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PUBLIC HEALTH SERVICES CONTRACT
APPENDIX A
SERVICE SPECIFICATIONS
Service Specification No.
Service
Authority Lead
Provider Lead
Period
Date of Review
A2.0 – COMMUNITY PHARMACY PROVISION OF SMOKING
CESSATION SERVICE
Community Pharmacy provision of Smoking Cessation
Service
Senior Public Health Manager, Wirral Council
Contractor
1st February 2014 – 31 January 2015
6 monthly contract review (and when there is an exception
report)
1. Population Needs
1.1 National/local context and evidence base
Mental Health
The Healthy Lives, Healthy People: Transparency in Outcomes Proposals for a Public Health
Outcomes Framework includes a new target D4.12 Smoking rate of people with serious mental
illness. People with mental ill health are much more likely to smoke and die younger. Almost half
of total tobacco consumption and smoking-related deaths occur in people with a mental disorder.
People with schizophrenia have an average 25-year lower life expectancy than the general
population, which is primarily due to smoking.
Local
Reducing the number of people in Wirral who smoke is a public health priority. Smoking is
implicated in around 70% of all deaths and is a significant causal factor in the development of
many cancers, CVD and respiratory conditions. A survey conducted in September/October 2012
indicated that in the most deprived neighbourhoods in Wirral, particularly within the Seacombe,
Birkenhead, Bidston and Tranmere areas, nearly 34% of the population smoke. This is compared
to an average of 23% across the whole of Wirral. As a result a high proportion of children in these
areas also live in a household where at least one parent/guardian smokes. This places a
significant burden on the health of the most deprived population and is the leading cause of
health inequalities and reduced life expectancy in Wirral.
It is our aim to increase the number of smokers making a quit attempt by offering choice,
removing barriers and encouraging smokers to move along the cycle of change. One of the
strategies used to achieve this will be via the community pharmacy setting. Pharmacies are
ideally placed in the community to issue and dispense Nicotine Replacement Therapy (NRT)
products and deliver stop smoking services.
2. Key Service Outcomes
2.1 Insert any locally agreed outcomes and quality requirements which are NOT Quality
Outcomes Indicators which should be set out in Appendix C (Quality Outcomes Indicators)
The service will ultimately contribute towards the following objectives within the Public Health
Outcome Framework:
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People are helped to live healthy lifestyles, make healthy choices and reduce health
inequalities
Reduced numbers of people living with preventable ill health and people dying
prematurely, while reducing the gap between communities
Smoking prevalence - adults (over 18)
Service outcomes:
To improve the health and wellbeing of Wirral residents who smoke by:
 Improving access to and choice of stop smoking services, including access to
pharmacological and non-pharmacological stop smoking aids.
 Increase the capacity in Wirral to deliver stop smoking services
 Increase the number of 4 week quitters in Wirral
 Helping service users’ access additional treatment by offering referral to specialist
services where appropriate.
2.2 Key Performance and quality outcome indicators
Performance Indicator
Indicator
Quit Dates set
Report on the number of
quit dates set by
smokers by organisation
CO validation
Of Service Users who
successfully quit at 4 or
12 weeks, the
percentage whose
smoking status was selfreported without an
‘attempt’ to otherwise
check smoking status
via CO
Threshold
No threshold
No more than
15%
Method of
Measurement
Consequence
of Breach
Provider to
collate and
submit as part
of the Monthly
Service
Quality
Performance
Report
Provider to
submit
explanation
for failure to
meet
standard and
planned
corrective
action
Provider to
collate and
submit as part
of the Monthly
Service
Quality
Performance
Report
Mitigating
action plan for
1 month.
Failure to
resolve any
performance
issues within
2 months will
result in
application of
financial
penalties
Provider to
collate and
submit as part
Between
of the monthly
4 week Quit Rates
35% and 70%
Service
Quality
Performance
Report
For full definitions of smoking quitters please see Department of Health Local Stop Smoking Services,
Service delivery and monitoring Guidance 2012-13.
Number of Service
Users successfully
quitting at 4 week followup as a percentage of all
those eligible for a 4
week follow-up
3. Scope
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3.1 Aims and objectives of service
Aims:
To contribute towards a reduction in smoking prevalence across Wirral by providing
pharmacotherapy (NRT products) only or pharmacotherapy and a high quality stop smoking
service for people that reside in, work in or are registered with a GP in Wirral.
Objectives:
 Promote and raise awareness of the community pharmacist’s role and display any
material e.g. posters and leaflets, provided by the Wirral Community NHS Trust to
promote and support the service
 Provide the full range of NRT products in line with current pharmacotherapy protocols
and prices
 Identify patients suitable for smoking cessation service
 Provide a high quality stop smoking support service that is equitable to all smokers
 Keep up-to-date with current protocols and procedures and NRT products and prices (by
preferred method of communication)
 Attend at least one network meeting per year provided by Wirral Community NHS Trust
 Maintain a list of staff who have received stop smoking service training that meets the
published National Centre for Smoking Cessation Training (NCSCT) standards
 Work in partnership with staff from the Community Trust to increase the numbers of staff
who are trained as stop smoking intermediate advisers (trained to Level 2 NCSCT
standards)
 Identify and communicate operational challenges to the Community Trust
 Link in with NHS stop smoking campaigns both nationally and locally
3.2 Service description/pathway
Service Description
Stop Smoking services should be seen in the same way as any other clinical service and offered
to anyone who expresses an interest in stopping. There are two core elements to this service:
provision of pharmacotherapy only and provision of pharmacotherapy and behavioural support.
If the contractor provides intermediate stop smoking behaviour support they must provide a
consultation area that is separate from the rest of the pharmacy. The client and adviser must be
able to be seated and conversations, held in normal speaking volume, must not be able to be
overheard
The adviser must be able to allocate dedicated time to clients. Each consultation should be
conducted without interruption.
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The service will consist of up to 8 consultations with the stop smoking adviser. Each
client will receive a course of treatment tailored to his or her individual requirements.
It is the clients’ responsibility to make initial contact with the adviser; thereafter the adviser
will arrange future appointments at mutually convenient times for both parties.
The adviser will follow up any clients failing to attend any session and encourage them to
continue the programme. If the client does not want to continue, the reason will be
recorded appropriately and the smoking status confirmed.
When a pharmacy is unable to support clients themselves, for whatever reason, then the
client must be referred to the Wirral Community NHS Trust (contact to be made through
the main service telephone number 0151 630 8383) who will provide the support. A
waiting list must not be in operation.
An adviser planning a period of leave will not start a client on a stop smoking programme
unless the pharmacy has a second adviser to continue one to one support for the client in
their absence.
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Support will be provided by Wirral Community NHS Trust to ensure that the service model is
consistent with NHS Stop Smoking Services – Service and Monitoring Guidance 2012/13
(Department of Health 2010).
Stop Smoking delivery model must be compliant with the Department of Health Service Delivery
Monitoring and Guidance
The pharmacy contractor will deliver interventions that:
 Reinforce the motivation to quit
 Set a quit date
 Inform client expectations regarding the structure and process of the intervention assess
Nicotine dependence and offer appropriate feedback
 Provide information on the nature of tobacco withdrawal and advice on the management
of withdrawal symptoms
 Give comprehensive advice on appropriate pharmacotherapies, possible side effects and
methods of access
 Monitor pharmacotherapy use
 Build a repertoire of coping strategies
 Include regular CO checks and give feedback on progress
 Troubleshoot specific client problems
 CO-verify quit status four weeks from the quit date, plan on going coping mechanisms
 Provide support and pharmacotherapy at the end of treatment and assess client
satisfaction with the intervention provided
 Provide a high quality service that is delivered in a safe and effective manner by staff that
is appropriately trained in regard to the welfare of children, vulnerable adults and
standards for older people.
 Ensure that formal systems are in place to refer to the specialist Community Trust where
necessary
The service must comply with requirements of the New Equality Bill 2010, and will not treat one
group of people less favourably than others because of their colour, race, culture, religion,
gender, nationality, age, marital status, sexual orientation, disability or ethnic origin.
It is the responsibility of the contractor/pharmacist/pharmacy staff to make reasonable
adjustments to meet the individual needs of their patients.
Carbon Monoxide (CO) monitors
Under this specification the Wirral Community NHS Trust will issue a CO monitor to each
contractor as they are trained and accredited. There will be a limit of one CO monitor per
contractor site. Wirral Community NHS Trust will be responsible for providing mouthpieces for
the monitors and for the calibration of the monitors at the annual update/network meetings.
Calibration is usually every 6 months and the process takes a matter of minutes. It is the
adviser’s responsibility to bring their CO monitor along for calibration. If the CO monitor breaks
the adviser should contact the Community Trust.
The CO monitor must be returned to Wirral Community NHS Trust if a pharmacy is no longer
offering the service.
3.3 Population covered
The service is open to Wirral residents (with a focus on those that live within the 20% most
deprived LSOAs) who are unregistered or registered with a GP within the Wirral boundary and
non- residents who are registered with a Wirral GP practice. People that work in Wirral will also
be eligible for the service, even if they do not reside in the area.
3.4 Any acceptance and exclusion criteria and thresholds
Exclusion - people that live outside Wirral’s Local Authority boundary
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3.5 Interdependencies with other services
This service cannot be delivered in isolation. It must work in partnership with a range of other
providers and organisations, including but not limited to:
 Wirral Council
 Wirral Community NHS Trust
 Third Sector Organisations
 Cheshire & Wirral Partnership NHS Foundation Trust
 Other health professionals
 Service users
3.6 Activity planning assumptions
N/A
4. Applicable Service Standards
4.1 Applicable national standards e.g. NICE
The service provided must be in line with relevant evidence and guidance notably:
In addition the provider should follow guidance set out by the National Institute for Health and
Clinical Excellence (NICE) These will include:
 Brief interventions and referral for smoking cessation in primary care and other settings
(PH001- NICE)
 Workplace health promotion: how to help employees to stop smoking (PH005 - NICE)
 Smoking cessation services in primary care, pharmacies, local authorities and
workplaces, particularly for manual working groups, pregnant women and hard to reach
communities (PH010-NICE)
 Stop Smoking Interventions in Secondary Care Guidance (Department of Health, 2009)
 Quitting smoking in pregnancy and following childbirth (PH026 - NICE)
 School-based interventions to prevent smoking (PH023 - NICE)
 Smoking and patients with mental health problems (Health Development Agency -2004)
4.2 Applicable local standards
Training and Accreditation
Training and accreditation for the provision of stop smoking services must follow the National
Centre for Cessation and Training (NCSCT) Training Standard (2010) www.ncsct.org.uk.
Stop Smoking Adviser status is gained by attending the equivalent of a 2 day Stop Smoking
Adviser (Level 2) course provided by Wirral NHS Community Trust. No fee will be charged for
attending the initial training or subsequent update training. Training dates/times/frequency will be
negotiated by the Community Trust locality team.
Network/update meetings
To ensure high quality service delivery is maintained and advisers are kept up to date with local
and national issues relating to stop smoking, all advisers must attend an update meeting. This is
a one 0.5 day session provided by Wirral Community NHS Trust. A morning, afternoon and two
evening sessions will be available to support attendance and this will be negotiated with the
Trust.
The contractor will nominate a suitable person who will ensure that all staff and locums are aware
of the correct procedures associated with this service.
Supply of Pharmacotherapy
Any pharmacotherapy issued will be in accordance with Protocol for Wirral Stop Smoking
Services (Annexe 1)
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The provider must fully understand and adhere to these guidelines.
 Advisers can supply all forms of NRT as appropriate following assessment.
 It is the responsibility of the adviser to ensure that the client meets the inclusion criteria for
the supply of NRT.
 A health assessment provided by the Trust must be completed with the client at the initial
consultation and signed by the client “as accurate” before an NRT supply is made
Clients who are eligible to pay prescription charges must pay the prescription fee for each
item. These payments will be deducted from the contractor’s reimbursement.
Clients who are usually exempt from prescription charges will not have to pay for their
NRT. The exemption status must be confirmed by the adviser and recorded appropriately
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Clients requesting Varenicline must be referred to Wirral Community NHS Trust or GP for
support.
Standard Operating Procedures (SOP) [SAMPLE ONLY]
See Sample Standard Operating Procedures courtesy of Community Pharmacy Scotland
(Annexe A2.3)
The contractor will have a Standard Operating Procedure (SOP) / protocol which specifically
detail the operational delivery of this service.
The contractor must ensure that all staff including those other than contractors/accredited staff,
involved in the provision of the service, have relevant knowledge, are appropriately trained and
operate within protocols / SOPs, this includes sensitive client centred communication skills
The SOP / protocol should be reviewed at least every two years or before if circumstances
dictate. Each review should be documented and the SOP / protocol subject to version control.
Staff must read, date and sign the SOP/protocol after a review.
Changes to procedure must be highlighted within the SOP / protocol for special attention.
The SOP / protocol must be available to Wirral Council Public Health if requested.
A staff training log which deals specifically with this service must be maintained and should be
available to Wirral Council on request.
The training log must be updated to reflect the review the SOP/ protocol.
It is the Contractors responsibility to ensure that staff they employ are trained and competent to
provide the service.
Contractors and / or staff should not provide the service until trained. The contractor must ensure
that there are systems in place to make locum contractors aware of the enhanced service.
It is the contractor’s responsibility to inform Wirral Council Public Health of any change to staffing
that would mean that the provider was no longer able to provide the minimum levels of service. If
a provider fails to provide the minimum level of service for three months consistently this would
be deemed a breach of contract and necessitate the contractor’s removal from the providers list.
Data training and management
 The Community Trust will provide training, CO monitors, promotional materials and
relevant paperwork
 All data input must be through the secure regional database Quit With Us or via a Trust
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monitoring return form (Annexe 3). If any contractor is unable to do this, the provision of
stop smoking support will not be allowed.
Recording of minimum data requirements and timely returns on completion of intervention
of appropriately completed paperwork is mandatory. Paperwork must be returned to
Wirral NHS Community Trust immediately following completion of the intervention.
Adhere to National Minimum Standards for Clinical Note Keeping
Ensure policies and practice guidance for user participation and involvement in record
keeping are developed and implemented
Ensure data protection protocols are adhered to
Have robust and routine performance management and clinical governance systems to
monitor service quality and facilitate independent audits. The pharmacy may be asked to
participate in Local Authority organised audit of service provision.
Risk Management
 The contractor will have in place robust systems for the identification, mitigation and
management of clinical and non-clinical risk
Evaluation
The Service Model will include regular consultation with service users using the NHS Stop
Smoking Client Satisfaction Survey. Wirral NHS Community Trust will regularly visit active
Contractors to determine the quality assurance of the programme and its delivery.
5. Location of Provider Premises
The Provider’s Premises are located at:
Wirral
6. Required Insurances
6.1 If required, insert types of insurances and levels of cover required (appendix B)
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Employers Liability Public Liability Professional Indemnity -
£10m minimum
£5m minimum
£2m minimum
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ANNEXE A2.1
PROTOCOL FOR
WIRRAL
STOP SMOKING
SERVICE
Public Health
2nd Floor South Wing, Old Market House, Hamilton Street, Birkenhead, Wirral, CH41 5AL
Telephone Number 0151 630 8383
Fax Number 0151 630 8389/90
www.wirralct.nhs.uk
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PROTOCOL FOR NHS WIRRAL STOP SMOKING SERVICE
Page
3
Introduction
Definition of service providers
5
Care pathway
6
Guidance on use of Nicotine Replacement Therapy (NRT), bupropion
(ZYBAN)
and varenicline (CHAMPIX)
8
Protocol for use of NRT
Including adolescents, pregnant/breastfeeding women
12
Smoking and Mental Health
14
Cautions for use of NRT
16
Protocol for use of bupropion
17
Protocol for use of varenicline
18
Monitoring Guidance
20
Protocol for Interventions
22
Carbon Monoxide Fact Sheets and Measurement
25
References
Appendix 1 – Clinically important drug-smoking interactions
Appendix 2 – Client Monitoring Form
Appendix 3 – GP permission letter for NRT
Appendix 4 – Youth Agreement
Appendix 5 – Client agreement for use of NRT during pregnancy
Appendix 6 – GP initiation for varenicline or bupropion
Appendix 7- Varenicline or bupropion follow on prescription request
Appendix 8 – NRT Pathway and appropriate letters for clients using
psychotropic medication
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NHS WIRRAL STOP SMOKING SERVICE
Introduction
Smoking is one of the most significant contributing factors to life expectancy, health
inequalities and ill health, particularly cancer, coronary heart disease and
respiratory disease.
The English Stop Smoking Services consist of a national network of NHS-funded
clinical services to help smokers to stop. They provide a combination of behavioural
support and medication. Research shows that they have the potential to increase
smokers’ chances of stopping by 300% (West, 2010)
NHS Wirral Stop Smoking Service (WSSS) operates under the terms determined by
the White Paper (Dec 98), Smoking Cessation Guidelines and their Cost
Effectiveness, Thorax, The Journal of the British Thoracic Society (Dec 98)
WSSS follows the most up-to-date version of the Department of Health (DH)
Service and Monitoring Guidance (Department of Health 2011). This provides the
guidelines for health professionals and commissioners on the cost effectiveness of
smoking cessation interventions.
All Stop Smoking Advisers need to receive specific training to carry out their role.
Training should conform to standards set out by the NHS Centre for Smoking and
Training (NCSCT)
Definition of service providers
WSSS is defined as the Specialist Service and designated persons who are
entitled to act for that service are known as Intermediate Service Advisers. The
Specialist Service is based at Old Market House, Hamilton St., Birkenhead. CH41
5AL.
Specialist Service
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Intensive stop smoking advice is provided either on an individual basis, in
groups or by proactive telephone counselling. Ongoing support is available
for up to 12 months. Home visits are available on a limited basis.
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The service encourages and develops Intermediate Stop Smoking Advisers
within Primary Care, Wirral University Teaching Hospital NHS Foundation
Trust, Youth Service, Schools and Workplaces by providing training and
ongoing support. Training and support is offered to other health professionals
in the community e.g. Pharmacists, Community Development Workers.
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The Specialist Service can provide help to GP practices to reduce waiting
lists or provide cover for staff absence ensuring a continuous smoking
cessation service. Availability of this service is limited and is restricted to a
specified number of weeks.
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WSSS can liaise with employers to provide a free service to suit employee
needs; from workplace clinics to provision of posters and booklets.
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Brief intervention training is offered to those working in Primary Care and
other settings.
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Monitoring data from both the specialist and intermediate services is collated
and fed back to Commissioners and DH
Intermediate Service
An intermediate stop smoking service consists of health professionals working
within their own sphere of practice offering cessation advice and ongoing support to
their patients / clients under the guidance of the local smoking cessation coordinator and the stop smoking team.
The Role of the Intermediate Practitioner/adviser
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Provide evidence based smoking cessation advice and follow-up support to
individual patients / clients
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Complete and return smoking cessation monitoring data within specified dates
for reporting to DH
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Take a leading role for smoking cessation within their work area by ensuring that
all staff
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are aware of the Intermediate service they are offering and
how patients/clients can access it
are aware of the Specialist service, when and how to make
appropriate referrals
Raise public awareness of the availability of stop smoking services e.g. leaflets,
posters etc
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CARE PATHWAY
Tiered Approach to Stop Smoking Support
It is thought that Brief Advice could be the key in persuading more
smokers to stop.
NICE March 2006
Very Brief advice
30 seconds ASK and record smoking status
ADVISE patient of health benefits
ACT on patient’s response
Brief Intervention
5-10 mins
Discuss Benefits, Treatments,
Refer on to Stop Smoking Service
Intensive support
> 6 weeks
See below
INTENSIVE SUPPORT CARE PATHWAY
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Assess motivation
Inform client about treatment programme
Assess current smoking and review past experiences of quitting
Discuss the use of NRT, bupropion, varenicline (as appropriate)
Discuss client’s behavioural support strategies
Help the patient set a date to stop
Provide useful literature
Explain and conduct Carbon Monoxide measurement
Encourage commitment to attend service
ARRANGE
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Yes
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Arrange weekly follow up visits for 4 weeks
Arrange supply of appropriate pharmacotherapy
At 4 week follow up:
Has the patient stopped smoking?
(See monitoring guidance)
Congratulate success
Complete monitoring data
Arrange follow up
appointment
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No
Complete monitoring data
Identify problem areas
Help reflect on experience
Assess use of therapy
Reinforce benefits of stopping
Ask them to re-commit at a later date
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GUIDANCE ON THE USE OF NRT, BUPROPION AND VARENICLINE
Guidance follows the recommendations made by NICE Technology Appraisal
Guidance 123, Varenicline for Smoking Cessation (July 2007), NICE Public Health
Guidance 10, Smoking Cessation Services (Feb 2008) and the NHS Stop Smoking
Services: Service and Monitoring Guidance 2010/11, NICE Public Health Guidance
26 ’Quitting Smoking in pregnancy and following childbirth’ (2010)
Nicotine Replacement Therapy (NRT), varenicline (Champix) and bupropion
(Zyban) are recommended for smokers who have expressed a desire to stop
smoking. NRT can be used for clients aged 12 years and over. Varenicline and
bupropion should not be used by those under the age of 18 and by women who are
trying to conceive, pregnant or breastfeeding.
Do not favour one medication over another - the clinician and patient should choose
the one that seems most likely to succeed. When deciding which therapy to use
and in which order, discuss the options with the client and take into account:
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Contraindications and the potential for adverse effects
The client’s personal preference
The availability of appropriate counselling or support
The likelihood that the client will follow the course of treatment
Their previous experience of smoking cessation aids
All treatments should only be prescribed as part of an abstinent-contingent
treatment (ACT) in which the smoker makes a commitment to stop smoking.
Do not prescribe NRT, bupropion or varenicline in any combination. This
information is monitored and the DH asks for numbers that have set a quit date and
successfully quit for:
 Those who received both NRT & Zyban either concurrently or consecutively
 Those who received NRT & Champix consecutively
Cigarette smoking can interact with certain medicines. Therefore, the potential for
interactions when a person stops or starts smoking should be borne in mind. Not all
drug-smoking interactions are clinically significant - see appendix 1 for a list of
important interactions.
Please refer to the manufacturer’s Summary of Product Characteristics (SPC) for
full prescribing guidance.
Second or Subsequent Client Referral
Any client may be referred or self-refer to the service on more than one occasion.
Time between treatment episodes
When a client has not managed to stop smoking there is no definitive period of time
between the end of one treatment episode and the start of another. The Stop
Smoking Adviser should use discretion and professional judgement when
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considering whether a client is ready to receive support to stop again (and therefore
start a new episode)
Clients who have Stopped Smoking Prior to Referral to the Service
Clients who present to the service who have already commenced a programme to
stop smoking and request extra support and guidance will still be eligible for NRT
provided they meet the criteria, and they have quit within the 14 days prior to
attending the service.
PROTOCOL FOR THE USE OF NRT
Department of Health guidance recommends offering all pharmaceutical therapies
as first line options to people who are planning to stop smoking. This open choice is
currently offered to residents of Wirral
NRT will be issued to clients if they meet the criteria below:
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Motivated to quit and ready to set a quit date
Have no health deficit which may preclude the use of NRT via the Stop
Smoking Service (following completion of the Initial Assessment Health
Questionnaire, see appendix 2)
Are over 12 years of age (see page 10 section for use of NRT by
adolescents of 12-18 years for further information)
Following a review by the Medicines and Healthcare products Regulatory Agency
(MHRA) in 2005, NRT can now be used by adolescents aged 12 and over, pregnant
women and people with cardiovascular disease, providing the risks and benefits
should be clearly explained and behavioural support given. www.mhra.gov.uk
Clients with Health Problems
If a client has answered ‘yes’ to any of the questions in the Initial Assessment
Health Questionnaire the adviser should consult ‘Cautions for Use of NRT’ page
14, and if still unsure, will approach the client’s GP (with the client’s agreement) for
permission to recommend the use of NRT. A standard letter is available with a
reply slip (appendix 3). Only with the GP’s permission will NRT be recommended
and a voucher issued.
Distribution Process
 After referral to NHS Wirral Stop Smoking Service, the client will commence a
stop smoking programme appropriate to their individual needs. He/she will be
encouraged and supported to set a quit date.
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An NRT voucher will only be issued to clients meeting the criteria described
above.
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The type and strength of NRT to be used will be discussed between the client
and the adviser and a recommendation entered on the voucher including the
quantity to be issued.
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A voucher for NRT can be issued weekly for the first 4 weeks.
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If at the 4 week follow-up the client has stopped smoking and has not had a
cigarette (even a puff) in the 3rd or 4th week, the remaining vouchers can be
issued for 2 weekly intervals if required.
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A maximum of 12 weeks NRT can be issued in total
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Consider offering a combination of nicotine patches and another form of NRT
(such as gum, inhalator, lozenge, nasal or mouthspray) to people who show a
high level of dependence on nicotine or who have found single forms of NRT
inadequate in the past.
Combination of products
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If combining NRT products e.g. patch plus 2mg gum, the smallest pack/item size
available of the supplementary product should be issued.
If combining NRT products e.g. a patch plus 2mg gum, the supplementary
product may only be issued to the client to a maximum of 4 (i.e. 1 week) vouchers
over the 12 week period. The vouchers do not have to be issued in the first 4
weeks, i.e. the client may choose to have a supplementary product issued every
two or three weeks.
The voucher should indicate 1 week of patches and 1 week of supplementary
product (maximum of 2 items)
If paying for the prescription this will cost £15+ (because of differing products)
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If the client finds the supplementary product useful, a larger pack can be issued
but only on THREE more occasions within the 12 week period. If after 4
vouchers the client feels they still need the supplementary product they will be
required to purchase it themselves
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the maximum amount of NRT that can be issued on ONE voucher is 2 items
o e.g. 2 weeks patches
o or 2 weeks lozenges
No more than two items can be issued on each voucher. If more than 2 weeks is
required because of shift work, holidays etc another post-dated voucher must be
written out.
If issuing NRT for two weeks, put two weeks patches on one voucher and
supplementary product on another voucher
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The voucher can be redeemed by the patient / client at a Wirral pharmacy of
his/her choice.
The legal responsibility for issuing the product rests with the pharmacist and all
participating Wirral pharmacists reserve the right to discuss the chosen product
again with the client. The pharmacist may issue a different form or dose of NRT if it
is felt appropriate, but an explanation for the reason for the modification must be
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given on the voucher.
discretion.
The brand of product chosen is at the pharmacist’s
Use of Nicotine Replacement Therapy by Adolescents of 12-17 years
NRT can be used by adolescents aged 12-17years but as there are limited data on
the safety and efficacy, duration should be restricted to 12 weeks. Treatment should
only be continued for longer than 12 weeks on the advice of a healthcare
professional.
The young person should have sufficient maturity to understand about the service
they are to receive. Once children reach the age of 16, they are presumed in law to
be competent to give consent for themselves. Clients under 16 who have sufficient
understanding and intelligence to enable them to understand fully what is involved
in a proposed intervention will also have the capacity to consent to that intervention.
This is sometimes described as being ’Frazer’ competent.
If the young person has answered ‘yes’ to any of the questions in the Initial
Assessment Health Questionnaire the adviser should consult ‘Cautions for Use of
NRT’ page 14, and if still unsure, will approach the client’s GP (with the client’s
agreement) for permission to recommend the use of NRT. A standard letter is
available with a reply slip (appendix 3). Only with the GP’s permission will NRT be
recommended and a voucher issued.
The young person should complete the Client Agreement for the use of NRT
form giving his/her signed consent to using NRT safely according to the written
guidance in the relevant Summary of Product Characteristics. This form should
also be signed by the adviser and kept with the young person’s records. (See
appendix 4)
Nicotine Replacement Therapy during Pregnancy and Breast Feeding
The data available on the use of NRT in pregnancy and breast feeding women is
limited. To eliminate all possible risks from nicotine a women would ideally stop
smoking without using NRT. However, the risk to the fetus of continued smoking is
likely to be greater than any potential risks from NRT because cigarette smoking, in
general, delivers more nicotine than does NRT, and it exposes both mother and
fetus to many other toxins. In light of this, the Working Group of the Committee on
Safety of Medicines (CSM) 2005 and NICE (2010) have advised that pregnant and
breastfeeding women, who cannot stop smoking on their own, can use NRT.
Pregnancy
The decision to use NRT should be made following a risk-benefit assessment as
early in pregnancy as possible. The aim should be to discontinue NRT after 2-3
months. Intermittent forms of NRT are preferable during pregnancy but a patch may
be appropriate if nausea and/or vomiting are a problem. A 16 hour patch is
preferable to a 24 hour patch and pregnant women who are using nicotine patches
should be advised to remove them before going to bed to avoid the administration
of nicotine overnight. The dosage of NRT suggested should be kept at a lower level
than the pregnant woman would be taking if she had continued to smoke and the
therapy be used for the shortest time possible.
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Breastfeeding
The amount of nicotine the infant is exposed to from breast milk is relatively small
and is less hazardous than the second-hand smoke the infant would otherwise be
exposed to if the mother continued to smoke. For breast-feeding mothers,
intermittent NRT products are preferred as they will allow the time between NRT
use and feeding to be as long as possible to minimise the amount of nicotine in the
milk.
Before issuing NRT via a voucher:
 Discuss the risks and benefits of NRT with pregnant women who smoke.
 Obtain written confirmation from the mother that the risks and benefits have
been explained and understood. This agreement form is to be kept with the
client’s smoking case notes. (See appendix 5)
Partners and others in the household who smoke
Provide clear advice about the danger that other people’s tobacco smoke poses to
the pregnant woman and to the baby – before and after birth. Recommend that
other members of the household do not smoke around the pregnant woman, mother
or baby. This includes not smoking in the house or car. Encourage other members
of the household to stop smoking (follow the care pathway Page 4).
Smoking and Mental Health
People with mental illness are more likely



To be heavy, more dependent smokers
Have smoked for a longer time
To be suffering from a smoking related illness –respiratory, cardiac etc
A longer treatment course may be necessary for smokers with mental health
problems.
Positive effects of smoking cessation on mental health
On cessation, depression and anxiety can decrease. However a minority may
experience an increase in depressive symptoms.
Smoking Cessation and Depression
Depression (and in rare cases suicidal thoughts) can be a symptom of nicotine
withdrawal with or without pharmacotherapy. Stop smoking advisers should be
aware of the possible emergence of significant depressive symptomatology in
clients undergoing a smoking cessation attempt, and should advise patients
accordingly.
Smoking Cessation and Schizophrenia
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No evidence to show any worsening of symptoms after stopping smoking.
Stopping smoking can result in significant reduction of dosage of mental health
medications.
Stopping smoking and medication
Smoking increases the metabolism of certain medications. Therefore smokers on
these medications need a larger dose to achieve a therapeutic effect.
A positive outcome of stopping smoking is that the patient may require a lower dose
of their mental health medication.
Clients using certain mental health medications may need monitoring by their health
care professional in case their dosage needs adjusting.
Medications affected in this way include, among many others:

Benzodiazepines: diazepam, zotepine

Antipsychotic medication: clozapine, fluphenazine,perphenazine,
Haloperidol (partly), olanzapine (partly)

Antidepressants: tricyclics – tertiary
Pharmacotherapy
NRT has no specific contraindications or cautions relating to mental health
disorders.
Bupropion has been shown to be effective for people with depression and
schizophrenia. Bupropion can also increase blood levels of citalopram, which
should be avoided for two weeks after stopping. It is also contraindicated with
monoamine oxidase inhibitors (MAOIs).
Medical history and current medications
Medical history and current medications should always be asked and recorded
during the first stop smoking appointment. If a client is using medications which
would be affected by stopping smoking the GP and key mental health worker
should be informed. See Appendix 8
Quit status should be regularly assessed and if client relapses, the health care
professional should be made aware to ensure appropriate readjustment of
medication.
CAUTIONS FOR USE OF NICOTINE REPLACEMENT THERAPY (NRT)
Risks/benefits must be considered before prescribing NRT in the following
circumstances (in line with Committee on Safety Medicines recommendations):
1. Cardiovascular disease
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For patients with stable cardiovascular disease, NRT is a lesser risk than continuing
to
smoke. Dependent smokers with severe or unstable cardiovascular disease
(including hospitalization with a recent myocardial infarction, severe arrhythmia or
recent cerebrovascular accident) should be encouraged to stop smoking with nonpharmacological interventions.
If this fails NRT may be considered but as data on safety in these patient groups
are limited, initiation of NRT should only be done under close medical supervision.
Contact GP by letter. Use short acting NRT (i.e. inhalator or lozenges).
2. Adolescents
Ideally, a young person should stop smoking without using NRT but if this is not
possible,
NRT may be used by adolescents aged 12 to 18 years. Duration should be
restricted to 12 weeks since there are limited data on safety and efficacy. Treatment
should only be
continued for longer than 12 weeks on the advice of a healthcare professional.
See WSSS’s protocol Page 9 for use of NRT with adolescents.
3. Pregnancy
Ideally, pregnant women should stop smoking without using NRT but if this is not
possible, NRT may be recommended to assist a quit attempt as it is considered that
the risk to the fetus of continued smoking by the mother outweighs any potential
adverse effects of NRT. The decision to use NRT should be made following a riskbenefit assessment as early in the pregnancy as possible. The aim should be to
discontinue NRT use after 2-3 months. Intermittent forms of NRT are preferable
during pregnancy although a patch may be appropriate if nausea and/or vomiting
are a problem. If patches are used, they should be removed before going to bed at
night – use the 16 hour patch. Ensure the dose is kept at a level lower than if the
patient had continued to smoke.
See WSSS’s protocol Page 10 for use of NRT with pregnant women.
4. Breastfeeding
NRT can be used by women who are breast-feeding. The amount of nicotine the
infant is
exposed to from breast milk is relatively small and less hazardous than the secondhand
smoke they would otherwise be exposed to if the mother continued to smoke. If
possible,
patches should be avoided. NRT products taken intermittently are preferred as their
use
can be adjusted to allow the maximum time between their administration and
feeding of the baby, to minimise the amount of nicotine in the milk.
See WSSS’s protocol Page 10 for use of NRT with women who are breast feeding.
5. Diabetes mellitus
Nicotine releases catecholamines that can affect carbohydrate metabolism. Diabetic
patients should be advised to monitor their blood sugar levels more closely than
usual when starting NRT.
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6. Renal or hepatic impairment
NRT should be used with caution in patients with moderate to severe hepatic
impairment
and/or severe renal impairment, as the clearance of nicotine or its metabolites may
be
decreased, with the potential for increased adverse effects.
7. Skin disease / broken skin
Avoid using patches.
8. Hyperthyroidism
If uncontrolled
9. Phaeochromocytoma
A vascular tumour in the adrenal medulla. There is uncontrolled and irregular
secretion of
adrenaline and nor adrenaline resulting in high blood pressure,
raised heart rate and headache.
10 Oesophagitis, gastritis, peptic ulcers
Caution with oral products
ADVERSE EFFECTS
If the patient experiences the following symptoms, NRT should be immediately
discontinued (if a patch is prescribed, it should be removed). Medical advice
should be
sought in the following situations:
• chest pains
• suspected thromboembolism
• palpitations
• significant rise in blood pressure
• severe skin reaction with use of patches
NRT may cause similar adverse reactions to smoking and include:
• headache
• cold and flu-like symptoms
• insomnia
• nausea
• dizziness
• myalgia
• dyspepsia
• throat irritation with inhalator/ heartburn with lozenges
• skin reaction with patches
PROTOCOL FOR THE USE OF BUPROPION (ZYBAN)
Bupropion is a prescription-only drug licensed for use in smoking cessation with
motivational support. Bupropion can only be issued on prescription and not through
the Wirral voucher scheme. However, the Specialist or Intermediate adviser should
provide ongoing support, advice and follow-up during the treatment period. A letter
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should be sent to the patient’s GP advising them that the patient has expressed an
interest in bupropion and asking them to clinically assess if it is appropriate for this
patient (appendix 6).
If the GP considers bupropion appropriate and has prescribed the initial
prescription, a follow on prescription can then be requested (appendix 7), providing
the patient has been reviewed by a Stop Smoking Adviser and has not suffered any
adverse effects.
Bupropion should not be used in combination with either NRT or varenicline and
should be prescribed in accordance with the recommendations in the Summary of
Product Characteristics (SPC).
Contraindications
 History of seizures or of eating disorders, bipolar disorder, a CNS tumour,
severe hepatic cirrhosis, patients experiencing acute symptoms of alcohol or
benzodiazepine withdrawal, risk factors for seizures (unless the potential
benefit of smoking cessation clearly outweighs the risk)
 Factors that increase the risk of seizures include concomitant administration
of drugs that can lower the seizure threshold (e.g. antidepressants,
antimalarials [such as mefloquine and chloroquine], antipsychotics,
quinolones, sedating antihistamines, systemic corticosteroids, theophylline,
tramadol), alcohol abuse, history of head trauma, diabetes, and use of
stimulants and anorectics.
 Concomitant administration of Monoamine-oxidase inhibitors (MAOIs)
 Women who are pregnant or breastfeeding
 Patients under 18years
Cautions
 Elderly patients (max dose150mg daily)
 Predisposition to seizures (see above)
 Monitor blood pressure before and during treatment
Interactions: Drugs known to lower the seizure threshold (e.g., antipsychotics,
antidepressants, antimalarials, tramadol, theophylline, systemic steroids,
quinolones and sedating antihistamines), citalopram, MAOIs, antipsychotics, beta
blockers, carbamazapine, phenytoin, valproate, ritonavir, theophylline, clozapine,
other drugs metabolised by CYP 2D6 or CYP 1A2, other inhibitors or inducers of
CYP 2B6. See SPC for full list of interacting drugs.
Dose: Start 1 – 2 weeks before stop date, initially 150mg daily for 6 days then
150mg twice daily (max. daily dose 300mg or 150mg in patients with risk factors for
seizures). See BNF / SPC for full prescribing details. Initial prescription should be
for 4 weeks.
PROTOCOL FOR THE USE OF VARENICLINE (CHAMPIX)
Varenicline is a prescription-only drug licensed for use in smoking cessation with
motivational support. Varenicline can only be issued on prescription and not
through the Wirral voucher scheme. However, the Specialist or Intermediate adviser
should provide ongoing support, advice and follow-up during the treatment period.
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An initial letter is sent to the patient’s GP advising them that the patient has
expressed an interest in varenicline and asking them to clinically assess if it is
appropriate for this patient (appendix 6). Varenicline has been shown to increase
the chances of long term abstinence two-to-three fold.
If the GP considers varenicline appropriate and has prescribed the initial
prescription, a follow on prescription can then be requested (appendix 7). This is
providing the patient has been reviewed by a Stop Smoking Adviser and has not
suffered any adverse effects.
Varenicline should not be used in combination with either NRT or bupropion and
should be prescribed subject to the contraindications and precautions listed in the
Summary of Product Characteristics (SPC) some of which are listed below.
Contraindications
 Women who are pregnant or breastfeeding
 Patients under 18 years
Cautions
 History of psychiatric illness (see below)
 Irritability, depression and insomnia on discontinuation
Adverse psychiatric reactions
A 2007 Cochrane review reported that the most common adverse effect was mild to
moderate levels of nausea, which subsided over time.
The Medicines and Healthcare products Regulatory Agency (MHRA) highlighted
that depression, suicidal thoughts, suicide attempts and completed suicides have
been reported in people taking Varenicline who have no pre-existing psychiatric
conditions and advises care if prescribing to those with psychiatric illnesses. If
patients who are taking varenicline who develop suicidal thoughts or who develop
agitation, depressed mood, or changes in behaviour that are of concern for the
doctor, patient, family, or caregiver should stop their treatment and contact their
doctor immediately.
Dose: Start 1 -2 weeks before stop date, initially 500mcg once daily for 3 days,
increased to 500mcg twice daily for 4 days, then 1mg twice daily for 11 weeks
(reduce dose to 500mcg twice daily if not tolerated). The initial prescription should
be for the varenicline 2 week starter pack of 11 x 500mcg tablets and 14 x 1mg
tablets). Locally it has been agreed that the duration of treatment is 12 weeks.
Interactions: No clinically meaningful interactions
MONITORING GUIDANCE
The Department of Health (DH) have issued guidance on the monitoring of Stop
Smoking Services.
A full copy may be seen at Wirral Stop Smoking Service
The minimum data requirements have been incorporated on the WSSS Client
Monitoring Form. WSSS adheres to the Russell Standard when recording the
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numbers of smokers entering treatment and the numbers successfully quit at 4
weeks.
It is important that all the data requested is collected. See Separate Data File
for notes on completion of monitoring form and completion of NRT
voucher/prescription.
Please note that only clients who actually set a quit date should be included.
(Anyone who receives a NRT voucher or a prescription for Bupropion (Zyban) or
Varenicline (Champix) is deemed as having set a quit date)
The Department of Health want to know the outcome of quitters 4 weeks after their
quit date using a Carbon Monoxide reading as verification.
This verification can be either -3 or +14 days either side of the 4 week follow up
date.
Follow Up
The 4 week follow-up and Carbon Monoxide (CO) validation, where possible should
be completed within six weeks of the quit date.
Up to three attempts should be made to reach the client by telephone/letter. Any
client not contacted after these attempts should be assumed to be 'lost to follow-up'
A client's permission should be sought for consent to treatment, follow up and
outcome data to be sent to WSSS. It is recommended that this is done during the
first consultation.
The client should understand that someone from WSSS may contact them at a
future date.
www.dh.gov.uk/en/publicationsandstatistics
www.scsrn.org/clinical_tools/russell_standard_clinical.pdf
The top white copy of each client's monitoring form can be sent to WSSS
as soon as the 4-week follow up is completed. Advisers can continue to see clients,
using the yellow copy of the client's monitoring form for their own information.
Carbon Monoxide Validation
Information on the outcome of CO ppm monitoring should be included on the
monitoring form.
CO ppm readings of less than 10ppm should be taken as an indication that the
client is not smoking at that point in time.
If a client does not wish or is unable to undertake validation, then this should be
recorded as an attempted validation and as a ‘Self Report Quit’
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Spontaneous Quitters
Smokers, who have stopped smoking when they first come to the attention of the
service, may only be counted as having been ‘treated’ if they have quit within the
last 14 days and are willing to attend appointments. If they have been quit for longer
than 2 weeks they should not be included in reporting data.
Protocol for Interventions:
Initial Consultation, Follow up
appointments, Rolling Group, Drop in, Closed Group, Telephone
Contact, Home Visit
All interventions should be multi sessional with a total potential client contact time of
at least 1.5 hours. This will ensure effective monitoring, client compliance and on
going access to medication.
Initial consultation
The initial consultation should take place in a confidential setting. The client will be
asked to complete a questionnaire on health status, smoking history and habits.
(Appendix 2) If the client has literacy difficulties, large print version is available or
the adviser will complete the questions with the client.
Thirty minutes is allocated to initial appointments and 15 minutes for follow up
appointments. The number of follow up appointments required will vary depending
on the need of the client.
If the client has failed to attend their first appointment or subsequent appointments,
contact should be attempted by letter or telephone (see letters)
Suggested Pathway for Initial Appointment depending on client’s needs












Welcome, establish rapport
Discuss confidentiality
Assess motivation
Inform client about treatment programme
Assess current smoking and review past experiences of quitting
Screen for medications
Discuss the use of NRT, bupropion, varenicline (as appropriate)
Discuss client’s behavioural support strategies
Help the patient set a date to stop
Provide useful literature
Explain and conduct Carbon Monoxide measurement
Encourage commitment to attend service
Follow up Appointments
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Follow up appointments lasting approximately 15 mins. should ideally be weekly for
first 4/5 weeks and subsequently every 2 weeks. During these sessions the
following topics should be covered depending on the client’s needs.









Assess progress
Withdrawal symptoms of stopping smoking and coping strategies
Suitability of chosen therapy, side effects and facilitate further supply as per
WSSS protocol
Reinforce benefits of stopping smoking that are personal to client
Carbon Monoxide measurement
Maximising the motivation to remain abstinent and achieve goal of
permanent cessation including discussing coping strategies for high risk
situations i.e. relapse prevention
Boosting self confidence
Encourage attendance particularly 4 week post quit date
Provision of telephone help lines
Rolling Group / Closed Group/ Home Visit
These types of intervention should follow the same specification as initial and follow
up appointments. If a Home Visit is required contact WSSS.
Telephone Contact
Proactive telephone intervention should follow the same specification as initial and
follow up appointments. It should begin and end with a face-to-face session for
Carbon Monoxide validation.
Reactive telephone support may be provided as part of a relapse prevention
strategy.
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CARBON MONOXIDE
Carbon monoxide (CO) is a poisonous, colourless, odourless gas that is emitted in
high concentrations from burning cigarettes, car exhaust fumes and faulty gas heaters.
Carbon Monoxide is poisonous because it binds strongly to haemoglobin displacing
oxygen. Up to 15% of a smoker’s blood can be carrying carbon monoxide instead of
oxygen. Reduced oxygen capacity is particularly damaging during pregnancy or if
lung function is impaired. The effects of chronic exposure to carbon monoxide include
headache, fatigue, and poor concentration. Many of the cardiovascular problems
arising in smokers are attributed to the effects of carbon monoxide.
The CO monitor is an extremely effective way of raising awareness about the harmful
effects of smoking and can act as an incentive to help smokers quit.
There are a number of CO monitors available and exact instructions vary. All the
monitors work by measuring the level of the gas exhaled in the breath, with the
reading shown on a display as parts per million or as the proportion of blood carrying
CO.
A rough guide to readings:
Cigarette
consumption
Carbon Monoxide
ppm
Carbon Monoxide as
% of haemoglobin
Non smoker
Light smoker
Heavy smoker
Suspected poisoning
0-5
6-10
11-70
>70
0-0.8%
1-1.6%
1.8-12%
>12
CO has a cumulative effect – with each cigarette smoked the levels in the blood can
increase by 5-10ppm. Smoking alone cannot lead to a lethal dose of CO as the body
has a self-regulating mechanism. This is why 60 a day smokers might not have twice
the CO of 30 a day smokers.
It should be stressed that after stopping smoking for 24 hours, the CO levels
drop to that of a non-smoker. This is an extremely positive short-term goal for
smokers and provides an almost immediate health gain.
FACTORS AFFECTING CARBON MONOXIDE LEVELS

Number of cigarettes smoked and depth of inhalations. Readings tend to be lower
in the morning and higher in the afternoon.
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
Time of last cigarette – smoking regularly over a long period produces lower
readings than smoking the same number in quick succession.

Type of cigarette – low tar brands, herbal and menthol tend to produce more CO.
Hand rolled cigarettes yield less CO but more tar.

Occupation. Workers exposed to large numbers of vehicle emissions are at risk of
having abnormally high CO levels irrespective of their smoking habit.

Cigar smokers, if they are ex cigarette smokers, may have very high CO readings.
This is because they have continued their practice of inhalation learnt whilst
smoking cigarettes.
ALSO REMEMBER
 All readings measure CO encountered over a 24-hour period.

There is no average or normal level of CO for smokers as it depends on other
factors as described above

People can eliminate the CO more rapidly by being more physically active.

CO reading is required at 4 week follow up to verify quit
Carbon Monoxide Poisoning
Common symptoms of mild CO poisoning are:




Headache
Feeling sick/nausea
Feeling tired and confused
Vomiting and abdominal pain
All clients who have CO readings higher than 10ppm despite stopping smoking can
be asked to call the free HSE Gas Safety advice line on 0800 300 363 for advice.
www.dh.gov.uk/en/publicationsandstatistics/Publications/PublicationsPolicyAnd
Guidance/DH_090124
Carbon Monoxide Monitor Protocol
Hand sanitiser gel
Hand sanitiser gel should be used before and after using machine. Hands must be dry
before touching CO monitor.
Cardboard mouthpieces
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Single use only, change for every patient/client. Ask the patient/client to put their own
tube into machine and remove after use.
Plastic adaptor piece
The adaptor contains a one way valve that prevents inhalation from the monitor. The
adaptor should be changed according to manufacturer’s instruction. (Micromedical
every 6 months)
Cleaning
The mouthpiece adaptor can be cleaned using a mild detergent solution.
The monitors should be wiped down using non-alcohol wipes, ideally at the end of
each session.
Calibrating
All monitors should be calibrated every 6 months. Contact Wirral Stop Smoking
Service to arrange calibration.
Operation Quick instructions
Select CO-ppm position on monitor.
See booklet for more information.
There is a 20sec countdown when patient should be asked to inspire and hold breath.
As this is too difficult for some, aim to get a breathhold of 10sec.
Ask patient to place lips around cardboard tube and exhale slowly and fully.
Before repeating, the unit should be turned off and plastic adaptor removed for 2
minutes.
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Useful Resources / References
www.smokefree.nhs.uk/resources
www.nice.org.uk/
www.mhra.gov.uk/index.htm
www.ash.org.uk/
www.breastfeedingnetwork.org.uk
www.smokefree-northwest.net
www.quit.org.uk
NHS STOP SMOKING SERVICES : Service and monitoring guidance 2010/11.
www.dh.gov.uk/publications
NHS STOP SMOKING SERVICES: Key updates to the 2011/12 service delivery and
monitoring guidance for 2012/13
Brief Interventions and referral for smoking cessation in primary care and other
settings. National Institute for Health and Clinical Excellence, March 2006
Rollnick S, Mason P, Butler C 1999.
practitioners. Churchill Livingstone.
Health Behaviour Change. A guide for
Harm Reduction in Nicotine Addiction. Helping people who cannot quit. A report of the
Tobacco Advisory Group of the Royal Physicians. Oct 2007. The Royal College of
Physicians
Appendix 1 – Clinically important drug-smoking interactions
BNF category/
Drug name
Nature of interaction
Clinical
relevance
Action to take when stopping
smoking
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2.8.2
Warfarin
Warfarin is partly metabolised
via CYP1A2. An interaction
with smoking is not clinically
relevant in most patients.
Moderate
If a patient taking warfarin stops
smoking, their INR might increase so a
healthcare professional should monitor
the INR more closely. Advise patients to
tell the physician managing their
anticoagulant control that they are
stopping smoking.
High
A healthcare professional should
monitor
plasma
theophylline
concentrations and adjust the dose of
theophylline accordingly.
The dose of theophylline may need to
be reduced by about one quarter to one
third one week after withdrawal.
The dose of warfarin is
adjusted according to a
patient’s INR (International
Normalised Ratio).
3.1.3
Theophylline
Theophylline is metabolised
principally via CYP1A2.
Smokers require higher doses
of theophylline than nonsmokers due to theophylline’s
shortened
half-life
and
increased elimination.
Some
reports
suggest
smokers may need twice the
dose of non-smokers.
4.2.1
Chlorpromazine
Chlorpromazine
metabolised principally
CYP1A2.
is
via
Advise the patient to seek help if they
develop signs of theophylline toxicity
such as palpitations or nausea.
Moderate
Be alert for increased adverse effects of
chlorpromazine
(e.g.
dizziness,
sedation, extra-pyramidal side effects).
If adverse effects occur, reduce the
dose as necessary.
Smokers have lower serum
levels
of
chlorpromazine
compared with non-smokers.
4.2.1
Clozapine
Clozapine
is
metabolised
principally via CYP1A2 and
clearance is increased in
smokers. Serum clozapine
levels are reduced in smokers
compared with non-smokers;
smokers may need higher
dosages.
There have been case reports
of adverse effects in patients
taking clozapine when they
have stopped smoking.
Monitor by a healthcare professional
High
Contact the pharmacy team at
Cheshire and Wirral Partnership
Trust for guidance
Monitor serum drug levels before
stopping smoking and one or two weeks
after stopping smoking.
Be alert for increased adverse effects of
clozapine. If adverse effects occur,
reduce the dose as necessary.
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4.2.1
Olanzapine
6.1.1
Insulin
Olanzapine is metabolised
principally via CYP1A2 and
clearance is increased in
smokers. Serum olanzapine
levels are reduced in smokers
compared with non-smokers;
smokers may need higher
dosages.
Moderate
Smoking is associated with
poor glycaemic control in
patients with diabetes.
Smokers may require higher
doses of insulin but the
mechanism of any interaction
is unclear.
Moderate
Monitor by a healthcare professional
Be alert for increased adverse effects of
olanzapine
(e.g.
dizziness,
sedation,
hypotension). If adverse reactions occur,
reduce the dose as necessary.
If a patient with insulin-dependent diabetes
stops smoking, their dose of insulin may
need to be reduced.
Advise the patient to be alert for signs of
hypoglycaemia and to test their blood
glucose more frequently.
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PLEASE PRINT IN CAPITALS
Clients Full Name
Health Questionnaire
TOP SECTION FOR ADMIN USE ONLY
Date of Birth
:
Time should be recorded in 24 hour clock.
All entries to be legible with adviser signature,
NHS Number
:
:
Appendix 2
followed by printed full name and designation
Thank you for using Wirral Stop Smoking Service for your quit attempt. We would be
grateful if you would fill in this questionnaire as accurately as possible as we have to
provide anonymous information to the Government and Department of Health.
This is to ensure that the service is meeting the needs of the population and so that we
can fully support you in your attempt to stop smoking.
By choosing your local NHS Stop Smoking Service you are four times more likely to stop
than if you quit alone. Our trained Advisers offer non-judgemental support and
motivation during your attempt and even If you start smoking again, we will be here to
support you if you wish to try and quit in the future.
Equality and Diversity Monitoring (Please tick in relevant box)
Gender
Male
Female
Transgender Other
Do you consider yourself to have a Yes
No
disability or long term health
condition?
If yes, please identify the
Condition
Sexual
Bisexual
Gay Man Gay Woman Heterosexual
Orientation
/ Lesbian
/ straight
Religion
belief
or Christianity
Sikhism
Prefer not
to say
Prefer not
to say
Prefer not
to say
Prefer not
to say
Buddhism Hindu
Judaism
Islam
Atheism
None
Prefer not
to say
Other
religion
Health Questionnaire. Please tick if you have ever suffered/currently suffer from
the following:
Asthma / breathing
difficulties
Heart disease / angina
Epilepsy / history of seizures
Dermatitis
disorders
or
other
skin
Stomach / duodenal ulcer
Stroke / Circulatory disorder /
High blood pressure
Mental ill Health.
Diabetes
Serious liver or kidney
disease
Overactive thyroid
Are you pregnant/trying to
become pregnant or
breastfeeding?
If yes, did you require any treatment?
Yes 
2013/14
PUBLIC HEALTH SERVICES CONTRACT
No 
Please list any other medical issues or current medications here:
Yes 
Are you entitled to free prescriptions?

Health Questionnaire
PLEASE PRINT IN CAPITALS
TOP SECTION FOR ADMIN USE ONLY
Clients Full Name
Time should be recorded in 24 hour clock.
All entries to be legible with adviser signature,
Date of Birth
:
NHS Number
:
followed by printed full name and designation
No
:
Smoking Habits and History
1
Have you ever tried to stop smoking Yes 
No 
before?
2
If yes, what methods did you use to stop? Nicotine Replacement Therapy 
Champix 
Zyban 
Other 
3
Do you smoke in the home or car?
Admin use
Home  Car 

No 
Smokefree
Pledge?
4
If yes, Do you live with children?
Yes
5
Do you use any other tobacco products?
Yes 
6
Do you hand roll tobacco? If yes, how _____________ Grammes / ounces
much /week
How soon after waking do you smoke
your first cigarette? (Please state.)
_____________ Minutes
7
8
9
10
Do you find it difficult to stop smoking in
no smoking areas?
Yes 
No 
No 
Which cigarette will you hate most to give
______________________________
up?
st
(For example 1 in the morning)
How many cigarettes per day do you
usually smoke? (Please state.)
______________________________
I confirm that the information on the previous pages is accurate to the best of my
knowledge.
Client signature: _____________________________ Date: _____________
Print name: _______________________________ Time: __________(24 hour)
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Adviser’s signature: _____________________________ Date: _____________
Print name: ______________________________________________________
Job title:
________________________________ Time:__________(24 hour)
2013/14
PUBLIC HEALTH SERVICES CONTRACT
PLEASE PRINT IN CAPITALS
Health Questionnaire
Clients Full Name
TOP SECTION FOR ADMIN USE ONLY
Time should be recorded in 24 hour clock.
All entries to be legible with adviser signature,
followed by printed full name and designation
Date
Time
Date of Birth
:
NHS Number
:
Notes
:
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Health Questionnaire
TOP SECTION FOR ADMIN USE ONLY
Time should be recorded in 24 hour clock.
All entries to be legible with adviser signature,
PLEASE PRINT IN CAPITALS
Clients Full Name :
Date of Birth
:
NHS Number
:
followed by printed full name and designation
Date
Time
Notes
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Appendix 3 – GP permission letter for NRT
Dear Dr
Your patient: ___________________________ Date of Birth ___/____/_____
The above patient is very keen to quit smoking and to use nicotine replacement
therapy (NRT), which has been shown to double quitting success rates, whilst
proving much less damaging to health than smoking even for those with established
health problems.
Following completion of the Initial Assessment Health Questionnaire the patient has
been identified as having a health problem in which the use of NRT is cautioned.
To enable us to recommend the use of NRT to your patient, please complete
the details below and return this letter to the Stop Smoking Service on:
Fax
Yours sincerely,
Stop Smoking Adviser
I agree / disagree to the above patient of mine using nicotine replacement therapy:
Doctors Name: ______________________
Signature: __________________________
Date: _____/____/_____
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Appendix 4 - Client Agreement for the use of Nicotine Replacement Therapy
(NRT) by Young People of 12-17 years
For attention of client
Name:
Address:
Please sign below to confirm that you have understood the information that has
been given to you by your Stop Smoking Adviser in relation to using Nicotine
Replacement Therapy.
I understand that:




This is a confidential service and my parents will not be contacted without my
agreement
I would like to use Nicotine Replacement Therapy
I should not exceed the recommended dose of nicotine
I should not use nicotine replacement therapy and smoke at the same time
Client signature:………………………………. Date:………………
For attention of Stop Smoking Adviser
I have discussed all the issues relating to the use of Nicotine Replacement
Therapy and the effects of smoking as listed below





Early signs of heart disease
Increase risk of lung cancer
Affects physical fitness
Early wrinkles and bad skin
Shortness of breath
Adviser signature……………………………… Date……………….
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PUBLIC HEALTH SERVICES CONTRACT
Appendix 5 - Client Agreement for the use of Nicotine Replacement Therapy
(NRT) in Pregnancy
For attention of the client
Name: ……………………………………………………
Address: …………………………………………………
……………………………………………………………
Please sign below to confirm that you have understood the information that
has been given to you by your health professional in relation to using
nicotine replacement therapy during pregnancy.
I understand that:
 I would like to use nicotine replacement therapy

Nicotine replacement is not harmless to my baby but is less harmful then
smoking

I should not exceed the recommended dose of nicotine

I should not use nicotine replacement therapy and smoke at the same time

I will report any changes in my condition to my Doctor
Client signature: ……………………………………. Date: ………………………
For use by Stop Smoking Adviser
I have discussed all issues relating to the use of nicotine replacement therapy
during pregnancy with the client
Adviser signature: …………………………………….. Date: …………………….
For Adviser’s information:
Client status: Married/Widowed/Single/Partner
Number of children……………….. No of weeks pregnant…………weeks
History of problems in pregnancy? ........................................................
Does client live with a smoker? Yes / No
Is client aware of effects of smoking in pregnancy?
Reduced oxygen supply to baby
Carbon Monoxide crosses the placenta
Low birth weight
Increased neonatal mortality/sudden infant death
Increased risk of spontaneous miscarriage
Effects of passive smoking on infants and children






Is client aware of long term health benefits to Mum and Dad
Discussed plus literature given

2013/14
PUBLIC HEALTH SERVICES CONTRACT
Appendix 6 – GP initiation letter for varenicline or bupropion
Date
Dear Doctor
Patient Name:
DOB
Address:
Your patient has been seen by an adviser from Wirral Stop Smoking Service and
has been assessed as motivated and ready to stop smoking/using tobacco. Your
patient has expressed an interest in Champix (Varenicline) □ Zyban (Bupropion)
□
In discussion your patient stated that:
 They are not pregnant
 They are using contraception and have been informed the therapy is contraindicated in pregnancy.
 They DO / DO NOT have a history of experiencing mental health problems.
Adviser comments…..
If you decide to issue a prescription your patient will continue to receive ongoing
motivational support and be monitored by our service.
Before they attend their next appointment, please could you complete and return
the information requested overleaf.
Alternatively if you decide the therapy is unsuitable our service is still available for
your patient.
Yours sincerely
Stop Smoking Adviser
P.T.O
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Please complete the details below and return to Wirral Stop Smoking Service
on
Fax: 0151 630 8390
…………………………………………………………………………………………………
…
1. I have provided ………………………………… …………
D.O.B…………………….. with a prescription for: (please tick)
Champix 2 week Starter Pack
Zyban
4 weeks supply
2. I find this patient unsuitable for treatment with the requested therapy
Doctor’s
Name………………………….Signature……………………...Date……..…….
For Admin use: Stop Smoking Adviser name and location.
GP Information
Nicotine replacement therapy (NRT), Varenicline and Bupropion may all be offered, as appropriate,
to people who are planning to stop smoking. The National Institute for Health and Clinical
Excellence (NICE) has produced guidance on smoking cessation services, which states not to favour
one medication over another. The clinician and patient should choose the one most likely to
succeed. Wirral Guidance has been updated in accordance with NICE.
Smoking cessation with or without drug therapy has been associated with depression. There have
been reports of depression and suicidal behaviour in patients stopping smoking using Varenicline.
Prescribers should exercise caution in prescribing Varencline particularly for patients with a history of
psychiatric conditions and patients should be advised to stop taking the drug and seek medical help
if they experience suicidal thoughts. All patients should be warned of the potential for Varenicline to
affect their ability to drive or operate machinery.
Please remember that Varenicline is a black triangle drug ▼ and all suspected adverse reactions
should be reported to the MHRA via the Yellow Card Scheme.
The CSM has also issued a reminder that Bupropion is contra-indicated in patients with a history of seizures or
of eating disorders, a CNS tumour, or who are experiencing acute symptoms of alcohol or benzodiazepine
withdrawal. Bupropion should not be prescribed to patients with other risk factors for seizures unless the
potential benefit of smoking cessation clearly outweighs the risk.
Factors that increase the risk of seizures include concomitant administration of drugs that can lower the seizure
threshold (e.g. antidepressants, antimalarials [such as Mefloquine and Chloroquine], antipsychotics,
quinolones, sedating antihistamines, systemic corticosteroids, theophylline, Tramadol), alcohol abuse, history
of head trauma, diabetes, and use of stimulants and anorectics.
Appendix 7 – Varenicline or bupropion follow on prescription request
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Date
Dear Doctor
Your patient: ___________________________ Date of Birth ___/____/_____
Has recently been issued with a prescription for
□
Varenicline (Champix)
□
Bupropion (Zyban)
The patient has been attending regular appointments with a Stop Smoking Adviser
and has not suffered any adverse effects.
□
Please consider issuing a follow on prescription for varenicline 1mg twice
daily tablets (maintenance pack of 56 tablets).
□
Please consider issuing a follow on prescription for bupropion 150mg twice
daily (maintenance pack of 60 tablets).
□
Please consider issuing a follow on prescription for bupropion 150mg once
daily (28 tablets).
I have informed the client of this letter being issued and have asked them to contact
the practice in a couple of days to arrange collection of a prescription.
Yours sincerely
Stop Smoking Adviser
Additional Information
Medication Commenced:…………
Quit date set:…………………………
Number of weeks quit:…………………
Appendix 8
NRT Pathway for clients using psychotropic medication
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Is the client currently using any psychotropic
medication? (Refer to CWP Trust NRT protocol).
Yes
No
Are there any contraindications
for NRT? (please see
contraindications within NRT
protocol).
Follow NRT
protocol.
Yes
No
Follow NRT protocol (Seek GP
consent before issuing NRT).
Contact client’s CPN and GP
using standard letters (1 and 2) to
inform them of the client’s intention
to cut down/stop smoking because
of the effect of stopping smoking on
medication.
Is consent given to
issue NRT?
Yes
Inform CPN of client’s
decision to quit/cut
down using standard
letter 2
Wait
for
CPN’s
response to letter 2
before issuing NRT.
Once response is
received, issue NRT if
appropriate
and
maintain
weekly
contact with client.
Wait for response from GP and
CPN before issuing NRT.
No
If agreement is given from GP and
CPN, if appropriate issue NRT
and maintain weekly contact with
the client.
No NRT to be
issued
Does the client still
wish to stop smoking
or cut down without
using NRT?
Yes
No
Inform client of service
details if they require
support in the future
Inform CPN of client’s intentions
using standard letter 2 because of
the effects stopping smoking has on
medication.
Offer client support in
stopping/cutting down
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Important: Update CPN and GP of outcome using standard letter to referrer.
Place a copy of this letter in the client’s file
Date
Dear Doctor
Re:
Your patient has attended the Wirral Stop Smoking Service and is;
Ready to stop smoking
□
Wishes to cut down
□
As this patient has mental health needs requiring the support of psychotropic drugs,
the effect of smoking cessation may require alteration of drug dose.
I will maintain regular contact with the patient and his/her CPN who will be informed
of any changes in the situation.
Your patient would like to use Nicotine Replacement Therapy which I can issue via
the service’s voucher/prescription scheme.
Please reply to this letter by ticking the appropriate statement and signing
below.
Fax back on
I agree to Wirral Stop Smoking Service providing the above patient with
NRT via voucher system
I do NOT agree with Wirral Stop Smoking Service providing the above
patient with NRT but am aware that they may continue their quit attempt
with your service
Doctor’s Name……………………Signature……………….……Date…………
Your support in this intervention would be appreciated.
Yours sincerely
Stop Smoking Adviser
Wirral Stop Smoking Service
2013/14
PUBLIC HEALTH SERVICES CONTRACT
Date
Dear
Re:
Your patient has attended the Wirral Stop Smoking Service and
Is ready to stop smoking
Wishes to cut down
□
□
As you are aware, smoking cessation may affect the levels of psychotropic drugs,
therefore closer monitoring of your client may be needed.
I will maintain regular contact with the patient and keep you informed of their
smoking status.
Please sign below and fax this form back to me on
I agree to support and monitor the patient according to CWP Trust NRT Protocol
Signed…………………………………………Date…………………………..
Your support in this intervention would be appreciated.
Yours sincerely
Stop Smoking Adviser
Wirral Stop Smoking Service
Additional information:
2013/14
PUBLIC HEALTH SERVICES CONTRACT
ANNEXE A2.2- Clinically important drug-smoking
interactions
BNF category/ Drug name
Nature of interaction
Clinical relevance
Action to take when
stopping smoking
2.8.2
Warfarin
Warfarin is partly
metabolised via the
enzyme CYP1A2. An
interaction with
smoking is not
clinically relevant in
most patients.
The dose of warfarin
is adjusted according
to a patient’s INR
(International
Normalised Ratio).
Moderate
3.1.3
Theophylline
Theophylline is
metabolised
principally via the
enzyme CYP1A2.
Smokers require
higher doses of
theophylline than nonsmokers due to
theophylline’s
shortened half-life
and increased
elimination.
Some reports suggest
smokers may need
twice the dose of nonsmokers.
High
4.2.1
Chlorpromazine
Chlorpromazine is
metabolised
principally via
CYP1A2.
Smokers have lower
serum levels of
chlorpromazine
compared with nonsmokers.
Moderate
If a patient taking
warfarin stops
smoking, their INR
might increase so a
healthcare
professional should
monitor the INR more
closely. Advise
patients to tell the
physician managing
their anticoagulant
control that they are
stopping smoking.
A healthcare
professional should
monitor plasma
theophylline
concentrations and
adjust the dose of
theophylline
accordingly.
The dose of
theophylline may
need to be reduced
by about one quarter
to one third one week
after withdrawal.
Advise the patient to
seek help if they
develop signs of
theophylline toxicity
such as palpitations
or nausea.
Monitor by a
healthcare
professional
Be alert for increased
adverse effects of
chlorpromazine (e.g.
dizziness, sedation,
extra-pyramidal side
effects). If adverse
effects occur, reduce
the dose as
necessary.
2013/14
PUBLIC HEALTH SERVICES CONTRACT
4.2.1
Clozapine
Clozapine is
metabolised
principally via
CYP1A2 and
clearance is
increased in smokers.
Serum clozapine
levels are reduced in
smokers compared
with non-smokers;
smokers may need
higher dosages.
There have been
case reports of
adverse effects in
patients taking
clozapine when they
have stopped
smoking.
High
Contact Lisa
Foulkes (pharmacy
team secretary) at
Cheshire and Wirral
Partnership NHS
Foundation Trust
(CWP)
IMMEDIATELY to be
directed to a
pharmacist for
guidance:
Tel: 01244 397 494
2013/14
PUBLIC HEALTH SERVICES CONTRACT
ANNEXE A2.3 - Smoking Cessation Service Standard
Operating Procedure (SAMPLE ONLY)
Re-produced with acknowledgement to Community Pharmacy Scotland
See enclosed PDF version of Annexe A2.3
2013/14
PUBLIC HEALTH SERVICES CONTRACT
ANNEXE A2.4 - Monitoring Form
FINAL PUBLIC HEALTH SERVICES CONTRACT
GATEWAY REFERENCE: 18533
49
2013/14
PUBLIC HEALTH SERVICES CONTRACT
ANNEXE A2.5 - NRT Price list
This price list is subject to change and will be reviewed bi-annually. Updated price
lists can be obtained from the network meetings and/or Community Trust Locality
team.
The maximum price paid for any NRT product will be line with the price list agreed for
the period in which the product was dispensed.
See Enclosed Annexe A2.5.1 – Excel Spreadsheet – NRT
Price List June 2013
FINAL PUBLIC HEALTH SERVICES CONTRACT
GATEWAY REFERENCE: 18533
50