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PRESCRIBING GUIDELINES FOR SMOKING CESSATION_PHA23_JUN 2019_V2

GUIDELINES FOR PRESCRIBING IN SMOKING CESSATION

AUGUST 2019

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Policy title Guidelines for Prescribing in Smoking Cessation

Policy reference

PHA53

Policy category Clinical

Relevant to Clinical staff

Date published August 2019

Implementation date

August 2019

Date last reviewed

August 2019

Next review date

August 2022

Policy lead Chief Pharmacist

Contact details Email: Lucy [email protected]

Accountable director

Medical Director

Approved by (Group):

Drugs and Therapeutics Committee

Approved by (Committee):

Quality Committee

Document history

Date Version Summary of amendments

Jan 2015 1 Original document

Dec. 2016 2 Update of medicine interactions. Update on dosing guidelines.

Aug 2019 3 Consultant initiation of varenicline

Membership of the policy development/ review team

Audrey Coker, Lead Pharmacist for Clinical Services

Consultation Christina Amin Lead Nurse for Physical Health, David Curren, Deputy Director of Nursing, Dr Andrew Black, Consultant Psychiatrist, Anthony Jemmott and Janice Dunn, Community Matrons, DTC

DO NOT AMEND THIS DOCUMENT

Further copies of this document can be found on the Foundation Trust intranet.

mailto:[email protected]

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Contents

1 Introduction 4

2 Definitions 4

3 Medicines available on Trust formulary 5

4 Guidance on prescribing 5

5 Medicines that require review on smoking cessation 10

6 Dissemination and implementation arrangements 16

7 Training requirements 16

8 Monitoring and audit arrangements 16

9 Review of the policy 17

10 References 17

11 Associated documents 18

Appendices: Dosing schedules for nicotine replacement therapies 19

Appendix 1: Patches 19

Appendix 2: Gums 20

Appendix 3: Lozenges 21

Appendix 4: Inhalator, mouth spray, nasal spray 22

Appendix 5: Equality impact assessment tool 23

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1. Introduction

These prescribing guidelines should be read in conjunction with the Trust Nicotine

Management Policy (2015).

All nicotine replacement therapy (NRT) products are licenced for reduction as

well as cessation of smoking, and are safe and effective for supporting

abstinence between opportunities to smoke. There is no evidence that using NRT

and continuing to smoke increases the level of overall nicotine dependence, and

supporting smokers to abstain from smoking without making a commitment to quit

increases the likelihood of a future successful quit attempt1.

Offering support to quit, rather than merely asking a smoker if they are interested in stopping, or telling them they should stop, leads to more people making a quit attempt.

All patients should be asked if they smoke, and all smokers should receive ‘very

brief advice’ as defined in the Nicotine Management Policy (2015).

As well as providing advice and information on smoking cessation,

pharmacological support should be made immediately available when needed.2

Licenced nicotine-containing products and other stop smoking pharmacotherapies

help people to stop smoking and reduce craving, and using NRT increases the

rate of quitting by 50-70%3.

Patients should also be advised that it is the ‘tar’ rather than the nicotine that is

the major cause of damage to people’s health from smoking tobacco, and that

any risks from using NRT products are much lower than those of smoking2.

2. Definitions

Smoking cessation advisors

‘Level 2’ smoking cessation advisors are staff members trained by local specialist

smoking cessation services to provide smoking cessation advice, and use

motivational interviewing techniques to support behavioural change.

All the advisors will be registered with their local smoking cessation service

provider and on their database. Advisors will be expected to attend an annual

update after accreditation in order to remain an accredited level 2 advisor.

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Complete abstinence

Smokers who are motivated to stop smoking and are willing to work with a

smoking cessation advisor to achieve lasting abstinence.

Temporary abstinence

Smokers who need NRT to manage the symptoms of nicotine withdrawal for the

duration of the admission, but do not wish to quit smoking.

3. Medications available in the Trust formulary4

Table 2: Nicotine Replacement Therapy (NRT) formulations

Route of administration Medication available

Transdermal (patch) Nicotine patches 7mg, 14mg, 21mg (24 hours) Nicotine patches 15mg, 25mg (16 hours)

Oral (lozenge, gum or spray) Nicotine lozenges 1.5mg, 2mg, 4mg (strength brand specific) Nicotine gum 2mg, 4mg Nicotine spray 1mg/metered dose (150 doses)

Nasal Spray Nicotine nasal spray 500mcg

Inhalator Nicotine inhaler 15mg (36 cartridge pack)

Varenicline is included in the trust formulary. However it should not be used for smoking cessation in patients who are acutely unwell Bupropion is not on the Trust formulary for smoking cessation due to contra indications (increased risk of manic episode in bipolar affective disorder and reduced seizure threshold).

4. Guidance on prescribing

Nicotine replacement therapy should be offered to all inpatient smokers. Varenicline should only be prescribed to patients whose mental health condition is generally stable and therefore is not recommended for acute inpatients. Varenicline should not be prescribed to breast feeding or pregnant women but it can be used with caution in people with mental health problems2. The initiation of varenicline should be agreed with the patient’s consultant and noted in Carenotes.

Nicotine Replacement Therapy (NRT)

Nicotine transdermal patches are a long-acting preparation available in a 16 hour formulation, and in 24 hour formulation.

Short-acting nicotine preparations (gum, lozenges, inhalator, nasal spray, and oral spray) are used whenever the urge to smoke occurs or to prevent cravings4.

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Using a combination of NRT products to control withdrawal symptoms is 35% more effective than a single preparation alone3. Combination therapy should be offered to all highly dependent patients (>10 cigarettes per day), and to patients who have found single forms of NRT inadequate in the past.2 Combination therapy would usually be a transdermal patch combined with an intermittent formulation for relief of breakthrough symptoms3,5. Each preparation can be prescribed in a dose up to 100% of the BNF limit, even when two preparations are used in combination.

Evidence suggests that due to higher degrees of nicotine dependence, people with mental health problems often need higher doses of NRT, and for longer periods than smokers in the general population2,6. One of the key aims of providing NRT in inpatient sites is to support abstinence by adequately managing dependency, and therefore timescales for reducing doses over time as provided below are for general guidance only, and may be premature for some of our patients.

Choice of formulation will be influenced by patient preference and experience, as well as their medical history. Capacity to understand how to safely use NRT, and an assessment of the potential for misuse, or accidental or deliberate overdose should also be considered4, especially with oral and nasal sprays, where devices contain comparatively large quantities of nicotine.

Service users receiving NRT in inpatient settings will need to have individual

doses administered by nursing staff. Therefore, when prescribing short acting

preparations in inpatient units please consider treatments where administration of

individual doses can be monitored by nursing staff, in the following order of

preference:

1. Inhalator (preferred due to least number of administrations required in

24hrs).

2. Lozenges.

3. Gum.

4. Mouth spray or nasal spray

Patches

A 24 hour patch should be chosen when the patient smokes first thing in the morning and last thing at night, or wakes during the night to smoke.4 Patches should not be used for people who do not smoke every day, and are generally not suitable for those with chronic skin conditions (e.g. psoriasis, chronic dermatitis or urticaria)5. Patches can cause skin reactions and should be stopped if severe. 16 hour patches must be applied in the morning and removed before bed. In the event of sleep disturbance from a 24 hour patch, a switch to the 16 hour preparation may be required. Patch should be applied each morning to dry, non-hairy skin on the hip, trunk or upper arm and held in place for 10-20 seconds. Sites should not be reused for several days. For the dosing schedule of the patches, see appendix 1.

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Gum

Gum comes in different flavours. It should be chewed until the taste becomes strong, then rested between the cheek and gum to allow nicotine absorption through the cheek, and process repeated when the taste fades.

People may experience wind, hiccups, sore mouth or throat, jaw ache and nausea, uncommonly urticaria and erythema and rarely, allergic reactions including angioedema.

For the dosing schedule of the patches, see appendix 2.

Lozenge

Similar to gum, except lozenge should be sucked and not chewed until taste becomes strong, then rest between cheek and gum, occasionally moving lozenge from one side of mouth to other.

Adverse effects are similar to those for gum.

For the dosing schedule of the patches, see appendix 3.

Inhalator

Cartridge is inserted to device and patients inhale through the mouthpiece when relief required. Absorption is oral mucosal, not pulmonary, so advise to inhale into mouth to reduce gastrointestinal side effects. Mild local reactions like cough and irritation of the throat and mouth may occur

For the dosing schedule of the inhalator, see appendix 4.

Nasal Spray and oral spray

Oral and nasal sprays are popular with heavily dependent smokers, as are perceived to have a rapid action, and also maintain plasma levels comparable to 4mg gum. The nasal spray is licensed only for smoking cessation.

Nicotine oral spray:

Nasal irritation, running nose, nose bleed, sneezing and watery eyes can occur. Advise not to use if driving.

Nicotine nasal spray: Care should be taken not to spray the eyes whilst administering the spray

The dosing schedules are in appendix 4.

Adverse effects of NRT

As well as the more localised effects associate with the above, there are some general side effects associated with NRT. These can be difficult to separate with the symptoms of nicotine withdrawal and include headache, dizziness, coughing, and gastrointestinal disturbances (nausea, vomiting, heartburn, and hiccups). Palpitations may occur, and rarely allergic reactions (including angioedema) and reversible atrial fibrillation (very rare) have been reported.5

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Overdose

Nicotine overdose is rare in smokers7. Cigarettes offer greater yields of nicotine to users than e-cigarettes and NRT, with the average smoker taking 2mg of nicotine from each cigarette. The risk of accidental nicotine overdose is low even with multiple forms of administration, ie: ‘dual use’. The minimum lethal dose of nicotine in a non-tolerant person is estimated at 500mg-1000mg8.

Nicotine consumption tends to be self-limiting even in heavily dependent smokers due to nausea/vomiting induced by low level overdose, and the short half-life of nicotine in the body.

Special Considerations

It is widely accepted that there are no circumstances where it is safer to smoke than to use NRT, however in some circumstances it is preferable to quit without the aid of NRT:

- Cardiovascular disease: In patients with stable cardiovascular disease, NRT is less of a risk than continuing to smoke.9 For dependent smokers with MI, severe dysrhythmia or recent CVA the advice is to stop smoking with non-pharmacological aids, with limited evidence on safety of NRT in this group.9 In the unlikely event of a patient this acutely unwell being managed on a psychiatric ward, specialist advice from cardiology should be sought on the use of NRT.

- Diabetes Mellitus: Nicotine releases catecholamines which can affect carbohydrate metabolism. Blood glucose levels should be monitored daily for insulin dependent diabetics when starting NRT as an inpatient, as insulin doses may need to be decreased.9 Recording and reporting should be completed using the NEWS charts, in accordance with the Physical Health and Wellbeing Policy (2013).

- Renal or hepatic impairment: Patients should be monitored for adverse effects of NRT, as clearance of nicotine and its metabolites may be decreased in patients with moderate/severe hepatic impairment and / or severe renal impairment9.

- Pregnancy: NRT risks and benefits should be discussed. NRT should be used if smoking cessation without NRT fails or patients express a clear wish to receive NRT, in which case professional judgement should be exercised.10

Intermittent forms of NRT are preferable (liquorice flavoured products are contraindicated) but patches can be used, though should be provided in 16 hour form9,10.

- Breastfeeding: Again, intermittent formulations are preferable (can be adjusted to allow maximum time between administration and feeding) and the amount of nicotine infant exposed to in breast milk less hazardous than second hand smoke they may otherwise be exposed to9.

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- Patches: Caution should be exercised with people who have experienced a previous reaction to patches, or are suffering a chronic generalised skin disease such as psoriasis, chronic dermatitis, and urticaria.

- Nasal spray: Exercise caution for people with chronic nasal disorders such as vasomotor rhinitis, perennial rhinitis, and polyposis.

Varenicline

Varenicline is a partial nicotinic receptor agonist which alleviates symptoms of craving and withdrawal and reduces the rewarding and reinforcing effects of smoking by preventing nicotine binding to the receptors.

- Advise stopping smoking 7-14 days after starting varenicline.

- Titrate to treatment dose of 1mg BD over 1 week (day 1-3 500micrograms od, day 4-7 500micrograms bd, day 8 onwards 1mg bd)

- Lower dose advised if unable to tolerate side effects or for people with severe renal impairment.

- Contraindications: pregnancy, breastfeeding, end stage renal disease (reduced doses in renal impairment), epilepsy.

- Case reports in the media have cited depression as an adverse effect, including suicidal thoughts and behaviour, however, large population level studies of self-harm in people taking smoking cessation medications have shown no relationship between varenicline and self-harm11,12.

- People with severe mental disorders were not included in the pre-licencing safety trials for varenicline, however subsequent studies of use in people with mental disorders have indicated that there is no evidence that people with pre-existing mental health problems are more vulnerable to neuropsychiatric side effects than other patients. Prescribing varenicline should be avoided on admission while patients are acutely unwell, but can be considered once mental state is more stable.

- BNF recommends cessation of treatment if agitation, depressed mood or changes in behaviour are observed, and for close monitoring in patients with a history of psychiatric illness6.

- Common side effects: nausea, headache, insomnia, abnormal dreams, increased appetite, somnolence, dizziness, vomiting, constipation, diarrhoea, abdominal distension and discomfort, dyspepsia, flatulence, dry mouth and fatigue.

- No known clinically meaningful medicine interactions.

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5. Medicines that require review on smoking cessation

Cigarette smoke interacts with some medicines, mostly due to polycyclic aromatic hydrocarbons in cigarette smoke that stimulate cytochrome P450 enzymes, particularly CYP1A2; some medicines are therefore more rapidly metabolised in smokers13,14. The enzyme inducing effect is removed when people stop smoking, potentially giving rise to higher plasma levels. Nicotine (NRT) has no effect on this process14,15.

As a precaution, patients who stop smoking on admission to an inpatient unit may need to have the doses of certain medications reduced. Similarly, on discharge from an inpatient unit, if the patient is likely to resume smoking the dose may need to be increased15. Table 3 provides guidance on dose modification for common medicines. However, each case must be considered individually. The extent to which doses are reduced will depend upon the most recent plasma level (where available), the number of cigarettes the patient regularly smokes, the patient’s mental state, and how well the patient tolerates the prescribed dose.15 Please refer to the references given for further information and guidance for other medicines. All patients admitted using the medicines in the following tables must have their prescribing reviewed within 48 hours of admission. In the community, patients prescribed any of the following medicines must have a treatment plan including medication and dosage reviews (by the medical team) in place prior to initiating NRT.

Benzodiazepines

Clozapine

Duloxetine

Fluphenazine

Olanzapine

Insulin

Tricyclic antidepressants Patients prescribed buprenorphine or methadone (who require nicotine replacement therapy products), must be provided the products via the Substance Misuse services in case dose adjustments are required. Aminophylline and theophylline have a narrow therapeutic index. Metabolism and clearance is more rapid in smokers and smoking cessation can potentially result in toxic plasma levels if appropriate dose adjustments are not made. Liaison with specialist services and the GP are necessary when planning smoking cessation for patients currently prescribed aminophylline or theophylline. Supply of NRT for these patients should not be done via the patient group direction.

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Table 3:Common psychotropic medicines affected by smoking status14–16, 22

Medicine Effect of smoking cessation

Action required on stopping smoking

Action required on discharge from hospital/ re-starting smoking

Clozapine Plasma levels may increase by up to 50%.

May be more in patients taking valproate.

Patients on stable dose: Take plasma levels before stopping smoking. On admission/stopping initially reduce clozapine dose by 25mg On stopping, reduce dose by 25% over a week. Repeat plasma level after one week. Anticipate further dose reductions.

Please note most patients are likely to be admitted because they have stopped clozapine prior to admission.

If admitted for re-titration of clozapine dose from the community. Plasma levels must be taken when the patient is prescribed a stable dose for 5-7 days. Final treatment dose of clozapine may be less than treatment dose if smoking cessation is maintained on discharge.

Particularly look out for tachycardia, hyper-salivation & increased drowsiness.

Take final plasma level before leaving hospital for all patients on clozapine.

For patients who have a change in their smoking status on discharge take another clozapine assay two weeks after discharge.

If patient re-starts smoking team to consider that there may need to be an increase in dose. Dose could be increased to previous dose over one week and repeat plasma level after 5-7 days on stable dose.

Olanzapine Plasma levels may increase by up to 50%.

On stopping, reduce dose by 25% over a week.

Adjust dose according to response or tolerability.

If patient admitted on full dose of olanzapine (20mg) - on admission reduce dose to 15mg and clinical team to

Increase dose to previous smoking dose over one week.

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review.

Please note most patients are likely to be admitted because they have stopped olanzapine prior to admission.

(Consider plasma levels in patients on high doses of Olanzapine or significant comorbidities at baseline and after one week.).

Chlorpromazine Plasma levels may increase.

Monitor closely, consider dose reduction.

Monitor closely, consider restarting previous smoking dose

Haloperidol Plasma levels may increase by around 20%.

Reduce dose by 10%.

Adjust dose according to response and tolerability.

Increase dose to previous smoking dose.

Fluphenazine Plasma levels may increase by up to 50%.

On stopping, reduce dose by 25% over a week. Monitor carefully for 4-8 weeks. Consider further dose reductions.


Zuclopenthixol Unclear, but effect probably minimal.

Monitor. Monitor.

Carbamazepine Plasma levels may increase, extent unknown


Monitor plasma levels. Adjust dose accordingly.

Agomelatine Plasma levels may increase.

Monitor closely, consider dose reduction.

Consider increasing the dose to previous smoking dose.

Duloxetine Plasma levels may increase by up to 50%.



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Fluvoxamine Plasma levels may increase by up to a third.



Mirtazapine Unclear. Plasma levels probably rise minimally.

Monitor. Monitor.

Tricyclic antidepressants

Plasma levels may increase by up to 25-50%.

Consider reducing dose by 10-25% over one week.



Benzodiazepines Plasma levels may increase by up to 50%.

Monitor closely, consider dose reduction by up to 25% over one week.

Monitor closely, consider restarting previous smoking dose

Methadone Plasma levels may increase by (possibly threefold).

Monitor closely for signs of opiate toxicity – please refer to trust SMS policy

If titrating a patient on methadone be cautious with dose and aware they may need a lower dose then previously.

If patient on stable dose of methadone this may need to be reduced .

Liaise with patient’s SMS team. Supplies via the NRT protocol must be via SMS only.

On discharge liaise with patient’s SMS team and inform of smoking status change and inform them of current dose of methadone

Insulin Smoking decreases the absorption of insulin and may increase insulin resistance. Smokers who have insulin dependent

Monitor for hypoglycaemia. Check blood glucose more frequently. Insulin-dependent diabetics may need less insulin. Quitting improves glycaemic control. Insulin requirement may be reduced. Dose may need

Check blood glucose more frequently. Inhaled insulin users will need an alternative form of insulin delivery (i.e., subcutaneous injection).

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diabetes may need more insulin than non-smokers. Inhaled insulin is contraindicated for use in smokers and in patients who have stopped smoking for less than six months. Inhaled insulin peaks faster and reaches higher concentrations in smokers compared with non-smokers thus increasing the risk of hypoglycaemia

to be adjusted according to individual need. Consult patient’s Endocrinologist/Diabetic clinic /GP.

Warfarin or heparin

Smoking may slightly increase Warfarin and Heparin metabolism and clearance - slightly reducing response to these medicines. Smokers may need higher doses to achieve anticoagulation

Dose requirements may be slightly increased. International Normalised ratio [INR] /Prothrombin time may increase - monitor closely. The dose of anticoagulant should be adjusted according to each patient’s International Normalised Ratio (INR) /Prothrombin time.

Monitor closely. Liaise with GP. The dose of Anticoagulant should be adjusted according to each patient’s International Normalised Ratio (INR) /Prothrombin time.

Aminophylline/

theophylline

Metabolism and clearance is more rapid and smokers

The plasma concentration of theophylline will increase significantly when

Possibly increase dose to previous level. Liaise with respiratory

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require higher doses than non-smokers. For heavy smokers the dose may need to be doubled. Plasma theophylline levels should be routinely monitored in smokers, and dosages should be adjusted.

smoking stopped. In patients who stop smoking, a reduction in the theophylline dose of up to 25 to 33% may be needed after one week, but full normalisation of hepatic function appears to take many months. Theophylline has a narrow therapeutic range – so toxicity is possible. Monitor for signs of toxicity e.g. nausea or palpitations. Plasma levels should be checked and dose adjusted accordingly [typically needs reduction by about a third]. The NRT protocol must not be used to supply NRT for patients prescribed aminophylline or theophylline.

specialist and GP.

Smoking and therefore smoking cessation may have effects on the metabolism of other medicines commonly used on inpatient wards4,13 Patients should be carefully monitored for adverse effects.14,17. If changes in observed adverse effects is noticed, seek advice from pharmacy and consider adjusting dosage appropriately.

Take particular care with patients on

- Warfarin (liaise with anti-coagulation clinic at UCH/Whittington Hospital). - Insulin (monitor BMs and seek advice from diabetic team) - Theophylline & aminophylline (monitor plasma levels and seek medical

advice). - Methadone (seek advice from patient’s substance misuse service). Please

check list of references for further information and guidance on other medication.

- Exercise caution when retitrating clozapine, in patients who are smokers immediately prior to admission. If the patient is no longer smoking, a lower target dose may be required to control symptoms and to avoid possible

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toxicity. Clozapine plasma levels should only be taken after target dose has been administered for at least 5-7 days.

REMEMBER to review smoking status and the possible effects on medication when leave is introduced or changed, as the effect of smoking on the medication metabolism is non-linear, with metabolism disproportionately increased by light smoking. Smoking only 7-12 cigarettes per day can significantly increase clozapine and olanzapine metabolism21.

It is also important to ensure that follow-up arrangements are in place for review of any medicines which may be affected by the patient’s smoking status.

6. Dissemination and implementation arrangements

This policy will be available on the Trust’s intranet website. Paper copies will be distributed to all doctors in their induction programme. For clarification or support in relation to any aspect of this policy, please contact the policy development team (contact details on page 2).

7. Training requirements

The local specialist smoking cessation services will provide training for staff to become ‘Level 2’ smoking cessation advisors and for them to be registered on the database of the local smoking cessation service provider. In order to remain an accredited level 2 advisor, an annual training update after accreditation is required.

For prescribers, regular training sessions will be provided in the local academic programmes.

For training requirements please refer to the Nicotine Management Policy (2015) and the Trust’s Mandatory Training Policy, Learning and Development Guide & Learning Opportunities Guide.

8. Monitoring and audit arrangements

Regular audits will be conducted on an annual basis to ensure that prescribing in

smoking cessation for adult inpatients is conducted in line with the policy. The

audits will aim to ensure that patients are appropriately assessed and prescribed

accordingly and that the process follows the guideline in this policy. The results

will be reported to the Trust’s audit committee. Learning from the audit will be

shared with staff.

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9. Review of the policy

This policy will be reviewed 3 years from the date of ratification.

10. References

1. Royal College of Physicians of London & Royal College of Psychiatrists.

Smoking and mental health: a joint report. (Royal College of Physicians : Royal College of Psychiatrists, 2013).

2. National Institute for Health Care and Excellence. Smoking cessation in secondary care: acute, maternity and mental health services. (2013).

3. Stead, L. F., Perera, R., Bullen, C., Mant, D. & Lancaster, T. in Cochrane Database of Systematic Reviews (ed. The Cochrane Collaboration) (John Wiley & Sons, Ltd, 2008). at <http://doi.wiley.com/10.1002/14651858.CD000146.pub3>

4. C&I NHS Trust. Patient Group Direction (PGD) for the administration of nicotine replacement therapy patches and the inhalator for patients seen at ascot clinic. (2014).

5. NICE Clinical Knowledge Summary. Smoking cessation - NICE CKS. (2014). at <http://cks.nice.org.uk/smoking-cessation>

6. Joint Formulary Committee. British National Formulary. (BMJ Publishing Group Ltd and Pharmaceutical Press, 2018). at <http://www.myilibrary.com?id=647830>

7. Cahill, K., Stevens, S., Perera, R. & Lancaster, T. in Cochrane Database of Systematic Reviews (ed. The Cochrane Collaboration) (John Wiley & Sons, Ltd, 2013). at <http://doi.wiley.com/10.1002/14651858.CD009329.pub2>

8. Mayer, B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch. Toxicol. 88, 5–7 (2014).

9. Medicines and Healthcare Products Regulatory Agency. New advice on use of nicotine replacement therapy (NRT): wider access in at-risk populations. (2012). at <http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON2022933>

10. National Institute for Health Care and Excellence. Quitting smoking in pregnancy and following childbirth. (2010).

11. Gunnell, D., Irvine, D., Wise, L., Davies, C. & Martin, R. M. Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database. BMJ 339, b3805–b3805 (2009).

12. Buggy, Y. et al. Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Drug Saf. 36, 521–531 (2013).

13. UK Medicines Information pharmacists for NHS healthcare professionals. What medicines need dose adjustment when a patient stops smoking? (2012). at <www.ukmi.nhs.uk>

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14. Taylor, D. et al South London and Maudsley NHS Trust. The Maudsley prescribing guidelines in psychiatry. (John Wiley & Sons, 2018).

15. South London and Maudsley NHS Foundation Trust. Medicines Bulletin. (2014).

16. Campion, J. & Hewitt, J. Guidance on Smoking Cessation in Mental Health Settings. (2011).

17. Robson, D. & Potts, J. Smoking Cessation and Mental Health: A briefing for front-line staff. (2014).

18. Pachas, G. N. et al. Varenicline for Smoking Cessation in Schizophrenia: Safety and Effectiveness in a 12-Week Open-Label Trial. J. Dual Diagn. 8, 117–125 (2012).

19. Williams, J. M. et al. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. J. Clin. Psychiatry 73, 654–660 (2012).

20. Cerimele, J. M. & Durango, A. Does varenicline worsen psychiatric symptoms in patients with schizophrenia or schizoaffective disorder? A review of published studies. J. Clin. Psychiatry 73, e1039–1047 (2012).

21. Haslemo T, Eikeseth PH, Tanum L, Molden E, Refsum H. (2006) The effect of variable cigarette consumption on the interaction with clozapine and olanzapine. Eur J Clin Pharmacol., 62(12), 1049-53. 22. South London and Maudsley NHS Foundation Trust. Patient group direction for the supply or administration of nicotine replacement therapy. By registered health professional groups for the treatment of tobacco dependence relating to planned abrupt cessation, gradual smoking cessation, temporary abstinence from smoking. 27/7/2014.

11. Associated documents These guidelines should be read in conjunction with:

1. Nicotine Management Policy

2. C&I NHS Trust. Patient Group Direction (PGD) for the administration of nicotine

replacement therapy patches and the inhalator for inpatients

3. Tobacco control policy

4. C&I NHS Trust. Physical Health and Wellbeing Policy

5. C&I NHS Trust. Mandatory Training Policy

6. C&I NHS Trust. Learning and Development Guide

7. C&I NHS Trust. Learning Opportunities

8. C&I NHS Trust. Patient group direction. For the supply of nicotine

replacement therapies (NRT) to patients under the care of the Camden

and Islington Integrated Practice Unit (IPU).

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Appendices: Dosing schedules for nicotine replacement therapies Appendix 1: Patches

Patches Nicotinell patches (24 hour patch)12

Niquitin patches (24 hour patch)19

Nicorette patches (16 hour patch)1

Smoking cessation schedule

>20 cigarettes/day - 21mg patch daily

>/=10 cigarettes/day - 21mg patch daily

>10 cigarettes/day - 25mg patch daily

< 20cigarettes/day 14mg patch daily

<10 cigarettes/day - 14mg patch daily

<10 cigarettes/day - 15mg patch daily

Duration of treatment 3 - 4 weeks per strength 21mg/day - 6 weeks 14mg/day – 2 weeks 7mg/day – 2 weeks If starting at 14mg:- 14mg/day – 6 weeks 17mg/day – 2 weeks

25mg/day – 8 weeks 15mg/day – 2 weeks 10mg/day – 2 weeks If starting at 15mg:- 15mg/day – 8 weeks 10mg/day – 4 weeks

Total duration period 3 months, but further treatments can be recommended if necessary.

10 weeks (8 weeks if a light smoker).

As above

Maximum duration of treatment

Six months Six months Six months

Smoking reduction schedule

As above. A patch can be used while the person continues to smoke. The person should reduce the number of cigarettes smoked as far as possible and make a quit attempt as soon as he/she feels ready..

Schedules as above. If the person reduces cigarettes to less than 10 cigarettes a day, the strength of the patch should be reduced to 15mg. A quit attempt should be made as soon as the person feels ready.

Excessive side effects Reduce the strength of the patch for the remainder of the initial period and then use the low strength for 2-4 weeks.

Reduce the strength of the patch to 14mg for the remainder of the initial period and then use 7mg for 2 weeks.

Reduce the strength of the patch for the remainder of the initial period and then use the 10mg for 4 weeks.

Licence Nicotinell patch is licensed for smoking cessation and smoking reduction.

Niquitin patch is licensed for smoking cessation and smoking reduction.

Nicorette patch is licensed for smoking cessation and smoking reduction.

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Appendix 2: Gums

Gums Nicotinell Gum21 Niquitin Gum20 Nicorette Gum13


>30 cigarettes a day, 4mg nicotine gum is indicated. 20 – 30 cigarettes /day, 2mg or 4mg are acceptable. <20 cigarettes per day, 2mg is indicated.

Sufficient gums should be used each day to a maximum of 15 per day.

20 cigarettes a day, 4mg nicotine gum is indicated. </=20 cigarettes per day 2mg nicotine gum. All cigarettes should be replaced with the gum. The gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Duration of treatment

After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product.

After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product.

As below.




As above. The gum should be used as needed, between smoking episodes with the intention to reduce smoking as much as possible. If the gum is regularly used after 6 months, then advice from a health professional must be sought.

The 4mg gum should be used as needed, between smoking episodes with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose 4mg: 15 pieces per day. 2mg: 25 pieces per day.

15 pieces per day. (2mg gum may be helpful when stopping treatment or reducing the number of gums used each day).

15 pieces per day. (2mg gum may be helpful when stopping treatment or reducing the number of gums used each day).

Licence Nicotinell gum is licensed for smoking cessation and smoking reduction.

Niquitin gum is licensed for smoking cessation, smoking reduction and gradual cessation of smoking.

Nicorette gum is licensed for smoking cessation and smoking reduction.

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Appendix 3: Lozenges

Lozenges Nicotinell Lozenge12 Niquitin Lozenge18 Nicorette Lozenge14


>30 cigarettes a day, 2mg nicotine lozenge is indicated. </=20 cigarettes per day. 20 – 30 cigarettes /day, 1mg or 2mg are acceptable. <20 cigarettes per day, 1mg is indicated.

>20 cigarettes per day - 4mg are acceptable. </=20 cigarettes per day, 1.5mg is indicated. Sufficient lozenges should be used each day to a maximum of 15 per day.

>20 cigarettes a day, 4mg lozenge is indicated. </=20 cigarettes per day 2mg nicotine gum. The lozenge should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.


After three months, the user should gradually cut down the number of pieces sucked each day until they have stopped using the product.

After six weeks, the user should gradually cut down the number of pieces sucked each day until they have stopped using the product.

As below.




As above. The lozenge should be used as needed, between smoking episodes with the intention to reduce smoking as much as possible.

The lozenge should be used as needed, between smoking episodes with the intention to reduce smoking as much as possible.

Maximum daily dose

1mg – 30 pieces per day 2mg – 15 pieces per day. 1mg lozenge may be helpful when stopping treatment or reducing the number of gums used each day).

15 pieces per day. 15 pieces per day. (2mg lozenge may be helpful when stopping treatment or reducing the number of gums used each day).

Licence Nicotinell lozenge is licensed for smoking cessation and smoking reduction.

Niquitin lozenge is licensed for smoking cessation, smoking reduction and gradual cessation of smoking.

Nicorette lozenge is licensed for smoking cessation and smoking reduction.

22

Appendix 4: Miscellaneous

Miscellaneous Inhalator17,22 Mouth spray16,22 Nasal spray15,22


Smokers willing/able to stop smoking immediately should replace all their cigarettes with the Inhalator and as soon as they are able, reduce the number of cartridges used until they have stopped.

Patients can use 1-2 sprays in the mouth when the urge to smoke occurs or to prevent cravings. Individuals must not exceed 2 sprays per episode (4 sprays per hour),

One spray to both nostrils when the urge to smoke occurs (up to two sprays to each nostril every hour). When withdrawing from therapy, the dose can be gradually reduced to 1 spray in 1 nostril


Use 1 – 6 cartridges daily for 4-8 weeks. Then reduce to 1-3 cartridges over the next 2 weeks. Then reduce to zero over 2 weeks.

2 sprays up to twice an hour for 16 hours a day as required – for 8 weeks Half usage – for two weeks Reduce usage to zero – for two weeks.

1 spray into each nostril up to twice an hour for 16 hours a day as required – for 8 weeks. Half usage – for two weeks. Reduce usage to zero – for two weeks. Spraying into a single nostril during this period may be helpful in achieving this


Smokers aiming to reduce cigarettes should use the Inhalator, as needed, between smoking episodes with the intention to reduce smoking as much as possible7. Each cartridge can be used for approximately eight 5-minute sessions, with each cartridge lasting approximately forty minutes of intense use.

Smokers aiming to reduce cigarettes should use the mouth spray, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready, smokers should aim to quit

Not licensed.

Maximum daily dose

6 cartridges in 24 hours 64 sprays in 24 hours 64 sprays in 24 hours

Licence The inhalator is licensed for smoking cessation and smoking reduction.

The mouth spray is licensed for smoking cessation and smoking reduction.

Smoking cessation

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Appendix 5

Equality Impact Assessment Tool

Yes/No Comments

1. Does the policy/guidance affect one group less or more favourably than another on the basis of:

No

Race No

Ethnic origins (including gypsies and travellers)

No

Nationality No

Gender No

Culture No

Religion or belief No

Sexual orientation including lesbian, gay and bisexual people

No

Age No

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2. Is there any evidence that some groups are affected differently?

No

3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

N/A

4. Is the impact of the policy/guidance likely to be negative?

No

5. If so can the impact be avoided? N/A

6. What alternatives are there to achieving the policy/guidance without the impact?

N/A

7. Can we reduce the impact by taking different action?

N/A

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