Local Authority Service Specification (LASS) for Pharmacy Support to Stop
Smoking 2015-2016
Contents:
1.
Background
2.
Service Aims
3.
Service Specification
4.
Clinical Governance Arrangements
5.
Criteria for Eligibility
6.
Reporting and Monitoring
Appendix 1 PGD for the supply of Varenicline (Champix®)
1.
Background
In North Somerset approximately 300 residents die prematurely from smoking-related illness
each year. In 2010/11 there were 2046 smoking attributable hospital admissions with an
estimated cost of £4.4 million. The estimated cost of lost productivity in the workplace from
smoking breaks in North Somerset is £9.2 million. The total cost to the NHS of smoking in North
Somerset is £8.5 million. Health damage from second hand smoke is substantial. Smoking is
the single greatest cause of premature death and disease in North Somerset. It is the single
largest factor in health inequalities and a major driver of poverty. There are an estimated 26,401
smokers in North Somerset and it is estimated that each year smoking costs society
approximately £43.6 million.
2.
Service Aims
The overall aim of this service is to support the reduction of smoking prevalence in North
Somerset and to reduce health inequalities. By supporting adults to stop smoking the service
will also help reduce the uptake of smoking in young people.
The Support to Stop Smoking service is a cost effective and evidenced based national
programme offering both support and medication to smokers who are motivated to quit.
Smoking cessation has been linked to the potential for teachable moments meaning that all
healthcare professionals can have a positive impact on a smoker’s decision to stop.
Pharmacies have daily contact with a significant number of smokers and can play a key role in
both identifying and referring patients (brief intervention), offering an NHS Support to Stop
Smoking service and therefore contribute to the reduction in morbidity and mortality as a result
of smoking.
3.
Service Specification
Pharmacies participating in this scheme will be expected to deliver the following
elements:
Promote the service and identify smokers
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
Ensure that all pharmacy staff who have face to face contact with customers have been
trained in Brief Interventions (available at no charge from Smokefree North Somerset)

Advertise the availability of the Support to Stop Smoking service within the pharmacy

Ensure a smoker does not have to wait more than 2 weeks for a stop smoking
appointment and if this is not possible contact Smokefree North Somerset so alternative
arrangements can be made.
Behavioural support and medication

Provide services consistent with the latest NICE guidance in NHS Stop Smoking
Services: Service and Monitoring Guidance – 2014 and accurately inform patients about
NRT, Varenicline and Bupropion and prescribe as appropriate to smokers being
supported by the Support to Stop Smoking advisor. In addition provide supporting
information for patients about the relative chances of success of each intervention type
e.g. one to one, groups etc. and pharmacotherapy

On receipt of a referral, the pharmacy based Support to Stop Smoking advisor will
confirm the client’s suitability for the programme by assessing motivation and
determining whether the client will benefit from intensive support. This may be conducted
face to face, by telephone or using a questionnaire. Clients not yet ready to quit should
be provided with brief advice and leaflets and advised to rejoin the scheme when ready
to set a quit date. Clients not wanting support to quit cannot receive NRT from the
pharmacy scheme but can still buy their NRT

Pharmacy–based Support to Stop Smoking advisor can host stop smoking groups inhouse if they have attended the relevant training in “Running a Stop Smoking Group”
provided by the Smokefree North Somerset or equivalent

Ensure that trained Support to Stop Smoking advisors keep up-to-date. An advisor within
the pharmacy is expected to attend at least one update meeting annually and update the
rest of the pharmacy re any new information or guidance

Ensure smoking cessation guidelines are included in written pharmacy protocols

Refer any smoker who requires more intensive specialist support including but not limited
to smokers with mental health problems or learning difficulties, to Smokefree North
Somerset Specialist Support to Stop Smoking service. If a smoker does not want to, is
not ready to, or is unable to stop smoking using the Abrupt Quit approach, alternative
options may be available via the Specialist Service. Those with known substance
misuse issues may be referred to the relevant agencies who are also equipped to deal
with smoking

Monitor, support and evaluate a quitter’s progress, particularly at 4 weeks following the
quit date, including those who do not attend (DNA)

CO testing should be carried out on all smokers as a minimum both a baseline (pre-quit)
level and a four week validation (post quit) level this includes those children aged 12
years and over eligible for NRT if Fraser competent
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
Complete monitoring forms (IRS) for each person setting a quit date, return all IRS forms
after 4 week follow-up, irrespective of outcome to Smokefree North Somerset

Organise an annual meeting of all pharmacy staff in conjunction with Smokefree North
Somerset to review this agreement

Service provision cannot be subcontracted to other parties and claims made on this basis
will not be paid

Smokefree North Somerset will provide a CO monitor for each pharmacy. The
responsibility for keeping the monitor in good working order and arranging to calibrate the
monitor if required every 6 months rests with the practice

All support to stop smoking advisors will be given help and support by the specialist
service who will monitor the progress and the quality of the service provided.
E-cigarettes

Electronic cigarettes are currently not included as pharmacotherapy and are therefore
not available on the supply form; however a client can receive behavioural support from
the advisor if they purchase their own e-cigs to support their quit attempt.
PGD Varenicline

4.
We operate a PGD for pharmacists to supply Varenicline in North Somerset. For those
pharmacies that wish to participate in the above scheme, the requirement is that they
have a trained Support to Stop Smoking advisor based in the pharmacy and that the
pharmacist completes
the annual pharmacy update training which includes any
updates to the PGD training offered by Smokefree North Somerset. They also need to
complete the relevant paperwork that supports the PGD delivery online via
pharmoutcomesand ensure that they familiarise themselves with any updates. If a
pharmacist has received PGD training for Varenicline in another area any training needs
will need to be assessed and met before being able to deliver the PGD in North
Somerset. The voucher handling fee (Appendix E) will apply.
Clinical Governance Arrangements
Support to Stop Smoking services should be delivered according to NICE guidance and in
accordance with the Service and Monitoring Guidance – 2014& National Centre for Smoking
Cessation and Training NCSCT training requirements.An advisor within the pharmacy is
expected to attend at least one update meeting annually and update the rest of the pharmacy re
any new information or guidance
Clinical Governance
Competence in providing a service is not only facilitated through training but in regular service
provision in order to cement learning through practical application of the skills learnt, the
expectation therefore is taht advisors see a minimum of 15 smokers during the year pharmacies
will be monitored this year against this recommendation with a view to set a minimum number
of clients to be seen in next years contract.
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Smokefree North Somerset will monitor and review services on a quarterly basis.
The pharmacy will use Smokefree North Somerset incident reporting framework to report any
clinical or non clinical risks associated with the provision of this service in a timely fashion.
5.
Criteria for Eligibility
All North Somerset pharmacies are eligible and encouraged to provide the Support to Stop
Smoking service.
Advisors who have received the Smokefree North Somerset 2 day advisor training for this role
from Smokefree North Somerset or an accredited NHS provider can deliver the service provided
they have been active in supporting smokers over the last year. Advisors are also encouraged
to undertake the free online NCSCT level 1 training within one year of having attended the
Smokefree North Somerset 2 day advisor training.
This training and group training will continue to be provided by Smokefree North Somerset at no
cost to the pharmacy.
6.
Reporting and Monitoring and Payment Arrangements
Smokefree North Somerset will monitor and review services on a quarterly basis and provide a
performance report for each pharmacy highlighting the percentage of CO verified quit attempts
and quit rates.
This is a cost and volume agreement with payments being made as set out below. Whilst
pharmacies are encouraged to achieve increasing levels of uptake Smokefree North Somerset
will closely monitor activity on a quarterly basis and may cap activity according to budget
allocation.
The payment associated with the provision of this service is based on the initial appointment
lasting at least 30 minutes and then weekly 10 – 15 minute appointments should be offered for
at least 4 weeks after the quit date, thereafter every two weeks up to a period of 12 weeks.
Each pharmacy contracted to provide this service will receive a fee of £30 for every client
setting a quit date and who is supported through to the four week follow up stage and if the
following criteria have been met:



Where possible the four week follow-up should be completed face to face and the client’s
carbon monoxide level recorded, along with the quit attempt outcome
If a client defaults from the scheme at any stage after setting a quit date, the advisor
must still follow up the client at four weeks, making at least 2 attempts by telephone.
These attempts must be recorded on the Individual Record Sheet
The four week follow up must be completed or attempted at least twice within 4 – 6
weeks of the quit date.
The fully completed individual record sheet ( IRS) monitoring form must be submitted prior to
the deadlines which will be available and circulated in due course.
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Incomplete monitoring forms will not receive a payment, monitoring forms returned after the six
week follow up date will also not receive a payment but will count towards targets.
It is the intention to move towards a paperless system. This will cut down on paperwork and
postage costs, help pharmacies meet the DOH deadlines and ensure that pharmacies receive
the correct payments. We will therefore be asking some pharmacies to pilot inputting the IRS
forms using an online database.
The cost of any pharmacotherapy supplied under the Pharmacy Support to Stop Smoking
scheme will be reimbursed (drug tariff cost plus VAT@5%) on a monthly basis, following the
receipt of a maximum of 3 supply forms which match a monitoring form. Payment for Varenicline
supply will be via Pharmoutcomes.
Payment will only be authorised for claims submitted within 6 months of the medication issue
date.
A handling fee of £1 will be paid for each four week supply of medication given to a client where
the Support to Stop Smoking advisor is based in a community setting. This fee will be pro-rata
accordingly.
Pharmacies will receive a one off payment of £150 if the pharmacy has signed up to and
delivered the PGD for Varenicline. In addition there will be a one-off payment of £150 to
pharmacies that deliver a Varenicline only service to clients who are receiving
behavioural support via the Support to Stop Smoking Service (StSS) and
roving/community advisors. The payment recognises the consultation and continuation
time of the pharmacist for this service.
The Contractor is expected to take part in any Smokefree North Somerset audit relevant to this
service that may periodically be requested.
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Appendix 1 PGD for the supply of Varenicline (Champix®)
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Patient Group Direction (PGD) for the supply of VARENICLINE
This Patient Group Direction (PGD) is a specific written instruction for the supply of
VARENICLINE to groups of patients within the area covered by NHS North Somerset.
This PGD will enable designated COMMUNITY PHARMACISTS to supply treatment in
accordance with the following protocol and the recommendations of the Department of Health
and NHS North Somerset’s Medicines Policy.
The majority of clinical care should be provided on an individual patient basis. The supply of
medicines under Patient Group Directions should be reserved for those limited situations where
this offers an advantage for patient care (without compromising patient safety) and where it is
consistent with appropriate professional relationships and accountability.
Background information
This PGD is a written with the objective of allowing the supply of a Prescription Only Medicine (POM) on
the NHS by health professionals who do not have prescribing rights.
Varenicline (Champix TM in the UK) was launched as a POM for smoking cessation in December 2006. It
was approved for use in Scotland by the Scottish Medicines Consortium in January 2007; and for use in
England and Wales by the National Institute of Health and Clinical Excellence (NICE) in July 2007. The
main recommendations of the two documents are consistent:
Varenicline is recommended within its licensed indications as an option for smokers who have expressed
a desire to quit smoking.
Varenicline should normally be prescribed only as part of a programme of behavioural support.
The purpose of this PGD is to enable a pharmacist working in North Somerset, who has received training
and has been assessed as competent, and is working with a smoking cessation practitioner ( formerly
known as trained level 2 Smoking Cessation Advisor) to supply varenicline in accordance with the
criteria set out for this patient group direction (PGD).
The MHRA have advised that medicines supplied under a PGD would usually be considered to be
"dispensed medicines". It is therefore considered appropriate for such medicines to be supplied to
patients with the same labelling and other information which they would otherwise receive if the
medicine had been supplied against a prescription. In a majority of cases, the pack to be issued
under a PGD will need to be labelled to reflect the dose exactly as authorised in the PGD, as if it
were being dispensed against a prescription.
1. Clinical condition or situation to which the direction applies
Indication
For adults who are accessing Pharmacy Stop Smoking Services and are in
need of pharmacological treatment as an aid to stop smoking


Criteria for inclusion


Dependent smoker (i.e. they smoke within 30 minutes of waking up
and/or find quitting unaided difficult)
Smoker, over 18yrs old, who has approached the Stop Smoking
Service and who satisfies the criteria for treatment by the stop
smoking service and as per the North Somerset Protocol (Appendix
1)
The patient should set a date to stop smoking. Varenicline dosing
should start 1-2 weeks before this date.
Patient should be willing to continue a course of treatment which
includes behavioural support for 12 weeks unless unable to because
of side effects
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
Valid consent





Patient under 18 years of age;
Tobacco users not sufficiently motivated to quit
Pregnancy;
Breast-feeding;
End-stage renal disease – creatinine clearance <30ml/min (use
with caution in elderly patients, if unsure of renal function refer to
a GP.)
Patients with a history of psychiatric illness, including a history of
depression should be referred to their GP.
Patients with unstable cardiovascular disease.
Clients with hypersensitivity to varenicline or any of its excipients
Patients with Epilepsy or history of seizures or conditions
that lower the seizure threshold.
Patients taking medication that lowers seizure threshold

Criteria for exclusion




Explain the reasons for exclusion under the PGD to the patient. Where
appropriate ensure they are advised to attend their GP practice to discuss
whether treatment by the GP is possible.
Action if excluded
2. Description of treatment
Name of Drug &
Strength
Varenicline (Champix) 0.5mg and 1mg
Formulation
Film coated Oral Tablets
Method/route
Varenicline tablets should be swallowed whole with water and can be taken
with or without food
Patients should be treated for 12 weeks. There should be clear labelling to
indicate instructions to follow for the course.
Days 1 – 3:
0.5 mg (white tablets) once daily
Days 4 – 7:
0.5 mg twice daily
Day 8 to the end of treatment:
1 mg (light blue tablets) twice daily
Dose, dose range,
frequency of
administration and
quantity to supply
Patients should be supplied a 14 day initiation pack and should set a quit
date 7 to 14 days after initiation;
Only 14-day prescription packs should be used at any one time throughout
the quit attempt
Patients should be seen weekly for at least 4 weeks after the quit date;
For patients with moderate renal impairment (creatinine clearance between
30 to 50ml/min) may require a dose reduction to 1mg daily if intolerable side
effects are experienced.
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Patients who cannot tolerate Varenicline because of adverse effects eg
nausea the dose can be temporarily lowered to 0.5mg twice daily. If used,
this lower dose should be reviewed at the follow up appointment.
For patients who have successfully stopped smoking at the end of 12
weeks one additional course of up to 12 weeks treatment with varenicline at
1 mg twice daily may be considered based on consultation with the client
and as per the NHS North Somerset protocol included in Appendix 1.
Legal status
POM – Prescription only medicine.

Patients should be advised to set a quit date 7 to 14 days after
initiation;

The major reasons for varenicline failure are:
- Unrealistic expectations;
- Lack of preparation for the fact that the tablets may cause nausea;
- Insufficient or incorrect use.

It is important to make sure that the patient understands the
following points:
1. Varenicline is not a magic cure: effort and determination are
crucial;
2. It works by acting on the parts of the brain which are affected by
nicotine in cigarettes;
3. It does not remove all temptation to smoke, but it does make
abstinence easier (‘it takes the edge off the discomfort’);
Advice to be given to
the patient before
treatment is provided
4. About a third of patients may experience mild nausea some 30
minutes after taking it. This reaction usually diminishes gradually
over the first few weeks, and most patients tolerate it without
problems;
5. Patients should be told to stop treatment and contact their
doctor immediately if they develop suicidal thoughts or
behaviour
6. Patients should be advised to discontinue treatment with
varenicline if agitation, depressed mood or changes in behaviour or
thinking that are of concern to the patient, pharmacist, doctor, family
or care-givers are observed.
7. Patients with pre-existing cardiovascular disease should be
advised to stop taking varenicline and seek advice from their
GP if they feel their symptoms are worsening. Advise that
medical help is sought right away if they have symptoms of a
heart attack or stroke.
8. Instruct on correct use and daily dose. Use the manufacturer’s
product packaging for the explanation. Patients should take
varenicline for 7 to 14 days before stopping smoking.
9. Varenicline may cause dizziness and somnolence and therefore
may influence the ability to drive and use machines. Patients are
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advised not to drive, operate complex machinery or engage in other
potentially hazardous activities until it is known whether this
medicinal product affects their ability to perform these activities.
10. In clinical trials and from post-marketing experience there have
been reports of seizures in patients with or without a history of
seizures, treated with Varenicline. Having a seizure affects your
legal ability to drive. If you have a seizure and do not stop driving
you may be breaking the law, your current driving licence may not
be valid and your vehicle insurance may not cover you. Following a
seizure, drivers of certain categories of vehicles may have to stop
driving for a minimum of five years.
11. Upon stopping treatment with varenicline, patients may
experience an increase in irritability, urge to smoke, depression
and/or insomnia. This can occur in up to 3% of patients.
Identification and
management of
adverse reactions
Reporting procedure
for adverse reactions
Supplies and
resources that must
be available at sites
where this PGD is in
use

Pharmacists can refer to the SPC for varenicline for more detailed
information. www.medicines.org.uk/emc/default.aspx

The very common (> 1 in 10; and common effects > 1 in 100) are:
Very Common - Abnormal dreams, insomnia, Headache, nausea
Common - Increased appetite, Somnolence, dizziness, dysgeusia,
Vomiting, constipation, diarrhoea, abdominal distension, stomach
discomfort, dyspepsia, flatulence, dry mouth, fatigue

Seizures are an uncommon side-effect.

Varenicline is a ‘black triangle’ drug. Therefore all adverse reactions
should be reported to the CSM using the ‘Yellow Card’ reporting system
https://yellowcard.mhra.gov.uk/
 A copy of this PGD

Access to latest Summary of Product Characteristics for varenicline
(available at www.medicines.org.uk)

Latest version of the British National Formulary

Information about services involved in providing healthy lifestyles
It is the responsibility of the individual pharmacist to ensure that they
and their staff are competent in all aspects of the supply of varenicline
and are updated on current medicines policies.

Ongoing supplies of
varenicline
Additional Facilities
Pharmacists must satisfy themselves on that the patient is still
eligible to receive treatment with varenicline at each supply. This
should include a re-examination of the exclusion criteria such as
recent onset of depressive symptoms.
Consulting Room
See Appendix 1 for all documentation and protocol
Records to be kept for
legal and audit
purposes

Patient’s name, address, date of birth and GP details;

Date supplied & Name of the pharmacist who supplied the
medication;
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
Start date and Quit date;

Batch number and expiry date;

Quantity supplied and dose advised

Reason for inclusion;

Advice given to patient;

Pharmacists must ensure that documentation is sent to the patients
GP informing them that varenicline has been issued under a PGD

Details of any adverse drug reaction and actions taken including
documentation in the patient’s medical record via GP;

Since varenicline is a ‘black triangle’ drug, all adverse reactions
should be reported to the CSM using the ‘Yellow Card’ reporting
system.
3. Characteristics of staff
It is the professional responsibility of the Health Care professional to work within their level of
competence. The healthcare professional will ensure he/she has the relevant training and is
competent to work under this PGD.
Qualification
requirements
Reference to
national/local policies
or guidelines
Pharmacist (registered with the GPhC and either trained themselves or
working with a smoking cessation practitioner (formally known as a Stop
Smoking Advisor accredited to provide Level 2 Stop Smoking advice). The
NHS North Somerset Stop Smoking Service will provide pharmacists with
training re: North Somerset protocol. This training is mandatory before
supply under this PGD can commence.

Department of Health (1998): Review of Prescribing, Supply
and Administration of Medicines. A report on the Supply and
the Administration of Medicines under Group Protocol

NICE Technology Appraisal – Smoking Cessation: Varenicline
– July 2007)

North Somerset Protocol
Clients wanting more information can be referred to:
The NHS Smoking Helpline: 0800 169 0 169;
Quit line:0800 002200
NHS North Somerset Stop Smoking Service
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Individual Pharmacist Authorisation- Varenicline
I have read and understood the Patient Group Direction (PGD) and agree to supply this
medicine only in accordance with this PGD.
PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR
ACCOUNTABILITY. It is the responsibility of each professional to practice only within the
bounds of their own competence and in accordance with their own code of professional
conduct.
Pharmacist
(Print)
name Pharmacist signature
Date form signed
Date
of
last
training attended
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