help2change shropshire standard operating procedure...be classified as successful quitters. o 12...
TRANSCRIPT
1
Help2Change Shropshire Standard Operating Procedure
Stop Smoking Service
April 2018
This document provides a framework for the delivery of stop smoking services in Shropshire. Guidance relating to referrals and treatment are based on NICE guidelines. All providers engaged in delivery of stop smoking services in Shropshire are required to operate to this procedural framework. Any changes to this Standard Operating Procedure (SOP) must be agreed with Help2Change. Help2Change retains the right to amend and update this SOP in light of local and national evidence of best practice. For all queries relating to this SOP, please contact Help2Change on 01743 454910.
2
Table of Contents
INTRODUCTION .................................................................................................................. 3
HELP2QUIT SERVICE DESCRIPTION ................................................................................ 3
Eligibility criteria .................................................................................................................... 3
Referral route ........................................................................................................................ 3
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.............................................................................................................. 7
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 ........................................................................ 47
APPENDIX 6 - HELP2CHANGE SERVICE USER SATISFACTION SURVEY .................... 49
3
INTRODUCTION This framework is intended to provide guidance and consistency in the delivery of Stop Smoking Services (known as Help2Quit) in Shropshire.
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 around 38,500 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 Health and Care Excellence (2018) NICE Guideline NG92 Stop Smoking Interventions and Services
Public Health England Local Stop Smoking Services: Service and Delivery guidance 2014
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.
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
Eligibility criteria To be eligible for the service, check that the Service User:
is resident in Shropshire &/or registered with GP in Shropshire;
is a current smoker of a tobacco product;
would like to stop smoking and receive support;
is not receiving stop smoking support from another Provider;
has not been registered on the programme more than twice in the last 12 months;is 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, or has already been on the programme twice within the last 12 months please seek prior approval from Help2Change.
Referral route Patients can access the service by:
4
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. Practices should use the GP record to routinely identify and refer at risk patients to the service.
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 (Shropshire Council’s Help2Change).
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 should be contacted within 48 hours of receipt of the enquiry or referral and offered an appointment within 2 weeks of first contact.
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 2 times during a 12 month period, after which approval for a repeat attempt must be sought from Help2Change.
Discharge criteria 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 has not stopped smoking by the 4-week follow up
The Service User starts smoking again after the 4-week follow up
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 recorded on the electronic templates provided by Help2Change (e.g. EMIS or PharmOutcomes).
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
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 Stop Smoking Service Delivery and Monitoring Guidance)
Provider assesses nicotine dependence (Appendix 2)
5
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 Smoking status should be determined at 4 weeks by asking if the Service User has
smoked at all in the last 2 weeks. Only those responding ‘No, not even a puff.” should be classified as successful quitters.
o 12 week smoking status must be established between 70 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
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.
first appointment - 30 minutes
face to face follow-up appointments - 15 minutes
Telephone consultations – 10 minutes
Proactive follow up (including text messaging, appointment reminders and telephone support) should be conducted to reduce lost to follow up and increase quit rates.
Stop smoking advisors 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 Carbon Monoxide monitors or other biochemical markers (Appendix 5).
Training requirements
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 on-line Training and Assessment Programme
1 day face to face Help2Quit training, including: o behavioural support training o smoking in pregnancy training (essential if any pregnant Service Users are recruited) o 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
6
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;
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.
Data requirements All data must be recorded in full using the stop smoking data templates provided by Help2Change, e.g. EMIS Web templates or PharmOutcomes, 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. Recording of smoking status should comply with the requirements laid out in Appendix 5.
All Service Users setting a quit date must be provided with a Service User satisfaction questionnaire within 4 weeks of the service end date (links available on the EMIS and PharmOutcomes templates - 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, stop smoking medicines must be issued according to the Help2Quit Pharmacotherapy Protocol (Appendix 4). NRT should be issued through the Help2Quit voucher scheme or via direct supply. 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
7
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 must 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.
8
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
9
APPENDIX 2 - Assessing nicotine dependence
Assessing nicotine dependence is the process by which 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
10
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 advisor 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 advisor/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 advisors 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 advisors 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
11
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 advisor/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 advisor 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.
12
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 2019 31 March 2017 31 March 2018
Contact details for enquiries Pat Thomas Help2Change Clinical Lead Help2Change Longbow House, Longbow Close Shrewsbury, SY1 3GZ Tel: (01743) 454910 Email: [email protected]
13
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
3 July 2017 Update logo: pages 1, 22, 27 Linda Offord, H2C Programme Lead
9 November 2017 Clarify process for reimbursement of pharmacotherapy: page 4 & 24
Pat Thomas, H2C Clinical Lead Craig McArthur, IT Infrastructure and Development Manager Linda Offord, H2C Programme Lead Angela Evans, H2C Administrator
28 March 2018 Revise flowchart for NRT (page 15) and include summary for bupropion and varenicline (page 16) Amend contact details for clozapine enquiries: page 36
Dr Kevin Lewis, Director, Help2Change Pat Thomas, H2C Clinical Lead Linda Offord, H2C Programme Lead Claire Sweeney, H2C Pregnancy Lead
14
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.
15
Flowchart for issue of Nicotine Replacement Therapy
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 (1 weeks supply at a time)
Help 2 Quit Advisor will issue a voucher to
be redeemed at a Pharmacy in Shropshire,
which will incur a prescription charge
(2 weeks supply at a time)
Client exempt from paying prescription charge Client not exempt from paying
prescription charge
Help 2 Quit Advisor will issue a voucher to
be redeemed at a Pharmacy in Shropshire
(1 weeks supply at a time)
OR
The voucher details will need to be entered into the NRT Voucher Transaction service in
PharmOutcomes (and the voucher retained by the pharmacy), or the voucher returned to Help 2
Quit, within 12 weeks of issue for reimbursement.
All voucher details must be entered/vouchers returned within the financial year of issue to
ensure reimbursement (by second week of April at the latest).
16
Flowchart for issue of bupropion or varenicline
Help 2 Quit provides training to Advisors so they can follow the protocol
to provide bupropion or varenicline
Help 2 Quit Advisor completes pharmacotherapy assessment form and prescription request for
2 weeks supply of varenicline, 4 weeks of bupropion for patient to take to their GP for approval
Repeat prescription request and patient assessment completed (for patients who have quit
smoking) for a further 2 week supply of varenicline, 4 weeks of bupropion for patient to take to
their GP for approval
17
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 2019
18
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.
19
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 the blood levels of Clozapine to rise. The Advisor 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
20
3 Treatment
3.1 Treatment program A weekly / fortnightly supply is provided (as in flowchart above)
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
21
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.
22
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.
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.
23
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.
24
Lozenge Dose
Nicotinell Those who have a strong nicotine dependency, i.e. who smoke more than 30 cigarettes a day, should use the 2mg lozenge. Those who smoke less than 30 cigarettes a day should use the 1mg lozenge. Most people use 8-12 lozenges per day. The maximum daily dose is 30 of the 1mg lozenges. The maximum daily dose is 15 of the 2mg lozenges. 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.
25
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.
26
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.
27
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.
28
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
29
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 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.
30
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.
31
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.
32
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
33
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
34
Appendix G Nicotine Replacement Therapy Assessment Form
35
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:
Advisors are asked to contact the Severnfields Mental Health Hub on 0300 303 3426 for advice before
supporting a patient using clozapine to stop smoking.
36
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 to claim their NRT. A prescription charge will apply (unless exempt). To help administration and payment associated with the vouchers, the pharmacy collecting these vouchers
will need to enter the voucher details into the NRT Voucher Transaction service in PharmOutcomes (and the
voucher retained by the pharmacy), or the voucher returned to Help 2 Quit, within 12 weeks of issue for
reimbursement. All voucher details must be entered/vouchers returned within the financial year of issue
to ensure reimbursement (by second week of April at the latest).
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
Client must
sign and date
37
not pay for prescriptions).
38
Appendix I Varenicline / Bupropion Initial Client Assessment
39
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. 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. Subsequent prescribing should be at fortnightly intervals. 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.
40
Appendix J Repeat Varenicline / Bupropion Prescription Request
Side A
Side B
41
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.
42
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.
43
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 advisor 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.
44
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.
45
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.
46
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
47
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 70 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.
48
Definitions
Self-reported four-week quitter A treated smoker who reports not smoking for at least days 15–28 of a quit attempt and is followed up 28 days from their quit date (-3 or +14 days). CO-verified four-week quitter A treated smoker who reports not smoking for at least days 15–28 of a quit attempt and whose CO reading is assessed 28 days from their quit date (-3 or +14 days) and is less than 10 ppm. CO verification should be conducted face to face and carried out in at least 85% of self-reported four-week quitters. Note: the -3 or +14 day rule allows for cases where it is impossible to carry out a face-to-face follow-up at the normal four-week point (although in most cases it is expected that follow-up will be carried out at four weeks from the quit date). This means that follow-up must occur 25 to 42 days from the quit date (Russell Standard). All outcomes not recorded in the 25-42 day window must be counted as lost to follow-up. Lost to follow-up (LTFU) A treated smoker who cannot be contacted face to face, via telephone, email, letter or text following three attempts to contact them at different times of day, at four weeks from their quit date (or within 25 to 42 days of the quit date). The four-week outcome for this client is unknown and should therefore be recorded as LTFU on the monitoring form. Socio-economic Classification
Examples for four of the classifications are provided below. Full details are available in the National Statistics Socio-economic Classification User Manual : http://webarchive.nationalarchives.gov.uk/20160105160709/http:/www.ons.gov.uk/ons/dcp14858_179140.xml
Home carers (unpaid): looking after children, family or home.
Managerial and professional occupations: accountant, artist, civil/mechanical engineer, medical practitioner, musician, nurse, police officer (sergeant or above), physiotherapist, scientist, social worker, software engineer, solicitor, teacher, welfare officer. Those usually responsible for planning, organising and co-ordinating work for finance. Intermediate occupations: call centre agent, clerical worker, nursery auxiliary, office clerk, secretary.
Routine and manual occupations: electrician, fitter, gardener, inspector, plumber, printer, train driver, tool maker, bar staff, caretaker, catering assistant, cleaner, farm worker, HGV driver, labourer, machine operative, messenger, packer, porter, postal worker, receptionist, sales assistant, security guard, sewing machinist, van driver, waiter/waitress. Pharmacotherapy treatment
Licensed nicotine containing product Any product containing nicotine that has received a license from the Medicines and Healthcare products Regulatory Agency (MHRA) for use as an aid to cessation. This applies to all products currently defined as nicotine replacement therapies (NRTs) and will apply to any nicotine containing products which receive licences from the MHRA during the course of this and future collections, such as may happen with an electronic cigarette type device. Unlicensed nicotine containing product Any product containing nicotine that has not received a license from the MHRA for use as an aid to cessation. It is expected that this term will mainly cover the use of unlicensed electronic cigarettes.
Licensed medication Any medicine that has received a license from the MHRA and includes NRT, varenicline and bupropion.
49
APPENDIX 6 - HELP2CHANGE SERVICE USER SATISFACTION SURVEY