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Shropshire Public Health Operating Procedure

Stop Smoking Services

October 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

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Table of Contents

INTRODUCTION .................................................................................................................. 3

HELP2QUIT SERVICE DESCRIPTION ................................................................................ 3

Referral criteria ..................................................................................................................... 3

Referral route ........................................................................................................................ 3

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 ................................................................................................................. 6

Electronic cigarettes.............................................................................................................. 6

Delivery location and days/hours of operation ....................................................................... 7

Service outcomes ................................................................................................................. 7

APPENDIX 1 - Service Delivery Options ............................................................................... 8

APPENDIX 4 - Pharmacotherapy........................................................................................ 12

APPENDIX 5 - Establishing smoking status ........................................................................ 45

APPENDIX 6 - HELP2CHANGE SERVICE USER SATISFACTION SURVEY .................... 46

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 01743 454910.

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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 www.nice.org.uk/nicemedia/pdf/PH010guidance.pdf

Department of Health’s (DH) Stop Smoking Service Delivery and Monitoring Guidance (http://www.ncsct.co.uk/publication_service_and_delivery_guidance_2014.php)

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 evidence-based 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.

Referral route There are three methods by which patients can access the service:

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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 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

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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 and 12 months (Appendix 5) 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) o 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) (http://www.ncsct.co.uk/usr/pdf/NCSCT-standard_treatment_programme.pdf).

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

15 minutes at 12 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 (www.ncsct.co.uk).

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

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

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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.

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

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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.

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APPENDIX 1 - Service Delivery Options

Assessing nicotine dependence

Behavioural support

Pharmacotherapy Establishing smoking status

Other service components

Must offer at least one of;

Quantitative approach

Heaviness of smoking index

Objective approach

at least one of;

One-to-one support

Closed group support

Proactive telephone outreach

at least one of;

NRT Products:

Combination therapy (NRT)

Varenicline

Bupropion

at least one of;

Carbon-monoxide

Cotinine

May offer any of:

Reactive telephone support

any of:

Preloading / nicotine-assisted reduction to quit

any of;

Self report (maximum of 15% of cases)

May offer with agreement from Help2Change

any of

Open (rolling) group support

Drop-in support

Text (SMS) support

On-line support

any of:

Lung function / spirometry

any of:

Relapse prevention

Exercise

Must not offer any of:

Allen Carr method

any of:

Anxiolytics (e.g diazepam)

Nicobrevin

NicoBloc

St John's wort

Glucose

Lobeline

any of:

Hypnosis

Acupuncture, acupressure, laser therapy and electro-stimulation

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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

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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 face-to-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 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 programmes are compared with websites that present simple advice on quitting smoking. Wherever possible, Providers of online smoking cessation interventions need to replicate

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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.

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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 2016

31 March 2017

Contact details for enquiries Pat Thomas Help2Change Clinical Lead Help2Change Longbow House, Longbow Close Shrewsbury, SY1 3GZ Tel: (01743) 454910 Email: patricia.thomas@help2changeshropshire.nhs.uk

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Authorisation

This protocol has been reviewed by;

Review Actions Reviewers 31 March 2016 Update logos, screenshots of vouchers,

use of generic names for medications Pat Thomas, H2C Clinical Lead Linda Offord, H2C Programme Lead

1 September 2016 Update logo: pages 1, 22, 24, 25, 27 Remove reference to varenicline being a black triangle drug: page 26 Clarify advice on combination therapy, (not more than 2 products): page 8, 18 Help2Quit vouchers to be returned monthly: page 24 Revised client assessment form, including pre-conception: page 25

Pat Thomas, H2C Clinical Lead Linda Offord, H2C Programme Lead Angela Evans, H2C Administrator

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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 2002.

Pharmacy Healthcare Scheme. Sample patient group direction and service specification for the supply of nicotine replacement therapy through pharmacies. London, June 2003.

Pharmacy Healthcare Scheme. Improving access to smoking cessation therapies by using patient group directions. London, January, 2003.

West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals. An update Thorax (2000), 55: 987-9.

Duff G. New Advice on Use of Nicotine Replacement Therapy (NRT): wider access in at-risk populations. Expert advice from a Working Group of the Committee on Safety of Medicines (CSM), November, 2005.

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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.

A choice will be made by the client of NRT which they will use to quit smoking.

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.

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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 2017

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2 Clinical Indication

2.1 Indication /

definition

Current smokers of tobacco products

2.2 Criteria for

inclusion

Tobacco users receiving support from Help 2 Quit.

Before Nicotine Replacement Therapy is supplied, the client must first set a

quit date.

2.3 Criteria for

exclusion

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

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.

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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 136.4 ‘Which medicines need dose adjustment when a patient

stops smoking?’ www.nelm.nhs.uk

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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 top up product, usually around one third of the daily

allowance is advised.. 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.

3.2 Advice to patient Advice to patients should include specific product advice plus

the following general advice on:

withdrawal symptoms

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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

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.

4.2 Requirements for

continuing training and

education for staff

All staff authorised to supply Nicotine Replacement Therapy

under this protocol are required to attend yearly update

training as required by Help 2 Quit.

4.3 Names of staff authorised

to supply products under this

protocol.

Will be kept on record at Help 2 Quit, available to

commissioners on request.

5 Records and Audit

5.1 Details of

records to be

kept

The following records should be kept for all products supplied under this Protocol.

Name of client

Date of birth of patient

Address of client

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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.

5.2 Safe

storage of NRT

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.

5.3 Giving

clients choice

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.

22

Appendix A Dosage and method of administration of NRT products

Gum Dose

Nicorette People who smoke up to 20 cigarettes a day should use the 2mg gum. People who smoke more than 20 cigarettes a day should use the 4mg gum. Clients should aim to use 8-12 pieces of gum a day up to maximum of 15 pieces a day. Nicotinell 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

Method of administration

Oral administration (as resin).

Specific side effects

Throat irritation, increased salivation, hiccups.

Specific advice to client

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

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.

Method of administration

Oral administration (nicotine-impregnated plug in mouthpiece).

Specific side effects

Throat irritation, cough, rhinitis, pharyngitis, stomatitis, dry mouth.

Specific advice to client

Air should be drawn into the mouth through the mouthpiece. Clients should be

warned that the inhalator requires more effort to inhale than a cigarette and that less

nicotine is delivered per inhalation. Therefore the client may need to inhale for longer

than with a cigarette. The inhalator is best used at room temperatures as nicotine

delivery is affected by temperature. Used cartridges will contain residual nicotine and

should be disposed of safely.

Lozenge Dose Nicotinell

23

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.

Method of administration

Oral administration (nicotine as bitartrate).

Specific side effects

Throat irritation, increased salivation, hiccups.

Specific advice to client

Nicotinell Lozenge: Lozenge should be sucked until the taste is strong and then ‘parked’ between the gum and the cheek until the taste fades. Once faded then sucking should recommence. Simultaneous use of coffee, acid drinks and soft drinks may decrease absorption of nicotine and should be avoided for 15 minutes prior to sucking lozenge. NiQuitin Lozenge: One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 –30 minutes). The lozenge should not be chewed or swallowed whole. Users should not eat or drink while a lozenge is in the mouth. 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.

24

Patches Dose

Apply on waking to dry, non-hairy skin on hip, chest or upper arm. Remove after time specified. New patch should be placed on a different area – avoiding ‘used’ sites for several days afterwards. 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 THEN Step 2 -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

Method of administration

Transdermal administration.

Specific side effects

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.

25

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 10-20 seconds.

Patches should not be applied to broken or inflamed skin.

Once the patch is spent it should be folded in half and disposed of carefully.

Storage safety, away from children and animals, away from direct sunlight.

Clients should not try to alter the dose of the patch by cutting it up.

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

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.

Method of administration

Oral administration (sublingual) – 2mg.

Specific side effects

Throat irritation, unpleasant taste.

Specific advice to client

Tablets should be placed under the tongue and allowed to dissolve slowly.

Nasal Spray Dose

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

Method of administration

Intranasal use

Specific side effects

Running nose, sneezing, and watery eyes.

Specific advice to client

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.

26

Mouth Strips Dose

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.

Method of administration

oral

Specific side effects

Dizziness, sleep disorders, headache, cough, pharyngitis, nausea, vomiting, stomatitis, flatulence, oral discomfort, hypersensitivity, hiccups, heartburn.

Mouth Spray Dose

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

Method of administration

oral

Specific side effects

Hiccups, indigestion, heartburn, sore throat, foul taste.

27

Appendix B Summary of NRT Products

Preparation Strength Pack Size Max/Day Nicotine Transdermal Patches Nicotinell Beige Patches TTS ‘30’

Nicotinell Beige Patches TTS ‘20’

Nicotinell Beige Patches TTS ‘10’

21mg / 24hours

14mg / 24hours

7mg / 24hours

7 Patches

1 patch

NiQuitin CQ Beige or Clear Patches Step 1

NiQuitin CQ Beige or Clear Patches Step 2

NiQuitin CQ Beige or Clear Patches Step 3

21mg / 24hours

14mg / 24hours

7mg / 24hours

7 Patches

1 patch

Nicorette Invisi Range

25mg / 16hours

15mg / 16hours

10mg / 16hours

7 Patches

1 patch

Nicorette ‘15’mg or Boots Nic Assist

Nicorette ‘10’mg or Boots Nic Assist

15mg / 16hours

10mg / 16hours

7 Patches

1 patch

Legacy Range ‘5mg’ or Boots Nic Assist 5mg / 16hours 7 Patches 1 patch

Nicotine Lozenges Nicotinell 1mg

2mg

36

96

15

15

NiQuitin CQ

2mg

4mg

36

72

15

15

Nicorette Cools

2mg

4mg

20 & 80

80

15

15

Nicotine Mini Lozenges NiQuitin Minis 1.5mg 20

40

60

15

NiQuitin Minis 4mg

20

40

60

15

Nicotine Inhalator

28

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 105 pieces

15

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.

29

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 are one patch plus one third the daily dose of one oral, faster acting NRT product. Please note: Nicotinell products have not been licensed for use in combination therapy.

Nicorette combi pack has not been licenced 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 alongside one oral product at around one third the daily dose.

Combination Therapy may be used for 12 weeks and only from the quit date onwards.

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 stages as required, 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 only one third the daily dose is used 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. Normally the oral product will last three to four weeks as it is packaged for sole usage.

30

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.

31

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 1985.

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

32

Appendix F Letter to GP

Help 2 Quit Advisor

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

Clozapine team been Informed

Receiving NRT Yes No

Yours faithfully

Name

Designation

GP’s Name

GP’s Address

GP’s Address

GP’s Address

GP’s Postcode

33

Appendix G Nicotine Replacement Therapy Assessment Form

34

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. Short-acting 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. 01743 210 007). 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. 01952 505 029). Dispensing staff are aware of the process in the absence of the pharmacist.

35

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

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. To ensure payment, the pharmacy collecting these vouchers will need to return them MONTHLY 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)

Client must

sign and date

36

Appendix I Varenicline / Bupropion Initial Client Assessment

37

Bupropion (Zyban®) information Bupropion (Zyban®) is a non-nicotine preparation which reduces the urge to smoke by inhibiting re-uptake of dopamine and noradrenalin in the

brain. It is an antidepressant but its smoking cessation properties are unrelated to its antidepressant effects, and it is licensed in the UK only as a smoking cessation aid.

Bupropion is packaged in boxes of 60 x 150mg slow-release tablets (1 month’s supply). It is licensed in the UK to be given as a 2-month course. Help 2 Quit recommends that patients be given 2 weeks supply (30 tablets) of bupropion initially, the remainder of the course being offered only to patients who remain quit.

Treatment is usually started while the patient is still smoking, and a quit date set for 1-2 weeks after the start of treatment.

The dose is 150mg (1 tablet) once daily for 6 days, then 150mg twice daily for the rest of the course. If the patient experiences minor side effects, the dose may be kept at 150mg once daily throughout the course (see also below).

The dose should be reduced to 150mg once daily throughout the course if the patient is elderly, or has mild to moderate renal or hepatic impairment.

Bupropion is not recommended for pregnant or breastfeeding women, nor currently for patients aged under 18 years.

Rarely (1 patient in 1,000), Bupropion can cause seizures. To reduce the risk of seizures, prescribes are advised that: o Bupropion is contraindicated in patients who have:-epilepsy or any history of seizures, current or previous eating disorders, a central

nervous system tumour, abrupt withdrawal from alcohol or benzodiazepines o Bupropion must not be prescribed to patients with other risk factors for seizures unless there is a compelling clinical justification that

outweighs the increased seizure risk. In such patients, a lower dose of 150mg once daily throughout the entire treatment period should be considered. Seizure risk factors include: concomitant use of a drug known to lower the seizure threshold, alcohol abuse, story of head injury, diabetes treated with hypoglycaemias or insulin, use of stimulants or anorectic products

Bupropion is contraindicated in patients who have: severe hepatic cirrhosis, bipolar disorder, recently taken monoamine oxidise inhibitors (MAOIs)known hypersensitivity to Bupropion

Patients taking Bupropion may experience minor side effects. The most common are: dry mouth, insomnia, headache, gastro-intestinal disturbance

Bupropion appears to be well tolerated from a cardiovascular point of view. Since there is no clinical experience of the drug’s use in patients immediately post myocardial infarction, however, caution has been advised in this group of patients.

Patients using Bupropion should be advised to avoid driving or operating machinery if they experience drowsiness as a result of taking the drug.

Bupropion has the potential to interact with many other medicines. These include antidepressants, antipsychotics, MAOIs, beta-blockers, theophyllines, type 1c antiarrythmics, antimalarials, sedating antihistamines, hepatic enzyme inducers or inhibitors, St John's Wort, and any drug which lowers the seizure threshold. For further information on potential drug interactions, see the accompanying Help 2 Quit leaflet 'Potential Drug Interactions with Bupropion '.

If bupropion is used in combination with NRT, weekly monitoring of blood pressure is recommended as in one study an associated rise in BP was reported.

Pharmokinetics – dose adjustments may be needed with Theophyline, warfarin, clozapine and insulin.

Varenicline (Champix®) information Action Varenicline binds with high affinity to the α4β2 neuronal nicotinic receptors, where it only partially stimulates dopamine release. This is sufficient to provide relief from cravings and withdrawal symptoms as the nicotine levels decline during the quit attempt. Because Varenicline binds to the receptor, it is therefore blocked and cannot be stimulated by nicotine. This reduces the pleasurable effect of smoking, potentially reducing the risk of relapse after a temporary lapse. Therefore do not use nicotine replacement therapy as an adjunct. This is a centrally acting drug so can affect people differently. Some people may experience dizziness which will affect their ability to drive. Anyone operating heavy machinery should be advised to start the treatment during their days off so that they can assess any problems. All trials done on this drug have used healthy adults. Therefore it is advisable not to use the drug with pregnant or breastfeeding women. This drug is excreted through the kidneys, so should only be used under medical supervision with end stage renal disease. Effectiveness NICE has recognised Varenicline as superior to NRT and bupropion in achieving continuous abstinence. It is considered as a useful addition to the variety of interventions available in smoking cessation. All treatments should be recommended to be used alongside Help2Quit counselling support. Evidence of 44.2% quit rate at 12 weeks has been demonstrated in trials. Dose A prescription for an initiation pack should be requested at the outset. This lasts 2 weeks, so a follow up appointment is made for 1 week to assess tolerance and any adverse effects. Titration in the first week before quitting is as follows.

Days 1-3: 0.5 mg once daily

Days 4-7 0.5 mg twice daily

Day 8 – End of treatment 1mg twice daily

Days 78 – 82 Only if advised 0.5mg twice daily (Starter pack in reverse)

Days 83 – 85 Only if advised 0.5mg once daily (Starter pack in reverse)

The patient should quit smoking during this pack when they feel ready, usually between day 4 to 7. If they have not quit by the end of the titration week they must set a date during the next week. If tolerant and quit after the initiation pack then a maintenance pack should be requested. This is a continuation of 1mg twice daily for 2 weeks. Treatments usually last 12 weeks, but can be continued up to 24 weeks where appropriate. Side effects Are usually gastrointestinal. Nausea (up to 30%), Vomiting, Constipation, Diarrhoea, Abdominal distension Stomach Discomfort, Dyspepsia, Flatulence, Dry Mouth Others may be Abnormal Dreams, Insomnia, Headaches, Increased Appetite, Somnolence, Dizziness, and Dysgeusis These effects are also associated with nicotine withdrawal; they are usually transient for the first two weeks. Cautions Renal insufficiency, Psychiatric illness, Epilepsy, Pharmacokinetics – dose adjustments of Theophyline, Warfarin, Clozapine and Insulin may be requires, seek medical advice see Appendix F Do not use with: Under 18s, or with those trying to conceive, Pregnant or breast feeding.

38

Appendix J Repeat Varenicline / Bupropion Prescription Request

Side A

Side B

Check with client No change Better Worse

Nausea

Headache

Insomnia

Abnormal Dreams

Suicidal Ideation

Depression / Mental State

Any Adverse Reaction

Yellow Card Report

Any Other Problems

39

Appendix K VARENICLINE (CHAMPIX®) INFORMATION SHEET

These tablets are designed to help you to stop smoking by replacing the nicotine which you get from your cigarettes.

The treatment must be taken for 12 weeks in order to break your addiction. Failure to take your tablets for the full course may cause you to fail your quit attempt.

You still need a lot of motivation to break the habit of smoking, so you need to attend the Help 2 Quit smoking clinic for help and support to make a successful quit attempt.

The clinic is run weekly during the treatment phase and we will arrange with you follow up appointments as appropriate for yourself for 1 year, but the more help and support that you get the better you will do.

How to take your tablets

At first you will get a prescription for a starter pack. This lasts 2 weeks, so a follow up appointment is made for 1 week to see if you have any problems or any adverse effects.

Week 1 Days 1-3: 0.5 mg once daily Starter pack

Days 4-7 0.5 mg twice daily Starter pack

Week 2 - 12 Days 8 – end of treatment 1mg twice daily Maintenance pack

Week 12 -14

Only if advised

Day 78 – 82 0.5mg twice daily Starter pack in reverse

Day 83 – 85 0.5mg once daily Starter pack in reverse

You should quit smoking during this 2 week period when you feel ready, it can be from day 4, but is usually between days 8 to 14. If you have not quit by the end of the first week you must set a date during the next week.

After the starter pack has finished you will get a maintenance pack if you are intending to quit smoking, this continues with 1mg tablets twice daily. If you forget to take a tablet there is no need to double up, simply continue with the next tablet due.

Treatments usually last 12 weeks, however it may occasionally be continued up to 24 weeks where appropriate.

Side effects

Very common side effects which may affect more than 1 person in 10 are listed below: Headaches, difficulty sleeping, abnormal dreams

Nausea

Common side effects which may affect more than 1 person in 100 are listed below: Increased appetite, changes in the way things taste, dry mouth

Sleepiness, tiredness, dizziness

Vomiting, constipation, diarrhoea, feeling bloated, stomach discomfort, indigestion, flatulence

These effects usually only last for the first two weeks. If you experience any other side effects please report this to your Doctor or Help 2 Quit advisor. 97% of patients have no ill effects stopping varenicline at the end of treatment. 3% of patients have complained of depression, irritability, anxiety or difficulty sleeping. If you experience any of these symptoms please contact your advisor or GP. Consult your doctor if you have depression or mental health illness.

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Appendix L NRT INFORMATION SHEET

Nicotine is the drug in tobacco that causes addiction. When you stop smoking, your body has a ‘need’ for nicotine that creates an urge to smoke again. You may suffer withdrawal effects such as irritability, loss of concentration, and sleepless nights.

Although nicotine makes you want to smoke, it is the other chemicals in tobacco smoke that cause the cancer, heart disease, bronchitis and other health problems associated with smoking.

Nicotine replacement therapy (NRT) can help you to stop smoking. By taking nicotine in a ‘clean' form through patches, chewing gum, tablets under your tongue, or an inhalator, withdrawal symptoms are reduced and you are twice as likely to stay quit. Nicotine replacement doesn’t completely remove the desire to smoke, though, and willpower is still needed.

As long as you don’t smoke, side effects of nicotine replacement therapy are usually mild. Some patients experience skin rash (for patches), sore mouth and throat (for gum or inhalator), nausea, muscle aches, or vivid dreams.

Nicotine replacement therapy is usually taken for 2 - 3 months after quitting. It does not have the same addictive potential as smoking, and few quitters feel the need to continue treatment for longer than this.

For nicotine Patch users:

The best time to put the patch on is first thing in the morning. Use ONE PATCH A DAY.

Use ONLY ONE PATCH AT A TIME. Take the old patch off before putting the next one on.

STICK YOUR PATCH ON A DIFFERENT PLACE EACH DAY. Avoid putting patches on broken skin. Keep to clean, dry areas. Common places to put your patch are your upper arm, hip or chest.

KEEP PATCHES AWAY FROM CHILDREN AND PETS. Fold used patches in half with the sticky side inside, wrap them up and dispose of them carefully, out of the reach of children or animals.

Store your patches somewhere cool but NOT IN A FRIDGE.

Do NOT try to reduce the dose of the patch by cutting it in half.

For nicotine Gum users:

Whenever you feel the urge to smoke, chew a piece of gum. You need to use 10 to 15 pieces of gum per day for maximum benefit. DO NOT USE MORE THAN 15 PIECES PER DAY OF HIGH STRENGTH GUM.

The nicotine is absorbed through the lining of your mouth. If you swallow it, the nicotine is wasted, and you may experience hiccups or indigestion.

You must CHEW NICOTINE GUM CORRECTLY. Chew the gum slowly until the taste becomes strong. Then stop chewing and rest the gum against the inside of your cheek. When the taste starts to fade, start chewing the gum slowly again until the taste becomes strong, then rest the gum again. Keep chewing and resting the gum for about half an hour per piece, until the gum no longer has any taste.

Avoid eating or drinking for 15 minutes before using, or while chewing the gum, as some beverages can reduce its effectiveness.

For nicotine Microtab users:

DO NOT USE MORE THAN 40 MICROTABS PER DAY

Whenever you feel the urge to smoke, pop a microtab under your tongue and let it dissolve slowly.

Most people require at least 8 microtabs per day for maximum benefit.

DO NOT CHEW OR SWALLOW THE MICROTAB. The nicotine is absorbed through the lining of your mouth. If you chew or swallow the microtab the nicotine is wasted, and you may experience hiccups or indigestion.

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For nicotine Inhalator users (15mg)

Whenever you feel the urge to smoke, pop a cartridge into your inhalator and suck hard on the mouthpiece until you can taste the nicotine. You can continue sucking on the inhalator until there is no more taste. Usually one cartridge lasts for about 40 minutes of heavy use. You will probably use around 3 cartridges per day. DO NOT USE MORE THAN 6 CARTRIDGES PER DAY.

On cold days you may find that you have to work harder to get the same amount of nicotine from the inhalator as you get on warmer days. The mouthpiece of the inhalator should be cleaned several times a week by rinsing in water.

For nicotine Lozenge users:

Whenever you feel the urge to smoke, suck a lozenge. If you smoke your first cigarette of the day within half an hour of waking up, the higher strength lozenge (4mg) is suitable, otherwise a lower strength lozenge (2mg or 1mg) is suitable. DO NOT USE MORE THAN 15 HIGH STRENGTH LOZENGES PER DAY. You need to use 10 to 15 lozenges per day for maximum benefit.

The nicotine is absorbed through the lining of your mouth. If you chew or swallow the lozenge, the nicotine is wasted, and you may experience hiccups or indigestion. Place one lozenge in your mouth, and suck it slowly until the taste becomes strong. Then rest the lozenge against the inside of your cheek until the taste begins to fade. Start sucking again until the taste becomes strong, then rest the lozenge against the inside of the other cheek. Keep sucking and resting the lozenge like this until it is completely dissolved (about 20-30 minutes). Avoid eating or drinking while the lozenge is in your mouth.

For Nasal Spray users:

Used in highly dependent smokers who experience strong cravings throughout the day, and /or who require rapid craving relief.

One spray to each nostril= one dose. The recommended dose is 1-2 doses per hour. One bottle has 100 doses (200 sprays). Gradually reduce over 8 weeks

Before use prime bottle by pressing the bottom and shoulders until a fine spray appears. Tip head slightly back. Insert spray tip into one nostril. Press bottle firmly and quickly Spray into other nostril if required.

For QuickMist users:

When using the spray prime the pump before use, point the spray away from you and other adults, children, pets or furniture and spray 2-3 times until a fine spray appears. This is then ready for use.

Nicorette QuickMist should be used whenever the urge to smoke is felt or to prevent cravings. Each mouthspray contains at least 150 sprays.

Use 1 or 2 sprays as informed by your adviser when cigarettes normally would have been smoked or if cravings emerge. If after the first spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays.

Most smokers require 1-2 sprays every 30 minutes to 1 hour. You may use up to 4 sprays per hour. Do not exceed 2 sprays per dosing episode and 64 sprays (4 sprays per hour over 16 hours) in any 24-hour period.

For Mouth Strip users:

A mouth strip can be used when there is an urge to smoke; Maximum dose is 15 strips a day. Each strip has 2.5mg of Nicotine Place 1 film on tongue and press to roof of mouth, it will fully dissolve in 3 minutes Most smokers will require one film every 1-2 hours in the first 1-6 weeks, reducing down to one film every

2-4 hours to week 9, then one film every 4-8 hours. If you wear full dentures you will have to remove them so the strip can dissolve.

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Appendix M BUPROPION (ZYBAN®) INFORMATION SHEET

These tablets help you stop smoking in combination with behavioural change and motivation support, by

reducing the withdrawal symptoms from nicotine addiction.

Our Advisors see you at the clinic weekly if possible during the treatment phase which last 12 weeks, but the

more help and support that you get the better you will do.

It is up to your GP to decide if this medication is suitable for you.

How to take your tablets

You will get a prescription request to take to your GP for approval, and to issue the prescription.

Days 1-6: One tablet (150mg) once daily

Days 7 – end of treatment One tablet (150mg) twice a day (with at least 8 hours between

doses)

Smokers need to start using bupropion at least 7 days (and up to 14 days) before their quit date. We will see

you weekly during the first 4 weeks of your quit to see if you have any problems or any adverse effects taking

the medication. You will get further prescription request at these appointments to take to your GP. A

bupropion standard course of medication is 7-9 weeks, with behaviour change support from your Specialist

Nurse / Advisor to 12 weeks.

There are certain medicines and medical conditions where it may be necessary that your dose of bupropion is

reduced, and you will stay on 150mg once a day, your GP will decide this.

Conditions and medicines that may need dose reduction of bupropion

Mild to moderate liver or kidney impairment

Some elderly patients

Certain antibiotics (for example, ofloxacin, levofloxacin or norfloxacin)

Tramadol, which is a strong pain killer

Slimming medicines or other stimulant medicine

Medicines that may need dose adjustments of current medication:

Insulin

Theophylline, which is a medicine used to treat chest conditions such as asthma

Warfarin

Clozapine

Chlorpromazine

Olanzapine While you are taking bupropion it is very important to tell your doctor or pharmacists before you take any

new medicines: including over the counter or herbal remedies.

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Side effects

Very common side effects

Dry mouth, insomnia, headache, gastro-intestinal disturbance.

Common side effects

Tremor, impaired concentration, dizziness, agitation, anxiety, rash, puritius, depression, sweating,

hypersensitivity reactions, fever, taste disturbance, chest pain, tachycardia, high blood pressure, flushing,

anorexia, tinnitus, visual disturbance

Rare side effects

Palpitations, postural hypotension, hallucinations, seizures, abnormal dreams, memory impairment, impaired

coordination, paraesthesia, urinary retention, urinary frequency , hepatitis, blood glucose disturbance,

jaundice, exacerbation of psoriasis

You may use bupropion but with caution:

Bupropion can increase the risk of seizure it’s the same risk increase as for most antidepressants. This is

something you and your GP decide if you are taking any of the medication listed below.

Taking antidepressants e.g. medicines to treat depression (clozapine, risperidone, thioridazine or olanzapine

Taking antimalarial’s

Taking antipsychotics

Taking quinolones e.g. certain type of antibiotics

Taking sedating antihistamines e.g., Piriton, Dimotane, Nytol or Panadol Night

Taking corticosteroids e.g. prednisolone

Taking theophylline e.g. which is a medicine used to treat chest conditions such as asthma

You may NOT use bupropion if you have a history of;

Epilepsy or any history of fits

Predisposition to seizure e.g. Head injury, brain tumour, alcohol abuse, withdrawal from benzodiazepines

Current or previous eating disorders,

Bipolar disorder, on MAOI medication

Under 18 years old, if you’re pregnant or breast feeding.

Severe Liver Cirrhosis

Please read the bupropion Patient Information Leaflet that comes with your medication carefully.

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Names of individuals authorised to supply under this Protocol

Advisor Practice / Pharmacy / Help 2 Quit Address………………………………………………………………………………………………………………………............................ Post Code…………………………………………………………………… Telephone number ……………………………………….

Name

Signature

Date

Designation

Name

Signature

Date

Designation

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APPENDIX 5 - Establishing smoking status This is the process by which the smoking status of a Service User is established 4 weeks and 12 weeks after a quit date has been set to determine whether the Service User has successfully quit:

4 week smoking status must be established between 25 and 42 days after the agreed quit date.

12 week smoking status must be established between 79 and 105 days after the agreed quit date. The smoking status of at least 85% of successful 4 week and 12 week quitters should be established through carbon monoxide (CO) testing. An ‘attempt’ to carry out CO verification should comprise a minimum of three separate attempts to contact the client via telephone, text or email in order to arrange a face-to-face CO validation.

Carbon monoxide: As self-reported smoking status can be unreliable, CO verification rates are an important marker of data quality. CO testing should be carried out on all adult smokers, wherever possible, to provide both a baseline (pre-quit) level and a four-week validation (post-quit) level. CO testing is quick to carry out, non-invasive and provides a cost-effective means of validating the smoking status of a significant number of clients. To achieve as accurate a reading as possible, clients should be asked to hold their breath for 20 seconds (15 seconds minimum) before blowing into the CO monitor. Some clients may not be able to physically complete CO testing due to the inability to hold their breath for 15 or more seconds. Service Users with a CO reading of less than 10ppm at 4 and 12 weeks can be regarded as successfully quitters.

CO Monitor Protocol (Infection Control)

All monitors must be subject to an annual calibration check. Additional calibration checks should be carried out if a CO monitor records unexpected readings.

The monitors should be wiped down using non-alcohol wipes, ideally at the end of every session.

Cardboard Tubes: A fresh cardboard disposable mouthpiece will be used for each patient tested. Ask the patient to put their own tube into machine and remove after use.

Plastic adaptor/t-piece: The adaptor contains a one-way valve that prevents inhalation from the monitor. o Changing adaptors depends on manufacturers’ guidance:

micromedical: the adaptor should be discarded and replaced every six months bedfont (Pico): the adaptor should be discarded and replaced monthly bmc-2000: adaptor should be changed quarterly, unless usage is heavy, in which case

change monthly: o Usage guidance

Less than 50 uses per month: change quarterly Between 51–200 uses per month: change bi-monthly More than 200 uses per month: change monthly.

Additional information about the DH guidelines for infection control can be found at http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_104398.pdf In addition, Self Reported Smoking Status can be used for up to 15% of Service Users:

Self-Reported Smoking Status: Although less reliable than carbon monoxide, a Service User can be asked to self-report their smoking status. The methods used to obtain a Service User’s self-reported smoking status is set out in the Russell Standards (http://www.scsrn.org/clinical_tools/russell_standard_clinical.pdf). Service Users should be asked the question “Have you smoked at all in the last 2 weeks?” Service Users’ responses should be coded into one of the following categories:

- “No, not even a puff” - “Yes, between one and five cigarettes” - “Yes, just a few puffs” - “Yes, more than 5 cigarettes ”

Only those responding ‘No, not even a puff.” should be classified as successful quitters.

Whilst it is preferable to derive a self-reported smoking status via a face-to-face consultation, it is permissible to gather the required information via a telephone consultation. The smoking status of no more than 15% of successful 4 week and 12 week quitters should be established using this method.

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APPENDIX 6 - HELP2CHANGE SERVICE USER SATISFACTION SURVEY