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NHS Walsall Protocol for the supply of Nicotine Replacement Therapy (NRT) under a voucher scheme Protocol for the supply of: Clinical need which this protocol is intended to address NICOTINE REPLACEMENT THERAPY (NRT) As an aid to treating tobacco dependence in clients receiving specialist advice and support from Walsall Community Health Specialist Service. Clients receiving specialist advice and support from trained advisors in other settings, e.g. Pharmacists, youth workers, who are trained in smoking cessation to the Walsall level 2 training standards. Relevant National Guidance National Institute for Health and Clinical Excellence – Smoking cessation services in primary care, pharmacies, local authorities and workplaces, particularly for manual working groups, pregnant women and hard to reach communities (PH10). London, February 2008 Duff G. New Advice on Use of Nicotine Replacement Therapy (NRT): wider access in at-risk populations. Expert advice from a Working Group of the Committee on Safety of Medicines (CSM), November, 2005. Department of Health – NHS Stop Smoking Services Service and Monitoring Guidance 2009 / 2010. London, March 2009 CLINICAL CONDITION 1. Definition of condition Clients assessed as nicotine dependent. 2. Criteria under which client will be eligible for inclusion Tobacco users identified as sufficiently motivated to quit, attending smoking cessation services and having been assessed as per Walsall Nicotine Replacement Therapy screening criteria. 3. Criteria for inclusion Tobacco users identified as sufficiently motivated to quit and have set a quit date through Walsall Stop Smoking Service Adolescents of 12 years and over. Treatment should not be longer than 12 weeks. In cardiovascular disease, NRT use is permitted in patients with stable disease. Pregnant women (who have previously tried to stop 1 smoking without the use of NRT) should preferably use short-acting preparations, though the 16 hours patch may be used if the mother is experiencing nausea/vomiting. 4. Criteria excluding the client from the treatment For breastfeeding mothers preferably short-acting preparations should be used, clients should be advised to allow the maximum time they can between NRT use and breastfeeding Consider offering a combination of nicotine patches and another form of NRT (such as gum, inhalator, lozenge or nasal spray) to people who show a high level of dependence on nicotine or who have found single forms of NRT inadequate in the past. Tobacco users not sufficiently motivated to quit or use NRT & attend specialist smoking cessation clinics. Clients under the age of 12 years. Clients with severe cardiovascular disease; including dysrythmia (irregular heartbeat), recent (i.e. less than 6 weeks) Myocardial Infarction (Heart Attack) or recent CVA (Stroke) – in these cases, a doctor’s advice must be sought before issuing treatment (see appendix 3). Clients with previous serious reaction to NRT or any of the other ingredients contained in the products, e.g. adhesive in patch. Patches only – clients with chronic generalised skin disease such as psoriasis, chronic dermatitis and urticency; clients who have had a previous reaction to transdermal patches; occasional smokers. Nasal spray only – clients with chronic nasal disorders such as polyposis, vasomotor rhinitis and perennial rhinitis. 5. Criteria for referral Clients with the following conditions (these are cautions in the SPC) where assessment suggest that there may be problems: Uncontrolled hyperthyroidism Severe renal or hepatic impairment Patients who are due to be administered adenosine (see drug interactions below) Clients taking theophylline or clozapine should inform their GP of their quit attempt (see ‘drug interactions’: section 13) Where intervention with Bupropion or Varenicline might be 2 more appropriate. Do not offer NRT, varenicline or bupropion in any combination. 6. Details of action to be followed for clients excluded under the protocol. Refer to GP with appropriate documentation (appendix 3) STAFF CHARACTERISTICS 1. Professional qualifications to be held by staff operating under this protocol Accredited specialist smoking cessation advisors employed or commissioned by Walsall Stop Smoking Service to provide specialist smoking cessation support. 2 Requirements for continuing training and education for staff operating under this protocol Attend annual update training personally or for an accredited colleague from within the department to attend the training and cascade to colleagues within the department. Assess client’s suitability for NRT specifically asking questions regarding medical history and previous NRT use. ADVISOR REPSONSIBILITIES Complete the NRT client assessment form (appendix 2) and maintain one copy with client records for reference purposes and give the carbon copy with the client’s first voucher to take to the pharmacist. Dependent on outcome either state client is suitable for NRT under Walsall voucher scheme and issue vouchers or refer client to GP / consultant. When GP / consultant consent is obtained indicate this on the voucher and issue to client (appendix 4). Initial NRT vouchers should only be issued weekly for the first two weeks of the client’s quit attempt and then fortnightly from week 3 to 8. Vouchers should be issued for 2 weeks supply of NRT for the first 4 weeks of a clients quit attempt (issued from quit week appointment and at week 2). 4 weeks supply can be issued for wks 9-12 of the clients quit attempt. A maximum of 12 weeks supply of NRT can be issued to each client accessing the voucher scheme. Complete the appropriate parts of the voucher (clients name, address and product to be supplied, advisor signature) and inform client of participating pharmacies. Use generic products unless there is a specific need for a named product, for example previous intolerance with a specific brand Advisor to retain the white copy of the voucher within the client’s records. This needs to be retained for a minimum of 2 years. Ask the client to take the yellow and green copies of the voucher to participating pharmacies. PHARMACISTS RESPONSIBILITIES To complete the bottom of the green and yellow voucher and supply NRT via NHS Walsall’s voucher scheme accordance with this protocol (appendix 4). Ensure adequate stocks of NRT products are available 3 within the pharmacy. Ensure clients sign their vouchers for supply of NRT. Complete the relevant section on the voucher and NRT claim form (appendix 5). On the voucher, to ensure clients fill out the reason for fee exemption (if applicable) and to sign that they have received the product and paid the prescription fee if not exempt. To collect a prescription fee from clients not eligible for free prescriptions. Retain the yellow copy of the voucher within the pharmacy. Send the green copy of the voucher together with the NRT claim form for reimbursement to the address at the bottom of the voucher. Take professional responsibility for the supply of the NRT. The voucher is not a prescription. The pharmacist is professionally accountable for supplying NRT on the NHS. The pharmacist retains professional discretion to judge the suitability of the NRT product recommended and change the product or refuse supply if deemed necessary. If the pharmacist has a query about the NRT recommended they must contact the issuing advisor. To ensure locum pharmacists are aware of the NRT voucher scheme and protocol so that supply can be made when they are covering. REIMBURSEMENT TO PHARMACISTS NRT will be reimbursed at a) drug tariff or b) chemist and druggist price if the product is not listed on the drug tariff. A handling fee of 90p per voucher will also be paid. Any collected prescription charges will be deducted from pharmacies’ reimbursement. MANAGEMENT AND MONITORING 1. Authors of this protocol 2. Name of committee authorizing the use of this protocol 1) Pharmacy commissioning Group 2) Local Pharmacy Committee 3. How can the health professional providing treatment be identified? Signature and designation on NRT voucher. 4. How can the patient receiving treatment Name and address on voucher. Bharat Patel (Head of Medicines Management) Hema Patel (Community Pharmacy Facilitator) be identified? 4 5. How can the medicine be identified Name, Dose, quantity identified on voucher. 6. Instructions on reporting suspected adverse drug reactions Client presenting with suspected serious adverse drug reaction should be referred to a doctor for further investigations. Serious adverse reactions should be reported to the Medicines and Healthcare products Regulatory Agency, using the yellow ADR card system available in the BNF or CSM website. http://www.mhra.gov.uk/home/idcplg?IdcService=SS _GET_PAGE&nodeId=276 7. Date of protocol TO BE COMPLETED. 8. Date this protocol becomes due for review TO BE COMPLETED (2yrs from initial date) or sooner in response to local/ national guidelines. TREATMENT 1. Name of medicine(s) administered/supplied under this protocol Nicotine Replacement Therapy (NRT) see Appendix 1 for further description of the different forms of NRT available. 2. Method of obtaining supplies Through voucher exchange at participating community pharmacies 3. How is consent obtained Monitoring form & NRT voucher. 4. Name of medicine(s) administered under this protocol NRT preparations listed in Appendix 1. 5. Legal status of medicine(s) GSL Nicorette patches Nicorette gum preparations Nicotinell patches Nicotinell gum preparations Nicotinell lozenges Niquitin patch preparations Nicorette Microtabs Nicorette Inhalator Niquitin lozenges Nicorette Nasal Spray 5 6. Doses of medicine(s) which can be administered/supplied Please refer to Appendix 1. 7. Method of route of administration Please refer to administration 8. Total dose of medicine to be supplied/administered. Maximum length of treatment under this protocol is 12 weeks. Appendix 1 for individual product Course of treatment should not be repeated unless 6 months has elapsed between quit attempts. However, if external circumstances interfere with an individual’s initial attempt to stop smoking, it may be reasonable to try again sooner. This decision will be at the Smoking Cessation Advisor’s discretion. 9. Period of time over which NRT vouchers and treatment may be administered. Weekly supplies to be given for the first two weeks of the quit attempt and then fortnightly supplies can be given to cover weeks 3 – 8 of the quit attempt. Provide weekly support for the first month of the quit attempt. Stopping smoking is difficult and the advisor may use their discretion whether to continue to issue NRT should the client have lapses. However, Walsall does not fund ‘cut down to quit’ and so we strongly recommend that vouchers are not issued if a client lapses for a total of four weeks (irrespective of whether the lapses occur in sequential or intermittent weeks). All NRT is available on GSL for the client to purchase if necessary. If the smoker has successfully stopped at 8 weeks then another 4 weeks supply can be given before revalidation at week 12. 10. Advice to be given by the stop smoking advisor to the client before or after treatment Advice to clients should include specific product advice plus the following general advice on: Withdrawal symptoms. Possible changes in the body on stopping smoking, e.g. weight gain, and how to manage these. The effects of smoking tobacco whilst using NRTparticularly in vulnerable groups, e.g. pregnant women, clients with cardiovascular disease. Follow- up and obtaining further supplies of NRT Advice on possible adverse reactions. These are usually transient but may include the following, some of which are a consequence of stopping smoking: Nausea, dizziness, headaches, cold and flu – like 6 symptoms, palpitations, dyspepsia and other gastro – intestinal disturbances, hiccups, insomnia, vivid dreams, myalgia, chest pain, blood pressure changes, anxiety and irritability, somnolence and impaired concentration, dysmennorhoea. GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers. Diabetic patients should monitor their blood sugar levels more closely than usual. Product-specific side effects are detailed in Appendix 1. Pregnant clients who develop complications of pregnancy should be advised to inform their obstetrician and midwife that they are using NRT. Written information on products supplied, self help leaflets and where to obtain more information, in particular NHS helpline numbers for: General advice- NHS Smoking Helpline: 0800 169 0 169 (Textphone users: 0800 169 0 171) Walsall Stop Smoking Service service): 0800 169 9346 (including pregnancy NHS Pregnancy Smoking Helpline (daily: 12pm – 9pm) 0800 169 9 169 NHS Asian Tobacco Helpline (Tues: 1pm – 9pm) 0800 169 0 881 (Urdu) 0800 169 0 882 (Punjabi) 0800 169 0 883 (Hindi) 0800 169 0 884 (Gujarati) 0800 169 0 885 (Bengali) 11. Site for treatment (i.e. location of service) Community settings at various locations across Walsall. 12. Treatment records which should be completed by the stop smoking advisor. A record of the consultation must be kept for at least two years, and the following documents in particular: A copy of the supplied vouchers must be kept with the client’s record for audit purposes. 7 A copy of the client’s consent obtained on the monitoring form. A copy of the client’s NRT assessment form. Drug interactions: 13. Special precautions concerning concurrent medication (checks to ensure patient is not currently taking medicine which duplicates or interacts with protocol medicine(s) Adenosine – NRT can have an adverse haemodynamic effect. Advice should be sort from the client’s doctor prior to supplying NRT. Theophylline – tobacco smoking increases the metabolism of theophylline, smoking cessation can cause theophylline plasma levels to rise. Clients taking theophylline should be supplied with NRT as appropriate but the service provider should inform their GP of their attempt to stop smoking. Clozapine – tobacco smoking increases the metabolism of clozapine. Smoking cessation can cause the blood level of clozapine to rise. The patient’s CPN and doctor must be informed of the client’s attempt to stop smoking in order for the client to be monitored for side effects of raised clozapine levels and monitor blood levels as appropriate. Permission to pass this information to the GP/Consultant will need to be obtained by the client. Smoking cessation may also cause alterations in the circulating drug levels of following: Insulin Adrenergic agonists and antagonists Benzodiazepines Duloxetine Fluphenazine Haloperidol Propranolol Tricyclic antidepressants Fluvoxamine Warfarin Clorpromazine Imipramine Olanzapine Flecainide Pentazocine Ropinirole Zolpidem Lithium Memantine Clients who are taking NRT together with any of the above medicines should be advised to inform their GP they are trying to stop smoking and or the client experiences problems. (see appendix 6 for more details) 8 Appendix 1 Dosage and method of administration Please note the details regarding these products may change frequently so it is prudent to check the latest Summary of Product Characteristics. A) GUM Dose Nicorette People who smoke up to 20 cigarettes a day should use the 2mg gum. People who smoke more than 20 cigarettes a day should use the 4mg gum. Clients should aim to use 8-12 pieces of gum a day up to maximum of 15 pieces a day. Nicotinell “Heavier smokers” should use the 4mg gum. “Lighter smokers” should use the 2mg gum. The gum should be used when the client feels the urge to smoke and they should aim to use between 8-12 pieces of gum per day. The maximum dose for the 4mg gum is 15 pieces a day. The maximum dose for the 2mg gum is 25 pieces a day. Method of administration Specific side effects Specific advice to client NiQuitin CQ Smokers who have their first cigarette within 30 minutes of waking should use the 4mg gum. Smokers who have their first cigarette after 30 minutes of waking should use the 2mg gum. Clients should aim to use between 8-12 pieces of gum per day up to a maximum of 15 pieces a day. Oral administration (as resin). Throat irritation, increased salivation, hiccups. Gum should be chewed until the taste becomes strong and then ‘parked’ between the gum and cheek until the taste fades. Recommence chewing once the taste has faded. This ‘chew-park-chew’ technique should be applied for 30 minutes. B) INHALATOR Dose Inhale when urge to smoke occurs. Advise using 6-12 cartridges (10mg / cartridge) daily for up to 8 weeks THEN Reducing the dose to 3 – 6 cartridges over the next 2 weeks THEN Reduce to 0 over next 2 weeks. Method of administration Specific side effects Oral administration (nicotine-impregnated plug in mouthpiece). Specific advice to client Air should be drawn into the mouth through the mouthpiece. Clients should be warned that the inhalator requires more effort to inhale than a cigarette and that less nicotine is delivered per inhalation. Therefore the client may need to inhale for longer than with a cigarette. The inhalator is best used at room temperatures as nicotine delivery is affected by temperature. Used cartridges will contain residual nicotine and should be disposed of safely. Advise the client to keep them in the case and dispose of them in household rubbish. Throat irritation, cough, rhinitis, pharyngitis, stomatitis, dry mouth. 9 C) LOZENGE Dose Nicotinell Those who have a strong nicotine dependency, i.e. who smoke more than 30 cigarettes a day, should use the 2mg lozenge. Those who smoke less than 30 cigarettes a day should use the 1mg lozenge. Most people use 8-12 lozenges per day. The maximum daily dose is 30 of the 1mg lozenges. The maximum daily dose is 15 of the 2mg lozenges. Contains aspartamine, and may be harmful for people with phenylketonuria. NiQuitin CQ Those who have their first cigarette within 30 minutes of waking should use the 4mg lozenge. Those who have their first cigarette after 30 minutes of waking should use the 2mg lozenge. The maximum daily dose is 15 lozenges. Contains aspartamine and may be harmful for people with phenylketonuria. Each lozenge contains 15 mg of sodium. People on a low sodium diet should take this into account Method of administration Specific side effects Specific advice to client Oral administration (nicotine as bitartrate). Throat irritation, increased salivation, hiccups. Nicotinell Lozenge: Lozenge should be sucked until the taste is strong and then ‘parked’ between the gum and the cheek until the taste fades. Once faded then sucking should recommence. Simultaneous use of coffee, acid drinks and soft drinks may decrease absorption of nicotine and should be avoided for 15 minutes prior to sucking lozenge. NiQuitin Lozenge: One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 –30 minutes). The lozenge should not be chewed or swallowed whole. Users should not eat or drink while a lozenge is in the mouth. D) PATCHES Dose Apply on waking to dry, non-hairy skin on hip, chest or upper arm. Remove after time specified. New patch should be placed on a different area – avoiding ‘used’ sites for several days afterwards. Nicorette – 16 hour patch 15mg patch for 16 hours daily for 8 weeks THEN 10mg “ “ “ “ “ “ 2 “ THEN 5mg “ “ “ “ “ “ 2 “ THEN review treatment Nicorette – 16 hour Invisipatch 25mg patch for 16 hours daily for 8 weeks THEN 15mg “ “ “ “ “ “ 2 “ THEN 10 10mg “ “ “ “ “ “ 2 “ Nb: those smoking less than 10 cigarettes a day are recommended to start on 15mg patch for 8 weeks and then decrease dose to 10mg for the final 4 weeks Nicotinell - TTS30 patch For individuals smoking more than 20 cigarettes per day – one patch (21mg) daily. Nicotinell – TTS20 patch For individuals smoking 20 cigarettes or less per day – one patch (14mg) daily. Nicotinell – TTS10 patch For individuals smoking 10 cigarettes or less per day – one patch (7mg) daily. It is recommended that smokers begin treatment with one of the stronger patches. Withdraw treatment gradually reducing the dose every 3-4 weeks. NiQuitin CQ For individuals smoking 10 or more cigarettes daily: 21mg patch daily for 6 weeks THEN 14mg “ “ “ 2 “ THEN 7mg “ “ “ 2 “ THEN review treatment Individuals who experience persistent side effects with the 21mg patch should switch to the 14mg for the remainder of the 6 weeks followed by the 7mg patch for 2 weeks as above. NiQuitin CQ For individuals smoking less than 10 cigarettes per day: 14mg patch daily for 6 weeks THEN 7mg “ “ “ 2 “ THEN review treatment Method of administration Specific side effects Transdermal administration. Specific advice to client Exercise may increase absorption of nicotine and therefore side effects. The patch should be applied once a day, normally in the morning, to a clean, dry, non-hairy area of skin on the hip, trunk or upper arm, then removed before reapplying the next one. Allow several days before replacing the patch on a previously ‘used’ area. Place the patch in the palm of the hand and hold onto the skin for 10-20 seconds. Patches should not be applied to broken or inflamed skin. Once the patch is spent it should be folded in half and disposed of carefully. Storage safety, away from children and animals, away from direct sunlight. Clients should not try to alter the dose of the patch by cutting it up. Skin reactions. Discontinue use if severe. E) SUBLINGUAL TABLET Dose For individuals smoking 20 cigarettes or less daily – one tablet (2mg) per hour. For patients who fail to stop smoking or have significant withdrawal symptoms consider increasing to 2 tablets (4mg) per hour sublingually. For individuals smoking more than 20 cigarettes a day – 4mg per hour. 11 Maximum dose: 40 tablets (80mg) per day Method of administration Specific side effects Specific advice to client F) NASAL SPRAY Dose Treatment should be continued for at least 3 months, gradually reducing the dosage over time. Oral administration (sublingual) – 2mg. Throat irritation, unpleasant taste. Tablets should be placed under the tongue and allowed to dissolve slowly. For the first 8 weeks as required to a maximum of one spray into each nostril twice an hour for 16 hours a day. For the subsequent 2 weeks, reduce usage by half. Final two weeks, reduce usage to zero. Maximum dose: 32 sprays per day Method of administration Specific side effects Specific advice to client Use should be restricted to 3 months. Intranasal use Running nose, sneezing, watery eyes. Nasal spray should not be used whilst driving or operating machinery. 12 APPENDIX TWO: NICOTINE REPLACEMENT THERAPY CLIENT ASSESSMENT FORM (top copy: keep with client notes; bottom copy: give to client with voucher one) Mr/Mrs/Miss/Ms Clients Full Name……………………………………… D.O.B…………………………. Circle appropriate answer 1. Is the client a tobacco user sufficiently motivated to quit Yes No 2. Has the client set a quit date through Walsall SSS Yes No 3. If the client is pregnant or breastfeeding have they tried quitting without nicotine replacement therapy? Yes No 4. Is the client aged 12 years or over Yes No 5. Current severe, unstable or worsening angina Yes No 6. Uncontrolled hypertension Yes No 7. Severe heartbeat irregularities Yes No 8. Recent heart attack (less than 6 weeks) Yes No 9. Recent Stroke (less than 6 weeks) Yes No 10. Uncontrolled hyperthyroidism Yes No 11.Severely impaired liver or kidney function Yes No 12. Active peptic ulcer Yes No 13. Severe skin disorders (excludes patch only) Yes No 14. Chronic nasal disorders (excludes nasal spray only) Yes No n/a Does the client have a history of: Advisor Name………………………………… Signature……………………………………… Date ………………………………………….. Enclosure 4. Medications: Seek GP / consultant approval before completing voucher Eligible for NRT under Walsall voucher scheme Is client taking bupropion or varenicline? Yes: do not issue NRT No Is client on adenosine? Yes: do not issue NRT No If client is taking any of the following: theophylline, Benzodiazepines, Chlorpromazine, Duloxetine, Fluphenazine, Fluvoxamine, Haloperidol, Olanzapine, Propranolol, Tricyclic antidepressants, Zolpidem, Lithium, Memantine have they been told to inform GP of their quit attempt? Yes No n/a If client is taking clozapine, have arrangements been Yes No n/a 13 Made to monitor plasma levels? APPENDIX THREE: LETTER REQUESTING GP ASSESSMENT FOR NRT (TO BE SENT ON HEADED PAPER) Date Re: Patient Name: ………………………………..D.O.B…………………. Dear Dr……………………. The above named patient is receiving smoking cessation support from ……………………………………..(name / location of advisor). Will you please assess the patient’s suitability for Nicotine Replacement Therapy (NRT) considering the following relevant medical history: ………………………………………………………………………………….. Please indicate below whether you recommend NRT for this patient. Yours sincerely Job title:………………………………………. Contact number:…………………………….. ………………………………………………………………………………….. GP/Consultant Declaration I do/do not* recommend NRT use by the above named patient GP/Consultant Name (please print):………………………………………. GP/Consultant Signature:…………………………………………………… Please * delete as appropriate Practice Stamp: 14 15 APPENDIX FOUR: VOUCHER OF RECOMMENDATON FOR NICOTINE REPLACEMENT THERAPY TOKEN No:…………………. Advisor Section: Patient Name: ………………………………………………………………………………………………………………. Patient Address: ……………………………………………………………………………………………………………. Service Provider Stamp & Advisor Signature: I, (print advisor name)……………………………………………………….am offering the above client behavioral smo king cessation support and recommend the following NRT: Product to be supplied: ……………………………………………….………..………….. for week number: ………….…… ………………………………………………………..…………… for week number: ………….…... ……………………………………………………..……………… for week number: ………………. ………………………………………………………………..…… for week number: ………………. Does the client need doctor’s approval for NRT? Yes No If yes, approval has been given by (Name of GP / consultant) …………………………………………………………….. Date of approval given: …………………………………… Pharmacy Section: Declaration of exemption: To be completed by the patient The patient does not pay because: A is 16, 17 or 18 and in full-time education B has a maternity exemption certificate C has a medical exemption certificate D has a prescription prepayment certificate E is named on a current HC2 charge certificate F Gets income support G Gets income based jobseeker’s allowance H Gets full working family tax credit or credit reduced by £70 or less I Gets full disabled persons tax credit or credit reduced by £70 or less I am the patient / patient’s representative (Circle as appropriate) To be completed by pharmacist. Was evidence of exemption seen? Yes / No (Circle as appropriate) PMR Number:……………………………………….. I, (print name)………………………………………………………………………..….…. have supplied the following products: ……………………………………………………………………………………………..……………………….………………… To cover treatment for weeks:………………………………… Pharmacist signature:………………………………………….. I have received the above Nicotine Replacement Therapy and paid a prescription fee if not exempt: …………………………………..……………Client / client representative Signature Date: ……………………….. Pharmacy Stamp: WHITE COPY: TO BE KEPT BY ADVISOR; YELLOW COPY: TO BE KEPT BY PHARMACIST GREEN COPY: TO BE SENT TO: ADMINISTRATOR, CONTRACTING DEPT, JUBILEE HOUSE, BLOXWICH LANE, WALSALL, WS2 7JL WITH COMPLETED CLAIM FOR NRT REIMBURSEMENT 16 APPENDIX SIX: MENTAL HEALTH MEDICATION AFFECTED BY TOBACCO SMOKING CYP450 Induction DRUG NAME EFFECTS OF SMOKING ON PLASMA LEVELS DOSE IN SMOKERS AFFECT OF SMOKING CESSATIO N MANAGEMENT OF MEDICATION WHEN STOPPING SMOKING Benzodiazepines Plasma levels reduced by between 0 – 50% Increase in plasma levels Chlorpromazine Plasma levels reduced Smokers may need larger doses of some benzodiazepines Smokers may need larger doses Clozapine Reduces plasma levels by up to 50% Smokers may need larger doses Increase in plasma levels Duloxetine Reduces plasma levels by up to 50% Plasma levels reduced Smokers may need larger doses Increase in plasma levels Monitor closely for excess sedation Consider dose reduction if adverse effects occur Monitor closely for adverse effects Consider dose reduction if patient suffers adverse effects such as drowsiness or EPSE Take a trough plasma level before stopping. On stopping reduce dose gradually (over a week) until around 75% dose is reached. Repeat plasma level 1-2 weeks after stopping. Consider further dose reductions depending on plasma levels. Monitor patient closely for adverse effects. Contact a pharmacist for further advice. Consider dose reduction Smokers may need larger doses Increase in plasma levels Reduces plasma levels Reduces plasma levels by around 20% Reduces plasma levels by up to 50% Plasma levels maybe reduced Smokers may need larger doses Smokers may need larger doses Increase in plasma levels Increase in plasma levels Smokers may need larger doses Increase in plasma levels Fluphenazine Fluvoxamine Haloperidol Olanzapine Propranolol Tricyclic antidepressants Increase in plasma levels Smokers may need Increase in larger doses plasma levels depending upon response Smoking reduces plasma levels of tricyclic antidepressants but the concentration of free and unbound antidepressant Monitor closely for adverse effects Consider dose reduction if patient suffers adverse effects such as drowsiness or EPSE Consider dose reduction Monitor for adverse effects Consider dose reduction. Monitor carefully for adverse effects e.g. EPSE. Consider dose reduction Monitor carefully for adverse effects. Consider dose reduction according to response. Monitor blood pressure. Monitor closely for adverse effects and consider dose 17 Zolpidem rises which appears to offset the effects of this interaction. Plasma levels Smokers may need Increase in may be lower larger doses plasma levels reduction if appropriate. Monitor for excess sedation and consider dose reduction if adverse effects occur Other Mechanisms Lithium Smoking may reduce xanthine levels resulting in higher lithium levels in smokers Memantine Competition with nicotine for cationic transport system, therefore potential for increased plasma levels Smokers may require lower doses Cessation of smoking theoretically raises xanthine levels increasing lithium secretion and lowering lithium levels Decreased plasma levels Monitor levels every 4-7 days and adjust dose until stability is achieved Higher doses may be required when smoking ceases Monitor patient The list of interactions is NOT exhaustive. It concentrates only on those interactions with medication used in mental health conditions and interactions most likely to be of clinical significance. References Taylor, D et al. The Maudsley Prescribing Guidelines. 9th Edition. Informa Healthcare. 2007 Baizire, S. The Psychotropic Drug Directory 2007. Cromwell Press Summary of Product Characteristics for individual drugs. Available at www.emc.medicines.org.uk UKMi Q and A sheet: Which medicines need dose adjustment when a patient stops smoking? Stockley, I. Drug Interactions. Fifth Edition. 2001. Pharmaceutical Press Cozza, K and Armstrong, S. Concise Guide to the Cytochrome P450 System. 2001. American Psychiatric Publishing. Appendix 6 taken from Factsheet written by Amanda Kelso 18