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

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1 Document Reference MM 048 Integrated Care Pathway (ICP) for the Management of clozapine INPATIENT INITIATION Surname Title Address Forenames Date of Birth RT/NHS number Care Co-ordinator GP CS number Consultant Allergies One booklet to be printed and 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 of 12

2 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 Initiation phase of clozapine 6 6 Inpatient initiation pathway Pre-admission 6.2 Titration 6.3 Monitoring and observations 7 Inpatient initiation dose regime 7 8 Inpatient initiation pathway observation record 8-10 Appendix 1 Clozapine initiation observations information of 12

3 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 of 12

4 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 (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 Tropinin 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 Inpatient Initiation Pathway Observation Record (Page 8) of 12

5 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) of 12

6 INPATIENT INITIATION PATHWAY 5 Initiation phase of clozapine. If any risks identified that are contraindications to outpatient initiation then follow inpatient initiation pathway 6 Inpatient initiation pathway. Inform CMHT Team of intention to initiate clozapine as inpatient (planned admission) Completed 6.1 Preadmission Ensure pre-initiation checks (Section 4) and baseline assessments (Section 5) are fully completed and ready to start on first day of admission. Obtain GREEN result from CS before initiation begins. Result / Date 6.2 Titration Dependant on tolerability and results of physical observations, it may be necessary to slow down the titration regime in some cases. 6.3 Monitoring and observations. Complete Clozapine Initiation Observations See Appendix 1 Complete Inpatient Initiation Pathway Observation Record See Page 8 Please also refer to Guidelines for the monitoring of physical health for patients taking clozapine (MM 042) of 12

7 7 Inpatient Initiation dose regime 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 and the Clozaril Patient Monitoring Service (CS). An inpatient clozapine titration prescription must be completed so that dose administrations can be recorded. Monitoring and observation of the patient should be undertaken as outlined in the table from page 8. The SHO clerks in patient and take initial blood samples to ensure a blood result is returned before initiation begins. A prescription with dose regime, completed for at least one week of treatment, must be in place using the variable dose section on the inpatient prescription chart. Complete the regular prescription also and endorse as Please see variable dose section in the instructions field underneath. When observations remain within normal range and the patient is stable on the dose regime, stop observations. 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 mg NIL mg 175mg mg 12.5mg mg 200mg mg 25mg mg 200mg 4 25mg 25mg mg 200mg 5 25mg 50mg mg 200mg 6 25mg 75mg mg 200mg 7 25mg 75mg mg 200mg 8 50mg 75mg mg 250mg 9 50mg 100mg mg 250mg 10 50mg 100mg mg 250mg 11 50mg 125mg mg 300mg mg 100mg mg 300mg mg 125mg mg 300mg mg 150mg mg 300mg of 12

8 8 Inpatient Initiation Pathway Observation Record Sitting BP Temperature Pulse Observations / Side Effects Standing Baseline DAY 1 and 2 DATES. Pre dose Day 1 Date.. 15 mins post dose Hourly for 6 hours post dose 1 hour 2 hours 3 hours 4 hours 5 hours 6 hours Pre dose Day 2 Date.. 15 mins post dose Hourly for 6 hours post dose 1 hour 2 hours 3 hours 4 hours 5 hours 6 hours of 12

9 DAY 3 to 6 DATES. 3 date 4 date 5 date 6 date of 12

10 Sitting BP Temperature Pulse Observations / Side Effects Standing DAY 7 to 14 DATES 7 6 hours post 8 6 hours post CRP check 9 6 hours post 10 6 hours post 11 6 hours post 12 6 hours post 13 6 hours post 14 6 hours post Troponin I or T check Continue observations until reached stable dose or discontinue observations when deemed appropriate of 12

11 DAY 15 to 28 DATES CRP check CRP check Troponin I or T check Troponin I or T check 29 CRP check Troponin I or T check 57 CRP check Troponin I or T check of 12

12 APPENDIX 1 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 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 by 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 dose if the doctor or pharmacist advises to do so. Observations for subsequent doses - Immediately prior to each titration dose until stabilisation of 12

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