous reaction to transdermal patches; occasional smokers. Exercise may increase absorption of nicotine and therefore side effects. The patch should be applied once a day, normally in the morning, to a clean, dry, non-hairy area of skin on the hip, trunk or upper arm. Allow several days before replacing the patch on a previously used area. Place the patch in the palm of the hand and hold onto the skin for seconds. Patches should not be applied to broken or inflamed skin. Clients should not try to alter the dose of the patch by cutting it up. After use, fold patch in half, adhesive side innermost and then place inside opened sachet or piece of aluminium foil. Dispose of carefully away from reach of children or animals. F) SUBLINGUAL TABLET Dose and method of administration Oral administration (sublingual) (Nicorette/Boots NicAssist Microtab 2mg). Smoking Cessation Adults (over 18 years of age) The initial dose is based on the individual s nicotine dependence. For individuals smoking 20 cigarettes or less daily and smokers who have their first cigarette of the day more than 30 minutes after waking 2mg per hour (one tablet). For patients who fail to stop smoking or have significant withdrawal symptoms consider increasing to 4mg per hour sublingually. For individuals smoking more than 20 cigarettes a day and smokers who have their first cigarette of the day within 30 minutes of waking up 4mg per hour (two tablets) 15

16 Side effects Specific advice to client Maximum dose: 80mg per day (40 tablets) Treatment should be continued for at least 12 weeks, Maximum treatment duration 6 months. Throat irritation, unpleasant taste, aphthous ulceration, sometimes swelling of the tongue. Tablets should be placed under the tongue and allowed to dissolve slowly. G) ORAL STRIPS Dose and method of administration Oral administration NiQuitin Strips Mint 2.5mg Oral Film Smoking Cessation Adults and children (12 years and over) Smokers who have the first cigarette >30 minutes a day after waking only. Max 15 films a day. Weeks 1-6 one film every 1-2 hours (min 9/day). Weeks 7-9 One film every 2-4 hours. Weeks One film every 4-8 hours. Then 1-2 films/day if strongly tempted to smoke. Side effects Dizziness, sleep disorders, headache, cough, pharyngitis, nausea, pharyngolaryngeal pain, GI disturbance, dry mouth, oral discomfort, angioedema, anaphylaxis Clients requiring a combination of NRT products A combination of NRT products is recommended. The combination of two different NRT formulations is more effective than a single NRT product. Possible combinations of NRT include the patch (a slow release form of NRT) with a faster-acting NRT such as the gum or nicotine spray (to allow good control over the nicotine dose during cravings). 16

17 APPENDIX 2 GUIDANCE FOR SPECIAL CLIENT GROUPS There is widespread professional recognition that NRT products are much less harmful than tobacco smoking & this was first substantiated in NICE technology appraisal on NRT - Guidance on the use of nicotine replacement therapy (NRT) & bupropion for smoking cessation. No 39, March 2002, now superseded by NICE Public Health Guidance 10 Smoking Cessation Services February NICE recommended that smokers under the age of 18 years, who are pregnant or breastfeeding, or who have unstable cardiovascular disease (CVD) should discuss the use of NRT with a relevant health-care professional before it is supplied. NICE PHG 10 recommends explaining the risks and benefits to young people aged years, pregnant and breastfeeding women, people who have unstable cardiovascular disorders. To maximise the benefit people in these groups should also be strongly encouraged to use behavioural support in their quit attempt. Please note that NRT is not contraindicated in the following client groups and conveys much less risk than continued smoking. Clients with a history of recent occlusive vascular event NRT is not to be used within 2 weeks of a cardiovascular episode. The precise definition of descriptive clinical terms such as severe immediate and recent cardiovascular problems will need to be specified locally by the authorising Senior Clinician or other appropriate expert, and included in the training programme for health professionals on the supply of NRT on the NHS. This includes cerebrovascular disease, including transient ischaemic attacks. Clients with diabetes In diabetes smoking cessation may affect the absorption and utilisation of insulin. This is due to smoking cessation per se and is not an adverse effect of NRT. It is prudent to ask smokers with diabetes to monitor their blood sugar levels regularly after stopping smoking. Clients who are pregnant or breast feeding Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt. Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the women is suffering from nausea during pregnancy. Patches should be removed before going to bed. 17

18 The aim should be to use NRT as early in pregnancy as possible with the aim of discontinuing use after 2-3 months. Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged. Clients with renal and hepatic impairment A risk benefit assessment should be made by an appropriate healthcare professional for patients with renal or hepatic impairment. Use 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. Clients with Phaeochromocytoma and uncontrolled hyperthyroidism A risk benefit assessment should be made by an appropriate healthcare professional for patients with phaeochromocytoma or uncontrolled hyperthyroidism. Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines 18

19 APPENDIX 3 Protocol for Professionals Prescribing Varenicline (Champix ) with Support from the Sirona Stop Smoking Service. Below is the pathway for Stop Smoking Advisor and patient interactions. All stop smoking advisors will have received training about Varenicline from the Stop Smoking Service. In addition, they are to have access to a copy of the Summary of Product Characteristics (SPC) that provides technical information ( Is the patient motivated to quit and willing to be supported by the stop smoking service? Trials have shown that support and counselling over the period helps quit rates No Offer information and help so that the patient may return to service when Yes NICE guidance (Public Health Guidance No 10 for smoking Cessation Services Feb 2008) states; Offer NRT or Varenicline, as appropriate to people who are planning to stop Do not favour one medication over another. The clinician and patient should choose the one that seems most likely to succeed Do not prescribe NRT in combination with Varenicline bupropion No Use an alternative cessation strategy Yes Is patient suitable for Varenicline? Do not use for < 18 years Pregnant or breastfeeding End stage renal disease Caution: Epilepsy - Severe renal impairment (Creatinine clearance < 30ml/ min) - Patients with a history of psychiatric illness (e.g. depression) Yes No Use an alternative cessation strategy Prescribe Varenicline at 2 week intervals, for 12 weeks with weekly Stop Smoking Service support for minimum of 6 weeks 19

20 Advise patient that: It is not a magic cure but it can make quitting easier (reduces urges to smoke and discomfort some smokers experience when trying to quit) more than doubles your chance of success 25 33% of patients may feel sick for a while after taking a tablet. This is usually mild but may persist. To help with this take the tablet with or after a meal and with a glass of water Some people report unusual/vivid dreams No known risks, but a new drug so please tell Advisor of anything unusual, not nausea, dreams, abdominal bloating or insomnia as these are known effects of the drug Take care when driving or operating machinery until you know how you react to it, this is a new drug that can commonly cause dizziness and or sleepiness. If patients report these symptoms, advise them to avoid driving or operating machinery Explain how to take Varenicline In 1-2 weeks before quit date, while still smoking take 1 x 0.5mg tablet in the morning for 3 consecutive days, e.g. Monday /Tuesday /Wednesday at the same time each day 1 x 0.5 mg tablets, morning and evening for the rest of the week Move to 1 x 1mg tablets morning and evening, set quit date during this period Initial prescription is for a starter pack for 2 weeks Next and following prescriptions are for follow on packs which cover 2 weeks or one month s supply, either at 1mg or 0.5mg strength. Some clients may benefit from continuing treatment with 0.5mg tablets twice daily if nausea is troublesome On next appointment Check that tablets suit the patient & are effective Still motivated to quit? Continue to support weekly, but prescribe every other week No Do not prescribe any more Varenicline and consider alternative cessation therapies 4 weeks post quit date Return completed stop smoking Individual Record Sheet (IRS Form) Continue to recommend Varenicline prescription up to a maximum of 12 weeks using 28 day supply pack Varenicline only to be supplied in prescriptions for 2 weeks at a time, up to 4 weeks post quit date then continue with 28 day prescriptions Please ensure that prescriptions are properly controlled, and only supplied in conjunction with support from the Stop Smoking Advisor Ensure any unused medication is returned to a pharmacist If feasible arrange to see patients a week before coming off the tablets to check their progress (After 12 weeks or earlier if patient feels they no longer need to continue treatment) consider recommending the starter pack with 0.5mg tablets to reduce the dosage gradually at the end of treatment. 20

21 Nicotine Replacement Therapy and Champix Service User Information Sheet Although nicotine in tobacco is addictive and makes you want to smoke, it is not nicotine but the other chemicals in tobacco smoke that cause cancer, heart disease, bronchitis and the other smoking-related health problems. When you stop smoking, your body still has a 'need' for nicotine, which creates an urge to smoke again. You may suffer withdrawal effects such as irritability, loss of concentration, and sleepless nights. By taking nicotine in a 'clean form' e.g. NRT, withdrawal symptoms are reduced and you are twice as likely to be successful in staying quit. Nicotine replacement doesn't completely remove the desire to smoke, though, and willpower is still needed. DO NOT SMOKE WHILE USING NICOTINE REPLACEMENT Side effects of nicotine replacement therapy are usually mild. Some patients experience skin rashes (for patches), sore mouth and throat (for gum or inhalator), nausea, dizziness, or vivid dreams. Nicotine replacement therapy is usually taken for 12 weeks. It does not have the same addictive potential as smoking and few quitters feel the need to continue treatment for longer than this. For Nicotine Patch users: The best time to put the patch on is first thing in the morning. Use ONE PATCH A DAY. Use ONLY ONE PATCH AT A TIME. Take the old patch off before putting the next one on. STICK YOUR PATCH ON A DIFFERENT PLACE EACH DAY. Avoid putting patches on broken skin. Keep to clean, dry areas. Common places to put your patch are your upper arm, hip or chest. KEEP PATCHES AWAY FROM CHILDREN AND PETS. Fold used patches in half with the sticky side inside, wrap them up and dispose of them Store your patches somewhere cool but NOT IN A FRIDGE. For Nicotine Gum users: Whenever you feel the urge to smoke, chew a piece of gum. You need to use 10 to 15 pieces of gum per day for maximum benefit. DO NOT USE MORE THAN 15 PIECES PER DAY OF GUM. The nicotine is absorbed through the lining of the mouth. If you swallow it, the nicotine is wasted, and you may experience hiccups or indigestion. You must CHEW NICOTINE GUM CORRECTLY. Chew the gum slowly until the taste becomes strong. Then stop chewing and rest the gum against the inside of your cheek. When the taste starts to fade, start chewing the gum slowly again until the taste becomes strong, then rest the gum again. Keep chewing and resting the gum for about half an hour per piece, until the gum no longer has any taste. For Nasal Spray users: Gives fast relief to heavy smokers. 21

22 One spray should be administered to each nostril per dose. Dose once or twice an hour as required. Nasal spray should not be used for more than nine months. May cause nasal irritation, sneezing, watering eyes and coughing at first. For Lozenges and Niquitin Mini s users: One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately minutes). The lozenge should not be chewed or swallowed whole. Mini s are available in mint 1.5 mg and 4mgs strengths and orange flavour in 1.5mgs DO NOT EXCEED 15 LOZENGES PER DAY You should not eat or drink while a lozenge is in the mouth. For Nicotine Microtab users: Whenever you feel the urge to smoke, pop a microtab under your tongue. You need to use 15 to 30 microtabs per day for maximum benefit. DO NOT USE MORE THAN 30 MICROTABS PER DAY DO NOT CHEW OR SWALLOW THE MICROTAB The nicotine is absorbed through the lining of your mouth. If you chew or swallow the microtab the nicotine is wasted, and you may experience hiccups or indigestion. For Nicotine Inhalator users: Whenever you feel the urge to smoke, pop a cartridge into your inhalator and suck hard on the mouthpiece until you can taste the nicotine. You can continue sucking on the inhalator until there is no more taste. Usually one cartridge lasts for about 20 minutes of heavy use. You will probably use around 6 cartridges per day. DO NOT USE MORE THAN 12 CARTRIDGES PER DAY On cold days you may find that you have to work harder to get the same amount of nicotine from the inhalator as you get on warmer days. The mouthpiece of the inhalator should be cleaned several times a week by rinsing in water. For Niquitin Strip users: One strip should be placed on tongue and pressed to roof of mouth until completely dissolved (approx. 3minutes) minty flavour, only available in 2.5mgs. DO NOT USE MORE THAN 15 STRIPS PER DAY For Quickmist users: Relieves craving within 60 seconds. One or two sprays should be administered to the mouth. Most smokers will require 1 2 sprays every 30 minutes to an hour. DO NOT USE MORE THAN 4 SPRAYS PER HOUR AND NO MORE THAN 64 SPRAYS IN ANY 24 HOUR PERIOD. The spray may require priming (pumping) prior to the initial use. 22

23 Varenicline* (Champix **) Varenicline (Champix ) is a drug that helps people stop smoking by reducing withdrawal symptoms when you stop smoking and the urges you might get to continue smoking. If you do smoke while taking it, it reduces the satisfaction you get from smoking. It is only available if you are regularly being seen by a Stop Smoking Advisor. Although it will make stopping easier it is not a magic cure and you will still need a lot of determination and willpower. Current knowledge suggests that varenicline has no clinically meaningful drug interactions but it is still a good idea to tell your Stop Smoking Advisor if you are on any other medication. 1. Dosage and administration: Start one to two weeks before the quit date. Take the tablets with or after meals with a glass of water. Recommended treatment schedule with varenicline tablets: Days 1-3: 0.5mg once daily Days 4-7: 0.5 mg twice daily Day 8 - end of treatment (12 weeks): 1mg twice daily Service users who cannot tolerate adverse effects (e.g. nausea) can have the dose lowered temporarily or for the rest of the course at 0.5mg twice daily providing the treatment continues to be effective. Varenicline is not recommended in the following groups Hypersensitivity to the active substance or any of the excipients Smokers with severe kidney malfunction Smokers under the age of 18 Pregnant or breastfeeding women Varenicline has not been tested in service users with epilepsy therefore caution is advised. If you have recently or are currently suffering from depression please let your Stop Smoking Advisor know as this medication may not be suitable for you. 2. Side effects are usually mild but can include: Nausea, headache, nasal symptoms, sleeplessness and abnormal dreams. Please note that stopping smoking with or without treatment is associated with various symptoms. For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking. There have been no studies to determine whether some side effects documented are as a result of stopping smoking versus varenicline. If you experience any other problems while taking this drug please let your Stop Smoking Advisor or your doctor or pharmacist know as soon as possible. You should also take care when driving or 23

24 operating machinery until you know what effects Varenicline has as it may cause dizziness or drowsiness. When you stop taking Varenicline you may experience increased irritability, an urge to smoke, depression and/or insomnia (noted in up to 3% of service users). Please make an appointment to see your Advisor when stopping the medication in order to check the withdrawal process. Richard Merrett Health Development Manager * Varenicline is the drug s proper name ** Champix is the brand name 24

25 APPENDIX 4 First Appointment /conversation: Cut down to Quit (CDTQ) Client asked if ready to quit. If yes then advised to work on total abstinence model, use of NRT or other pharmacotherapy and set a quit date. If no then recommend Cut Down To Quit (CDTQ) Please refer clients who want to use this approach to the Specialist Stop Smoking Service for support Cut down to Quit process: Week one client smokes as normal and keeps a diary of their smoking. Week two client looks at diary and reduces cigarettes by one quarter using one oral product. NOT mouth spray or nasal spray. Asked if still happy to continue on CDTQ or if would like to proceed to total abstinence (TA). Continues to keep diary. Week three client looks at diary and reduces cigarettes by one quarter using one oral product. NOT mouth spray or nasal spray. Asked if still happy to continue on CDTQ or if would like to proceed to total abstinence (TA). Continues to keep diary. Week four client looks at diary and reduces cigarettes by one quarter using one oral product. NOT mouth spray or nasal spray. Asked if still happy to continue on CDTQ or if would like to proceed to total abstinence (TA). Continues to keep diary and starts to make plans for quit day. If client wants to quit on Champix then contact GP with recommendation. Week five client makes quit attempt using either Champix or NRT. If client is unable to quit at week five then stop NRT/Champix not recommended and ask to come back when ready to try again. 25

26 APPENDIX 5 RECOMMENDATION FOR NRT Date.. Client Name..Date of Birth:. Client Address. Postcode:. I have discussed NRT treatment with this client today and I should be grateful if you would consider dispensing the following NRT products: (Repeat recommendations will only be given if client continues to access support and does not smoke) Nicotine Replacement Products NICOTINE PATCH 15mg/16 hours NICOTINE PATCH 10mg/16 hours NICOTINE PATCH 5mg/16 hours NICOTINE PATCH 21mg/24 hours * NICOTINE PATCH 14mg/24 hours NICOTINE PATCH 7mg/24 hours NICOTINE PATCH 25mg/16hours (clear) * NICOTINE PATCH 15mg/16 hours (clear) NICOTINE PATCH 10 mg/16 hours (clear) NICOTINE GUM 4mg NICOTINE GUM 2mg NICOTINE NASAL SPRAY NICOTINE SUBLINGUAL TABLET NICOTINE LOZENGES MINIS 1.5mgs NICOTINE LOZENGES - MINIS 4mgs NICOTINE LOZENGES - COOLS 2mgs NICOTINE LOZENGES COOLS 4mgs NICOTINE LOZENGE original 4mg NICOTINE LOZENGE original 2mg NICOTINE LOZENGE original 1mg NICOTINE ORAL STRIPS 2.5mg (15 or 60) NICOTINE INHALATOR 15mg NICOTINE MOUTHSPRAY (Quick Mist) 1mg Amount Required (* Also available as pack of 14 patches = 2 weeks supply) Tick Name.. Signed Registered address: Sirona Care & Health CIC, St Martin s Hospital, Clara Cross Lane, Bath BA2 5RP Co Reg. No: VAT No: