Policies, Procedures, Guidelines and Protocols

Transcription

1 Policies, Procedures, Guidelines and Protocols Title Trust Ref No Local Ref (optional) Main points the document covers Who is the document aimed at? Owner Approved by (Committee/Director) Approval Date 18/7/2016 Initial Equality Impact Screening Full Equality Impact Assessment Lead Director Category Sub Category Document Details Protocol for the Supply of Pharmacotherapy for Smoking Cessation to School Age and Family Nurse Partnership Clients for Help 2 Quit This policy details the protocols required to deliver smoking cessation intervention and nicotine replacement therapy to School Age and Family Nurse Partnership Clients for Help 2 Quit This policy is aimed for the Shropshire School Nursing Team and Family Nurse Partnership Kirsten Ellmore (School Nurse Team Leader) and Sarah Rock (Family Nurse Partnership Supervisor) Approval process Clinical Policies Group Steve Gregory- Director of Nursing and Operations Clinical Review date 18/7/2019 Who the policy will be distributed to Method Required by CQC Required by NHLSA Keywords No Date Amendment 1 June 2016 New Policy Distribution Shropshire School Nurse Team and Family Nurse Partnership Dissemination via Datix alerts to managers and available to all staff via the trust website. Document Links H2Q, Help to Quit, smoking, stop smoking, NRT, Nicotine Replacement Therapy, smoking cessation, Amendments History

2 Shropshire Community Health NHS Trust Contents 1 Introduction 2 2 Purpose 2 3 Definitions 2 4 Duties Directors and Managers 2 5 Protocol for the Supply of Pharmacotherapy for Smoking Cessation to School Age and Family Nurse Practitioner Clients for Help 2 Quit 3 6 Flow Chart of Activity 4 7 Giving Clients Choice 4 8 Safe Storage of Nicotine Replacement Therapy 4 9 Criteria for Inclusion 5 10 Nicotine Replacement Therapy 5 11 Record Keeping 5 12 Consultation 5 13 Dissemination and Implementation 5 14 Training 6 15 Review 6 16 Monitoring Compliance 6 17 References 6 18 Associated Documents 7 Appendix 1: Protocol for the Supply of Pharmacotherapy for Smoking Cessation in Help2Quit Error! Bookmark not defined. Protocol for Smoking Cessation H2Q Page 1 Datix July 2016

3 Shropshire Community Health NHS Trust 1 Introduction Shropshire Community Health Trust School Nurses and Family Nurse Partnership (FNP) provide smoking cessation services according to the Help2Quit pathway as part of the Help2Changes service. The Trust provides services appropriate to the age and location of our service users, delivering alternative service provision, to support existing provider, (Help 2 Change) to maximize reach of difficult to engage clients. This document must be read in conjunction with the Protocol for the supply of pharmacotherapy for smoking cessation in Help2Quit (Appendix 1) and outlines the areas where our service provision differs. This document authorises and sets out the conditions under which pharmacotherapy can be supplied to service users of Help2Quit, by named individuals working for Help2Quit and organisations contracted by them to provide Stop Smoking Services under this Protocol. This service is an additional Service Level Agreement between Help2Change and School Nurse Service and Family Nurse Partnership. 2 Purpose To safely deliver smoking cessation services to school age children and FNP clients To outline where service delivery to these clients differs from existing Help2 Change service 3 Definitions NRT NCSCT CO monitoring FNP H2Q SN SLA GP Nicotine Replacement Therapy National Centre for Smoking Cessation and Training Carbon Monoxide monitoring Family Nurse Partnership Help2Quit School Nurse Service level agreement General Practitioner 4 Duties 4.1 Directors and Managers Directors and Managers of Services are responsible for ensuring the safe and effective delivery of services they manage; this includes securing and directing resources to support the implementation of this best practice guidance protocol. They must ensure that: All staff must be made aware of and have access to this protocol Protocol for Smoking Cessation H2Q Page 2 Datix July 2016

4 Shropshire Community Health NHS Trust Staff authorised to supply Nicotine Replacement Therapy under Service Level Agreement with Help2Change must have NCSCT stop smoking practitioner training and have completed Help2Quit Local Training 5 Protocol for the Supply of Pharmacotherapy for Smoking Cessation to School Age and Family Nurse Practitioner Clients for Help 2 Quit Pharmacotherapy is offered in line with the Protocol for the supply of pharmacotherapy for smoking cessation in Help2Quit. The service utilises a number of treatment routes to make access and compliance as easy as possible. All products currently licensed as stop smoking medicines (Nicotine Replacement Therapy [NRT], Bupropion and Varenicline) are made available as first-line treatments unless clinically contraindicated. Bupropion and Varenicline is prescribed via the General Practitioner (GP), so any young person eligible and requesting this treatment option will be signposted to the GP, these treatment options would not be given or recommended by the school nursing service or family nurse partnership. Before prescribing a treatment, service users will be informed of the use, action, side effects, cautions, consideration and efficacy of all available treatments. The individual s preference, previous experience and medical history are taken into account when discussing medications. The service will provide, and manage NRT according to the attached Appendix 1. The service will provide NRT through direct supply for service users exempt from paying a prescription fee, simplifying access to the service by removing the need to visit a pharmacy. Service users required to pay a prescription fee (as deemed necessary by the Department of Health and NHS Business Services Authority) will be offered a voucher, please see Appendix 1, redeemable at all local pharmacies. Help2Quit will continue to work with all pharmacies and the Local Pharmaceutical Committee to ensure a seamless service for service users. Permission is sought from the service users GP, specialist or consultant where a caution is identified. Help2Quit has an annual contract for direct supply of NRT products, attracting discounts for bulk purchases over the contractual period. NRT products are supplied to each advisor who keeps a locked supply for use at specific venues. Where transportation of NRT is needed, it is kept in a locked case, in a locked vehicle out of sight. No medication is left in a vehicle parked overnight. The service has an audit trail set up to monitor the route of all NRT thought the service. Training and mentoring is in place for advisors as well as continuing update and education run at 6 monthly intervals. Protocol for Smoking Cessation H2Q Page 3 Datix July 2016

5 Shropshire Community Health NHS Trust 6 Flow Chart of Activity The flowchart below outlines the process for Smoking Cessation support. Help 2 Quit provides training to Advisors so they can follow the protocol to provide Nicotine Replacement Therapy Directly to clients. Help 2 Quit Advisor will, assess nicotine dependence, readiness to quit and ensure inclusion criteria for the Stop Smoking Service is met and explain all pharmacotherapy options to the client. Help 2 Quit Advisor will complete a Pharmacotherapy assessment for each client and apply relevant actions i.e. GP notification Help 2 Quit Advisor will issue direct supply of Nicotine Replacement Therapy free to the client. OR Help 2 Quit Advisor will issue a voucher to be redeemed at the Pharmacy, which will incur prescription charges. This voucher will need to be returned to Help 2 Quit for reimbursement. OR Signpost to the GP for consideration if Varenicline or Bupropion are requested. 7 Giving Clients Choice Clients will be offered this service as part of existing contacts, however they may also be offered alternative service delivery as appropriate across Shropshire. Clients must be given the choice of medications and decide with the advisor which one is best for them. 8 Safe Storage of Nicotine Replacement Therapy All Nicotine Replacement Therapy (NRT) products MUST be: Kept out of the reach of children and animals Be transported to school settings in a lockable container If transported by car, must be in a locked boot out of sight. All NRT to be kept in a locked cabinet as per medicines management policy Protocol for Smoking Cessation H2Q Page 4 Datix July 2016

6 Shropshire Community Health NHS Trust 9 Criteria for Inclusion Current smokers of tobacco products Tobacco users receiving support from Help2Quit Before medication is supplied, the client must first set a quit date. Practitioners to signpost to GP if under client is 12 years of age or meets exclusion criteria as outlined in Appendix 1. GP s are informed of NRT prescriptions and ongoing support via Help2Change 10 Nicotine Replacement Therapy Indications and dose: School Nurses NicQuitin fresh mint 2mg (medicated chewing gum) Nicorette 15mg Inhalator NicQuitin 2mg lozenge NicQuitin Transdermal patch 25mg, 15mg and 10mg/ 16hour Family Nurse Practitioners NicQuitin fresh mint 2mg medicated chewing gum Nicorette 15mg Inhalator NicQuitin 2mg lozenge NicQuitin Transdermal patch25mg, 15mg,10mg / 16 hour NicQuitin Transdermal patch 21mg, 14mg, 7 mg /24 hour Nicorette 500 micrograms/dose nasal spray Niquitin 2.5mg orodispersible film Link: British National Formulary nicotine.htm?q=nicotine%20replacement%20therapy&t=search&ss=text&tot=2& p=1#php46773-indications-and-dose 11 Record Keeping Copies of any documentation used to deliver this Protocol services should be kept in the relevant client records. Original documentation is sent to Help2Change for entering into their clinical system (EMIS). 12 Consultation The Policy has been developed in conjunction with Help2Change Clinical Lead, Pat Thomas; School Nurse Team Leader, Kirsten Ellmore; and Family Nurse Partnership Supervisor, Sarah Rock. 13 Dissemination and Implementation This Protocol will be disseminated via Datix alerts to managers and will be available to all staff via the trust website. Protocol for Smoking Cessation H2Q Page 5 Datix July 2016

7 Shropshire Community Health NHS Trust 14 Training The following training is available and all staff are to complete: The National Centre for Smoking Cessation and Training online course and received 1 day face-to-face training delivered by Help2Change, with optional shadowing of existing practitioners The Yearly update, delivered by Help2Change. This Protocol and the Protocol for the supply of pharmacotherapy for smoking cessation in Help2Quit (Appendix 1) will be available to all trained staff following training to support safe delivery along with a service specific standard operating procedure. 15 Review This protocol will be reviewed in two years or earlier if subjected to any changes in legislation, codes of practice or good working practice. The review will be carried out by the School Nurse Team Leader and the Family Nurse Partnership Supervisor in consultation with specialist staff from Help2Change. 16 Monitoring Compliance All monitoring paperwork is as per Help2Change Protocol for the supply of pharmacotherapy for smoking cessation in Help2Quit - Appendix References Relevant guidance: Public Health England, Local Stop Smoking Services: Service and delivery guidance 2014 National Institute of Clinical Excellence. Technology Appraisal Guidance No 39. Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. London, March Pharmacy Healthcare Scheme. Sample patient group direction and service specification for the supply of nicotine replacement therapy through pharmacies. London, June Pharmacy Healthcare Scheme. Improving access to smoking cessation therapies by using patient group directions. London, January, West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals. An update Thorax (2000), 55: 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, Protocol for Smoking Cessation H2Q Page 6 Datix July 2016

8 Shropshire Community Health NHS Trust 18 Associated Documents The following Trust documents contain information that relates to this procedure: Medicines Policy Service Level agreement through schools (School Nurse Service only) Nicotine Replacement Therapy assessment form Consent to Examination or Treatment Policy Protocol for Smoking Cessation H2Q Page 7 Datix July 2016

9 Shropshire Public Health Operating Procedure Stop Smoking Services April 2016 This document provides a framework for the delivery of stop smoking services in Shropshire County. Guidance relating to referrals and treatment are based on NICE guidelines. All providers engaged in delivery of stop smoking services in Shropshire County are required to operate to this procedural framework. Any changes to this Operating Procedure must be agreed with Help2Change. Help2Change retains the right to amend and update this Operating Procedure in light of local and national evidence of best practice. For all queries relating to this Operating Procedure, please contact Help2Change on

10 Table of Contents INTRODUCTION... 3 HELP2QUIT SERVICE DESCRIPTION... 3 Referral criteria... 3 Referral route... 4 Exclusion criteria... 4 Response time & detail and prioritisation... 4 Discharge Criteria... 4 Help2Quit outline service model... 4 Training requirements... 5 Data requirements... 6 Equipment use... 6 Pharmacotherapy... 7 Electronic cigarettes... 7 Delivery location and days/hours of operation... 7 Service outcomes... 7 APPENDIX 1 - Service Delivery Options... 8 APPENDIX 4 - Pharmacotherapy APPENDIX 5 - Establishing smoking status APPENDIX 6 - HELP2CHANGE SERVICE USER SATISFACTION SURVEY

11 INTRODUCTION This framework is intended to provide guidance and consistency in the delivery of Stop Smoking Services (known as Help2Quit) in Shropshire County. Smoking is the leading cause of death and illness in the UK. Smoking can contribute towards the development of many diseases, but is most commonly linked with coronary heart disease, stroke, lung cancer, asthma and chronic obstructive pulmonary disease. It is estimated that there are almost 37,500 smokers in Shropshire aged 18 years or above. For those who smoke, quitting is often the single most effective method of improving health and preventing illness. Evidence-based Stop Smoking Services are highly effective in both cost and clinical terms. This evidence base is summarised in the: National Institute for Clinical Excellence (NICE) Public Health Guidance 10 - Smoking Cessation Services Department of Health s (DH) Stop Smoking Service Delivery and Monitoring Guidance ( Smoking is also a key driver of health inequalities. Smoking prevalence is highest in deprived communities. Reducing the prevalence of smoking among these communities will help reduce health inequalities more than any other measure to improve the public's health. A high level of intervention is vital to deliver effective, cross-social group reach on this, the biggest single public health issue. HELP2QUIT SERVICE DESCRIPTION The purpose of stop smoking services is to reduce the number of smokers by providing evidencebased treatment and behavioural support to smokers making quit attempts. The delivery of the service will reduce levels of smoking-related illness, disability, premature death, and health inequality. Services are offered free at point of use and will be delivered in-line with the most recent best practice recommendations for stop smoking services issued by the National Institute for Health and Care Excellence (NICE) and the Department of Health (DH) and the Service Delivery Options outlined in Appendix 1. The objectives are to provide a stop smoking support service that: is equitably accessible to all smokers supports people to successfully quit smoking offers the most effective, evidence-based treatments available achieves high levels of Service User satisfaction Referral criteria To be eligible for the service check that the Service User is: resident in Shropshire &/or registered with GP in Shropshire; would like to stop smoking and receive support; is not receiving stop smoking support from another Provider; is a current smoker of a tobacco product; age 12 years Where a service user meets all other eligibility criteria but is neither registered with any GP nor has a fixed abode, or is aged under 12, please seek prior approval from Help2Change to provide a stop smoking service. 3

12 Referral route There are three methods by which patients can access the service: Referral - Service Users can be referred to the service by a healthcare professional such as a GP, practice nurse, community nurse or a hospital consultant Self-Referral - Service Users can access the service directly in response to general information and publicity about available services Recruitment service users can be actively recruited into the service Service user consent must be obtained including consent to signing up to the support programme and the sharing of Service User details with, and being contacted by, other organisations directly related to service provision (Shropdoc and Help2Change). Exclusion criteria People who do not meet the eligibility criteria and are not eligible to access the service. If you have concerns about the suitability of a Service User that has been referred to the service, please seek agreement from Help2Change before refusing to provide the service. Response time & detail and prioritisation Service Users must be contacted within 48 hours of receipt of the enquiry or referral and offered an appointment within 2 weeks of first contact. A 'freephone' or local rate contact number should be provided to Service Users. This must be appropriately staffed or regularly checked so that Service Users are not waiting for long periods for a response. Stop smoking advisors may need to be in telephone contact with Service User and will need regular access to either mobile or landline telephones. Many smokers will need to make multiple attempts to quit before achieving long-term success. However, the stop smoking service advisor should use discretion and professional judgement when considering whether a client is ready to receive support to immediately attempt to stop again. If this is the case, the client must start a new treatment episode, i.e. attend one session of a structured, multi-session intervention, consent to treatment and set a quit date with a stop smoking advisor, in order to be counted as a new quit attempt on a new monitoring form. Service Users can be recruited up to 3 times during a 12 month period, after which approval for a repeat attempt must be sought from Help2Change. Discharge criteria Service Users who fail to attend sessions will be discharged after 3 failed contacts and will be notified accordingly. Service Users will be discharged from the service when one of the following occurs; A referred Service User is found not to be eligible for the service The Service User completes the 12 week programme and successfully stops smoking The Service User completes the 12 week programme but does not stop smoking The Service User informs the Provider that he/she no longer wishes to receive the service The Provider attempts to contact a Service User on 3 separate occasions but fails to make contact with the Service User All service users, including those lost to follow up, should be read coded and recorded on the appropriate electronic systems. Help2Quit outline service model Stop smoking services are time-limited interventions to support people who smoke to successfully and permanently stop smoking. The core elements of the service (Appendix 1) are the provision of 4

13 behavioural support and pharmacotherapy to a large number of smokers, working closely with all GP practices in Shropshire. Service delivery models should be consistent with the following framework: Service User referred or recruited into the services Service User s eligibility checked Service User sets a quit date (this is the date that the service user plans to stop smoking altogether with support from the service for definitions see the DH Stop Smoking Service Delivery and Monitoring Guidance) Provider assesses nicotine dependence (Appendix 2) Service User receives behavioural support (Appendix 3) and pharmacotherapy (Appendix 4) from the provider Services User s smoking status checked at 4 week & 12 weeks (Appendix 5) o o 4 week smoking status must be established between 25 and 42 days after the agreed quit date (at least 85% quitters carbon monoxide verified; 35% quit rate) 12 week smoking status must be established between 79 and 105 days after the agreed quit date (at least 85% quitters carbon monoxide verified). The components of a structured individual face to face smoking cessation intervention are detailed in the Help2Quit training course booklet and the Standard Treatment Programme published by the National Centre for Smoking Cessation and Training (NCSCT) ( To ensure effective monitoring, Service User compliance and ongoing access to medication, all interventions should be multi-sessional with a total potential Service User contact time of: 1.5 hours (from pre-quit preparation to four weeks after quitting) and 1.5 hours between 4 weeks and 3 months Interventions should offer weekly support for at least the first four weeks following the quit date, the first appointment being 30 minutes, subsequent face to face appointments 15 minutes. Proactive follow up (including text messaging and telephone support) should be conducted to reduce lost to follow up and increase quit rates. Appointments should be scheduled when Service Users are booked into treatment. Stop smoking advisers should show empathy for their Service User and adopt a motivational approach. Service user confidentiality should be respected at all times. Prior to treatment, the Service User should be informed of all available (evidence-based) treatment options both locally and nationally. There should be a strong emphasis on verifying the smoking status of 4 week and 12 week quitters using biochemical markers (Appendix 5). Training requirements Client interventions must be delivered by a stop smoking advisor who has received stop smoking service training that meets NCSCT standards for one-to-one and/or group support ( All advisors delivering stop smoking interventions must attend and complete the following training (provided and/or facilitated by Help2Change): NCSCT training Face to face behavioural support training Face to face smoking in pregnancy behavioural support training if any pregnant Service Users are recruited 5

14 Face to face pharmacotherapy training Other specialist NCSCT training modules should be completed as developed All advisors should then receive the following support: Observe an experienced practitioner to deliver behavioural support to a number of clients at various points in the quit cycle. An experienced practitioner can be someone, in agreement with Help2Change, who is confident and competent in supporting clients and is involved in current practice; Be observed by an experienced practitioner; Receive regular supervision; Attend to their continuing professional development; See enough Service Users (minimum of 20 a year) to maintain their skills and knowledge. Staff delivering rolling groups or drop-ins should be trained to NCSCT standards and such interventions should be delivered or supervised by experienced specialists with sufficient expertise to support quitters at different stages of the quitting process simultaneously. The provider will deliver to Making Every Contact Count (MECC) principles, ensuring staff have the appropriate skills and knowledge to give brief opportunistic advice to service users as appropriate, and support them to adopt healthy lifestyles. For information on delivering or advising on other lifestyle services please refer to the standard operating procedures for Weight Management Services, Physical Activity or NHS Health Check. Data requirements All data must be recorded in full using agreed EMIS Web template provided by Shropdoc to ensure accurate read coding. All data must be auditable and payment is conditional on receipt of accurate and full data reporting for all service users formally entered into the service. Patients declining referral should also be recorded. All Service Users setting a quit date must be provided with a service user satisfaction questionnaire within 4 weeks of the service end date (available on the EMIS template - see Appendix 6). Paper copies can be obtained from Help2Change and should be returned to Help2Change on a quarterly basis. All service user records must be securely stored. Equipment use Equipment necessary for the delivery of the stop smoking service, as detailed below, will be provided by, and remain the property, of Help2Change: Carbon monoxide (CO) monitor CO monitor mouthpieces All equipment should be fully functional, used regularly, CE marked, validated, maintained and recalibrated according to the manufacturer s instructions (see Appendix 5). Recalibration of equipment is the responsibility of the service provider. All equipment checks and maintenance should be documented and auditable. Local service awareness initiatives should be agreed with Help2Change and be integrated with local, regional and national campaigns, using locally branded materials to help smokers identify with local support services and thereby promote self-referrals. Additional promotional resources and support may be provided by Help2Change on request. 6

15 Pharmacotherapy Pharmacotherapy is the provision of pharmaceutical products, medicines or medicaments. Service Users must be offered all types and forms of stop smoking medication pharmacotherapy (Appendix 4). Combining behavioural support with pharmacotherapy increases a smoker's chances of successfully stopping by up to four times. The only types of stop smoking medications currently approved by NICE are: Nicotine replacement therapy (NRT), bupropion (Zyban ) and varenicline (Champix ). NRT is available in several forms - patch, gum, lozenge, microtab, nasal spray, mouthspray and inhalator. Following assessment, NRT should be issued according to the Help2Quit NRT protocol through the Help2Quit voucher scheme or via direct supply (see Appendix 4). Varenicline and bupropion checklists should be completed prior to the product being requested from the Service Users GP on prescription (see initial client assessment and sample request letters in the protocol in Appendix 4). Any other MHRA licensed products may only be offered with consent from the commissioner. Electronic cigarettes E-cigarettes are devices that deliver nicotine within an inhalable aerosol by heating a solution that typically contains nicotine, propylene glycol and/or glycerol, plus flavours. Whilst it is generally acknowledged that e-cigarettes are considerably safer than smoking, they are not entirely without harm. Public Health England recommends that stop smoking services should offer support to people who are using e-cigarettes in a quit attempt. Help2Quit welcomes clients into the service who wish to use their own, self-funded e-cigarette though continues to recommend the use of licensed stop smoking medications (NRT, bupropion and varenicline) as first-line treatments, unless clinically contraindicated. Delivery location and days/hours of operation The service will be readily accessible and suitable for eligible Service Users. The opening times of the service can be determined by the Provider and will respond to service user demand for out of hours services. Service outcomes The following quality service outcome indicators should be met: 35% 4-week quit rate (percentage of service users setting a quit date who have successfully quit at 4 week follow-up) 85% of 4 & 12 week quitters to be CO validated At least 90% of service users responding to the satisfaction survey must report that they were satisfied with the service. 7

16 APPENDIX 1 - Service Delivery Options Assessing nicotine dependence Behavioural support Pharmacotherapy Establishing smoking status Other service components Must offer at least one of; at least one of; at least one of; at least one of; May offer Quantitative approach Heaviness of smoking index Objective approach One-to-one support Closed group support Proactive telephone outreach any of: NRT Products: Combination therapy (NRT) Varenicline Bupropion any of: Carbonmonoxide Cotinine any of; Reactive telephone support Preloading / nicotine-assisted reduction to quit Self report (maximum of 15% of cases) May offer with agreement from Help2Change Must not offer any of Open (rolling) group support Drop-in support Text (SMS) support On-line support any of: any of: any of: Lung function / spirometry any of: Relapse prevention Exercise any of: Allen Carr method Anxiolytics (e.g diazepam) Nicobrevin NicoBloc St John's wort Glucose Lobeline Hypnosis Acupuncture, acupressure, laser therapy and electrostimulation 8

17 APPENDIX 2 - Assessing nicotine dependence Assessing nicotine dependence is the process by which a the extent to which Service Users are addicted to tobacco products can be established. The nicotine dependence of all Service Users must be assessed using at least one of the following three approaches; Quantitative approach Heaviness of smoking index Objective approach Quantitative approach: Tailoring stop smoking support for an individual starts with assessing their dependence on nicotine, as this will have a bearing on the severity of the withdrawal symptoms they may experience, and therefore the intensity of support they require. It may also be used to indicate the most appropriate medication. The Fagerström test for nicotine dependence (FTND) provides a quantitative measure and is the most widely used. It consists of six questions. The higher a client scores, the greater their nicotine dependency. Heaviness of Smoking index: The two most important indicators of dependence, however, are considered to be: 'How soon after you wake do you smoke your first cigarette?' and 'How many cigarettes per day do you smoke?' It is therefore deemed adequate to use just these two questions as a shortened version of the FTND. Cigarette consumption alone is not a good indicator of dependence, as it does not take into account the different ways people smoke their cigarettes. This may be particularly true for smokers who cut down the number they smoke but continue to get the same amount of nicotine from their reduced number of cigarettes by taking deeper and more frequent puffs, smoking more of each cigarette or blocking the vent holes. Objective approach: Objective biochemical validation methods such as cotinine assessment can also be used to assess nicotine dependency by measuring the quantity of nicotine metabolites present. CO testing measures smoke intake and provides an immediate and cheaper alternative to cotinine testing 9

18 APPENDIX 3 - Behavioural support Behavioural support consists of advice, discussion and exercises provided face-to-face (individually or in groups). It can also be delivered by telephone. It aims to make a quit attempt successful by: setting quit date helping clients escape from or cope with urges to smoke and withdrawal symptoms maximising the motivation to remain abstinent and achieve the goal of permanent cessation boosting self-confidence maximising self-control optimising use of pharmacotherapy advice to change routine All Service Users must be offered at least one of the following types of behavioural support: One-to-one support Closed group support Proactive telephone support One-to-One Support: This is an intervention between a single stop smoking adviser and a single smoker, at a specified time and place. It is usually delivered face-to-face. Closed group Support: A face-to-face intervention facilitated by a stop smoking adviser/s, with a number of smokers at a specified time and place. For example, a group may be held once a week, over a specific number of weeks, e.g. every Tuesday evening from 7.00pm to 8.00pm for six to seven weeks. To account for diminishing client returns, a minimum of eight members is recommended. Proactive telephone support: This intervention should be delivered by stop smoking advisers and follow the same specification as one-to-one support. It should begin and end with a faceto-face session for CO validation and access to stop smoking pharmacotherapy on prescription should be available throughout the treatment episode. All proactive telephone interventions should have a total potential contact time with the client of a minimum of 1.5 hours duration (from pre-quit preparation to the four-week post-quit period). This is to ensure regular monitoring, client compliance and continual access to pharmacotherapy. A minimum of 10 interventions in a 12-week period is recommended with a minimum of 10 minutes per intervention, apart from the first session, which will need to be longer to allow for assessment and planning. In addition, any of the following types of behavioural support may be offered: Reactive telephone support On-line support Reactive telephone support: Ongoing support following the four-week quit date may be provided over the telephone as part of a relapse prevention strategy. Only stop smoking advisers should deliver this intervention. Online Support: A rapid review of the evidence in this area concluded that online support for smoking cessation can be acceptable to users and is of superior efficacy to other wide-reach interventions and of similar efficacy to face-to-face interventions. However, more research is needed to determine how effective purpose-built, interactive, web-based stop smoking 10

19 programmes are compared with websites that present simple advice on quitting smoking. Wherever possible, Providers of online smoking cessation interventions need to replicate standard outcome measures. This would mean developing innovative ways of biochemically verifying self-reported abstinence at the four-week mark. In addition, with the prior agreement of Help2Change, any of the following types of behavioural support may be offered: Open (rolling) group support Drop-in support Text (SMS) support Online support Open (rolling) group support: A face-to-face intervention facilitated by a stop smoking adviser/s, with a number of smokers at a specified time and place. Drop-in Support: A face-to-face intervention provided at a specified venue or selection of venues at an unallocated time (although it could be a specified time slot, e.g. between 10.00am and 12.00pm). The service is provided by an individual stop smoking adviser with an individual smoker within the wider confines of an open access service. Once the smoker has set a quit date and consents to treatment it is important that they are offered and encouraged to receive weekly support sessions for behavioural support, carbon monoxide (CO) monitoring and to check compliance with medication. While venues and appointment times can be flexible, the client must be advised to attend regularly to get the maximum benefit. Text (SMS) support: There is currently insufficient evidence to demonstrate the efficacy of text support as the main intervention type. However, text may prove useful as part of a wider support programme or as a way of recruiting smokers to the service, reminding them of appointment times or providing ongoing reactive support. Online Support: A rapid review of the evidence in this area concluded that online support for smoking cessation can be acceptable to users and is of superior efficacy to other wide-reach interventions and of similar efficacy to face-to-face interventions. However, more research is needed to determine how effective purpose-built, interactive, web-based stop smoking programmes are compared with websites that present simple advice on quitting smoking. Wherever possible, Providers of online smoking cessation interventions need to replicate standard outcome measures. This would mean developing innovative ways of biochemically verifying self-reported abstinence at the four-week mark. The following types of behavioural support must not be offered (please note that this list is not exhaustive): Allen Carr method - RCT data is required to assess true efficacy. 11

20 APPENDIX 4 Pharmacotherapy Protocol for the Supply of Pharmacotherapy for Smoking Cessation by Help 2 Quit Document Control Document name Protocol for the supply of Pharmacotherapy by Help 2 Quit Date authorised 20 April 2015 Valid from 01 April 2015 Planned review dates 31 March March 2017 Contact details for enquiries Pat Thomas Help2Change Clinical Lead Help2Change Longbow House, Longbow Close Shrewsbury, SY1 3GZ Tel: (01743) patricia.thomas@help2changeshropshire.nhs.uk 12

21 Authorisation This protocol has been reviewed by; 13

22 Overview This document authorises and sets out the conditions under which pharmacotherapy can be supplied to service users of Help 2 Quit, by named individuals working for Help 2 Quit and organisations contracted by them to provide Stop Smoking Services under this Protocol. Relevant guidance Public Health England, Local Stop Smoking Services: Service and delivery guidance 2014 National Institute of Clinical Excellence. Technology Appraisal Guidance No 39. Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. London, March Pharmacy Healthcare Scheme. Sample patient group direction and service specification for the supply of nicotine replacement therapy through pharmacies. London, June Pharmacy Healthcare Scheme. Improving access to smoking cessation therapies by using patient group directions. London, January, West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals. An update Thorax (2000), 55: 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,

23 Flow Chart of Activity Help 2 Quit provides training to Advisors so they can follow the protocol to provide Nicotine Replacement Therapy Directly to clients. Help 2 Quit Advisor will, after assessing nicotine dependence, readiness to quit and ensuring inclusion criteria for the Stop Smoking Service, explain all pharmacotherapy options to the client. Help 2 Quit Advisor will complete a Pharmacotherapy Assessment for each client who requests Nicotine Replacement Therapy and apply relevant actions i.e. GP notification. Help 2 Quit Advisor will issue direct supply of Nicotine Replacement Therapy free to the client. OR Help 2 Quit Advisor will issue a voucher to be redeemed at the Pharmacy, which will incur prescription charges. This voucher will need to be returned to Help 2 Quit for reimbursement. 15

24 1 Scope and Focus 1.1 Name of authorising body Help2Change 1.2 Description of medicine Nicotine Replacement Therapy 1.3 Legal classification GSL (General Sales List) 1.6 Supply outside the Summary of Product Characteristics (SPC) There is widespread professional recognition that NRT products are much less harmful than tobacco smoking. Shropshire authorises the supply of NRT outside the licence specifications to groups where continued smoking might cause considerable harm to themselves or others, or where combinations of NRT products or extended periods of treatment with NRT might be necessary. The supply of NRT is authorised in the following circumstances outside the SPCs; Patients from 12 years Pregnant or breastfeeding women Patients with stable CVD who have not experienced an acute cardio-vascular event requiring treatment in the last 4 weeks Patients that have experienced an acute cardio-vascular event in the last 4 weeks with a recommendation from the consultant or GP for NRT treatment. In combination with other NRT products (see appendix C) 1.7 Period 1 April 2015 to 31 March

25 2 Clinical Indication 2.1 Indication / definition Current smokers of tobacco products 2.2 Criteria for inclusion 2.3 Criteria for exclusion Tobacco users receiving support from Help 2 Quit. Before Nicotine Replacement Therapy is supplied, the client must first set a quit date. Clients aged under 12 years. Clients who have experienced an acute cardio-vascular event in the last 4 weeks without a written recommendation from the consultant/gp 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). 2.4 Criteria for seeking advice of a Consultant / GP When the following criteria apply, further advice should be sought from Consultant /GP and documented in the client record. There is doubt about whether an exclusion criteria applies Clients below the age of 12 years Clients who have experienced an acute cardio-vascular event in the last 4 weeks (unstable angina, heart attack or stroke) Clients with a moderate or severe liver impairment. Clients with severe kidney impairment. Clients with uncontrolled diabetes. Clients with active stomach ulcer Patients with uncontrolled Hyperthyroidism 2.5 Criteria for notification to GP / Consultant Smoking cessation, with or without nicotine replacement therapy, may alter the effects of certain other medications (listed below) which may require dose adjustment. Advisors must notify GP / prescriber to ensure any required alterations to dosage are made by the prescriber and are being monitored. This can be by letter, phone, inputting direct into surgery database or in person but must be documented in the client health record. If relapse occurs and the client starts to smoke again then the advisor must inform the prescriber. Letter template see appendix F 17

26 Insulin: If a client with insulin dependent diabetes stops smoking, their dose of insulin may need to be reduced. Advise patient to be alert for signs of hypoglycaemia and test their blood glucose more frequently. Theophylline: Smokers need higher doses of Theophylline than non smokers due to Theophylline shortened half life and increased elimination. Some reports suggest smokers may need twice the normal dose. GP needs to monitor plasma Theophylline concentrations and adjust dose accordingly. Warfarin: If a patient taking Warfarin stops smoking their International Normalised ratio (INR) might increase. Advise clients to see Practice Nurse for INR check, to add NRT on anticoagulation card as a new medicine, and watch out for signs of over coagulation. Clients should amend NRT doses on anticoagulation card along treatment path way. Clozapine: Tobacco smoking increases the metabolism of Clozapine. Smoking cessation can cause their blood levels of Clozapine to rise. The Nurse/ Pharmacist should notify the Clozapine team. See appendix G Chlorpromazine: Reports of increased adverse effects and increased plasma levels after stopping abruptly. Advise clients to be alert for increased adverse effects e.g. dizziness, sedation, extra-pyramidal symptoms. If adverse effects occur prescriber will need to reduce dose as necessary. Olanzapine: There have been case reports of adverse effects in patients when they have stopped smoking. Advise clients to be alert for adverse affects e.g. dizziness, sedation and hypotension. If adverse effects occur prescriber will need to reduce dose as necessary. Methadone: There has been a case report of respiratory insufficiency and altered mental status when a patient taking methadone for analgesia stopped smoking. Advise client to be alert for signs of opioid toxicity. If adverse effects occur prescriber will need to reduce dose as necessary Ref DH Guidance 2011/12 Local stop smoking services & Medicines Q&As/ UKMi Q&A Which medicines need dose adjustment when a patient stops smoking? 18

27 3 Treatment 3.1 Treatment program A weekly / fortnightly supply is provided after review and carbon monoxide verification of being smoke free. Treatments last for up to 12 weeks. Weekly visits are preferable during this treatment phase, but can be negotiated for example where people are working shifts. Mono Therapy Mono therapy is one Nicotine Replacement Therapy product as directed up to the maximum dose, see appendix B. Combination Therapy Combination therapy is a patch with one other oral product used to top up as necessary. They should not use the full quantity of oral product as it is a secondary product. The client should only be issued with a further supply of the oral product when necessary, to avoid product wastage or overdose. See Appendix C Side effects from Nicotine Replacement Therapy are usually transient but may include the following, some of which are a consequence of stopping smoking; nausea dizziness headaches cold and flu-like symptoms palpitations indigestion, heart burn, wind, constipation or diarrhoea. hiccups sleep disturbance vivid dreams muscular pain chest pain blood pressure changes anxiety and irritability drowsiness and impaired concentration See appendix A for NRT dose, administration method, and product-specific side effects. 19

28 3.2 Advice to patient Advice to patients 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 possible side effects the effects of smoking tobacco whilst using NRT written information on products supplied, self-help leaflets and where to obtain more information prescription charges and exemptions 3.3 Informed consent Client information relating to the supply of NRT under the protocol may be passed to other health service organisations, for example, a client's GP and Commissioners, for a variety of purposes such as audit or payment. The client's informed consent must be obtained before information can be passed on and is collected as part of the data set required by Help 2 Quit. For Under 16 s use specific consent form, see appendix E 3.4 Clinical pathway The supply of nicotine replacement therapy under this protocol should only take place as part of the delivery of a comprehensive stop smoking service delivered by an organisation contracted by Shropshire to deliver stop smoking services. 3.5 Site of Treatment Supply of NRT should be carried out in suitable premises with facilities for private consultations where necessary. 4 Staff Characteristics 4.1 Special qualifications / experience and competence considered necessary and relevant 4.2 Requirements for continuing training and education for staff 4.3 Names of staff authorised to supply products under this protocol. Staff authorised to supply Nicotine Replacement Therapy under this protocol must have: NCSCT stop smoking practitioner training Completed Help 2 Quit level 2 Local Training Be competent to follow and administer the Protocol showing a clear understanding of drug administered including side effects and contraindications. All staff authorised to supply Nicotine Replacement Therapy under this protocol are required to attend yearly update training as required by Help 2 Quit. Will be kept on record at Help 2 Quit, available to commissioners on request. 20

29 5 Records and Audit 5.1 Details of records to be kept 5.2 Safe storage of NRT 5.3 Giving clients choice The following records should be kept for all products supplied under this Protocol. Name of client Date of birth of patient Address of client Completed pharmacotherapy assessment form see appendix G Name of product(s) supplied Quantity and dosage of product supplied Date of supply Signature of Nurse /Pharmacist /Advisor issuing voucher Completed Help 2 Quit Voucher This information will be recorded on the Help 2 Quit voucher (see appendix H) and directly onto the client health record or in patient notes until inputted on to data management system. All NRT products MUST be Kept out of the reach of children Kept in a locked cupboard Transported in a lockable container and if put in a car, must be in a locked boot out of sight. Client must be given a choice of products and decide with the advisor which one is best for them. See appendix B for summary of NRT products 5.4 Stock control When requesting NRT for direct supply, order small quantities to avoid waste and use that with the closest expiry date first. Any returns from a client cannot be re-issued but can be used for demonstration or training purposes. For supplies of demo packs contact Help2Change. 21

30 Appendix A Gum Dose Method of administration Specific side effects Specific advice to client Dosage and method of administration of NRT products 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 The strength of gum to be used will depend on the smoking habits of the individual. In general, if the client smokes 20 or less cigarettes a day, 2mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking. The maximum dose for the 4mg gum is 15 pieces a day. The maximum dose for the 2mg gum is 25 pieces a day. NiQuitin 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. Treatment should be continued for at least 3 months, gradually reducing the dosage over time 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 each time. Inhalator Dose Method of administration Specific side effects Specific advice to client Advise using 1-6 cartridges (15mg / cartridge) daily for up to 4-8 weeks THEN Reducing the dose to 1-3 cartridges over the next 2 weeks THEN Reduce to 0 over next 2 weeks. Oral administration (nicotine-impregnated plug in mouthpiece). Throat irritation, cough, rhinitis, pharyngitis, stomatitis, dry mouth. 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. 22

31 Lozenge Dose Method of administration Specific side effects Specific advice to client 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. NiQuitin 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. NiQuitin Minis Those who smoke 20 or more cigarettes per day should use the 4mg mini-lozenges. Those who smoke less than 20 cigarettes per day should use the 1.5mg mini-lozenges. Use the lozenges whenever there is an urge to smoke. Sufficient lozenges should be used each day, usually 8-12, up to a maximum of 15. Treatment should be continued for at least 3 months, gradually reducing the dosage over time. Cools Those who smoke 20 or more cigarettes per day should use the 4mglozenges. Those who smoke less than 20 cigarettes per day should use the 2mg lozenges. Use the lozenges whenever there is an urge to smoke. Sufficient lozenges should be used each day, usually 8-12, up to a maximum of 15. Treatment should be continued for at least 3 months, gradually reducing the dosage over time. 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 minutes). The lozenge should not be chewed or swallowed whole. Users should not eat or drink while a lozenge is in the mouth. Niquitin Minis 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 10 minutes). The lozenge should not be chewed or swallowed whole. 23

32 Patches Dose Method of administration Specific side effects 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. 16 hour patch Nicorette 16 hour patch Nicorette invisi Step 1-25mg patch for 16 hours daily for 8 weeks THEN Step 2-15mg patch for 16 hours daily for 2 weeks Step 2 THEN -10mg patch for 16 hours daily for 2 weeks THEN review treatment Lighter smokers (i.e. those than smoke less than 10 cigarettes per day are recommended to start at Step 2 (15mg) for 8 weeks and decrease the dose to 10mg for the final 4 weeks. 24 Hour Patch 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 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 For individuals smoking less than 10 cigarettes per day: 14mg patch daily for 6 weeks THEN 7mg 2 THEN review treatment Transdermal administration. Skin reactions discontinue use if severe. Potential sleep disturbance/vivid dreams with the 24 hour patch. Patches are normally applied in the morning; however, if the 24 hour patch is causing sleep disturbance/vivid dreams, the client can be advised to change their patch before going to bed at night, as the nicotine in the patch will be at the lowest level when the patch is first applied. This can also be useful for those who have a cigarette first thing in the morning. 24

33 Patches Continued Specific advice to client Exercise may increase absorption of nicotine and therefore side effects. The patch should be applied once a day, 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 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. Patches should not be given to clients with a generalised skin disease such as psoriasis, chronic dermatitis, clients who have had a previous reaction to transdermal patches; occasional smokers. Sublingual Tablet Dose Method of administration Specific side effects Specific advice to client For individuals smoking 20 cigarettes or less daily one tablet (2mg) per hour. For clients who 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. Maximum dose: 40 tablets (80mg) per day 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. Nasal Spray Dose Method of administration Specific side effects Specific advice to client 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: 64 sprays per day Intranasal use Running nose, sneezing, and watery eyes. Nasal spray should not be used whilst driving or operating machinery. Not to be given to clients with chronic nasal disorders such as polyposis, vasomotor rhinitis and perennial rhinitis. 25

34 Mouth Strips Dose Method of administration Specific side effects Mouth Spray Dose Method of administration Specific side effects Oral NRT 2.5mg mint Film. Fully dissolves in approximately 3 minutes, Place on tongue and press to roof of mouth. Mono therapy: For individuals smoking more than 30 minutes after waking. Max Dose: 15 films in a day. Weeks 1-6: One Film every 1-2 hours (min 9 films a day recommended), Week 7-9: One Film every 2-4 hours, Week 10 to 12 : One Film every 4-8 hours. Dual therapy, reduce number of Films a day by at least half. oral Dizziness, sleep disorders, headache, cough, pharyngitis, nausea, vomiting, stomatitis, flatulence, oral discomfort, hypersensitivity, hiccups, heartburn. For the first 8 weeks as required to a maximum of 2 spray 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: 64 sprays per day oral Hiccups, indigestion, heartburn, sore throat, foul taste. 26

35 Appendix B Summary of NRT Products Preparation Strength Pack Size Max/Day Nicotine Transdermal Patches Nicotinell Beige Patches TTS 30 21mg / 24hours Nicotinell Beige Patches TTS 20 Nicotinell Beige Patches TTS 10 NiQuitin CQ Beige or Clear Patches Step 1 NiQuitin CQ Beige or Clear Patches Step 2 NiQuitin CQ Beige or Clear Patches Step 3 Nicorette Invisi Range Nicorette 15 mg or Boots Nic Assist 14mg / 24hours 7mg / 24hours 21mg / 24hours 14mg / 24hours 7mg / 24hours 25mg / 16hours 15mg / 16hours 10mg / 16hours 15mg / 16hours 7 Patches 1 patch 7 Patches 1 patch 7 Patches 1 patch Nicorette 10 mg or Boots Nic Assist 10mg / 16hours 7 Patches 1 patch Legacy Range 5mg or Boots Nic Assist 5mg / 16hours 7 Patches 1 patch Nicotine Lozenges Nicotinell 1mg mg NiQuitin CQ 2mg mg Nicorette Cools 2mg 20 & mg Nicotine Mini Lozenges NiQuitin Minis 1.5mg NiQuitin Minis 4mg

36 Nicotine Inhalator Nicorette (with inhalator) or Boots Nic Assist refill 10mg / cartridge 42 cartridge 12 Nicotine Nasal Spray Nicorette nasal spray 0.5mg / metered spray 64 sprays 200 sprays unit Nicotine Sublingual Tablet Nicorette Microtab (with dispenser) 2mg 2 X 15 tablet discs 40 Nicorette Microtab (refill) 2mg 7 X 15 tablet discs 40 Nicotine Chewing Gum Nicorette or Boots Nic Assist 2mg or 4mg 30 or pieces NiQuitin CQ or Nicotinell 2mg or 4mg 12, 24, 96 pieces 15 Nicotinell Liquorice 2mg or 4mg 24 or 96 pieces 15 Nicotine Mouth Spray Nicorette Quick Mist 1mg per spray Single or Duo pack 64 sprays in 24hours Nicotine Mouth Strips NiQuitin Strips 2.5mg per strip 15 and 60 strips 15 strips in 24 hours. 28

37 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 a majority of 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 which can be used for Combination Therapy NiQuitin 24hr patch 21mg, 14mg, 7mg or Nicorette 16hr patch (Invisi range) 25mg, 15mg, 10mg or In conjunction with one of the following oral/flexible products: NiQuitin Lozenge 2mg, 4mg NiQuitin Gum 2mg, 4mg Nicorette Gum 2mg, 4mg Nicorette Inhalator Nicorette Microtab Nicorette Nasal Spray Nicorette Quick mist NiQuitin Minis Mini lozenge (4mg, 1.5mg) NiQuitin Strips Please note Nicotinell products have not been licensed for use in combination therapy. Nicorette combi pack has not been licences for use in pregnancy Who should use Combination Therapy? Subject to suitability, all patients aged 12 years and over who are receiving support from a Stop Smoking Advisor within the Stop Smoking Service should be offered the use of combination therapy. Who should not use Combination Therapy? Patients under 12 yrs old Patients who have had a recent cardiovascular event (within the past 4 weeks, see section 2.3) How should Combination Therapy be used? Treatment should be based on a transdermal NRT patch. An oral/flexible form of NRT (gum, inhalator, microtab, lozenge or nasal spray) is to be used when required. Combination Therapy should be used for 12 weeks and only from the quit date onwards (i.e. Combination Therapy cannot be used in conjunction with Nicotine assisted reduction to quit). 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 Advisor will assist the patient in planning their titration of the oral product. Oral NRT can be issued in up to 4 stages (2 weeks, 2 weeks, 4 weeks, 4 weeks) for the complete abstinence programme to make up the total 12 week post-quit date supply. However, it is good practice to monitor closely how much of the oral product the patient is using, as they may not use the full quantity due to the fact it is a secondary product. The patient should only be issued with a further supply of the oral product when necessary, to avoid product wastage. 29

38 Appendix D Nicotine assisted reduction to quit guidance Nicotine assisted reduction to quit (where commissioned) can help patients cut down smoking prior to a quit attempt. Nicotine assisted reduction to quit can only be used for a maximum of 4weeks and a quit date must be set prior to the patient starting a programme. This will increase a patient s maximum allowance of NRT to 16 weeks (4weeks nicotine assisted reduction to quit, 12 weeks cessation). Nicotine assisted reduction to quit can help those patients who: Lack confidence in their ability to quit Are a heavy smoker (i.e. smokes on average 20 or more cigarettes per day) Have tried to quit before but did not succeed Products which can be used for Nicotine assisted reduction to quit NiQuitin Lozenge 2mg, 4mg NiQuitin Mini 1.5mg, 4mg NiQuitin Gum 2mg, 4mg Nicorette Gum 2mg, 4mg Nicorette Inhalator Nicorette Microtab NiQuitin Strips Research A reduction programme has been shown to increase motivation to stop smoking and also help smokers gain confidence in their control over their smoking behaviour (Fagerstrom, et al, 1997) Several studies have investigated the effect of using Nicotine replacement Therapy to cut down prior to a quit date and have concluded this promotes smoking cessation (Landfeld, B et al, 2004) Guidance for Nicotine assisted reduction to quit 1. At patient s initial visit, inform patient of the Nicotine assisted reduction to quit option and discuss if this would be suitable for them. If Nicotine assisted reduction to quit is something the patient would like to do, discuss with the patient: How long for, when their quit date will be Cut down targets for each week What product would be most suitable 2. Complete monitoring form 3. NRT for the Nicotine assisted reduction to quit programme should be issued in 2 week supplies unless the patient is only cutting down for 1 week 4. A patient must be seen at least once during the Nicotine assisted reduction to quit programme to ensure supply of NRT is provided for the cessation programme. 5. Once a patient is nearing their quit date an appointment must be made to both support the patient in their complete abstinence programme and reassess the patient s NRT for complete abstinence. The product used for Nicotine assisted reduction to quit will either be: Discontinued Used for the complete abstinence programme as the only product Used for the complete abstinence programme as part of combination therapy Please Note: A patient should not start the Nicotine assisted reduction to quit programme until a quit date has been set Pregnant Women Ideally pregnant women should be encouraged to quit as soon as possible, however if this is not realistic Nicotine assisted reduction to quit may be considered. 30

39 Appendix E Consent to medical treatment for under 16 (all other consent on H2Q monitoring form) 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 following issues at each consultation. This should be fully documented and should include an assessment of the young person's maturity. Assessment (Fraser competency) Yes No Understanding of advice given Encouraged to involve parents The effect on the physical or mental health of young person if advice / treatment withheld Action in the best interest of the young person Healthcare professional Name Date Designation Client I consent to treatment and confirm that the above assessment has been completed. Name Date Signature 31

40 Appendix F Letter to GP Help 2 Quit Advisor GP s Name GP s Address GP s Address Help 2 Quit Longbow House Longbow Close Shrewsbury SY1 3GZ Date Dear Dr Under the protocol which enables the supply of NRT through Help 2 Quit, I am required to inform you the client named below is currently receiving stop smoking support/ has DNA / has lapsed to smoke again, as it may necessitate a dose adjustment of their current medication. Name Address Date of Birth Medication (tick as appropriate) Theophylline Warfarin Insulin Chlorpromazine Olanzapine Methadone Receiving NRT Yes No Clozapine team been Informed Yours faithfully Name Designation 32

41 Appendix G Nicotine Replacement Therapy Assessment Form 33

42 Nicotine replacement therapy (NRT) is a clean form of nicotine helping smokers overcome withdrawal symptoms (without exposure to the 4,000 other chemicals found in cigarettes). NRT is well tolerated and improves success rates. There is little difference in effectiveness between products and patient choice will usually determine which product is used. Treatment is for up to 12 weeks. Patients should be advised to quit completely when they use NRT. Weaning off NRT is not necessary, as patients do not normally experience withdrawal on completion of treatment. Side effects may include vivid dreams, nausea, indigestion, bowel disturbance, muscle discomfort, difficulty sleeping, skin rash with the patch, mouth irritation with oral products, cough and sore throat with the inhalator. Nicotine can affect the cardiovascular system and can increase heart rate and blood pressure but this is not normally clinically significant. NRT has been found to be well tolerated in patients with stable cardiovascular disease including following a heart attack. However NRT should not be prescribed within 4 weeks of a heart attack- unless you have permission from the GP or consultant and document in patient records. In patients with recent history of stroke NRT should not be used until the patient is stable you must wait a minimum of 4 weeks, unless you have permission from the GP / consultant and document in patient records. Patients with severe renal, moderate / severe liver disease metabolise medication at different rates and may need dose adjustments of NRT and blood test of kidney or liver function. Patients with uncontrolled hyperthyroidism metabolise medication at different rates and may need dose adjustments of NRT and thyroid function tests In diabetic patients blood sugar should be monitored more closely than usual. In pregnancy smoking may lead to growth retardation, low birth weight, and neonatal mortality. The use of NRT in pregnancy poses a theoretical risk to the baby but the level of risk is considered to be considerably lower than that from smoking (which also exposes the baby to numerous other toxic chemicals and to carbon monoxide). If the pregnant woman is unable to quit without medication, then NRT may be used, but not the 24 hour patch. In breast-feeding, nicotine is excreted via the milk. It is preferable if a breast-feeding mother avoids smoking and NRT use but if she is unable to quit without medication then NRT may be supplied. Shortacting products should be used, to allow the time between NRT use and breast-feeding to be as long as possible. Young people that are nicotine dependant are likely to benefit from NRT. GP approval must be sought for supplying to under 12 year olds. Stopping smoking can affect the metabolism of many regularly prescribed drugs. Clients should be advised to have a medications review from their GP / consultant. Clozapine: New patients on Clozapine will have weekly blood tests. Results and prescriptions for the first 4 months will be monitored at the Redwoods Centre by pharmacist Richard Heys (Tel ). Dispensing staff are aware of the process in the absence of the pharmacist. It is not recommended that clients make a quit attempt during this phase of their treatment. Clients from 4 months onwards will have blood tests every other week. Results and prescriptions will be monitored at Lloyds Pharmacy, Dawley High Street by pharmacist Joan Neather (Tel ). Dispensing staff are aware of the process in the absence of the pharmacist. 34

43 Appendix H Help 2 Quit Voucher When supplying the client with nicotine replacement therapy please complete the front and back of voucher. Example voucher shown below. Example 1 Example 2 Client must sign and date Redeeming Voucher at Pharmacy The client can take this voucher to any pharmacy within Shropshire (including Telford and Wrekin) to claim their NRT. Prescription charges will apply. The pharmacy collecting these vouchers will need to return these to the Help 2 Quit Administration Team for processing and reimbursement. Direct Supply of NRT The Help 2 Quit Advisor will supply the client with the required Nicotine Replacement Therapy from their stock levels and ensure all pertinent data as shown under details of records to be kept on this protocol is recorded on the client health record for monitoring and audit purposes. (Only available to clients who do not pay for prescriptions) 35

44 Appendix I Varenicline / Bupropion Initial Client Assessment 36