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Protocol for wirral support stop smoking service

Smoking Cessation Pharmacotherapy Guidelines
Introduction
This document is aimed at Specialist Advisors from NHS Wirral Stop Smoking
Service (SSS) and Intermediate Advisors who have attended SSS training to
help patients stop smoking. It is based on NICE Public Health guidance 10
‘Smoking cessation services’ (2008), NICE Technology Appraisal 123
‘Varenicline for smoking cessation (2007), NICE Public Health Guidance 26
‘Quitting smoking in pregnancy and following childbirth’ (2010) and the
Department of Health NHS Stop Smoking Services: Service and Monitoring
Guidance 2010/11. It provides guidance on the use of Nicotine Replacement
Therapy (NRT), bupropion and varenicline.

The use of NRT, Bupropion and Varenicline

Nicotine Replacement Therapy (NRT), varenicline (Champix) and bupropion (Zyban) are recommended for smokers who have expressed a desire to stop smoking. NRT can be used for clients aged 12 years and over. Varenicline and bupropion should not be used in those under the age of 18 and in women who are pregnant or breastfeeding. The clinician and patient should choose the medication that seems most likely to succeed, and should not favour one over the other. When deciding which therapies to use and in which order, discuss the options with the client and take into account:  Contraindications and the potential for adverse effects  The availability of appropriate counselling or support  The likelihood that the client will follow the course of treatment  Their previous experience of smoking cessation aids All treatments should only be prescribed as part of an abstinent-contingent treatment (ACT) in which the smoker makes a commitment to stop smoking. Subsequent prescriptions should only be given to people who have demonstrated, on re-assessment that their quit attempt is continuing. NRT, bupropion or varenicline should not be prescribed in any combination. Cigarette smoking can interact with certain medicines. Therefore, the potential for interactions when a person stops or starts smoking should be borne in mind. Not all drug-smoking interactions are clinically significant - see appendix 1 for a list of important interactions. Please refer to the manufacturer’s Summary of Product Characteristics (SPC) for full prescribing guidance. Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013 NICOTINE REPLACEMENT THERAPY (NRT)
A voucher for NRT can be issued weekly for the first 4 weeks. If at the 4
week follow-up the client has stopped smoking and has not had a cigarette in
the 3rd or 4th week, the remaining vouchers can be issued for 2 weekly
intervals if required. A maximum of 12 weeks NRT can be issued in total.
A combination of nicotine patches and another form of NRT (such as gum,
inhalator, lozenge or nasal spray) can be offered to people who show a high
level of dependence on nicotine or who have found single forms of NRT
inadequate in the past.
If combining NRT products e.g. patch plus 2mg gum, the supplementary
product should not automatically be issued on each voucher, but only
according to need.

Specific Client Groups
In 2005 the Working Group of the Committee on Safety of Medicines (CSM)
considered the available evidence of the safety and efficacy of NRT products
with particular reference to cardiovascular risk, pregnancy and use in under-
18s. They concluded that NRT could now be used in these groups but the
risks and benefits should be clearly explained and behavioural support
options should be encouraged.

Cardiovascular Disease

The CSM recommended that in stable cardiovascular disease, NRT presents
a lesser hazard than continuing to smoke. Dependent smokers with severe or
unstable cardiovascular disease (including hospitalisation with a recent
myocardial infarction, severe arrhythmia or recent cerebrovascular accident)
should be encouraged to stop smoking with non pharmacological
interventions. If this fails, NRT may be considered but as data on safety in this
group are limited, initiation should be under medical supervision.
Therefore, NHS Wirral recommends that if a client has answered yes to any of
the questions in the Initial Assessment Health Questionnaire the Specialist or
Intermediate practitioner will approach the client’s GP (with the client’s
agreement) for permission to recommend the use of NRT. Only with the
GP’s permission will NRT be recommended and a voucher issued.

Use of Nicotine Replacement Therapy by Adolescents of 12-17 years
NRT can be used by adolescents aged 12-17 years but as there are limited
data on the safety and efficacy, duration should be restricted to 12 weeks.
Treatment should only be continued for longer than 12 weeks on the advice of
a healthcare professional.
The young person should have sufficient maturity to understand about the
service they are to receive. Once children reach the age of 16, they are
presumed in law to be competent to give consent for themselves. Clients
under 16 who have sufficient understanding and intelligence to enable them to
understand fully what is involved in a proposed intervention will also have the
Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013 capacity to consent to that intervention. This is sometimes described as being
‘Gillick competent’.
Nicotine Replacement Therapy during Pregnancy and Breast-feeding
The data available on the use of NRT in pregnancy and breast-feeding
women is limited. To eliminate all possible risks from nicotine a woman would
ideally stop smoking without using NRT. However, the risk to the fetus of
continued smoking is likely to be greater than any potential risks from NRT
because cigarette smoking, in general, delivers more nicotine than does NRT,
and it exposes both mother and fetus to many other toxins. In light of this, the
Working Group of the Committee on Safety of Medicines (CSM) 2005 and
NICE (2010) have advised that pregnant and breastfeeding women, who
cannot stop smoking on their own, can use NRT.
NICE recommends that smoking advisors should discuss the risks and
benefits of NRT with pregnant women who smoke. Only use NRT if smoking
cessation without NRT fails. If they express a clear wish to receive NRT, use
professional judgement when deciding whether to offer a prescription.

Pregnancy
The decision to use NRT should be made following a risk-benefit assessment
as early in pregnancy as possible. The aim should be to discontinue NRT
after 2-3 months. Intermittent forms of NRT are preferable during pregnancy
but a patch may be appropriate if nausea and/or vomiting are a problem. A 16
hour patch is preferable to a 24 hour patch and pregnant women who are
using nicotine patches should be advised to remove them before going to bed
to avoid the administration of nicotine overnight. The dosage of NRT
suggested should be kept at a lower level than the pregnant woman would be
taking if she had continued to smoke and the therapy be used for the shortest
time possible.
Breast-feeding
The amount of nicotine the infant is exposed to from breast milk is relatively
small and is less hazardous than the second-hand smoke the infant would
otherwise be exposed to if the mother continued to smoke. For breast-
feeding mothers, intermittent NRT products are preferred as they will allow the
time between NRT use and feeding to be as long as possible to minimise the
amount of nicotine in the milk.
Partners and others in the household who smoke
Clear advice should be provided about the danger that other people’s tobacco
smoke poses to the pregnant woman and to the baby – before and after birth.
Recommend that other members of the household do not smoke around the
pregnant woman, mother or baby. This includes not smoking in the house or
car. Encourage other members of the household to stop smoking.
Other Cautions
Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013  Diabetes Mellitus – monitor blood-glucose concentration closely when  Oral Preparations only: oesophagitis, gastritis, peptic ulcers  Patches: skin disorders (patches should not be placed on broken skin) Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013 BUPROPION (ZYBAN)

Bupropion is a prescription-only drug licensed for use in smoking cessation
with motivational support. Bupropion can only be issued on prescription and
not through the Wirral voucher scheme. However, the Specialist or
Intermediate advisor should provide ongoing support, advice and follow-up
during the treatment period.

Bupropion should not be used in combination with either NRT or varenicline
and should be prescribed subject to the contraindications and precautions
listed in the Summary of Product Characteristics (SPC) some of which are
listed below.
Contraindications
 History of seizures or of eating disorders, bipolar disorder, a CNS tumour, severe hepatic cirrhosis, patients experiencing acute symptoms of alcohol or benzodiazepine withdrawal, risk factors for seizures (see below)  Factors that increase the risk of seizures include concomitant administration of drugs that can lower the seizure threshold (e.g. antidepressants, antimalarials [such as mefloquine and chloroquine], antipsychotics, quinolones, sedating antihistamines, systemic corticosteroids, theophylline, tramadol), alcohol abuse, history of head trauma, diabetes, and use of stimulants and anorectics.  Concomitant administration of Monoamine-oxidase inhibitors (MAOIs)  Women who are pregnant or breastfeeding
Cautions
 Elderly patients (max dose150mg daily)
 Predisposition to seizures (see above)  Monitor blood pressure before and during treatment
Interactions: Drugs known to lower the seizure threshold (e.g.,
antipsychotics, antidepressants, antimalarials, tramadol, theophylline,
systemic steroids, quinolones and sedating antihistamines), citalopram,
MAOIs, antipsychotics, beta blockers, carbamazapine, phenytoin, valproate,
ritonavir, theophylline, clozapine, other drugs metabolised by CYP 2D6 or
CYP 1A2, other inhibitors or inducers of CYP 2B6. See SPC for full list of
interacting drugs.
Dose:
Start 1 – 2 weeks before stop date, initially 150mg daily for 6 days then
150mg twice daily (max. daily dose 300mg or 150mg in patients with risk
factors for seizures). Bupropion should be used for 7-9 weeks. If at seven
weeks no effect is seen, treatment should be discontinued. See BNF / SPC
for full prescribing details.
The initial and maintenance prescriptions should be for no more than 4 weeks
at a time.
Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013 VARENICLINE (CHAMPIX)
Varenicline is a prescription-only drug licensed for use in smoking cessation
with motivational support. Varenicline can only be issued on prescription and
not through the Wirral voucher scheme. However, the Specialist or
Intermediate advisor should provide ongoing support, advice and follow-up
during the treatment period.
Varenicline should not be used in combination with either NRT or bupropion
and should be prescribed subject to the contraindications and precautions
listed in the Summary of Product Characteristics (SPC) some of which are
listed below.
Contraindications
 Women who are pregnant or breastfeeding
 Patients under 18 years
Cautions
 History of psychiatric illness (see below)

Adverse psychiatric reactions

Psychiatric disorders are the most commonly reported suspected adverse
reactions for varenicline in the UK. Depression and suicide-related events
have been reported in patients using varenicline who are trying to stop
smoking. The Medicines and Healthcare products Regulatory Agency
(MHRA) and Commission on Human Medicines have advised that patients
who are taking varenicline who develop suicidal thoughts or who develop
agitation, depressed mood, or changes in behaviour that are of concern for
the doctor, patient, family, or caregiver should stop their treatment and contact
their doctor immediately.

Dose:
Start 1 -2 weeks before stop date, initially 500mcg once daily for 3
days, increased to 500mcg twice daily for 4 days, then 1mg twice daily for 11
weeks (reduce dose to 500mcg twice daily if not tolerated).
The initial prescription should be for the varenicline 2 week starter pack of 11
x 500mcg tablets and 14 x 1mg tablets. The follow on prescriptions should be
for a maximum of 4 weeks treatment at a time.
**Locally it has been agreed that the duration of treatment is 12 weeks
and that it is not appropriate to give an additional 12 week course**

Discontinuation of varenicline may be associated with irritability, an urge to
smoke, depression and/or insomnia in up to 3% of patients. The prescriber
should inform the patient accordingly and discuss or consider the need for
dose tapering over 1 or 2 weeks. (This should be included in the 12 weeks of
treatment).
Interactions: No clinically meaningful interactions
Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral
and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013 Appendix 1 – Clinically important drug-smoking interactions*

BNF category/
Nature of interaction
Clinical
Action to take when stopping
Drug name
relevance
physician managing their anticoagulant control that they are adjusted according to a patient’s INR (International they develop signs of theophylline toxicity such as palpitations or nausea. Chlorpromazine metabolised principally via effects occur, reduce the dose as necessary. Contact Lisa Foulkes
(pharmacy team secretary) at
Cheshire and Wirral
Partnership NHS Foundation
Trust (CWP) IMMEDIATELY to
be directed to a pharmacist for
guidance:
Tel: 01244 397 494
taking clozapine when they have stopped smoking. Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013 signs of hypoglycaemia and to test their blood glucose more frequently. Written by: Rachael Stevenson, Clinical Effectiveness Pharmacist, NHS Wirral and Carol Corvers, Programme Manager, Stop Smoking Service, NHS Wirral Approved by Wirral Drug and Therapeutics Committee: Sept 2010 Review date: Sept 2013

Source: http://www.wirral.nhs.uk/document_uploads/Disclosure-Mar2011/FOI1060AttSmokCesPharmGdlines.pdf

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