Protocol for the Use and Administration of Clozapine

1 Status: Guideline Issue date: 30/01/2014 Revised: July 2015 Approved by: ABUHB Mental Health D+T Review by date: 30/01/2017 Page 1 of 43 Aneurin Bevan University Health Board Protocol for the Use and Administration of Clozapine Staff should be discouraged from printing this document. This is to avoid the risk of out of date printed versions of the document. The Intranet should be referred to for the current version of the document. Status: Guideline Issue date: 30/01/2014 Revised: July 2015 Approved by: ABUHB Mental Health D+T Review by date: 30/01/2017 Contents: 1. INTRODUCTION .. 3 AIMS .. 3 OBJECTIVES .. 3 SCOPE .. 3 ROLES AND RESPONSIBILITIES.

2 3 ACKNOWLEDGMENTS .. 3 2. USING Clozapine FOR TREATMENT RESISTANT SCHIZOPHRENIA .. 4 3. BEFORE STARTING Clozapine TREATMENT .. 4 4. INPATIENT INITIATION OF Clozapine .. 5 FLOW CHART .. 5 summary OF Clozapine MINIMUM BLOOD TEST REQUIREMENTS .. 6 5. OUTPATIENT INITIATION OF Clozapine .. 6 6. DISCHARGING PATIENTS .. 6 7. ONGOING TREATMENT AND 7 Clozapine CLINICS .. 7 PROBLEMS WITH BLOOD SAMPLING .. 10 DEFAULT ON MEDICATION OR MEDICATION COLLECTION .. 10 IF A PATIENT PRESCRIBED Clozapine MOVES OUT OF AREA:.. 10 THERAPEUTIC DRUG MONITORING .. 11 INTERACTIONS WITH Clozapine .. 12 PHYSICAL HEALTH MONITORING .. 13 Clozapine IN PREGNANCY AND BREASTFEEDING.

3 14 SERIOUS ADVERSE EVENTS .. 15 8. FURTHER SOURCES OF INFORMATION .. 17 APPENDICES .. 18 APPENDIX 1 .. 19 OBSERVATION RECORD .. 36 APPENDIX 2 .. 38 APPENDIX 3 .. 39 APPENDIX 4 .. 41 Status: Guideline Issue date: 30/01/2014 Revised: July 2015 Approved by: ABUHB Mental Health D+T Review by date: 30/01/2017 1. Introduction Clozapine (Trade name Zaponex , Clozaril or Denzapine ) is an effective antipsychotic medication used in the treatment of treatment resistant schizophrenia (TRS), and in psychotic disorders occurring in Parkinson s disease, in cases where standard treatment has failed. The standardisation of practices in the prescribing, administering and monitoring of the use of Clozapine will ensure good evidence-based practice if followed by staff, which will enhance patient care and reduce the potential for error and possible litigation.

4 Aims This policy aims to provide guidance to staff on how Clozapine prescribing and administering should be conducted; the documentation that should be used and the provision of information to patients and carers. Objectives The over-arching objective of this guidance is to ensure that all monitoring procedures for the safe Administration of Clozapine are followed across the Health Board, and in a timely and appropriate manner. This will ensure that there is a standardisation of practice across the Health Board and that delivery of care can be appropriately and effectively audited. Scope This policy must be used in conjunction with the summary of product Characteristics, Manufacturers published guidance and BNF guidance, It is intended to add to these references, not replace them.

5 These guidelines are intended to be used in all situations where treatment with Clozapine is initiated on an in-patient ward. The decision to initiate Clozapine must be made after consultation with the community mental health team (CMHT), other professionals, patient and carers but the responsibility rests with the responsible Consultant Psychiatrist. The most significant risks to consider include severe hypotension with cardiovascular collapse, myocarditis or cardiomyopathy, severe hyperthermia, neutropaenia and seizures. Interactions with other prescribed medication, especially other antipsychotics, benzodiazepines and cardiac medication must also be considered.

6 Written information must be given to the patients and their carers about the risks associated with treatment with Clozapine . These risks must be fully explained and discussed with the patient. Roles and Responsibilities This policy is for all mental health workers who are involved in any aspect of prescribing, supplying or administering Clozapine . Acknowledgments This policy has been developed from the previous ABHB Clozapine policy and also using the Sussex Partnership NHS Foundation Trust Procedure and Guidance for the use of Clozapine . Status: Guideline Issue date: 30/01/2014 Revised: July 2015 Approved by: ABUHB Mental Health D+T Review by date: 30/01/2017 2.

7 Using Clozapine for Treatment Resistant Schizophrenia Clozapine is indicated in the UK for treatment-resistant schizophrenia and for psychosis in Parkinsons disease patients who are non-responsive or intolerant of antipsychotics. Non-response Lack of satisfactory clinical improvement despite the use of at least two marketed antipsychotics prescribed at adequate doses for an adequate duration Intolerant The impossibility of achieving clinical benefit with conventional antipsychotics because of severe or untreatable neurological or other adverse reactions, extrapyramidal or tardive dyskinesia Patient requirements Hospital based for initiation.

8 Normal white blood cell count and differential blood counts. Registered with Zaponex Treatment Access System (ZTAS) Prescriber and dispensing requirements Consultant must be registered with ZTAS. Hospital or nominated Community Pharmacy must be registered with ZTAS. 3. Before starting Clozapine treatment The Clozapine Initiation and Treatment pathway should be followed as soon as a decision has been made to start Clozapine . See Appendix 1. Where possible, the provision of information, consent and monitoring procedures will be undertaken by specialist staff working within a Clozapine Clinic setting. If no Clinic is available, then the Responsible Clinician must organise alternatives to ensure that the same procedures are undertaken and results obtained and acted upon if abnormal.

9 The pathway ensures that; the patient fits the licensed indications for prescribing Clozapine , that any contra-indications for starting Clozapine have been considered, that consent has been obtained and that all the blood testing and initial investigations have been done before Clozapine is prescribed. Status: Guideline Issue date: 30/01/2014 Revised: July 2015 Approved by: ABUHB Mental Health D+T Review by date: 30/01/2017 4. Inpatient Initiation of Clozapine Prescribing, dispensing and administering Clozapine should be done following the Inpatient Clozapine Initiation and Treatment pathway. The pathway ensures that all prescribing and monitoring requirements are followed to ensure safe initiation.

10 Flow Chart Obtain a full blood count and baseline investigations Gain consent and register patient with ZTAS Baseline observations (temp, pulse BP) Doctor to prescribe Clozapine on Clozapine initiation chart and drug chart Ward to fax chart to Pharmacy Pharmacy to supply Clozapine once green result obtained Administer Clozapine (must use named supply) Monitor BP, pulse and temperature (use pathway guidelines) Take full blood count weekly Green result Amber result Red result Continue Clozapine Continue Clozapine treatment. Sample blood twice weekly until advised otherwise STOP immediately. Sample blood daily until counts resolve.