Guidance for the Recommended Supply of Nicotine
Replacement Therapy (NRT) to Clients Aged 12 and Over
Version:
Classification :
Name of author:
Post Title:
Contact Details:
Target audience:
Equality Impact Assessment carried out:
Name of responsible committee:
Date Approved:
Ratified by:
Date issued:
Review date:
Date of Original Policy: (Version 1)
Date of first audit: (month 6)
Date of second audit: (month 18)
Clinical Protocol for the Recommended Supply of
Version 8
8
Clinical Protocol
Majella Johnston,
Stop Smoking in Pregnancy Coordinator,
Lifestyle Services
02476961590
Trained Stop Smoking Advisors working for or on behalf
of Coventry and Warwickshire Partnership Trust
(CWPT)
Yes
Physical Health Drugs and Therapeutics committee
May 2016
Physical Health Drugs and Therapeutics committee
6 June 2016
May 2017
February 2009
Jan 2016
June 2017
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 1 of 50
Contribution List
Key individuals involved in developing the document
Name
Designation
Organisation
Majella Johnston
Priti Ved
Mohammed Patel
Bethan Alper
Emily Hackett
Stop Smoking in Pregnancy
Coordinator
Deputy Chief Pharmacist
Lifestyles Service Manager
Stop Smoking Lead
Stop Smoking in pregnancy
Midwife
CWPT
CWPT
CWPT
CWPT
CWPT
Circulated to the following for comments
Name
Designation
Organisation
David Tait
Priti Ved
Mohammed Patel
Bethan Alper
Emily Hackett
CWPT
CWPT
CWPT
CWPT
CWPT
Chief Pharmacist
Deputy Chief Pharmacist
Lifestyles Service Manager
Stop Smoking Lead
Stop Smoking in pregnancy
Midwife
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
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CONTENTS
1
APPROVED FOR USE BY:………………………………………………………………………………….
5
2
CAPACITY AND CONSENT ………………………………………………………………………………..
5
3
4
5
CLINICAL CONDITION …………...…………………………………………………………………………
5
3.1
Define Situation / Condition ………………………………………………………………………………………..
5
3.2
Aim of treatment or Care …………………………………………………………………………………………..
6
3.3
Criteria for Inclusion …………………………………………………….…………………………………………..
6
3.4
Criteria for Exclusion………………………………………………………………………………………………..
6
3.5
Cautions when issuing vouchers for NRT…………………………………………………….………………….
7
3.6
Criteria for Seeking Further Advice …………………………………………………………………...................
7
3.7
Action if Excluded …………………………………………………………………………………………………..
8
3.8
Action if Patient Declines or Does Not Adhere to Care Under Protocol …….………………………………..
8
3.9
Facilities / Supplies to be Available ………………………………………………………………………………
8
DESCRIPTION OF MEDICINE ……………………………………………………………………………..
8
4.1
Transdermal Patches …..……………………………………………….……………………………..…………..
9
4.2
Nicotine Gum ……………………………………………….…………………………………………..…………..
10
4.3
Nicotine Lozenge ………………………………………………………….………………………………………..
12
4.4
Minis Lozenge …………….……..…………………………………….………………………………..…………..
14
4.5
Sublingual Tablets …………………………………….………………………………………………..…………..
14
4.6
Inhalator .………………………..………………….…………………………………………………..…………..
15
4.7
Nasal Spray ………………..…………………………………………………………….……………..…………..
17
4.8
Mouth Spray …………………………………………………………………………………………………………
18
4.9
Oral Strips……………………………………………………………………………………………………………
20
SPECIFIC CATEGORIES …………………………………………………………………………………..
21
5.1
Adults ………………………………………………………………………………………………………………..
21
5.2
Children ……………………………………………………………………………………………………………..
21
5.3
Pregnant Women …………………………………………………………………………………………………..
21
5.4
Combination Therapy ………………………………………………………………………………………………
22
5.5
Side Effects of NRT …………………………………………………………………………………………………
23
5.6
Interactions …………………………………………………………………………………………………………..
23
5.7
Follow Up …………………………………………………………………………………………………………….
24
5.8
Advice / Warnings to Patients ……………………………………………………………………………………..
24
5.9
Clients who use Shisha Pipes ……………………………………………………………………………………..
25
TRAINING AND COMPETENCY …………………………………………………………………………..
25
6.1
Training for CWPT Employees ………………………………………………….…………………………………
25
6.2
Competency …………….………………………………………….………………………………………………..
26
6.3
Performance Requirements ………………………………………………………………………………………..
26
RECORDS MANAGEMENT…………………………………………………………………………………
26
7.1
Patient Clinical Records………………………………………………………….…………………………………
27
7.2
Non Clinical Records …………………………………………….…………………………………………………
27
7.3
Subcontractors who Deliver Under the Protocol ………………………………………………………………..
27
8
EQUALITY …………………………………………………………………………………………………….
27
9
DATA PROTECTION ………………………………………………………………………………………..
28
10 FREEDOM OF INFORMATION …………………………………………………………………………….
28
11 DEVELOPMENT ……………………………………………………………………………………………...
28
11.1 VERSION DEVELOPMENT ………………………………………………………….……………………………
28
6
7
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11.2 REVIEW …………………………………………………………….………………………………………………..
29
12 MONITORING COMPLIANCE ………………………………………………………………………… …..
29
13 DISCIPLINE …………………………………………………………………………………………………...
29
14 CLINICAL PROTOCOL APPROVED BY …………………………………………………………...........
29
15 REFERENCES ………………………………………………………………………………………………..
30
APPENDIX A – TEMPLATE FOR PROTOCOL STAFF REGISTER …………………………….…………
31
APPENDIX B - VERSION CONTROL SHEET ………………………………………………………….……..
32
APPENDIX C – NRT VOUCHER FORM ………………………………………….........................................
33
APPENDIX D – MEDICAL QUESTIONNAIRE......................................................................………….….
34
APPENDIX E – DOSAGE AND METHOD OF ADMINISTERING NRT PRODUCTS...............................
35
APPENDIX F – LETTER TO GP – REFERRAL AS UNABLE TO TREAT/CONTRAINDICATIONS......
38
APPENDIX G – LETTER TO GP - MEDICINES INTERACTIONS/CONTRAINDICATIONS…………….
40
APPENDIX H – LETTER TO GP – CAUTIONS CATEGORY……...........................................................
41
APPENDIX I – LETTER TO GP – REVIEW MEDICATION SUBSEQUENT TO FAILED QUIT………..
42
APPENDIX J – LETTER TO PHARMACIST – REASON FOR EXCESS OF 2/52 SUPPLY……………
43
APPENDIX K – CONSENT FORMS........................................................................................................
44
APPENDIX L – ABBREVIATION LIST...................................................................................................
47
Clinical Protocol for the Recommended Supply of
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1. Approved for use by:
Named stop smoking advisors working within Coventry Healthy Lifestyle Service, its
subcontracted providers, and named individuals trained in supporting clients to stop
smoking and accessing clients within their current job role (for example, school
nurses/assistants, youth workers, pharmacy technicians, practice nurses, health care
assistants, Children Centre staff), for or on behalf of Coventry and Warwickshire
Partnership Trust (CWPT)
A register of clinicians competent to operate under this clinical protocol (see
Appendix A) must be held by the Service Lead, together with a master copy of the
clinical protocol for that service. This register must be updated each time new staff
are deemed competent to work under this Protocol.
2. Capacity and Consent
Adults
CWPT recognizes the need to consider the capacity of the individual to understand
and consent to medical support and intervention. Due consideration must be given to
whether a significant decision has to be made by or on behalf of any individual. There
is a legal presumption that adults have capacity to decide their own treatment unless
there is evidence to the contrary. When an adult is felt to lack capacity, all decisions
must comply with the Mental Capacity Act 2005.
Children/Young People
The Welfare Reform Act 2013 This gives young people aged 16 or 17 years the
same legal right to give consent as adults. However they do not have a
corresponding right to refuse consent and someone with parental responsibility or the
courts may have the right to override such refusal.
Fraser Competence
When an individual is below 16 years of age the child/young person’s capacity to give
consent must be assessed in each case. Lord Fraser ruled that a child may give his
or her own consent if and when that child achieves sufficient understanding and
intelligence to enable him/her to understand fully what is proposed (Gillick v West
Norfolk & Wisbech Area Health Authority [1985] 3 All ER 402 (HL). Again there is no
corresponding right to refuse.
3. Clinical Condition
3.1 Define situation /
condition
3.2 Aim of treatment
or care
Nicotine Replacement Therapy (NRT) is an aid to treating
nicotine dependence in clients who want to stop smoking
with the help and support of the Coventry Healthy Lifestyle
Service, or its sub contractors.
The Service will support the supply of NRT via a regional
NRT voucher scheme (see appendix C), delivered by
trained stop smoking advisors.
To provide nicotine replacement products and behavioural
support to clients with tobacco smoking dependence.
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3.3 Criteria for
Inclusion
3.4 Criteria for
exclusion
Therefore providing relief of nicotine withdrawal symptoms,
and aiding smoking cessation.
Tobacco smokers identified as sufficiently motivated to quit
i.e. willing to set a quit date and receive weekly support for
the first four/five weeks and thereafter fortnightly support.
• Inability to consent to treatment
• Clients not sufficiently motivated to quit or use NRT
• If medical questionnaire has not been completed (see
appendix D) or there are doubts about the clients
suitability for NRT
• Clients taking Clozapine (significant drug interaction
possible). NRT needs to be prescribed by a
psychiatrist/GP in these clients as dosage review/careful
monitoring will be necessary. Above clients may be seen
and supported by advisors, but referred to GP for a
prescription for NRT. See letter in appendix G and I
• Clients taking Theophylline (significant drug interaction
possible). NRT needs to be prescribed by a GP in these
clients as dosage review/careful monitoring will be
necessary. Above clients may be seen and supported
by advisors, but referred to GP for a prescription for
NRT. See letter in appendix G and I
• Clients under 12 years of age (or under 18 for lozenges
– see below)
• Clients already using Bupropion (Zyban®)
• Clients already using Varenicline (Champix®)
• Clients who have experienced an acute cardio-vascular
event in the last 4 weeks, i.e. myocardial infarction( heart
attack), cerebral vascular accident (stroke) or heart
surgery.
• Clients who have had a previous serious reaction to NRT
or any of the other ingredients contained in the products
(e.g. glue in patch).
• Patches should not be placed on broken skin and are not
recommended where clients have a generalised skin
disease or for occasional smokers.
• Nasal spray - is not recommended for clients with chronic
nasal disorders or bronchial asthma.
• Lozenges are not recommended for clients aged 12 – 18
years
• Lozenges are not recommended for those required to
follow a low sodium diet and those with Phenylketonuria
(PKU).
• Microtabs are not recommended for clients with
phenylketonuria (PKU)
• NiQuitin Strips – Patients with unstable Angina, Severe
Cardiac Arrhythmias or uncontrolled hypertension should
be excluded from treatment
• Clients must remove patch 24 hours prior to surgery and
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3.5 Cautions When
Issuing Vouchers for
NRT
stop using all other forms of NRT 8 hours prior to surgery
Medical Conditions:
• Diabetes: if the client is diabetic advise them to monitor
their blood sugars more frequently. (Report of the
committee on Safety of Medicines working group on
Nicotine Replacement Therapy, 2006)
• Clients who have a history of thyroid, kidney (renal), liver
(hepatic) disorders and phaeochromocytoma (tumor
affecting the adrenal medulla) problems. (British National
Formulary (BNF) Online April 2016 )
• Clients with active peptic ulcer disease BNF online April
2016
• Pregnant and breast feeding clients– see section 5.3
• Clients taking the following medications: Insulin,
Warfarin, Propranolol, and mental health medications –
including antidepressants, antipsychotic, or medications
for anxiety (NHS Stop Smoking Services: Service and
Monitoring Guidance 2010/11, 2011/12, Protocol for the
supply of Nicotine Replacement Therapy via Voucher
2011). This is due to changes in the metabolism of
these drugs when clients quit smoking.
•
Potential risks and benefits of nicotine should be
carefully evaluated before use in subjects taking anticonvulsant therapy or with a history of epilepsy, as cases
of convulsions have been reported in association with
nicotine
For the above clients and with the client’s consent a
cautions letter should be sent to their GP notifying them
that NRT has been commenced. The letter needs to be
copied and filed in the notes. Clients who are on the
above medications will also need another letter to GP if
they fail to quit or DNA due to potential drug changes
that may have been made. See letter in Appendix H and I
•
Clients who have a history of ulceration/gastric problems
can commence NRT but may find that oral products
worsen this condition. (BNF Online April 2016 )
Patients with obstructive lung disease (COPD) may find
use of the inhalator difficult, and an alternative product
may be preferred in such cases. The inhalator should be
used with caution in clients who have chronic throat
disease and bronchospastic disease.
3.6 Criteria for
seeking further
advice
•
If an advisor feels unsure of a client’s medical condition
due to cautions, or the client has multiple medical issues,
refer the client to their GP for NRT prescription.
• Young people between ages 12 and 15. Line managers
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•
3.7 Action if
excluded
•
•
•
3.8 Action if patient
declines or does not
adhere to care under
protocol
•
3.9 Facilities /
supplies to be
available
•
•
•
•
•
•
•
•
•
•
can be accessed for further advice for this category
where necessary. (See section 5.2 for further
information).
Frequent service users who present to the service
should be fully assessed to ensure they are motivated to
stop smoking. Clients can be discussed with line
managers to ensure appropriate care pathway is
followed. (Alternative medication or therapeutic approach
should be considered e.g. oral medications or Healthy
Lifestyle referral).
Explain reason for exclusion and refer to GP if
appropriate
Document in patients clinical record
Provide further information and support on alternative
options to assist the client in stopping smoking
Provide further information and support to assist the
client in stopping smoking, and benefits of behavioural
support.
Document in patients’ clinical record (including reason if
given)
Regional NRT Voucher.
Patient information leaflets
Hand Decontamination equipment
Carbon Monoxide (CO) Monitor
D piece filter
Single use cardboard tubes Non-alcoholic wipes
Appropriate waste facilities according to infection control
policies
Clinical notes for record keeping / electronic records
Copy of protocol
4. Description of Medication
This clinical protocol covers a range of NRT products, which are:
• Patches: 25mg/16hours
15mg/16 hours
10mg/16 hours
21mg/24hours
14mg/24hours
7mg/24hours
•
Gum – 2mg , 4mg and 6mg
•
Lozenge – 1mg, 2mg, 4mg
•
Mini lozenge – 1.5mg and 4mg
•
Microtab tablet – 2mg
•
Inhalator - 15mg cartridge
•
Nasal spray – 500 micrograms(0.5mg)/metered spray
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•
Mouth Spray – 1mg per spray
• Oral Strips – 2.5 mg per strip
Each of these will be described separately below, but for all supplies, in accordance
with product license, treatment to last for 8 - 12 weeks providing the client has
remained quit.
4.1.
Transdermal Patches
Brand(s), dose, pack
size, duration,
directions for
use/frequency of
administration
Nicorette – 16 hour invisi patch
25mg/15mg/10mg
Directions: one patch to be applied on waking and kept on for 16
hours. Clients smoking over 10 cigarettes per day are
recommended to start on:
25 mg /16 hours patch (Step 1) using one patch daily for 8 weeks
15 mg/16 hours patch (Step 2) should be used daily for 2 weeks
10 mg/16 hours patch (Step 3) daily for 2 weeks.
Lighter smokers (i.e. those who smoke less than 10 cigarettes per
day) are recommended to:
Start at Step 2
15 mg/16 hour patch for 8 weeks
Followed by step 3 10 mg/16 hour patch for the final 4 weeks.
All patches should be removed after 16 hours (usually at bedtime).
Maximum period of treatment: 12 weeks per intervention
Nicotinell - 24 hour patch
21mg/14mg/7mg
Directions: For individuals smoking more than 20 cigarettes /day:
Nicotinell 21mg patch applied every 24 hours for 3-4 weeks
Nicotinell 14mg patch applied every 24 hours for 3-4 weeks
Nicotinell 7mg patch applied every 24 hours for 3-4 weeks
Maximum period of treatment: 12 weeks per intervention
Directions: For individuals smoking less than 20 cigarettes /day:
Nicotinell 14mg patch applied every 24 hours for 3-4 weeks
Nicotinell 7 mg patch applied every 24 hours for 3-4 weeks
Maximum period of treatment: 8 weeks per intervention
NiQuitin - 24 hour patch
21mg/14mg/7mg
Directions:
For individuals smoking more than 10 cigarettes /day:
Apply each patch every 24 hours using the following regime
Step 1 NiQuitin 21mg
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Step 2 NiQuitin 14mg
Next 2 weeks
Step 3 NiQuitin 7mg
Last 2 weeks
Maximum period of treatment: 10 weeks per intervention
For individuals smoking less than 10 cigarettes /day:
Step 2 NiQuitin 14mg First 6 weeks
Step 3 NiQuitin 7mg Last 2 weeks
Legal Classification
Storage
Specific written and
verbal advice to
client
Specific side effects
4.2.
Maximum period of treatment: 8 weeks per intervention
GSL – General Sales List
Store below 25c
• Read and adhere to product information leaflet that
accompanies NRT product
• The patch should be applied once a day, normally in the
morning, to a clean, dry, non-hairy area of skin e.g. on the hip,
or upper arm. Allow at least seven days before replacing the
patch on a previously ‘used’ area. Place the patch in the palm
of the hand and apply onto the selected area and hold in place
for 10-20 seconds.
• Patches should not be applied to broken or inflamed skin. Care
should be taken during handling and in particular contact with
the eyes and nose avoided.
• Once the patch is used it should be folded in half and disposed
of carefully.
• Clients should never alter the dose of the patch by cutting it up.
• Exercise may increase the absorption of nicotine and therefore
side effects
• Refer to cautions and contraindications category listed in 3.4
and 3.5
Skin reactions. Discontinue use if severe.
Sleep disturbance including abnormal dreams and insomnia
(especially 24 hour patch)
Headaches, dizziness, nausea and vomiting
(See SmPC. for full list of side effects.)
Nicotine Gum
Brand(s), dose, pack
size, duration,
directions for
use/frequency of
administration
Nicorette Gum
2mg, 4mg & 6mg
Directions:
If smoking over 20 cigarettes per day: commence 4mg dose, if
smoking under 20 cigarettes per day use 2mg dose.
6mg Gum relieves and/or prevents craving and nicotine withdrawal
symptoms associated with tobacco dependence in highly
dependent smokers (> 20 cigarettes per day). Nicorette
6mg gum can be recommended particularly to those requiring
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enhanced craving relief compared to 4mg gum.
6mg Gum is indicated in pregnant and lactating women making a
quit attempt
Use the gum whenever there is an urge to smoke to maintain
complete abstinence from smoking. Sufficient gums should be
used, usually 8-12 per day, up to a maximum of 15.
For those using the 6 mg Gum, switching to the 2 or 4 mg Gums
may be helpful when stopping treatment or reducing the number of
gums used each day.
When daily use is 1-2 gums, use should be stopped.
The “chew and rest” technique should be used to absorb the
nicotine from the gum. After about 30 minutes of such use, the gum
will be exhausted.
Maximum period of treatment: 12 weeks per intervention
Nicotinell Gum
2 and 4mg
Directions: The 4 mg chewing gum is intended to be used by
smokers with a strong or very strong nicotine dependency i.e. at
least above 20 cigarettes per day, and those who have previously
failed to stop smoking with the aid of NRT. The 2mg dose is
intended for those who have a low to moderate dependency on
nicotine i.e. less than 20 cigarettes per day.
One piece of Nicotinell gum to be chewed when the user feels the
urge to smoke. Normally, 8-12 pieces per day can be used, up to a
maximum of 15 pieces per day for 4mg dose.
Maximum dose for 2mg gum is up to 25 pieces per day
The Chew and rest technique should be used for a duration of 30
minutes per piece.
Note Nicotinell gum is sugar free
Maximum period of treatment: 12 weeks per intervention
NiQuitin Gum
2 and 4mg
Directions: NiQuitin 4 mg Mint Gum is suitable for smokers who
have their first cigarette of the day within 30 minutes of waking. The
2mg dosage is appropriate for those who have their first cigarette
more than 30 minutes after waking. Sufficient gums should be
used each day, usually 8 12, up to a maximum of 15 for either
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product.
The gums should be used whenever there is an urge to smoke
according to the “chew and rest” technique described on the pack.
After about 30 minutes of such use, the gum will be exhausted. Not
more than 15 pieces of the chewing gum may be used each day.
When daily use is 1 2 gums, use should be stopped
Maximum period of treatment: 12 weeks per intervention
Legal Classification
Storage
Specific written and
verbal advice to
client
GSL
Store below 25c
• Read and adhere to product information leaflet that
accompanies NRT product
• 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 ‘chewrest-chew’ technique should be applied for 30 minutes.
• Use of acidic beverages such as coffee or soda may decrease
the absorption of nicotine. Acidic beverages should be avoided
for 15 minutes prior to chewing the gum.
•
Specific side effects
4.3
Liquorice flavoured products are not suitable for pregnant
women
• The product may not be suitable for clients with dentures.
• Oral products may exacerbate symptoms of GI disease.
• Refer to cautions and contraindications category listed in 3.4
and 3.5
Throat irritation, increased salivation, hiccups, dizziness,
headaches jaw muscle ache
(See SmPC. for full list of side effects.)
Nicotine Lozenge
Brand(s), dose,
pack size,
duration,
directions for
use/frequency
of
administration
Nicotinell Lozenge
1 and 2mg
Directions: Nicotinell Mint 2 mg lozenge is intended to be used by
smokers with a strong or very strong nicotine dependency i.e. at least
over 20 cigarettes per day and those who have previously failed to stop
smoking with the aid of NRT. Low to medium dependency smokers are
Not suitable for recommended to try 1mg dose (less than 20 cigarettes per day).
pregnancy
Lozenges 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.
On average 8-12 lozenges daily, not exceeding 15 lozenges per day for
2mg dose and 30 lozenges per day for 1mg dose.
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One lozenge every 1-2 hours in week 1-6
Then one lozenge every 2-4 hours weeks 7-9
Reducing down to 1-2 a day by week 12.
Maximum period of treatment: 12 weeks per intervention
NiQuitin Lozenge
2 and 4mg
Directions: For individuals who do not have the urge to smoke within
30minutes of waking; consider initiating on 2mg lozenge. For those who
need to smoke within 30 minutes of waking; consider 4mg lozenge.
Step 1
Step 2
Step 3
Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
Initial treatment
period
Step down treatment
period
Step down treatment
period
1 lozenge every 1 to
2 hours
1 lozenge every 2 to 4 1 lozenge every 4 to 8
hours
hours
During weeks 1-6 it is recommended that a minimum of 9 lozenges and
a maximum of 15 lozenges per day are taken.
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
Nicorette Cools Lozenge
2 and 4 mg
Directions: Nicorette Cools 2 mg Lozenge is suitable for smokers who
smoke 20 or less cigarettes per day. The 4 mg Cools Lozenge is
suitable for smokers who smoke more than 20 cigarettes per day.
Nicorette Lozenge should be used whenever the urge to smoke is felt or
to prevent cravings in situations where these are likely to occur.
Most smokers require 8 to 12 lozenges per day, not to exceed 15
lozenges.
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. You
should not chew or swallow the lozenge. You should not eat or drink
while a lozenge is in the mouth
Clinical Protocol for the Recommended Supply of
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A tapering down dose following the recommended schedule is advised:
One lozenge every 1-2 hours in week 1-6
Then one lozenge every 2-4 hours weeks 7-9
Reducing down to 1-2 a day by week 12.
Maximum period of treatment: 12 weeks per intervention
GSL
Legal
Classification
Do not store above 25C
Storage
Specific written • Read and adhere to product information leaflet that accompanies
and verbal
NRT product
advice to client • 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.
• Oral products may exacerbate symptoms of GI disease.
• Lozenges are not suitable for under 18’s, those required to follow a
low sodium diet and those with phenylketonuria (PKU).
• Liquorice lozenge products are not suitable for pregnant women
• Refer to cautions and contraindications category listed in 3.4 and 3.5
Throat irritation, increased salivation, hiccups, coughing, sore mouth or
Specific side
throat.
effects
(See SmPC. for full list of side effects.)
4.4
Minis Lozenge
Brand(s), dose,
pack size,
duration,
directions for
use/frequency
of
administration
NiQuitin Minis Lozenges
1.5mg & 4mg
Directions: 1.5mg (suitable for those smoking 20 or less cigarettes per
day), 4mg (suitable for those smoking more than 20 per day). Use the
lozenges whenever there is an urge to smoke.
Sufficient lozenges should be used each day, usually 8 12, up to a
maximum of 15.
Continue use for up to six weeks to break the habit of smoking, and then
gradually reduce lozenge use. When daily use is 1-2 lozenges, use
should be stopped.
Legal
Classification
Storage
Maximum period of treatment: 12 weeks per intervention
GSL
Do not store above 30c
Specific written •
and verbal
advice to client •
Read and adhere to product information leaflet that accompanies
NRT product
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
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dissolved (approximately 10 minutes).
The lozenge should not be chewed or swallowed whole. Users
should not eat or drink while a lozenge is in the mouth. .
• Oral products may exacerbate symptoms of GI disease.
• Minis maybe given to under 18’s
• Refer to cautions and contraindications category listed in 3.4 and 3.5.
Nausea, hiccups, flatulence, GI disturbance, vomiting, diarrhoea,
dyspepsia, fatigue, malaise, sleep disorders (See SmPC. for full list of
side effects.)
•
Specific side
effects
4.5
Sublingual Tablet
Brand(s), dose,
pack size,
duration,
directions for
use/frequency
of
administration
Nicorette Microtab
2mg sublingual tablets
Directions: The initial dose is based on the individual's nicotine
dependence. The tablet is used sublingually with a recommended dose
of one tablet per hour, or for heavy smokers (smoking more than 20
cigarettes per day), two tablets per hour.
Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed
40 tablets per day.
The nicotine dose should then be gradually reduced, by decreasing the
total number of tablets used per day. The treatment should be stopped
when the daily consumption is down to one or two tablets.
Maximum period of treatment: 12 weeks per intervention
Legal
Classification
Storage
Specific written
and verbal
advice to client
Specific side
effects
4.6
GSL
Do not store above 25c
• Read and adhere to product information leaflet that accompanies
NRT product
• Tablets should be placed under the tongue and allowed to dissolve
slowly.
• Nicorette Microtab Lemon contains the ingredient aspartame which is
a source of phenylalanine and may be harmful for people with
phenylketonuira.
• Oral products may exacerbate symptoms of GI disease.
• Refer to cautions and contraindications category listed in 3.4 and 3.5.
Throat irritation, unpleasant taste, dizziness, palpitations, coughing,
hiccups.
(See SmPC. for full list of side effects.)
Nicorette Inhalator – 15mg cartridge
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Brand(s), dose,
pack size,
duration,
directions for
use / frequency
of
administration
Nicorette Inhalator
15mg cartridge plus mouthpiece
Directions: Nicorette Inhalator should be used whenever the urge to
smoke is felt or to prevent cravings in situations where these are likely to
occur.
Smokers should replace all their cigarettes with the Inhalator.
Directions: Use 3-6 cartridges daily for up to 8 weeks. Then reduce the
dose to 1-3 cartridges over the next 2 weeks, and then reduce the dose
to 0 over the final 2 weeks.
Maximum number of inhalator cartridges per day is 6.
Each cartridge can be used for approximately eight 5-minute sessions,
with each cartridge lasting approximately 40 minutes of intense use. The
more the subject is able to use the inhalator, the easier it will be to quit
smoking completely.
When a patient draws air into the mouth through the mouthpiece, nicotine
is vaporised and absorbed via the lining of the mouth. Minimal nicotine
reaches the lungs. The amount of nicotine from a puff is less than that
from a cigarette. To compensate for less nicotine delivery from a puff it is
necessary to inhale more often than when smoking a cigarette.
The number of cartridges, frequency, puffing/inhalation time and
technique does vary between individuals.
The actual time that the cartridge is active depends on the intensity of
use. After about 40 minutes of intense use the maximal dose is achieved
and it is about then that the nicotine amounts released from the cartridge
begin to fall away, such that the cartridge is rejected by the user.
The product is suitable for those over 12 years.
Maximum period of treatment: 12 weeks per intervention
Legal
Classification
Storage
Specific written
and verbal
advice to client
GSL
Store below 25c.
This product works best at room temperature. In cold conditions (below
15°C) the nicotine evaporates less readily and it will be necessary to
inhale more frequently, whilst in warm conditions (above 30°C) nicotine
will evaporate more readily and inhalation should be less frequent to
avoid overdose.
• Read and adhere to product information leaflet that accompanies NRT
product.
• Air should be drawn into the mouth through the mouthpiece. Clients
should be warned that the inhalator requires more effort to inhale than
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a cigarette and that less nicotine is delivered per inhalation.
The inhalator is best used at room temperature 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 and keep away from children/pets etc.
• Potential choking hazard: This product contains some small parts.
• Patients with obstructive lung disease may find use of the Inhalator
difficult. Other oral forms of NRT may be preferred in such cases.
• Nicorette Inhalator should be used with caution in patients with
chronic throat disease and lung disease.
• Inhaled products may exacerbate symptoms of Gastro-intestinal
disease.
• Once inserted into the mouthpiece the cartridge should be disposed of
within 48 hours even if it has not been used.
• Refer to cautions and contraindications category listed in 3.4 and 3.5
Cough, headache, throat and mouth irritation, dizziness, nasal
congestion, stomach discomfort, hiccups, nausea and vomiting (See
SmPC. for full list of side effects.)
•
Specific side
effects
4.7
Nasal Spray
Brand(s), dose,
pack size,
duration,
directions for
use/frequency
of
administration
Nicorette Nasal Spray (10ml)
Each spray delivers 0.5mg of nicotine
200 sprays per bottle
Directions:
1) Remove the protective cap.
2) Prime Nicorette Nasal Spray by placing the nozzle between first and
second finger with the thumb on the bottom of the bottle. Press several
times firmly and quickly until a fine spray appears (up to 7-8 strokes).
Important: Point the spray safely away when priming it. Do not prime it
near children or pets.
3) Insert the spray tip into one nostril, pointing the top towards the back
of the nose. Press firmly and quickly. Give a spray into the other nostril.
4) Put on the protective cap
On commencing treatment the patient uses the spray to treat craving as
required, subject to a limit of one spray to each nostril twice an hour.
Each spray delivers 0.5 mg of nicotine, about half of which is absorbed.
The daily limit of use is 32mg of nicotine (64 sprays) which is the
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equivalent of two sprays to each nostril every hour for 16 hours.
For 8 weeks the patient uses the spray as required, subject to the
maximum described above, to relieve craving.
After this period the patient reduces usage until after 4 more weeks
treatment has ended. It is suggested that after 2 weeks into this period
usage will have been reduced by a half and usage be zero by the last
day.
The patient should understand the aim of decreasing the use of the
spray to make a final break with nicotine at the end of the course, and
also accept that for the first few days of the course nasal irritation may
be unpleasant.
Legal
Classification
Storage
Maximum period of treatment: 12 weeks per intervention
GSL
No special temperature conditions. Should be stored protected from
light.
Specific written • Read and adhere to product information leaflet that accompanies
and verbal
NRT product
advice to client • Warn of possible local effects but also that these tend to lessen
within a few days.
• Warn patient that the bottle may need priming before use
• Advice on correct use of spray
• The nasal spray should not be used whilst the user is driving or
operating machinery as sneezing and watering eyes could contribute
to accidents.
• Spray products may exacerbate symptoms of Gastro-intestinal
disease.
• This product must only be used in combination with other NRT
products under the advice of a healthcare professional i.e. nurse,
midwife, doctor
• Not recommended for those with nasal problems e.g. polyps, nose
bleeds
• Bronchial asthma: A few cases of exacerbation of brochospasm in
patients with bronchial asthma have been reported. Use of the spray
in patients with hyperreactive airways is not recommended
• Refer to cautions and contraindications category listed in 3.4 and 3.5.
Specific side
effects
4.8
Nose and throat irritation, nosebleeds, watering eyes, ear sensations,
dizziness, coughing, sneezing
(See SmPC. for full list of side effects.)
Mouth Spray
Brand(s), dose,
pack size,
duration,
Nicorette QuickMist
Mouth spray – 1 mg spray
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directions for
use/frequency
of
administration
150 sprays per bottle
2- 4 bottles
This spray is a colorless to light yellow solution with a scent of
peppermint. If you are using mouth spray for the first time or if you have
not used the spray for 2 days, you must first prime the spray pump.
Priming:
1. Point the spray safely away from you and any other adults, children or
pets that are near you.
2. Press the top of the spray with your index finger 3 times until a fine
spray appears.
Note: priming reduces the number of sprays you may get from the
spray.
Directions: After priming, point the spray nozzle as close to the open
mouth as possible. Press the top of the dispenser and release one spray
into your mouth, avoiding the lips. Do not inhale while spraying to avoid
getting spray down your throat. For best results, do not swallow for a
few seconds after spraying.
Use 1 or 2 sprays when cigarettes normally would have been smoked or
if cravings emerge. If after the first spray cravings are not controlled
within a few minutes, a second spray should be used. If 2 sprays are
required, future doses may be delivered as 2 consecutive sprays.
Most smokers will require 1-2 sprays every 30 minutes to 1 hour.
You may use up to 4 sprays per hour. Do not exceed 2 sprays per
dosing episode and 64 sprays (4 sprays per hour over 16 hours) in any
24-hour period.
Use the following weaning down process:
•
Weeks 1-6: 1-2 sprays when you would normally smoke a cigarette
or have cravings to smoke (use the second spray if your cravings are
not reduced within a few minutes)
For many smokers this means 1-2 sprays every 30minutes to 1 hour.
• Week 7-9: Start reducing the number of sprays per day
By the end of week 9 you should be using HALF the average
number of sprays per day that you used in weeks 1-6
•
Week 10 -12 Continue reducing the number of sprays per day so
that you are not using more than 4 sprays per day during week 12
Maximum period of treatment: 12 weeks per intervention
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Legal
Classification
Storage
GSL
Specific written
and verbal
advice to client
•
Do not store above 25°C
•
•
Read and adhere to product information leaflet that accompanies
NRT product
The patient should not eat or drink when administering the spray
The mouth spray contains small amounts of ethanol (alcohol), less
than 100 mg per spray
•
Care should be taken not to spray the eyes whilst administering the
mouth spray
•
Warn patient that the bottle may need priming before use
•
Advice on correct use of spray
•
Specific side
effects
Oral products may exacerbate symptoms of Gastro-intestinal
disease.
• Refer to cautions and contraindications category listed in 3.4 and
3.5.
Dysgeusia (distortion of taste), headache, Pre syncopal symptoms (light
headiness), dizziness, paraesthesia (tingling sensation) hiccups, nausea
and vomiting symptoms, dyspepsia, constipation. Oral soft tissue pain
and paraesthesia, stomatitis, salivary, cough, naso -pharyngistis,
hypersecretion, burning lips, dry mouth, gingival bleeding. Increased
frequency of apthous ulcer (which also can be an effect of stopping
smoking),
(See SmPC. for full list of side effects.)
4.9 NiQuitin Strips
Brand(s), dose,
pack size,
duration,
directions for
use/frequency
of
administration
NiQuitin Strips
2.5mg
Directions: NiQuitin Strips are suitable for smokers who have their first
cigarette of the day more than 30 minutes after waking up. Place one
film on the tongue. Close the mouth and press the tongue gently to the
roof of the mouth until the nicotine film dissolves (approximately 3
minutes). The film should not be chewed or swallowed whole.
Users should not eat or drink while a nicotine film is in the mouth.
Behavioural therapy, advice and support will normally improve the
success rate.
Suitable for :
Adults (18 years and over):
Adolescents (12-17 years) if abrupt cessation
Use the following weaning down process:
Abrupt cessation of smoking:
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Recommended treatment schedule:
Step 1 - Weeks 1 to 6 Initial treatment period
1 nicotine film every 1 to 2 hours
Step 2 - Weeks 7 to 9 Step down treatment period
1 nicotine film every 2 to 4 hours
Step 3 -Weeks 10 to 12 Step down treatment period
1 nicotine film every 4 to 8 hours
During weeks 1 to 6 it is recommended that users take a minimum of 9
films per day. Users should not exceed 15 films per day.
Those who have quit smoking but are having difficulty discontinuing
using NiQuitin Strips are recommended to seek additional help and
advice from a healthcare professional.
Maximum period of treatment: 12 weeks per intervention
Legal
Classification
Storage
Specific written
and verbal
advice to client
Specific side
effects
GSL
Do not store above 30°C Store in the original; package to protect from
light and moisture
• Read and adhere to product information leaflet that accompanies
NRT product
• Oral products may exacerbate symptoms of Gastro-intestinal
disease.
• Refer to cautions and contraindications category listed in 3.4 and
3.5. Note patients with unstable angina, severe cardiac arrhythmias or
uncontrolled hypertension should be excluded from treatment.
(See SmPC. for full list of side effects.)
Vomiting, dyspepsia, upper abdominal pain, diarrhoea, dry mouth,
constipation, hiccups, stomatitis, flatulence, oral discomfort. nausea
headache*, dizziness
*(May also be due to withdrawal symptoms following smoking
cessation)
Specific Categories
5.1 Adults:
•
•
5.2 Children:
•
For clients aged 16 and over NRT can be used as described on
the product depending on their Nicotine dependence and
product specification.
Certain factors, including gender, pregnancy and oral
contraceptives, can affect the rate at which a smoker
metabolises nicotine. This may have implications for the choice
and strength of pharmacotherapy required. (NHS Stop
Smoking Services: and Monitoring Guidance 2010/11,
2011/12)
NRT is not licensed for use in those under 12 years of age.
For Children aged 12 to 15 NRT is licensed for use. If being
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5.3 Pregnant women
issued to this age group without an adults support the child
must understand the full impact of the treatment and be
competent to consent to treatment.
• To ensure competency is assessed appropriately 12-15 year
olds must be assessed using the departmental guidelines and
additional consent form for 12-15 year olds, see appendix K.
• Mono/single therapy NRT should not be given for a period
longer than 12 weeks to 12-18 year olds.
(Report of the committee on Safety of Medicines working group
on Nicotine Replacement Therapy, 2006)
• Combination therapy can be offered for children aged 12-15,
following a comprehensive assessment. However
combination therapy should not last for longer than a
period of 8 weeks.
Tobacco users who are pregnant or breastfeeding and are unable
to stop smoking without the use of NRT is supported by NICE
guidance (, 2010).
The process for dealing with pregnant women is as follows:
• Behavioural support as a first line of treatment for those who
have never tried to stop smoking, and ideally they should try to
give up smoking without using NRT.
•
NRT can be used if above is unsuccessful. Oral products are
the first line of treatment for these women (but not liquorice
flavoured products). Intermittent oral products are
recommended as they give the foetus a break from nicotine.
However it is well documented that many pregnant women will
experience nausea and will not be able to tolerate oral NRT
products.
•
If oral products are unsuccessful or can not be tolerated due to
nausea, 16 hour patches can be used, but not a 24 hour patch.
(NICE Public Health Guidance 10: Smoking Cessation
Services 2008)
•
If mono therapy is unsuccessful, or clients have a high
fagerstrom dependency score, combination therapy can be
offered to pregnant women.
•
Fast metabolism of nicotine from NRT products means that
some quitters will need higher doses to control their cravings
and other withdrawal symptoms. This is especially relevant to
pregnant smokers who may need higher doses of NRT but may
be concerned or cautious about using it. Where appropriate,
stop smoking advisors should advise pregnant women to use
NRT in line with the product specification but should be
especially careful about this client group under-dosing or
stopping the treatment early. (NHS Stop Smoking Services:
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and monitoring guidance 2010/11, 2011/12).
•
THE 25MG PATCH can be used in combination but only where
the client has been assessed as having a high nicotine
dependence or experiencing cravings as described above.
•
In the third trimester nicotine has haemodynamic effects (e.g.
changes in foetal heart rate) which could affect the foetus close
to delivery. Therefore Nicotinell lozenge should not be used in
pregnancy
Note: many pregnant women who access the service will have
taken some of the steps above before their appointment; this
should be taken into account at the initial assessment.
5.4 Combination
Therapy
Always ensure the risks/benefits of stopping smoking have been
discussed in full and consent form for treatment has been
completed.
Combination therapy should also be considered for those:
a) Who have failed to quit previously using NRT and
behavioural support.
b) For those who show a high level of dependence on nicotine.
(NICE Public Health Guidance 10: Smoking Cessation
Services 2008).
“A combination of NRT products (combination therapy) has been
shown to have an advantage over using just one product. It is also
considered cost-effective. NHS stop smoking service should
therefore routinely offer clients combination therapy wherever
appropriate” (NHS Stop Smoking Services – Service and
Monitoring Guidance 2010/2011 2011/12).
Combination therapy is supported by NICE and National
Guidelines. NICE recommends combination of nicotine patches
and a form of oral NRT. Good practice would suggest a high dose
of one form of NRT and a low dose of the second product. (NICE
Public Health Guidance 10: Smoking Cessation Services 2008,
Last modified November 2013).
Nasal spray: This product must only be used with other NRT
products under the advice of a healthcare professional.
5.5 Side effects of
NRT
These are usually transient but could include the following (some
of which are the result of stopping smoking),
• nausea,
• dizziness,
• headaches,
• cold and flu like symptoms, fatigue
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•
•
•
•
•
•
•
•
•
•
5.6 Interactions
palpitations, tachycardia
dyspepsia and other gastro-intestinal disturbances,
hiccups,
insomnia,
vivid dreams,
myalgia (muscle pain),
Asthenia (pins and needles)
chest pain,
blood pressure changes,
anxiety, nervousness and irritability, and impaired
concentration,
• dysmenorrhoea (painful menstruation).
Clients taking Clozapine and/or Theophylline are
excluded from this Protocol.
If a patient stops smoking certain hepatic enzymes may
decrease. This may result in slower clearance of some
medications and resulting high serum levels of these
drugs. The following medications may be affected and
lower doses of these medications may be needed to
achieve the same effect.
• Antipsychotics, and antidepressants
• Insulin
• Warfarin
NB – if a client were to start smoking/increase level of
smoking again this could have the reverse effect and
higher doses of these medications may be needed
Advisors will undertake the health questionnaire with each client,
and identify any contraindication or cautions in the protocol and act
accordingly. However once a voucher is issued the designated
pharmacist working under the terms and conditions of the voucher
system, has a responsibility to check for contraindications and
assess suitability of proposed product for the patient.
(Regional protocol for supply of nicotine replacement therapy via a
voucher 2011).
5.7 Follow up
The risks associated with the use of NRT are substantially
outweighed in virtually all circumstances by the well-established
dangers of continuing smoking.
• The client will receive individual tailored support i.e. one-toone, group support, telephone support, self-help booklet,
text or email.
• The client will have an initial assessment; using approved
clinical records and be recommended an NRT product as
appropriate.
• The client will be offered weekly support for the first 4/5
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5.8 Advice /
warnings to patient
•
•
•
•
•
•
•
•
5.9 Clients who use
Shisha pipes
•
•
weeks, and then fortnightly up to 12 weeks. Pregnant
clients will be followed and supported until they are
postnatal.
• Regular contact will be maintained to ensure abstinence
and check correct use of product. No further NRT will be
issued if the client is still smoking, unless the client is
motivated to set a new quit date and restart the programme.
• A maximum of 2 weeks NRT will be recommended at any
one time.
• Only in exceptional circumstances will more than 2 weeks
supply of NRT be recommended. In these circumstances
the reasons must be clearly documented in the records. A
letter explaining this request will also need to be completed
and given to the client to present with the voucher at the
pharmacy. A copy of the letter is to be filed in the records.
See appendix M
• Suspected adverse reactions should be reported to a
clinical manager in order to seek advice. A review of the
treatment should be undertaken to establish if the patient
should continue the treatment or referral to the GP if
appropriate. The manager will help to complete the
Committee on Safety of Medicines Yellow Card scheme
and document in the client’s records.
• A copy of the completed Yellow Card should be forwarded
to the Partnership Trust’s Clinical Governance Pharmacists.
• Adverse reactions can be reported via the website:
www.yellowcard.gov.uk
Advise on correct use of product
Advise to dispose of used nicotine products safely away from
children.
Advise the client to check the date of expiry of medication
supplied.
Advise clients not to share NRT with any other individual.
Highlight to client if any adverse reactions to product occur, to
cease use of the product and contact the service/GP/NHS
Direct for further advice.
Advise clients not to smoke when using NRT.
Check that the patient has relevant information on how to use
the product.
Ensure consent form has been explained to client and signed.
See appendix K.
Shisha smokers who also smoke cigarettes can be seen
and assessed under the protocol on the basis that their NRT
dependency and subsequent dosage is ascertained according
to their cigarette smoking patterns only, i.e. number of
cigarettes smoked per day, time from waking to smoking first
cigarette.
For sole Shisha users: they can be seen by the service for
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behavioural support only. As there is no identified process for
assessing these clients for medication support and as NRT
products have not been tested, or licensed for use in sole
shisha smokers there are no recommendations as to
usage/dosage.
•
Therefore sole shisha users can access the service for
behavioural and CO monitoring support only. They cannot be
given any medication to stop shisha smoking; for example
NRT.
5. Training and Competency
6.1 Training for
CWPT employees
Staff need to complete training which is accredited to Level 2
National Centre for Smoking Cessation Training (NCSCT).
Online training modules are also available for those supporting
pregnant women and clients with mental health issues.
Staff should have access to supervision in their clinical settings.
Maintaining their skills and competencies. Staff will be assessed
via 12 monthly PDR and competency assessment. Evidence of
competence will be collected in the staff members KSF portfolio.
Staff new to the trust who have been performing the skills
elsewhere, will need to be familiar with the Trust’s policy and
standards of care by a recognised trainer/assessor. Evidence of
previous education and training will be required. Managers need
to ensure staff have access to the protocol and are trained in its
use.
Line managers need to ensure that appropriate education,
supervision and personal development reviews are in place to
ensure safe practice. A record of training will be kept for audit
and standard purposes.
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6.2 Competency
6.3 Performance
Requirements
Knowledge of the range of NRT products available
• Knowledge of contraindications and cautions when using the
product
• Knowledge of gaining consent
• Knowledge of potential side effects or excess NRT
• Knowledge of how to use all NRT products
• Knowledge of the treatment of pregnant women and drug
specific considerations
• Understanding of combination therapy
• Knowledge of 12-15 year old drug specific considerations and
additional consent
• Understanding of advice and follow up information to be given
to clients
• Knowledge of infection control policies.
• Knowledge of potential sources of infection and actions to
minimise the risks
• Knowledge of decontamination of CO monitors
• Knowledge of policies and procedures relating to record
keeping, storage and confidentiality
• Knowledge of accurate and timely data inputting into Quit
Manager Database
• Ability to case load clients with timely interventions and follow
up procedures, and manage clinics accordingly.
• Able to assess patients’ needs and nicotine dependence
• Able to prepare the patient both physically and psychologically
for smoking cessation
• Able to obtain consent
• Able to encourage and answer questions
• Able to assemble and prepare CO monitor
• Able to decontaminate CO monitor
• Able to carry out procedure according to Trust guidelines
• Able to observe infection control measures thoroughly
• Able to respond to any adverse reactions/complications and
report and inform the appropriate health profession/lead
• Able to dispose of equipment and waste material in a safe and
correct manner
• Able to complete appropriate documentation
6. Record Management
7.1 Patient Clinical
Records
Record keeping should be in accordance with Coventry and
Warwickshire Partnership Trust Policies and Procedures for
Records Management and will include:• Name of the protocol being followed
• Generic name, strength and dose of drug
• Route, site and frequency of administration
• Amount recommended
• Date
• Information supplied to the patient
• The stop smoking records must be used and completed in
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7.2 Non-clinical
record keeping
•
•
7.3 Subcontractors
who deliver under
the protocol
•
•
•
•
full including fagerstrom, motivational questions, full medical
questionnaire, consent and carbon monoxide level. Details
of each intervention must be recorded, including justification
for type of NRT programme chosen and follow up
arrangements.
Child health records will be retained until their 25th birthday
or 26th if the young person was aged 17 at conclusion of
treatment. If the illness could have potential relevance to
adult conditions, the advice of clinicians should be sought as
to whether the records should be retained for a longer
period.
Adult health records will be retained for 8 years following
completion of treatment. All records will be archived and
destroyed under confidential conditions. This is in-line with
CWPT Records Management Policy.
Subcontractors who have signed up to the protocol require
the same level of training, supervision and management.
This will be the responsibility of the organisation they are
employed by and who have signed up to the terms and
conditions of the contract for the provision of stop smoking
services.
Subcontractors will be offered support by the CWPT Healthy
Lifestyle team in relation to level 2 training, six monthly
updates, and activations in practice.
Subcontractors are expected to adapt record keeping
policies and procedures that meet NHS guidance and
standards, with particular emphasis on confidentiality and
correct storage of client records. Record management
policies should also be adhered to as identified in section 7.
Competency and performance issues identified in 6.2 and
6.3 should be applied.
7. Equality
CWPT recognises the diversity of the local community and those in its employ. Our
aim is therefore to provide a safe environment free from discrimination and a place
where all individuals are treated fairly, with dignity and appropriately to their need.
CWPT recognises that equality impacts on all aspects of its day to day operations
and has produced a Single Equality Scheme to reflect this. This protocol is a clinical
guideline for a specific and predefined clinical population, and therefore deemed not
to require formal equality impact assessment. However the trust confirms that this
protocol is driven by clinical factors, and does not differentiate purely on age,
disability, gender, race religion or belief, sexual orientation, gender reassignment, nor
discriminate against human rights, unless clinical or pharmaceutical safety dictates
All policies and procedures are assessed by completion of an equality impact
assessment.
8. Data Protection
Clinical Protocol for the Recommended Supply of
Version 8
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 28 of 50
The Data Protection Act 1998 protects personal data (for a definition and more
information see the Data Protection Policy), which includes information about staff,
patients and carers. Unlawful of unfair processing of personal data may result in
CWPT being in breach of its Data Protection obligations.
9. Freedom of Information
Any information that belongs to CWPT may be subject to disclosure under the
Freedom of Information Act 2000. From the 1 January 2005, the Freedom of
Information Act 2000 allows anyone, anywhere to ask for information held by CWPT
to be disclosed (subject to limited exemptions). Further information is available in the
Freedom of Information Act 2000 Policy.
10. Development
10.1 Versions developed by:
Version
1
Lead person(s)
Natalie Hutton
Job title
Tobacco Control &
Stop Smoking
Services Lead
2
Natalie Hutton
Lifestyles service
Manager
3
Majella
Johnston
Stop smoking in
pregnancy Coordinator and Service
Manager
Hayley Sparks
Lifestyle Primary
Care Team Manager
David Tait
Chief Pharmacist
4
Hayley Sparks
Lifestyle Services
Manager
5
Cathy Hamilton
Senior Lifestyle
Advisor
Majella
Johnston
Stop Smoking in
pregnancy
Coordinator
Stop Smoking in
pregnancy
6
Majella
Johnston
Clinical Protocol for the Recommended Supply of
Version 8
Date
Feb 2009
Place of work
Coventry Stop
Smoking Service,
Coventry &
Warwickshire
Hospital
April 2010 Coventry Stop
Smoking Service,
Coventry &
Warwickshire
Hospital
November Healthy Lifestyle
2011
Services, Coventry
and
Warwickshire
Hospital
Medicines
Management,
Wayside House.
November Healthy Lifestyle
2012
Service, Coventry
and Warwickshire
Hospital Site
Feb 2014
Healthy Lifestyle
Service, Coventry
Feb 2014 and Warwickshire
Hospital Site
April 2015
Healthy Lifestyle
Service, Coventry
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 29 of 50
Coordinator
7c
Majella
Johnston
Stop Smoking in
pregnancy
Coordinator
Nov 2015
and Warwickshire
Hospital Site
Healthy Lifestyle
Service, Coventry
and Warwickshire
Hospital Site
11. Review date
This clinical procedure will be reviewed by the clinical lead in May 2017, or prior to
this if there are additional national guidelines/evidence or any other circumstances
such as changes in clinical practice
12. Monitoring compliance
Monitoring of the use of Clinical Protocols is a requirement of the NHS Litigation
Authority. It is the responsibility of the Lead Professional for the procedure to ensure
that appropriate audits are undertaken within each service / department in month 6
and 18 Months following approval. The audit should cover the implementation,
application and compliance of the policy, procedure or guidance.
The results of audits must be sent to the Clinical Audit Officer within one month of the
audit.
Dates for audit are: December 2016
13.Discipline:
Breaches of this policy will be investigated and may result in the matter being treated
as a disciplinary offence under CWPT disciplinary procedure.
14. Clinical Protocol Approved by:
Chief Pharmacist
Name
David Tait
Lifestyle Services
Manager
Majella Johnston
Chair of Drugs and
Therapeutic committee
Jane Hill
Clinical Protocol for the Recommended Supply of
Version 8
Signature
Date
Signature redacted, original
held by Medicines
Management
Signature redacted, original
held by Medicines
Management
Signature redacted, original
held by Medicines
Management
26.05.16
26.05.16
06.06.2016
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 30 of 50
15. References
British National Formulary Online, Accessed on 14th April 2016 BNF 65
Committee on Safety of Medicines – Medicines and Healthcare products Regulatory
Agency (12 June 2013) Report of the committee on safety of medicines working
group on nicotine replacement therapy
Coventry and Warwickshire Partnership Trust (2014) Record Keeping Policy
Coventry and Warwickshire Partnership Trust (2014) Consent to Treatment policy
Coventry and Warwickshire Partnership Trust (2015) Hand Decontamination Policy
Coventry and Warwickshire Partnership Trust (2015) Medicines Policy
Coventry and Warwickshire Partnership Trust (2015) Waste Management Policy
Department of Health (2005) Mental Capacity Act
The Welfare Reform Act 2012 (Commencement No. 13 and Transitional and
Transitory Provisions) Order 2013. Family Law Reform Act (1969)
Gillick v West Norfolk & Wisbech Area Health Authority [1985] 3 All ER 402 (HL).
National Institute for Health and Care Excellence (2013) Harm-reduction apprto
smoking
National Institute for Health and Care Excellence (2013) Smoking cessation in
secondary care: acute, maternity and mental health services (PH48)
National Institute for Health and Care Excellence (2010) Smoking: stopping in
pregnancy and after childbirth (PH26)
National Institute for Health and Care Excellence (2008) Smoking Cessation
Services, NICE public health guidance 10 (last modified: November 2013)
guidance.nice.org.uk/ph10
NHS Stop Smoking Services: Service and monitoring guidance 2010/2011
2011/2012
Protocol for Supply of Nicotine Replacement Therapy via Voucher 2011
Clinical Protocol for the Recommended Supply of
Version 8
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 31 of 50
NHS Centre for Smoking Cessation and Training 2013
www.ncsct.co.uk/
Clinical Protocol for the Recommended Supply of
Version 8
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 32 of 50
Appendix A - Template for Staff Register
Protocol Name:
Recommended Supply of Nicotine Replacement Therapy to clients aged 12 and over
Version: 4
The staff listed below have signed to acknowledge that they have read this clinical procotol in full, have received appropriate
training and updates and are competent to use it.
Full Name
Designation
Clinical Protocol for the Recommended Supply of
Version 8
Date competency
gained
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 33 of 50
Date of
signing
Signature
Appendix B – Version Control Sheet
Version
1
2
3
3
3.1
4
5
7
7c
Date
Feb 2009
April 2010
July 2011
October
2011
February
2012
February
2013
Feb 2014
May 2015
Author
Natalie Hinsley
Natalie Hinsley
Majella Johnson &
Hayley Sparks
Majella Johnson &
Hayley Sparks
Majella Johnson &
Hayley Sparks
Status
Approved
Approved
Draft 1
Comment
Draft 2 Approved
Draft 1 –
approved by
CPAG
Submitted to November CPAG for comments /
approval
Submitted to February CPAG for approval.
Hayley Sparks
Cathy Hamilton
Majella Johnston
Hayley Sparks
Majella Johnston
Majella Johnston
Clinical Protocol for the Recommended Supply of
Version 8
Submitted to David Tait for comments
Submitted to February D&T committee for approval
Approved
Submitted to May D&T for approval
Approved
Submitted to May D&T for approval
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 34 of 50
Appendix C - NRT Voucher Form
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 35 of 50
Medical Questionnaire
Name……………………………………..................................
DOB………………………………………………………………
For the supply of NRT Voucher
under protocol
NHS number.………………………………………….…………
CONTRAINDICATIONS: The following clients CANNOT have NRT under the protocol
Is the client
Under 12 years of age?
Yes
No
Taking Buproprion (Zyban) or Varenicline (Champix)
Yes
No
Any known serious reaction to nicotine?
Yes
No
Suffered a heart attack in last 4 weeks
Yes
No
Unstable angina
Yes
No
Undergone heart surgery in last 4 weeks
Yes
No
Been treated for an irregular heart beat
Yes
No
Had a stroke or mini stroke in the last 4 weeks
Yes
No
Taking Clozapine (Clozaril, Denzapine or Zaponex)
Yes
No
Taking Theophyline
No
Yes
(Also known as: Dimethylxanthine Nuelin SA, Slo-phylin, Uniphylin Continus,
Aminophylin, or Phyllocontin Continus)
If YES to any of
these questions,
NRT should not
be given on a
voucher and must
be prescribed by
a doctor
Please send
contraindications
letter to GP
Please send
medications letter
to GP
For Behavioural
support only
Assessment for suitability for NRT under the protocol
• Is the client under 16 years of age?
• If yes have you assessed competency and Consent according to
department guidelines?
Contraindications for Patches only
• Serious reaction to NRT patches previously?
Yes
(If client has had a reaction or skin condition such as Eczema,
Chronic Dermatitis, Psoriasis & Urticeria other products may
be more suitable)
Contraindications for Nasal Spray only
• Chronic nasal disorder * If yes advise on other NRT
Yes
product
CAUTIONS UNDER PROTOCOL
Pregnant/breast feeding
• NRT can be used if client has tried unsuccessfully
without
• Preferably use behavioural support first followed by oral
products (not liquorice flavour)
• If experiencing nausea -16 hour Patch can be used if
unable to tolerate oral products.
• Combination therapy can be given as per protocol
Does the client have a history of liver problems?
Does the client have a history of kidney problems?
Does the client have a history of thyroid problems?
Does the client have a history of epilepsy?
Does the client have a history of seizures?
Does the client have a history of phaeochromocytoma? (Tumor
affecting the adrenal medulla)
Does the client have a history of active peptic ulcer disease
(stomach ulcers)? (Oral products may worsen this condition; ensure the
Yes
Yes
No
No
No
Not applicable
No
Not applicable
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
Yes
Yes
No
No
Not applicable
client is aware, patch may be more appropriate)
Is the client taking any of the following medications?
• *Insulin?
• *Warfarin?
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 36 of 50
•
*Propranolol?
Yes
No
Insulin dependent Diabetic? – Client needs to be advised to
monitor blood sugar levels more closely when stopping smoking.
Yes
No
*Mental Health drug medications including antidepressants,
antipsychotics or anxiety medications?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
If YES to any of the above, please send cautions letter to
GP
*If clients DNA, please send letter informing GP as
medications may have been changed.
Does the client have Phenylketonuria (PKU, an inability to
metabolise an essential amino acid). If yes, do not give lozenges
and microtabs.
Does the client need to follow a low sodium diet? If yes, please
avoid lozenges.
Does the client have bronchial disease? If yes, please avoid
nasal spray and inhalator
Has the client received support from any of the following mental
health services in the last few months – Community health team,
assertive outreach team, early intervention, crisis intervention,
home treatment team?)
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 37 of 50
Appendix E - Dosage and Method of Administration of NRT
Products
Suggested prescribing for two-week nicotine replacement therapy (NRT) supply
May 2016
Brand
2-week supply/use. If combination therapy is to be
given please note that the second product (oral)
should be lower strength/amounts
Please contact your line manager if you have any
concerns regarding clients and the use of NRT
products.
Specific
side
effects
For individuals who smoke 20 or more cigarettes a day start with 21mg.
Up to 12 week course: 21mg for 3-4 weeks, 14mg for 3-4 weeks and 7mg for 3-4
weeks.
For individuals who smoke less than 20 cigarettes a day start with 14mg.
Up to 8 week course: 14mg for 3-4 weeks and 7mg for 3-4 weeks.
Skin Reactions.
Discontinue use
if severe.
Abnormal
dreams – remove
patch before bed.
Nicorette 16-hour
Invisi patch
Semi-transparent
patch
For individuals who smoke 10 or more cigarettes a day start with 25mg.
12 week course: 25mg for 8 weeks, 15mg for 2 weeks and 10mg for 2 weeks.
For individuals who smoke less than 10 cigarettes a day start with 15mg.
12 week course: 15mg for 8 weeks and 10mg for 4 weeks.
Skin Reactions.
Discontinue use
if severe.
NiQuitin 24-hour
patch*
For individuals who smoke 10 or more cigarettes a day start with 21mg.
10 week course: 21mg for 6 weeks, 14mg for 2 weeks and 7mg for 2 weeks.
For individuals who smoke less than 10 cigarettes a day start with 14mg.
8 week course: 14mg for 6 weeks and 7mg for 2 weeks.
Skin Reactions.
Discontinue use
if severe.
Abnormal
dreams – remove
patch before bed.
Chew one piece slowly for 30 minutes (using chew and rest technique) when there
is an urge to smoke.
For individuals smoking 20 cigarettes or less consider initiating 2mg.
For individuals smoking more than 20 cigarettes consider initiating 4mg.
For individuals who are highly dependent smokers (> 20 cigarettes per day).
particularly to those requiring enhanced craving relief compared to 4mg gum
the 6 mg gum can be recommended
For those using the 6 mg Gum, switching to the 2 or 4 mg Gums may be helpful
when stopping treatment or reducing the number of gums used each day.
Throat irritation.
Increased
salivation.
Hiccups. Jaw
muscle ache.
Nicotinell
24-hour patch*
Beige patches
*Not to be used in pregnancy.
Beige or clear
patches
*Not to be used in pregnancy.
Nicorette
2mg/4mg/6mg
Average use 8 - 12 pieces per day. Max use 15 pieces per day
When daily use is 1-2 gums, product should be stopped.
Use for up to 12 weeks.
Nicotinell 2mg/4mg
gum
liquorice*,*not to be used
in pregnancy
NB Nicotinell gum is sugar
free
NiQuitin 2mg/4mg
gum
Chew one piece slowly for 30 minutes (using chew and rest technique) when there
is an urge to smoke
The 4 mg chewing gum is intended to be used by smokers with a strong or very
strong nicotine dependency i.e. at least above 20 cigarettes per day and those who
have previously failed to stop smoking with the aid of nicotine replacement therapy.
The 2mg dose is intended for those who have a low to moderate dependency on
nicotine i.e. less than 20 cigarettes daily.
Average use 8 - 12 pieces per day. Max use 25 pieces x 2m g /15 pieces x 4mg per
day.
Use for up to 12 weeks.
Chew one piece slowly for 30 minutes (using chew and rest technique) when there
is an urge to smoke.
NiQuitin 4 mg Mint Gum is suitable for smokers who have their first cigarette of the
day within 30 minutes of waking up. The 2mg dosage is appropriate for those who
have their first cigarette more than 30 minutes after waking.
Sufficient gums should be used each day, usually 8 12, up to a maximum of 15 for
either product.
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 38 of 50
When daily use is 1-2 gums, product should be stopped. Use for up to 12 weeks.
Nicotinell 1mg/2mg
lozenge*
* Do not issue Lozenges to
under 18 – Not licensed to use
*Not to be used in pregnancy
Not recommended for
individuals on low sodium diet
or who have phenylketonuria
(PKU)
SUGAR FREE
Nicorette Cools
Lozenge
2 and 4 mg
* Do not issue Lozenges to
under 18 – Not licensed to use
Not recommended for
individuals on low sodium diet
or who have phenylketonuria
(PKU)
NiQuitin 2mg/4mg
lozenge*
* Do not issue Lozenges to
under 18
Not recommended for
individuals on low sodium diet
or who have phenylketonuria
(PKU)
SUGAR FREE
NiQuitin 1.5mg/4mg
Minis Lozenges
SUGAR FREE
Nicorette microtab
2mg
*Not recommended for
individuals who have
phenylketonuira ( PKU)
Nicorette inhalator
15mg
*Patients with obstructive lung
disease may find use of the
inhalator difficult, use in
caution with patients who
have chronic throat disease.
Lozenge needs to be sucked until taste is strong and then parked between gum
and cheek to dissolve. When taste fades, sucking recommences.
Nicotinell Mint 2 mg lozenge is intended to be used by smokers with a strong or
very strong nicotine dependency i.e. at least smoking over 20 cigarettes per day,
and those who have previously failed to stop smoking with the aid of nicotine
replacement therapy. Low to medium dependency smokers are recommended to
try 1mg dose (less than 20 cigarettes per day).
Average use 8 -12 pieces per day.
Week 1-6: One lozenge every 1-2 hours on urge to smoke.
Week 7-9: Reduce to one lozenge every 2-4 hours.
Week 10-12: Reduce to one lozenge every 4-8 hours.
Max use 30 pieces x 1mg /15 pieces x 2mg per day.
Use for up to 12 weeks.
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. You should not chew or swallow
the lozenge. You should not eat or drink while a lozenge is in the mouth
Nicorette Cools 2 mg Lozenge is suitable for smokers who smoke 20 or less
cigarettes per day. The 4 mg Cools Lozenge is suitable for smokers who smoke
more than 20 cigarettes per day. Nicorette Lozenge should be used whenever the
urge to smoke is felt or to prevent cravings in situations where these are likely to
occur. Most smokers require 8 to 12 lozenges per day, not to exceed 15 lozenges.
Throat irritation.
Increased
salivation.
Hiccups.
A tapering down dose following the recommended schedule is advised:
One lozenge every 1-2 hours in week 1-6
Then one lozenge every 2-4 hours weeks 7-9
Reducing down to 1-2 a day by week 12.
Use for up to 12 weeks
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
For individuals who do not have the urge to smoke within 30minutes of waking;
consider initiating on 2mg lozenge. For those who need to smoke within 30 minutes
of waking; consider 4mg lozenge.
Average use up to week 6 – minimum 9 pieces per day. Max use 15 pieces per day
Week 1-6: One lozenge every 1-2 hours on urge to smoke.
Week 7-9: Reduce to one lozenge every 2-4 hours.
Week 10-12: Reduce to one lozenge every 4-8 hours.
Use for up to 12 weeks.
1.5mg - Suitable for smokers who smoke 20 cigarettes or less a day. 4mg - Suitable
for smokers who smoke 20 cigarettes or more a day.
Lozenge should be placed in mouth to dissolve, periodically, the lozenge should be
moved from one side of the mouth to the other, and repeated, until the lozenge is
completed dissolved.
Continue to use for up to 6 weeks to break the habit of smoking and gradually
reduce lozenge use. When daily use is 1-2 lozenges, use should be stopped.
Average use 8-12 pieces per day. Max use 15 pieces per day. Use for up to 12
weeks.
Nausea.
Hiccups.
Flatulence.
Gastro
disturbance.
Vomiting.
Less than 20 cigarettes 1 tablet per hour. More than 20 cigarettes 2 tablets per
hour. Most smokers require 8-12 or 16 to 24 tablets per day. Max use 40 tabs per
day
Use for up to 8 weeks to break the habit of smoking, then gradually reduce the dose
over a 4 week period
Stop treatment when only 1-2 tablets are taken each day. Use for up to 12 weeks
Throat irritation.
Unpleasant taste.
Smokers should replace all their cigarettes with the Inhalator.
Cough.
Headache.
Throat irritation.
Rhinitis.
Pharyngitis.
Stomatitis.
Indigestion.
Directions: Use 3-6 cartridges daily for up to 8 weeks. Then reduce the dose to 1-3
cartridges over the next 2 weeks, and then reduce the dose to 0 over the final 2
weeks.
Maximum number of inhalator cartridges per day is 6.
Each cartridge can be used for approximately eight 5-minute sessions, with each
cartridge lasting approximately 40 minutes of intense use. The more the subject is
able to use the inhalator, the easier it will be to quit smoking completely.
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 39 of 50
Nicorette nasal spray
10ml
*Not to be used in
Combination treatment by a
non-registered health care
professional, or for individuals
who have chronic nasal
disorders/bronchial asthma
Nicorette QuickMist
mouth spray
13.2ml
Frequency of use is dependant on level of nicotine addiction.
The daily limit of use is 32mg of nicotine (64 sprays) which equates to two sprays to
each nostril every hour for 16 hours per day, for a period of 8 weeks.
Reduce usage by half over next 2 weeks, and then withdraw totally after further 2
weeks. Max use 64 sprays per day. Use for up to 12 weeks
NB the bottle may need priming before use
Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings
emerge. If after the first spray cravings are not controlled within a few minutes, a
second spray should be used. If 2 sprays are required, future doses may be
delivered as 2 consecutive sprays.
Most smokers will require 1-2 sprays every 30 minutes to 1 hour.
You may use up to 4 sprays per hour. Do not exceed 2 sprays per dosing episode
and 64 sprays (4 sprays per hour over 16 hours) in any 24-hour period.
Weeks 1-6: 1-2 sprays when you would normally smoke a cigarette or have
cravings to smoke (use the second spray if your cravings are not reduced within a
few minutes)
For many smokers this means 1-2 sprays every 30minutes to 1 hour.
Week 7-9: Start reducing the number of sprays per day
By the end of week 9 you should be using HALF the average
number of
sprays per day that you used in weeks 1-6
Week 10 -12 Continue reducing the number of sprays per day so that you are not
using more than 4 sprays per day during week 12
Maximum period of treatment: 12 weeks per intervention
need priming
NiQuitin Oral Strips
2.5mg
Note patients with unstable
angina, severe cardiac
arrhythmias or
uncontrolled hypertension
should be excluded from
treatment.
Oral soft tissue
pain and
paraesthesia,
stomatitis,
salivary
hypersecretion,
burning lips, dry
mouth, gingival
bleeding
NB: bottle may
NiQuitin Strips are suitable for smokers who have their first cigarette of the day
more than 30 minutes after waking up. Place one film on the tongue. Close the
mouth and press the tongue gently to the roof of the mouth until the nicotine film
dissolves (approximately 3 minutes). The film should not be chewed or swallowed
whole.
Users should not eat or drink while a nicotine film is in the mouth.
Behavioural therapy, advice and support will normally improve the
success rate.
Suitable for :
Adults (18 years and over):
Adolescents (12-17 years) if abrupt cessation
Use the following weaning down process:
Vomiting,
dyspepsia, upper
abdominal pain,
diarrhoea, dry
mouth,
Constipation,
hiccups,
stomatitis,
flatulence, oral
discomfort.
nausea
headache*,
dizziness
Abrupt cessation of smoking:
Recommended treatment schedule:
Step 1 - Weeks 1 to 6 Initial treatment period
1 nicotine film every 1 to 2 hours
*(May also be
due to withdrawal
symptoms
following
smoking
Step 2 - Weeks 7 to 9 Step down treatment period
1 nicotine film every 2 to 4 hours
Step 3 -Weeks 10 to 12 Step down treatment period
1 nicotine film every 4 to 8 hours
During weeks 1 to 6 it is recommended that users take a minimum of 9
films per day. Users should not exceed 15 films per day.
Those who have quit smoking but are having difficulty discontinuing
using NiQuitin Strips are recommended to seek additional help and
advice from a healthcare professional.
Maximum period of treatment: 12 weeks per intervention
Coventry Stop Smoking Service, CWPT, NHS Coventry © Jan 2016
Clinical Protocol for the Recommended Supply of
Version 8
Nasal irritation
Nose bleeds
Running nose
Sneezing
Watery eyes
Headache
Coughing
Dysgeusia
(distortion of
taste), headache,
dizziness/light
headiness ,
paraesthesia
(tingling
sensation)
hiccups, nausea
and vomiting
symptoms,
Indigestion.
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 40 of 50
cessation)
Appendix F - Referral to GP for NRT due to contraindications.
C
NHS number: ______/_______/_____
Coventry Healthy Lifestyles Service
Paybody Building
City of Coventry Health Centre
Coventry and Warwickshire Hospital Site
2 Stoney Stanton Road
Coventry
CV1 4FS
Tel: 024 76 961590
Fax: 024 76 961591
www.covwarkpt.nhs.uk
Date:
Clients name and address:
DOB:
Telephone:
Dear Dr
A consultation with the above client who is attending stop smoking services, has
indicated that Nicotine Replacement Therapy is contra-indicated under our service
protocol, and therefore I am unable to supply a product. I believe a clinical opinion is
required due to the following reason/condition that the client has highlighted:
_____________________________________________________________
However during the consultation, the client indicated that they would like to try the
product below to support their quit attempt.
_____________________________________________________________
If appropriate please provide supply in order to cover the first 2 weeks of their quit
attempt.
Nicotine Replacement Therapy is usually used for 8-12 weeks. If the client remains
abstinent when returning to the service to receive behavioural support and CO
monitoring a further 2 weeks supply will be requested.
Name of advisor:
Contact telephone number:
Signature:
Jagtar Singh – Chair
Simon Gilby - Chief Executive
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 41 of 50
Referral to GP for continued NRT due to contraindications
NHS number: ______/_______/_____
Coventry Healthy Lifestyles Service
Paybody Building
City of Coventry Health Centre
Coventry and Warwickshire Hospital Site
2 Stoney Stanton Road
Coventry
CV1 4FS
Tel: 024 76 961590
Fax: 024 76 961591
www.covwarkpt.nhs.uk
Clients name and address:
DOB:
Telephone number:
Dear Dr
A follow-up appointment with the above client has indicated that they are still
abstinent from smoking. However, under the current service protocol I am unable to
supply due to the following reason/condition that the client highlighted.
As you have supported their quit attempt to date please prescribe a further 2 weeks
supply of:
I will continue to offer behavioural support and CO monitoring to the client. If the
client remains abstinent I will request a further prescription from you. Nicotine
Replacement Therapy is usually used for 8-12 weeks of a smoker’s quit attempt.
Name of advisor:
Contact telephone number:
Signature:
Jagtar Singh – Chair
Simon Gilby - Chief Executive
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 42 of 50
Appendix G - Referral to GP for clients taking Clozapine or Theopylline
Medications
NHS number: ______/_______/_____
Coventry Healthy Lifestyles Service
Paybody Building
City of Coventry Health Centre
Coventry and Warwickshire Hospital Site
2 Stoney Stanton Road
Coventry
CV1 4FS
Tel: 024 76 961590
Fax: 024 76 961591
www.covwarkpt.nhs.uk
Date:
Clients name and address:
DOB:
Telephone number:
Dear Dr
A consultation with the above client, who is attending stop smoking services, has indicated that
Nicotine Replacement Therapy is contra-indicated under the services protocol.
This is due to recommendations in national guidance that dosage levels for certain drugs should be
measured, monitored and reduced as appropriate before, during and after smoking cessation.
Therefore I am unable to give a supply of NRT. I believe a clinical opinion is required due to the
patient taking the following medication:
_____________________________________________________________
However, a consultation with the above client indicated that they would like to try the product below to
support their quit attempt, whilst also receiving behaviour support from the stop smoking service.
_____________________________________________________________
If appropriate and when time scales allow please provide supply in order to cover the first 2 weeks of
their quit attempt.
Nicotine Replacement Therapy is usually used for 8-12 weeks. If the client remains abstinent when
returning to the service to receive behavioural support a further 2 weeks will be requested.
Please note that if the client starts smoking again their medication may need to be reviewed again,
thus we will inform you if this client defaults from the service or fails in their quit attempt.
Name of advisor:
Contact telephone number:
Signature:
Jagtar Singh – Chair
Simon Gilby - Chief Executive
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
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Appendix H - Letter to GP for clients on programme and in caution category:
Date:
NHS number: ______/_______/_____
Coventry Healthy Lifestyles Service
Paybody Building
City of Coventry Health Centre
Coventry and Warwickshire Hospital Site
2 Stoney Stanton Road
Coventry
CV1 4FS
Tel: 024 76 961590
Fax: 024 76 961591
www.covwarkpt.nhs.uk
Clients name and address:
DOB:
Telephone number:
Dear Dr
A consultation with the above client has resulted in enrolment on the stop smoking service
providing both behavioural support and Nicotine Replacement Therapy.
However I have noted that this client has the following condition: and/or are taking the
following medication/s:
Conditions:
Medications:
Diabetes/Thyroid problems/Kidney
problems/Liver problems/
Phaeochromocytoma/Pregnancy/ is breast
feeding/Peptic ulcer disease
History of Seizures or taking anti Convulsant
therapy (please circle)
Insulin/Propranolol/Warfarin/Mental health
drugs: including drugs for depression, anxiety
antipsychotics, anti Convulsant therapy
(please circle)
These conditions are listed by the service as
a caution and our protocol therefore requires
us to inform their GP that NRT has been
commenced.
For the medications highlighted above it may
be necessary to make a dose adjustment as
smoking increases the metabolism of these
medications.
Please note that if the client starts smoking
again their medication may need to be
reviewed again, thus we will inform you if this
client defaults from the service or fails in their
quit attempt.
Nicotine Replacement Therapy is usually used for 8-12 weeks. If the client remains abstinent
when returning to the service to receive behavioural support, a further 2 weeks of NRT will
be supplied, and this will be ongoing until the programme has been completed.
Please contact us if you have any queries.
Name of advisor:
Contact telephone number:
Signature:
Jagtar Singh – Chair
Simon Gilby - Chief Executive
Clinical Protocol for the Recommended Supply of
Version 8
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 44 of 50
Appendix I - Referral to GP to Review Medication Subsequent to Failed Quit
Attempt
NHS number: ______/_______/_____
Coventry Healthy Lifestyles Service
Paybody Building
City of Coventry Health Centre
Coventry and Warwickshire Hospital Site
2 Stoney Stanton Road
Coventry
CV1 4FS
Tel: 024 76 961590
Fax: 024 76 961591
www.covwarkpt.nhs.uk
Date:
Clients name and address:
DOB:
Telephone:
Dear Dr
I am writing regarding the above clients stop smoking attempt with Coventry Healthy Lifestyle
Service.
Unfortunately due to this patients non attendance / continuing to smoke. I need to advise you
that a previous letter may have caused you to adjust some of the clients medications due to
stopping smoking, and this may now need reviewing.
If you have any queries please contact me on the number shown below.
Name of advisor:
Contact telephone number:
Signature:
Jagtar Singh – Chair
Simon Gilby - Chief Executive
Clinical Protocol for the Recommended Supply of
Version 8
Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 45 of 50
Appendix J – Letter to Pharmacist: Reason for Excess of 2/52 Supply
NHS number: ______/_______/_____
Coventry Healthy Lifestyles Service
Paybody Building
City of Coventry Health Centre
Coventry and Warwickshire Hospital Site
2 Stoney Stanton Road
Coventry
CV1 4FS
Tel: 024 76 961590
Fax: 024 76 961591
www.covwarkpt.nhs.uk
Date………………….
Dear Pharmacist
Due to the requirements of the West Midlands Nicotine Replacement Therapy
voucher scheme, I am informing you that I have issued two vouchers for two weeks
of nicotine replacement therapy products (total of 4 weeks) for this client because of
the following reason:
Client
Name………………………………………………………D.O.B.………………………….
Address.........................................................................................................................
.......................................................................................................................................
Post Code…………………….
Reason………………………………………………………………………………………
………………………………………………………………………………………………..
With regards
…………………………………….
Stop Smoking Advisor
Coventry Health Lifestyles Service
Jagtar Singh – Chair
Simon Gilby - Chief Executive
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
Page 46 of 50
Appendix K
Client Name: __________________________________
Database number: ___________
D.O.B. ___/ ___/______
NHS number: ______/__________/______
Consent Form for Stop Smoking Programme
(This section to be completed by advisor)
I have discussed the stop smoking programme in respect to
appointments and duration of support.……………………………………………………..
I have explained the protocol in respect to contra indications ….……………………
I have discussed stop smoking medications with the client in order to
establish the appropriate product…………………..……………………………………...
I have explained the health risks and benefits of the
medication…………………………
I have explained how to use the medication………………………………………………..
I have discussed possible side effects……………………………………………………..
I have given appropriate written materials………………………………………………….
Name of advisor (print) ….………………..…….Sign…..………..…………Date………..
(This section to be completed by the client)
I understand that this is a stop smoking programme and that I will set
a Quit Date and undertake Carbon Monoxide testing……………..………………………
I understand that I should take medications according to the
manufacturer’s instructions and stop smoking once taking
medications………………….
I have received clear instruction and written materials……………………………………
I agree that I will not give the medication to anyone else…………………………………
I agree to attend appointments with an advisor for the duration of the programme
and will call if unable to attend to re book………………………………………………….
I consent to the advisor passing information to my GP/Midwife/Health professional
and for the NHS stop Smoking Services to record my details on stop smoking
databases for monitoring, recording and audit purposes.………………………………
Signature of Client ……………………………………………...Date……...……………
Clinical Protocol for the Recommended Supply of
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12 -15 year olds - Additional Consent guidance
A health professional can proceed without the parents’ knowledge and consent IF:
1.
The young person understands the advice
(a) Does the client understand what the intervention entails?
*If NO - do not recommend medication, explain intervention and send client away with
follow up appointment to enable them to understand and digest information. Check
understanding at follow up appointment.
b)
Does the client understand the advice regarding complete abstinence?
Setting a quit date and stopping?
*If NO - explain our service is based around setting a quit date and stopping completely. If the
client is not ready to stop completely, provide relevant information e.g. and contact details, and
ask client to return when ready to stop completely.
c)
Does the client understand the advice regarding using medication and NOT smoking?
*If NO - do not issue medication and offer behavioural support.
*If YES - ask client to repeat advice back to you to check understanding and then document in
client notes and ask client to countersign your documented notes.
d)
Is the client motivated to stop smoking completely?
*If NO – explain our service is based around setting a quit date and stopping completely. If
client is not ready to stop completely, provide relevant information and ask client to return
when ready to stop completely. Discuss motivation levels and ask client to think about reasons
for stopping and what would improve their motivation.
If the clients understanding meets YES to all of above then you can be confident the young
person understands the advice. If you have any doubt regarding their understanding of advice
do not proceed with intervention
2.
The young person cannot be persuaded to inform their parents
a) Have you discussed with the client if their parents or trusted adult e.g. teacher know they
smoke?
*If YES – encourage the client to inform their parent/trusted adult and support their
appointments within clinic
*If NO – the client is not required to inform a parent or trusted adult
b) Have you discussed and encouraged the client to inform their parents that they smoke and
they wish to stop smoking and use medication (NRT) to support their quit attempt?
Think about NRT that may be discreet or not used at all times if they need to ensure their
parents do not find out. Do not issue full dosage of NRT (dependent on smoking behaviour).
There is flexibility to issue 1 week at a time. Ensure client is aware of only using
recommended amount, not utilising above daily amount and not smoking whilst using NRT.
Ask client to countersign once you have discussed with them.
3.
4.
5.
The young person is likely to smoke anyway.
The young person’s physical and mental health would suffer.
The young person’s best interests require it.
Check the young person has an understanding of the risks of smoking and the importance of
quitting. They also understand it is in their best interests to use NRT as they are more likely to
quit smoking.
Ensure above discussions are documented in clients notes and medical assessment sheet
completed accordingly.
June 2011
Clinical Protocol for the Recommended Supply of
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Nicotine Replacement Therapy (NRT) to Clients Aged 12 and Over
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UNDER 16’s Competent Statement and Additional Consent
Name of Client …………….……………..……… DOB………….….Age ……………
Database Number…………...…NHS number………………………………..................
I ………………………………………..(Name of Practitioner) am satisfied that:•
He/she understands the advice being given.
•
He/she could not be persuaded to tell his/her parents themselves or permit a health
professional to do so.
•
Unless he/she receives the advice or treatment his/her physical or mental health or
both are likely to suffer.
•
His/her best interests require the advice, treatment or both without parental consent.
I have determined that he/she is competent to consent to this episode of advice
or treatment.
Signed: ……………………………..…
Print Name:
…………………………………….
Designation: …………………………………………….. Date... …………………………..
OR
I have determined that he/she is not competent to consent to this episode of
advice or treatment
The reasons
are...…………………...................................................................................……………
……..………………………………………………………………………………………….
Signed: ……………………………..……. Print Name:
……………………………………..
Designation: …………………………………………….. Date...
……………………………
___________________________________________________________________
To be signed by Client
I confirm that the above issues have been discussed with me.
(Signed by young person)………………………….………………
Date……………………
Clinical Protocol for the Recommended Supply of
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Appendix L – Abbreviations List
Abbreviations used within this document:
BNF
CO
CPAG
CPCT
GP
GSL
NICE
NRT
PDP
SPC
DNA
British National Formulary
Carbon Monoxide
Clinical Policies Approval Group
Coventry Teaching Primary Care Trust
General Practitioner
General Sales List
National Institute for Clinical Excellence
Nicotine Replacement Therapy
Personal Development Plan
Summary of Product Characteristics
Did Not Arrive
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