Clinical SOP Out-patient Clozapine Initiation Procedure SOP Document Control Summary Status: Replacement supersedes Clozapine Policies and Procedures Version: v1.0 Date: October 2017 Hayley Smart Mo Azar Author/Title: Owner/Title: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation Date: Review Date: Key Words: Associated Policy or Standard Operating Procedures Policy & Procedures Committee Date: 18 January 2018 Policy & Procedures Committee Date: 18 January 2018 Medicines Optimisation Strategy 2013-2018: Making the Most of Medicines February 2018 October 2020 Clozapine, CPMS, Bloods Clozapine Policy POCHI SOP Contents 1. Introduction... 3 2. Purpose... 3 3. Scope... 3 4. Clinical Team Responsibilities... 3 5. Initiation Procedure... 4 6. Continuation of clozapine... 8 7. General Information... 9 8. Process For Monitoring Compliance And Effectiveness... 9 Appendix 1: Individual Out-patient Checklist... 10 Appendix 2: Clozapine Prescription Out-patient Initiation... 12 Appendix 3: Clozapine Initiation Observation Record... 13
Appendix 4: Lloyds Out-patient Repeat Prescription... 16 Appendix 5: Continuation of Clozapine - Flowchart... 17 Change Control Amendment History Version Dates Amendments Page 2 of 17
1. Introduction Hospital admission for the initiation of clozapine is no longer a mandatory requirement, therefore certain patients who fit the criteria for clozapine treatment according to NICE guidance (see Clozapine Policy) may be appropriate for initiation in the community setting. This SOP supports clinicians with the initiation of clozapine in the community. This SOP must be read in conjunction with the Clozapine Treatment and Operational Procedures Policy, Guidelines for the Management of Specific Clinical Situations arising with the use of Clozapine Policy and POCHI machine SOP. In order for clozapine to be initiated in the community setting, the patient must be deemed appropriate for treatment as set out in the Clozapine Policy and also be assessed according to the following criteria. Inclusion criteria: Patient must be fairly mentally stable Patient is able to understand the risks and potential side effects, and be aware of what they need to report to the team Patient consents to treatment, blood tests and frequency of home visits to monitor physical health A maximum of one antipsychotic must be in use before switching to clozapine Exclusion criteria: Patient lives alone with no overnight support available during titration period Patient suffers from diabetes mellitus, or has a history of cardiac disease, seizures, haematological disorders, neuroleptic malignant syndrome (NMS) Patient is pregnant or breastfeeding Patient is <16 or >65 years of age Patient s medication regime will require complex cross-titration due to polypharmacy or interacting medicines, e.g. carbimazole, carbamazepine or antibiotics Patient is a heavy smoker Patient is alcohol dependent or has substance misuse problems 2. Purpose To provide staff with guidance on safely initiating clozapine in the community setting. 3. Scope This procedure applies to all staff who deal with clozapine in community setting throughout SSSFT. 4. Clinical Team Responsibilities Clozapine should only be prescribed under the supervision of a consultant registered with the CPMS. All professional responsibilities described in the Clozapine Policy apply, with the addition of: Page 3 of 17
Patients and relatives/carers should be provided with information about clozapine, particularly regarding: o Realistic expectations for recovering including timeframe o Recognition of adverse reactions and what to do if they occur o Importance of adherence Patient-specific tasks must be completed, as for any clozapine initiation, e.g. full medical history, physical health assessment, consideration of concomitant medications, plan for switching regime. Decide, after discussion with patient, whether the first three days of treatment will occur on a ward or at home, and make the necessary arrangements. The Clinical Lead must ensure there is capacity within the community and home treatment teams to support community initiation; this includes availability of team members with skills to undertake supervision of clozapine administration and monitoring (blood pressure, pulse, temperature) and understanding of when to refer (see). Team members must have access to ecpms or equivalent (see Clozapine Policy for more information). Essential equipment must be available: couch for physical examination, thermometer, BP machine, and watch for pulse (if not done by BP machine), access to ECG testing and interpretation, locked box/ safe for safe storage within home. The team must ensure that there is a family/carer network available; ideally someone to stay overnight for the first two weeks to ensure patient safety. The patient must be provided with emergency contact details both in and out of hours. The clinical team must ensure they have up to date contact details for the patient and relatives/carers. There should be a contingency plan in place incase a patient defaults from visits or becomes non-compliant. The doctor must see (or make contact with) the patient regularly, at a minimum of once weekly during the initiation phase these appointments should be booked before treatment starts. Patient-held folders will be provided for each patient undergoing home initiation. This will contain as a minimum: contact information for services, a copy of the current prescription, a monitoring form, a patient information leaflet on Clozapine. Records of administration and monitoring will be made in the patient-held folder, which after initiation will be transferred to the main care record. NB the current prescription will become electronic on the RiO system as this is implemented. Items 1-12 on Individual Out-Patient Checklist (appendix 1) must be completed prior to initiation. 5. Initiation Procedure 1. Take initial blood test the week before treatment is due to start 2. Register patient with CPMS this includes communicating their FBC result. N.B. The patient must be registered by the Consultant in charge of their care. 3. Inform clinical team and the appropriate hospital pharmacy of the plan. 4. Send signed initiation prescription to pharmacy one week prior to starting initiation (see appendix 2). If this has not been hand-delivered, contact pharmacy to ensure it has arrived. Page 4 of 17
5. Arrange with pharmacy when medication will be collected to ensure it is ready in advance. 6. Complete careplan detailing when and where observations will be taken and by whom, as per timetable in appendix 3. 7. Collect initial supply from pharmacy this will be for 3 days. Make a copy of initiation prescription, upload onto Rio and place in patient s Clozapine Information Folder. 8. Commence therapy this can occur as an inpatient for the first three days, or at home if arrangements are in place for appropriate observations. See flowchart below for details. Page 5 of 17
Ward initiation Home initiation Day 1 Admit to identified ward with clozapine supply and any other patient s own medication Ward doctor to prescribe first 3 days doses, as per out-patient initiation regime, along with any other medications. Monitoring to be done by ward staff as per Inpatient SOP. Second blood test taken on ward, sent locally (or follow POCHI SOP if appropriate). Day 1 Pulse, temperature and standing and sitting BP to be taken prior to supervised administration of dose and every hour for 6 hours after dose taken. Assess patient s general condition. Leave Clozapine Information Folder at patient s home. Take second blood test, send locally (or follow POCHI SOP if appropriate). Day 2 Monitoring to be done by ward staff as per Inpatient SOP. Day 2 Pulse, temperature and standing and sitting BP to be taken prior to supervised administration of dose and at 2 and 6 hours after dose taken. Assess patient s general condition. Day 3 Monitoring to be done by ward staff as per Inpatient SOP. Order the next 7 days supply from pharmacy. Patient discharged from ward with 7 days supply of clozapine. First 3 doses to be crossed off community initiation prescription by prescriber. Leave Clozapine Information Folder at patient s home. Day 3 Pulse, temperature and standing and sitting BP to be taken prior to supervised administration of dose and 6 hours after dose taken. Assess patient s general condition. Order next 7 days supply from pharmacy to be collected/delivered on/after Wednesday.
Days 4-7 Pulse, temperature and standing and sitting BP to be taken prior to supervised administration of dose and 6 hours after dose taken. Assess patient s general condition. Patient should be assessed by responsible doctor, as arranged prior to commencement of therapy. Week 2 Take third blood test on the Monday of week two, send locally (or follow POCHI SOP if appropriate). Pulse, temperature and standing and sitting BP to be taken prior to supervised administration of both morning and evening doses. Order further 7 days supply from pharmacy to be collected/delivered on/after Wednesday. Patient should be assessed by responsible doctor, as arranged prior to commencement of therapy. Week 3 Unless clinically indicated, stop supervision of administration and monitoring. Take next blood test on Monday, send locally. Patient should be assessed by responsible doctor, as arranged prior to commencement of therapy. Check compliance. Complete Outpatient repeat prescription and send to pharmacy (see appendix 4). Explain arrangement for blood testing and supply of medication to patient. Page 7 of 17
After 6 months: f-lipid, pulse & BP, BMI 6. Continuation of clozapine Weekly monitoring For the first 18 weeks of treatment, clozapine supply is made weekly following confirmation of a valid FBC result. For this 18 week period blood tests should be sent locally (or use POCHI SOP), and supply will be made by the Trust pharmacy (delivery/collection subject to local arrangements). Fortnightly monitoring Monitoring frequency is reviewed by CPMS and a notification will be sent for the patient when their frequency has changed (usually around 18 weeks from the start of treatment). Blood tests can then be sent to CPMS* (or use POCHI SOP). Supply is still made by Trust pharmacy, but supply can be made every 2 weeks. Four-weekly monitoring When CPMS notify that the patient can be monitored every 4 weeks (usually around week 52), supply can then be passed on to Lloyds Pharmacy (see Clozapine Policy for location of Lloyds Pharmacy depending on area). Bloods continue to go to CPMS.* *N.B. Pharmacy may advise to send locally around bank holidays when delays are expected. See flowchart in appendix 5. In addition to the FBC monitoring, the following physical health monitoring is also required for all patients: Record BP, pulse, temperature and weight at each outpatient appointment Baseline measurements as outlined in Clozapine Policy. At 1 month: BMI, f-glucose, HBA1c At 3 months: f-lipid, f-glucose, HBA1c, U&Es, LFTs At 9 months: f-lipid, pulse & BP At 1 year: f-glucose, HBA1c, f-lipids, U&Es, FBC, LFTs The GP should then be asked to follow these up annually thereafter. These blood tests should be collected in a gold top sample tube and sent to the local general hospital laboratory for analysis. Calculate the Body Mass Index (BMI) every three months and record in RiO. A BMI calculator link is available within the new physical health assessment document in RiO. Measure the waist circumference very three months. Complete an annual review of Lifestyle factors, more frequently if indicated (to include- smoking status, alcohol use, drug use, activity, diet).
ECGs should be completed annually but more frequently if the patient is on two antipsychotics or on clozapine above BNF limits as per the High Dose Antipsychotic Procedure. If required, ECGs can be ordered by clinic staff as a 12-lead ECG with the results to be returned to the clinic. Either the patient or clinic staff can arrange the appointment with the local ECG service. Alternatively some clozapine clinics may be able to be set up to carry out their own ECGs. Clozapine Plasma Levels can also be taken if requested by the Consultant Psychiatrist, NMP or lead prescriber. There is no set frequency for these tests; refer to the Trust s Clozapine Guidelines for more details. The results of all of these tests should be reviewed by the clinic s NMP or Consultant Psychiatrist (or deputy) or junior doctor assigned to the team. Once signed off, the results should be scanned into the patient s RiO notes and where necessary forwarded to the GP for information or action. 7. General Information Refer to Clozapine Treatment and Operations Policy for information on how to deal with Red or Amber results, missed doses/treatment breaks. Refer to Guidelines for the Management of Specific Clinical Situations arising with the use of Clozapine Policy for information on cardiomyopathy, side effects, plasma levels. Refer to POCHI SOP if applicable to area. 8. Process For Monitoring Compliance And Effectiveness Review of safeguarding incident reports by the Medicines Incident Review Group (MIRG) and the Medicines Optimisation Committee (MOC). Page 9 of 17
Appendix 1 Name Address Date of Birth NHS number INDIVIDUAL OUT- PATIENT CHECKLIST FOR INITIATION OF CLOZAPINE Please file in patient s notes Date Consultant... Key worker.. Other individuals involved... GOAL/AIM Short term: To initiate clozapine treatment and monitor his/her physical and mental health during the initial stages of treatment. Long term: To maintain and stabilize his/her mental health to enable optimum level of functioning in the community. PLAN OF CARE SIGN DESIGNATION DATE 1. Doctor to explain the need for blood testing i.e. NEUTROPENIA, its consequences, how it may affect physical health and symptoms to be reported to doctor immediately (sore throat and fever). 2. Doctor or pharmacist to explain procedure involved in switching medications before treatment can be commenced. 3. Care coordinator to ensure that education is provided to the patient and family/carers regarding therapeutic effects and possible side effects of clozapine,and to re-iterate the reason for regular blood testing. 4. Ensure written information has been provided. 5. Complete full physical examination, including ECG, as per Clozapine Policy.
6. Register patient with Clozaril Patient Monitoring Service (CPMS tel. 0845 769 8269). CPMS number 7. Agree date for initiation this must be at the beginning of the week. Date for initiation. 8. Take initial blood sample 7 days prior to agreed initiation date and send locally to be tested. 9. Following confirmation of a green blood result, clozapine may be commenced. 10. Initiation prescription must be signed by the doctor and sent to pharmacy 7 days prior to commencement of therapy (see appendix 2) 11. A copy of this prescription must be uploaded onto Rio and kept in the home folder along with observations form (appendix 3) emergency contact details, a copy of Out-patient Checklist (appendix 1) and Clozapine fact sheet. 12. Care-coordinator to ensure there is ongoing support and education available to the patient. Signature of care co-ordinator. Date. Signature of service user Date Page 11 of 17
Appendix 2 CLOZAPINE PRESCRIPTION: OUT-PATIENT INITIATION Name: Address: Consultant: Contact number: DOB: NHS No: Allergies: CPMS number : Day Date AM dose Time taken PM dose Time taken 1 12.5mg (half a tab) - 2 12.5mg (half a tab) - 3 25mg (one tab) - 4 25mg (one tab) - 5 50mg (two tabs) - 6 50mg (two tabs) - 7 50mg (two tabs) - 8 25mg (one tab) 50mg (two tabs) 9 25mg (one tab) 50mg (two tabs) 10 50mg (two tabs) 50mg (two tabs) 11 50mg (two tabs) 50mg (two tabs) 12 50mg (two tabs) 75mg (three tabs) 13 50mg (two tabs) 75mg (three tabs) 14 50mg (two tabs) 75mg (three tabs) 15 50mg (two tabs) 100mg (four tabs) 16 50mg (two tabs) 100mg (four tabs) 17 50mg (two tabs) 125mg (five tabs) 18 50mg (two tabs) 125mg (five tabs) 19 50mg (two tabs) 150mg (six tabs) 20 50mg (two tabs) 150mg (six tabs) 21 50mg (two tabs) 150mg (six tabs) Doctor s signature:. Date. Print name
Appendix 3 CLOZAPINE INITIATION OBSERVATION RECORD Name: NHS Number: Date of Birth: Start Date: Baseline Day 1 Day 2 Day 3 Date Time BP Lying BP standing Pulse Temp Comments Signature 1 hour postdose 2 hours postdose 3 hours postdose 4 hours postdose 5 hours postdose 6 hours postdose Pre-dose 2 hours postdose 6 hours postdose Pre-dose
Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 6 hours postdose Pre-dose 6 hours postdose Pre-dose 6 hours postdose Pre-dose 6 hours postdose Pre-dose 6 hours postdose Pre-dose AM Pre-dose PM Pre-dose AM Pre-dose PM Pre-dose AM Pre-dose PM Pre-dose AM Pre-dose PM Pre-dose AM Pre-dose PM Pre-dose AM Pre-dose PM Pre-dose AM Pre-dose PM Page 14 of 17
Seek Medical Advice if: Postural Drop is.30mmhg (either systolic or diastolic or as a combination of the two) Pulse over 100bpm Temp>38oC Intolerable side effects e.g. excess sedation Page 15 of 17
Appendix 4 Lloyds Outpatient Repeat Prescription Park House, Cannock WS11 1JN St George s Hospital, Stafford, ST16 3AG The Redwoods Centre, Shrewsbury, SY3 8DS Powys THB, Bronllys, LD3 0LS Compliance Aid? (only with prior agreement) State YES or NO (Please select base) CPMS No: Consultant: CMHT: Name of CMHN/Care Co-ordinator: (Contact for Lloyds if query with blood tests) Deliver to: Clozapine to be supplied in accordance with CPMS protocol and approved SOP, on receipt of a satisfactory FBC. The prescription can be used for up to a maximum of 6 months. Specify in Valid For box below Name: Address: DoB: NHS number: GP: TO BE COMPLETED BY SSSFT STAFF ONLY Date Prescription (include drug, dose and frequency) Prescriber s signature Monitoring Frequency TO BE COMPLETED BY LLOYDS PHARMACY STAFF Valid For Date Issue Strength Strength Disp Chk Page 16 of 17
Appendix 5 INITIATION COMPLETE Consultant writes Lloyds out-patient prescription and sends to local Trust pharmacy Trust pharmacy continues supply until patient goes on to 4 weekly FBC monitoring. Bloods sent to CPMS once patient reaches fortnightly monitoring. 4 weekly monitoring ( week 52) Prescription sent to Lloyds pharmacy via post or Lloyds transport driver Lloyds pharmacy supply medication contact Trust pharmacy for local collection/delivery arrangements. Bloods sent to CPMS