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QUITHELPING SMOKERSAdding value to every clinical contact by treating tobacco dependence

1Why and how to prescribe varenicline in hospital - March 2016

Why and how to prescribe varenicline in hospitalHelping smokers quit in hospital - safe and effective treatment of tobacco dependence

Who is this information for?

Hospital clinicians who are prescribers (doctors and independent prescribers – pharmacists and others) and are involved in the delivery of care to people who are smokers , i.e. tobacco dependent, but who do not have much experience of prescribing varenicline as a smoking cessation medication.

Why has it been provided?

Clinicians often raise a number of concerns about varenicline that make them cautious about prescribing. This is compounded by varenicline prescribing historically having been the responsibility of smoking cessation specialists. Therefore many clinicians have not been trained, and do not have experience, in prescribing varenicline (or nicotine replacement therapy).

What are some of the common clinician concerns about prescribing varenicline?

• I see patients who smoke who have mental health problems. Is it safe in this population? Will adverse effects increase their length of stay?

• Can people really make the decision to quit smoking and rationally choose varenicline when they are ill in hospital?

• Patients in hospital cannot smoke - our hospital and grounds aresmoke free - so how can we prescribe varenicline when the product recommendation is that people should smoke, at least in the first week of the starter pack and into the second week until their agreed quit date?

• If I do prescribe varenicline for an inpatient what do I do aboutprescribing nicotine replacement therapy (NRT)?

• Is it the responsibility of hospitals to force a ‘lifestyle’ choice onpatients when they feel vulnerable? Surely this is something they need to do with their GP, practice nurse or pharmacist who they know?

• The course needs ongoing support and is 12 weeks long; we don’t have a smoking cessation specialist who can see patients on the wards and our hospital stays are too short to initiate this therapy.

• Is varenicline a cost-effective treatment for treating tobacco dependence?

Who is this information written by and why?

This guide has been written by a group of London clinicians who work in hospital and community settings, in general practice, and in pharmacies, who have several years’ experience of using varenicline and is coordinated by the Helping Smokers Quit in London Delivery Team, sponsored by the London Clinical Senate. In learning to prescribe varenicline, we had to review the evidence and guidance and learn from quit smoking specialist colleagues who already prescribed varenicline. The aim of this guide is to collate this information to make it easier (and save time) for hospital colleagues who also want to be able to prescribe varenicline safely and effectively.

What information is provided?

The following information is included as we believe this addresses most clinical concerns:

• Top ten tips for clinician prescribing of varenicline in hospitals

• Clinical review of the evidence and national guidance forvarenicline as a treatment for tobacco dependence (including safety and cost-effectiveness)

• Clinical review of the evidence and national guidance on varenicline prescribing in hospitals

• Clinician experiences of prescribing varenicline



1. Identify all patients who are tobaccodependent by asking every patient about smoking – hospital staff have to believe it is important to know smoking status and be confident to ask. All London clinicians working in acute trusts and mental health trusts should complete the Very Brief Advice Training at elearning.ncsct.co.uk/vba-stage_1 or equivalent. The training takes only 20 minutes and the conversation with a patient can take as little as 30 seconds.

2. Measure Carbon Monoxide (CO) routinely on,and during, admissions - having CO monitors available and staff trained and confident in their use make this easier to do. (Ref. 1)

3. Offer combination nicotine replacementtherapy (NRT) to manage withdrawal to every smoker. Combination NRT is usually a patch plus faster acting NRT.

4. Assess motivation to quit and perceived abilityto quit for every smoker and arrange for a hospital smoking cessation specialist to see any patient on the ward who is ready to stop smoking.

5. Ensure all members of the clinical team knowabout varenicline, that it is a safe and effective treatment for smoking cessation, and how to offer it to patients.

6. Start supervised varenicline loading on theward, as soon as agreed with a patient, with continuation of NRT for the first 7-14 days to treat withdrawal. Regularly ask about, and address, side effects (nausea, headache) to increase patient adherence.

7. Ensure people with mild, moderate or severemental illness in mental health and physical health wards have the same equity of access to varenicline as those without mental illness. The more complex the mental health problem the more involvement with mental health teams will be required.

8. Document details of stop smoking treatmentin the records, letters and discharge summary and include a clear plan about what should happen next and with whom to continue the quit smoking support.

It helps to document tobacco dependence as a diagnosis and the contribution of smoking to admission in records, letters and discharge summaries.

9. Ensure that when patients prescribed varenicline leave hospital they have enough varenicline and NRT prescribed to allow for unintended delays in GP prescribing or contact with community smoking cessation specialists.

10. Monitor outcomes and feedback success to allmembers of the team. This increases individual and team confidence and motivation to treat tobacco dependence. While total numbers treated with varenicline may be small, the impact of a sustained quit is great and this patient group is often well known to many health professionals.

Top Ten TipsSafe and effective varenicline prescribing - helping smokers in hospital who want to quit



Clinical review of the evidence and national guidance for varenicline as a treatment for nicotine dependence (Ref. 2)

Varenicline (Champix®) is an orally administered partial agonist of the alpha4beta2 nicotinic acetylcholine receptor. It helps people to stop smoking by relieving craving and withdrawal symptoms and reducing the rewarding effect of smoking. It has been available in the UK and recommended by NICE (Ref. 3) as a medication for smoking cessation since 2007. It is licensed for use in adults over 18 years old who are not pregnant or breast-feeding (Ref. 4). NICE recommends that every smoker who takes varenicline should also receive behavioural support (Ref. 3).

Varenicline is more effective than NRT used in single forms (e.g. patch or gum) and in some settings is also more effective than combination NRT (patch plus a fast-acting form) (Refs 2, 3, 5, 6). It is the most effective monotherapy for smoking cessation and has no known drug-drug interactions.

Both NICE and the National Centre for Smoking Cessation and Training (NCSCT) recommend varenicline as a first line treatment and that smokers should be routinely offered it as one of the options available to them. This recommendation is based on evidence of effectiveness and the health risks from continued smoking; every year that smoking cessation is delayed after the age of 35 years results in a loss of three months’ life expectancy (Ref. 7). To optimise effectiveness, varenicline should only be prescribed in association with skilled behaviour change support and follow-up, as is the case for NRT.

Initially concerns were raised about possible serious side effects with varenicline including increased risk of suicide and increase in risk in cardiovascular serious adverse events. These risks have not been confirmed in practice. Varenicline has also been shown to be effective and safe both when used by smokers with mental illness (Refs 8, 9) and smokers with cardiovascular disease (Refs 10, 11).

A number of large studies have shown no evidence of an increased risk of suicide or suicidal ideation due to varenicline (Ref. 8). There is also no evidence that smokers with pre-existing mental health problems are more vulnerable to neuropsychiatric side effects than other patients. A recent systematic review and network meta-analysis of 14 randomised controlled trials (RCTs), involving about 400 patients, showed varenicline was more effective than placebo (OR 5.17 95% CrI 1.78 to 15.06) and was an acceptable treatment to patients (Ref. 9).

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Mental health guidance therefore specifically recommends that patients with mental health problems, who have high levels of tobacco dependence and risk of harm from smoking, should not be excluded from taking varenicline. Current Medicines & Healthcare products Regulatory Agency (MHRA) advice is that patients with a history of psychiatric illness should be monitored closely while taking varenicline and all patients taking varenicline should be advised to discontinue treatment and seek prompt medical advice if they develop agitation, depressed mood, changes in behaviour or thinking that are of concern, or if the patient develops suicidal thoughts or behaviour. The standard guidance on impact of stopping smoking on other medication e.g. clozapine, used for patients with mental illness who embark on smoking cessation, should be followed regarding supervision of doses and need for dose reduction (Ref. 12).

Support = specialist individual behavioural support



Current data indicates that any increase in cardiovascular risk with varenicline is small, not statistically significant, or clinically meaningful, and any slight increase in cardiovascular risk with varenicline is mitigated by the benefit of successfully stopping smoking and associated reduction in cardiovascular risk. There is RCT evidence that varenicline is safe and effective in smokers with stable cardiovascular disease (Ref. 10) and more recently RCT evidence that varenicline is both safe and effective in patients with acute coronary syndrome (ACS) (Ref. 11). In this study of 300 patients with ACS 36% quit rates at 24 weeks were achieved with varenicline compared to 26% with placebo (P=0.081). The number needed to treat to achieve smoking cessation at 6 months in these patients with ACS was 10 (Ref. 11).

The most common side effect reported from the use of varenicline is nausea (30%). In the majority of cases nausea is manageable by taking varenicline with food and a full glass of water and subsides over time. Only 3% of patients have to stop taking it because of nausea. London-wide acute trust varenicline prescribing data

shows, as expected, that hospital varenicline prescribing is much more likely when smoking cessation specialists work on hospital wards and with inpatient teams.

Varenicline in combination with NRT has been shown to be safe and studies are ongoing to evaluate whether varenicline in combination with NRT increases quit rates (Ref. 14). Applying this evidence, our practice and recommendation is that when varenicline is prescribed in hospital, it is prescribed in combination with NRT, with NRT prescribed for up to 2 weeks to treat withdrawal and varenicline used as the ongoing treatment to support smoking cessation.

There is also some evidence that varenicline can also be used to support harm reduction in smokers who do not feel able to quit (Ref. 15).

Sample of variation in London-wide acute and mental health trust varenicline prescribing April 2015 - June 2015

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Cost-effectiveness of varenicline as a treatment for tobacco dependence

Varenicline costs ~£170 for a full 12 week course of treatment (Ref. 4). The cost per QALY for a course of varenicline ranges from £940 to £1,150. It is highly cost-effective when compared with minimal advice and has been shown to be more cost-effective than either NRT or bupropion in the UK. Varenicline is therefore endorsed as both a clinically and cost-effective treatment for nicotine dependence by NICE guidelines. (Refs 16, 17)

To put the cost of quit smoking pharmacotherapy into context the graph below (Ref. 16) compares pharmacotherapy for smoking cessation against QALYs gained for other accepted treatments of smoking-related diseases. NRT, which is less effective than varenicline, is used as the comparator and demonstrates a QALY that compares favourably with other treatments for value and is a long way below the NICE £20,000-£30,000 per QALY threshold.

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Hospital staff have to believe it is important to know smoking status and be confident to ask



Clinical review of the evidence on varenicline prescribing in hospitals

Smokers who are hospitalised are at very high risk of continued tobacco-caused morbidity. They are placed in a setting of forced abstinence and feel especially vulnerable thus creating a “teachable moment” yet, tobacco dependence treatment services have been historically underutilized during hospitalisation. (Refs 18, 19, 20)

While there is good evidence to support use of varenicline in sick smokers, there is currently limited evidence of the impact of varenicline initiation in hospitals. The 2013 NICE Guidance, Smoking cessation in secondary care: acute, maternity and mental health services (Ref. 21), comments that ‘There is relatively little evidence from trials in secondary care that include bupropion or varenicline as a means of helping people to stop smoking’ but goes on to conclude: ‘these pharmacotherapies are highly effective in trials with the general population, and the programme development group felt there was no reason why this would not apply to people in secondary care settings.’

Three studies that looked at the outcomes from varenicline prescribed in hospital are summarised below. The results are encouraging in terms of long term quit rates overall and also are reassuring about safety. Patients in these studies had forced abstinence due to hospitalisation and therefore commenced varenicline as ‘ex-smokers’.

The first RCT of hospital-based prescription of varenicline, published in 2011, compared varenicline with placebo in a US hospital where patients were in a situation of forced abstinence (Ref. 18). There was no difference in abstinence at 24 weeks between varenicline (23%) and placebo (31%). This may reflect study size, that those included often smoked other substances and had co-existing mental health problems, so are likely to be amongst the sickest and most dependent smokers – a situation that hospital clinicians in London would recognise, and/or the fact that only 40% of patients engaged with treatment after leaving hospital. However, those who were prescribed varenicline and did engage with ongoing treatment had significantly higher abstinence rates than those not prescribed placebo (53.1% vs. 8.5%). Importantly, adverse events were similar in both groups with the only significant difference being, as expected, more nausea in the varenicline group (25% vs. 5%; p < 0.01).

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A second RCT involving 400 patients in three hospitals in Australia, published in 2012, showed that significantly more smokers admitted with a smoking-related illness who were prescribed varenicline with psychological support were continuously abstinent at 12 months (31%) compared to those who only received counselling (21%; p=0.03). (Ref. 22)

More recently a study of patients admitted to hospital for respiratory illness (asthma, COPD, pneumonia) showed patients treated with varenicline and support had much higher quit rates at 6 months at 64% compared to 25% for patients who received psychological support/ counselling only. (Ref. 23)

National guidance on varenicline prescribing in hospitals

The 2013 Smoking: acute, maternity and mental health services NICE guideline on smoking cessation in hospitals, due to be updated in 2016, recommends that varenicline should be available and prescribed to patients who are nicotine dependent in hospital:

‘Ensure hospital pharmacies stock varenicline, bupropion and a range of licensed nicotine-containing products (including transdermal patches and a range of fast-acting products) for patients and staff.’

‘Recommend and offer:

- licensed nicotine-containing products (usually a combination of transdermal patches with a fast-acting product such as an inhalator, gum, lozenges or spray) to all people who smoke or

- varenicline or bupropion as sole therapy as appropriate. Do notoffer varenicline or bupropion to pregnant or breastfeeding women or people under the age of 18. Varenicline and bupropion can be used with caution in people with mental health problems

The British Thoracic Society (BTS) has also published national guidelines, ‘Recommendations for Secondary Care Tobacco Smoking Cessation Services’ (2012) (Ref. 24), and ‘The Case for Change: Why dedicated, comprehensive and sustainable stop smoking services are necessary for hospitals’ (2013) (Ref. 25) that recommend availability and use of a full complement of

NICE-recommended pharmacotherapies, including varenicline, on formulary to assist smoking cessation, and to prevent nicotine withdrawal while in hospital.

‘Licensed pharmacotherapy for smoking cessation should be readily available at all times of day in the hospital wards / pharmacy. NRT (all modalities) and varenicline (Champix®) should be available on hospital formulary and easily accessible from ward and/or pharmacy stocks. Patients in hospital who are current smokers should be offered and encouraged to accept NRT or varenicline (with support from the Hospital Smoking Cessation Practitioner (HSCP)) to alleviate withdrawal whilst in a smoke-free hospital.’

‘Hospitals should routinely offer a full range of nicotine replacement therapies (NRT), varenicline (Champix®) and bupropion (Zyban®). The counsellor and/or consultant with responsibility for the service should agree with the hospital pharmacy an efficient way of providing this pharmacotherapy to both outpatients, in-patients and staff who smoke and wish to quit.’

‘The HSCP should be able to prescribe or recommend medications so that all patients and staff who want to quit have timely access to all licensed pharmacotherapies All hospitals should offer NRT (ideally all forms) and varenicline (Champix®) and bupropion should be available.’



Clinician experiences of prescribing varenicline

Learning from the experience of colleagues commonly shapes prescribing practice. For safe and effective varenicline prescribing, this has specific additional benefit because of the current small number of published studies on the role of varenicline for hospital patients who are nicotine dependent, particularly in UK settings.

We therefore include a summary of the learning from introducing varenicline prescribing by clinicians in one acute hospital in London:

Following the publication of the 2007 NICE guidance varenicline was added to the Whittington Health hospital formulary in November 2010. The respiratory consultants and trainees were supported to offer and prescribe it working with the hospital smoking cessation specialists. (Ref. 26)

As smoking cessation is seen as a part of treatment, hospital smoking cessation specialists work as members of the multi-disciplinary team and all members of the medical team are trained in smoking cessation conversations, prescription of NRT and varenicline and Carbon Monoxide (CO) measurements are used routinely as a motivational tool.

This change in prescribing was retrospectively evaluated and varenicline was found to be a highly effective and safe treatment for smoking cessation when started during hospital admission. As a result it is now routinely offered as an option and prescribed for hospital inpatients on the respiratory ward who want to stop smoking with ongoing smoking cessation support and follow-up. (Ref. 27)

The reasons for the, now routine, use of varenicline by the Whittington Health respiratory team are outlined below:

• Many of the in-patients who are cared for are highly tobaccodependent and continued smoking is a contributing factor to their hospital admission e.g. 37% of patients admitted to hospital with COPD in England are current smokers (National RCP COPD Audit 2014).

• Hospital admission is a quit opportunity in a supervised settingthat should be used to greatest patient benefit. Many patients are motivated to start a quit attempt following admission; they have had frightening symptoms leading to admission, feel too unwell to smoke when admitted, and are in a ward setting where they are unable to smoke.

• ‘Sick smokers’ who are in hospital are very aware of the harmfrom smoking and their level of addiction and have often made previous quit attempts using a range of NRT products.

• When such in-patients are offered the full range of stop smokingmedication as first line, many patients choose to use varenicline. Understandably, they are not interested in trying something that they feel has not worked previously and want to try something new with an evidence base for effectiveness.

• Varenicline is offered to patients who want to stop smoking andnot to patients who want withdrawal management. Combination NRT is used to treat withdrawal.

• Varenicline has no known drug-drug interactions, is safe and iswell-tolerated. This is important as many in-patients are on a large number of other medications.

• Being an inpatient enables close monitoring of varenicline soany side effects can be addressed, especially nausea, by changes in doses and timing. This means that patients leave hospital already established on, and confident to continue taking varenicline. Fewer than 10% of Whittington Health inpatients have needed to stop varenicline because of side effects (nausea and headaches). Starting varenicline has not increased length of stay. The converse is not true; covert continued smoking during admission in patients with severe respiratory disease and respiratory failure has lengthened hospital admission.

• Varenicline was effective - with varenicline started as aninpatient, and skilled quit smoking support and follow-up, CO-validated 4-week quit rate was 48% and self-reported 6-month and 1-year quit rates were 41% and 20% respectively for a group of highly dependent sick smokers with respiratory disease (Ref. 27, Appendix 1).

Practicalities of safe varenicline prescribing:

• Acute withdrawal also needs treating following hospitaladmission. As there is a ‘lead time’ for patients starting varenicline, NRT (as for all smokers admitted to hospital) is also offered to help with the management of nicotine withdrawal in the first 7-14 days of using varenicline. This is well tolerated by patients with no reported adverse effects.



Appendix 2 provides a prescribing guide for NRT and varenicline for use by prescribers in London.

• Varenicline prescription is delivered as part of a service thatenables sick smokers to be introduced to, and meet with, a hospital smoking cessation specialist on the ward and continue with supervised follow-up (as recommended by NICE).

o Tobacco dependence is documented as a diagnosis andthe contribution of smoking to admission is recorded on their discharge summary.

o A patient’s GP is informed that they have been started on varenicline as an inpatient in their discharge summary.

o Patients are offered follow up either as an outpatient by oneof the hospital smoking cessation specialists or at home by the quit smoking specialist who sees patients at home.

o Patients leave hospital with the date and time of their first appointment.

o Further supplies of varenicline are either prescribed by amember of the medical team or by the patient’s GP according to patient need and preference agreed at their smoking cessation follow up appointment.

o Alternatively, if a patient wishes to continue their treatment for their tobacco dependence with their GP, the hospital smoking cessation specialist liaises with their GP and/or level 2 quit smoking specialist at the practice, to ensure the patient has a follow up appointment booked before they leave hospital and support from the hospital quit smoking team is offered to their GP/Level 2 smoking cessation specialist if they have any questions.

• The number of varenicline prescriptions is not large, and hasremained steady, at about one Whittington Health clinician-initiated new varenicline prescription per week for the respiratory team patient group.

Very Brief Advice Training only takes 20 minutes and the conversation with a patient can take as little as 30 seconds



References

1. The expired carbon monoxide (CO) test – guidance forhealth professionals www.londonsenate.nhs.uk/wp-content/uploads/2015/04/Helping-Smokers-Quit-Programme-The-expired-carbon-monoxide-CO-test.pdf

2. Varenicline: effectiveness and safety. 2013 National Centre forSmoking Cessation and Training (NCSCT).

3. www.nice.org.uk/guidance/ta123

4. Pfizer Ltd. Summary of Product Characteristics CHAMPIX® 0.5mg film-coated tablets; CHAMPIX® 1 mg film-coated tablets. 2014.

5. Cahill K, Stevens S, Perera R, Lancaster T. Pharmacologicalinterventions for smoking cessation: an overview and network meta-analysis. Cochrane database of systematic reviews (Online) 2013;5:CD009329.

6. Mills EJ, Wu P, Lockhart I, Thorlund K, Puhan M, Ebbert JO.Comparisons of high-dose and combination nicotine replacement therapy, varenicline, and bupropion for smoking cessation: A systematic review and multiple treatment meta-analysis. Ann Med 2012;44(6):588–97.

7. Doll R, Peto R, Boreham J, Sutherland I. Mortality in relationto smoking: 50 years’ observations on male British doctors. BMJ (Clinical research ed 2004;328(7455):1519.

8. Thomas KT, Martin RM, Knipe DW, Higgins JPT, Gunnell D. Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis. BMJ 2015;350:h1109 | doi: 10.1136/bmj.h1109

9. Roberts E, Evins EA, McNeill A, Robson D. Efficacy andacceptability of pharmacotherapy for smoking cessation in adults with serious mental illness: A systematic review and network meta-analysis. Addiction 2015. onlinelibrary.wiley.com/doi/10.1111/add.13236/abstract

10. Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D,Tonstad S. Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Cardiovascular Disease A Randomized Trial. Circulation. 2010;121:221-229. www.ncbi.nlm.nih.gov/pubmed/20048210?dopt=Abstract

11. Eisenberg MJ, Windle SB, Roy N, Old W, et al. Vareniclinefor Smoking Cessation in Hospitalized Patients With Acute Coronary Syndrome. Circulation. 2016;133:00-00. DOI: 10.1161/CIRCULATIONAHA.115.019634. circ.ahajournals.org/content/early/2015/11/07/CIRCULATIONAHA.115.019634.abstract

12. Smoking Cessation and Mental Health: A briefing for front-linestaff, page 14. National Centre for Smoking Cessation and Training (NCSCT) Authors: Deborah Robson and Jennifer Potts www.ncsct.co.uk/usr/pdf/mental_health_briefing_A4.pdf

13. West R, Owen L (2012) Estimate of 52-week continuous abstinence rates following selected smoking cessation interven-tions in England. www.smokinginengland.info/reports/ Version 2

14. Efficacy of Varenicline Combined With Nicotine ReplacementTherapy vs Varenicline Alone for Smoking Cessation A Randomized Clinical Trial Koegelenberg CFN, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O’Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen, TM, Irusen, EM. JAMA. 2014;312(2):155-161. doi:10.1001/jama.2014.7195

15. Ebbert JO, Hughes JR, West RJ, Rennard SI, Russ C, McRae TD,Treadow J; Yu C-R, Dutro MP, Park PW. Effect of Varenicline on Smoking Cessation Through Smoking Reduction A Randomized Clinical Trial JAMA. 2015;313(7):687-694. doi:10.1001/jama.2015.280

16. Shahab L, McEwan A, et al. Cost-effectiveness ofpharmacotherapy for smoking cessation. 2012 www.ncsct.co.uk/usr/pub/B7_Cost-effectiveness_pharmacotherapy.pdf

17. Effectiveness and cost-effectiveness of programmes to helpsmokers to stop and prevent smoking uptake at local level. (2015) National Centre for Smoking Cessation and Training (NCSCT)

18. Steinberg, Randall, Greenhaus, Schmelzer, Richardson, Carson.Tobacco dependence treatment for hospitalized smokers: A randomized, controlled, pilot trial using varenicline. Addict Behav. 2011 Dec;36(12):1127-32. doi: 10.1016/j.addbeh.2011.07.002. www.ncbi.nlm.nih.gov/pubmed/21835552

19. Emmons et al. The use of nicotine replacement therapy duringhospitalization. Ann Behav Med. 2000 Fall; 22(4):325-9 www.ncbi.nlm.nih.gov/pubmed/11253444

20. Koplan, Regan, Goldszer, Schneider, Rigotti. A computerizedaid to support smoking cessation treatment for hospital patients. J Gen Intern Med. 2008 Aug;23(8):1214-7. doi: 10.1007/s11606-008-0610-4. Epub 2008 May 9. www.ncbi.nlm.nih.gov/pubmed/18465176

21. www.nice.org.uk/guidance/ph48



Helping Smokers Quit Delivery Team

Dr Louise Restrick – Acute Trust Consultant Physician

Dr Mike Gill – Consultant Physician

Dr Noel Baxter – GP and Commissioner

Darush Attar-Zadeh – Community Pharmacist and Smoking Cessation Specialist

Mary Arnott-Gee – Mental Health Trust Smoking Cessation Nurse Specialist

Siân Williams – Programme consultant

With contributions from the London Procurement Partnership, Elizabeth Pang – Quit Smoking Specialist and Ameet Vaghela – Respiratory Pharmacist, at Whittington Health.

Conflicts of interest

Darush Attar-Zadeh: Has worked with all companies involved in smoking cessation pharmacotherapies to promote evidence based behavioural support alongside medication.

No other conflicts of interest

London Clinical Senate Website

www.londonsenate.nhs.uk/helping-smokers-quit/

22. Smith BJ et al Research letter. Smoking Termination Opportunityfor inPatients (STOP): superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 12-month randomised controlled trial for inpatients. thorax.bmj.com/content/early/2012/09/18/thoraxjnl-2012-202484.short

23. Alexander Politis et al Smoking cessation in hospitalizedpatients with comorbidities. www.ncbi.nlm.nih.gov/pmc/articles/PMC4332068/

24. British Thoracic Society Recommendations for Hospital SmokingCessation Services for Commissioners and Health Care Professionals www.brit-thoracic.org.uk/document-library/clinical-information/smoking-cessation/bts-recommendations-for-smoking-cessation-services/

25. The Case for Change: Why dedicated, comprehensive andsustainable stop smoking services are necessary for hospitals British Thoracic Society Reports, Vol 5, Issue 2, 2013www.brit-thoracic.org.uk/document-library/clinical-information/smoking-cessation/bts-case-for-change/

26. Pang E and Stern M. Providing support to patients who wish to quit smoking. Prescriber 5 April 2014 www.networks.nhs.uk/nhs-networks/london-lungs/documents/providing-support-to-patients-who-wish-to-quit-smoking/view

27. Ainley A, Pang E, Coleman B, Stern M, Restrick LJ. Assessing The Impact Of Varenicline Initiation During Acute Hospital Admission For Current Smokers With Respiratory Diseases: 18-month Experience From An Inner City District Teaching Hospital. Thorax 2014;69:Suppl 2 A199 doi:10.1136/thoraxjnl-2014-206260.403

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.



Appendix 1 -

Assessing The Impact Of Varenicline Initiation During Acute Hospital Admission For Current Smokers With Respiratory Diseases: 18-month Experience From An Inner City District Teaching Hospital (Ref. 27)



Appendix 2 -

Prescribing Guide for Some of the Most Widely Prescribed Stop Smoking Pharmacotherapies in London

PRODUCT DOSE HOW TO USE IT ADVANTAGES & DISADVANTAGES

Patches Smoking history >20/day

Smoking history <20/day to ≥10/day

Apply each morning to dry, non-hairy skin on the trunk or upper arm. Place new patch on a different site. Skin sites should not be reused for several days.

Some patches are only applied for 16 hours. Do not cut patches.

Easy to use.

24-hour patch can help with clients who get up to smoke in the night or have early morning cravings.

Steady-state nicotine levels are achieved within 10 hours of application.

Nicotinell TTS (24hr)

30cm2 then reduce patch size every 3-4 weeks

20cm2 for 3-4 weeks then 10cm2

NiQuitin and NiQuitin Clear

(24hr)

21mg for 6 weeks, 14mg for 2 weeks, 7mg for 2 weeks

21mg for 6 weeks, 14mg for 2 weeks, 7mg for 2 weeks

Not for occasional smokers.

Does not mimic the nicotine level swings obtained from smoking.

May irritate skin. Avoid in chronic skin disease.24-hour patches may disturb sleep.

No oral involvement.

Nicorette Invisi (16hr)

25mg patch for 8 weeks then 15mg for 2 weeks then 10mg for 2 weeks

15mg patch for 8 weeks then 10mg for 4 weeks

Gum Smoking history > 20/day

Smoking history ≤ 20/day

Chew a piece of gum until the taste becomes strong then rest between the gum and cheek. When the taste fades, start chewing again. The chewing routine should be repeated for 30 minutes.

Immediate effect. Easy to regulate dose, can help to stop overeating. Available in a variety of flavours. Can be used for smoking reduction prior to smoking cessation.

Nicorette 6mg (fruitfusion)4mg (freshmint, icywhite)Max use: 15/day

2mg (freshmint, freshfruit, mint, plain)Max use: 15/day.

Nicotinell 4mg (classic, fruit, mint and liquorice)Max use: 15/day

2mg (classic, fruit, mint and liquorice)Max use: 15/day.

Difficult to use with dentures and may damage them.

Avoid coffee, acidic drinks or soft drinks 15mins before chewing as they may interfere with nicotine absorption.

NiQuitin 4mg (mint)Max use: 15/day.

2mg (mint)Max use: 15/day.

InhalatorNicorette 15mg/

cartridge

Max use: 6/day Inhale when needed. One cartridge lasts for 40mins of intensive use or about 8 ‘puffing’ sessions.

Keeps hands busy, easy to regulate dose.

Can be used for smoking reduction prior to smoking cessation.

Patients with obstructive lung disease may find it difficult to use. Coughing, throat and mouth irritation can occur.

Nasal SprayNicorette10mg/ml (500mcg/

spray)

Max use: 64 sprays/day (or max.1 spray to each nostril twice an hour for 16hrs/day).

Use one spray in each nostril when needed.

Most rapidly acting form of NRT. Provides fast relief for cravings, easy to adjust dose.

May cause nasal and throat irritation. Avoid in patients with hyperactive airways e.g. asthma.

MicrotabNicorette 2mg

Smoking history: >20/dayUse two microtabs (4mg) hourly.Max use: 40 tabs/day

Smoking history: <20/dayUse one microtab hourly. Max use: 40 tabs/day.

Place the tablet under the tongue when needed.

Discreet, easy to adjust dose. Can be used for smoking reduction.

Must be used correctly, wasted if swallowed. Taste may be unpleasant.



PRODUCT DOSE HOW TO USE IT ADVANTAGES & DISADVANTAGES

Lozenge Smoking history: >30/day

Smoking history: ≤ 30/day

Suck slowly until taste is strong then hold lozenge between gum and cheek. Suck again when taste fades. Lozenge dissolves in around 30 min. It should not be chewed or swallowed whole. Do not eat or drink while a lozenge is in mouth.

Discreet and easy to use.

Nicotinell 2mg (mint) every 1-2 hrs.

Max use: 15 /day

1mg (mint) every 1-2 hours

Max use: 30/day

May cause throat irritation and indigestion. Slower sucking may help.

Avoid coffee, acid drinks or soft drinks 15 mins before use as they may interfere with nicotine absorption.

Niquitin 4mg (plain, mint) every 1 or 2 hrs. Max use: 15 /day

2mg (plain and mint) every 1 or 2 hrs. Max use: 15 /day

MouthsprayNicorette QuickMist10mg/ml

(1mg/spray)

Max use: 64 sprays/day (or max.4 sprays an hour for 16hrs/day).

Prime and point spray nozzle to the side wall of the mouth. Press the top fast and firm and release one spray into your mouth, avoiding lips. Do not inhale while spraying to avoid getting spray down your throat. Do not swallow for a few seconds after spraying.

Most rapidly acting form of NRT. Provides fast relief for cravings, easy to adjust dose. One or two sprays to be used when cigarettes normally would have been smoked or if cravings emerge.

May cause irritation to the mouth and throat. Hiccups are common and patients should be advised accordingly (refer to the SPC for the full list of adverse events).

Oral stripsNiquitin 2.5mg transparent film

Available as boxes of 15

and 60

1 nicotine film every 1-2 hours in weeks 1-6, then 1 film every 4-8 hours in weeks 10-12. Max use: 15 films per day.

Place strip on tongue, it sticks to roof of mouth and allow to dissolve. Buccal mucosal delivery. Use 1 strip at a time.

Do not chew or swallow; should not eat or drink while strip is in the mouth.

When opening pack - fold over on the dotted lines and peel in a semi-circle to reveal strip. Do not consume acidic foods/drinks (citrus fruits, fizzy drinks & alcohol) immediately before or after -> will reduce nicotine absorption.

Claims to relieve cravings within 50 seconds.

Gastric upset, hiccups, nausea, headaches, coughs

VareniclineChampix® ▼

Tablets

Starter pack,1mg follow up

pack

Day 1-3: 0.5mg once daily

Day 4-7: 0.5mg twice daily

Day 8 onwards: 1mg twice daily for 11 weeks

For inpatients, can be combined with a NRT patch for first 7-14 days to treat withdrawal.

12 week course Partial nicotinic receptor agonist and antagonist. Currently the most effective pharmacotherapy when combined with behavioural support. Can smoke for 1st week.

May cause nausea (so have with food and a full glass of water). Explain possible abnormal dreams. Not for under 18s, pregnant & lactating women, non-daily smokers, end stage renal disease. Caution in epilepsy.

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