Title: CLINICAL GUIDELINES ID TAG Smoking Cessation Guideline for the Prescribing, Issue and Administration of Nicotine Replacement Therapy on Inpatient Wards Lyn Watt Pharmacy Patient Services Manager Pharmacy Author: Designation: Speciality / Division: Directorate: Acute Services, OPPC Inpatient Wards & MHD Inpatient Wards Date: 9 th March 2016 Consulted Upon: Southern Trust Smoke Free Steering Approved By: Applicable to: (delete Yes / No as appropriate) Group D&T section of the AMD Dept./ Division Only No Directorate Only: No Trust-wide No Review Date: 28 th February 2018 Clinical ID: CG0392
Guidelines for the Prescribing, Issue and Administration of Nicotine Replacement Therapy on Inpatient Wards Introduction The SHSCT Smoke Free Policy was introduced March 2016 and does not permit smoking or the use of E Cigarettes anywhere in Trust buildings or grounds. Nicotine Replacement Therapy (NRT) will be available for all patients to help with the withdrawal symptoms during their inpatient stay and for those wishing to stop smoking permanently. Help and support will be made available to patients during their inpatient stay and advice and follow up will be available after discharge. Smoking Cessation Service On admission to hospital the Smoke Free Policy will be explained to all patients. They will then be asked if they currently smoke. If the answer is yes, the healthcare professional admitting the patient will assess the patient for NRT. If appropriate the patient will be offered NRT along with support and counselling. If a patient wishes to stop permanently, additional information will be provided including the contact details for the Trust s Stop Smoking Service and follow-up after discharge. A patient can be reassessed at any time during their inpatient stay and referred to the Trust s Stop Smoking Service - Tel: 02837415333 or email: stop.smoking@southerntrust.hscni.net Nicotine Replacement Therapy (NRT) NRT is a pharmacological aid that can help patients maintain abstinence from The following NRT products are available to inpatients. Nicotine Patches 16 hour and 24 hour Nicotine Inhalator Nicotine Orodispersible film NRT can be considered for 1. Patients who are highly motivated to stop smoking Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 1
2. Patients who need to manage the symptoms of nicotine withdrawal for the duration of their admission. NRT products available to patients will be in the form of long acting NRT as patches or a short acting or intermittent NRT as an inhalator or orodispersible film. The products will be prescribed on a patient-by-patient basis according to their needs. Some patients may require the patches alone; others may require a combination of the patches and the inhalator or orodispersible film. If a patient is already using NRT prior to admission, where possible the same type of NRT will be made available for them during their inpatient stay. Refer to the BNF for detailed information on the complete range of NRT products available. To determine a patient s nicotine dependence and select the most appropriate NRT product the Fagerstrom Test should be completed. (Table 1) Table 1 Fagerstrom Test for Nicotine Dependence Circle a number for each question How soon after waking do you smoke your first cigarette? Within 5 minutes 5-30 minutes 31 60 minutes 3 2 1 Do you find it difficult to refrain from smoking in places where it is forbidden? E.g. Church, Library etc Yes No 1 0 Which cigarette would you hate to give up? The first in the morning Any other 1 0 How many cigarettes a day do you smoke? 10 or less 11 20 21 30 31 or more 0 1 2 3 Do you smoke more frequently in the morning? Yes No 1 0 Do you smoke even if you are sick in bed most of the day? Yes No 1 0 Total Score SCORE 1 2 = low dependence 5 7 = moderate dependence 3 4 = low to moderate dependence 8 + = high dependence Add up the scores from the questionnaire Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 2
Scoring the Fagerstrom Test for Nicotine Dependence Score of 1 2 A patient who scores between 1 and 2 on the Fagerstrom Test for Nicotine Dependence is classified as having a low dependence on nicotine. This suggests that they may not need Nicotine Replacement Therapy (NRT) although it is recommended that they still be monitored for withdrawal symptoms. Score of 3 4 A patient who scores 3 or 4 would be considered to have a low to moderate dependence on nicotine and could be offered patches, inhalator or orodispersible film. Score of 5 7 A patient who scores between 5 and 7 would be considered to be moderately dependent on nicotine and can be offered patches, inhalator or orodispersible film. They can also be offered the combined therapy of patches with orodispersible film. Score of 8 and over A patient who scores 8 and over would be considered to be highly dependent on nicotine and can be offered a patch, inhalator or orodispersible film. They can also be offered the combined therapy of a patch and orodispersible film. A combination of the patch (long-acting NRT) and the inhalator or orodispersible film (short-acting NRT) should be prescribed for patients who have a high level of nicotine dependence or who have failed with previous NRT. Those patients who do not want regular NRT should be prescribed the inhalator or orodispersible film. Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 3
The following NRT treatments will be kept in pharmacy and may be ordered on a non stock requisition or kept as stock on inpatient wards. Table 2 Long - Acting NRT Moderate to High dependency NRT > 20 Cigarettes / day 10 20 Cigarettes / day Smoking Rate to Moderate dependency NRT < 10 Cigarettes / day Administration Long- Acting NRT NICOTINE PATCH ( Nicorette Invisi 16 hr, Nicotinell TTS 24 hr) Nicorette Invisi Patch (25mg / 16 hour patch) Nicotinell TTS 30 Patch (21mg / 24 hour patch) Nicorette Invisi Patch (25mg / 16 hour patch)) Nicotinell TTS 20 Patch (14mg / 24 hour patch) Nicorette Invisi Patch (15mg / 16 hour patch) Nicotinell TTS 20 Patch (14mg / 24 hour patch) Apply one patch on waking and remove before bed. Apply one patch on waking and remove 24 hours later. Apply fresh patch to alternative site. (Do NOT use 24hr patch in pregnancy) Apply to dry, non-hairy skin on the hip, trunk, or upper arm. Place next patch on a different area and avoid using the same site for several days Table 3 Short Acting NRT Short Acting NRT NICOTINE INHALATOR 15mg Cartridges (Nicorette ) Used as required when the urge to smoke occurs or to prevent cravings. A single 15mg cartridge lasts for approximately 40 minutes of intense use. Not suitable for heavy smokers unless used in combination with NRT patches. Some denture wearers and patients with obstructive respiratory disease may find it difficult to use. NICOTINE ORODISPERSIBLE FILM (NiQuitin Strips) Suitable for smokers who have their first cigarette of the day more than 30 minutes after waking up. Place one film on the tongue. Close the mouth and press the tongue gently to the roof of the mouth until the nicotine film dissolves (approximately 3 minutes). The film should not be chewed or swallowed whole. Patients with full upper dentures should remove the denture to use the nicotine orodispersible film. Patients should not exceed 6 cartridges of the 15mg strength daily. Users should not eat or drink while a nicotine film is in the mouth. Patients should not exceed 15 films per day. Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 4
To maintain abstinence and advice on dose reduction follow the treatment programme described in each of the products Summary of Product Characteristics found by accessing http://www.medicines.org.uk/emc/, or alternatively contact the Trust s Stop Smoking Service. NRT Contra-indications, Special Warnings and Precautions for Use Contra-indications Patients who have an allergy or hypersensitivity to nicotine or any component of the patch, inhalator or the orodispersible film should not be prescribed NRT. Special Warnings and Precautions for Use Underlying cardiovascular disease: Patients currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with nonpharmacological interventions. If this fails, NRT may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism. Renal or hepatic impairment: NRT should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, NRT should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole. Dermatological disorders: Patients with dermatological disorders such as psoriasis, chronic dermatitis or urticarial should not use NRT patches. Seizures: Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine. Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 5
Alcohol: The orodispersible film contains no more than 3.9mg of ethanol per film. When prescribing the film caution in patients taking disulfiram due to its ethanol (alcohol) content. Patients aged 16 18 years NRT may be recommended in patients aged 16 to 18 years. The dose and method of use is the same as for adults, however there is limited safety data and the recommended duration is a maximum of 12 weeks. Pregnancy Ideally smoking cessation during pregnancy should be achieved without NRT. However if the mother cannot quit without pharmacological support, NRT may be recommended as the risk to the fetus of continuing to smoke outweighs any potential adverse effects of NRT. Ideally intermittent NRT is preferable because of the potential for nicotine free periods. However if patches are necessary the patch should be removed at night, therefore only use the Nicorette Invisi 16 hour Patch. Lactation NRT can be used in women who are breastfeeding. The small amounts of nicotine found in breast milk during NRT use are less hazardous than the infant being exposed to second hand smoke. Intermittent dose forms such as the inhalator or orodispersible film are preferable to patches as their use can be adjusted to allow the maximum time between administration and breast feeding, to minimise the amount of nicotine in the milk. Side Effects Below are symptoms associated with nicotine withdrawal on cessation of smoking Irritability / aggression Dysphoria / depressed mood Anxiety Restlessness Poor concentration Increased appetite / weight gain Urges to smoke (cravings) Night time awakenings / sleep disturbance Decreased heart rate Increased frequency of aphthous ulcer may occur after abstinence from Patch Mild local skin reactions Itching Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 6
Erythema Some patients may experience skin blistering or a burning sensation Dizziness, headache Gastrointestinal discomfort, nausea or vomiting. Inhalator / Orodispersible film Coughing, pharyngitis Irritation in mouth and throat Nasal congestion Dizziness, headache Gastrointestinal discomfort, nausea or vomiting, hiccups. Interactions with other medicinal products No clinically relevant drug interactions with NRT and other drugs have definitely been established. However nicotine may enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration. Effect of smoking cessation on Drug Metabolism Cigarette smoking can interact with some medicines. However in most cases it is the tobacco smoke and not the nicotine that causes these drug interactions. The majority of the interactions are due to polycyclic aromatic hydrocarbons in cigarette smoke that induce hepatic drug metabolising cytochrome P450 enzymes, particularly CYP1A2. As a result smokers have a higher clearance of some drugs and may require higher doses than non-smokers. The amount of tobacco smoking needed to have an effect is not established and the assumption is that any smoker is susceptible to the same degree of interaction. Not all drug smoking interactions are clinically significant. Influencing factors include: CYP1A2 being the main elimination pathway for the medicine and The medicine having a narrow therapeutic index, with small changes in drug concentration creating significant clinical effects. It takes approximately one week for the effect of the induction of CYP1A2 to wear off after smoking cessation and thus the dose adjustment is not necessary in situations where there is a temporary smoking cessation, e.g. during a short term hospital stay. The majority of drug interactions are not clinically significant but the potential should be bourne in mind if the patient stops Since the majority of drug interactions are due to the polycyclic aromatic hydrocarbons in cigarette smoke and Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 7
not nicotine these interactions are not expected to occur with NRT. The information in the table applies to patients who stop smoking regardless of whether they use NRT or not. Table 4 below shows some of the interactions with Table: 4 Drug Name Nature of Interaction Clinical Relevance Warfarin An interaction with Moderate smoking is not clinically relevant in most patients. The dose of warfarin is adjusted according to a patient s INR. Theophylline Smokers need higher High doses of theophylline than non-smokers due to theophylline s shortened half-life and increased elimination. Some reports suggest smokers may need twice the dose of nonsmokers. Chlorpromazine Clozapine Smokers have lower serum levels of chlorpromazine compared with nonsmokers. 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 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 Moderate High Action to take when stopping smoking INR might increase on stopping Monitor INR more closely. Advise patients to tell the physician managing their anticoagulant control that they are stopping Monitor plasma theophylline concentrations and adjust the dose of accordingly. Theophylline dose 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 weekly. Advise the patient to seek help if they develop signs of theophylline toxicity such as palpitations or nausea. effects of chlorpromazine (e.g. dizziness, sedation, extrapyramidal symptoms). If adverse effects occur, reduce the dose as necessary. Monitor serum drug levels before stopping smoking and one or two weeks after stopping effects of clozapine such as sedation, hypersalivation. If adverse effects occur, reduce the dose as necessary. Recommend to stop smoking slowly Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 8
Olanzapine 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 High effects of olanzapine (e.g. dizziness, sedation, and hypotension). If adverse effects occur, reduce the dose as necessary. Recommend to stop smoking slowly Methadone There has been a case report of respiratory insufficiency and altered mental status when a patient taking methadone for analgesia stopped Moderate Be alert for signs of opioid toxicity and reduce the methadone dose accordingly. Insulin Smoking is associated with poor glycaemic control in patients with diabetes. Smokers may require higher doses of insulin but the mechanism of any interaction is unclear. Moderate If a patient with insulindependent diabetes stops smoking, their dose of insulin may need to be reduced. Advise the patient to be alert for signs of hypoglycaemia and to test their blood glucose more frequently. Flecainide Smoking increases the clearance of flecainide. Smokers appear to need higher doses of flecainide, compared with non-smokers. Be alert for dose-related adverse effects of flecainide such as dizziness and visual disturbances. If adverse effects occur, reduce the dose as necessary. Mexiletine Melatonin Benzodiazepines Mexiletine is metabolised partly via CYP1A2 and its half-life may be reduced in smokers compared to non-smokers. The dose of mexiletine is titrated according to response. Melatonin is metabolised principally via CYP1A2; plasma levels may be lower in smokers than nonsmokers. Smokers taking benzodiazepines may experience less drowsiness than nonsmokers. Results from pharmacokinetic studies have been mixed and the interaction may be due to stimulation of the central nervous system from Be alert for adverse effects of mexiletine (e.g. nausea, tremor, and hypertension) and reduce the dose as necessary. Be alert for increased effects of melatonin if a patient stops Patients may experience an enhanced effect of benzodiazepines after stopping If so, consider reducing the dose. Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 9
Benperidol Fluphenazine Haloperidol Lithium Tricyclic antidepressants Selective serotonin reuptake inhibitors Benperidol is metabolised via liver enzymes, possibly including CYP1A2 but there are no documented cases of an interaction with Studies suggest that smokers have increased fluphenazine clearance compared with nonsmokers and may require higher doses, but have not shown any difference in behavioural and adverse effects. Studies suggest that smokers have increased haloperidol clearance compared with nonsmokers and may require higher doses, but have not shown any difference in behavioural and adverse effects. There is a theoretical indirect interaction between smoking and lithium. Stopping smoking could lead to increased xanthine levels by reducing metabolism of dietary caffeine. Raised xanthine levels could in turn lead to increased lithium excretion. There are no documented cases of an interaction. Serum levels of amitriptyline, clomipramine, imipramine and nortriptyline are lower in smokers than in nonsmokers, but the concentration of free drug rises, which appears to offset the effects of this interaction. Fluvoxamine is the only SSRI expected to interact with Fluvoxamine is metabolised by CYP1A2 and plasma levels may effects of benperidol. If adverse effects occur, reduce the dose as necessary. effects of fluphenazine (e.g. drowsiness, extra-pyramidal symptoms). If adverse effects occur, reduce the dose as necessary. effects of haloperidol (e.g. drowsiness, extra-pyramidal symptoms). If adverse effects occur, reduce the dose as necessary. None effects of the antidepressant. If adverse effects occur, reduce the dose as necessary. effects of fluvoxamine. If adverse effects occur, reduce the dose as necessary. Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 10
Ropinirole Riluzole Sulphonylureas Cinacalcet Quinine be lower in smokers than non-smokers. Smokers might need higher doses than nonsmokers. Ropinirole is metabolised principally via CYP1A2 and smokers may require higher doses than nonsmokers. The dose of ropinirole is titrated according to response. Riluzole is metabolised principally via CYP1A2 but there are no documented cases of an interaction with Smoking is associated with poor glycaemic control in patients with diabetes. There is a theoretical interaction between sulphonylureas and smoking but this has not been studied. Cinacalcet is metabolised partly via CYP1A2. Dose adjustment may be required if a patient starts or stops There are no documented cases of an interaction. The clearance of quinine appears to be increased in healthy smokers. If a patient taking quinine stops smoking, plasma levels of quinine might rise but there are no documented cases of an interaction. effects of ropinirole (e.g. nausea, dizziness). If adverse effects occur, reduce the dose as necessary. effects of riluzole (e.g. gastrointestinal effects, weakness). If adverse effects occur, reduce the dose as necessary. If a patient taking a sulphonylurea stops smoking, their dose may need to be altered. Advise the patient to be alert for signs of hypo- and hyperglycaemia. Advise the patient to inform their nephrologist when they stop Monitor parathyroid hormone levels and adjust the dose accordingly. If a patient taking quinine stops smoking, be alert for increased adverse effects or signs of quinine toxicity (e.g. nausea, tremor, tinnitus, and visual disturbance). If adverse or toxic effects occur, reduce the dose or stop the drug as necessary. Patients with acute falciparum malaria have reduced clearance of quinine and this effect opposes the effect from Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 11
References Southern Health and Social Care Trust, Smoke Free Policy 2016 Fagerstrom Test for Nicotine Dependence accessed 04/11/2015 at http://ndri.curtin.edu.au/btitp/documents/fagerstrom_test.pdf. British National Formulary 70 September 2015 - March 2016 NiQuitin Strips 2.5mg Oral Film SPC accessed 04/11/2015 at http://www.medicines.org.uk/emc/ Nicorette 15mg Inhalator SPC accessed 02/11/2015 at http://www.medicines.org.uk/emc/ Nicorette Invisi Patch SPC accessed 02/11/2015 at http://www.medicines.org.uk/emc/ Nicotinell TTS Patch \SPC accessed 02/11/2015 at http://www.medicines.org.uk/emc/ UK Medicines Information for NHS healthcare professional. Medicines Q&Qs which medicines need dose adjustment when a patient stops smoking? August 2012 Medicines and Healthcare Products Regulatory Agency. Drug Safety Update - smoking and smoking cessation: clinically significant interactions with commonly used medicines, October 2009 accessed 18/09/2015 at www.mhra.gov.uk/safetyinformation/drugsafetyupdate/con087705 Handy Fact Sheet smoking and olanzapine Health and Social Care Board. Handy Fact Sheet smoking and clozapine Health and Social Care Board. Medications interactions with smoking and smoking cessation accessed 27/07/15 at http://www.health.nsw.gov.au/tobacco/publications/tool-14- medication-intera.pdf Public Health Smoking Cessation e-learning NICPLD http://www.nicpld.org/online Author: Lyn Watt Pharmacist SH&SCT Version 1. March 2016 12