Initiation of Clozapine Treatment Community Patients
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1 Initiation of Clozapine Treatment Community Patients Who Should Read This Policy Target Audience All clinical staff working in the community N/A N/A
2 Initiation of Clozapine Treatment for Patients in the Community CONTENTS 1.0 Introduction Appropriate Clients Preparation Program for Home Initiation Program for Day Care Initiation (includes partial hospitalisation and patients in crisis flats) Documentation and Support Tools Training and Audit 8 APPENDICES PAGE NUMBER 1. Clozapine Out-Patient Initiation Checklist Clozapine Initiation Prescription Chart 11/12 3. Titration and use of other Antipsychotics 13 Version 1.0 January
3 1. Introduction 1.1 Clozapine has been established as an effective therapy for treatmentresistant psychosis. It has been shown to have benefits in terms of quality of life and reduction of both positive and negative symptoms and it is cost-effective in the long term because of the reduction in hospital admissions. For suitable patients, community initiation of clozapine will improve their access to an effective treatment. It will allow patients to be treated in the environment most appropriate for them. It is also likely to result in a more effective use of in-patient beds. 1.2 Day care and home initiation should not be seen as separate entities. With some patients it may be more appropriate to use a combination of the two with patients attending day care on some days and being visited by a health care professional in their homes on others. 1.3 Abbreviated information contained in the following sections 2 5 are contained in the attached out patient initiation checklist (appendix 1) and out patient initiation daily planner (appendix 2). 2. Appropriate Clients 2.1 Patients should consent to clozapine treatment and blood tests and be aware of and agree to the necessity for an initial period of daily contact at home or daily attendance at an Acute Directorate Day Hospital. 2.3 A full history and clinical investigations should be performed to identify patients for whom home initiation is excluded (history of seizures, NMS) or where caution including slower titration should be exercised (diabetes or history of cardiac disease, harmful substance abuse, older persons, patients receiving potent sedatives or benzodiazepines). 2.4 Patients with a supportive family or carer network and home environment may be more suitable for home initiation. It will be preferable but not essential for a carer to stay with the patient overnight. 3. Preparation 3.1 The sector consultants would be responsible for making the initial decision to start Clozapine and to prepare the client for home initiation. Each case should be considered on an individual basis with individualized decision making and planning involving the patient and carers where possible. Patients, family members and carers should be provided with written information about clozapine. 3.2 Arrangements will be then made by the medical staff from their team to perform a physical examination as a normal workup for anti-psychotic Version 1.0 January
4 medication including base line weight, temperature, pulse and blood pressure (lying and standing). Further investigations may include ECG, blood glucose, according to clinical indications and judgment. 3.3 Psychiatric base line measurements wherever possible should be conducted in order to measure response. 3.4 Pharmacy should be informed about the decision to start Clozapine and the necessary forms completed. The Zaponex Treatment Access Service (ZTAS) requires the Patient Data form to be signed by the pharmacist before faxing it to them. 3.5 The Client should be registered with the Zaponex Treatment Access Service (ZTAS) before referral to the CR/HT team. A baseline full blood count (white cells, neutrophils and platelets) should be taken and the result written on the registration form. 3.6 Special consideration should be given to concomitant medications likely to involve possible drug interactions e.g. bone marrow suppressants, benzodiazepines, anti-cholinergics, anti-hypertensives, alcohol, MAOI s, CNS depressants, highly protein bound drugs, phenytoin, lithium. 3.7 The patient s GP should be informed of the initiation of clozapine (appendix 4 gives Zaponex abbreviated prescribing information) and an emergency contact number for the treating team. This is in the event of a patient seeking help from the GP for an adverse reaction. There is no expectation that the GP will be required to take on the prescribing of clozapine. 3.8 The patient must be provided with an emergency contact number for the treating team and out-of-hours services. 3.9 There should be a contingency plan in case the patient defaults from visits or becomes non-compliant. This contingency plan should address the issues of the management of relapse, haematological monitoring which continues for four weeks after cessation, and a plan for either restarting clozapine or alternative antipsychotic medication The mode of transfer from previous medication to clozapine needs to be planned according to severity of symptoms and risk of relapse. Complex out patient cross titration of antipsychotics should be avoided Routine blood samples will be taken on Tuesdays, with tablets being ready for collection Friday. Version 1.0 January
5 4. Program for home initiation 4.1 The CR/HT Consultant will assume responsibility for home initiation after the client has been prepared and referred to the service. A nurse co-ordinator will be appointed to coordinate the client s care whilst with the CR/HT team. After an initial assessment clients deemed suitable would be started on the program. Day 1 should be a Monday avoiding weeks with bank holidays. This will enable the first post initiation full blood count (taken on Tuesday) to be obtained and sent to the ZTAS central lab. It will also ensure maximum availability of staff and support services. The critical period, especially for clozapine naïve patients, will be the early days of treatment and associated with dose increases. Risks include sudden collapse, syncope, cardiac and respiratory complications. 4.2 The patient should be visited by a suitably trained healthcare professional every weekday, ideally for the first 2 weeks but as a minimum for 1 week. The actual length of attendance is subject to medical review. 4.3 Day 1 (Monday) A suitably trained healthcare professional must remain with the patient in his/her home for at least the first few hours after administering the clozapine dose; pulse, temperature and blood pressure (lying and standing) should be taken before giving the clozapine and every hour after initial dose for a few hours. (NB. Patient can attend day-care for this first day if this is more convenient, different healthcare professionals may stay with the patient in shifts throughout the day). Being physically present for long periods may not be necessary for patients with previous uneventful exposure to clozapine who are restarting after breaks in treatment. Lying and standing BP may not always be possible or indicated where the patient is sedated. NOTE: the start day must be within 9 days of the baseline blood test. 4.4 Day 2 (Tuesday) healthcare professional takes the patient s pulse, temperature and blood pressure (lying and standing). They then administer the clozapine dose and repeat the pulse, temperature and BP at 2 hours and then at 6 hours after dose. There is not a requirement to stay with the patient between observations. 4.5 The second blood test should be taken on day 2 (Tuesday) and posted to the ZTAS central laboratory to ensure that the result is available to allow dispensing of the medication to continue into the second week. The blood tests are then to be performed weekly thereafter on Tuesday until otherwise advised. 4.6 Day 3 onwards healthcare professional takes the patient s pulse, temperature and blood pressure. They then administer the Version 1.0 January
6 clozapine dose. They must return after 6 hours to repeat the pulse, temperature and BP and assess the patient. 4.7 Pulse, temperature and standing and lying BP should be performed at least twice a day by the healthcare professional. 4.8 Utilise flexible dosage titration some patients may require slow titration (appendix 3). 4.9 Do not increase the dose of clozapine at the weekend or on Bank Holidays Clozapine dose may be divided after one week depending on preference for type of dosing regimen and adverse reactions experienced A doctor should visit regularly and at a minimum once every week. The doctor should assess the patient in a similar way to that which would be carried out if the patient were an in-patient i.e. assessing the patient s progress, assessing any adverse reactions to clozapine, adjusting the titration rate, managing anti-psychotic medication crosstitration, reassuring the patient At regular intervals, psychiatric measurements should be performed and risk assessed in order to monitor progress After the completion of treatment the client should be handed back to his sector consultant with arrangements in place for further monitoring and follow up such as out patient appointments, clozapine clinic appointments, etc Any adverse event should be reported to the ZTAS as well as to the R.M.O and appropriate action should be taken that may include reducing/ stopping clozapine,hospitalisation etc. 5. Program for day care initiation (includes partial hospitalisation and patients in crisis flats) 5.1 Day 1 should be a Monday avoiding weeks with bank holidays. This will enable the first post initiation full blood count (day 2) to be obtained and sent to the ZTAS central lab. It will also ensure maximum availability of staff and support services. The critical period, especially for clozapine naïve patients, will be the early days of treatment and associated with dose increases. Risks include sudden collapse, syncope, cardiac and respiratory complications. 5.2 Patient to attend day-care every weekday ideally for the first 2 weeks but as a minimum for 1 week. Actual length of attendance is subject to Version 1.0 January
7 medical review. Patients must be accompanied home either by a carer / relative or a healthcare worker from day care. 5.3 Day 1 (Monday) patient attends day-care in the morning and receives clozapine dose. Pulse, BP (lying and standing) and temperature are taken before giving the clozapine and then at hourly intervals for 6 hours. Patient stays at day-care all day. Patient must be accompanied home either by a carer / relative or a healthcare worker on each day. Lying and standing BP may not always be possible or indicated where the patient is sedated Day 2 patient attends day-care in the morning and has pulse, temperature and BP performed before receiving clozapine dose. Pulse, temperature and BP should be recorded at 2 hours and then at 6 hours after dose. Patient stays at day-care all day The second blood test should be taken on day 2 (Tuesday) and posted to the ZTAS central laboratory to ensure that the result is available to allow dispensing of the medication to continue into the second week. The blood tests are then to be performed weekly thereafter on Tuesday until otherwise advised. 5.5 Day 3 patient attends day-care in the morning with pulse, temperature and BP being done on arrival before receiving clozapine dose and before going home. Although patient may be allowed to leave the unit during the day, they should return for their final pulse, temperature and BP readings 6 hours after the dose of clozapine was given. 5.6 Every weekday patient attends day-care in the morning with pulse, temperature and BP being done on arrival before receiving clozapine dose and before going home. Although patient may be allowed to leave the unit during the day, they should return for their final pulse, temperature and BP readings 6 hours after the dose of clozapine was given. Patient is given weekend supply of medication on Fridays. 5.7 There should be somewhere for patient to sit or lie quietly should they need to. 5.8 Utilise a flexible dosage titration some patients may require slow dosage titration. 5.9 Do not increase the dose of clozapine at the weekend or on bank holidays Clozapine dose may be divided after one week depending on preference for type of dosing regimen and adverse reactions experienced. Version 1.0 January
8 5.11 A doctor should see the patient regularly and at a minimum once every week. The doctor should assess the patient in a similar way to that which would be carried out if the patient was an in-patient, i.e. assessing the patient s progress, assessing any adverse reactions to clozapine, adjusting the titration rate, managing anti-psychotic medication cross-titration, reassuring the patient. 6. Documentation and support tools 6.1 Patient s case notes should be used to document the giving of information to patients and their families and the patient s consent. The out patient initiation checklist (appendix 1) should be completed, signed by the patient and a copy given to the patient. 6.2 Results from investigations should be filed in the patient s notes. A temperature, pulse and blood pressure chart should be used throughout the period of initiation and filed in the patient s notes. 6.3 Records should be detailed in the case notes of patient s experience and formal assessment of side effects. 6.4 Any adverse event should be reported to the ZTAS as well as to the R.M.O and appropriate action should be taken that may include reducing/ stopping clozapine,hospitalization etc. 7. Training & Audit This service will be audited for the numbers referred, started on clozapine, successful completion as well as adverse events. There is sufficient experience within the team to be able to initiate clozapine and a refresher course will be arranged for those needing to update their skills and knowledge. 8. Abbreviations. BP: Blood pressure. ZTAS: Zaponex Treatment Access system. Version 1.0 January
9 R.M.O: Responsible Medical Officer. G.P: General Practitioner. CR/HT Crisis Resolution/Home Treatment team. MAOI: Monoamine oxidase inhibitors. CNS: Central Nervous system ECG: Electro cardiogram NMS: Neuroleptic Malignant Syndrome. Version 1.0 January
10 Clozapine Out-Patient Initiation Checklist Initiation of Clozapine Treatment for Patients in the Community Appendix 1 Start Date (Day 1, Monday): Patient name: Patient date of birth: Patient s address: Consultant: Key worker: Patient s emergency contact tel. no: Setting: Ward Day care Home / hostel Current medication name Current dose Before giving clozapine: Patient considered suitable for out-patient care Patient given clozapine information including expected time frame for recovery Family/carer given clozapine information including expected time frame for recovery Patient aware of necessity for daily attendance / home visits Person available to accompany patient home (if applicable) Family / carer available to stay overnight Patient given information on recognition of side effects & what to do if they occur Family/carer given info. on recognition of side effects & what to do if they occur Patient has given their consent for clozapine treatment and blood tests Recent full history taken & recorded Recent clinical examination performed & recorded Completed ZTAS Registration form sent to Pharmacy First blood taken (local). Green blood test result required. GP informed of start date; provided with guidelines & emergency contact number(s) Emergency contact number provided to patient Medication Collected from Pharmacy Signature of care co-ordinator/ nominated team member:... Signature of Patient: Copy Given to Patient / Carer Version 1.0 January
11 Appendix 2 Clozapine Initiation Prescription Chart Patients Name: Age: Consultant: Notes: This prescription chart is only used for prescribing and recording the administration of clozapine during initiation of treatment. Please refer to the main prescription chart for any other medication. The responsible medical officer should sign the chart at the start of each week and insert the appropriate date in each of the boxes provided. The nurse administering the clozapine should sign in the box beside the relevant dose. Please consult the guidance notes for further information. WEEK No. 1. Signature of Medical officer: Day Total daily dose Date Morning Dose Given by Evening Dose Given by mg Clozapine 12.5mg None 2 25mg Clozapine 12.5mg Clozapine 12.5mg mg Clozapine 12.5mg Clozapine 25mg 4 50mg Clozapine 25mg Clozapine 25mg 5 75mg Clozapine 25mg Clozapine 50mg 6 100mg Clozapine 25mg Clozapine 75mg 7 100mg Clozapine 25mg Clozapine 75mg WEEK No. 2 Signature of Medical Officer: 8 125mg Clozapine 50mg Clozapine 75mg 9 150mg Clozapine 50mg Clozapine 100mg mg Clozapine 50mg Clozapine 100mg mg Clozapine 50mg Clozapine 125mg mg Clozapine 100mg Clozapine100mg mg Clozapine 100mg Clozapine 125mg mg Clozapine 100mg Clozapine 150mg Version 1.0 January
12 Patients Name: Age: Consultant: If it is not intended to continue dose titration to 400mg, then the boxes not required should be crossed out. When the required dose is reached, this chart should be crossed out and initialled by the medical officer. The final dose should be written up in the normal inpatient prescription chart. WEEK No.3 Signature of Medical officer: Day Total Daily Dose Date Morning Dose Given by Evening Dose Given by mg Clozapine 100mg Clozapine 175mg mg Clozapine 100mg Clozapine 200mg mg Clozapine 100mg Clozapine 200mg mg Clozapine 100mg Clozapine 200mg mg Clozapine 100mg Clozapine 200mg mg Clozapine 100mg Clozapine 200mg mg Clozapine 100mg Clozapine 250mg WEEK No. 4 Signature of Medical officer: mg Clozapine 100mg Clozapine 250mg mg Clozapine 100mg Clozapine 250mg mg Clozapine 100mg Clozapine 300mg mg Clozapine 100mg Clozapine 300mg mg Clozapine 100mg Clozapine 300mg mg Clozapine 100mg Clozapine 300mg mg Clozapine 100mg Clozapine 300mg Version 1.0 January
13 Appendix 3 Example Community Initiation of Clozapine sliding dosage schedule. Titration and use of other antipsychotics Day Clozapine dose (daily) Comments mg 2 25mg mg 4 50mg 5 75mg 6,7 (weekend) 75mg Do not increase over weekend 8 100mg 9 125mg thereafter Increase by 25mg every 2 days Increase to 300mg daily, then review The dose should be increased more gradually if side effects appear. Version 1.0 January
14 Policy Details Title of Policy Unique Identifier for this policy State if policy is New or Revised Initiation of Clozapine Treatment Community Patients New Previous Policy Title where applicable Policy Category Clinical, HR, H&S, Infection Control etc. Executive Director whose portfolio this policy comes under Policy Lead/Author Job titles only Committee/Group responsible for the approval of this policy Month/year consultation process completed * n/a Medicines Management Medical Director Month/year policy approved January 2015 Month/year policy ratified and issued January 2015 Next review date February 2016 Consultant for Crisis Resolution & Home Treatment Medicines Management Committee Implementation Plan completed * Equality Impact Assessment completed * Previous version(s) archived * Disclosure status Yes Yes Yes B can be disclosed to patients and the public Key Words for this policy * For more information on the consultation process, implementation plan, equality impact assessment, or archiving arrangements, please contact Corporate Governance Review and Amendment History Version Date 1.0 January 2015 Details of Change Reformatted to meet new Trust policy template Version 1.0 January
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