patient group direction for the supply of varenicline ... · pdf file(champix ®) by...

Title:

NHS Scotland Patient Group Direction for the supply of varenicline ▼ (Champix ®) by authorised community pharmacists working in Scotland

Identifier: NHSG/PGD/varCP/MGPG655 Replaces: Across NHS Boards

Organisation Wide

Directorate Clinical Service Sub Department Area

Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author’s representative. Author: NHS Scotland, adapted for NHSG by PGD pharmacist,

Pharmacy and Medicines Directorate Subject Patient Group Direction Key word(s): PGD patient group direction varenicline Champix pharmacist Policy application: NHS Grampian Purpose: This Patient Group Direction (PGD) authorises appropriately

qualified and trained pharmacist to supply of varenicline ▼ (Champix ®) to individuals without the requirement for a patient specific prescription written by a medical practitioner.

Responsibilities for implementation: Organisational: Chief Executive and Management Teams Corporate: Senior Managers Departmental: Heads of Service/Clinical Leads Area: Line Managers Hospital/Interface services:

Assistant General Managers and Group Clinical Directors

Operational Management Unit:

Unit Operational Managers

Policy statement: It is the responsibility of individual pharmacists and their line

managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence.

Review: This policy will be reviewed at least every two years or sooner if

current treatment recommendations change.

UNCONTROLLED WHEN PRINTED Review Date: May 2016 Identifier: NHSG/PGD/varCP/MGPG655 - i - NHS Scotland PGD For The Supply Of Varenicline▼ (Champix ®) By Community Pharmacists Working In Scotland - Version 1

NHS Scotland Patient Group Direction For The Supply Of Varenicline▼(Champix ®) By Authorised Community

Pharmacists Working In Scotland Contents Page No

General Policy

2-3

Patient Group Direction For The Supply Of Varenicline

4-7

Appendix 1 - Health Care Professional Agreement To Supply Medicines Under Patient Group Direction

8

Appendix 2 - Certificate Of Authorisation To Supply Medicines Under Patient Group Direction

9

Appendix 3 - Treatment Plan

10

Appendix 4 – Varenicline Clinical Risk Assessment Form

11

Appendix 5 - Letters To GP

12

Appendix 6 - Notification Of Supply Of Varenicline To Patient Through Community Pharmacy

13

UNCONTROLLED WHEN PRINTED Review Date: May 2016 Identifier: NHSG/PGD/varCP/MGPG655 - 1 - NHS Scotland PGD For The Supply Of Varenicline▼ (Champix ®) By Community Pharmacists Working In Scotland - Version 1

General Policy For Community Pharmacist Supplying Varenicline▼ (Champix®) Supply of varenicline Varenicline may be supplied as part of the National Public Health Service (PHS) contract to support quit attempts where the pharmacist has completed the Patient Group Direction (PGD) training relevant to this product. The monthly payments associated with supply in this way will be made through the national scheme. Varenicline must be supplied using a CPUS prescription. Varenicline is second line to NRT. In order for a client to be considered for varenicline, the client must have tried NRT on more than one occasion for a reasonable time period and have had support from a recognised stop smoking service. Varenicline must be supplied along with weekly support. The client must be assessed for varenicline suitability before being signed up to the scheme. The client must be appraised of the need for them to provide medical information to allow the pharmacist to make an informed assessment of the suitability of the client to receive varenicline. The client should be informed of the risks and benefits of using varenicline to support a smoking cessation attempt in order that the client can make an informed decision. If the GP has to be contacted due to the patient’s medical history, in some cases there may be a delay is starting the client on varenicline and the patient should be informed of this. Accredited Pharmacists • Varenicline may only be supplied by an accredited pharmacist. Medicine

counter staff must be trained to refer each request for varenicline to that pharmacist. The pharmacist must have successfully completed training approved by NES Pharmacy or the local health board.

Approved Premises • The service can only be provided in an approved pharmacy, which must have a

suitable area for consultation with patients. This should be a consultation room (or quiet area within the pharmacy if a room is not available).


Indemnity The pharmacist must ensure that the organisation that provides their professional indemnity has confirmed that this activity will be included in their policy. Patient Confidentiality General Medical Council statement: “Patients are entitled to expect that the information about themselves or others which a doctor learns during the course of a medical consultation, investigation or treatment, will remain confidential. Any explicit request by a patient that information should not be disclosed to particular people, or indeed to any third party, must be respected save in the most exceptional circumstances, for example where the health, safety or welfare of someone other than the patient would otherwise be at serious risk” Pharmacists and their staff must respect this duty of confidentiality and information should not be disclosed to any third party without the client’s consent. Clinical Support The accredited pharmacist will not be working in isolation and must feel confident to refer to other sources of information and support services including Smoking Cessation Services and the patient’s GP. Adverse Drug Reaction (ADRs) Varenicline is a relatively new drug and thus carries a black triangle (▼). The Medicines and Health Products Regulatory Agency (MHRA) asks that all suspected reactions (including those not considered to be serious) are reported through the Yellow Card Scheme. An adverse reaction should be reported even if it is not certain that the drug has caused it, or if the reaction is well recognised, or if other drugs have been given at the same time. Report ADRs on line at: www.yellowcard.gov.uk


http://www.yellowcard.gov.uk/

Patient Group Direction For The Supply Of Varenicline▼(Champix ®) By Authorised Community Pharmacists

Indication Clients accessing the pharmacy smoking cessation service who have tried to stop through a recognised service using NRT with motivational support.

Inclusion Criteria

• Dependent smoker (i.e. they smoke within 30minutes of waking up and /or find quitting unaided difficult) identified as sufficiently motivated to quit

• Clients over 18 years of age • The client agrees to receive behavioural support according to the

agreed protocol • A full medical history is taken and documented and there are no

contraindications or cautions for treatment with varenicline (see criteria for exclusion and referral)

• No indication on the PMR that the patient is unsuitable for varenicline

Exclusion Criteria

• Smokers not sufficiently motivated to quit • Client under 18 years of age • Pregnant or breastfeeding women • Sensitivity to varenicline or any of its excipients • Moderate to severe renal impairment (use with caution in elderly

patients) • End-stage renal disease • Not to be used in conjunction with other smoking cessation

therapies • PMR indicates that the patient is unsuitable for varenicline

Referral criteria and Precautions

Pharmacists should refer clients (Appendix 5) to their GP for clinical assessment when client is considered eligible for varenicline but precautions are applicable • Patients with a history of serious psychiatric illness such as

schizophrenia, bipolar disorder and major depressive disorder. • Previous psychiatric illness where pharmacotherapy or

psychotherapy had been given • Epilepsy • Patient on theophylline or warfarin or insulin This may include any of the conditions referred to above or previously unrecognised co-morbidities

Caution Patients on insulin may be supplied with varenicline. However patients should be advised to monitor their blood glucose level closely


Action if patient declines

Discuss alternative products if suitable and/or offer a referral to the Specialist Smoking Cessation service for further assessment

Action if Included Supply varenicline (Champix®) 500 mcg and 1mg tablets.

Action if excluded Refer to GP or Specialist Smoking Cessation Service

Details of treatment course

Drug name

Varenicline ▼ (Champix®) Tablets

Strength and form 500 mcg and 1mg film coated tablets

Route Oral

Legal status PoM Prescription-only Medicine Black Triangle ▼

Dose(s) Days 1 - 3: 500 mcg (white tablets) once daily Days 4 – 7: 500 mcg tablets twice daily Day 8 to the end of the treatment: 1mg (blue tablets) twice daily for 11 weeks. (Reduce to 500 mcg twice daily if not tolerated) Maximum single dose 1mg Maximum daily dose 2mg Client should set a date to stop smoking. Client should start taking varenicline 1-2 weeks before this date. Tablets should be swallowed whole with plenty of water and can be taken with or without food Patients who cannot tolerate the adverse effects of varenicline may have the dose lowered temporarily or permanently to 500 mcg twice daily.

Treatment regime 1st consultation (Assessment) Client should set a quit date between the next 8-14 days. Supply 14 day starter pack (11 x 500 mcg tabs with 14 X 1mg tablets) Set a formal quit date between one and two weeks after starting varenicline Take a carbon monoxide (CO) reading 2nd Consultation (before quit date) Confirm quit date. Monitor carbon monoxide reading. Supply 1mg varenicline tablets as required.


3rd consultation (First follow up). Monitor carbon monoxide reading and confirm abstinence. Supply varenicline tablets as required. (Refer to Appendix 1) Subsequent consultations Supply varenicline tablets if patient has stopped smoking and carbon monoxide reading confirms abstinence. (Refer to Appendix 3) Final consultation (week 10 – 12) Discuss coping strategies when the support service finished. Supply varenicline tablets (if required) if patient has stopped smoking and carbon monoxide reading confirms abstinence. (Refer to Appendix 3)

Drug Interactions No clinical meaningful drug interactions have been reported. Since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline and therefore a dose adjustment of varenicline would not be required.

Side Effects • Nausea • Sleep disorders/ abnormal dreams • Headache • Appetite changes • Dry mouth /taste disturbances • Drowsiness • Dizziness For less common side effects please refer to BNF

Advice and Support • Advice to clients should include specific product advice on dosage, method of administration and side effects

• If client experiences any extreme side effects they should seek medical advice - Varenicline should be discontinued immediately if agitation,

depressed mood or changes in behaviour that are of concern for the pharmacist, patient’s family or caregiver are observed or if the patient develops suicidal thoughts or suicidal behaviour

• The major reasons for varenicline failure are: - Unrealistic expectations; - Lack of preparation for the fact that tablets may cause nausea; - Insufficient support from trained smoking cessation advisor

• It is important to make sure that the client understands the following points: 1. Varenicline is not a magic cure: effort and determination are

crucial 2. Varenicline works by acting on the parts of the brain which are

affected by the nicotine in cigarettes 3. Varenicline does not remove all the temptation to smoke, but it

does make abstinence easier (it takes the edge off the


discomfort by reducing the severity of tobacco withdrawal symptoms such as craving to smoke, irritability, poor concentration and low mood)

4. Varenicline is safe, but about a third of clients may experience mild nausea usually about 30 minutes after taking it. This reaction often diminishes gradually over the first few weeks, and most patients tolerate it without problems;

The following general advice should also be given: • Follow-up and obtaining further supplies • Possible changes in the body on stopping smoking e.g. weight gain • Effects on driving or using machinery • Patient on insulin should monitor blood glucose closely • At the end of treatment, discontinuation of varenicline has been

associated with an increase in irritability, urge to smoke, and/or insomnia in up to 3% of patients. The pharmacist should inform the patient accordingly

Informed Consent Clients must be informed that information relating to the supply of varenicline under a PGD needs to be passed to other health service organisations in particular their GP and NHS Scotland to ensure proper record keeping and patient safety.

Records

• Patient’s name, address, date of birth and GP details; • Date supplied and name of the pharmacist who supplied the

medication; • Reason for inclusion; • Advice given to patient; • Details of any adverse drug reaction and actions taken including

documentation in the patient’s medical record via GP; • Since varenicline is a ‘black triangle drug’ all adverse reactions

should be reported to the MHRA using the ‘Yellow Card’ reporting system

• The varenicline clinical risk assessment form should be completed for each client and retained in the pharmacy for a minimum of 3 years.

References

• British Nation Formulary (BNF) • Summary of Product Characteristics (SPC) for Champix®.

www.emc.medicines.org.uk. National Institute for Health and Clinical Excellence. Varenicline for smoking cessation. NICE technology appraisal 123, July 2007.

• Medicines and Health Product regulatory Agency (MHRA) safety alert: November 2008


http://www.emc.medicines.org.uk/

Appendix 1

Health Care Professional Agreement To Supply Medicines Under Patient Group Direction

I:

(Insert name)

Working within:

Pharmacy name

I agree to act as an approved practitioner within the terms of the Patient Group Direction and proforma and to supply accordingly within the following Patient Group Direction NHS Scotland Patient Group Direction for the supply of varenicline ▼ (Champix ®) by authorised community pharmacists working in

Scotland

• I have successfully completed the training which community pharmacists must complete before being authorised to supply varenicline under the relevant Patient Group Direction. • I enclose a NES certificate of completion for varenicline training. • I agree to maintain my clinical knowledge appropriate to my practice by attending relevant study days and courses and will make myself aware of appropriate current literature. • I confirm my indemnity insurance covers my scope of practice. • I understand that by agreeing to act as an approved practitioner under the Patient Group Direction and service level agreement I am adjusting my scope of professional practice. Signed:

Print Name:

Date:

GPhC Registration No:


Appendix 2

Certificate Of Authorisation To Supply Medicines Under Patient Group Direction This authorises:

Working within:

e.g. CHP, Practice To supply medicines under the following Patient Group Direction

NHS Scotland Patient Group Direction for the supply of varenicline▼(Champix ®) by authorised community pharmacists

working inScotland

The above named person has satisfied the training requirements and is authorised to supply medicines under the above Patient Group Direction and agreed profprmas. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed:

Director of Pharmacy

Print Name:

Date:



Appendix 3 Treatment Plan

onsultations

Treatment plan

C

1st week- Assessment eek

Client should set a quit date between the next 8-14 days. Supply 14 day starter pack (11 x 500 mcg tabs with 14 X 1mg tablets) *Make arrangement to see client again before tablets run out i.e. between days 10- 14

w

3rd week Client should have set a quit date. Monitor carbon ing, he/she should

be informed that treatment with varenicline would have to be stopped if he/she continued to smoke.

monoxide level. If client is still smok

Supply 1mg varenicline tablets if required. Make arrangement to see client the following week

4th- 12th week Monitor carbon monoxide level and check if client has

If side effects are tolerable then continue supplying varenicline 1mg tablets as required. If client is troubled by side effects assess whether they are tolerable or whether supply should be stopdiscuss the option to dose tapeof stopping varenicline after 12 weeks of treatment. Note: A 14 day starter pack (11 x 500 mcg tabs with 14 x 1mg tabs) can be supplied for the last two weeks of treatment. Ensure the patient has clear instructions to take the tablets in the starter pack in reverse

stopped smoking. If client is still smoking, treatment with varenicline should be stopped. If client has quit smoking supply 1mg varenicline tablets as required.

ped. Here you may at week 10 with aim r

order n.

to facilitate tapered discontinuatio

Appendix 4

Version 1

Pharmacist Varenicline Clinical Risk Assessment Form

Factor Yes No Notes

Pharmacy Stamp Client name: Address:

Telephone number: irth: e & address:

Date of bGPs nam

Is client under 18 years of age

Is client pregnant or breastfeeding?

Does client suffer from renal impairenal disease?

rment or has end stage

D(P

oes client have a history of psychlease refer to PGD)

iatric illness

Does client suffer from epilepsy?

Is client currently on another smoki cessation therapy?

ng

Is client on any other medication?

Is client hypersensitive to varenicli

ne or any of its excipients?

Special circumstances and any other relevant notes: Only make a supply if you are certain that to the best of your knowledge, it is appropriate to do so. Action taken: Supply: Referral to: Advice given:

The above information is correct to the best of my nowledge. I have been counselled on the use of arenicline and understand the advice given to me y the pharmacist.

Client’s signature: Date:

The action specified was based on the information given to me by the client, which, to the best of my knowledge, is correct Pharmacist’s signature: Date:

kvb

UNCONTROLLED WHEN PRINTED Review Date: May 2016 Identifier: NHSG/PGD/varCP/MGPG655 - 11 - NHS Scotland PGD For The Supply Of Varenicline▼ (Champix ®) By Community Pharmacists Working In Scotland -

Appendix 5


CONFIDENTIAL: Data protection confidentiality note: T e is intended only for the use of the individual or entity to whom it is addressed and may contain information that is privileged, confidential and exempt from disclosure under law. If the reader of this message is no nt, you are hereby notified that any dissem , distribution or copying of this communica ted.

Date: GP nam GP Address:

The followin at this pharmacy for support to help them stop smoking. Please advise suitable to receive varenicline, for up to 12 weeks, to help in their quit smoking attempt. The client has previously used NRT unsucc other attempt to quit smoki g.

Date of birth

Last 4 digits of CHI number (if known) Their c

10 or ore than 30 (Cigarettes or cigarette equivalents per day) Client declaration: I agree to the pharmacy passing on this information to my GP in order to determine my clinical suitability to receive varenicline. Client signature: Date: This fo-----------------------------------------------------------------------------------------------------------------------------------------

NHS Grampian R erral To Suitability

For Supply Of Varenicline By Community Pharmacists ef General Practitioners For Assessment Of Client Clinical

his messag

t the intended recipietion is strictly prohibiination

Pharmacy stamp

DD / MM / YY

e:

g client has registered if you consider this client clinically

essfully and is motivated for an n

NamAddress:Postc Or cli

e:

ode:

ent name and address label

N / N / N / N I DD / MM / YY

urrent tobacco use is:- fewer 11 – 20 21 – 30 M

rm should be sent to the client’s GP.

DD / MM / YY

FOR GENERAL PRACTICE USE ONLY Clien __________________________ I have assessed the risks and benefits for the above client and consider that they are NOT SUITABLE to re king c I hav patierecei ssat

* Please tick appropriate box

General Practitioner signature Print name Date

t Name:____

ceive varenicline for 12 weeks to support a smo

assessed the risks and benefits for the abovee varenicline for 12 weeks to support a smoking ce

essation quit attempt. *

nt and consider that they ARE SUITABLE to ion quit attempt. *

ev

DD / MM / YY

Appendix 6


patient group direction for the supply of varenicline ... · pdf file(champix ®) by...

Documents