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G/TGH/HQSecs/TD/LS/Clinical procedures/Clozapine ICP. Community initiation. Version 2. Amended January 2015 1 of 22

Surname

Title Address

Forenames Date of Birth RT/NHS number

Care Co-ordinator GP

CPMS number

Consultant Allergies

One booklet to be completed for each patient initiated on clozapine treatment

Approved by the Horizon Scanning and Prescribing Guidance sub group 23 November 2012 Review date: 23 November 2015

Integrated Care Pathway (ICP)

for the

Management of clozapine

COMMUNITY INITIATION

Document Reference MM 049


Contents

Page

1 Pre-initiation phase of clozapine 3 - Checklist 2

Routine baseline assessment

4

3

Decision processes for initiation of clozapine

5

4

Rationale

5

5 Community initiation pathway 6

5.1 Titration

5.2 Monitoring and observations 6 Community initiation standard dose regime 7 7 Community initiation pathway observation record 8 – 11

Appendix 1

Clozapine initiation observations information 12

Appendix 2

Clozapine home treatment care plan 13 – 17

Appendix 3 Community initiation of clozapine treatment prescription Day 1 – 7

18


19


20


21


PRE-INITIATION PHASE 1 Pre-initiation phase of clozapine. A full description for the initiation of clozapine is given in the Summary of Product Characteristics (SPC) for ‘Clozaril®’. All staff involved in this process should familiarise themselves fully with these guidelines.

Pre-initiation checklist

YES

NO

Does the patient have a diagnosis of treatment resistant schizophrenia?

Has the patient been prescribed two previous antipsychotic agents, including a second generation antipsychotic, for a minimum of six weeks each?

Does the patient fulfil the criteria for other indications as per the SPC?

- Severe, untreatable neurological adverse reactions to other antipsychotic agents.

- Psychotic disorders occurring during the course of Parkinson’s Disease, where standard treatment has failed.

- Has there been a full multidisciplinary meeting to discuss initiation as per CPA policy (Consultant Psychiatrist, Care Co-ordinator and other interested/involved parties)?

Has the clinical team given consideration to the identified contra-indications to the use of clozapine?

Contraindications (SPC ‘Clozaril’ – Novartis Pharmaceuticals UK)

Patients unable to undergo regular blood tests.

History of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/ agranulocytosis from previous chemotherapy).

History of clozapine-induced agranulocytosis.

Impaired bone marrow function.

Uncontrolled epilepsy.

Alcoholic and other toxic psychoses, drug intoxication, comatose conditions.

Circulatory collapse and/or CNS depression of any cause.

Severe renal or cardiac disorders (e.g. myocarditis).

Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure.

Paralytic ileus.

Has the General Practitioner been contacted to determine any concurrent physical health concerns/investigations/treatments, and the use of any other prescribed medications as per Procedure for medicines reconciliation on admission of patients to hospital (MM 026)?

Clozapine treatment must not be started concurrently with drugs known to have a


substantial potential for causing agranulocytosis; concomitant use of depot antipsychotics is to be discouraged. PLEASE NOTE: If the answers to the questions above contraindicate the initiation of clozapine treatment, please refer to the following points:

• If the answers to the check list above are specifically contraindicated by the Clozaril Patient Monitoring System (CPMS) the patient must not be commenced on clozapine and must be referred back to the Consultant

• If there is a complexity issue or unlicensed use issue then a further multidisciplinary team (MDT) meeting is called, the issues are discussed and a decision made regarding inpatient or community initiation of clozapine.

2 Routine Baseline Assessment

Completed

Full medical and psychiatric history (including previous treatment concordance).

Physical examination: weight, height, pulse, blood pressure (sitting and standing), temperature, and waist circumference

Electrocardiogram

Blood tests

Full blood count

Differential white cell count

LFTs

U & Es

Lipids

TFTs

Random blood glucose

Troponin I or T

CRP

Medicines reconciliation – GP contacted to advise of all medications prescribed and any other physical health concerns/treatments

Substance history including alcohol, smoking, caffeine, illicit substances Details: -

COMPLETE BASELINE OBSERVATIONS using Community Initiation Pathway

Observation Record (Page 8).


3 Decision Processes for the initiation of clozapine

YES

NO

Patient agreeable to initiation of treatment?

Carers present?

Carers agreeable to support initial treatment regime?

Diagnosis confirmed?

Physical health acceptable?

Bloods taken and within acceptable ranges?

Consent obtained?

Decision to initiate treatment?

Inpatient initiation

Outpatient initiation

4 Rationale Concurrent processes prior to initiation of clozapine. Check that the following has been completed: -

Completed

Inform pharmacy department/ mental health pharmacist.

Inform CPMS and obtain registration number

Inform clozapine clinic of intention to treat

Inform General Practitioner (GP) (See GP support pack)


COMMUNITY INITIATION PATHWAY 5 Community initiation pathway

YES

NO

Patient is aware of the need for daily attendance/ home visit by Home Treatment (HT) Team?

A Clozapine Home Treatment Care Plan has been completed and is in place? (See APPENDIX )

GP has been informed of clozapine start date?

A carer/ relative should stay with the patient overnight and this has been agreed?

Contact numbers have been given? (HT Team, CPMS advice line, GP, Nurse on Block/ Wards)

The patient has a GREEN result from CPMS?

The Community Initiation of Clozapine Treatment Prescription Day 1 – 7 has been completed and dispensed by pharmacy ready for Day 1 [insert day of the week]?

An observation record has been completed and is in place?

5.1 Titration

Dependant on tolerability and results of physical observations, it may be necessary to slow down the titration regime in some cases.

5.2 Monitoring and observations.

• Complete Clozapine Initiation Observations (Appendix 1)

• Complete Community Initiation Pathway Observation Record (Page 8)

It is imperative that observations are undertaken when initiating clozapine in community settings as robustly as in inpatient settings. The team responsible for community initiation will stay with the patient for the 6 hours necessary to complete all observations. A review will be undertaken by the SHO/SHO on call/Advanced Practitioner. If observations are stable and following review, the patient can be at home with family/carer support with advice to contact HT Team/attend A&E/other if necessary and as appropriate. A Home Treatment Care Plan must be completed and in place before the patient returns home. (See Appendix 2). Please also refer to

• Guidelines for the monitoring of physical health for patients taking clozapine (MM 042)


6 Community Initiation Dose Regime. Pre-initiation checks complete and baseline assessments fully completed and ready to start on first day of initiation. This should always be Tuesday to take weekends into account for supplies of medication. The Advanced Practitioner/ SHO clerks in patient and takes initial blood samples to ensure a green blood result is obtained from CPMS before initiation begins. Result from CPMS. The dose and monitoring regime outlined below is a guide to treatment as recommended by the manufacturer of Clozaril, Novartis, and is available via the website www.clozaril.co.uk and the Clozaril Patient Monitoring Service (CPMS).

• Monitoring and observation of the patient should be undertaken as outlined in the table from page 8.

• The first Community Initiation of Clozapine Treatment Prescription for Day 1 – 7, must be completed by the prescriber and issued by pharmacy when a green result is obtained and before treatment begins. Subsequent prescriptions to be completed as required (Appendix 3 – 6) or complete the inpatient prescription chart and variable dose section, and request supplies from pharmacy using an outpatient prescription.

• Advanced Practitioner/ SHO to review patient prior to leaving department.

• When observations remain within normal range and the patient is stable on the dose regime, observations may be stopped. A discussion must take place with the Consultant to confirm that the observations and dose are stable. At this point the patient will normally be discharged from the HT into care of the care co-ordinator and Consultant unless an alternative arrangement has previously discussed and agreed by the Advanced Practitioner/SHO.

• The patient should be monitored through the current clozapine clinic pathway and via the GP.

• Blood tests should be taken on Days 1, 8, 15 and 22.

• Medical and pharmacy review twice a week on initiation and weekly thereafter.

Day Morning dose

Evening dose

Day Morning dose

Evening dose

1

Tuesday

12.5mg

NIL

15

Tuesday

100mg

125mg

2

Wednesday

25mg

NIL

16

Wednesday

100mg

150mg

3

Thursday

37.5mg

NIL

17

Thursday

100mg

175mg

4

Friday

50mg

NIL

18

Friday

100mg

200mg

5

Saturday

50mg

NIL

19

Saturday

100mg

200mg

6

Sunday

50mg

NIL

20

Sunday

100mg

200mg

7

Monday

75mg

NIL

21

Monday

100mg

250mg

8

Tuesday

50mg

50mg

22

Tuesday

100mg

250mg

9

Wednesday

50mg

75mg

23

Wednesday

100mg

250mg

10

Thursday

75mg

75mg

24

Thursday

100mg

250mg

11

Friday

75mg

100mg

25

Friday

100mg

300mg

12

Saturday

75mg

100mg

26

Saturday

100mg

300mg

13

Sunday

75mg

100mg

27

Sunday

100mg

300mg

14

Monday

100mg

100mg

28

Monday

100mg

300mg

Result / Date


7 Community Initiation Pathway Observation Record

BP

Temperature

Pulse

Observations

Sitting

Standing

Baseline

DAY 1 DATE ……………………. (Tuesday)

Pre AM dose 15 mins post AM dose

Ho

url

y f

or

6

ho

urs

po

st

AM

d

ose

1 hour 2 hours 3 hours 4 hours 5 hours 6 hours

DAY 2 Date …………..(Wednesday)

Pre AM dose 15 mins post AM dose

Ho

url

y f

or

6

ho

urs

po

st

AM

d

ose

1 hour 2 hours 3 hours 4 hours 5 hours 6 hours


BP

Temperature

Pulse

Observations

Sitting

Standing

DAY 3 to 7

3

Thur

AM

Pre dose 2 hours post 6 hours post

4 Fri

AM


5

Sat

AM


6

Sun

AM


7

Mon

AM


DAY 8 to 14


8

Tues

AM

Pre dose 1 hour post

CRP check Troponin I or T check PM


9

Wed

AM


PM


10 Thur

AM


PM


11 Fri

AM


PM



DAY 8 to 14

Cont’d

BP

Temperature

Pulse

Observations

Sitting

Standing

12 Sat

AM


PM


13 Sun

AM


PM


14 Mon

AM


PM



DAY 15 to 28

15 Tues

AM CRP check Troponin I or T check

PM

16 Wed

AM PM

17 Thur

AM PM

18 Fri

AM PM

19 Sat

AM PM

20 Sun

AM PM

21 Mon

AM PM

22 Tues

AM CRP check Troponin I or T check

PM

23 Wed

AM PM

24 Thur

AM PM

25 Fri

AM PM

26 Sat

AM PM

27 Sun

AM PM

28 Mon

AM PM

29 Tue

CRP check Troponin I or T check

57 Tue

CRP check Troponin I or T check


Clozapine Initiation Observations Information

Baseline blood pressure, pulse and temperature should be known. Observations should be taken prior to the first dose, 15 minutes after and every hour up to six hours, as a minimum, after the first dose, on DAY ONE and DAY TWO. Repeat the observations if outside the above parameters after 15 minutes. If still outside the above parameters call the doctor for advice. Only omit the dose if the doctor or pharmacist advises to do so. Observations for subsequent doses - Immediately prior to each titration dose until stabilisation.

Parameters Take action if: - Blood pressure Systolic < 100 or > 170 (Sitting and Diastolic < 60 or > 100 standing) OR a postural drop of 30mmHg Pulse > 100bpm (> 120bpm or increased by 30bpm repeat ECG) Temperature > 38.4 degrees C OR < 35.5 degrees C

APPENDIX 1


Clozapine Home Treatment Care Plan

Surname

Forenames

DOB

RT Date

Address Diagnosis

Name

Address & Contact numbers

Plan copied to

(tick) Patient

See above

See above

Main Carer

Consultant

Social Worker

CPN

GP

Others

Next of Kin

APPENDIX 2


Medication

Dose

Frequency

Indication

Issues (side effects,

concurrence etc) Clozapine (Clozaril)

Increasing dose

Daily

Antipsychotic

Patients commencing clozapine require careful monitoring. This is due to side effects which will be discussed with XXXX and their carer along with the appropriate action to be taken.

EMERGENCY CONTACT NUMBERS Home Treatment Team (HT) GP Clozaril Patient Monitoring Service (CPMS) CRISIS PLAN: Action to be taken, patient and HT team responsibilities Should XXXX develop any of the serious side effects of clozapine such as

• fever

• sore throat

• rash or other signs of infection

• extremely high pulse rate or fainting INFORM HT. TEAM Stop clozapine. Take FBC blood test. If HT are unable to respond XXXX should attend A&E department stating that clozapine is being taken, the dose, and the symptoms they are concerned about. IMMEDIATE attendance to A&E if the following side effects occur:

• seizure

• palpitations

• chest pain

• difficulty breathing

• extremely high pulse rate for a long period of time INFORM CRHT. Patient given copy of HT information sheet (please circle)

Yes

No


IDENTIFIED NEED

INTERVENTIONS

ACHIEVED

XXXX is to commence clozapine whilst in the community. To ensure safe initiation of clozapine and monitor its effects and side effects

HT team to arrange pre commencement checks and tests. As a minimum this will include WBC, LFT U&E, Cholesterol, Glucose, TFT, and an ECG, Troponin I or T, CRP. These must be carried out within 10 days of commencing clozapine. Clozapine initiation will start on a [insert day of the week] either in the patient’s own home or in a treatment suite where available. On the first 2 days XXXX will be monitored for 6 hours by CRHT staff. BP, Pulse and Temperature will be monitored pre-dose, then hourly by a RMN. XXXX will be able to be at home after the 6 hours only if agreed by the Advanced Practitioner/ SHO. If there are any concerns a Dr should be informed. A blood test will be required on Day 3 – to be arranged by CRHT. From Day 3 XXXX will be monitored at home. This will mean that a responsible adult must be with XXXX for 24 hours a day. The HT team will visit 4 times daily. Visit 1 – to take BP, pulse and Temperature and monitor any other side effects, then administer the AM dose of clozapine. HT team will then visit 2 and 6 hours after this to check BP, Pulse and Temperature. A further visit will be carried out in the evening, to check side effects and observations Day 3-7 – There will be 4 visits as described above. Day 8-14 – Observations will be required to be taken once, with there being 2 visits a day (AM & PM) Day 15-19 – One visit per day to check observations. If on stable dose and no unacceptable side effects, XXXX will be discharged from HT team and into the care of the Clozapine Clinic and their care co-ordinator. During the course of clozapine initiation, regular blood tests will be required, a minimum of once per week. These will be arranged by HT team.

Cont’d…..


IDENTIFIED NEED

INTERVENTIONS

ACHIEVED

Clozapine is known to have certain side effects, which are manageable, these are symptoms such as constipation, excessive salivation, weight gain

• XXXX to be educated regarding the common side effects of clozapine

• XXXX to be encouraged to consume a high fibre diet. Along with avoiding processed, high fat foods.

• Should constipation become an issue, XXXX to inform the team so that medical staff can review and prescribe appropriate treatment.

• Hyper-salivation (“drooling”) – This is a common side effect of clozapine and can be managed by use of other medication. XXXX to inform the team if this occurs.

• XXXX to be educated regarding healthy eating and exercise as a means for reducing/preventing weight gain. It is also important that XXXX monitors their weight and is reviewed by the medical team for signs of metabolic syndrome, whereby weight increases, along with raised cholesterol, blood glucose and blood pressure.

• Clozapine can often cause sedation. Whilst this can be difficult to combat, it is usually a temporary side effect and will diminish over time. Regular exercise, healthy eating and good sleep hygiene can help reduce the effect of sedation.

Blood tests and result monitoring: Clozapine requires regular blood monitoring – At least once per week during the first 18 weeks.

• HT team to arrange the pre clozapine blood test and ensure XXXX is registered with CPMS.

• This will enable the initial prescription of clozapine to be completed

• A further test will be required on Day 3.

• After this blood tests will be required every [insert day of the week].

• Clozapine will be prescribed on a weekly basis, assuming that the blood results are “green”

• If there is an “amber” result there must be a repeat blood test performed as soon as possible.

• If there is a “red” result, clozapine must be stopped and urgent repeat bloods taken.

• XXXX should be aware of the frequency of bloods tests and that additional tests may be required at the medical team’s request.

• Clozapine will then be released from the hospital pharmacy on a [insert day of the week]. HT team will usually arrange for this to be collected.


REVIEW Date

Comments

Patient signature: ___________________________________________________ Date: _____________________________ HT team practitioner Signature: ___________________________________________________ Date: _____________________________


COMMUNITY INITIATION OF CLOZAPINE TREATMENT PRESCRIPTION DAY 1 TO 7 (inclusive) To the Prescriber If an alternate dose to the standard CPMS recommended dose is required, the printed dose must be crossed through clearly and the

new dose written in the ‘change to’ column, each change must be initialled before the prescription is signed and dated. To Pharmacy Please dispense sufficient tablets/ liquid for the doses stated below and photocopy this prescription for your records, returning the

complete book with the medication supplied. Please label with directions or supply dose reminder card. Patient name: DOB: Result from CPMS

(include date)

DAY

DATE

MORNING DOSE

Dose administered by

Observations Completed by

EVENING DOSE



CPMS dose

Change to

Initials Time Sign

CPMS dose

Change to

Initials Time Sign

Tues 1

12.5mg

NIL

Weds 2

25mg

NIL

Thurs 3

37.5mg

NIL

Fri 4

50mg

NIL

Sat 5

50mg

NIL

Sun 6

50mg

NIL

Mon 7

75mg

NIL

Prescriber signature Print name Date Bleep/ contact tel. no.

………………………………………… ………………………………………… ………………………………………… …………………………………………

PHARMACY USE ONLY Quantity supplied:

Dispensed by: 25mg tablets

Checked by: 100mg tablets

Date dispensed: Liquid 100mg/5ml

APPENDIX 3



new dose written in the ‘change to’ column, each change must be initialed before the prescription is signed and dated. To Pharmacy Please dispense sufficient tablets/ liquid for the doses stated below and photocopy this prescription for your records, returning the

complete book with the medication supplied. Please label with directions or supply dose reminder card. Patient name: DOB: Result from CPMS

(include date)

DAY

DATE

MORNING DOSE



EVENING DOSE



CPMS dose

Change to

Initials Time Sign

CPMS dose

Change to

Initials Time Sign

Tues 8

50mg

50mg

Weds 9

50mg

75mg

Thurs 10

75mg

75mg

Fri 11

75mg

100mg

Sat 12

75mg

100mg

Sun 13

75mg

100mg

Mon 14

100mg

100mg


………………………………………… ………………………………………… ………………………………………… …………………………………………





APPENDIX 4




complete book with the medication supplied. Patient name: DOB: Result from CPMS

(include date)

DAY

DATE

MORNING DOSE



EVENING DOSE



CPMS dose

Change to

Initials Time Sign

CPMS dose

Change to

Initials Time Sign

Tues 15

100mg

125mg

Weds 16

100mg

150mg

Thurs 17

100mg

175mg

Fri 18

100mg

200mg

Sat 19

100mg

200mg

Sun 20

100mg

200mg

Mon 21

100mg

250mg


………………………………………… ………………………………………… ………………………………………… …………………………………………





APPENDIX 5




complete book with the medication supplied. Patient name: DOB: Result from CPMS

(include date)

DAY

DATE

MORNING DOSE



EVENING DOSE



CPMS dose

Change to

Initials Time Sign

CPMS dose

Change to

Initials Time Sign

Tues 22

100mg

250mg

Weds 23

100mg

250mg

Thurs 24

100mg

250mg

Fri 25

100mg

300mg

Sat 26

100mg

300mg

Sun 27

100mg

300mg

Mon 28

100mg

300mg


………………………………………… ………………………………………… ………………………………………… …………………………………………





APPENDIX 6

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