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Transcript
NHS Walsall Protocol for the supply of Nicotine Replacement Therapy (NRT) under a
voucher scheme
Protocol for the supply of:
Clinical need which this protocol is intended
to address
NICOTINE REPLACEMENT THERAPY (NRT)
As an aid to treating tobacco dependence in clients
receiving specialist advice and support from Walsall
Community Health Specialist Service.
Clients receiving specialist advice and support from trained
advisors in other settings, e.g. Pharmacists, youth workers,
who are trained in smoking cessation to the Walsall level 2
training standards.
Relevant National Guidance
National Institute for Health and Clinical Excellence –
Smoking cessation services in primary care, pharmacies,
local authorities and workplaces, particularly for manual
working groups, pregnant women and hard to reach
communities (PH10). London, February 2008
Duff G. New Advice on Use of Nicotine Replacement
Therapy (NRT): wider access in at-risk populations. Expert
advice from a Working Group of the Committee on Safety
of Medicines (CSM), November, 2005.
Department of Health – NHS Stop Smoking Services
Service and Monitoring Guidance 2009 / 2010. London,
March 2009
CLINICAL CONDITION
1. Definition of condition
Clients assessed as nicotine dependent.
2. Criteria under which client will be eligible
for inclusion
Tobacco users identified as sufficiently motivated to quit,
attending smoking cessation services and having been
assessed as per Walsall Nicotine Replacement Therapy
screening criteria.
3. Criteria for inclusion

Tobacco users identified as sufficiently motivated
to quit and have set a quit date through Walsall
Stop Smoking Service

Adolescents of 12 years and over. Treatment
should not be longer than 12 weeks.

In cardiovascular disease, NRT use is permitted in
patients with stable disease.

Pregnant women (who have previously tried to stop
1
smoking without the use of NRT) should preferably
use short-acting preparations, though the 16 hours
patch may be used if the mother is experiencing
nausea/vomiting.
4. Criteria excluding the client from the
treatment

For breastfeeding mothers preferably short-acting
preparations should be used, clients should be
advised to allow the maximum time they can
between NRT use and breastfeeding

Consider offering a combination of nicotine patches
and another form of NRT (such as gum, inhalator,
lozenge or nasal spray) to people who show a high
level of dependence on nicotine or who have found
single forms of NRT inadequate in the past.

Tobacco users not sufficiently motivated to quit or use
NRT & attend specialist smoking cessation clinics.

Clients under the age of 12 years.

Clients with severe cardiovascular disease; including
dysrythmia (irregular heartbeat), recent (i.e. less than 6
weeks) Myocardial Infarction (Heart Attack) or recent
CVA (Stroke) – in these cases, a doctor’s advice must
be sought before issuing treatment (see appendix 3).

Clients with previous serious reaction to NRT or any of
the other ingredients contained in the products, e.g.
adhesive in patch.
Patches only – clients with chronic generalised skin
disease such as psoriasis, chronic dermatitis and
urticency; clients who have had a previous reaction to
transdermal patches; occasional smokers.
Nasal spray only – clients with chronic nasal disorders
such as polyposis, vasomotor rhinitis and perennial
rhinitis.
5. Criteria for referral
Clients with the following conditions (these are cautions in
the SPC) where assessment suggest that there may be
problems:

Uncontrolled hyperthyroidism

Severe renal or hepatic impairment

Patients who are due to be administered adenosine
(see drug interactions below)

Clients taking theophylline or clozapine should inform
their GP of their quit attempt (see ‘drug interactions’:
section 13)
Where intervention with Bupropion or Varenicline might be
2
more appropriate.
Do not offer NRT, varenicline or
bupropion in any combination.
6. Details of action to be followed for
clients excluded under the protocol.
Refer to GP with appropriate documentation (appendix 3)
STAFF CHARACTERISTICS
1. Professional qualifications to be held by
staff operating under this protocol
Accredited specialist smoking cessation advisors employed
or commissioned by Walsall Stop Smoking Service to
provide specialist smoking cessation support.
2 Requirements for continuing training and
education for staff operating under this
protocol
Attend annual update training personally or for an
accredited colleague from within the department to attend
the training and cascade to colleagues within the
department.
Assess client’s suitability for NRT specifically asking
questions regarding medical history and previous NRT use.
ADVISOR REPSONSIBILITIES
Complete the NRT client assessment form (appendix 2)
and maintain one copy with client records for reference
purposes and give the carbon copy with the client’s first
voucher to take to the pharmacist. Dependent on outcome
either state client is suitable for NRT under Walsall voucher
scheme and issue vouchers or refer client to GP /
consultant.
When GP / consultant consent is obtained indicate this on
the voucher and issue to client (appendix 4).
Initial NRT vouchers should only be issued weekly for the
first two weeks of the client’s quit attempt and then
fortnightly from week 3 to 8.
Vouchers should be issued for 2 weeks supply of NRT for
the first 4 weeks of a clients quit attempt (issued from quit
week appointment and at week 2). 4 weeks supply can be
issued for wks 9-12 of the clients quit attempt. A maximum
of 12 weeks supply of NRT can be issued to each client
accessing the voucher scheme.
Complete the appropriate parts of the voucher (clients
name, address and product to be supplied, advisor
signature) and inform client of participating pharmacies.
Use generic products unless there is a specific need for a
named product, for example previous intolerance with a
specific brand
Advisor to retain the white copy of the voucher within the
client’s records. This needs to be retained for a minimum
of 2 years.
Ask the client to take the yellow and green copies of the
voucher to participating pharmacies.
PHARMACISTS RESPONSIBILITIES
To complete the bottom of the green and yellow voucher
and supply NRT via NHS Walsall’s voucher scheme
accordance with this protocol (appendix 4).
Ensure adequate stocks of NRT products are available
3
within the pharmacy.
Ensure clients sign their vouchers for supply of NRT.
Complete the relevant section on the voucher and NRT
claim form (appendix 5).
On the voucher, to ensure clients fill out the reason for fee
exemption (if applicable) and to sign that they have
received the product and paid the prescription fee if not
exempt. To collect a prescription fee from clients not
eligible for free prescriptions.
Retain the yellow copy of the voucher within the pharmacy.
Send the green copy of the voucher together with the NRT
claim form for reimbursement to the address at the bottom
of the voucher.
Take professional responsibility for the supply of the NRT.
The voucher is not a prescription. The pharmacist is
professionally accountable for supplying NRT on the NHS.
The pharmacist retains professional discretion to judge the
suitability of the NRT product recommended and change
the product or refuse supply if deemed necessary. If the
pharmacist has a query about the NRT recommended they
must contact the issuing advisor.
To ensure locum pharmacists are aware of the NRT
voucher scheme and protocol so that supply can be made
when they are covering.
REIMBURSEMENT TO PHARMACISTS
NRT will be reimbursed at a) drug tariff or b) chemist and
druggist price if the product is not listed on the drug tariff. A
handling fee of 90p per voucher will also be paid. Any
collected prescription charges will be deducted from
pharmacies’ reimbursement.
MANAGEMENT AND MONITORING
1. Authors of this protocol


2. Name of committee authorizing the use
of this protocol
1) Pharmacy commissioning Group
2) Local Pharmacy Committee
3. How can the health professional
providing treatment be identified?

Signature and designation on NRT voucher.
4. How can the patient receiving treatment

Name and address on voucher.
Bharat Patel (Head of Medicines Management)
Hema Patel (Community Pharmacy Facilitator)
be identified?
4
5. How can the medicine be identified
Name, Dose, quantity identified on voucher.
6. Instructions on reporting suspected
adverse drug reactions
Client presenting with suspected serious adverse drug
reaction should be referred to a doctor for further
investigations.
Serious adverse reactions should be reported to the
Medicines and Healthcare products Regulatory Agency,
using the yellow ADR card system available in the BNF or
CSM website.
http://www.mhra.gov.uk/home/idcplg?IdcService=SS
_GET_PAGE&nodeId=276
7. Date of protocol
TO BE COMPLETED.
8. Date this protocol becomes due for
review
TO BE COMPLETED (2yrs from initial date) or sooner in
response to local/ national guidelines.
TREATMENT
1. Name of medicine(s)
administered/supplied under this protocol
Nicotine Replacement Therapy (NRT)
see Appendix 1 for further description of the different forms
of NRT available.
2. Method of obtaining supplies
Through voucher exchange at participating community
pharmacies
3. How is consent obtained
Monitoring form & NRT voucher.
4. Name of medicine(s) administered under
this protocol
NRT preparations listed in Appendix 1.
5.

Legal status of medicine(s)
GSL










Nicorette patches
Nicorette gum preparations
Nicotinell patches
Nicotinell gum preparations
Nicotinell lozenges
Niquitin patch preparations
Nicorette Microtabs
Nicorette Inhalator
Niquitin lozenges
Nicorette Nasal Spray
5
6. Doses of medicine(s) which can be
administered/supplied
Please refer to Appendix 1.
7. Method of route of administration
Please refer to
administration
8. Total dose of medicine to be
supplied/administered.
Maximum length of treatment under this protocol is 12
weeks.
Appendix
1
for
individual
product
Course of treatment should not be repeated unless 6
months has elapsed between quit attempts. However, if
external circumstances interfere with an individual’s initial
attempt to stop smoking, it may be reasonable to try again
sooner. This decision will be at the Smoking Cessation
Advisor’s discretion.
9. Period of time over which NRT vouchers
and treatment may be administered.
Weekly supplies to be given for the first two weeks of the
quit attempt and then fortnightly supplies can be given to
cover weeks 3 – 8 of the quit attempt. Provide weekly
support for the first month of the quit attempt.
Stopping smoking is difficult and the advisor may use their
discretion whether to continue to issue NRT should the
client have lapses. However, Walsall does not fund ‘cut
down to quit’ and so we strongly recommend that vouchers
are not issued if a client lapses for a total of four weeks
(irrespective of whether the lapses occur in sequential or
intermittent weeks). All NRT is available on GSL for the
client to purchase if necessary.
If the smoker has successfully stopped at 8 weeks then
another 4 weeks supply can be given before revalidation at
week 12.
10. Advice to be given by the stop smoking
advisor to the client before or after treatment
Advice to clients should include specific product advice plus
the following general advice on:

Withdrawal symptoms.

Possible changes in the body on stopping smoking,
e.g. weight gain, and how to manage these.

The effects of smoking tobacco whilst using NRTparticularly in vulnerable groups, e.g. pregnant women,
clients with cardiovascular disease.

Follow- up and obtaining further supplies of NRT

Advice on possible adverse reactions. 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
6
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, dysmennorhoea.
GI disease: Swallowed nicotine may exacerbate
symptoms in patients suffering from oesophagitis,
gastritis or peptic ulcers.
Diabetic patients should monitor their blood sugar
levels more closely than usual.
Product-specific side effects are detailed in Appendix 1.

Pregnant clients who develop complications of
pregnancy should be advised to inform their
obstetrician and midwife that they are using NRT.

Written information on products supplied, self help
leaflets and where to obtain more information, in
particular NHS helpline numbers for:
General advice- NHS Smoking Helpline:
0800 169 0 169
(Textphone users: 0800 169 0 171)
Walsall Stop Smoking Service
service): 0800 169 9346
(including
pregnancy
NHS Pregnancy Smoking Helpline (daily: 12pm – 9pm)
0800 169 9 169
NHS Asian Tobacco Helpline (Tues: 1pm – 9pm)

0800 169 0 881 (Urdu)

0800 169 0 882 (Punjabi)

0800 169 0 883 (Hindi)

0800 169 0 884 (Gujarati)

0800 169 0 885 (Bengali)
11. Site for treatment (i.e. location of service)
Community settings at various locations across Walsall.
12. Treatment records which should be
completed by the stop smoking advisor.

A record of the consultation must be kept for at least
two years, and the following documents in particular:

A copy of the supplied vouchers must be kept with the
client’s record for audit purposes.
7

A copy of the client’s consent obtained on the
monitoring form.

A copy of the client’s NRT assessment form.
Drug interactions:
13. Special precautions concerning
concurrent medication (checks to ensure
patient is not currently taking medicine which
duplicates or interacts with protocol
medicine(s)

Adenosine – NRT can have an adverse haemodynamic
effect. Advice should be sort from the client’s doctor
prior to supplying NRT.

Theophylline – tobacco smoking increases the
metabolism of theophylline, smoking cessation can
cause theophylline plasma levels to rise. Clients taking
theophylline should be supplied with NRT as
appropriate but the service provider should inform their
GP of their attempt to stop smoking.

Clozapine – tobacco smoking increases the
metabolism of clozapine. Smoking cessation can cause
the blood level of clozapine to rise. The patient’s CPN
and doctor must be informed of the client’s attempt to
stop smoking in order for the client to be monitored for
side effects of raised clozapine levels and monitor
blood levels as appropriate.
Permission to pass this information to the GP/Consultant
will need to be obtained by the client.
Smoking cessation may also cause alterations in the
circulating drug levels of following:
 Insulin
 Adrenergic agonists and antagonists
 Benzodiazepines
 Duloxetine
 Fluphenazine
 Haloperidol
 Propranolol
 Tricyclic antidepressants
 Fluvoxamine
 Warfarin
 Clorpromazine
 Imipramine
 Olanzapine
 Flecainide
 Pentazocine
 Ropinirole
 Zolpidem
 Lithium
 Memantine
Clients who are taking NRT together with any of the above
medicines should be advised to inform their GP they are
trying to stop smoking and or the client experiences
problems. (see appendix 6 for more details)
8
Appendix 1
Dosage and method of administration
Please note the details regarding these products may change frequently so it is prudent to check the latest
Summary of Product Characteristics.
A) GUM
Dose
Nicorette
People who smoke up to 20 cigarettes a day should use the 2mg gum.
People who smoke more than 20 cigarettes a day should use the 4mg
gum. Clients should aim to use 8-12 pieces of gum a day up to maximum
of 15 pieces a day.
Nicotinell
“Heavier smokers” should use the 4mg gum.
“Lighter smokers” should use the 2mg gum.
The gum should be used when the client feels the urge to smoke and they
should aim to use between 8-12 pieces of gum per day.
The maximum dose for the 4mg gum is 15 pieces a day.
The maximum dose for the 2mg gum is 25 pieces a day.
Method of
administration
Specific side effects
Specific advice to
client
NiQuitin CQ
Smokers who have their first cigarette within 30 minutes of waking should
use the 4mg gum.
Smokers who have their first cigarette after 30 minutes of waking should
use the 2mg gum.
Clients should aim to use between 8-12 pieces of gum per day up to a
maximum of 15 pieces a day.
Oral administration (as resin).
Throat irritation, increased salivation, hiccups.
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-park-chew’ technique should be
applied for 30 minutes.
B) INHALATOR
Dose
Inhale when urge to smoke occurs.
Advise using 6-12 cartridges (10mg / cartridge) daily for up to 8 weeks
THEN
Reducing the dose to 3 – 6 cartridges over the next 2 weeks THEN
Reduce to 0 over next 2 weeks.
Method of
administration
Specific side effects
Oral administration (nicotine-impregnated plug in mouthpiece).
Specific advice to
client
Air should be drawn into the mouth through the mouthpiece. 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.
The inhalator is best used at room temperatures as nicotine delivery is
affected by temperature.
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.
Throat irritation, cough, rhinitis, pharyngitis, stomatitis, dry mouth.
9
C) LOZENGE
Dose
Nicotinell
Those who have a strong nicotine dependency, i.e. who smoke more than
30 cigarettes a day, should use the 2mg lozenge.
Those who smoke less than 30 cigarettes a day should use the 1mg
lozenge.
Most people use 8-12 lozenges per day.
The maximum daily dose is 30 of the 1mg lozenges.
The maximum daily dose is 15 of the 2mg lozenges.
Contains aspartamine, and may be harmful for people with
phenylketonuria.
NiQuitin CQ
Those who have their first cigarette within 30 minutes of waking should use
the 4mg lozenge.
Those who have their first cigarette after 30 minutes of waking should use
the 2mg lozenge.
The maximum daily dose is 15 lozenges.
Contains aspartamine and may be harmful for people with
phenylketonuria.
Each lozenge contains 15 mg of sodium. People on a low sodium diet
should take this into account
Method of
administration
Specific side effects
Specific advice to
client
Oral administration (nicotine as bitartrate).
Throat irritation, increased salivation, hiccups.
Nicotinell Lozenge:
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.
NiQuitin Lozenge:
One lozenge should be placed in the mouth and allowed to dissolve.
Periodically, the lozenge should be moved from one side of the
mouth to the other, and repeated, until the lozenge is completely
dissolved (approximately 20 –30 minutes). The lozenge should not
be chewed or swallowed whole. Users should not eat or drink while
a lozenge is in the mouth.
D) PATCHES
Dose
Apply on waking to dry, non-hairy skin on hip, chest or upper arm.
Remove after time specified.
New patch should be placed on a different area – avoiding ‘used’ sites for
several days afterwards.
Nicorette – 16 hour patch
15mg patch for 16 hours daily for 8 weeks THEN
10mg “
“ “ “
“
“ 2 “
THEN
5mg “
“ “ “
“
“ 2 “
THEN review treatment
Nicorette – 16 hour Invisipatch
25mg patch for 16 hours daily for 8 weeks THEN
15mg “
“ “
“
“ “ 2 “
THEN
10
10mg “
“ “
“
“ “ 2 “
Nb: those smoking less than 10 cigarettes a day are recommended to start
on 15mg patch for 8 weeks and then decrease dose to 10mg for the final 4
weeks
Nicotinell - TTS30 patch
For individuals smoking more than 20 cigarettes per day – one patch
(21mg) daily.
Nicotinell – TTS20 patch
For individuals smoking 20 cigarettes or less per day – one patch (14mg)
daily.
Nicotinell – TTS10 patch
For individuals smoking 10 cigarettes or less per day – one patch (7mg)
daily. It is recommended that smokers begin treatment with one of the
stronger patches.
Withdraw treatment gradually reducing the dose every 3-4 weeks.
NiQuitin CQ
For individuals smoking 10 or more cigarettes daily:
21mg patch daily for 6 weeks THEN
14mg “
“ “ 2 “ THEN
7mg “
“ “ 2 “ THEN review treatment
Individuals who experience persistent side effects with the 21mg patch
should switch to the 14mg for the remainder of the 6 weeks followed by the
7mg patch for 2 weeks as above.
NiQuitin CQ
For individuals smoking less than 10 cigarettes per day:
14mg patch daily for 6 weeks THEN
7mg “
“ “ 2 “ THEN review treatment
Method of
administration
Specific side effects
Transdermal administration.
Specific advice to
client
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, then
removed before reapplying the next one. 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.
Storage safety, away from children and animals, away from direct sunlight.
Clients should not try to alter the dose of the patch by cutting it up.
Skin reactions. Discontinue use if severe.
E) SUBLINGUAL TABLET
Dose
For individuals smoking 20 cigarettes or less daily – one tablet (2mg) per
hour.
For patients who fail to stop smoking or have significant withdrawal
symptoms consider increasing to 2 tablets (4mg) per hour sublingually.
For individuals smoking more than 20 cigarettes a day – 4mg per hour.
11
Maximum dose: 40 tablets (80mg) per day
Method of
administration
Specific side effects
Specific advice to
client
F) NASAL SPRAY
Dose
Treatment should be continued for at least 3 months, gradually reducing
the dosage over time.
Oral administration (sublingual) – 2mg.
Throat irritation, unpleasant taste.
Tablets should be placed under the tongue and allowed to dissolve slowly.
For the first 8 weeks as required to a maximum of one spray into each
nostril twice an hour for 16 hours a day. For the subsequent 2 weeks,
reduce usage by half. Final two weeks, reduce usage to zero.
Maximum dose: 32 sprays per day
Method of
administration
Specific side effects
Specific advice to
client
Use should be restricted to 3 months.
Intranasal use
Running nose, sneezing, watery eyes.
Nasal spray should not be used whilst driving or operating machinery.
12
APPENDIX TWO: NICOTINE REPLACEMENT THERAPY CLIENT ASSESSMENT FORM
(top copy: keep with client notes; bottom copy: give to client with voucher one)
Mr/Mrs/Miss/Ms Clients Full Name……………………………………… D.O.B………………………….
Circle appropriate answer
1. Is the client a tobacco user sufficiently motivated to quit
Yes
No
2. Has the client set a quit date through Walsall SSS
Yes
No
3. If the client is pregnant or breastfeeding have they tried
quitting without nicotine replacement therapy?
Yes
No
4. Is the client aged 12 years or over
Yes
No
5. Current severe, unstable or worsening angina
Yes
No
6. Uncontrolled hypertension
Yes
No
7. Severe heartbeat irregularities
Yes
No
8. Recent heart attack (less than 6 weeks)
Yes
No
9. Recent Stroke (less than 6 weeks)
Yes
No
10. Uncontrolled hyperthyroidism
Yes
No
11.Severely impaired liver or kidney function
Yes
No
12. Active peptic ulcer
Yes
No
13. Severe skin disorders (excludes patch only)
Yes
No
14. Chronic nasal disorders (excludes nasal spray only)
Yes
No
n/a
Does the client have a history of:
Advisor Name…………………………………
Signature………………………………………
Date …………………………………………..
Enclosure 4.
Medications:
Seek GP /
consultant
approval
before
completing
voucher
Eligible
for NRT
under
Walsall
voucher
scheme
Is client taking bupropion or varenicline?
Yes: do not issue NRT
No
Is client on adenosine?
Yes: do not issue NRT
No
If client is taking any of the following: theophylline,
Benzodiazepines, Chlorpromazine, Duloxetine, Fluphenazine,
Fluvoxamine, Haloperidol, Olanzapine, Propranolol,
Tricyclic antidepressants, Zolpidem, Lithium, Memantine
have they been told to inform GP of their quit attempt?
Yes
No
n/a
If client is taking clozapine, have arrangements been
Yes
No
n/a
13
Made to monitor plasma levels?
APPENDIX THREE: LETTER REQUESTING GP ASSESSMENT FOR NRT (TO BE SENT ON HEADED PAPER)
Date
Re: Patient Name: ………………………………..D.O.B………………….
Dear Dr…………………….
The
above
named
patient
is
receiving
smoking
cessation
support
from
……………………………………..(name / location of advisor). Will you please assess the patient’s
suitability for Nicotine Replacement Therapy (NRT) considering the following relevant medical
history:
…………………………………………………………………………………..
Please indicate below whether you recommend NRT for this patient.
Yours sincerely
Job title:……………………………………….
Contact number:……………………………..
…………………………………………………………………………………..
GP/Consultant Declaration
I do/do not* recommend NRT use by the above named patient
GP/Consultant Name (please print):……………………………………….
GP/Consultant Signature:……………………………………………………
Please * delete as appropriate
Practice Stamp:
14
15
APPENDIX FOUR: VOUCHER OF RECOMMENDATON FOR NICOTINE REPLACEMENT THERAPY
TOKEN No:………………….
Advisor Section:
Patient Name: ……………………………………………………………………………………………………………….
Patient Address: …………………………………………………………………………………………………………….
Service Provider Stamp & Advisor Signature:
I, (print advisor name)……………………………………………………….am offering the above client behavioral smo king
cessation support and recommend the following NRT:
Product to be supplied: ……………………………………………….………..………….. for week number: ………….……
………………………………………………………..…………… for week number: ………….…...
……………………………………………………..……………… for week number: ……………….
………………………………………………………………..…… for week number: ……………….
Does the client need doctor’s approval for NRT?
Yes
No
If yes, approval has been given by (Name of GP / consultant) ……………………………………………………………..
Date of approval given: ……………………………………
Pharmacy Section: Declaration of exemption: To be completed by the patient
The patient does not pay because:

A
is 16, 17 or 18 and in full-time education
B
has a maternity exemption certificate
C
has a medical exemption certificate
D
has a prescription prepayment certificate
E
is named on a current HC2 charge certificate
F
Gets income support
G
Gets income based jobseeker’s allowance
H
Gets full working family tax credit or credit reduced by £70 or less
I
Gets full disabled persons tax credit or credit reduced by £70 or less
I am the patient / patient’s representative (Circle as appropriate)
To be completed by pharmacist.

Was evidence of exemption seen? Yes / No (Circle as appropriate)
PMR Number:………………………………………..
I, (print name)………………………………………………………………………..….…. have supplied the following products:
……………………………………………………………………………………………..……………………….…………………
To cover treatment for weeks:………………………………… Pharmacist signature:…………………………………………..
I have received the above Nicotine Replacement Therapy and paid a prescription fee if not exempt:
…………………………………..……………Client / client representative Signature
Date: ………………………..
Pharmacy Stamp:
WHITE COPY: TO BE KEPT BY ADVISOR;
YELLOW COPY: TO BE KEPT BY PHARMACIST
GREEN COPY: TO BE SENT TO: ADMINISTRATOR, CONTRACTING DEPT, JUBILEE HOUSE, BLOXWICH LANE,
WALSALL, WS2 7JL WITH COMPLETED CLAIM FOR NRT REIMBURSEMENT
16
APPENDIX SIX: MENTAL HEALTH MEDICATION AFFECTED BY TOBACCO SMOKING
CYP450 Induction
DRUG NAME
EFFECTS OF
SMOKING
ON PLASMA
LEVELS
DOSE IN
SMOKERS
AFFECT OF
SMOKING
CESSATIO
N
MANAGEMENT OF
MEDICATION WHEN
STOPPING SMOKING
Benzodiazepines
Plasma levels
reduced by
between 0 – 50%
Increase in
plasma levels
Chlorpromazine
Plasma levels
reduced
Smokers may need
larger doses of
some
benzodiazepines
Smokers may need
larger doses
Clozapine
Reduces plasma
levels by up to
50%
Smokers may need
larger doses
Increase in
plasma levels
Duloxetine
Reduces plasma
levels by up to
50%
Plasma levels
reduced
Smokers may need
larger doses
Increase in
plasma levels
Monitor closely for excess
sedation
Consider dose reduction if
adverse effects occur
Monitor closely for adverse
effects
Consider dose reduction if
patient suffers adverse
effects such as drowsiness or
EPSE
Take a trough plasma level
before stopping. On stopping
reduce dose gradually (over a
week) until around 75% dose
is reached. Repeat plasma
level 1-2 weeks after
stopping. Consider further
dose reductions depending on
plasma levels. Monitor patient
closely for adverse effects.
Contact a pharmacist for
further advice.
Consider dose reduction
Smokers may need
larger doses
Increase in
plasma levels
Reduces plasma
levels
Reduces plasma
levels by around
20%
Reduces plasma
levels by up to
50%
Plasma levels
maybe reduced
Smokers may need
larger doses
Smokers may need
larger doses
Increase in
plasma levels
Increase in
plasma levels
Smokers may need
larger doses
Increase in
plasma levels
Fluphenazine
Fluvoxamine
Haloperidol
Olanzapine
Propranolol
Tricyclic
antidepressants
Increase in
plasma levels
Smokers may need
Increase in
larger doses
plasma levels
depending upon
response
Smoking reduces plasma levels of tricyclic antidepressants
but the concentration of free and unbound antidepressant
Monitor closely for adverse
effects
Consider dose reduction if
patient suffers adverse
effects such as drowsiness or
EPSE
Consider dose reduction
Monitor for adverse effects
Consider dose reduction.
Monitor carefully for adverse
effects e.g. EPSE.
Consider dose reduction
Monitor carefully for adverse
effects.
Consider dose reduction
according to response.
Monitor blood pressure.
Monitor closely for adverse
effects and consider dose
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Zolpidem
rises which appears to offset the effects of this
interaction.
Plasma levels
Smokers may need
Increase in
may be lower
larger doses
plasma levels
reduction if appropriate.
Monitor for excess sedation
and consider dose reduction if
adverse effects occur
Other Mechanisms
Lithium
Smoking may reduce xanthine
levels resulting in higher lithium
levels in smokers
Memantine
Competition with
nicotine for
cationic transport
system, therefore
potential for
increased plasma
levels
Smokers may
require lower
doses
Cessation of
smoking
theoretically
raises xanthine
levels
increasing
lithium
secretion and
lowering
lithium levels
Decreased
plasma levels
Monitor levels every 4-7 days
and adjust dose until stability is
achieved
Higher doses may be required
when smoking ceases
Monitor patient
The list of interactions is NOT exhaustive. It concentrates only on those interactions with
medication used in mental health conditions and interactions most likely to be of clinical
significance.
References
Taylor, D et al. The Maudsley Prescribing Guidelines. 9th Edition. Informa Healthcare. 2007
Baizire, S. The Psychotropic Drug Directory 2007. Cromwell Press
Summary of Product Characteristics for individual drugs. Available at www.emc.medicines.org.uk
UKMi Q and A sheet: Which medicines need dose adjustment when a patient stops smoking?
Stockley, I. Drug Interactions. Fifth Edition. 2001. Pharmaceutical Press
Cozza, K and Armstrong, S. Concise Guide to the Cytochrome P450 System. 2001. American Psychiatric Publishing.
Appendix 6 taken from Factsheet written by Amanda Kelso
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