Pharmacy Enhanced Service
Nicotine Replacement Therapy
(NRT)
Voucher Scheme
Service Specification and formulary
December 2008
Page 2 of 33
D:\106766852.doc
COMMUNITY PHARMACY ENHANCED SERVICE
NRT VOUCHER SCHEME
SERVICE SPECIFICATION
1st December 2008
Page 3 of 33
D:\106766852.doc
CONTENTS
INTRODUCTION
6
AIMS OF THE SERVICE
7
SERVICE DETAILS
8
1.
Review Date
8
2.
Who can Access the Pharmacy enhanced Service NRT
Voucher Scheme?
8
3.
Exclusion Criteria for the NRT Voucher Scheme
8
4.
Criteria for informing the GP of attempt to quit
9
5.
Duration of supply of NRT on the voucher scheme
10
6.
Pregnancy and Breast feeding mothers
10
7.
Using NRT as part of a reducing to quit programme
11
8.
Dosages alterations when stopping smoking
11
9.
Side effects
12
10.
Advice to clients
12
11.
Informed consent
14
12.
NHS fee
14
SERVICE REQUIREMENTS
1.
Who can provide the service
14
2.
Pharmacist and Pharmacy Staff Accreditation
15
3.
Sign up and termination
15
4.
Display
15
5.
Record Keeping
15
6.
Payments
15
Page 4 of 33
D:\106766852.doc
CLINICAL GOVERNANCE IMPLICATIONS
1.
Audit
17
2.
Risk Assessment
17
3.
Clinical Support
19
4.
Standard Operating Procedures
19
5.
Client and Public Involvement
19
6.
Information Governance
19
KEY POINTS ABOUT STOP SMOKING ADVISORS
1.
Referral process
20
2.
Operating times
20
3.
Outline of service programme
20
4.
Clinic venues
21
5.
Services provided
21
1.
Service Level Agreement
23
2.
Stop Smoking Service contacts details
25
3.
Monthly usage form (pharmacy use only if desired)
28
4.
Formulary
29
5.
Summary of process at the NHS Stop Smoking Service
31
6.
Summary of process at the Pharmacy
32
APPENDIX
REFERENCES
33
SAMPLE VOUCHER
34
Page 5 of 33
D:\106766852.doc
Introduction
Expanding the NRT Voucher Scheme across Central Lancashire
The NHS Stop Smoking Service offers advice and support to smokers who are motivated
to stop smoking. This support is currently provided both within General Practice, by trained
Practice Nurses and Health Visitors and by the Specialist Stop Smoking Service. NICE
Technological Appraisal Guidance on NRT and Bupropion for Smoking Cessation has
indicated that NRT is both clinically and cost effective and significantly increases the
chances of a successful quit attempt.
Smokers who are referred, or refer themselves, to the Specialist Service and wish to use
pharmacological support (NRT) in addition to support from the Service in their attempt to
stop smoking, have received differing levels of service across Central Lancashire. For the
past four years, Chorley and South Ribble locality based service has operated an NRT
voucher scheme which has allowed the support service to liaise directly with community
pharmacy for the provision of NRT to support the quit attempt of the smoker.
In comparison, Preston and West Lancashire based service provided stop smoking
support but needed to refer back to the GP for NRT prescriptions. The requirement to refer
smokers from the Stop Smoking Service back to General Practice to receive their
pharmacological support to aid the quit attempt leads to confusion for patients and
inappropriate consultations.
The Stop Smoking Service aims to provide an efficient and effective support service
consistent across Central Lancashire so that any patient accessing the service can expect
to receive the same level of support regardless of geographical location.
The expansion of the scheme will be in effect from December 2008. It will be based on a
Service Level Agreement with Community Pharmacists who will have undertaken
accredited CPPE Stop Smoking training. In addition to this and to maximise the potential
of the scheme, pharmacy technicians may also be trained to operate the NRT voucher
scheme. The supply of NRT through the voucher scheme would specifically be for those
smokers who are not contraindicated to NRT products. Those smokers who are
contraindicated to these products will be referred back to their GP for assessment. It is
anticipated that these numbers will be few. The community pharmacist operating the
scheme maintains professional responsibility to ensure that the NRT supplied is safe and
suitable for the patient.
Page 6 of 33
D:\106766852.doc
AIMS OF THE SERVICE
The service is designed to meet the following aims for:
1.
Patients






2.
G.Ps


3.
To improve access to and choice of Stop Smoking Services, including
access to pharmacological and non-pharmacological stop smoking aids.
To reduce smoking related illnesses and deaths by helping people to
give up smoking
To improve the health of the population by reducing exposure to passive
smoke.
To reduce waiting times
To offer an alternative to a GP consultation
To remove anxiety about “bothering a doctor”
To reduce inappropriate consultations
To help achieve access targets
Pharmacists


To provide an opportunity to work more closely with healthcare
providers and raise the profile of community pharmacy
To deliver the vision of the Pharmacy white Paper; Building on Strengths
Delivering the future. April 2008
Page 7 of 33
D:\106766852.doc
SERVICE DETAILS
1.
Review Date
The Pharmacy Enhanced Service NRT voucher scheme service specification will
be due for review in November 2010 or earlier in the light of significant change.
2.
Who Can Access the Pharmacy Enhanced Service NRT voucher
scheme?
The Pharmacy Enhanced Service NRT voucher scheme will be offered to any
tobacco using client aged 12 years and over, registered with a G.P practice in NHS
Central Lancashire. The client must be sufficiently motivated to quit and must have
received specialist stop smoking advice and support from NHS Central Lancashire
Stop Smoking Service.
Please be aware that clients who work inside the boundaries of NHS Central
Lancashire, but not registered with a GP in NHS Central Lancashire are eligible to
access the Stop Smoking Service. However their NRT will be supplied through a
prescription from their own GP and not the pharmacy enhanced service NRT
voucher scheme.
Clients registered with either G.P practice in Longridge (Berry Lane Medical Centre
or Stonebridge Surgery, East Lancs PCT) are eligible to access the Stop Smoking
Service and may receive NRT following a consultation in any pharmacy across
Central Lancashire PCT. Documentation and reimbursement requirements are
identical to that of all other patients managed under this service.
3.
Exclusion criteria for the NRT Voucher Scheme.
The following clients are excluded from NRT treatment through the voucher
scheme:










Clients with known hypersensitivity to nicotine.
Clients with renal or hepatic impairment.
Clients with oesophagitis, gastritis, gastric or peptic ulcers are excluded
from the use of oral NRT preparations. If appropriate patches could be
supplied.
Clients with hyperthyroidism
Clients with phaeochromocytoma (tumor of cells secreting hormones
which regulate heart rate and blood pressure)
Clients taking theophylline or Clozapine1
Clients under the age of 12 years.
When intervention with bupropion or varenclicine might be more
appropriate
Clients hospitalised in the previous 4 weeks as a result of myocardial
infarction, severe dysrhythmia or CVA. Any clients in this category or
those with severe or unstable conditions under the care of the cardiac
specialist should be referred to their G.P.
Clients with any contra-indication to NRT
Page 8 of 33
D:\106766852.doc
Prior to the client presenting at the pharmacy with a voucher, the Stop Smoking
Advisor from the Stop Smoking Service will check that the client does not meet any
exclusion criteria (as listed above).
If the client meets one or more of the exclusion criteria the Stop Smoking Advisor
will complete the ‘Referral to G.P Practice for Assessment of Pharmacological
Intervention’ form. The client can continue to receive support from the Stop
Smoking Advisor, however provision of treatment will be at the doctor’s discretion
and if appropriate treatment will be supplied through a prescription.
Pharmacists providing the NRT voucher scheme maintain professional
responsibility for the safe and appropriate supply of NRT to all clients. Therefore it
is important that both the Stop Smoking Advisor and the Pharmacist verify that the
client does not meet any exclusion criteria. When presented with a voucher and a
client that meets the exclusion criteria the pharmacist should not supply the
product and refer the client back to the Stop Smoking Advisor to enable the advisor
to complete the ‘Referral to the G.P Practice for Assessment of Pharmacological
Intervention’ form and make future arrangements for that client.
4.
Criteria for informing the G.P of attempt to quit.
The majority of clients accessing the Stop Smoking Service will receive NRT
through the voucher scheme without their GP being notified.
However there are some instances when the Stop Smoking Advisor is required to
notify the client’s GP. These include:




Client is pregnant
Client is breast feeding
Client with Type I or Type II diabetes
Clients taking warfarin, chlorpromazine, olanzapine or insulin1
For these specific clients the attempt to stop smoking and the use of NRT should
be recorded in the patient medical records held at the G.P practice. This will be
achieved by completion of the ‘Information for patient records’ form which is faxed
to the clients GP by the Stop Smoking Advisor.
Pharmacy staff will be made aware that this requirement has been fulfilled through
the annotation on the voucher under the Advisors Signature.
Information for patient record sent to GP because…………………………..
The client will continue to receive support and treatment from the Stop Smoking
Advisor as appropriate, unless the G.P informs the Stop Smoking Advisor
otherwise.
Again, community pharmacists operating the scheme maintain professional
responsibility for the safe and appropriate supply of NRT to all clients. If any criteria
listed above are identified by the pharmacist and the voucher not annotated with
information for patient record sent to GP, the pharmacist may supply the product
providing the Stop Smoking Advisor is informed with out delay and the ‘Information
for Patient Records form’ is completed and faxed to the G.P practice by the Stop
Smoking Advisor.
Page 9 of 33
D:\106766852.doc
5.
Duration of supply of NRT
The standard duration of treatment on the Pharmacy Enhanced Service NRT
voucher scheme is three months. The initial voucher will provide two weeks
therapy; subsequent vouchers will provide four weeks therapy.
The voucher will be valid for 28 days from the issue date.
Clients requiring treatment for longer than the standard three month duration will
be assessed on an individual basis. Adolescents between the age of 12-18 yrs,
pregnant or breast feeding clients would rarely be treated for longer than the
standard three months duration.
6.
Pregnancy & Breast feeding Mothers
Written confirmation must be obtained from the mother to document that the risks
and benefits have been explained and understood. The Stop Smoking Advisors will
ensure that the client completes the ‘Informed consent form for the use of NRT
during pregnancy and Breast feeding’.
The Stop Smoking Advisor will also complete the ‘Information for patient records’
form and ensure that this is faxed to the clients G.P surgery. Pharmacy staff will be
made aware that this requirement has been fulfilled through the annotation on the
voucher under the Advisors Signature.
Information for patient record sent to GP because…………………………..
If pharmacy staff become aware that the client is pregnant or breastfeeding and the
voucher not annotated with information for patients record sent to G.P then the
pharmacist may supply the product providing the Stop Smoking Advisor is informed
without delay and the ‘Information for patient records’ form is completed and faxed
to the G.P practice by the Stop Smoking Advisor. The Stop Smoking Advisor must
ensure that the informed consent form for the use of NRT during pregnancy/breast
feeding has been completed.
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.2,3,4,5
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 or as soon as possible.2,3,4,5
NARS (Nicotine assisted reduction to stop) or smoking reduction strategies are not
seen as appropriate smoking cessation method for pregnant women who smoke.
Pregnant women must be encouraged to quit as soon as possible. 5
Intermittent formulations of NRT (e.g gum or lozenge) are preferable during
pregnancy although a patch may be appropriate if nausea and/or vomiting are a
problem. If patches are used, a 16-hour patch, removed at night, is preferable. 2,3,4,5
Liquorish flavor products should be avoided during pregnancy.6
Page 10 of 33
D:\106766852.doc
NRT can be used by women who are breast-feeding. It is not known how much
nicotine is transferred into breast milk from NRT, however the dangers of
continuing to smoke are well established and considerably more damaging to
mother and baby.2,6 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 the baby, to minimize the amount of
nicotine in the milk. The use of products should be avoided for one hour before
breastfeeding.6
7.
Using NRT as part of a reducing to quit programme.
For clients who are clearly unwilling or unable to quit abruptly a number of products
are now licensed to be used whilst smoking as part of a reducing to quit
programme;





Nicorette Gum
Nicorette Inhalator
Nicorette Microtab or Boots NicAssist 2mg microtab
Niquitin Lozenge
Niquitin Gum
If appropriate the Stop Smoking Advisor may suggest a reducing to quit
programme for up to two weeks. A quit attempt should then be made. Complete
cessation must be no later than six months. This reducing to quit programme is not
seen as an appropriate method for pregnant/breastfeeding women who smoke.
8.
Dosage alterations when stopping smoking.
The Stop Smoking Advisor will ask the client for a drug history and proceed as
advised in section 3. Exclusion criteria for the NRT Voucher Scheme & section 4.
Criteria for informing the G.P of attempt to quit. However the community
pharmacist operating the scheme maintains professional responsibility for the safe
and appropriate supply of NRT to all clients. The Patient Medical Record held in
the pharmacy may help acquire an accurate drug history.
Cigarette smoking can interact with some medicines. This is mainly due to
polycyclic aromatic hydrocarbons in cigarette smoke that stimulate cytochrome
P450 enzymes, particularly CYP1A2. A number of therapeutic drugs that are
metabolized via CYP1A2, may consequently be more rapidly metabolized in
smokers.1
Clients on Clozapine or theophylline are excluded from the Pharmacy
enhanced service NRT voucher scheme. See section 3. Exclusion criteria for the
NRT Voucher Scheme.
The majority of interactions are not considered to be of clinical significance but the
potential for interaction should be borne in mind if a patient starts or stops
smoking.1 Therefore clients taking any of the following agents may be supplied
NRT on the voucher scheme, but the Stop Smoking Advisor will also complete the
‘Information for patient record’ form and ensure it is faxed to the client’s G.P
Page 11 of 33
D:\106766852.doc
surgery. Pharmacists will be made aware that this requirement has been fulfilled
through the annotation on the voucher under the Advisors Signature.
Information for patient record sent to GP because…………………………..

Clients on Warfarin
Pharmacy staff should advise all clients to tell the physician managing
their anti coagulant control that they are stopping smoking.1

Clients on Chlorpromazine
Pharmacy staff should advise all clients to be aware of increased side
effects of the chlorpromazine (e.g dizziness, sedation, extra-pyramidal
side effects) Contact their G.P if present.1

Clients on Olanzapine
Pharmacy staff should advise all clients to be aware of increased adverse
effects of olanzapine (e.g. dizziness, sedation, hypotension). Contact
their G.P if present.1

Clients on Insulin
Pharmacy staff should advise all clients to be alert for signs of
hypoglycaemia and to consider testing their blood glucose more
frequently when initially stopping to smoke.1
Bupropion or varenicline are not available through the pharmacy enhanced
service NRT voucher scheme because these are Prescription Only Medicines and
the patient’s medical history is required to ensure there are no contra-indications.
Therefore the pharmacological assessment and decision for treatment with these
products is to be determined by the G.P practice.
9.
Side effects
These 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, dyspepsia
and other gastro-intestinal disturbances, hiccups, insomnia, vivid dreams, myalgia,
chest pain, blood pressure changes, anxiety and irritability, somnolence and
impaired concentration, dysmenorrhoea, abnormal hunger, rash.
Further information on specific withdrawal symptoms is detailed in Section 10.
Advice to Clients
Further information on product-specific side effects are detailed in Appendix 6.
Formulary
10.
Advice to clients
Advice to clients will be given by the Stop Smoking Advisor. Pharmacy staff should
check that this advice has been understood and be able to answer any related
questions. Pharmacy staff should provide product specific advice on
administration (see Appendix 4) plus the following general advice on:
Page 12 of 33
D:\106766852.doc
Withdrawal symptoms;
Symptom
Duration
Prevalence
Irritability
Depression(predicts relapse)
Restlessness
Poor concentration
Increased appetite
Light-headedness
Night-time waking
Urges to smoke
<4weeks
<4weeks
<4weeks
<2weeks
>10weeks
<48weeks
<1week
>2weeks
50%
60%
60%
60%
70%
10%
25%
70%
Use of more than one NRT product;
Although only one product per voucher per person can be supplied on the
pharmacy enhanced service NRT voucher scheme, if appropriate the Stop
Smoking Advisors may advise clients on which NRT products could be used in
conjunction with other NRT products in order for the client to purchase the second
product from a pharmacy. As with any other product purchased in a pharmacy,
this remains the responsibility of the pharmacist in charge.
Benefits of giving up smoking;7
Time from quitting
Your body on the mend
20 minutes
Blood pressure and pulse return to normal.
Circulation improves - especially in hands & feet
Blood oxygen levels return to normal and chance of
heart attack falls.
Carbon monoxide leaves the body. Lungs start to clear
out mucus and debris.
Body is now nicotine free. Sense of taste and smell
improve
8 hours
24 hours
42 hours
72 hours
Breathing is easier. More energy
2 – 12 hours
Circulation improved throughout body, easier to walk
and exercise
3 – 9 months
Lung efficiency is improved by 5 – 10%,
breathing/coughing/wheezing improving
5 years
Half the chance of heart attack compared to a smoker
10 years
Chance of lung cancer half that of a smoker.
Chance of heart attack same as if never smoked.
Page 13 of 33
D:\106766852.doc
Follow-up and obtaining further supplies of NRT;
The Stop Smoking Advisor will have arranged an appointment due before the
supply of NRT is expected to run out. Pharmacy staff will ensure that this date is
understood before supplying NRT from the voucher.
11.
Informed consent
Client information relating to the supply of NRT through the voucher scheme has to
be passed to other health service organisations, for example, client's GP, NHS
Stop Smoking Service, NHS Central Lancashire and LaSCA, for a variety of
purposes such as audit or payment. The client's declaration of exemption and
consent for information to be shared with the PCT, G.P and other healthcare
professionals will be recorded on each voucher. This will be completed and signed
on redemption of the product at the pharmacy.
12.
NHS Fee
An NHS fee will apply for NRT supplied under this service level agreement. Clients
not exempt from prescription charges require a charge at the current prescription
fee. Clients exempt from prescription charges should complete the declaration of
exemption.
SERVICE REQUIREMENTS
1.
Who Can Provide the Pharmacy Enhanced Service NRT Voucher
scheme?
This service may be provided by any authorized community pharmacy within NHS
Central Lancashire, subject to the following:





The pharmacy contractor must agree to participate in all parts of the
service as detailed in the service specification. This agreement will be
documented in the form of a Service Level Agreement signed by the
contractor or the representative of the contractor. (Appendix 1)
The pharmacy must have an accredited consultation room
A standard operating procedure (SOP) that clearly defines the roles and
responsibilities of relevant staff must be produced and followed for each
individual pharmacy.
An accredited qualified Dispensing Technician may be delegated to
undertake the consultation provided they adhere to the SOP. Overall
responsibility and accountability will remain with the pharmacist in charge.
This service cannot be provided solely by an accredited pharmacy
technician. At all times an accredited pharmacist must be present and
accountable 75% of opening hours, except for annual leave and sick
leave, when a locum (accredited or not accredited) may temporarily
continue accountability of the service.
Page 14 of 33
D:\106766852.doc
2.
Pharmacist and Pharmacy Staff Accreditation


3.
Sign Up and Termination





4.
Pharmacist Training & Qualifications
Pharmacists involved in the provision and/or accountability of this service
must have completed the distance learning package ‘Stop Smoking’
available from the Centre for Postgraduate Pharmaceutical Education.
This is available as a CD-ROM. Information is available from
www.cppe.manchester.ac.uk.
Pharmacy Technician Training & Qualifications
Qualified Dispensing Technicians (NVQ level 3) must have received
training by NHS Central Lancashire to supply NRT under the scheme.
Registered Technicians are also encouraged to complete the CPPE.
All pharmacists and pharmacies must agree to the terms of service
contained within this service specification/service level agreement.
Participating authorised pharmacies may withdraw from the scheme at
any time. The PCT may also terminate provision from a pharmacy. Any
such intention must be made in writing to the same individual identified on
the Enhanced Service agreement form. A notice of 28 days applies.
If pharmacies withdraw from the scheme, then the accredited pharmacist
may continue to provide the service from other authorized pharmacy
premises located within NHS Central Lancashire
Changes of ownership will require reapplication to provide the service.
Changes to pharmacy staff (e.g new manager or regular locum) who are
not already accredited will require accreditation to continue provision of
the service.
Display
All participating authorized pharmacies may be required to display posters and
leaflets indicating the availability of treatment through the NRT scheme from the
pharmacy.
5.
Record Keeping



6.
A record of medication supplied through the pharmacy enhanced service
NRT voucher scheme will be documented in the Patients Medication
Record on the pharmacy IT system.
Although not a requirement of the service contractors may wish to
complete Appendix 3 a monthly usage form to help reconcile payment.
The voucher will be sent to LaSCA for payment.
Payments
Pharmacy contractors will be reimbursed according to the following payment
structure:

A consultation fee of £3.00 per voucher form sent to Lancashire and
South Cumbria Agency (LASCA)
Page 15 of 33
D:\106766852.doc


The list price of the medication supplied plus VAT
Minus the sum of prescription levies collected.
Claims for payments should be made by the 5th working day of the following month;
late submission may delay payments, by submission of the consultation form to
Lancashire and South Cumbria Agency (LaSCA) at:
Contractor Services
Lancashire and South Cumbria Agency
3 Caxton Road
Fulwood, Preston
PR2 9ZZ
Payments will be made at the end of the month following that to which the payment
relates and can be identified from the pharmacy contractors PPA statement.
Incomplete consultation forms will be deemed invalid and as such will be returned
to the contractor for resubmission, which will delay payments.
Page 16 of 33
D:\106766852.doc
CLINICAL GOVERNANCE IMPLICATIONS
For pharmacies providing NRT from the voucher scheme.
1.
Audit;
As with any new service, initial and ongoing evaluation is necessary to ensure it is
working correctly, meets the needs of patients, healthcare professionals and the
NHS and to check whether any improvements could be made.
It is anticipated that periodic audits will be provided for accredited pharmacists to
complete. More details will be provided as these are produced. The completion of
these occasional audit/evaluations is included in the reimbursement for the service.
From time to time the PCT may select a number of authorised pharmacies for more
in depth verification checks. This will be undertaken by a variety of methods, but
most often cross referencing monthly return forms with the records held in the
authorised pharmacy. The authorised pharmacy must participate in these checks if
identified.
2.
Risk Management;
“In 2006 the Medicines and Healthcare Products Regulatory Agency (MHRA)
issued guidance on the use of nicotine replacement therapy (NRT) in special
patient populations. This followed recognition that licensing restrictions were
presenting a barrier to wider usage of NRT products, especially in groups that
would derive most benefit. Since then, the manufacturers have revised their
product information accordingly. To maximise the benefits of NRT, NICE suggest
the risks and benefits of using NRT in young people aged 12 to 17, pregnant or
breastfeeding women, and people who have unstable cardiovascular disorders
should be explained and strongly encouraged to also use behavioural support in
their quit attempt.” 5

Pregnancy/breast feeding;
Smoking in pregnancy or around young children can cause a range of problems.
Pregnancy or breast feeding are no longer a contraindication to NRT use. When
appropriate NRT can now be acquired through the NRT voucher scheme providing
certain criteria are fulfilled;







The client will have had to attempt to stop smoking without NRT
NRT should be used as early on in pregnancy as possible, and with the
aim of discontinuing after two to three months’ use.
Reducing to stop is not recommended in pregnancy/breast feeding.
Intermittent forms will be recommended. If patches are used they must be
removed at night.
The Stop Smoking Advisor will provide written guidance notes for the
client to take home.
The Stop Smoking Advisor will explain the risks and benefits of
smoking/NRT during pregnancy/breast feeding.
The client will sign the informed consent form to confirm that they
understand the risks and benefits.
Page 17 of 33
D:\106766852.doc


The Stop Smoking Advisor will complete the ‘Information for patient
records’ form and forward it to the clients G.P practice so that the attempt
to quit is documented in their medical records.
Age
The lower age limit for NRT is now 12years of age. When appropriate NRT can be
acquired through the NRT voucher scheme. The Stop Smoking Advisor will check
that they are fully committed to trying to stop smoking permanently before offering
NRT whilst assessing readiness to change, motivation and dependency. The Stop
Smoking Advisor will explain the risks and benefits of smoking/NRT and will aim to
supply the NRT voucher for a maximum duration of 12 weeks. Professional
judgement should be used to decide whether the patient understands the potential
risks and benefits of the treatment. When a patient is judged not to be competent,
they should be referred to their G.P practice.

Cardiovascular disease
It is now recognised that in stable cardiovascular disease, NRT presents a lesser
hazard than continuing to smoke. There is a theoretical potential that NRT could
trigger cardiovascular events in vulnerable patients. 4,5
As a sensible precaution any clients that have been hospitalised in the previous
four weeks as a result of myocardial infarction, severe dysrhythmia or CVA, or
those with severe or unstable conditions under the care of a cardiac specialist are
excluded from this voucher scheme. They may receive support from the Stop
Smoking Advisor, but require referral to the G.P practice for assessment of
pharmacological intervention and subsequent treatment.

Diabetes
Clients with diabetes will be advised to be aware of changes in their blood sugar
levels. This is because catecholamine release can affect carbohydrate metabolism
and vasoconstriction may delay/reduce insulin absorption. 4,5 When appropriate
diabetic clients can acquire NRT through the voucher scheme providing,
‘Information for the patient records’ form is sent to the clients G.P practice. This
ensures that the attempt to quit smoking will be recorded in the client’s medical
record for future reference and clinical management.

Renal or Hepatic Impairment
Medicines and Healthcare Products Regulatory Agency have advised that NRT
should be used with caution in patients with moderate to severe hepatic
impairment and/or severe renal impairment as they may be at risk of increased
adverse effects.2,4,5 Any clients with known renal or hepatic impairment are
excluded from the voucher scheme. They may receive support from the Stop
Smoking Advisor, but would require referral to the G.P practice for assessment of
pharmacological intervention and subsequent treatment.
Page 18 of 33
D:\106766852.doc
3.
Clinical Support
The accredited pharmacist and Stop Smoking Advisor should not feel that they are
working in complete isolation and must feel confident to refer to other sources of
information and support services, such as other accredited pharmacists, Stop
Smoking Advisors or general practitioners, subject to the requirement for
confidentiality. This could include advice on how to deal with a difficult consultation.
4.
Standard Operating Procedures
Staff must be supported and fully trained to deliver this enhanced service. A
standard operating procedure must be written specific to the pharmacy and it
should clearly define staff roles and responsibilities, including how to deal with
customers requesting access to the scheme.
5.
Client and Public Involvement
Pharmacies must run their own internal complaints procedures consistent with the
NHS’ requirements and apply the standard NHS complaints procedure, if required
by a client. Refer to service specification 2.1.5 of Essential Service 8.
Pharmacists should also note that participation in any scheme such as this also
entails agreement to the right of inspection from NHS Patients’ Forums. Refer to
service specification 2.1.6 and 2.1.7 of Essential service 8.
6.
Information Governance - Patient Confidentiality
Pharmacists and their staff clearly owe a duty of confidentiality to their patients.
Pharmacists should ensure that all their staff have confidentiality clauses within
their contracts and that they are aware of what these mean. Advice on appropriate
wording can be obtained from the PCT if necessary.
Finally pharmacists must adhere to service specification 2.7.2, 2.7.3 and 2.7.4 of
essential service 8 that deals with information governance issues.
Page 19 of 33
D:\106766852.doc
KEY POINTS ABOUT STOP SMOKING ADVISORS
1.
Referral process
The service has an open referral system and encourages self referral as this is
recognised as the referral source which results in the greatest success rates.
Health professionals and other frontline staff are also encouraged to signpost
smokers to the service.
Clinic timetables and contact cards are available in all potential referral points
including GP surgeries, community venues and pharmacies. Details of the service
are also available on the PCT website and the website of key partners. Referrals
are also forwarded from smokers who have contacted the National Helpline. An
electronic referral system is also in place with the Acute Trust.
The service has developed a comprehensive marketing strategy to increase
awareness of stop smoking support especially for target groups.
2.
Operating times
The service offers support 52 weeks per year across Central Lancashire, including
the Christmas period but excluding Bank Holidays. The time that support is offered
varies but does include evening clinics.
The service can be contacted between the hours of 9am and 5pm, messages can
be left on an answer machine outside office hours.
3.
Outline of Support programme
The service provides evidence based stop smoking interventions as outlined in
NICE guidance. The Stop Smoking Advisor will agree with the client the chosen
treatment pathway, ensuring the person understands the ongoing support and
monitoring arrangements.












Assessment of motivation to quit and setting of a quit date;
Assessment of nicotine dependence and appropriate feedback to client;
Advice and information about available/appropriate drug treatments and
methods of access;
Help to build a range of coping strategies;
Provide information on the nature of tobacco withdrawal and advice re:
management of withdrawal symptoms;
Offer regular Carbon Monoxide (CO) checks and feed back on progress;
Ongoing monitoring use of pharmacotherapy;
Troubleshooting for specific client problems/issues that impact on
smoking using motivational interviewing techniques;
CO verification of quit status at 4 weeks from quit date;
Onward planning (at end of treatment) in relation to coping mechanisms,
follow-up/support options and pharmacotherapy;
Assessment of client satisfaction with the intervention provided;
The service collects and records information regarding the throughput
and success rates of the interventions provided to smokers.
Page 20 of 33
D:\106766852.doc
4.
Clinic venues
The service can be assessed in a variety of settings across NHS Central
Lancashire. These include:









5.
Health Centres/community Centres
Pharmacies
Children’s Centres
Schools/Colleges/Youth and community Centres
Hospitals
Workplaces
Prisons
GP Practices
Leisure/sports Centres
Services Provided








Individual, group and family sessions following a rolling programme
Drop in sessions
Structured group sessions in the workplace, schools etc
Phone consultations
Group training at level 1 and level 2 across primary and secondary
care/pharmacists/community workers/partners
Update training sessions
Health promotion activities across primary care, secondary care and third
sector/voluntary organizations.
Education activities with children, young people and families in
appropriate locations.
The Stop Smoking Service responds to any queries from pharmacists and other
health professionals in support of stop smoking interventions.
Page 21 of 33
D:\106766852.doc
Page 22 of 33
D:\106766852.doc
Appendix 1
SERVICE LEVEL AGREEMENT FORM
NICOTINE REPLACEMENT THERAPY SCHEME
AGREEMENT
I apply to be paid for the provision of Nicotine Replacement Therapy supplied at
the premises named below, in line with the pharmacy enhanced service NRT
voucher scheme service specification.
Signed by/on behalf of
contractor:
……………………………
Pharmacy Name:
……………………………
Pharmacy Address:
Tel No:
Date:
……………………………
……………………………
……………………………
……………………………
……………………………
Signed by CLPCT
Pharmacy Advisor:
Date:
……………………………
………… …………………
Pharmacy Stamp
Relevant training courses attended by supervising pharmacists and
accredited pharmacy technicians who work routinely at the premises.
Pharmacists Name*
(Please print and sign)
Date of course
Organiser
Title
And Pharmacy
Technician**
(Please print and sign)
* By signing this form the pharmacist is declaring that they have completed the CPPE “Stop
Smoking” open learning pack OR will complete the pack within 3 months from the date of this form.
**Pharmacy Technicians must have attended the PCT Stop Smoking training event as a minimum
requirement.
Please return FAO Stephen Gough, Central Lancashire PCT, Jubilee House
Centurion Way, Lancashire Business Park, Leyland, PR26 6TR or Fax 01772
227025
Page 23 of 33
D:\106766852.doc
Page 24 of 33
D:\106766852.doc
Appendix 2
NHS STOP SMOKING SERVICE
CHORLEY AREA
Monday
Tuesday
Wednesday
Thursday
Friday
Please call
Outpatients Department, Chorley Hospital:
09.00 – 12.00
Leyland Clinic Yewlands Drive, Leyland:
09.00 - 12.00
St. Mary’s Health Centre, Penwortham:
16.00 - 19.00
Highfield Children’s Centre, Chorley:
15.00 -18.00
Leyland Clinic, Yewlands Drive, Leyland:
09.00 - 11.00
Bamber Bridge Clinic, School Lane, Bamber Bridge:
08.30 - 12.00
Clayton Green Leisure Centre, Centre Drive:
17.00 - 20.00
Coppull Primary School, Park Road, Coppull:
09.00 - 11.00
St. Mary’s Health Centre, Cop Lane, Penwortham:
16.00 - 19.00
Chorley Health Centre, Collinson Avenue, Chorley:
15.00 - 18.00
Leyland Leisure Centre, Leyland:
16.00 – 19.00
Wade Hall Children’s Centre, Leyland:
16.00 – 17.00
All Seasons Leisure Centre, Chorley:
Drop-in session - no appointment necessary
16.00 -17.00
17.30
Outpatients Department, Chorley Hospital:
13.00 - 17.00
Wellfield Children’s Centre, Leyland:
14.00 - 17.00
Whittle Surgery , Preston Road, Whittle le Woods:
13.00 - 16.00
St Mary’s Health Centre, Cop Lane, Penwortham:
10.00 – 13.00
Leyland Leisure Centre, Leyland:
15.00 – 18.30
0800 328 6297 to arrange an appointment
Page 25 of 33
D:\106766852.doc
NHS STOP SMOKING SERVICE
PRESTON AREA
Monday
Geoffrey Street Health Centre:
9am – 4: 30pm
Occupational Health – RPH:
9am –12 noon
Ingol Health Centre:
1pm – 4:30pm
Fulwood Clinic:
Healthport:
Tuesday
Wednesday
2pm – 4pm
Avenham Clinic:
4pm – 7.30pm
SureStart, Ribbleton Hall Drive:
10am –12noon
Geoffrey Street Health Centre:
12.30pm – 4pm
Boots Pharmacy Lane Ends:
Chest Clinic Royal Preston Hospital:
Brookfield Clinic:
Briarwood Medical Centre:
Ribbleton Moor Nook Clinic:
Preston Muslim Forum:
Friday
3.15pm – 5.15pm
9am– 12noon
10.30am – 12.30pm
9.30am – 1pm
1pm – 5pm
1.30pm – 2.30pm
3pm – 5pm
Longridge Community Hospital:
3pm – 5pm
Longridge Community Hospital:
6pm – 8pm
Ashton Health Centre:
9am – 12 noon
Antenatal Clinic:
11am – 12noon
The National football Museum:
1pm – 6pm
10am – 12 noon
0800 328 6297 to arrange an appointment
Page 26 of 33
D:\106766852.doc
2.pm – 4pm
Smithsons Pharmacy:
Ashton Health Centre:
Please call
9am – 12noon
Boots Deepdale:
Boots Fishergate:
Thursday
6pm – 8pm
NHS STOP SMOKING SERVICE
WEST LANCS AREA
Monday
Tuesday
Sandy Lane Health Centre:
11am –12 noon
Hillside Health Centre:
2pm – 3pm
Ormskirk College, Room H012 Hants Lane:
6pm – 7pm
First Steps, Sure start, Digmoor Shopping
Parade:
4pm – 5pm
Ecumenical Centre, Skelmersdale:
Wednesday
New Church House, Ormskirk:
5pm-7pm
1.30pm-2.30pm
Park Children’s Centre, Barnes Rd:
Thursday
Friday
Please call
Birleywood Health Centre:
11am – 12noon
St. John’s Children’s Centre, Birch Green:
2pm – 3.30pm
-
0800 328 6297 to arrange an appointment
Page 27 of 33
D:\106766852.doc
4pm-5pm
Appendix 3.
MONTHLY CLAIM FORM
THIS FORM IS FOR INTERNAL RECORDS ONLY IT IS NOT COMPULSORY TO
COMPLETE AND MUST NOT BE SUBMITTED TO LASCA OR THE PCT
Pharmacy Name……………………………………………………………………………Month………………………………………
Product and
Unit
Cost Price
£
Record Number
of units
supplied
Total number of
units supplied
Nicotine patch
21mg 24hr (7)
Nicotine patch
14mg 24hr (7)
Nicotine patch
7mg 24hr (7)
Nicotine patch
15mg 16hr (7)
Nicotine patch
10mg 16hr (7)
Nicotine patch
5mg 16hr (7)
Nicotine gum
2mg (96)
Nicotine gum
2mg (105)
Nicotine gum
4mg (96)
Nicotine gum
4mg (105)
Nicotine Inhalator
Nicotine lozenge
1mg (72)
Nicotine lozenge
1mg (96)
Nicotine lozenge
2mg (72)
Nicotine lozenge
2mg (96)
Nicotine lozenge
4mg (72)
Nicotine lozenge
4mg (96)
Nicotine microtab
Nicotine nasal
spray
Total Cost
Monthly Total
VAT @ 5%
Number of
consultations @ £3.00
Monthly Total
Page 28 of 33
D:\106766852.doc
Total cost
Appendix 4
Administration
PHARMACY ENHANCED SERVICE
NRT VOUCHER SCHEME FORMULARY
Dose
Advantages
Disadvantages
Nasal
Spray
Tip head back slightly – insert spray tip into
one nostril and point to back of nose. Press
firmly & quickly. Spray into other nostril if
required.
Maximum 64 sprays per day.
Week 1-8 = 1-2 doses per hr as required.
Week 9-10 = half number of doses
Week 11-12 = gradually reduce to 0
NICORETTE 500mcg/metered
spray
> 20 cigarettes per day.
Useful in heavy
smokers as the
absorption is
faster than other
products. Peak
plasma levels:10
minutes.
Can cause nasal irritation, watering
eyes, throat irritation, headaches
and dizziness. Should improve after
first few days. Not suitable for those
who suffer stomach ulcers or other
stomach problems. Not suitable for
those with hyperactive airways
disease.
Lozenge
One lozenge should be placed in mouth and
allowed to dissolve.Periodically, the lozenge
should be moved to one side of mouth to the
other, rest between gum and cheek and repeat
process until lozenge has dissolved (approx 30
mins) Should not be chewed or swallowed.
Maximum 15 lozenges per day.
(Nicotinell 1mg - Max 30 loz per day.)
Week 1-6 = 1 lozenge every 1-2 hrs
Week 7-9 = 1 lozenge every 2-4 hrs
Week 10-12 = 1 lozenge every 4-8 hrs and
then gradually reduce to 0.
NIQUITIN
2mg - 1st cigarette > 30 minutes
after waking.
4mg - 1st cigarette < 30 minutes
after waking
Discreet and easy
to use.
May cause throat irritation,
indigestion, increased salivation,
laxative effect and hiccups.
Not suitable for those who suffer
stomach ulcers or other stomach
problems.
Do not eat or drink while lozenge is
in mouth.
Those on low sodium diet should
take salt content of lozenge into
account.
Microtab
NICOTINELL
1mg - < 20 cigarettes per day.
1mg or 2mg - 20-30 cigarettes per
day.
2mg - > 30 per day
Place 1-2 tablets under the tongue and allow to NICORETTE or BOOTS
NICASSIST 2MG MICROTAB.
dissolve slowly.
Should not be chewed or swallowed.
1 tab per hr < 20 cigarettes per
Maximum 40 per day.
day
2 tabs per hr > 20 cigarettes per
Gradually reduce after 12 weeks to 1-2 tabs
per day then stop.
day
Page 29 of 33
D:\106766852.doc
Preferred choice
in pregnancy or
breastfeeding.
Lozenges are
sugar free.
Discreet, easy to
adjust dose, few
side effects.
Must be used correctly, wasted if
swallowed.
Not suitable for those who suffer
stomach ulcers or other stomach
problems.
Administration
Gum
Patch
PHARMACY ENHANCED SERVICE
NRT VOUCHER SCHEME FORMULARY
Dose
Use gum whenever urges to smoke.
Chewed until taste becomes strong and
then parked between the gum and the
cheek until taste fades. Recommence
chewing once taste faded. The ‘chew-restchew’ technique should be applied for 30
mins.
Maximum 15 pieces per day. (25 pieces of
the 2mg Nicotinell gum)
Treatment continued for 3 months then
gradually reduced and stopped when dose
reduced to 1-2 pieces gum per day.
Apply to clean, dry, intact area on non-hairy
skin. e.g hip, chest or upper arm.
Avoid used sites for several days.
Inhalator
For optimum results the 10 week course (8
weeks for light smokers) should be
completed.
Daily treatment commences with one patch
applied on waking and removed dependent
on 16hr or 24hr patch used.
Avoid contact with eyes or nose and rinse
hands in water after application.
Inhale when the urge to smoke occurs –
either through deep inhalation or by shallow
puffing. Best used at room temperature.
Maximum 12 cartridges per day
Week 1-8 = 6-12 cartridges per day
Week 9-10 = 3-6 cartridges per day
Week 10-12 = gradually reduce to 0
Rinse mouthpiece in water several times a week
NICORETTE & NICOTINELL
2mg - < 20 cigarettes per day.
4mg - > 20 cigarettes per day.
Can step down to 2mg gum during
withdrawal of the 4mg gum.
NIQUITIN
2mg - 1st cigarette > 30 mins after
waking.
4mg - 1st cigarette < 30 mins of
waking.
Disadvantages
Easy to regulate dose, can
help to stop over eating.
Liquorice contraindicated
in pregnancy.
Not suitable for those who
suffer stomach ulcers or
other stomach problems.
Difficult for denture
wearers
Side effects can include
throat irritation, >
salivation and hiccups.
Avoid alcohol for 15mins
prior to chewing
24hr patch is
contraindicated in
pregnancy.
Not recommended for
those who suffer allergic
reactions to plaster or
diseases of the skin.
Not suitable for occasional
smokers.
Sugar free.
Preferred choice in
pregnancy or breast
feeding.
NICORETTE ( 16 hr):
15mg for 8 weeks, if successfully
Easy to use.
abstained
10 mg 2 weeks, 5 mg 2 wks.
24 hour patch can help
with early morning craving.
NIQUITIN(24HR)/NICOTINELL(24hr):
Niquitin do clear patch.
Smoke > 10/day Smoke > 20/day
21 mg 6 wks
21mg 3 - 4 wks.
14 mg 2 wks
14mg 3 - 4wks.
7 mg 2 wks
7mg 3 - 4 wks
Smoke < 10/day Smoke < 20/day.
14mg 6 wks.
14mg 3 - 4wks.
7 mg 2 wks.
7mg 3 - 4 wks.
NICORETTE 10 mg/cartridges
Each cartridge has approx 20 mins
use dependent on number, freq &
puffing /inhalation time. The
amount of nicotine from a puff is
less than that from a cigarette
therefore advise to inhale for longer
than when smoking a cigarette.
Page 30 of 33
D:\106766852.doc
Advantages
24 hr patches may disturb
sleep or cause vivid
dreams.
Keeps hands busy, easy to
regulate dose.
Suitable for lighter
smokers and highly
behaviour-dependent
smokers.
May cause cough &
irritation to throat & mouth
Not as suitable for heavy
smokers and not discreet.
Not suitable for patient
with stomach ulcers /
problems. Caution with
throat problems
Appendix 5
Summary of process at the NHS Stop Smoking Service:
Client attends NHS Stop Smoking Service.
Motivational advice & support is provided.
NRT products discussed and the most appropriate
product identified.
Check;
 Contraindications to the product?
 Exclusion criteria to voucher scheme?
 Does G.P practice need to be informed of
quit attempt?
If contraindications or
exclusion criteria to the
voucher scheme; Stop Smoking
Advisor to continue support
and complete ‘Referral to GP
Practice for Assessment of
Pharmacological Intervention’.
If G.P practice is to be informed
of the quit attempt; Stop
Smoking Advisor to continue
support, supply voucher
(indicate on it the reason G.P
informed) and complete
‘Information for patient records’
If pregnant/breast feeding also
complete ‘Informed consent’
and provide guidance notes
If no contra-indications or exclusions to the voucher scheme,
Stop Smoking Advisor to complete NRT voucher and issue to
the client for redemption at a participating pharmacy.
Page 31 of 33
D:\106766852.doc
Appendix 6
Summary of process at the Pharmacy:
Pharmacy receives client with NRT Voucher.
Client to complete the declaration of exemption and consent
to share information on the voucher.
Pharmacy staff to recheck;
 Contraindications to the product?
 Exclusion criteria to voucher scheme?
 Does G.P practice need to be informed of
quit attempt?
If the recommended product is
contraindicated, or the client has
exclusion criteria pharmacy staff
should not supply the product,
contact the
Stop Smoking
Service and arrange for the client
to return for re-assessment.
If the G.P needs to be informed
of the quit attempt, pharmacy
staff can check that this
requirement has been fulfilled
through the annotation on the
voucher under the Advisors
signature. If not fulfilled,
pharmacy staff must inform the
Stop Smoking Advisor without
delay but may supply the
product if appropriate.
Record supply on Patient Medication Records.
Provide advice and support regarding the product supplied and the
attempt to quit smoking.
Pharmacy to sent vouchers to LaSCA by the 5TH day of the
following month.
An NHS fee is chargeable at the current prescription charge for those clients
who are not exempt from prescription charges.
Page 32 of 33
D:\106766852.doc
REFERENCES
1.
UKMI Q&A 136.2
Which medicines need dose adjustment when a patient stops smoking?
2.
Committee on Safety of Medicines Working Group
replacement therapy. CSM & MHRA, November 2005.
3.
Smoking Cessation services in Primary care, pharmacies, local authorities
and workplaces, particularly for manual working groups, pregnant women
and hard to reach communities. NICE public health guidance 10 February
2008.
4.
Nicotine replacement therapy. Guidance for health professionals and
changes in the licensing arrangements for NRT ASH December 2005.
on
Nicotine
5.
UKMI Q&A 1329.2
What factors need to be considered for special patient groups when
selecting
NRT?
6.
National Electronic Library for Health. 2008. Smoking Cessation [on line]
Version 1.2 updated October 2008.
http://cks.library.nhs.uk/smoking
Accessed 1.10.08.
7.
Stop smoking Start Living. Department of Health.
(DofH 273950 April 2007).
Page 33 of 33
D:\106766852.doc
A Smokefree Guide