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Solihull Stop Smoking Service Protocol for the supply of Nicotine
Replacement Therapy (NRT)
For the supply of NRT by named Pharmacy Advisors (Pharmacists
& *Pharmacy Technicians) trained in smoking cessation.
Location where this Protocol applies: Community Pharmacies
 It is the responsibility of the named Advisor working under this protocol to
verify that the patient fulfils the stated criteria for the supply of the
treatment concerned

It is not appropriate to have a Protocol in place that is infrequently used by
the Pharmacy Advisor because of progressive unfamiliarity with its
contents. Any Advisor that works to a protocol infrequently should consider
whether to cease doing so.

This protocol will be reviewed every 2 years, or sooner in light of new
guidance.
1. Reason for introducing Protocol
To increase accessibility and availability of NRT within the Community Pharmacy setting for people who want to
stop smoking
2. Clinical Condition or situation to which this protocol applies
2.1
Define condition/situation As an aid to treating nicotine dependence in clients who want to stop smoking
with the help and support of a named Pharmacy Advisor
2.2

Criteria for inclusion
Tobacco users identified as sufficiently motivated to quit (i.e. willing to set a
quit date and receive weekly support for at least the first four weeks of a quit
attempt).
Can also be used in pregnancy see 4.2

‘P’ medicines may only be supplied, if the supply is being made at a registered
pharmacy by or under the supervision of a pharmacist.
2.3
Criteria for exclusion
Assessment form must
be completed. If the
Community Pharmacist
does not feel confident
to supply NRT they
should refer the client
to their GP using the
referral form (see
appendix 6)
Motivation and smoking cessation history
 Clients not sufficiently motivated to quit or use NRT.
 Clients who are requesting a second course of NRT within 6 months of
a previous attempt to stop smoking using NHS services. However,
NICE Guidelines state that if external factors interfere with the initial
attempt to quit smoking, it may be reasonable to try again sooner, in
such cases the Pharmacy Advisor should use their professional
discretion.
 Clients who have been using NRT continuously for 3 months and there
is no valid reason to continue supply.
Vascular Disease
 *Severe cardiovascular disease (including severe arrhythmia, acute
coronary syndrome, unstable or worsening angina, immediate postmyocardial infarction).
 *Recent cerebrovascular accident including transient ischaemic attack.
 *Severe peripheral vascular disease.
 Recent heart surgery
Other Disease
 *Severe Liver or Kidney disease
 Uncontrolled Thyroid Disease
*The suggested minimum length of time between a “severe” or “recent”
cardiovascular episode and patient starting NRT is 4 weeks.
NRT Product
Clients with previous serious reaction to NRT or any of the other ingredients
contained in the products, e.g. Glue in the patch.
 Nasal spray only – clients with chronic nasal disorders such as
polyposis, vasomotor, rhinitis and Perennial rhinitis.
 Patches only – clients with chronic generalised skin disease such as
psoriasis, chronic dermatitis and urticaria; clients who have had a
previous reaction to transdermal patches.
 Clients must remove patch 24 hours prior to surgery and stop using all
other forms of NRT prior to surgery
Drug Interactions:
There are no specific drug interactions with NRT; however, stopping smoking
may cause an increase in the circulating levels of Theophylline.
If a client is taking Theophylline, NRT should not be supplied under this
protocol and the patient should be referred to their GP
Other:
 Clients under 16 years old
 Clients already using Bupropion (Zyban) or Varenicline
(Champix▼)
 No Valid consent
2.4
Cautions
Side Effects:
These are usually transient but could include the following (some of which are
the result of stopping smoking), nausea, dizziness, headaches, cold and flu
symptoms, palpitations, dyspepsia and other gastro-intestinal disturbances,
hiccups, insomnia, vivid dreams, myalgia, chest pain, blood pressure changes,
anxiety and irritability, and impaired concentration, dysmenorrhoea.
2.5
Patient Consent
2.6
Action if client excluded
3. Characteristics of Staff
3.1
Class of professional for
whom this protocol is
applicable.
3.2
Additional requirements /
specialist qualifications
required.
3.3
Continued training
requirements
4. Description of treatment
4.1
Generic name of medicine
form and legal status
Client information relating to the supply of NRT under this protocol will be
passed on to other organisations within the health service (e.g. Clients GP,
NHS Stop Smoking Service, CT) for purposes such as referral, audit or
payment. The client’s informed consent must be obtained before information
can be passed on (Appendix 3)
1. Document reasons for exclusion in client’s records.
2. Review if client becomes motivated to quit smoking, where
appropriate.
3. Provide further support and information on alternative options to assist
the client in stopping smoking.
Named Community Pharmacy Advisor
Smoking Cessation Training approved by Solihull Stop Smoking Service.
Training to supply Nicotine Replacement under this protocol.
Annual update training
NRT may be supplied in the following forms:
Gum (GSL) - 4mg; 2mg.
Patch (GSL) – 21mg/24hours; 14mg/24hours; 7mg/24hours;
15mg/16hours; 10mg/16hours; 5mg/16hours
Lozenge (GSL) – 1mg00;2mg;4mg
Sublingual tablet – (GSL) 2mg
Inhalator (P) – 10mg/cartridge
Nasal Spray (P) – 500 micrograms/metered spray.
Note:
‘P’ medicines may only be supplied, if the supply is being
made at a registered pharmacy by or under the supervision of
a pharmacist.
All supplies:
In accordance with the NICE guidelines, treatment will normally last up to
8 weeks providing the client has remained abstinent.
Treatment may be extended beyond the initial 8 weeks, however this is at
the discretion of the Specialist Advisor in cases where continuing
treatment is deemed likely to prevent relapse.
A maximum of 2 weeks NRT will be given at any one time.
4.2
When supplies can be made
outside the terms of the
summary of the product
characteristics (SPC)
For client’s who are motivated to quit smoking, the use of NRT outside of
the terms of the SPC is supported by NICE guidance and it may be
supplies to the following:
 Patients who are under 18 years but over 16 years.
 Pregnant or breastfeeding women; intermittent products (e.g.
nicotine gum) should be recommended as first line treatment,
however if the smoker cannot tolerate oral products then a patch
can be worn for a maximum of 16 hours.
 Patients with a history of diabetes, thyroid disease,
cardiovascular disease, peptic ulcer disease who are not in the
exclusion criteria 2.3 above.
Dose
Assessment for dose and product are made on the following criteria:
 Time to first cigarette
 Number of cigarettes smoked per day
 Carbon Monoxide reading
 Patient choice
Refer to Appendix 1
4.3
4.4
4.5
4.6
4.7
Route / method of
administration
Frequency
Total dose and number of
times treatment can be
administered; state time
frame.
Information on follow-up
management
Written / verbal advice for
patient/carer before/after
treatment.
Refer to Appendix 1
Refer to Appendix 1
Refer to Appendix 1
The client will receive individual tailored support i.e. one to one or group
support, telephone support, self help booklet.
Advice to clients should include specific product advice plus the following
general advice on:
 Withdrawal symptoms and advice on how to manage these.
 The effects of smoking tobacco whilst using NRT – particularly in
vulnerable groups, e.g. pregnant women, clients with a
cardiovascular disease.
 Written information on products supplied, self-help leaflets and
where to obtain more information, in particular NHS Helpline
numbers for: Solihull Stop Smoking Service 0121 712 8333
 Follow-up and obtaining further supplies of NRT.
 Give individualised advice to clients under the age of 18 years
and to pregnant or breastfeeding women. The administration of
their treatment may differ to that specified in the product
information leaflet.
Combination Therapy

4.8
Instructions on identifying,
managing & reporting
adverse drug reactions
Refer to the SSSS guidelines for the most up-to-date
guidance on combination therapy. At present, the Pharmacy
based Advisor may only supply one form of NRT. Combining NRT
may be more efficacious than a single form, and thus may be
useful for clients who are unable to quit using only one form of
NRT. If combination NRT is deemed necessary, the Pharmacy
Advisor should recommend one product under this protocol and
the patient must fund additional NRT.
There are no specific drug interactions with NRT; however, stopping
smoking may cause an increase in circulating levels of Theophylline (see
2.3).
Erythema may occur in some cases when using patches. If it is severe or
4.9
Arrangements for referral for
medical advice.
4.10
Facilities & Supplies, which
should be available at sites
where care is provided.
persistent, treatment should be discontinued and another form of NRT
should be considered.
The Pharmacy Advisor will refer clients for medical advice who are
motivated to quit but are in the criteria for exclusion (see 2.6). Medical
opinion will be sought to assess whether the benefit of using NRT
outweighs the risk of continued smoking (See appendix 5).
Under this protocol, a supply of NRT will be issued once a full assessment
has been conducted (by the Pharmacy Advisor) under the criteria defined
in the ‘Guidelines for Solihull Stop Smoking Service Primary Care Service
Providers’ (under development).
A supply of NRT will be given to the client in one of the following ways:
1. The named Pharmacy Advisor will supply NRT directly to the
client.
2. An ‘NRT Supply Request Form’, stating type and strength of NRT,
signed and dated by the named Pharmacy Advisor; will be taken /
faxed to the GP. The GP will then take the decision to supply the
product requested.
Action will be documented.
4.11
Details on record keeping
The Pharmacy Advisor must keep a record of the consultation for at least
two years (may be kept electronically), and the following documents in
particular:


5. Audit
All information will be audited by
Solihull Stop Smoking Service
Audit will include:









6. Management
6.1
Protocol developed by:
6.2
Name of Managers
authorising protocol:
6.3
Name of person
responsible for identifying
practitioners for approval
Clients records of treatment and advice given.
Details of the product(s) supplied and prescription charges
collected should be recorded as required for audit purposes.
Number of clients setting a quit date.
Number of clients quit at 4 weeks.
Number of clients quit at 12 months.
NRT product used (type and quantity).
Success rate of product used.
Quit rate by postcode.
Use in pregnancy.
Use in under 18’s
Documentation and record checks.
Solihull Stop Smoking Service
Public Health Directorate
2nd Floor, Mell House
46, Drury Lane,
Solihull,
B91 3BU
Tel: 0121 712 8333
Stop Smoking Service Manager – Alison Trout
Address as above.
Lead for Medicines Management – Mary Malloy
Stop Smoking Service Manager – Alison Trout
Address as above.
6.4
6.5
and auditing protocol.
This protocol has been ratified and agreed by:
Clinical Effectiveness Committee – Solihull Care Trust March 2007
Review date: March 2009
Updated for Pharmacy Scheme July 2007
7. References and Sources of Information
1. Guidelines for Solihull Stop Smoking Service Primary Care Service Providers.
2. NICE Guidance on the use of nicotine replacement therapy (NRT).
Appendix 1 For full details see the product’s SPC
Drug Name
/ Form
Dose:
Nicotine Gum
Frequency:
1 piece per hour. 15
pieces per day
Route:
Number of
doses in
one weeks
supply:
Oral
105 piecesNicorette,
96 piecesNicotinell
105 pieces-NiQuitin
CQ
Temporo-mandibular
joint disease
Contraindications
specific to
this drug:
Specific
Advice to
client
2mg (light to medium
smoker)
Gum should be
chewed until the
taste becomes
strong and then
‘parked’ between the
gum and cheek until
the taste fades.
Recommence
chewing once the
taste has faded.
This ‘chew-restchew’ technique
should be applied for
30 minutes.
Nicotine
Microtab
2mg
sublingual
tablet
Nicotine Patch
1 tablet per
hour
minimum.
15-40
tablets per
day.
Oral
105 tablets
1 patch per day
Tablets
should be
placed
under the
tongue and
allowed to
dissolve
slowly.
Nicotine
Nasal Spray
500
micrograms
/metered
sprays
Nicotine Inhalator
1 puffing session
per hour
(minimum) 6-12
cartridges per day.
Transdermal
105 tablets
1 spray to
each nostril
per hour
(minimum).
24-64 doses
per day.
Nasal Spray
1 bottle
Nicotine
Lozenge
1mg, 2mg: (light
to medium
smokers)
4mg: (heavy
smokers)
1 lozenge per
hour (minimum).
15-25 lozenges
per day.
Inhaled
42 cartridges
Oral
72 lozenges
Eczema allergy to
sticking plaster
Chronic nasal
spray
Exercise may increase
absorption of nicotine
and therefore side
effects.
The patch should be
applied once a day,
normally in the morning,
to a clean, dry, non-hairy
area of skin on the hip,
trunk or upper arm.
Allow several days
before replacing the
patch on a previously
‘used’ area. Place the
patch in the palm of the
hand and hold onto the
skin for 10-20 seconds.
Patches should not be
applied to broken or
inflamed skin.
Once the patch is spent
it should be folded in half
and disposed of
carefully.
Clients should not try to
alter the dose of the
patch by cutting it up.
Advise on
correct use of
spray.
Warn of
possible local
effects but
also that
these tend to
lessen within
a few days.
The nasal
spray should
not be used
whilst the
user is driving
or operating
machinery as
sneezing and
watering eyes
could
contribute to
accidents.
Clients should be
warned that the
inhalator requires
more effort to
inhale than a
cigarette and that
less nicotine is
delivered per
inhalation.
Therefore the client
may need to inhale
for longer than with
a cigarette.
Used cartridges
will contain
residual nicotine
and should be
disposed of safely.
Advise the client to
keep them in the
case and dispose
of them in
household rubbish.
Lozenge should
be sucked until
the taste is
strong and then
‘parked’
between the
gum and the
cheek until the
taste fades.
Once faded
then sucking
should
recommence.
Simultaneous
use of coffee,
acid drinks and
soft drinks may
decrease
absorption of
nicotine and
should be
avoided for 15
minutes prior to
sucking
lozenge.
24 hour patch: 21mg,
14mg, 7mg
16 hour patch:
15mg, 10mg, 5mg
10mg cartridges
Appendix 2
Please update your records
Date:
/
/
GP Name
GP Address
GP Fax
Confidential
Dear Dr.
Re: Client receiving Nicotine Replacement Therapy and Smoking
Cessation Support
I am writing to inform you that your patient……………………………DOB…………
is currently being supported by Solihull Stop Smoking Service and has been
given ……………………………………..(Nicotine Replacement Therapy product)
at …………………………………………………... Further requests for NRT will be
contingent upon this client remaining abstinent.
Yours Sincerely,
Community Pharmacy Stop Smoking Advisor
Appendix 3
CONSENT FORM
NAME:
DOB:
ADDRESS:
Please sign below to say that you understand the information that has
been given to you.








I have completed a risk assessment form.
I have been advised not to exceed the recommended dose of NRT.
I understand that I must refrain from smoking whilst using NRT.
I have been given the opportunity to ask questions.
Where an NRT product has been given to me, I have received
clear written (patient information leaflet) and verbal instructions
about the correct use of this product.
I agree to the Stop Smoking Advisor passing on my information to
my Consultant/GP and the NHS Stop Smoking Service if
necessary.
I agree to be supported by the Stop Smoking Advisor throughout
the course of treatment.
I understand that my GP will be informed that I have received a
supply of NRT from the Stop Smoking Service and a copy will be
held in my client file.
Client
signature………………………………………………………………………………
Date………………………………….
Stop Smoking Advisor details:
Name:
Signature……………………………………………
Date………………………………….
Appendix 4
Assessment Protocol and Supply Details
Client Name____________________________
DOB __________________ Ref. NO:_________________
Client Address_____________________________________________________________________________
Is the client smoking daily and sufficiently motivated to stop smoking?
YES / NO
If no, DO NOT continue with this form/supply NRT. Advise the client to return when they are ready to make a quit
attempt.
Contraindications:
Is / has the patient:

Under 16 years old

Taking Buproprion or Varenicline

Has severe liver or kidney disease
Had a Recent Cerebrovascular accident including:

A stroke / TIA within the last 4 weeks
Has Severe Cardiovascular disease including:

Had a heart attack within the last 4 weeks

Has unstable angina?

Has severe cardiac arrhythmia?

Had coronary artery bypass graft or other heart surgery within last 4 weeks?

Had angioplasty within the last 4 weeks

Uncontrolled thyroid disease
*Theophylline – if a client is taking Theophylline, NRT should not be supplied under this protocol
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
If the answer to any of the above is YES, then the patient must be
referred to a doctor or asked to return at a later date.
Cautions:











Has cardiovascular disease
Pregnant or breast feeding
(Intermittent NRT preferred)
Has already been using NRT for 3 months or longer
Second course of NRT prescribed within 6 month period
Has peripheral vascular disease
Severe liver/renal disease is under contraindications
Has tumour of adrenal glands
History of stomach ulcers?
Has an overactive thyroid?
Has Diabetes
Under 18 but over 16 years old
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
If the answer to any of the above is YES, consider if it is still appropriate to supply NRT, and if so complete
GP notification form and give additional advice if required. Please refer client to GP if you are not prepared to
supply or recommend NRT.
Consent obtained
Is the use of NRT appropriate in this instance?
YES / NO
YES / NO
If NO, please state why ---------------------------------------------------------------------------------------------------------------------------Client’s NRT treatment of choice --------------------------------------------------------------------------------------------------------------Name of Advisor:
---------------------------------------------------Date: -------------------------
Signature::
------------------------------------------------------------------------------------
Appendix 5
Please update your records
Referral to GP for Client contra-indicated to use Nicotine
Replacement under Stop Smoking Service Protocol
FAO: GP Name
GP Address
______
Client’s Name and address
DOB
Telephone
_____
Dear Dr _______________________,
A consultation with the above client indicated that NRT may be contraindicated and feel unable to supply. I believe a clinical opinion is required for
the following reason(s):
--------------------------------------------------------------------------------------------------I have therefore recommended that this client arrange an appointment to see
their doctor to discuss the use of this medication or alternative interventions.
Name of Advisor: __________________________________
Contact Telephone Number:___________________________________
Signature:_______________________Date:______________________