Integrated Care Pathway (ICP) for the. Management of clozapine COMMUNITY INITIATION

Document Reference MM 049 Integrated Care Pathway (ICP) for the Management of clozapine COMMUNITY INITIATION Surname Title Address Forenames Date of Birth RT/NHS number Care Co-ordinator GP CS number Consultant Allergies One booklet to be completed for each patient initiated on clozapine treatment Approved the Horizon Scanning and Prescribing Guidance sub group 23 November 2012 Review date: 23 November 2015 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 1 of 22

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 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 Appendix 4 Appendix 5 Appendix 6 Community initiation of clozapine treatment prescription Day 1 7 Community initiation of clozapine treatment prescription Day 8 14 Community initiation of clozapine treatment prescription Day 15 21 Community initiation of clozapine treatment prescription Day 22 28 18 19 20 21 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 2 of 22

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 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 Coordinator and other interested/involved parties)? Has the clinical team given consideration to the identified contra-indications to the use of clozapine? YES NO 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 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 3 of 22

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 the Clozaril Patient Monitoring System (CS) 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 Full medical and psychiatric history (including previous treatment concordance). Physical examination: weight, height, pulse, blood pressure (sitting and standing), temperature, and waist circumference Electrocardiogram Completed 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). G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 4 of 22

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 CS and obtain registration number Inform clozapine clinic of intention to treat Inform General Practitioner (GP) (See GP support pack) G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 5 of 22

COMMUNITY INITIATION PATHWAY 5 Community initiation pathway YES NO Patient is aware of the need for daily attendance/ home visit 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, CS advice line, GP, Nurse on Block/ Wards) The patient has a GREEN result from CS? The Community Initiation of Clozapine Treatment Prescription Day 1 7 has been completed and dispensed 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 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) G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 6 of 22

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 CS before initiation begins. Result from CS. Result / Date The and monitoring regime outlined below is a guide to treatment as recommended the manufacturer of Clozaril, Novartis, and is available via the website www.clozaril.co.uk and the Clozaril Patient Monitoring Service (CS). 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 the prescriber and issued 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 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 regime, observations may be stopped. A discussion must take place with the Consultant to confirm that the observations and 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 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 Evening Day Morning Evening 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 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 7 of 22

7 Community Initiation Pathway Observation Record BP Temperature Pulse Observations Sitting Standing Baseline DAY 1 DATE. (Tuesday) Pre 15 mins post Hourly for 6 hours post 1 hour 2 hours 3 hours 4 hours 5 hours 6 hours Pre 15 mins post Hourly for 6 hours post 1 hour 2 hours 3 hours 4 hours 5 hours 6 hours DAY 2 Date..(Wednesday) G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 8 of 22

BP Temperature Pulse Observations Sitting Standing 3 Thur 4 Fri 5 Sat 6 Sun 7 Mon 2 hours post 6 hours post 2 hours post 6 hours post 2 hours post 6 hours post 2 hours post 6 hours post 2 hours post 6 hours post DAY 3 to 7 DAY 8 to 14 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 9 of 22

8 Tues 9 Wed 10 Thur 11 Fri CRP check Troponin I or T check G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 10 of 22

12 Sat DAY 8 to 14 Cont d Sitting BP Temperature Pulse Observations Standing 13 Sun 14 Mon G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 11 of 22

DAY 15 to 28 15 Tues 16 Wed 17 Thur 18 Fri 19 Sat 20 Sun 21 Mon 22 Tues 23 Wed 24 Thur 25 Fri 26 Sat 27 Sun 28 Mon 29 Tue 57 Tue CRP check CRP check CRP check CRP check Troponin I or T check Troponin I or T check Troponin I or T check Troponin I or T check G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 12 of 22

APPENDIX 1 Clozapine Initiation Observations Information Baseline blood pressure, pulse and temperature should be known. Observations should be taken prior to the first, 15 minutes after and every hour up to six hours, as a minimum, after the first, on DAY ONE and DAY TWO. Parameters Take action if: - Blood pressure Systolic < 100 or > 170 (Sitting and Diastolic < 60 or > 100 standing) OR a postural drop of 30mmHg Pulse Temperature > 100bpm (> 120bpm or increased 30bpm repeat ECG) > 38.4 degrees C OR < 35.5 degrees C 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 if the doctor or pharmacist advises to do so. Observations for subsequent s - Immediately prior to each titration until stabilisation. G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 13 of 22

APPENDIX 2 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 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 14 of 22

Medication Dose Frequency Indication Issues (side effects, concurrence etc) Clozapine (Clozaril) Increasing 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 (CS) 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. TE 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, 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 G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 15 of 22

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 CRHT staff. BP, Pulse and Temperature will be monitored pre-, then hourly a RMN. XXXX will be able to be at home after the 6 hours only if agreed 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 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 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 ( & ) Day 15-19 One visit per day to check observations. If on stable 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 HT team. Cont d.. G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 16 of 22

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 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 the medical team for signs of metabolic syndrome, where 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 CS. 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. G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 17 of 22

REVIEW Date Comments Patient signature: Date: HT team practitioner Signature: Date: G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 18 of 22

COMMUNITY INITIATION OF CLOZAPINE TREATMENT PRESCRIPTION APPENDIX 3 DAY 1 TO 7 (inclusive) To the Prescriber To Pharmacy If an alternate to the standard CS recommended is required, the printed must be crossed through clearly and the new written in the change to column, each change must be initialled before the prescription is signed and dated. Please dispense sufficient tablets/ liquid for the s stated below and photocopy this prescription for your records, returning the complete book with the medication supplied. Please label with directions or supply reminder card. Patient name: DOB: Result from CS (include date) DAY DATE MORNING DOSE CS Change to Initials Dose administered Time Observations Completed CS 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. EVENING DOSE Change to PHARMACY USE ONLY Dispensed : Checked : Date dispensed: Initials Dose administered Time Sign Quantity supplied: 25mg tablets 100mg tablets Liquid 100mg/5ml Observations Completed G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 19 of 22

COMMUNITY INITIATION OF CLOZAPINE TREATMENT PRESCRIPTION APPENDIX 4 DAY 8 TO 14 (inclusive) To the Prescriber To Pharmacy If an alternate to the standard CS recommended is required, the printed must be crossed through clearly and the new written in the change to column, each change must be initialed before the prescription is signed and dated. Please dispense sufficient tablets/ liquid for the s stated below and photocopy this prescription for your records, returning the complete book with the medication supplied. Please label with directions or supply reminder card. Patient name: DOB: Result from CS (include date) DAY DATE MORNING DOSE CS Change to Initials Dose administered Time Observations Completed CS 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 Prescriber signature Print name Date Bleep/ contact tel. no. EVENING DOSE Change to PHARMACY USE ONLY Dispensed : Checked : Date dispensed: Initials Dose administered Time Sign Quantity supplied: 25mg tablets 100mg tablets Liquid 100mg/5ml Observations Completed G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 20 of 22

COMMUNITY INITIATION OF CLOZAPINE TREATMENT PRESCRIPTION APPENDIX 5 DAY 15 TO 21 (inclusive) To the Prescriber To Pharmacy If an alternate to the standard CS recommended is required, the printed must be crossed through clearly and the new written in the change to column, each change must be initialed before the prescription is signed and dated. Please dispense sufficient tablets/ liquid for the s stated below and photocopy this prescription for your records, returning the complete book with the medication supplied. Patient name: DOB: Result from CS (include date) DAY DATE MORNING DOSE CS Change to Initials Dose administered Time Observations Completed CS 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 Prescriber signature Print name Date Bleep/ contact tel. no. EVENING DOSE Change to PHARMACY USE ONLY Dispensed : Checked : Date dispensed: Initials Dose administered Time Sign Quantity supplied: 25mg tablets 100mg tablets Liquid 100mg/5ml Observations Completed G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 21 of 22

COMMUNITY INITIATION OF CLOZAPINE TREATMENT PRESCRIPTION APPENDIX 6 DAY 22 TO 28 (inclusive) To the Prescriber To Pharmacy If an alternate to the standard CS recommended is required, the printed must be crossed through clearly and the new written in the change to column, each change must be initialed before the prescription is signed and dated. Please dispense sufficient tablets/ liquid for the s stated below and photocopy this prescription for your records, returning the complete book with the medication supplied. Patient name: DOB: Result from CS (include date) DAY DATE MORNING DOSE CS Change to Initials Dose administered Time Observations Completed CS 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 Prescriber signature Print name Date Bleep/ contact tel. no. EVENING DOSE Change to PHARMACY USE ONLY Dispensed : Checked : Date dispensed: Initials Dose administered Time Sign Quantity supplied: 25mg tablets 100mg tablets Liquid 100mg/5ml Observations Completed G/TGH/HQSecs/TD/LS/Clinical procedures/clozapine ICP. Community initiation. Version 2. Amended January 2015 22 of 22