Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers Step 3: Pass the . P3 - The 2012 Policy Management System and the Policy Format: ... administration and monitoring of clozapine. Example Clozapine S100 Prescription 37 6.8. Clozapine treatment during Covid-19 outbreak. GG&C will use Magnalabs. Clozapine Patient Counselling 36 6.7. Side effect monitoring care plan. The increased risk of myocarditis is greatest in the first two months of treatment. The drug is subject to strict monitoring requirements because it is associated with serious side effects, such as neutropenia, agranulocytosis, seizures, myocarditis and cardiomyopathy. Clinical studies have indicated a therapeutic window for clozapine serum levels in schizophrenic and schizo-affective patients during acute treatment, i.e. Clozapine: safe prescribing Mental health MediCines ManageMent adverse drug reaCtions Key Messages: along with new research, has reiterated the need for A co-ordinated approach is required between the mental health and primary care teams so that patients treated with clozapine do not experience gaps in care; monitoring may be delegated to primary care on a case-by-case basis … Download. Staff Information 1. Clozapine carries a black box warning for drug-induced agranulocytosis (lowered white blood cell count). Prescribers have the ability to identify and associate designees (e.g., nurse, pharmacist) to their Clozapine liquid. Clozapine will only be provided to centres that are The Policy & Forms website is the official source of current approved policies, procedures, directives, standards, protocols and guidelines. An uncommon but serious side effect of clozapine is severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/μL. Titration form. All clozapine manufacturers and monitoring services have a service level agreement with an external laboratory to perform clozapine plasma levels. Clozapine Monitoring Form (PDF 265KB) This form is designed to document the face to face clinical review and monitoring requirements for consumers on clozapine. label or block print CLOZAPINE MONITORING FORM MRxxx DO NOT WRITE IN MARGIN Clozapine Monitoring.indd 1 10/08/2017 3:50 PM . 2. 3x weekly … All questions relate to the previous week. Appendix 16 GASS monitoring form for Clozapine 45 . Weekly for patients 1 –6 months on therapy • Bi-weekly for patients 6 – 12 months on therapy • Monthly for patients >12 months on therapy Mild neutropenia 1000 – 1499/cmm . Patient information standards (Clozapine) Out-patient prescription form. Objective: Therapeutic drug monitoring (TDM) of the atypical antipsychotic drug clozapine is recommended. Clozapine plasma levels are not performed by local GGC labs. The two clozapine patient monitoring systems or services require all patients, prescribing doctors, dispensing pharmacists, centre coordinators and centres using clozapine to be registered. Initiation (Day 1) 6.3.2. Knowledge Assessment for Healthcare Providers. Each Centre must have at least one Centre Coordinator, and consideration should be given to having more than one where required for continuity of service. Prescriber Designee P rocess. Introduction 1.1 Purpose of these guidelines This document sets out the practice criteria to be followed by Sussex Partnership NHS Foundation Trust (SPFT) healthcare professionals for the prescribing, administration and monitoring of clozapine. for patients who do not respond to treatment with typical antipsychotics. The incidence of neutropenia among clozapine-treated patients is 2% and agranulocytosis 0.8%. 2. Clozapine and seizures. Once Registered, you will have access to the GenCAN™ database, which will assist you in the Monitoring of your Patients. relevant form, along with the rationale for the override, to the National Clozapine Coordinating Center (NCCC). Introduction 1.1 Purpose of these guidelines This document sets out the practice criteria to be followed by Sussex Partnership NHS Foundation Trust (SPFT) healthcare professionals for the prescribing, administration and monitoring of clozapine. Clozapine tablets are available as 25 mg, 50 mg, and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side and as a 200 mg oval shape, pale-yellow, uncoated tablet with a facilitated score on one side. the required Serious Adverse Event form(s) and send this form(s) directly to AA-Clozapine Patient Care Network within 24 hours via fax to 18668366778 or report via phone to 18772762569. Clozapine therapy: role of therapeutic drug monitoring (TDM) Although antipsychotic efficacy with Clozaril ® (clozapine) can be expected with doses of 200 to 450 mg/day, the approved dose range extends up to 900mg/day. Clozapine blood count monitoring. Clozapine REMS Prescriber Enrollment Form Step 2: Review . Use Clozapine Monitoring Form (Appendix 5) to guide physical health monitoring protocols Ensure GP is aware of ongoing clozapine prescription and FBC requirements. Clozapine – Monitoring Summary 32 6.3. Day 2 Onwards 6.4. Please indicate N (Normal) or A/N (Abnormal) in relevant white b ox once test completed (grey boxes are not mandatory but repeat te sts if clinically indicated) CLINICAL REVIEW REMINDERS Baseline 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks 7 weeks 8 weeks 9 weeks 10 … Clozapine is an atypical antipsychotic that is used for treatment-resistant schizophrenia. ANC Level ANC Monitoring Frequency of ANC Lab Tests Normal range . Referral to Clozapine Clinic - Process on Discharge 35 6.6. Ongoing Treatment and Monitoring 7.1 Clozapine clinics The Clozapine Clinic is a centralised resource and information centre for patients, carers and other Health Professionals. Information should be readily available to staff and patients e.g. The evidence found in the published literature and from patient reports submitted to Health Canada showed that the risk of low numbers of white blood cells remains for over a year after starting treatment. Smoking cessation during Covid-19 pandemic. leaflets, DVDs, dosing schedules and patient’s monitoring records. Appendix 16 GASS monitoring form for Clozapine 45 . 3. Monitoring the risk of low white blood cell counts is still important for the safe use of clozapine. • Interrupt treatment for suspected clozapine induced neutropenia • Resume treatment once ANC normalizes to ≥ 1000/μL BEN POPULATION • Recommend hematology consultation • Continue treatment GENERAL POPULATION • Recommend hematology consultation • Interrupt treatment for suspected clozapine induced neutropenia • Do not rechallenge unless prescriber determines benefits outweigh Magna Laboratories also performs the clozapine assays for monitoring of drug levels in the blood. Phone: 1-877-276-2569 / Fax: 1-866-836-6778 / W. ebsite: www.aaspire.ca . Monitor leucocyte and differential blood counts. If you are a Healthcare Provider and would like to initiate Gen-clozapine therapy, please complete a Patient Registration Form and fax it to GENCAN. This non-mandatory form can be used after the WA Clozapine Initiation and Titration Chart. Clozapine requires differential white blood cell monitoring weekly for 18 weeks, then fortnightly for up to one year, and then monthly as part of the clozapine patient monitoring service. Clozapine oro-dispersible tablets. Monitoring must continue throughout treatment and for 4 weeks after complete ... reaction to clozapine that contraindicates further use of any clozapine containing product. Neutrophils are a type of white blood cell that combats infection. High-dose monitoring and clozapine physical state monitoring are not equivalent in our area and are unlikely to be uniform in other regions. Purpose This document sets out the practice criteria to be followed by HPFT healthcare professionals for the prescribing, dispensing, administration and monitoring of clozapine. 5 1. Clozapine lowers the seizure threshold in a dose-dependent manner and may induce myoclonic jerks or generalised seizures. CLOZAPINE MONITORING FORM To be used after WA Clozapine Initiation and Titration Chart SURNAME UMRN / MRN GIVEN NAMES DOB GENDER ADDRESS Hospital / Health Service TELEPHONE Please use I.D. A hospital may be one or multiple centres. Packs and forms for measuring clozapine levels are available from the respective clozapinem onitoring services. Neutropenia, the milder form of agranulocytosis, occurs in an additional 3% of people who take Clozapine. Download *Clozapine monitoring form and *Guidelines for completing the clozapine monitoring form Clopine ® Product Information, approved by the Therapeutics Goods Administration 14 July 2004, amended 12 June 2009 Click to download Click to download. Mandatory Monitoring . Monitoring for agranulocytosis and neutropenia Agranulocytosis only happens to a very small number of people who take Clozapine (less than 1%). AA-Clozapine Patient Care Network - PATIENT REGISTRATION . Clozapine Observation Monitoring Chart (Inpatients) 33 6.3.1. Neither set of requirements subsumes the other; both should be conducted on patients on clozapine antipsychotic polypharmacy who are in the high-dose range. All clozapine manufacturers and monitoring services have a service level agreement with an external laboratory to perform clozapine plasma levels. Dosage Forms and Strengths. ANC ≥ 1500/cmm . A centre is defined as a hospital, clinic or other facility that is involved with the use of clozapine. Treatment plan for managing contraindicated treatment. 4 1. Complete Clozapine Clinic Referral Form (required at initiation of therapy) Record baseline monitoring on the Clozapine Physical State Monitoring Form (Weeks 0 - 4) Prescribe clozapine On confirmation of patient registration and satisfactory blood result initiate treatment as per Summary of Product Characteristics (SmPC). not be allowed to receive Clozapine unless you have an up-to-date blood result. Please use the enclosed clozapine assay form (yellow). Clozapine Monitoring Form (Currently being trialled) Revised April 2017 (Draft for trial) Compliant with: Australian Standard AS2828 – Paper based Health Care Records 1999 Purpose of the form This form is designed to document the face to face clinical review and monitoring requirements for consumers on clozapine. Update care plan 3 monthly. Therefore, the monitoring should continue throughout the duration of use. clozapine must be registered with the relevant clozapine patient monitoring program. and monitoring of clozapine (Med20) Review date: 20/10/2018 Version No: 4.0 Page 1 of 37 Procedure for the prescribing, administration and monitoring of clozapine (Med20) Document author Assured by Sarah Jones (Locality Lead Pharmacist, BaNES) and Terri Turner (Locality Lead Pharmacist, Swindon) AWP Medicines Optimisation Group This document is version controlled. In the United States, the Food and Drug Administration requires regular blood count monitoring of all patients taking clozapine. Please indicate N (Normal) or A/N (Abnormal) in relevant … In order to ensure the safe use and continued monitoring of all patients taking clozapine, the physician must have obtained consent from the patient for the potential sharing of hematological and other safety data between clozapine registries. CLOZAPINE MONITORING FORM MR170.4.1 DO NOT WRITE IN MARGIN WACHS VERSION SEPTEMBER 2017 WMR170.4.1 XC303100. Guidelines for Clozapine Monitoring Form (PDF 170KB) This document provides guidance on completing the Clozapine Monitoring Form. Contraindications. Download. Blood clozapine concentration should be monitored in certain clinical situations—consult product literature. Clozapine is associated with an increased risk of myocarditis which has, in rare cases, been fatal. Allow the service user to fill in the side-effects scale themselves. Scoring Without monitoring, agranulocytosis occurs in about 1% of people who take clozapine during the first few months of treatment; the risk of developing it is highest about three months into treatment, and decreases substantially thereafter, to less than 0.01% after one year. Clozapine Outpatients – Ongoing Monitoring Summary 34 6.5. NOTE: Recommencing clozapine therapy after interruption Dosing recommendations if clozapine dose is missed for > 48 hours • Obtain psychiatric review prior to recommencing clozapine. 1165 Creditstone Rd., Unit 1, Vaughan, Ontario L4K 4N7 19 … OBJECTIVES To support safe initiation of clozapine therapy by outlining clinical responsibilities for therapeutic monitoring.

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