Procedure for Nicotine Replacement Therapy on Inpatient Units

Procedure for Nicotine Replacement Therapy on Inpatient Units PROCEDURE NO CL 005????? DATE RATIFIED December 2014 REVIEW DATE December 2017 APPROVED BY Drugs and Therapeutics ACCOUNTABLE DIRECTOR Chief Pharmacist AUTHOR Lead Pharmacist Procedure Statement/Key Objective: To ensure that all those who smoke have immediate access to Nicotine Replacement Therapy on admission To ensure that Nicotine Replacement Therapy is used safely and effectively Date of issue: 9 th Dec 2014 Page 1 of 15

Executive Summary Trust Procedure: Information Subject: Nicotine Replacement Therapy on Inpatient Units Applicable to: All inpatient units Key Procedure Issues: To ensure that all those who smoke have immediate access to Nicotine Replacement Therapy on admission To ensure that Nicotine Replacement Therapy is used safely and effectively Date Issued: December 2014 Dates Procedure Reviewed: n/a Next Review Date: December 2017 Procedure written by/lead: Procedure Lead Monitoring Arrangements: Approved by: Authorised by: Signature: Related Documents: Links to CQC outcomes Lead Pharmacist, Central Lancashire Lead Pharmacist, Central Lancashire Drugs and Therapeutics Committee Smoke Free Working Party Drugs and Therapeutics Committee Drugs and Therapeutics Committee Nicotine Management Policy Policy for the Management of All Aspects of Medication Procedure for the Prescribing of Medication Procedure for the Administration of Medicines 9 Acknowledgements: Large sections of this procedure are taken directly from the All Wales Guide Pharmacotherapy for Smoking Cessation developed by the All Wales Medicines Strategy Group. Date of issue: 9 th Dec 2014 Page 2 of 15

Table of Contents 1.0 Introduction... 4 2.0 Scope... 5 3.0 Duties... 5 4.0 Definitions... 5 5.0 The Procedure... 5 6.0 Training... 8 7.0 Monitoring (including Standards)... 8 8.0 Associated Documents... 8 9.0 References... 9 Appendix 1 Flowchart of process following admission Appendix 2 Nicotine Replacement Therapy Assessment and Administration Record Appendix 3 summary of cautions in the use of NFT in special populations Appendix 4 BNF Date of issue: 9 th Dec 2014 Page 3 of 15

1. Introduction Both behavioural support and pharmacotherapies are effective in helping people to stop smoking. Combining both treatment approaches is recommended where possible. Nicotine replacement therapy (NRT), varenicline and bupropion are the three forms of pharmacotherapy that are licensed for use in the UK to assist with smoking cessation. A Cochrane network meta-analysis concluded that each of these improves the chances of quitting. Combination NRT (the use of an immediaterelease formulation plus patches) is as effective as varenicline, and more effective than single types of NRT. The aim of using NRT is to reduce withdrawal symptoms by providing some of the nicotine that would be obtained from cigarettes, without providing the harmful chemicals present in tobacco smoke. NRT delivers nicotine to the body but at a lower dose and slower rate compared with smoking. There are eight different types of NRT formulations available (patches, gum, lozenges, sublingual tablets, inhalator, oral spray, oral films, and nasal spray) and a variety of strengths. This offers a variety of approaches to best match individual smokers needs and preferences. All formulations of NRT have similar effectiveness. Therefore, the choice of NRT depends largely on: Patient preference Previous patient experience of the type of formulation(s), if any, tried before Contraindications, cautions and the potential for adverse effects Patients with a high level of nicotine dependence, or those who have failed with NRT previously, may benefit from using combination NRT through use of an immediaterelease preparation and patches to achieve abstinence. Level 2 trained smoking champions will be available on mental health inpatient wards to support patients, assess the most suitable form and formulation of pharmacotherapy to support smoking cessation and advise prescribers so treatment can be prescribed on the inpatient prescription chart. Level 2 training covers the treatment options available, and the differences, advantages and disadvantages of each formulation of NRT, varenicline and bupropion. At Longridge Hospital, GPs will be responsible for prescribing pharmacotherapy Given contraindications of bupropion in certain mental illnesses and potential interactions with psychotropic medication bupropion will not be prescribed to aid smoking cessation within Lancashire Care NHS Foundation Trust (LCFT) Given the anticipated delay in assessment by a level 2 trained champion and the fact that a prescription chart may not be written immediately on admission, this procedure is designed to support registered nurses and prescribers in the assessment and administration of combination NRT immediately on admission and for up to 72 hours thereafter. Following consultation with Stop Smoking Services, a decision has been taken that NRT patches and lozenges will be the combination therapy offered immediately post-admission. This procedure therefore only considers nicotine Date of issue: 9 th Dec 2014 Page 4 of 15

patches with nicotine lozenges. A flowchart of the process following admission is included in appendix 1. 2. Scope This procedure applies to all inpatient units and staff working within them and becomes operational on 1 st January 2015 3. Duties LCFT is responsible for ensuring that service users have access to pharmacological treatments which will support and aid smoking cessation 3.1. Senior Managers, Ward Managers, and Team Leaders are required to: Ensure all staff and service users are aware of and can access this procedure Ensure Level 2 trained staff have time to fulfil their responsibilities in relation to the assessment of patients for NRT or varenicline 3.2 All members of the inpatient multidisciplinary team are responsible for: Familiarising themselves with the procedure Adhering to and implementing the procedure. Seeking the advice of the stop smoking service or medicines management team when appropriate Being aware of side effects to monitor Monitoring the patient in accordance with the procedure and any additional guidance from Level 2 smoking champions or prescribers 3.3. The Pharmacy Team are responsible for: 4. Definitions Ensuring stocks of nicotine patches and lozenges are available on the ward Reviewing stock levels according to demand Responding to queries from nursing staff and prescribers in relation to this procedure Nicotine Replacement Therapy- a tobacco cessation method intended to reduce nicotine cravings and ease the symptoms of withdrawal by substituting another source of nicotine, such as a specially formulated lozenge, gum, nasal spray, inhalant, or skin patch for tobacco products. 5. The Procedure 5.1. On admission patients must be asked whether they smoke. If they do smoke, advise about the nicotine management policy in place and consider whether they have the capacity to consent to pharmacotherapy to support smoking cessation. Date of issue: 9 th Dec 2014 Page 5 of 15

Should they lack capacity to consent then the necessary safeguards must be progressed in line with the mental capacity act. 5.2. Ask whether they would like nicotine replacement therapy to control any nicotine withdrawal symptoms. If they confirm that they would like access to NRT, advise them that they will be assessed for a NRT patch with supplementary lozenges immediately pending a more detailed assessment by a specially trained member of staff. 5.3. If the patient indicates that they would like NRT, take a copy of the NRT assessment and administration form (Appendix 2) and see whether they are eligible for the patch and lozenges. Whilst combination therapy is preferred, should patients have a preference to use a patch or lozenges on their own then this will also be facilitated This form is only for use in the first 72 hours following admission, but should be suspended as soon as a Level 2 smoking champion has assessed the patient and the recommended product/s have been prescribed on the in-patient prescription chart by a prescriber..level 2 smoking champions will consider whether the person is best placed remaining on a patch with lozenge or switching to an alternative product e.g. patch with inhalator, oral sprays or films, varenicline. 5.4. Cautions and Contraindications. Most of the health warnings associated with NRT also apply to continued smoking, but the risks of continued tobacco smoking outweigh any risks of using NRT preparations in virtually all situations. Before using NRT in those with acute cardiovascular events, swallowing difficulties, pregnancy or breastfeeding refer to a prescriber or level 2 smoking champion for further advice. Document the advice given in the clinical record including the name of the person who gave the advice NRT can be considered for all people attempting to quit smoking, including pregnant and breast-feeding women (but see people), and young people aged 12 to 18 years old. All forms of NRT can be used by patients with stable cardiovascular disease, but should be used with caution in those in hospital for acute cardiovascular events. The use of NRT in pregnancy is considered preferable to the continuation of smoking, but should be used only if smoking cessation without NRT fails. Intermittent therapy is preferable to patches, but avoid liquorice-flavoured products. Patches may be appropriate if pregnancy-related nausea and vomiting is a problem. If patches are used they should be removed at night before going to bed. Intermittent therapy is preferable for breast-feeding women. For the purposes of this procedure referral to a prescriber is only required if any of the conditions specified on the Nicotine Replacement Therapy Assessment and Administration Record apply (Appendix 2). Further information on specific cautions for NRT is provided in Appendix 3. Lozenges would not be advised in those with known/assessed swallowing difficulties Date of issue: 9 th Dec 2014 Page 6 of 15

If none of the cautions apply, then remove a NRT patch from stock and administer this. Advise the patient that there are also lozenges available should they need additional NRT. Record administration of administered NRT on the form and staple the form to the prescription chart in the section reserved for consent to treatment documentation, or at Longridge the section of the prescription chart used to record intravenous infusions. Record issue of any NRT through any stock level records that may be in use on the ward If any of the cautions apply then speak to a prescriber about use of NRT. If the prescriber approves this, make a daily entry in the clinical record indicating the name of the prescriber consulted and advice given 5.5. Drug Interactions. Tobacco smoking increases the metabolism of some medicines by stimulating the hepatic enzyme CYP1A2. Further information is provided in the UK Medicines Information Q&A 136.4 Which medicines need dose adjustment when a patient stops smoking? A summary of interactions from this document deemed to be of moderate or high clinical relevance is included in Appendix 4. Moderate to high clinically relevant interactions may result with NRT and warfarin, theophylline, chlorpromazine, clozapine, olanzapine, methadone and insulin requiring increased monitoring and possible dose reductions. The full document including interactions of no/low clinical relevance can also be accessed via the link below or on the prescribing and monitoring section of the pharmacy intranet page: http://www.medicinesresources.nhs.uk/upload/documents/evidence/medicines%20q %20&%20A/NW%20QA136.4%20Smoking%20and%20drug%20interactions.doc When smoking is discontinued, the dose of these medicines, in particular theophylline, cinacalcet, ropinirole, and some antipsychotics (including clozapine, olanzapine, chlorpromazine and haloperidol), may need to be reduced. Regular monitoring for increased side effects of the medication is advised and prescribers should be contacted if concerns arise. Should patients be taking any of these medications, prescribers or level 2 smoking cessation champions should inform nursing staff of the additional monitoring required for treatment emergent side effects once they have assessed the patient and prescribed further treatment. Plasma level monitoring is indicated where clozapine is prescribed in line with the Trust Guidelines For Monitoring Clozapine Plasma Levels. Clozapine plasma levels should be repeated one to two weeks after stopping smoking unless treatment emergent side effects indicate earlier monitoring is required. Levels can then be compared with those taken prior to smoking cessation If the patient resumes smoking after discharge and the dose of clozapine was reduced in response to smoking cessation, then the dose will likely need to be increased again. This needs to be considered as part of the discharge planning process. Clozapine levels should be repeated one to two weeks after smoking resumes. Date of issue: 9 th Dec 2014 Page 7 of 15

5.6. Side Effects. Most adverse effects experienced with NRT are not serious and are similar to the effects experienced from nicotine obtained by smoking. Minor adverse effects are common with NRT use, particularly in patients using high-strength formulations. They usually improve with time but treatment may need to be reviewed if they continue or become troublesome. However, patients may confuse the side effects of NRT with nicotine withdrawal symptoms. Common symptoms of nicotine withdrawal include malaise, headache, dizziness, sleep disturbance, coughing, influenza-like symptoms, depression, irritability, increased appetite, weight gain, restlessness, anxiety, drowsiness, mouth ulcers, decreased heart rate, and impaired concentration. Common adverse effects of NRT include headache, dizziness, coughing, and gastrointestinal disturbances. Palpitations may occur and, rarely, allergic reactions (including angioedema) and (very rarely) reversible atrial fibrillation. Mild local reactions are common on initiation of NRT because of the irritant effect of nicotine. Minor skin irritation at the application site(s) of patches may occur. If the skin reaction becomes more severe or more widespread, treatment with patches should be discontinued. Dry mouth, sleep disturbances including abnormal dreams. Chest pain, sweating, myalgia and arthralgia have been reported with use of NRT patches Gastrointestinal disturbances are common with oral forms of NRT and may be caused by swallowed nicotine; nausea, vomiting, dyspepsia, and hiccupping occur most frequently. Common side effects of lozenges include dry mouth, increased salivation, mouth ulcers, and sore mouth or throat. Less commonly: thirst, taste disturbance, gingival bleeding, and halitosis may occur. Patients with assessed/known risks re swallowing should not receive lozenges 6. Training All members of the inpatient multidisciplinary team are required to read the procedure and direct any questions to the ward pharmacist or ward managers 7. Monitoring Completion of the NRT assessment and administration form will be assessed as part of the annual prescription chart audit 8. Associated Documents Nicotine Management Policy Policy for the Management of All Aspects of Medication Procedure for the Prescribing of Medication Procedure for the Administration of Medicines Trust Guidelines for Monitoring Clozapine Plasma Levels Date of issue: 9 th Dec 2014 Page 8 of 15

9. References NICE (2013) Smoking cessation in secondary care: acute, maternity and mental health services. Public health guidance 48 http://www.nice.org.uk/guidance/ph48/resources/guidance-smoking-cessation-insecondary-care-acute-maternity-and-mental-health-services-pdf (accessed 10.7.14) Stead LF, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database of Systematic Reviews 2012; (10). Cahill K, Stevens S, Perera R et al. Pharmacological interventions for smoking cessation: an overview and network meta-analysis (Review). Cochrane Database of Systematic Reviews 2013; (5). All Wales Medicines Strategy Group. All Wales Guide: Pharmacotherapy for Smoking Cessation. July 2014. British Medical Association, Royal Pharmaceutical Society. British National Formulary. No 67. 2014 National Institute for Health and Care Excellence. Public Health Guidance 26. Quitting smoking in pregnancy and following childbirth. 2010 Medicines Q&A 136.4 Which medicines need dose adjustment when a patient stops smoking? From the NHS Evidence website www.evidence.nhs.uk Date of issue: 9 th Dec 2014 Page 9 of 15

Appendix 1. Flowchart of process following admission Ask Patient on admission if they smoke If patient smokes Explain the Nicotine Management Policy and ask if they would like access to NRT. Consider capacity to consent and best interest test if unable to consent NRT declined Inform the patient that they should ask staff for NRT should they change their mind NRT requested Is there a level 2 trained smoking champion currently on the unit? YES Smoking champion assess patient and recommends pharmacotherapy. Entry made in clinical record outlining advice to prescriber NO Is there a prescriber currently on the unit? NO Registered nurse assesses suitability for patches and lozenges using this procedure Patient not suitable YES Patient suitable Prescriber writes on the prescription chart either:- Pharmacotherapy recommended by smoking champion if they agree with one recommendation OR Patches and lozenges as outlines n the procedure pending assessment by level 2 trained smoking advisor (where available) Registered nurse completes the Nicotine Replacement Therapy Assessment and Administration Record. This is stapled to the prescription chart and is used until a prescriber attends the unit to admit the patient and write up medication and NRT. The form can be used for a maximum period of 72 hours Prescriber is contacted for advice Date of issue: 9 th Dec 2014 Page 10 of 15

Appendix 2 Nicotine Replacement Therapy Assessment and Administration Record FOR USE DURING THE FIRST 72 HOURS OF ADMISSION ONLY WARD PATIENT NAME NHS NUMBER Nicotine Patches Nicotine patches should not be placed on broken skin and should be used with caution in patients with skin disorders. Refer to a prescriber if the patient is pregnant or breastfeeding. Monitor blood glucose closely if the patient has diabetes mellitus Dose: 21mg/24 hours if patient smokes more than 10 cigarettes per day 14mg/24 hours if patient smokes less than 10 cigarettes per day After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. Skin sites should not be reused for at least seven days. Use of the patch over 24 hours is recommended to optimise the effect against morning craving. Patches may be removed before going to bed if there is an adverse effect on sleep. Date Time Strength of patch (14mg or 21mg) SIGNATURE PRINT NAME Nicorette cool Lozenges Refer to a prescriber if the patient has oesophagitis, oral or pharyngeal inflammation, gastritis, or gastric/peptic ulcers, is pregnant or breastfeeding. Monitor blood glucose closely if the patient has diabetes mellitus Dose: Patient smokes less than 20 cigarettes per day - 2mg lozenge PRN. Maximum of 8 in 24 hours Patient smokes more than 20 cigarettes per day - 4mg lozenge PRN. Maximum of 8 in 24 hours The 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. The lozenge should not be chewed or swallowed. Food or drink should not be consumed while a lozenge is in the mouth. Date Time Strength 2mg/4mg SIGNATURE Date Time Strength 2mg/4mg SIGNATURE Date of issue: 9 th Dec 2014 Page 11 of 15

Appendix 3. SUMMARY OF CAUTIONS IN THE USE OF NRT IN SPECIAL POPULATIONS Special population Pregnant women Breast-feeding women Cardiovascular disease Diabetes mellitus Hepatic impairment Renal impairment Predisposition to seizures Phaeochromocytoma Uncontrolled hyperthyroidism NRT NRT use in pregnancy is preferable to the continuation of smoking, but should only be used if smoking cessation without NRT fails. Intermittent therapy is preferable to patches. Avoid liquoriceflavoured NRT. Patches are useful, however, if the patient is experiencing pregnancy-related nausea and vomiting. If patches are used, they should be removed before bed. Nicotine from NRT is present in breast milk; however, the amount to which the infant is exposed is small and less hazardous than second-hand smoke. Intermittent therapy is preferred. Caution in use with haemodynamically unstable patients hospitalised with severe arrhythmias, myocardial infarction, or cerebrovascular accident. Initiation should only be under medical supervision. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the dose should be reduced or discontinued. Care in use in patients with diabetes mellitus. Blood glucose concentration should be monitored closely while using NRT. Caution in use with moderate to severe hepatic impairment Caution in use with severe renal impairment. Potential risks and benefits of NRT should be considered before use in patients taking anticonvulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine Caution in use Caution in use Date of issue: 9 th Dec 2014 Page 12 of 15

Appendix 4 BNF category/ Drug name Nature of interaction Clinical relevance Action to take when stopping smoking 2.8.2 Warfarin 3.1.3 Theophylline Warfarin is partly metabolised via CYP1A2. An interaction with smoking is not clinically relevant in most patients. The dose of warfarin is adjusted according to a patient s INR (International Normalised Ratio). Theophylline is metabolised principally via CYP1A2. Smokers need higher doses of theophylline than nonsmokers due to theophylline s shortened half-life and increased elimination. Some reports suggest smokers may need twice the dose of non-smokers. Moderate High If a patient taking warfarin stops smoking, their INR might increase so monitor the INR more closely. Advise patients to tell the physician managing their anticoagulant control that they are stopping smoking. Monitor plasma theophylline concentrations and adjust the dose of theophylline accordingly. The dose of theophylline may need to be reduced by about one quarter to one third one week after withdrawal. However, it may take several weeks for enzyme induction to dissipate. Monitor theophylline concentration periodically. Advise the patient to seek help if they develop signs of theophylline toxicity such as palpitations or nausea. 4.2.1 Chlorpromazine Chlorpromazine is metabolised principally via CYP1A2. Smokers have lower serum levels of chlorpromazine compared with non-smokers. A case report describes a 25 year old patient with schizophrenia who experienced increased adverse effects of chlorpromazine (sedation and dizziness) and increased plasma chlorpromazine levels after abruptly stopping smoking. Moderate Be alert for increased adverse effects of chlorpromazine (e.g. dizziness, sedation, extrapyramidal symptoms). If adverse effects occur, reduce the dose as necessary. Date of issue: 9 th Dec 2014 Page 13 of 15

BNF category/ Drug name Nature of interaction Clinical relevance Action to take when stopping smoking 4.2.1 Clozapine Clozapine is metabolised principally via CYP1A2 and clearance is increased in smokers. Serum clozapine levels are reduced in smokers compared with nonsmokers; smokers may need higher doses. There have been case reports of adverse effects in patients taking clozapine when they have stopped smoking. High Monitor serum drug levels before stopping smoking and one or two weeks after stopping smoking. Be alert for increased adverse effects of clozapine. If adverse effects occur, reduce the dose as necessary. 4.2.1 Olanzapine Olanzapine is metabolised principally via CYP1A2 and clearance is increased in smokers. Serum olanzapine levels are reduced in smokers compared with nonsmokers; smokers may need higher doses. There have been case reports of adverse effects in patients taking olanzapine when they have stopped smoking. High Be alert for increased adverse effects of olanzapine (e.g. dizziness, sedation, hypotension). If adverse effects occur, reduce the dose as necessary. 4.10 Methadone Methadone is metabolised via isoenzymes including CYP1A2. There has been a case report of respiratory insufficiency and altered mental status when a patient taking methadone for analgesia stopped smoking. Moderate Be alert for signs of opioid toxicity and reduce the methadone dose accordingly. 6.1.1 Insulin Smoking is associated with poor glycaemic control in patients with diabetes. Smokers may require higher doses of Moderate If a patient with insulindependent diabetes stops smoking, their dose of insulin may need to be reduced. Advise the patient to be alert Date of issue: 9 th Dec 2014 Page 14 of 15

BNF category/ Drug name Nature of interaction Clinical relevance Action to take when stopping smoking insulin but the mechanism of any interaction is unclear. for signs of hypoglycaemia and to test their blood glucose more frequently. Date of issue: 9 th Dec 2014 Page 15 of 15