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Leeds PCT’s Smoking Services
Nicotine Replacement Therapy (NRT)
Pharmacy Access Scheme
Heather J Thomson
Leeds Smoking Services
Co-ordinator
Kate Jacobs
East Leeds PCT
Smoking Cessation
Development Facilitator
1
2
Summary
Tobacco is the biggest single cause of premature death in the country. Every year
tobacco use is related to 120,000 deaths in the UK, though cancer, heart disease,
stroke and other smoking related diseases.
The Government is committed to reducing smoking rates, (1,2) and smoking
cessation guidelines have been published including the cost effectiveness of
interventions for smoking cessation (3). These guidelines recommend that all
smokers should be asked about their smoking habit at every opportunity, advised
to stop smoking, offered assistance where appropriate and follow up arranged to
reassess smoking status. The guidelines include the provision of nicotine
replacement therapy as a pharmacological aid for smoking cessation.
Nicotine replacement therapy has been shown to approximately double cessation
rates compared with controls (3), and smoking cessation guidelines recommend
that smokers should be encouraged to used NRT as a cessation aid.
Efficacy
Cochrane carried out a meta-analysis of 81 trials involving 25,600 smokers to
examine the effectiveness of all forms of NRT, compared with placebo or no NRT
(4). This study showed that all forms of NRT were significantly more effective than
placebo, or no NRT, in helping smokers to achieve abstinence. The pooled results
for all forms of NRT showed that 18% of all patients receiving treatment were still
abstinent at 52 weeks, compared with 11% in the control group.
Data on direct comparisons of the different forms of NRT with each other are
limited. Overall, there is little evidence to suggest superiority of any one form of
NRT (5). It is recommended that choice of product is tailored to the patient (6).
Adverse Effects
NRT products provide much lower doses of nicotine than is obtained by smoking
and its adverse effects are not complicated by the additional toxic affects of tar
and carbon monoxide generated by cigarette smoke.
With the use of patches there is a possibility of localised skin reaction (7). Nicotine
can also exacerbate symptoms in patients with peptic ulcers or gastritis, and the
possibility of this is greater with the gum than other NRT products, as nicotine
may be swallowed and enter the stomach directly (7). Denture wearers may also
have difficulty in chewing gum.
In addition, NRT products may produce the same range of side effects as nicotine
from smoking (hiccups, sore throat, headache, nausea and dizziness). However,
these side-effects are less likely to occur than with smoking, and clinical trials
have shown most to be comparable to those caused by placebo (8).
3
Special Precautions
Nicotine is a known stimulant and is associated with an increased risk of angina,
artherosclerosis, stroke and other cardiovascular disease.
The manufacturers advise that doctors should assess the possible risks and
benefits of using NRT versus cigarettes in the following patient groups






History of angina
Recent myocardial infarction
Recent cerebrovascular accident
Serious cardiac arrythmias
Peripheral vascular disease
Pregnant and breast feeding women
But these are not contra-indications and it is preferable for a patient in any of the
above groups to stop smoking with the use of NRT rather than continue smoking.
Nicotine can also stimulate production of adrenaline, therefore NRT should be
used with caution on patients with diabetes mellitus, hyperthyroidism or
phaeochromocytoma. Again NRT presents a lesser hazard than smoking.
Recent significant changes in the use of NRT with previously cautioned /
contra-indicated groups
Ref:
Safety of NRT – Helping Smokers to Stop – Advice for Pharmacists in
England (9)
Report of the Committee on Safety of Medicines Working Group on NRT (10)
Adolescent smokers
Many young smokers show signs of nicotine dependence. Although there is little
published data demonstrating the efficacy of NRT in young smokers, there is no
logical reason why it should not help as long as it is used correctly and the smoker
is determined to give up. NRT products are now licensed for use, on medical
advice, by smokers under 18. Ultimately the decision to use NRT should be based
on the smoker’s determination to quit, and on their level of dependence (as
opposed to age). Given that NRT is less harmful than smoking, safety concerns
should not be a barrier to use.
Cardiovascular disease
Although nicotine has some acute effects on the cardiovascular system, unlike
tobacco smoke it is not a significant risk factor for cardiovascular disease or acute
cardiac events. Nicotine replacement therapy provides less nicotine, less rapidly
than cigarette smoking, without substances such as carbon monoxide (which is
known to have adverse effects on the cardiovascular system). On this basis,
experts agree that all NRT products can be safely used by smokers with stable
cardiovascular disease. It is recommended that the risks and benefits of using
4
NRT should be assessed for smokers with unstable cardiovascular disease, or
who have suffered an acute event in the past four weeks. If the only other option
for this group is continued smoking, a risk–benefit assessment invariably leads to
recommending NRT. When using NRT for smokers with unstable cardiovascular
disease, it is advisable to use the shorter-acting oral products which can be
discontinued immediately in the event of any problems. Nicotine patches, even
once removed, leave a small reservoir of nicotine under the skin.
Pregnant and breastfeeding women
Smoking during pregnancy is associated with large risks to both mother and
foetus, and later to the newborn and growing infant. Although nicotine may be
implicated in some of the adverse effects of smoking (e.g. low birth weight and
behavioural problems in infants), NRT delivers much less nicotine than cigarettes
without the other harmful ingredients of tobacco smoke. It is better for pregnant
women to be both nicotine- and tobacco-free. Product licences are changing and
some now suggest that NRT use may be considered for pregnant women who are
unable to give up without the use of NRT. This is in line with international
guidance and expert opinion. When considering NRT use, it is prudent to
document any discussion of risks and benefits, and oral products should be
recommended initially as these will provide less nicotine to the foetus than a
patch. If oral products are not acceptable a patch may be considered, but this
must be removed before going to bed, i.e. the patch should not be used for more
than a 16 hour period, with a break of 8 hours between patches. Treatment should
be provided as early in pregnancy as possible, with the aim of being smoke-free
and nicotine-free by the third trimester.
Use of NRT while breastfeeding, is associated with very few risks to the child.
Nicotine does accumulate in breast milk but relatively little is absorbed from the
infant’s gut, and this then undergoes first pass metabolism resulting in a low
plasma concentration. Any small risk to the child from this low level of nicotine is
preferable to the risk of the breastfeeding woman continuing to smoke.
Smoking can cause great harm to the mother, the unborn child and the newborn
infant, and would-be parents should be advised of these risks. Treating pregnant
smokers involves specific challenges (e.g. the immediacy of the need to stop; the
mother’s fear of being judged), and clients may be best supported by a specialist
smoking and pregnancy advisory service, where these exist. Fresh Air Babies
(FAB) are part of Leeds NHS Stop Smoking Services and offer intensive support
via home visits for pregnant women and their families. Pharmacists will need to
discuss local treatment options carefully with pregnant women and help them
decide which service is likely to be the most appropriate for their needs.
The following table indicates specific actions to be followed for patients with a
variety of underlying conditions which may impact on their use of NRT products.
5
Guidance summarised from Report on Safety of Medicines Working Group on Nicotine
Replacement Therapy
Medicines and Healthcare products Regulatory Agency / Committee on Safety of
Medicine (Dec 2005)
Question
Is the voucher holder
aged between 12 and
18?


Is the voucher holder
pregnant or breast
feeding?


Action if yes
Confirm the client is being
supported by a trained smoking
cessation advisor
Dispense product if no
contraindications
Confirm the client has already
received at least 1 prescription
during this quit attempt from
their GP. If not refer client to GP
for first prescription using letter
provided. Contact advisor who
issued voucher to inform them
that a referral has been made.
Is client already using one NRT
product? Refer to GP for
prescription for any additional
product.



Has the voucher holder
recently been
hospitalised with a
recent myocardial
infarct, severe
dysrythmia or recent
cerebrovascular
accident and/or are
considered to be
haemodynamically
unstable?
Does the voucher
holder suffer from lung
disease? E.g. Asthma /
COPD / chronic throat
disease


Refer patients to their GP /
Consultant using letter provided.
Contact advisor who issued
voucher to inform them that a
referral has been made

Consideration of appropriate
product

6

Suggested product
Any product suitable
Intermittant dosing
products may be
preferable as these
usually provide a
lower daily dose of
nicotine than
patches. Slow
release 24 hour
patches should not
be used to avoid the
administration and
exposure of the fetus
to nicotine overnight.
However, if the
woman suffers from
nausea and/or
vomiting, a 16-hour
patch removed at
night is preferable.
For breast feeding
mothers, intermittent
NRT products will
allow the time
between NRT use
and feeding to be as
long as possible
This group should be
encouraged to stop
smoking with nonpharmacological
interventions
With GP or
Consultant approval
any product could be
dispensed
Patients with
obstructive lung
disease may find use
of the inhalator
difficult, nicotine
Does the voucher
holder suffer from
diabetes mellitus?

Does the voucher
holder suffer from
moderate to severe
hepatic impairment
and/or severe renal
impairment?
Is the voucher holder
taking drugs
metabolised by CYP
1A2 / CYP 1A1 e.g.
theophylline, clozapine
and ropinirole?

Does the voucher
holder suffer from GI
disease?

Does the voucher
holder suffer from any
generalised
dermatological
disorders?
Does the voucher
holder suffer from
phaeochromocytoma
and / or uncontrolled
hyperthyroidism?



Advise client to monitor blood
sugar levels more closely as
catecholamines released by
nicotine can affect carbohydrate
metabolism
Use with caution with this group
as the clearance of nicotine or
its metabolites may be
decreased with the potential for
increased side effects.

gum, patch, nasal
spray, lozenge or
sublingual tablet may
be preferred in such
cases.
Any product suitable

Any product suitable
Advise patient to inform their
consultant they have stopped
smoking. Polycyclic aromatic
hydrocarbons in tobacco smoke
induce the metabolism of drugs
metabolised by CYP 1A2 (and
possible CYP 1A1). When a
smoker stops smoking, this may
result in slower metabolism and
a consequent rise in blood levels
of such drugs. This is of
potential clinical importance for
products with a narrow
therapeutic window e.g.
theophylline, clozapine and
ropinirole
Advise client swallowed nicotine
may exacerbate symptoms in
patients suffering from
oesophagitis, gastritis or peptic
ulcers and oral NRT
preparations should be used
with caution in these cases.
Patients with chronic
generalised dermatological
disorders such as psoriasis,
chronic dermatitis or urticaria
should not use NRT patch.
As nicotine causes the release
of catecholamines, NRT should
be used with caution in patients
with phaeochromocytoma and /
or uncontrolled hyperthyroidism.

Any product suitable

Patch (24 and 16 hr)

Nicotine gum, nasal
spray, lozenge or
sublingual tablet,
inhalator,

Any product suitable
Interaction with other medicinal products and other forms of interactions
7
No clinically relevant interactions between NRT and other drugs has definitely been
established. However nicotine may possibly enhance the haemodynamic effects of
adenosine i.e. increase in blood pressure and heart rate and also increase pain response
(angina-pectoris type chest pain) provoked by adenosine administration.
Protocol for providing Nicotine Replacement Therapy via the access
scheme:
Dispensing details

Only clients of Leeds NHS Stop Smoking Service who are attending a
specialist smoking cessation clinic provided by the service and delivered by a
named specialist advisor will be able to be issued with a supply of NRT
through the scheme, or those attending a service delivered by a Smoking
Cessation Advisor trained to Level 2 Smoking Skills registered with Leeds
NHS Stop Smoking Service, in a named pharmacy which is contracted to
deliver by Leeds PCT(s).

NRT vouchers will only be redeemable at a pharmacy which has signed up to
dispense via the access scheme.

All clients will be screened to assess nicotine dependency, motivation and
readiness to have a cessation attempt by the named smoking advisor and for
medical suitability, by the contracted pharmacist, using the guidelines provided
by Leeds NHS Stop Smoking Service.

Should a client fall into a patient group with special precautions, where a
second opinion should be sought, a prescription will be required from the
patients GP or hospital specialist before NRT may be issued. A letter supplied
by Leeds NHS Stop Smoking Service should be completed by the pharmacist
and either be given to the patient to be taken to their GP/hospital specialist or
sent directly to the GP/hospital specialist. In these cases the voucher should
be retained, marked as VOID and returned with the monthly summary sheet.
The advisor who issued the voucher should be informed as soon as
possible.

Prior to their quit day, as part of the cessation planning and preparation
process, the client will initially receive a voucher for 2 weeks supply of NRT to
commence use on the day they stop smoking. In some cases 2 products may
be requested on 1 voucher. (Vouchers will be valid for 4 weeks from the issue
date)

At one week after ‘quit day’, the client will be issued with a voucher for a
further 2 weeks supply of NRT.
.

Should the initial NRT product be unsuitable for the client, an alternative
product may be supplied on subsequent weeks at the pharmacist’s discretion
or by request of the advisor.
8

3 weeks following the client’s ‘quit’ day, the client will be assessed for
abstinence from smoking using carbon monoxide verification.
 If there is evidence the client is still smoking, no further NRT vouchers will be
issued.
 Should the client’s abstinence be verified vouchers for a further supply of NRT
to complete the course of treatment will be issued.

Following the initial medical assessment, it is the responsibility of the
dispensing pharmacist to check there have been no changes in the client’s
medical status. Should a client present a voucher for continued treatment to a
pharmacist who did not conduct the initial assessment, a new assessment
should be completed.
Payment details

Should the client pay for prescriptions a fee equal to that of the normal
prescription charge should be collected per item dispensed.

Should the client receive free prescriptions evidence MUST be presented
before the product is dispensed and the reverse of the voucher completed.

It is the pharmacist’s responsibility to confirm exemption from prescription
charges.

Clients who hold pre payment certificates are NOT exempt from the
dispensing fee
Reimbursement

At the end of each month the pharmacist should collate the vouchers where
products have been dispensed and collate the information on the summary
sheet.

The pharmacist should send the BOTTOM COPY OF THE VOUCHER (with
the exemption information) and a copy of the summary sheet to Leeds NHS
Stop Smoking Service.
Fees

The PCT will pay the pharmacists £3.00 per exchanged voucher. On a
quarterly basis (timescale subject to review) the PCT will monitor the number
of vouchers exchanged against the fees collected by the pharmacist and the
debit / credit balance will be reimbursed / collected.

The PCT will reimburse the pharmacist the cost of the product (PPA Drug
Tariff) on a monthly basis.
9
The proposed scheme:

Applies to Leeds NHS Stop Smoking Service (specialist services). Its intended
purpose is to enhance the chances of success of a client, attending a
structured programme, in their attempt to stop smoking.

Applies to named specialist smoking cessation advisors employed by a Leeds
Primary Care Trust.





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
















Dorothy Read
Paul Lambert
Karen Haw
Maggie Day
Rachel Northen
Alan Brearley
Emma Fletcher
Julie Clarkson
Fran Faflik
Caroline Bradbury
Helen Hartley
Susanne Stainsby Frauendorf
Jane Edwardson
Laura Kerridge
Nicola Bettis
Mu’azzam Zafar
Maria Spellacy
Mark Burke
Julie Sutcliffe
Emily Williams
Sandra Dickenson
Heather Thomson
Kate Jacobs

A trained (Level 2) smoking cessation advisor, who is registered with Leeds
NHS Stop Smoking Service, operating within a locally enhanced service
agreement in a pharmacy setting.
10
References
1. Government White Paper – Smoking Kills (Dec 1998)
2. NSF Framework for CHD – (July 2000)
3. Smoking Cessation Guidelines and their Cost Effectiveness Thorax (Dec
1998) ; 53: S1-S38
4. SilagyC., Mant D. et al. Nicotine Replacement Therapy for Smoking
Cessation (Cochrane review). In The Cochrane Library Issue 2. Oxford,
Update Software, 1998. (updated quarterly)
5. Nicotine replacement to aid smoking cessation. Drug Ther. Bulletin 1999;
37(7): S2-S4
6. Nicotine replacement therapy. MeReC 1999; 10, (3) 9-12
7. Division of Drugs and Toxicology. Drugs Evaluation Annual 1994. Chicago:
American Medical Association (1994)
8. Nathan A. Smoking Cessation Products. Pharmaceutical Journal 1998;
260: 340-343
9. McRobbie,H. & McEwen, A. Helping smokers to stop: advice for
pharmacists in England. National Institute for Health and Clinical
Excellence, Royal Pharmaceutical Society of Great Britain and
PharmacyHealthLink 2005; 14-15.
10. Report of the Committee on Safety of Medicines Working Group on
Nicotine Replacement Therapy. Medicines and Healthcare products
Regulatory Agency. Committee on Safety of Medicines. November 2005
11
12
Leeds PCT’s
Access Scheme to Supply Nicotine Replacement Therapy to
Patients of the Leeds NHS Stop Smoking Service
Issued: 1st June 2006
Date of Review: 31st March 2007
Drawn up by: Heather Thomson, Kate Jacobs
This Access Scheme has been approved by:
Title
Leeds
Pharmaceutical
Committee
Service coordinator Leeds
Smoking
Services
Heads of
Medicines
Management
Name
Peter Dawson
Heather
Thomson
Gillian Laurence
Sarah Thompson
Helen Lidell
Andy Hutchinson
Jo Alldred
Clinical Condition or Situation to which the Access Scheme Applies:
Define situation/condition
Objectives of care
Criteria for inclusion
Adjunct to specialist smoking cessation group
therapy
To reduce the craving for nicotine on cessation
of smoking
 All clients attending specialist smoking
cessation clinic.
 All patients wishing to try nicotine
replacement therapy.
 Clients who have been assessed for nicotine
dependency, motivation and readiness to
stop smoking by a specialist advisor.
 Clients who have been assessed for special
precautions by a listed pharmacist.
13
Action if special precautions with NRT
Action if patient declines
treatment
Refer to GP / consultant
Not Applicable
Characteristics of Smoking Cessation Advisor:
Registration required
Continued training
requirements
Registered with Leeds NHS Stop Smoking
Service
Annual update
Characteristics of Listed Pharmacist:
Qualifications required
Additional experience /
training required
Registered pharmacist
Attended pharmacy access scheme workshop /
or meeting with representative of Leeds NHS
Stop Smoking Service
Management and monitoring of Access Scheme:



The Access Scheme is to be read, agreed to and signed by all Registered
Smoking Advisors it applies to.
One signed copy will be given to each Specialist Advisor with the original
being kept on file by the manager.
Details of all patients who have been issued with Nicotine Replacement
Therapy under the Access Scheme will be recorded for audit purposes
within the PCT confidentiality procedures.
14
Leeds PCT’s Smoking Services
Nicotine Replacement Therapy (NRT) Pharmacy Access Scheme
Applies to the use of Nicotine Replacement Therapy products, including specific groups as listed under special precautions provided
through the Leeds PCT Pharmacy Access Scheme. See pages 4 to 8 for more detailed guidance.
Heather J Thomson
Leeds Smoking Services
Co-ordinator
Kate Jacobs
East Leeds PCT
Smoking Cessation
Development Facilitator
15
Drug
Special
Precautions
Gum
Nicotine replacement gum
containing 4mg nicotine





Nicotine replacement gum
containing 2mg nicotine



Cardiovascular disease
GI Disease(inc Peptic
ulcer)
Diabetes Mellitus
Renal or hepatic
impairment
Phaeochromocytoma and
uncontrolled
hyperthyroidism
Pregnant/breastfeeding
(avoid liquorice flavoured
gum during pregnancy) *
Oral inflammation or
oesophagitis
Those taking medication
which may require dose
adjustment
Inhalator
Inhalator containing 10mg
nicotine per cartridge




Cardiovascular disease
GI Disease(inc Peptic
ulcer)
Diabetes Mellitus
Renal or hepatic
impairment
Formulation and Route
of Administration
Nicotine bound to an ion
exchange resin
Chewing releases nicotine
which is absorbed through the
mouth
Mouthpiece containing a plug
impregnated with nicotine
Provides nicotine via oral
inhalation. Nicotine is
absorbed mainly via the
buccal mucosa. Use when the
urge is felt, up to a max usage
16
Dose and Frequency
Duration
4mg as required – up to a
maximum of 15 pieces daily
(individual manufacturers may
vary) Avoid acidic beverages,
coffee and soft drinks 15
minutes before use
Continue us for up to 3
Months then gradually reduce
gum use. When daily us is 1-2
gums, use should be stopped
2mg as required – up to a
maximum of 15 pieces daily
(individual manufacturers may
vary)Avoid acidic beverages,
coffee and soft drinks 15
minutes before use
Continue us for up to 3
Months then gradually reduce
gum use. When daily us is 1-2
gums, use should be stopped
6-12 cartridges per day
Reduce number of cartridges
used by half
12 week broken down as
below
8 weeks
2 weeks





Phaeochromocytoma and
uncontrolled
hyperthyroidism
Chronic throat disease
and bronchospastic
disease
Oral inflammation or
oesophagitis
Pregnant/breastfeeding
women *
Those taking medication
which may require dose
adjustment
of 12 cartridges per day
Each cartridge can be used
for approximately 4 sessions,
with each one lasting approx
20 minutes.
The actual time the cartridge
is active depends on intensity
of use
Patient draws air through
mouthpiece may find deep
drawing or short sucks on
mouthpiece most effective.
17
Reduce gradually to zero by
last day
2 weeks
Drug
Special
Precautions
Microtab
Microtabs containing 2mg
nicotine per cartridge







Cardiovascular disease
GI Disease(inc Peptic
ulcer)
Diabetes Mellitus
Renal or hepatic
impairment
Phaeochromocytoma and
uncontrolled
hyperthyroidism
Pregnant/breastfeeding *
Those taking medication
which may require dose
adjustment
Nasal Spray
Nasal spray releasing 0.5mg
nicotine per spray.









Cardiovascular disease
GI Disease(inc Peptic
ulcer)
Diabetes Mellitus
Renal or hepatic
impairment
Chronic nasal disorders
Phaeochromocytoma and
uncontrolled
hyperthyroidism
Bronchial asthma
Pregnant/breastfeeding *
Those taking medication
which may require dose
adjustment
Formulation and Route
of Administration
2mg nicotine bound to cyclodextrin as a complex
Nicotine sublingual tablet
placed under the tongue.
Nicotine absorbed via the
buccal mucosa
Small multi-dose bottle
containing nicotine solution.
The spray delivers 50l of
solution per spray
Sprayed into the nostril.
Nicotine rapidly absorbed
through the thin nasal mucosa
18
Dose and Frequency
Duration
1-2 microtabs per hour
determined by smoker’s
nicotine dependency
(maximum 40 tabs per day)
Duration of treatment is
individual, but at least 3
months of treatment is
recommended
Gradually reduce dose by
decreasing the total number of
tablets used per day. Stop
treatment when daily
consumption is down to 1 per
day
1 dose =
1 spray in each nostril
12 week programme broken
down as below
1-2 doses per hour as
required determined by the
smokers nicotine dependency
Maximum daily limit 64 sprays
which is the equivalent of 2
sprays to each nostril every
hour
Reduce usage by half
Reduce to zero by last day
Spraying into a single nostril
may be helpful in achieving
this. Treatment should be
limited to 3 months
8 weeks
2 weeks
2 weeks
Drug
Special
Precautions
Patch – 16 hr
Patches containing 15mg
nicotine released over 16hrs
Patches containing 10mg
nicotine released over 16hrs
Patches containing 5mg
nicotine released over 16hrs







Cardiovascular disease
Diabetes Mellitus
Renal or hepatic
impairment
Phaeochromocytoma and
uncontrolled
hyperthyroidis
Pregnant/breastfeeding *
Generalised
dermatological disorders
Those taking medication
which may require dose
adjustment
Patch – 24 hr
Formulation and Route
of Administration
Self adhesive transdermal
delivery system
Self adhesive patch.
A transdermal delivery system
which slowly releases a
controlled daily amount of
nicotine into the skin
To be applied on waking and
removed at bedtime.
Application limited to 16 hrs
Dose and Frequency
1 patch per day
12 week programme broken
down as below
8 weeks 15mg/16hr
1 patch per day
2 weeks 10mg/16hr
1 patch per day
2 weeks 5mg/16hr
Self adhesive transdermal
delivery system
Patches containing 21mg
nicotine released over 24hrs



Patches containing 14mg
nicotine released over 24hrs
Patches containing 7mg
nicotine released over 24hrs





Cardiovascular disease
Diabetes Mellitus
Renal or hepatic
impairment
Phaeochromocytoma and
uncontrolled
hyperthyroidis
Pregnant/breastfeeding *
Generalised
dermatological disorders
Pregnant/breastfeeding
women
Those taking medication
which may require dose
adjustment
Self adhesive patch.
A transdermal delivery system
which slowly releases a
controlled amount of nicotine
into the skin over 24hrs
Apply 1 patch soon after
waking and wear continuously
for 24 hrs then remove
Skin site should not be reused
for several days
19
Duration
1 patch per day
1 patch per day
1 patch per day
10 - 12 week programme
broken down as below.
(individual manufacturers
vary)
4 weeks
6 weeks
21mg/24hr
21mg/24hr
4 weeks
14mg/24hr
4 weeks
7mg/24hr
2 weeks
14mg/24hr
2 weeks
7mg/24hr
Drug
Special
Precautions
Formulation and Route
of Administration
Dose and Frequency
Duration
1mg Lozenge
Suck until taste becomes
strong then lodge between
gum and cheek. When taste
fades recommence the above
technique.
Nicotine absorbed via the
buccal mucosa (Avoid acidic
beverages, coffee and soft
drinks 15 minutes before use)
1 lozenge every 1-2 hours
normally 8-12 lozenges per
day (maximum dose 25
lozenges per day)
1 lozenge every 1 to 2 hours
Recommended minimum 9
per day
Maximum dose 15 per day
Treatment time is individual
normally continues for at least
3 months. Then gradually
reduce number of lozenges
and discontinue when the
dose has been reduced to 12 per day.
Lozenge
Lozenge containing 1mg
nicotine





Lozenge containing 4mg
nicotine




Cardiovascular disease
Recent CVA
Diabetes Mellitus
Renal or hepatic
impairment
Phaeochromocytoma and
uncontrolled
hyperthyroidis
Pregnant/breastfeeding *
Phenylketonuria
Sodium content
Those taking medication
which may require dose
adjustment
2mg /4mg Lozenge
Place in mouth and allow 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.
Step 1
Weeks 1 to 6
1 lozenge every 2 to 4 hours
Step 2
Weeks 7 to 9
1 lozenge every 4 to 8 hours
Step 3
Weeks 10 to 12
* Pregnancy and breast feeding are not listed as a special precaution within NRT product licensing but have been included in the above list for the
purpose of administering this scheme
20
Name of Specialist Advisor………………………………………………………
Is authorised to supply Nicotine Replacement Therapy vouchers under
this Access Scheme
Signature of Specialist Advisor…………………………………………………..
Date……………………………………
Review Date: 31st March 2007
21
Name of Listed Pharmacy………………………………………………………
Address:…………………………………………………………………………….
…………………………………………………………………………………………..
…………………………………………………………………………………………..
…………………………………………………………………………………………..
Telephone: ……………………………………………………………………………
Is authorised to exchange Nicotine Replacement Therapy vouchers
under this Access Scheme
Signature of Pharmacist…………………………………………………..
Date……………………………………
Review Date: 31st March 2007
22
The Access Scheme
Patient presents
voucher
Medical assessment
Special
precaution
Request
prescription from
GP. Inform advisor
who issued voucher
No cautions
Prescription obtained
Exempt
Not Exempt
Client receives free
NRT on evidence
of exemption
Client pays
dispensing fee
Pharmacist
collects vouchers
Pharmacist
completes payment
summary form
Pharmacist
sends form and
vouchers back to
Leeds NHS Stop
Smoking Service
Payment to
pharmacists
23
Yes
No
NRT can be given
NRT cannot be
given
24