This standard operating procedure applies to stop smoking services provided by North 51.

Transcription

1 NUR-SOP-SSS-001-v09 Author Name/Title Melanie McIlvar, Bid Development Manager Author Signature Date: 4 th October 2017 Approver Name/Title Jason Shelley, Group Director of QA/RA Approver Signature Date: 4 th October 2017 Issue Date 4 th October 2017 Effective Date 18 th October 2017 Review Date 4 th October 2019 Page Number Page 1 of Purpose This document authorises and sets out the conditions under which nicotine replacement therapy (NRT) can be supplied directly to clients receiving stop smoking support from North 51 Ltd who, through their Public Health and Lifestyle Services Division, is commissioned to provide Stop Smoking Services. North 51 is registered with the CQC. Bionical Ltd is North 51 s parent company encompassing the Public Health & Lifestyles Division. 2. Scope This standard operating procedure applies to stop smoking services provided by North 51. This policy should be read in conjunction with relevant NCSCT Guidelines. North 51 is contracted by several local authority and other commissioners to provide a local stop smoking service. 3. Affected Staff All staff members of Bionical Limited and North 51 Limited, working within the following divisions: Public Health and Lifestyle Services Stop Smoking Practitioners are either directly employed by North 51 or working for a subcontracted provider. Stop Smoking Practitioners provide stop smoking support directly to clients either in person or remotely e.g. telephone support. Refer to the training plan for the Stop Smoking Practitioners affected by this procedure.

2 Page Number Page 2 of Related and Reference Documents NUR-SOP-SSS Supporting E-Cigarette Users Policy NUR-SOP-SSS Protocol for the Delivery of Stop Smoking Medications NUR-SOP-SSS Nicotine Replacement Therapy Decision Tree NUR-SOP-SSS Nicotine Replacement Therapy Decision Tree Pregnancy NUR-SOP-SSS-006 Protocol for the Disposal and Recall of Nicotine Replacement Therapy NUR-SOP-GEN Data Protection and Confidentiality Policy NUR-SOP-GEN Lone Worker Policy NUR-SOP-GEN-012 Consent NUR-SOP-GEN-018 Storage and Management of Records NICE PH48 Smoking: acute, maternity and mental health services. London, November 2013 West, R. (2012) Stop smoking services: increased chances of quitting. NCSCT Briefing #8. London; National Centre for Smoking Cessation and Training National Institute of Clinical Excellence. Stop Smoking Services PH10 (updated) London, 2013 Public Health England. Local Stop Smoking Services Service and delivery guidance 2014 The SNAP Trial: Cooper, S. et al. A randomised placebo-controlled trial of nicotine replacement therapy in pregnancy - clinical effectiveness and safety until 2 years after delivery, with economic evaluation. Health technology assessment, Vol. 18, No. 54, 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 Pharmacy Healthcare Scheme. Improving access to smoking cessation therapies by using patient group directions. London, January NCSCT Briefing Combination nicotine replacement therapy (NRT) (2012) NCSCT Smoking Reduction (2012)

3 Page Number Page 3 of 30 NSCST Smoking Cessation and Mental Health A briefing for Frontline Staff (2014) UKMi, Medicines Q&A s. Which medicines need dose adjustment when a patient stops smoking? UKMi Abbreviations Used Within This Procedure CQC CSM CVD DOC GP GSL HCP LA NARS NCSCT NHS NICE NRT QM SOP SPA SPC UKMi Care Quality Commission Committee on the Safety of Medicines Cardiovascular Disease Controlled Document General Practitioner General Sales List Health Care Professional Local Authority Nicotine Assisted Reduction to Quit National Centre for Smoking Cessation and Training National Health Service National Institute for Health and Clinical Excellence Nicotine Replacement Therapy QuitManager Standard Operating Procedure Single Point of Access Summary of Product Characteristics United Kingdom Medicines Information 6. Definitions Used Within This Procedure

4 Page Number Page 4 of 30 N/A 7. Procedure 7.1. Scope and Focus Name of authorising body North Description of medicine Nicotine Replacement Therapy (NRT) Legal Classification GSL (General Sales List) Clients Clients who smoke and are receiving support from a North 51 Stop Smoking Practitioner Professionals who may supply under the direction Prior to being able to deliver under this protocol. Stop Smoking Practitioners must be NCSCT certified and have completed face-to-face training in behaviour change techniques for smoking cessation. The Stop Smoking Practitioner must be directly employed by North 51 or by a sub-contractor providing stop smoking support on behalf of North 51. North 51 s named registered professional Clinical Lead supports Stop Smoking Practitioners providing direct supply of NRT. All Stop Smoking Practitioners must be competent staff and will be monitored by their line manager, or in the case of sub-contracted practitioners, their named service representative Supply outside the Summary of Product Characteristics (SPC) The details of the Practitioners authorised to supply NRT products are listed under Appendix A There is widespread professional recognition that NRT products are much less harmful than tobacco smoking. The supply of NRT outside the license specifications is authorised in the following circumstances: Combination therapy (Appendix C) [Nicotinell lozenge only (1mg & 2mg)] - Pregnant or breastfeeding women - Clients aged between 12 and 18 There are also circumstances where it is first necessary to seek advice from the Clinical Lead, and possibly the client s GP, before NRT can be supplied. These are listed in Indemnity North 51 Ltd has medical malpractice insurance as protection against legal action arising from any adverse effects of NRT administration through a North 51 Stop Smoking Service.

5 Page Number Page 5 of Period 1 st September 2017 to 31 st August Clinical Condition/Indication Indication / definition of Tobacco Dependence condition Criteria for inclusion Tobacco users receiving stop smoking support from North 51. Before NRT is supplied, the client must first set a quit date Criteria for exclusion Clients not receiving support from a North 51 Stop Smoking Service (or not consenting to support) Clients who have not yet set a quit date Clients who are currently hospitalised because of: - a myocardial infarction (heart attack) - unstable or worsening angina (including Prinzmetal s angina) - severe dysrhythmia or CVA (cerebral vascular accident, i.e. stroke) and considered to be unstable and/or have uncontrolled hypertension (blood pressure) without a written recommendation from the consultant for NRT treatment Clients with previous serious adverse reaction to NRT or any of the other ingredients contained in the products (e.g. glue in patch) [Patches only] clients with a generalised skin disease such as psoriasis, chronic dermatitis, or, clients who have experienced a previous, or new, severe or persistent local reaction at the application site(s) (e.g. severe erythema (redness of the skin), pruritus (itching), oedema (swelling)) or a generalised skin reaction (urticaria (hives) or general rash) should discontinue use and see GP [Gum only) Denture wearers [Nasal spray only] clients with hyperactive airways e.g. bronchial asthma [Nicotinell gum and lozenges only, all strengths] clients with rare hereditary condition of fructose intolerance (as these products contain sorbitol) Currently using Bupropion or Varenicline, or their use may be more appropriate (e.g. where the patient s previous NRT use has been ineffective or not tolerated) Criteria for seeking advice When the following criteria apply, further advice should

6 Page Number Page 6 of 30 from the Clinical lead or referring to a GP be sought in the first instance from the Clinical Lead and if necessary the Clinical Lead - or Stop Smoking Practitioner supported by the Clinical Lead - should liaise with the client s GP if deemed necessary. There is doubt whether an exclusion criterion applies Clients taking anti-convulsant therapy or with a history of epilepsy Clients with uncontrolled diabetes Clients with oesophagitis, gastritis, active peptic ulcer, active gastric ulcer, oral or pharyngeal inflammation who want to use an oral product Clients with a moderate or severe hepatic (liver) impairment Clients with severe renal (kidney) impairment Clients with pheochromocytoma (rare tumour of the adrenal glands) Clients with uncontrolled hyperthyroidism (overactive thyroid) Clients with lung disease (including chronic throat disease and bronchospastic disease) who want to use the inhalator Clients using adenosine Clients below the age of 12 years Depending on individual area contracts, some of the above instances may also require commissioner approval Treatment Name of Medicine NiQuitin 24hr Patch (21mg, 14mg, 7mg) * NiQuitin Mini Lozenge (4mg, 1.5mg) Nicotinell 24hr Patch (21mg, 14mg, 7mg) * Nicotinell Gum (4mg, 2mg) Nicotinell Lozenge (1mg, 2mg) Nicorette Invisi Patch (25mg, 15mg, 10mg) Nicorette Nasal Spray (10mg) Nicorette Inhalator (15mg) Nicorette Gum (6mg, 4mg, 2mg) Nicorette Quick Mist Mouth Spray (1mg) Nicorette Microtab (2mg) Nicorette Cools Lozenge (4mg, 2mg) *pregnant women should be advised to remove patches at night and therefore not recommended a 24-

7 Page Number Page 7 of 30 hour patch See Appendix H for NRT products advice sheet. Please note that the exact range of products available may be dependent upon local contractual agreements Dosage All products must be given out in accordance with the Summary of Product Characteristics (SPC). The SPC for each product can be found on Frequency A maximum two-week supply of NRT should be given to a client at any one time (up to a total supply equivalent to 12 weeks) and only as part of an intervention session. Authorised exceptions to the twoweek limit are listed below. Any other circumstances must be first authorised by the Clinical Lead. Client is past the four-week quit point, is due to go on holiday and would run out of NRT before next scheduled intervention session (a maximum of four weeks supply permitted) With the exclusion of clients on a gradual reduction programme (see Appendix D) the first supply of NRT should only be given once a quit date is set. Subsequent supplies should only be provided if the client has remained abstinent from smoking (excluding reduction programmes) or, in the case of a lapse, presents as committed to achieving abstinence between the current intervention session and the next. In some circumstances, it may be appropriate to continue to supply NRT following the end of the 12- week programme to prevent clients relapsing or reentering the service. Where a Stop Smoking Practitioner believes this is likely to be beneficial, further supply should be provided in line with local contractual arrangements i.e. via continued direct supply this should be discussed with the Clinical Lead before additional NRT is supplied and in advance of the client s existing supply running out via the clients GP. See Appendix E for the template letter client self-funds, purchasing NRT over-thecounter Method of Administration All products must be given out, and should be used, as per their SPC. The SPC for each product can be found on

8 Page Number Page 8 of Total quantity which may be supplied / period over which medicine can be supplies The quantity supplied to the client should be enough to cover the period between appointments e.g. 2 weeks supply of patches equates to 14 patches only. When using an oral product please refer to the SPC for each product. At each appointment clients, should be assessed on their usage of oral products and adjusted according to their use. See Appendix H for NRT products advice sheet Drug interactions No clinically relevant interactions between NRT and other drugs has been established, although nicotine may possible enhance the blood flow of adenosine (used to slow fast or uneven heartbeats called 'arrhythmias'). However, hydrocarbons in tobacco smoke reduce the metabolism of certain drugs. Therefore, when someone stops smoking, irrespective of stop smoking medication use, the metabolism of such drugs may slow down, increasing blood levels. To avoid toxicity, drug levels need to be checked, monitored and adjusted as required (see Appendix I). Clients using Insulin should be advised to monitor their blood sugar levels regularly whilst stopping smoking. Clients using adenosine can only be provided with NRT upon receipt of written consent from their GP. If the client is diabetic or is taking one of the medicines listed below, the Stop Smoking Practitioner can continue to supply NRT but, should also seek consent from the client to notify their GP or an appropriate alternative healthcare professional (HCP) about their quit attempt. The HCP will also need to be informed if the client relapses and returns to smoking (see Appendices E & F for template letters). Letters should only be sent to and from nhs.net accounts, safe-haven fax or handed over in person. Letters MUST not be posted or sent from and to a nonnhs.net account or non-safe haven fax facility. Carbamazepine Clozapine Benzodiazepines Chlorpromazine Duloxetine Fluphenazine Fluvoxamine

9 Page Number Page 9 of 30 Haloperidol Insulin Methadone Mirtrazapine Olanzapine Theophylline Tricyclic antidepressants Warfarin Where the client does not consent to their GP or other relevant HCP being informed of their quit attempt, the client should be advised to inform their HCP themselves and this advice must be documented in the session notes Side effects / adverse reactions Side effects from NRT are usually transient. A summary of the very common / common undesirable effects can be found in the SPC for each product Clients should be advised to read the patient information leaflet (PIL) included with their NRT. However, Stop Smoking Practitioners should be aware that some of the reported side effects may be due to stopping smoking rather than the specific use of NRT Advice to clients Advice given to clients must be recorded in the appropriate session notes on QM. Advice to clients should include specific product advice plus the following general advice: Withdrawal symptoms associated with stopping smoking Possible changes in the body on stopping smoking, e.g. weight gain Possible side effects Diabetic clients should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated The effects of smoking tobacco whilst using NRT Potential interactions between stopping smoking and certain drugs (see 7.3.6) Written information on NRT products supplied, self-help leaflets and where to obtain more information. Clients should be encouraged to

10 Page Number Page 10 of 30 read the patient information leaflet (PIL) contained within their medications Prescription charges and exemptions (see section 7.4.2) Providing NRT products to clients All clients should be warned about the danger NRT can pose to small children. Doses of nicotine tolerated by adults and adolescents can produce severe toxicity in small children that may be fatal. Clients should be advised to ensure anything containing nicotine is not left where it may be misused, handled or ingested by children (or animals). All NRT must be given to the client that is receiving the support either in person, or via recorded delivery addressed to the client following a telephone consultation Prescription Charges In the first instance, a client should be asked whether they pay for prescriptions. If a client does not pay for prescriptions (i.e. is exempt from charges), the reason for exemption must be recorded and evidence obtained. Refer to Appendix J Prescription Exemption categories and proof required. If a valid certificate of exemption has been shown, for example a medical exemption certificate or prepayment certificate, and noted on Quit Manager along with the certificate s expiry date, it is not necessary to ask the client to show proof again within the validity of that certificate. Patients claiming exemption because they receive Income Support or Jobseeker s Allowance (income-based) should be asked to provide their evidence of entitlement on each occasion. Reason for exemption, and the exemption reference number, must be entered onto Quit Manager within the session notes. If a client does need to pay for their prescriptions, they should be advised of the NHS pre-payment certificate system, which in many cases will be more costeffective than paying for individual items. If a client wishes to obtain a pre-payment certificate, evidence should be obtained prior to supply of the medicine. If a client is not exempt, and does not wish to pay for a pre-payment certificate, payment should be taken for NRT at the standard prescription charge rates. Payment is made per item, per supply.

11 Page Number Page 11 of 30 Before supplying the drug, the practitioner should advise the client claiming exemption from payment of NHS prescription charges where evidence is required but not provided that NHS checks are routinely undertaken to verify that such persons are exempt from payment of NHS prescription charges, as part of arrangements for preventing or detecting fraud or error. Ensure a note to say this advice has been given is recorded in the session notes Informed consent Informed consent to share information relating to the supply of NRT under this protocol and the quit attempt with the client s GP or other relevant Health and Social Care Professional, must be requested of all clients and recorded in Quit Manager Combination Therapy Guidance Nicotine Assisted Reduction to Quit (NARS) Guidance Pregnant and Breastfeeding women Where consent is not given this should be recorded in Quit Manager. The client should be advised to inform their GP or relevant Health and Social Care Professional themselves and this advice should be documented in the session notes. A copy of the consent to treatment for year old s (Fraser guidelines) can be found in Appendix B. This document must be used with all clients in this age group and held on record for 8 years. All see Consent SOP NUR-SOP-GEN-012-v01 See Appendix C See Appendix D The data available on the use of NRT in pregnancy and breastfeeding women is limited, however, there is conclusive evidence that the dangers of continuing to smoke far outweigh any potential dangers of using NRT to mother and baby during pregnancy. A recent SNAP Trial showed that NRT patches had no enduring, significant effect on smoking in pregnancy; and it was found that 2-year-olds born to women who used NRT were more likely to have survived without any developmental impairment. Therefore, NICE guidance and the Expert Committee on Safety of Medicine Working Group advise that pregnant women, who cannot stop smoking on their own, can use NRT, as can breast feeding women Clinical pathway The supply of NRT under this protocol should only take place as part of the North 51 Stop Smoking Service Standard Treatment Programme Site of treatment Supply of NRT should be carried out in suitable

12 Page Number Page 12 of 30 premises with facilities for private consultations Staff Characteristics Professional status / qualifications to be held by staff supplying products under this protocol Special qualifications / experience and competence considered necessary and relevant Requirements for continuing training and educations for staff Names of staff authorised to supply products under this protocol Stop Smoking Practitioners must be NCSCT certified and have completed face-to-face training in behaviour change techniques for smoking cessation. All Stop Smoking Practitioners authorised to supply NRT under this protocol must be named in this protocol. See Appendix A. Authorised Stop Smoking Practitioners must be competent to follow and administer NRT under the protocol - showing a clear understanding of any drug administered including side effects and contraindications. All Stop Smoking Practitioners authorised to supply NRT under this protocol are required to attend all refresher/update training. See Appendix A Records, Ordering and Auditing Details of records to be kept The following records must be kept for all NRT products supplied to clients under this Protocol: Name of client Address of client Date of birth of client Eligibility for prescription charges Evidence of prescription exemption (as appropriate) Name of product(s) Quantity, flavour and dosage of product(s) Date of supply to client Batch number Expiry date The following records must be kept for all NRT products stocked under this protocol: Name of NRT product Dosage, flavour and quantity of product/s Batch number

13 Page Number Page 13 of 30 Expiry date Signature of person signing stock in Signature of person signing stock out Name and signature of Stop Smoking Practitioner Quit Manager is used to capture all NRT given out to ensure a robust audit trail for monitoring and invoicing purposes. Details should be entered onto Quit Manager at the point of supply, or at least within 24 hours of the NRT being supplied. Also see Storage and Management of Records SOP (NUR-SOP-GEN-018) Safe storage of NRT All NRT products MUST be: Kept in accordance with the manufacturer s instruction Kept in lockable storage units Kept out of the reach of clients and children Never left in a car unattended Transported from the Direct Supply Unit in a lockable container Never left unattended when in a transportable container Kept at a stable and dry temperature. Products should be stored in a dry place at a temperature not exceeding 25 C Recall procedure for NRT If a NRT product needs recalling, the supplier of the NRT product will use their stock control records to identify where the products have been distributed to and alert North 51. Clients issued with a recalled NRT product(s) will be identified and contacted centrally in line with North 51 s Protocol for the Disposal and Recall of Nicotine Replacement Therapy (NUR-SOP-SSS-006). Stop Smoking Practitioners must respond immediately to any requests for recalled stock to be returned to the central SPA. Recalled stock must not be kept for use as demonstrator products Disposal of Waste NRT Products Any NRT products returned by a client must be returned to the central SPA to be disposed of in line with North 51 s Protocol for the Disposal and Recall of Nicotine Replacement Therapy (NUR-SOP-SSS-006).

14 Page Number Page 14 of 30 Returned products, even if seemingly unused, MUST not be re-issued to another client or kept by Stop Smoking Practitioners for use as demonstrator products Giving clients choice The Stop Smoking Practitioner, in consultation with the client, will suggest and guide a choice of combination NRT products (up to two different products), considering the client s individual needs. See Appendix H for NRT products advice sheet. 8. Storage and Retention of Records 8.1. Refer to the above tables. Records should be retained for a minimum of 8 years. 9. Version History Version Change Request Reference Reason for Change 07 N/A Transition to new Bionical standard operating procedure format. 08 N/A Protocol reviewed in line with national guidelines 09 N/A Note added to to also refer to local contractual agreement. Clarification added to regarding client needing to be at least four weeks quit Date of Issue 23 rd May th September th October 2017

15 Page Number Page 15 of Appendices Appendix A - Names of individuals authorised to supply NRT products under this Protocol Name of Stop Smoking Provider: Name of Clinical Lead: Signature: Date: Names of individuals (practitioners) authorised to supply NRT under this Protocol Name Mobile Telephone Number Address

16 Page Number Page 16 of Appendix B - Consent to Nicotine Replacement Medical Treatment for yearold clients (Fraser Competency) For all clients aged between years Adults, defined as people over the age of 18, are usually regarded as competent to decide their own treatment. The Family Law Reform Act 1969 also gives the right to consent to treatment to anyone aged 16 to 18. Young people under the age of 16 can consent to medical treatment if they have sufficient maturity and judgement to enable them fully to understand what is proposed. This was clarified in England and Wales by the House of Lords in the case of Gillick vs West Norfolk and Wisbech AHA & DHSS in Discussion with the young person should explore the issues below at each consultation. This should be fully documented and should include an assessment of the young person's maturity. Assessment (Fraser competency) for clients over 12 and up to 16 years Yes No Understanding of advice given Encouraged to involve parents The effect on the physical or mental health or young persons if advice / treatment withheld Action in the best interest of the young person Client I consent to treatment and confirm that the above assessment has been completed. Name Date Signature Stop Smoking Practitioner Name Date Signature

17 Page Number Page 17 of Appendix C - Combination therapy guidance Tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit. Effective treatments exist, however, that can significantly increase rates of long term abstinence (Clinical Practice Guideline 2008 update). Nicotine withdrawal symptoms are the major cause of relapse in smokers. It has been shown that there is an inverse relationship between nicotine withdrawal symptoms and baseline nicotine plasma levels (Russell, 1990, Hurt eta al, 1993) Many smokers have not succeeded in quitting using a single NRT product and it has been shown that most smokers using any single type of NRT are not adequately receiving replacement doses (Hurt et al. 1993: Benowitz: 1991) Smokers can be safely and successfully treated symptomatically for nicotine withdrawal relief using combination therapy aggressively and there have been no adverse side effects of toxicity from combination therapy use (Hughes, 1995; Paaoletti et al., 1996; Killen et al., 1999) Products that can be used for Combination Therapy NiQuitin 24hr patch 21mg, 14mg, 7mg or Nicotinell 24hr patches 21mg, 14 mg, 7mg or Nicorette 16hr patch (Invisi range) 25mg, 15mg, 10mg In conjunction with one of the following oral/flexible products: NiQuitin Minis Lozenge 4mg, 1.5mg Nicorette Gum 2mg, 4mg, 6mg Nicorette Quick Mist Mouth Spray 1mg Nicorette Inhalator 15mg Nicorette Lozenge 4mg, 2mg Nicotinell Lozenge 1mg Nicotinell Gum 2mg, 4mg Who should use Combination Therapy? Subject to suitability, all clients aged 12 years and over 1 who are receiving support from a Stop Smoking Provider within the Stop Smoking Service should be offered the use of combination therapy. In some instances, advice from the Clinical Lead or a referral to the client s GP may be required before NRT can be supplied see section subject to local contracts

18 Page Number Page 18 of 30 Who should not use Combination Therapy? Clients for whom the Criteria for Exclusion (section 7.1.3) apply How should Combination Therapy be used? Treatment should be based on a transdermal NRT patch plus an oral / flexible form of NRT except where the use of a patch is not appropriate and therefore two oral/flexible products can be used. An oral/flexible form of NRT (gum, inhalator, lozenge (including mini lozenge) or mouth spray) is to be used when required. Combination Therapy should be used for 12 weeks and only from the quit date onwards. A patch is used daily during this time and should be used in the same way as if being used in single form. The Stop Smoking Practitioner will assist the client in planning their titration of the oral product, which is likely to be lower than the daily maximum allowance. Dependent upon use, further supplies of the secondary (i.e. oral / flexible) product, may not be required as frequently as every two weeks. Therefore, to avoid product wastage, the client should only be issued with a further supply of the oral/flexible product when necessary, whilst ensuring the client has sufficient supply to support their quit attempt and effectively manage withdrawal symptoms.

19 Page Number Page 19 of Appendix D - Nicotine assisted reduction to stop (NARS) guidance ONLY AVAILABLE WHERE LOCALLY COMMISSIONED REFER TO LOCAL CONTRACT The North 51 Smoking Cessation Standard Treatment Programme is focused upon abrupt quitting however, in some contracts, North 51 is commissioned to also deliver tobacco reduction programmes including Nicotine Assisted Reduction to Stop (NARS). NARS can help clients cut down smoking prior to a quit attempt. However, abrupt cessation support should always be offered as first line treatment prior to a reduction programme. Reduction programmes can either be rapid (up to four weeks prior to a quit date) or gradual (up to 9 months in total). Products that can be used for nicotine assisted reduction: NiQuitin 24hr Patches 21mg, 14mg, 7mg NiQuitin Mini 4mg, 1.5mg Nicorette 16hr Invisi Patch 25mg, 15mg, 10mg Nicorette Gum 6mg, 4mg, 2mg, Nicorette Inhalator 15mg Nicorette Microtab 2mg Nicorette QuickMist Mouth Spray 1mg Nicorette Lozenges 4mg, 2mg Nicotinell 24hr Patches 21mg, 14mg, 7mg Nicotinell Gum 4mg, 2mg Nicotinell Lozenge 2mg, 1mg Research Evidence shows that abrupt cessation results in the highest quit rates, particularly when clients use stop smoking medication and receive behavioural support in combination. However, for some clients a reduction programme has been shown to increase motivation to stop smoking and help smokers gain confidence in their control over their smoking behaviour (Fagerström, et al, 1997). Several studies have investigated the effect of using NRT to cut down prior to a quit date and have concluded this promotes smoking cessation (Landfeld, B et al, 2004).

20 Page Number Page 20 of Appendix E Letter to GP to Request Additional NRT (after 12 weeks) Dear Dr RE: Ongoing supply of NRT As part of the stop smoking service specification, the service is commissioned to supply 12 weeks of NRT for patients who have signed up to a structured behavioural support programme and quit smoking. However, in some cases patients may require additional support to avoid relapse and we refer them back to their GP for continued support. Patient Name Date of Birth Address & Telephone Number Quit Date We have rece ntly supported the above patient to stop smoking. To avoid relapse we recommend an additional supply of NRT as follows: NRT product Flavour Strength Duration (weeks) Thank you for your consideration with this matter. Yours faithfully Name: Job title Telephone no. and address:

21 Page Number Page 21 of Appendix F Letter to Health Care Professional (Drug Interactions starting a quit attempt) Dear The patient named below is currently receiving stop smoking support and has informed me they are (tick as appropriate): Diabetic Prescribed Carbamazepine Prescribed Clozapine Prescribed Benzodiazepines Prescribed Chlorpromazine Prescribed Duloxetine Prescribed Fluphenazine Prescribed Fluvoxamine Prescribed Haloperidol Prescribed Insulin Prescribed Methadone Prescribed Mirtrazapine Prescribed Olanzapine Prescribed Theophylline Prescribed Tricyclic antidepressants Prescribed Warfarin Patient Name Address Telephone Number Date of Birth Under our protocol which enables the direct supply of NRT through our stop smoking service, I am required to inform you of their quit attempt as stopping smoking may necessitate a dose adjustment of their current medication. Yours faithfully Name: Job title Telephone no. and address:

22 Page Number Page 22 of Appendix G Letter to Health Care Professional (drug interactions smoking relapse) Dear I recently informed you that the patient named below was attempting to stop smoking. However, unfortunately on this occasion they have been unsuccessful and returned to smoking. As they are diabetic and/or using one of the medications, listed below I am writing to advise you again, as their relapse back to smoking, may necessitate dose adjustment of their medication or closer monitoring of their condition. (Stop Smoking Practitioner to tick as appropriate) Diabetic Prescribed Carbamazepine Prescribed Clozapine Prescribed Benzodiazepines Prescribed Chlorpromazine Prescribed Duloxetine Prescribed Fluphenazine Prescribed Fluvoxamine Prescribed Haloperidol Prescribed Insulin Prescribed Methadone Prescribed Mirtrazapine Prescribed Olanzapine Prescribed Theophylline Prescribed Tricyclic antidepressants Prescribed Warfarin Patient Name Address Telephone Number Date of Birth Yours faithfully Name: Job title: Telephone no. and address:

23 Page Number Page 23 of Appendix H - Advice sheet of NRT products supplied under this protocol Product Strength Pack Size Two-Week Supply Max/Day Nicorette Invisi Patch 16hr Clear Invisi Patch 10mg 7 patches 2 x boxes (14 patches) 1 Clear Invisi Patch 15mg 7 patches 2 x boxes (14 patches) 1 Clear Invisi Patch 25mg 7 patches 2 x boxes (14 patches) 1 Nicorette - Gum (Fruitfusion Freshmint Freshfruit Icy White Non-flavoured) Chewing gum 2mg 105 pieces 2 x boxes of 105 pieces 15 Chewing gum 4mg 105 pieces 2 x boxes of 105 pieces 15 Chewing gum 6mg 105 pieces 2x boxes of 105 pieces 15 Nicorette Sublingual Tablet Microtab original 2mg 100 tablets 6 x 100 tablets 40 Nicorette Inhalator Inhalator 15mg Pack 36 cartridges Nicorette Nasal Spray Nasal Spray 10ml 1x 200 spray bottle Nicorette Mouth Spray 3 x 36 cartridges 6 cartridges 5 x bottles 64 sprays Quick Mist 13.2ml (1mg) Quick Mist 13.2ml (1mg) Nicorette Lozenge 1 x 150 spray bottle 2 x 150 spray bottles 6 x 150 spray bottles 64 sprays 3 x spray bottles 64 sprays Lozenge 4mg 80 pieces 3 x boxes of 80 pieces 15 Lozenge 2mg 80 pieces 3 x boxes of 80 pieces 15 NiQuitin Patch - 24 hr NiQuitin Patch - 21mg 7 patches 2 x boxes (14 patches) 1 24 hr NiQuitin Patch - 14mg 7 patches 2 x boxes (14 patches) 1 24 hr NiQuitin Patch - 24 hr 7mg 7 patches 2 x boxes (14 patches) 1 NiQuitin Mini Lozenges

24 Page Number Page 24 of 30 Product Strength Pack Size Two-Week Supply Max/Day Mini Lozenge 1.5mg 60 lozenges 4 x 60 pieces 15 Mini Lozenge 4mg 60 lozenges 4 x 60 lozenges 15 Nicotinell Patch - 24hr Skin coloured 21mg 7 patches 2 x boxes (14 patches) 1 Patch Step 1 TTS 30 Skin coloured 14mg 7 patches 2 x boxes (14 patches) 1 Patch Step 2 TTS 20 Skin coloured Patch Step 3 TTS 10 7mg 7 patches 2 x boxes (14 patches) 1 Nicotinell Chewing Gum (Mint Fruit) Chewing gum 4mg 96 pieces 3 x boxes of 96 pieces 15 Chewing gum 2mg 96 pieces 4 x boxes of 96 pieces 25 Nicotinell Lozenge Lozenge 2mg 96 pieces 3 x boxes of 96 pieces 15 Lozenge 1mg 96 pieces 5 x boxes of 96 pieces 30 Please note This is a guidance sheet only and following points should be considered All NRT products should be issued according to this protocol for the direct supply of NRT. Clients will not usually require the suggested 2-week supply of intermittent use products, when being used in combination with a patch. If necessary a Practitioner can use their professional judgement and give weekly supplies of NRT to support monitoring compliance and effectiveness, if there are doubts over compliance or tolerability of products.

25 Page Number Page 25 of Appendix I - Effects of smoking on certain drugs Information and advice regarding the effects of smoking on certain drugs can be found here (page 18) and here.

26 Page Number Page 26 of Appendix J Prescription Exemption categories and proof required Exemption Category Age exempt Full-time Students aged 16, 17 or 18 Patients who have a valid Maternity Exemption Certificate Patients who have a valid Medical Exemption Who is exempt? Proof Required How to Obtain the Required Proof? Children under 16 years of The patient must N/A age and men and women complete an exemption aged 60 years and over declaration. Evidence are entitled to exemption. that could be shown includes a passport, birth certificate, or any other official papers showing the patient s name and date of birth. For children under 16, if the child is obviously under 16, no evidence Must be aged 16, 17 or 18 and in full-time education. Full-time education means you must be receiving fulltime instruction from a recognised educational establishment, such as a school, college or university; therefore, apprenticeships are not eligible. (However, patients may qualify for a HC2 certificate under the NHS Low Income Scheme) Pregnant women and those who have had a baby in the last 12 months get free prescriptions if they have a valid Maternity Exemption Certificate. To claim exemption under this category, it is necessary for the patient is required. Evidence that should be shown is proof of the patient s date of birth (see above) and proof that the patient is a fulltime student (e.g. Student Card or letter from school/college). A patient in receipt of a Maternity Exemption Certificate who has a miscarriage, abortion/termination of pregnancy or stillborn birth is entitled to use their Maternity Exemption Certificate for NHS Prescriptions until the certificate expires. The list of conditions which would entitle a patient to a medical Proof can be obtained from the patient s school, college, university or local education authority (LEA). Patients are required to complete a FW8 form available from GPs, Midwives and health visitors. The GP, Midwife or Health professional is required to sign the form and send it off to the Pricing Authority who will issue the certificate. More information is available on their website. Patients are required to complete a FP92A form which is

27 Page Number Page 27 of 30 Exemption Category Certificate Patients who have a valid Prescription Pre-Payment Certificate (PPC) The patient is named on a current HC2 Who is exempt? Proof Required How to Obtain the Required Proof? to have a valid medical exemption certificate, not simply a medical condition. Anyone can purchase a PPC. Anyone on a low income can apply to get this certificate. exemption certificate can be found in Part XVI of the Drug Tariff. Medical exemption certificates are typically, although not uniformly valid for 5 years. Note: a medical exemption certificate is always required the fact that a patient has one of the qualifying conditions is not sufficient to claim entitlement to exemption from the charge. Appropriate evidence of exemption would be the certificate itself. Note: Patients may backdate their PPC up to one month from the date that they apply. If the patient intends to buy a PPC, they should be asked to pay for their prescription, provided with the FP57 Receipt and advised on how to obtain a refund. (Pharmacies can obtain copies of Form FP95 PPC application leaflet from their local NHS England team). The cost of prescription prepayment certificates is currently for 3 months or for 12 months. Appropriate evidence of exemption would be the certificate itself. Patients available from GP surgeries. The GP is required to sign the form and send it off to the Pricing Authority who will issue the certificate. More information is available on their website. Patients can obtain a prescription prepayment certificate by completing a FP95 form which is available from pharmacies and doctors surgeries. Pharmacies can obtain copies of the FP95 form from their local NHS England team. Alternatively, patients can order a PPC over the telephone with a credit or debit card ( ) or from the NHSBSA website. The Pricing Authority is responsible for issuing Prescription Pre-Payment Certificates. More information is available on their website. Patients may claim for help with health costs under the NHS

28 Page Number Page 28 of 30 Exemption Category Charges Certificate The patient or his/her Partner is entitled to, or named on, a valid NHS Tax Credit (TC) Exemption Certificate The Patient or his/her Partner is receiving Income Support (IS) Who is exempt? Proof Required How to Obtain the Required Proof? who are not entitled to Low Income Scheme help with health costs using the HC1 form, under any other obtainable from category may apply for Jobcentre Plus help under the NHS Office or by calling Low Income Scheme HC1 forms may also be available from the local hospital, dentist, optician or GP surgery. Pharmacies can obtain copies of Form HC1 by calling 3M Supplies on Option 1. The Pricing Authority administer the NHS Low Income Scheme, more information is available on their Not all patients receiving tax credits are entitled to free prescriptions those patients that are entitled are automatically sent an NHS Tax Credit Exemption Certificate by the Pricing Authority. Exemption certificates are sent automatically to eligible patients. Appropriate proof of exemption would be the NHS Tax Credit Exemption Certificate. Note some letters and documents issued by the DWP about income support, while relating to the patient (or their partner) do not show dates of entitlement therefore these are not acceptable evidence. An entitlement letter from the Jobcentre Plus website. Exemption certificates are sent automatically to eligible patients. Patients who are unsure as to whether they are entitled to help with health costs via tax credits, can contact HM Revenue and Customs for support: Patients can speak to their Jobcentre Plus Office.

29 Page Number Page 29 of 30 Exemption Category People Receiving Income-based Jobseeker s Allowance Universal Credit (UC) The Patient or his/her Partner is getting Pension Credit Guarantee Credit (PCGC) The Patient is a War Pensioner holding a War Pension Exemption Who is exempt? Proof Required How to Obtain the Required Proof? Office would be appropriate evidence of exemption. Note there are two types of Jobseeker s Allowance (JSA), income based and contribution based. Only receipt of income based JSA entitles patients to free prescriptions. As part of the government s changes to the benefit system, UC is a new benefit introduced from April Those receiving this benefit will be eligible for free prescriptions. Those in receipt of PCGC. Those holding a War Pension Exemption Certificate. JSA is paid by giro cheque or BACS two weeks in arrears so patients may not have evidence. A letter from the DSS/patient s local Job Centre Plus Office that states their entitlement would be appropriate evidence. The letter must confirm that the patient was entitled to free prescriptions on the date the patient completed the exemption declaration. A valid UC award letter bearing their name (either as the recipient or because they are a partner or child of the recipient) is appropriate proof; they should sign to declare their exemption and will need to tick the box for income based Jobseeker s Allowance. A letter from the DSS/patient s local Job Centre Plus Office would be appropriate proof. The letter must confirm that the patient was entitled to free prescriptions on the date the patient completed the exemption declaration. Appropriate proof of exemption would be a war pension exemption certificate. Patients can speak to their Jobcentre Plus Office. Please see our page on Universal Credit update or further information can be found here. Patients can speak to their Jobcentre Plus Office. Patients can apply for a war pension exemption certificate by writing to The

30 Page Number Page 30 of 30 Exemption Category Certificate and the Prescription is for the Accepted Disablement Employment and Support Allowance (ESA) Prisoners on Release Who is exempt? Proof Required How to Obtain the Required Proof? Veterans Agency, Norcross, Blackpool FY5 3WP. or telephoning Only patients receiving the The patient should be Patients can speak income related strand of able to provide to their Jobcentre ESA will be entitled to free evidence in the form of Plus Office. prescriptions. a DWP award notice. Prisoners on release and those released from secure accommodation (secure accommodation is defined as a court, a secure training centre or a secure children s home) who present an FP10 or FP10 (MDA). The letters HMP, and the prison or secure accommodation address and telephone number must be printed in the box provided for the practice address on the front of the form, along with the prescribing code and the cost centre code for the organisation. N/A