Ref No:
STANDARD OPERATING PROCEDURE (SOP)
Varenicline ▼ (Champix®) Voucher
SECTION 1
Version
Date
Draft 1
20/2/14
Author
Simon Lister
Stop Smoking Service
Manager
Committee Ratified by
Drug and Therapeutics
Committee
Status
Comment
Issue Date
Review date
1/4/2014
1/4/2015
1. Purpose
The purpose of this SOP is to enable the issuing of a voucher for the supply of
Varenicline ▼ (Champix®) to appropriate clients attending the Doncaster and
Rotherham Smoke Free Services (DRSFS).
The rationale for supplying products via a voucher is to provide greater access
to Varenicline ▼.
2. Scope
This SOP covers all specialist and advisor staff working for the DRSFS to
issue Varenicline ▼ vouchers.
Only clients receiving stop smoking support from the DRSFS may be issued
with a Varenicline voucher. Clients must meet the support with medication
criteria (see appendix 1).
3. Applicable Regulations and Policies
I.
Smoking cessation services in primary care, pharmacies, local
authorities and workplaces, particularly for manual working groups,
pregnant women and hard to reach communities (NICE 2008). Visit:
http://publications.nice.org.uk/smoking-cessation-services-ph10
4.
II.
Local Stop smoking Services: Service delivery and monitoring
guidance 2011/12. (Department of Health 2011). Visit:
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/docum
ents/digitalasset/dh_125939.pdf
III.
SWYPFT Patient Identification Policy.
Who will Undertake the Procedure
All specialist and advisor staff working for the DRSFS who have completed
the services Intermediate Training.
The DRSFS Service Manager is responsible for holding/monitoring a training
log.
5.
I.
II.
Procedure
Check the client’s identification in accordance with the Trust’s Identification Policy
and against the record on Quitmanager (if available).
Check the client’s eligibility against the inclusion criteria, vouchers will only be
issued to clients who meet all of the inclusion criteria below. Please note: it is
the dispensing pharmacist’s responsibility to complete the
inclusion/exclusion criteria and client consent sections of the voucher and
the pharmacist carries the legal responsibility for the supply of Varenicline
under the PGD.
Varenicline ▼ Voucher Inclusion Criteria
Registered with a Doncaster or Rotherham General Practice
Attending a Doncaster and Rotherham Smoke Free Services clinic
Set a quit date.
Age 18 years or above
Consent has been obtained and recorded.
(Clients must be informed that information relating to the supply of
Varenicline under the PDG needs to be passed to other health service
organisations, in particular their GP and their local Smoke Free Service in
order to ensure proper record keeping and patient safety.)
III.
IV.
Check the client’s eligibility against the exclusion criteria on the voucher.
Vouchers must not be issued if the client meets (or is unable/unwilling to answer)
any of the exclusion criteria in the table below
Varenicline ▼ Voucher Exclusion Criteria
Person is aged under 18 years
Pregnant or breastfeeding women
The client has a history of:
Renal disease
Epilepsy
Sensitivity to Varenicline or any of its excipients
Psychiatric illness
V.
VI.
VII.
VIII.
Pack
Day
Dose
Titration pack
1-3
4-7
8-14
0.5mg (white tablets) once a day
0.5mg (white tablets) twice a day
1mg (blue) twice a day
Maintenance pack
15 to end of treatment
1mg (blue) twice a day
IX.
X.
XI.
XII.
XIII.
Discuss how to use Varenicline (i.e. explain how to use the titration and
maintenance packs/ that clients should plan to quit within 1-2 weeks of starting
Varenicline /each tablet should be swallowed whole with plenty of water and can
be taken with or without food)
Discuss possible side effects.
Advise the client to read the product information leaflet prior to commencement of
treatment.
Complete the first 3 sections of the voucher (see appendix 2), i.e. the client
details, the advisor details and whether the client requires the titration or
maintenance pack (see table below).
Supply per
voucher
(2 weeks)
11 tablets
14 tablets
28 tablets
Vouchers will be issued on a fortnightly basis to a maximum total of 12 weeks
(i.e. a maximum of 6 vouchers per client).
Issue the top 2 copies of the voucher (blue and yellow copies) to the client and
retain the bottom pink copy for record keeping purposes, vouchers cannot be
issued to a client representative.
Inform the client of the participating pharmacies where the voucher can be
redeemed (see attached list).
Record the voucher number/dose/quantity in the ‘session’ screen in
QuitManager.
Varenicline will be supplied under the supervision of a pharmacist in line with the
Varenicline PGD.
6. Side effects
Mild side effects include: nausea, vomiting, GI discomfort, diarrhoea,
dyspepsia, constipation, increased appetite, somnolence, flatulence,
dizziness, headache, drowsiness, dry mouth and fatigue
Severe side effects include chest pain, psychosis and suicide ideation. For
more detail on the potential side effects of varenicline visit the Electronic
Medicines Compendium at: http://www.medicines.org.uk/emc/default.aspx
The Latest MHRA safety bulletin gives the following advice for health
professionals:
• Patients and their family or care-givers should be made aware of the
possibility that trying to stop smoking might cause symptoms of depression.
• Patients who are taking varenicline who develop suicidal thoughts or
behaviour should stop their treatment and contact their doctor immediately.
• Varenicline should be discontinued immediately if agitation, depressed
mood, or changes in behaviour are observed that are of concern for the
doctor, patient, family, or caregiver.
• Patients with serious psychiatric illness did not participate in the
premarketing studies of varenicline, and the safety and efficacy of varenicline
in such patients has not been established. Care should be taken when
prescribing varenicline to patients who have a history of
psychiatric illness
(Please note: clients will a history of psychiatric illness are excluded
from the PDG)
For the full bulletin visit:
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON084736
7. Adverse Reaction Procedure
Compliance and adverse reactions will be monitored at the weekly follow-up.
Mild adverse reaction such as nausea will be recorded in the client record and
the client will be advised to stop taking Varenicline and to consider Nicotine
Replacement Therapy.
Severe adverse reactions such as suicide ideation will be recorded in the
client record and reported to the DRSFS Service Manager (or deputy)
immediately. The client will be advised to stop taking Varenicline
immediately. The Service Manager will investigate the incident and contact
the Mental Health Access Team (Rotherham – 01709 302670 OR Doncaster
01302 798400) for advice. The incident will be escalated through the Trusts
incident reporting system and reported to the clients GP
Staff will report any adverse reactions in accordance with the UK Adverse
Drug Reaction Reporting Guidelines (Yellow card system available at;
http://www.yellowcard.gov.uk/).
The MHRA recommend all adverse reactions to black triangle medications
should be reported.
8. Follow-up Advice
Clients will be seen by the Stop Smoking Advisor weekly for at least 4 weeks
after the quit date and by the pharmacist at each supply of Varenicline. Advise
the client to call the DRSFS (Doncaster 01302 640064 OR Rotherham 01709
422444) if they need advice in addition to the weekly visit.
Criteria for the stopping Varenicline treatment immediately:

The Client does not want to continue treatment.

The stop smoking advisor or pharmacist believes that Varenicline
treatment is no longer appropriate.

An absolute contra-indication is brought to light or develops.

The client develops agitation, depressed mood, suicidal thoughts or
other serious mood changes (client to be referred to GP for prompt
medical advice)

Side effect is so severe as to impair quit attempt
9. Supporting Materials
Varenicline Client Assessment Form (the voucher).
Access to Quitmanager
10. Definitions
Quitmanager is the Doncaster and Rotherham Smoke Free Services
dedicated electronic client record.