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 smokingrelated 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:
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Promote the service and identify smokers

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 in-house 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
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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

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

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.
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4.
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.
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.
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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.
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.
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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
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








Criteria for
exclusion




Action if excluded
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
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
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.
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
Dose, dose range,
frequency of
administration and
quantity to supply
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
Patients should be supplied a 14 day initiation pack and should set
a quit date 7 to 14 days after initiation;
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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.
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.

Advice to be given
to the patient
before treatment is
provided
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’);
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
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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 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

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/
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Supplies and
resources that
must be available
at sites where this
PGD is in use

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;

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
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
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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.
Reference to
national/local
policies or
guidelines

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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Appendix 2 Initial consultation sheet
Treatment can only be initiated by a pharmacist who has completed
training and signed the PGD - Please refer back to this form each
time you supply varenicline
Initial Consultation Sheet
Checklist for the supply of Varenicline ▼ (Champix®) via Patient
Group Direction
Situation/
Condition
Nicotine dependent adult motivated to quit (must be willing and able to
attend structured stop-smoking behavioural support as part of the
pharmacy 1-1 Support to Stop Smoking Service)
Pharmacist’s name
Patient’s name
Patient’s Post Code
Date of consultation
No
DoB
Inclusion criteria for supply of varenicline by community Yes
pharmacists
Dependent smoker (smoke within 30 mins of waking or unable to
quit unaided)
Age over 18 and satisfies the criteria for treatment as per the
North Somerset protocol (Appendix 1)
Quit date discussed
Patient able to continue a 12 week course of treatment including
behavioral support
Valid consent obtained
No
Exclusion criteria for supply of Varenicline by community Yes
pharmacists
Patients under 18 years of age
Tobacco users not sufficiently motivated to quit
Not willing to attend follow-up sessions
Pregnancy and those planning to become pregnant
Breastfeeding women
End stage renal disease or concern about renal function (use with
caution in elderly. If unsure of renal function refer to a GP)
History of psychiatric illness (including depression).
Existing unstable cardiovascular disease (recent MI or unstable
angina)
Hypersensitivity to Varenicline or any of its excipients
Patient has history of epilepsy or seizures, or has a condition or
concurrent medication that lowers seizure threshold (refer to GP)
Patient is not recommended to use Varenicline by their GP
No
If the answer to any of the exclusion criteria is “yes” the patient is NOT eligible
for supply of Varenicline from the Pharmacist under the terms of the PGD.
Refer patient to their GP (if applicable) or make them aware of alternatives
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ACTION TAKEN
Suitable for Varenicline via pharmacy PGD
Yes
No
Exclusion – reason:
Pharmacist’s signature
The action specified was based upon the information given to
me by the patient which (to the best of my knowledge) is
correct.
Patient’s signature
The above information is correct to the best of my knowledge.
I have been counselled on the use of Varenicline and
understand the advice given to me by the Smoking Cessation
Practitioner and/or Pharmacist
Date
Treatment can only be initiated and continued by a pharmacist who has completed
the training and signed the PGD
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Information to be given to the patient during the initial consultation
Patients should be advised to set a quit date 7 to 14 days after
□ Set quit
initiation of Varenicline
date
□ Treatment
schedule
□ Advice
about
treatment with
varenicline
□ Very
Common side
effects
□ Common
side effects
□ Changes in
mood
Days 1-3
Days 4-7
Day 8 to
treatment
the
end
of
0.5mg (white) once daily
0.5mg (white) twice daily
1mg (blue) twice daily
Tablets should be swallowed whole with water, with or without food.
Nausea may be reduced if taken with or after food
1. Varenicline failure
The main reasons are:
- Unrealistic expectations
- Lack of preparation for the fact that the tablets may cause
nausea
- Insufficent or incorrect use
2. Mode of action
Varenicline works by acting on the part of the brain which is affected
by nicotine. It is not a magic cure; effort and determination are still
required. Varenicline does not remove all temptation to smoke, but it
makes abstinence easier.
3. Side Effects
(i) Very Common (> 1 in 10)
Abnormal dreams, insomnia, headache and nausea
Note: about one-third of patients may experience mild nausea some
30 minutes after taking Varenicline. This reaction usually diminishes
over the first few weeks.
(ii) Common (> 1 in 100)
Increased appetite, somnolence, dizziness, dysgeusia, vomiting,
constipation, dyspepsia, flatulence, dry mouth, fatigue.
Note: patients should be advised that if they are affected by
dizziness and/ or somnolence, they should not drive, operate
complex machinery or engage in otherwise hazardous activities until
it is known whether this medicinal product affects their ability to
perform these activities.
(iii) Other notable adverse reactions
Changes in mood
 Patients should be told to stop treatment and contact their
doctor immediately if they develop suicidal thoughts or
behavior
 Patients should be advised to stop treatment with Varenicline if
agitation, depressed mood or changes in behavior or thinking
occur that are of concern to the patient, pharmacist, doctor, family
or care-giver.
 Patients with cardiovascular problems should be told to stop taking
Varenicline and seek advice from their GP, if they feel that their
symptoms are worsening during treatment with Varenicline.
Seizures
Patients should be warned that there have been reports of seizures
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□
Cardiovascula
r disease
□ Seizure
warning
in patients with or without a history of seizures.
- Having a seizure affects their legal ability to drive.
- If the patient has a seizure and does not stop driving they may
be breaking the law, their current driving license may not be
valid and their vehicle insurance may not cover them.
- Patients MUST stop taking Varenicline and contact their GP if
they suspect that you have had a seizure whilst on treatment
with Varenicline. Following a seizure, drivers of certain
categories of vehicle may have to stop driving for a minimum
of five years.
N.B. During subsequent consultations for on-going supply of
Varenicline, the pharmacist must check for the presence of
these side effects.
 Patients should be warned that they may experience an increase
in irritability, urge to smoke, depression and/or insomnia upon
stopping Varenicline. This may occur in up to 3% of people who
have been prescribed varenicline. It should be pointed out that
people who stop smoking without support often feel these effects.
□ Stopping
varenicline
Note: 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
relating to the supply of Varenicline under the PGD will
□ Consent to Information
be passed on to their GP and N Somerset Support to Stop Service to
share
ensure proper record-keeping and client safety. The patient gives
information
consent for this information to be shared.
General smoking cessation advice, particularly with regard to:
□ General
Stop Smoking  Withdrawal symptoms
 Possible changes in the body on stopping smoking e.g. weight
Advice
gain
should be advised how to obtain further supplies of
□ Follow up Patients
Varenicline from the pharmacy.
Patients wanting more information can be referred to:
□ More
North Somerset Support to Stop Service
01275 456 744
information
NHS Smoking Helpline
0800 022 4 332
Quit Line
0800 00 22 00
I have understood the information given to me by the pharmacist
□ Patient
understands
advice given
Signed…………………………………………….Date……………………
…
Pharmacy stamp
This record should be kept for a minimum of 8 years
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Appendix 3 Varenicline supplies
Varenicline Supplies
Pharmacist’s record sheet for starting and continuing supplies of Varenicline
(Champix®)
(This record should be kept for a minimum of 8 years)
Please note: You must assess continuing suitability for supply of Varenicline under
the PGD before each supply is made
Patient’s name
Date of Birth
Packs
Date
given
Batch
No.
Expiry
date
Ongoing
Side
suitability
for effects
supply
of discussed
Varenicline
under
PGD
assessed
Pharmacist
initials and
GPhC
reg.no.
Starter
Weeks 1 & 2
Continuation
Weeks 3 & 4
Continuation
Weeks 5 & 6
Continuation
Weeks 7 & 8
Continuation
Weeks 9 & 10
Continuation
Weeks 11 &
12
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Appendix 3a Confidential Fax Front Sheet
Confidential Fax – Front Sheet
Notification to supply/not supply Varenicline (Champix®) under an agreed
PGD protocol
TO:
FAO (GP Name)
GP Practice
address)
(name
and
Fax No
Patient’s name
FROM:
Pharmacist’s name
Pharmacist’s stamp
Pharmacy
number
Date
Number of pages
telephone Telephone
Pharmacy fax
2 (including this sheet)
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Appendix 3b Confidential letter/Fax to GP (notification to supply Varenicline)
Pharmacist’s
Fax/Letter
to
GP
(Confidential)
Notification to supply/not supply Varenicline (Champix®) under an agreed
PGD protocol
Please give your patient a photocopy of this fax/letter
GP name,
address
practice
and
The following patient has attended the pharmacy and been assessed by the Pharmacist under the
guidance of the Patient Group Direction (PGD) for Varenicline for smoking cessation treatment.
According to the information given by the patient the criteria for inclusion
□
Have been met and they are eligible to receive Varenicline to help with stopping
smoking
□
Have NOT been met and places them outside the criteria for eligibility to receive
Varenicline
through the PGD (see below)
Patient’s name
Address
DoB
Patient’s telephone number
Quit date
Pharmacy Name, Address
(or stamp)
Pharmacy telephone and fax Telephone
number
Fax
Pharmacist’s name
Date
Pharmacist’s signature
If appropriate - reason for exclusion/referral (indicate all that apply)
Unwilling to attend pharmacy for support
History of psychiatric illness (including depression)
Epilepsy
Unsure of renal function (elderly or has existing renal problems)
Unstable Cardiovascular disease
Other
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Appendix 4 Confidential letter/Fax to GP (discontinuation of support for Varenicline)
GP Fax/Letter - confidential
Discontinuation of support of Varenicline (Champix®) using
PGD protocol – EXCEPTIONAL CIRCUMCUMSTANCES
GP name, practice name
and address
The following patient has attended the pharmacy and has been using Varenicline for
smoking cessation treatment under the guidance of the Patient Group Direction
(PGD)
Patient’s name
Patient’s Address
Patient’s DoB
Patient’s telephone number
Unfortunately our pharmacy is no longer able to support the patient because:
(√)
The PGD trained pharmacist is away or has moved
The PGD trained pharmacist is on long term sick
The PGD trained pharmacist has taken a sabbatical
Other
The client remains motivated and committed to using Varenicline to help them quit. I
have asked them to attend the surgery to discuss this further with their GP. If
behavioural support is not available from your service, please contact the Stop
Smoking Service on 01275 546 744.
(A copy of the client’s paperwork will be faxed/sent to you at your GP practice)
Pharmacy Name, Address
(or stamp)
Pharmacy telephone
fax number
Pharmacist’s name
and Telephone
Pharmacist’s signature
Fax
Date
Data protection confidentiality note: This message is intended only for the use of the individual or entity to which it is addressed
and may contain information that is privileged, confidential & exempt from disclosure under law. If the reader of this message is
not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is
strictly prohibited.
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Appendix 5 Confidential letter/Fax to GP (outcome of support for Varenicline)
GP Fax/Letter - confidential
Outcome of support of Varenicline (Champix®) using PGD
protocol
GP name, practice name
and address
The following patient has attended the pharmacy and has been using Varenicline for
smoking cessation treatment under the guidance of the Patient Group Direction
(PGD)
Patient’s name
Address
Patient’s telephone number
DoB
The outcome of the patient’s quit attempt is:
Quit - CO Verified
Quit - Self-report
Not Quit
Lost to follow up
Date
of
last
appointment
The patient has been given relapse prevention advice and can return for
support if necessary
Pharmacy Name, Address
(or stamp)
Pharmacy telephone
fax number
Pharmacist’s name
and Telephone
Pharmacist’s signature
Fax
Date
Data protection confidentiality note: This message is intended only for the use of the individual or entity to which it is addressed
and may contain information that is privileged, confidential & exempt from disclosure under law. If the reader of this message is
not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is
strictly prohibited
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P:\2 Business Management\Contracts\2015-16\4. Draft contract\Pharmacy