Medication Management Policy & Protocol TITLE:

Clozapine Management

Sponsor:

Drugs & Therapeutics Committee

Approved by:

Medical Advisory Committee

Applies To:

Pharmacy and Programs

TABLE OF CONTENTS PREAMBLE................................................................................................................ 2 POLICY ...................................................................................................................... 2 PROTOCOL A. Patient Selection.................................................................................................. 2 B. Patient Education and Consent ........................................................................... 3 C. Initial Application for Clozapine Therapy Outpatient Funding .............................. 4 D. Registration with CSAN ....................................................................................... 5 E. Initiation of Clozapine Therapy ............................................................................ 6 F. Prescribing, Monitoring, and Dispensing Procedure ............................................ 6 G. Dispensing Summary IWK Pharmacy Department ............................................ 10 H. Purchasing ........................................................................................................ 10 I. Discharge Coordination .................................................................................... 10 References ............................................................................................................... 11 Related Documents .................................................................................................. 11 APPENDICES ABCDEF-

Definitions ...............................................................................................................................13 Nova Scotia Clozapine Program Initial Application for Outpatient Funding ............................14 Clozapine - Nova Scotia Patients ...........................................................................................15 CSAN Form #1 Enrollment/Modification/Discontinuation .......................................................16 CSAN Online Portal Blood Test Entry Instructions .................................................................17 Guidelines for Discharge and Coordination of Clozapine Therapy for 19 Nova Scotia Patients G. Guidelines for Discharge and Coordination of Clozapine Therapy for Patients 23 Living OUTSIDE Nova Scotia I. Guidelines/Fax to Community Pharmacy dispensing clozapine 24

Clozapine Program – Nova Scotia Patients – Policy 4.31

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PREAMBLE The IWK Health Centre’s primary responsibility shall be to safely prescribe, monitor, and distribute clozapine primarily to inpatients. The Nova Scotia Department of Health & Wellness funds clozapine to approved outpatients through the Nova Scotia Clozapine Program administered by Dartmouth General Hospital Pharmacy. This is especially important for patients with no drug coverage and/or for patients who cannot afford the copayment For patients that are not currently living in the province of Nova Scotia or will be moving to another province upon discharge, funding for clozapine on an outpatient basis is run by provincial programs. Each province has its own program which may not mirror the same process that the Nova Scotia Clozapine Program follows. Regardless of whether patients require provincial funding through the Nova Scotia Clozapine Program or any other provincial program, all patients on clozapine in Canada must be registered with a monitoring and distribution system through the drug manufacturer. For the province of Nova Scotia, the contractual agreement is with the Clozaril® Support and Assistance Network (CSAN) with HLS Therapeutics to comply with mandatory monitoring requirements. All physicians and pharmacies involved must also be registered with CSAN. There may be select patients in Nova Scotia or outside the province who are already on clozapine, but are being monitored by another monitoring and distribution system such as GenCAN (Gen-Clozapine® Access Network). Regardless, patients and healthcare providers must comply with the national monitoring system. HLS Therapeutics owns both Novartis Clozaril® and CSAN.

POLICY IWK Pharmacy shall distribute Clozaril® and comply with the CSAN monitoring system as per the HealthPRO contract. This monitoring system ensures: weekly, every-two week or every-four-week lab testing prior to the dispensing of the next period's supply of clozapine. All patients starting treatment must undergo weekly lab test monitoring for the first 26 weeks after application and clearance from to CSAN. Lab test results must be faxed or entered online on the CSAN portal by the healthcare provider in order to be communicated to CSAN in a timely manner. Some laboratories may fax the results directly to CSAN (example: IWK Core Lab) eliminating the requirement to fax or enter lab test results in the online portal. Results must meet pre-specified criteria for normal in order for further supplies of clozapine to be dispensed by the pharmacy.

PROTOCOL A. Patient Selection I. Patients being considered for clozapine therapy should undergo a thorough pretreatment work-up that is ordered by the treating physician. Some components of the work-up are mandatory and others are discretionary based upon the patient’s clinical situation. Refer to Clozapine Product Monograph and recommendations put forth by Novartis located in the Novartis Clozaril® Binder under the tab Healthcare Professionals, document titled “Clozaril® Checklist for Healthcare Professionals”. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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1. Baseline complete blood count (CBC) with differential is mandatory. Generally, the client/patient must be started on the drug within 28 days of the baseline hematology or the White Blood Cell (WBC) and Absolute Neutrophil Count (ANC) must be repeated II. Patients being considered for clozapine therapy must meet each of the following criteria: 1. Diagnosis of schizophrenia, schizoaffective disorder, bipolar, or other. 2. Resistance to treatment or poor tolerance to at least two antipsychotic agents. 3. Absence of the following contraindications: (Refer to Clozaril® Product Monograph) 3.1 Patients with known hypersensitivity to clozapine or any other components of Clozaril®. 3.2 Patients with myeloproliferative disorders, a history of toxic or idiosyncratic agranulocytosis or severe granulocytopenia (with the exception of granulocytopenia/ agranulocytosis from previous chemotherapy). [Clozapine should not be used simultaneously with other agents known to suppress bone marrow function.] 3.3 Patients with active liver disease associated with nausea, anorexia, or jaundice; progressive liver disease; hepatic failure. 3.4 Patients unable to undergo blood tests. 3.5 Other contraindications include severe central nervous system depression or comatose states, severe renal or cardiac disease (e.g., myocarditis), paralytic ileus, uncontrolled epilepsy. 4. Patient or surrogate consenter delegate must give consent to treatment and consent should be documented (Refer to Section B) 5. Application for clozapine outpatient funding should be completed for all patients (Refer to Section C) 5.1 This is highly recommended even if the patient has third party drug coverage and can afford the co-payment 6. Patient must be registered with Clozaril® Support and Assistance Network (CSAN) (Refer to Section D) B.

Patient Education and Consent Patients (and their families where involved), must be fully informed about clozapine prior to initiation of therapy. They should be informed of: o potential benefits and adverse effects of clozapine therapy including the risk of death from agranulocytosis, o need for frequent lab test monitoring, in addition to alternative treatments. o potential benefits and risks of alternative treatments and of no treatment. The Novartis “Welcome to Clozaril®” patient information pamphlet or an alternative patient pamphlet on clozapine must be given to the patient and/or family and discussed preferably by a pharmacist. The following Clozaril® website, www.Clozaril.ca, can be used as an educational tool as it includes useful information that can be related to the patient and/or family as well as illustrative videos that can guide the educational session. To enter the site, the patient and/or family member will need the Drug Identification Number located on the Clozaril® package, alternatively any healthcare provider can enter the site by inputting “123456” in the license number field requested. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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Informed consent must be obtained from the patient, or, if found incompetent to give consent, then from a guardian or next of kin as defined in The Hospitals Act. CSAN is within the “Circle of Care” therefore when a patient consents to clozapine treatment they consent to the blood monitoring system. The signature of the treating physician on the patient registration form is confirmation for CSAN that consent has been obtained. Informed consent retrieved from the patient and/or family should be documented in the medical chart. C.

Initial Application for Clozapine Therapy Outpatient Funding Patients who have successfully undergone the psychiatric, medical, and laboratory examinations; who meet the selection criteria; and who consent to treatment with clozapine should be approved by the Nova Scotia Clozapine Committee prior to initiation of clozapine therapy. It is not a mandate to have approval if the patient has a third party drug plan that covers clozapine and if the patient/family can afford the co-payment. Nevertheless, it is good practice to have ALL patients approved in case drug coverage lapses to ensure that the patient is registered and set up within the system preventing any interruption in treatment. The attending psychiatrist must make application to the Nova Scotia Clozapine Committee. A Clozapine Application for Outpatient Funding must be completed and signed by the physician prior to initiation of clozapine therapy. The pharmacist involved may assist in completing the application (Application for Outpatient Funding - Appendix B). The final application should be faxed to Dartmouth General Hospital Pharmacy at 902-465-8548. Any inquires can be handled over the phone by Dartmouth General Hospital Pharmacy at 902-465-8544. The Nova Scotia Clozapine Committee shall review applications for clozapine therapy on a regular basis and shall recommend to the Department of Health & Wellness whether or not to fund outpatient clozapine therapy under the program. The evaluation is based on review of the reports submitted rather than on direct patient examination. The Committee serves to ensure that only patients meeting the selection criteria are funded for clozapine therapy and that those most in need and likely to benefit will get priority. The names of patients approved for clozapine therapy are placed on the Nova Scotia Clozapine Register and entered into the system. The pharmacy should maintain a manual record of patients approved on the clozapine registry in the clozapine binder (Clozapine Nova Scotia Patients - Appendix C). In situations where the patient was previously approved by the program and in the process of being re-started on clozapine, it may be sufficient to call the Dartmouth General Hospital Pharmacy and provide the information over the phone so that the application can be re-instated. Otherwise, one can also fax the application a second time to reinstitute the patient’s status as active (Application for Outpatient FundingAppendix B).

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Clozapine Program – Nova Scotia Patients – Policy 4.31

D.

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Registration with Clozaril® Support and Assistance Network (CSAN) For newly admitted patients and for patients who are already on clozapine treatment, confirmation with CSAN that the client/patient is registered, has an active CSAN number and authorized to receive doses is required. The providers including the psychiatrist and pharmacist/pharmacy must also all be registered with CSAN. Approval for funding of clozapine therapy by the Nova Scotia Clozapine Committee should ideally be processed prior to registration with CSAN or concurrently as outlined in Section C above. Practitioners must familiarize themselves with the Clozaril® Product Monograph and the CSAN program. Registration with CSAN for the healthcare team and the patient requires the following: 1. If not registered previously, the psychiatrist, pharmacy, and/or local case coordinator are considered registered once their information is sent to CSAN via the initial application for the patient on CSAN Form #1 as outlined below. Registration with CSAN needs to take place once for everyone involved, thereafter, there is no need to re-register. (CSAN Form #1 Enrolment/Modification/Discontinuation - Appendix D). 2. An online portal exists, www.csan.ca, and may be used to track patients and upload blood work in lieu of faxing the lab test results to CSAN. The online profile for each patient also details information which includes but is not limited to the CSAN registration number, last blood test date, next blood test date, last blood test alert status, and all lab test results. The online portal gives visibility to all patients within the healthcare centre that are registered with CSAN and receiving drug at the institution. Although it is not mandatory to register to the online portal it is highly recommended for all providers involved. The initial registration for the online system may be completed by calling CSAN at 1-800-267-2726 and providing the information requested. An email confirmation with a user name and password will be sent once registration is processed. The registration needs to take place one-time only. 3. In order to register the patient, the psychiatrist involved shall complete and sign Sections 1, 2, 4, and, as required, Section 5 (for treatment discontinuation) of CSAN Form # 1. The form requires basic client/patient information, institution specific information, and the physician and pharmacist signature. The pharmacist may assist in completing the form. (CSAN Form #1 Enrolment/Modification/Discontinuation – Appendix D). 4. Partially completed CSAN Form #1 by the psychiatrist should then be sent to the hospital pharmacy either prior to or with the initial Clozapine order for completion. The pharmacist involved shall complete and sign Section 3 of CSAN Form #1 and Fax copies of Form #1 to CSAN Fax # 1-800-465-1312. If baseline CBC with differential (including WBC and ANC) is already available and, if normal, lab test results should either be 1) faxed to CSAN Fax # 1-800-465-1312 or; 2) entered in the online database (www.csan.ca) if the provider and patient are already registered (CSAN Online Portal Blood Test Entry Instructions – Appendix E). Communicating the baseline lab test should be completed by the care unit involved in the patient’s care and/or pharmacist – coordination should take place between the two parties in regards to this responsibility. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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5.

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If baseline lab test is not already available, the treating psychiatrist shall obtain baseline CBC and differential (including WBC and ANC) and, if normal, lab test results should either be 1) faxed to CSAN Fax # 1-800-465-1312 or 2) entered in the online database (www.csan.ca) if the provider and patient are already registered (CSAN Online Portal Blood Test Entry Instructions – Appendix E).

6. Once the paperwork (CSAN Form # 1) is forwarded to CSAN and the baseline required lab test result has either been faxed or uploaded online, the psychiatrist, pharmacy, and/or local case coordinator will receive confirmation from CSAN that the client/patient has been enrolled via the fax number(s) originally provided on CSAN Form # 1 for all parties involved. Approved patients will be given a CSAN registration number. An Alternative to waiting for the fax confirmation to arrive is to call CSAN at 1-800-267-2726 at least one hour after faxing CSAN Form # 1 and the baseline lab test required. Treatment should only be started upon receipt of formal notification from CSAN or confirmation over the phone. If for any reason, the patient is not cleared by CSAN to start treatment, this would be indicated on the communication from CSAN. Generally, the client/patient must be started on clozapine within 28 days of the baseline lab work or the WBC and ANC must be repeated. The pharmacy dispensing clozapine should enter patient name and CSAN registration number on tracking form (Clozapine Nova Scotia Patients - Appendix C) and include a copy of the fax confirmation from CSAN in the Pharmacy Clozapine binder under the patient’s newly created or already existing section/tab. 7. The pharmacist is authorized to dispense clozapine upon confirmation of registration with CSAN. If any questions arise contact CSAN at 1-800-267-2726 or email CSAN at [email protected]. The pharmacy user name and password for the online database www.csan.ca is for pharmacy use only and can be found in the pharmacy clozapine binder or alternatively in the Formulary Comments section of clozapine on Meditech. E.

Initiation of Clozapine Therapy Initiation of clozapine therapy first requires appropriate patient selection, patient education and consent, committee approval (highly recommended even if patient has their own drug coverage), normal baseline CBC and differential within 28 days of the first dose, and registration with CSAN for the patient and providers involved as outlined in Sections A, B, C, and D, respectively. Clozapine may then be dispensed and administered in accord with a psychiatrist’s written order.

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F.

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Prescribing, Monitoring, and Dispensing Procedure(s) Prescribing and Monitoring  Prescribers must use the Clozapine Initiation Orders FORM ID IWKCLIN to initiate an order for clozapine for a patient admitted to hospital.  Before prescribing may occur, patients must be registered with the CSAN program (refer to Section D) and have an active CSAN number. The client/patient must be started on the drug within 28 days of the baseline lab test results if normal or the WBC and ANC must be repeated.  Patients shall have their WBC count and differential granulocyte count checked on a weekly basis for the first 26 weeks of treatment. An order for weekly laboratory CBC with differential should be written by the treating psychiatrist and changed accordingly each time the frequency of monitoring changes in accordance with set forth guidelines. If acceptable WBC and ANC have been maintained during the first 26 weeks of continuous therapy, the WBC and differential count can be performed at two-week intervals for the next 26 weeks. Thereafter, if acceptable WBC counts and ANCs have been maintained during the second 26 weeks of continuous therapy, the WBC count and differential count can be performed every four weeks throughout treatment.  Changes from weekly to every two week or every four week testing will be communicated by CSAN to the treating physician, pharmacy, and local case coordinator via the fax number that was originally provided on CSAN Form # 1 at the time of enrollment. The date of the next due lab test and frequency of monitoring will be indicated on the fax communication. Alternatively, the next lab test date and monitoring frequency are updated online on the patient profile that can be accessed on www.csan.ca by authorized users. Once the frequency of monitoring changes, the treating physician must then discontinue the previous laboratory monitoring order and rewrite a new laboratory monitoring order for CBC with differential to reflect the change in frequency.  Where the WBC results allow, and the monitoring frequency has been changed, the psychiatrist may reorder the clozapine therapy for another week (or 14 or 28 days where approved).  Lab test results will be monitored weekly/biweekly/monthly as appropriate by all parties involved including the physician, pharmacist, and the CSAN coordinator.  If the treating psychiatrist would like to change the monitoring frequency or request a change that is outside the parameters of the Clozaril® product monograph, he/she can fax a note detailing the request and the reason for the request to CSAN. Additionally, completion of a waiver would be requested from CSAN to make the change at the discretion of the treating psychiatrist.  IWK Laboratory requires a note that the lab work requested is for a clozapine patient. This is indicated in Meditech by placing “CSAN” in the “other provider” ordering doctor field when placing the lab test order. This code flags the laboratory to fax results directly to CSAN. Outside of faxing baseline lab test results prior to initiation of clozapine therapy there should generally not be a need for the care team or pharmacy to fax or upload ongoing lab tests online unless for some reason it does not get communicated appropriately by the IWK lab to CSAN. 

The physician and pharmacist shall interpret the lab test results as per the CSAN colour-coded laboratory monitoring guidelines listed below (Refer to CSAN’s “Hematological Quick Reference Chart” found in the clozapine binder): This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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1.BASELINE CHECK 1.1 WBC greater than or equal to (>) 3.5 1.2 ANC greater than or equal to (>) 2 2.GREEN: 2.1 Criteria for Green 2.1.1 WBC greater than or equal to (>) 3.5 AND 2.1.2 ANC greater than or equal to (>) 2 (and patient feels well and is afebrile). 2.2 Response to Green 2.2.1 Continue to dispense Clozaril® 2.2.2 Monitor as follows for eligible patients 2.2.2.1 Weekly for the first 26 weeks 2.2.2.2 Every 2 weeks for the subsequent 26 weeks 2.2.2.3 Every 4 weeks as of 52 weeks 3.AMBER: 3.1 Criteria for Amber 3.1.1 WBC between 2.0-3.5 3.1.2 ANC (granulocytes) between 1.5-2.0 3.1.3 Flu-like complaints or other signs or symptoms that might suggest infection (e.g. fever) 3.1.4 Single fall or sum of falls in WBC greater than or equal to 3 is measured in the last 4 weeks, reaching a value below 4. 3.1.5 Single fall or sum of falls in ANC of greater than or equal to 1.5 is measured in the last 4 weeks reaching a value below 2.5. 3.2 Response for Amber 3.2.1 Monitor twice weekly until results turn to GREEN 3.2.2 Continue to dispense Clozaril®. 4.RED 4.1 Criteria for Red 4.1.1 WBC below 2 and/or ANC below 1.5 4.1.2 A second red result (from a new blood sample) is considered a “confirmed” RED 4.2 Response for Red 4.2.1 Notify CSAN at 1-800-267-2726 4.2.2 Confirm laboratory results by drawing another sample within 24 hours! 4.2.3 STOP CLOZAPINE THERAPY IMMEDIATELY IF RESULTS ARE CONFIRMED. Monitor for 4 weeks. 4.2.3.1 Monitor for flu-like complaints or other symptoms that might suggest infection. 4.2.3.2 Patient should be treated for potential agranulocytosis. 4.2.4 DO NOT RESUME CLOZARIL® THERAPY (unless exceptions are made in consultation with CSAN) 4.2.5 A non-re-challengeable status is immediately assigned to the patients profile. 4.2.6 Re-challenging a client/patient after a confirmed Red Alert

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Clozapine Program – Nova Scotia Patients – Policy 4.31

4.2.6.1

4.2.6.2

4.2.6.3

4.2.6.4 4.2.6.5

4.2.6.6

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After a confirmed red alert occurs cessation of clozapine is mandatory. However once risks and benefits have been carefully considered, re-challenge may be justified in some clients/patients The decision to re-challenge is at the discretion of the treating psychiatrist and in consultation with CSAN and their haematologist. A psychiatrist who wishes to re-challenge must complete the steps for a routine enrolment. In addition to routine forms the psychiatrist must apply for and complete a Treating Physician’s Agreement from CSAN and waiver. The psychiatrist should fax CSAN a note detailing a request to re-challenge based on a previous RED and provide the reason. The CSAN site coordinator is available to assist with the application for this agreement. CSAN would send the history and request to their haematologist. It is recommended to titrate the dose slowly. Haematological monitoring must be completed a minimum of twice weekly for the first 6 weeks or as outlined by CSAN’s haematologist upon approval to restart. The psychiatrist may consider the use of concomitant medication with known neutrophilic effects.

*Exceptions in coordination with the registry may occur. Some client/patients are provided with Special Monitoring Guidelines (lower cut-offs for amber and red statuses). These guidelines are communicated by CSAN to the physician and pharmacist. 



 



Dispensing An initial order for clozapine must be received on the clozapine PPO Form ID IWKCLIN. Pharmacy may dispense clozapine if the lab test result is within normal range in accordance with the CSAN monitoring guidelines listed above. The pharmacist should make a copy of the recently checked lab test result for the patient and place it in the patient-specific tab in the Pharmacy Clozapine Binder. The pharmacist should be aware of any changes in monitoring frequency required depending on the results. Clozapine may be dispensed on the basis of a WBC count taken within the previous seven days (14 or 28 days where approved) provided that a new blood sample is collected, a report of the results is expected within 24 hours, and the patient can be contacted within 24-48 hours should the WBC be low. Clozapine may be dispensed if there is a dosage change that requires additional supply to be sent prior to the next scheduled lab test. The supply should last until the next scheduled lab test. Clozapine may not be dispensed to patients who have missed or refused the scheduled lab tests unless special arrangements have been made between the pharmacist and the treating physician on account of extenuating circumstances and in consultation with CSAN. The pharmacy may dispense up to a 10-day supply for the initial outpatient prescription upon discharge.

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G. Dispensing Summary - IWK Pharmacy This is only meant as a summary. Refer to the appropriate section of the policy for complete details. Inpatient Dispensing (including initial discharge supply provided): Initial Order:  Ensure patient is registered with CSAN (Section D)  Enter patient’s name and CSAN # on Clozapine NS Patient’s List (Clozapine Nova Scotia Patients Appendix C)  Dispense following usual inpatient order entry procedure  Draw stock from inpatient supply  Enter patient’s name, amount dispensed, etc. (Clozapine Drug Accountability Log –for Inpatients or Non-approved Outpatients - Appendix F). NOTE: There is a separate log for each clozapine strength.  Print receipt.  File order in Clozapine File Refill: Ensure patients lab test results have been checked before refilling order (Section F). Place a copy of the checked lab test results in the Pharmacy Clozapine binder under the patient’s newly created or already existing section/tab The pharmacy may dispense up to a 10 day supply for the initial outpatient prescription H.

Purchasing: 



The health centre pharmacy shall acquire inpatient and non-approved outpatient clozapine stock directly from the Provincial Drug Distribution Program (PDDP), expect a 2 day lag time - mark order for inpatient use. Inpatients costs shall be charged to the care area cost centre. The initial outpatient prescription (up to a 10 day supply) upon discharge is not generally covered by the Nova Scotia Clozapine Outpatient Program and shall be charged to the discharging care area cost centre similar to the inpatient costs.

 I.  

Discharge Coordination Refer to Appendix F for details on patients living in Nova Scotia and Appendix G for patients living outside of Nova Scotia. Appendix H includes a fax that can be sent to community pharmacy’s that are signing up to dispensing clozapine for a first time.

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REFERENCES:  

Nova Scotia Department of Health, Mental Health Services, Nova Scotia Clozapine Program, Revised Protocol January 1998. Novartis Clozaril® Product Monograph.

RELATED DOCUMENTS Forms        

Nova Scotia Clozapine Program Initial Application (Appendix B) Clozapine Nova Scotia Patients (Appendix C) CSAN Form #1 Enrollment/Modification/Discontinuation (Appendix D) CSAN Online Portal Blood Test Entry Instructions (Appendix E) Clozapine Initiation Orders ID IWKCLIN Guideline for Discharge and Coordination of Clozapine Therapy for Nova Scotia Patients(Appendix F) Guidelines for Discharge and Coordination of Clozapine Therapy for Patients Living OUTSIDE Nova Scotia (Appendix G)\ Guidelines/Fax to Community Pharmacy Dispensing Clozapine

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APPENDIX A DEFINITIONS Nova Scotia Clozapine Committee

Committee responsible for advising the department of Health regarding the program and for evaluating eligibility of patients for the program based on written submissions.

Program Co-Ordinator

Person responsible for processing applications for approval for clozapine, maintaining Clozapine Register, co-ordinating communication between hospital facilities, NS Hospital Pharmacy, CSAN and Department of Health and for general education.

Clozapine Register

List of current patients approved for the Nova Scotia Clozapine Program.

Clozaril® Support and Assistance Network (CSAN)

Network established for healthcare professionals (doctors, nurses, and pharmacists); to manage the possible risks of adverse events with Clozaril®; to optimize the communication between the clinic, laboratory, and pharmacy; to manage the risk of agranulocytosis.

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APPENDIX B (Policy 4.31) NOVA SCOTIA CLOZAPINE PROGRAM

APPLICATION for OUTPATIENT FUNDING Patient’s Name: ______________________________ CSAN or GenCAN #: ______________ Health Card Number: ___________________________ Age: __________

Sex: __________

Date of Birth:_________________

Third Party Health Insurer ____________________

Psychiatrist: _______________________

Hospital or Clinic: ________________________

1. Diagnosis  Schizophrenia  Schizoaffective Disorder  Bipolar  Other (please specify) ________________________________________________ Length of Illness: ____________________________________________________________ Number of Hospitalizations: ____________________________________________________ 2. Response To Previous Antipsychotics Has the patient demonstrated an inadequate response or poor tolerance to at least two antipsychotics, one of which is a novel agent, used at therapeutic doses for six weeks or more?  Yes (If yes please list in chart below)  No Drug Name

Highest Dose (mg/day)

Duration of Treatment

Response? (yes or no)

Intolerance?* (yes or no)

1. 2. 3. 4. * If intolerance, list side effects: _________________________________________________ __________________________________________________________________________

_______________________ Date

_____________________________________ Psychiatrist Signature

Contact information (Phone, email) to communicate application decision ______________________________________________________________ Please fax form to Dartmouth General Hospital Pharmacy at 465-8548; further inquiries by phone to 465-8544

ENSURE COMPLETION OF APPLICATION TO BE CONSIDERED FOR APPROVAL Registration with the Manufacturer’s Blood Monitoring Program is a SEPARATE PROCESS- complete before starting therapy Form review date – August 2016 This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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APPENDIX C CLOZAPINE – NOVA SCOTIA PATIENTS

NAME

CSAN #

APPROVED

NON-APPROVED

12/16

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APPENDIX D

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APPENDIX E Blood test Entry Method #1

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Blood test entry method #2: If you already have looked at the patient before, on the Home page, click on the Hyperlink under Recent Items.

This brings you to the patient’s page. If you scroll down the patient page, you can see the current physician and pharmacy on file.

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APPENDIX F Guidelines for Discharge and Coordination of Clozapine Therapy for Nova Scotia Patients   

Coordination of outpatient clinical, laboratory, and pharmacy services must be individualized for each patient prior to discharge. This coordination is the responsibility of the care team. The patient must first be set-up with an outpatient psychiatrist who will follow and monitor the patient’s progress, prescribe clozapine, and order necessary lab tests. Scenario # 1: If the patient has a drug plan/coverage AND can afford the copayment: o Coverage of clozapine on the drug plan should be confirmed by the IWK pharmacist involved prior to coordination with a community pharmacy. The IWK pharmacist should also confirm that the patient and/or family can afford the co-payment. o It is highly recommended that a Clozapine Application for Outpatient Funding be completed and signed by the physician (refer to Section C) even if the patient has drug coverage. This is in case drug coverage lapses to ensure that the patient is registered and set up within the system preventing any interruption in treatment. o Patient may fill the clozapine prescription at any outpatient community pharmacy provided the community pharmacy is aware and willing to provide the necessary supports required. o To assist the pharmacy in making an informed decision, the IWK pharmacist involved will provide the community pharmacy with the necessary information required to register with CSAN or an alternative program depending on the brand of clozapine that will be dispensed in addition to information about clozapine and the necessary monitoring requirements. o The IWK pharmacist should fax the document in Appendix G “Guideline to Dispending Clozapine to Outpatients by Community Pharmacy” to help guide the community pharmacy. o If community pharmacy agrees to dispense and monitor clozapine, they must follow the necessary steps to register with CSAN or an alternative program (refer to Section D for CSAN specific information). o The community pharmacy may purchase the Clozaril® brand or other brand from their distributer. The IWK pharmacist involved with the patient’s care should advise the community pharmacy of the patient’s current dosage so that the community pharmacy can set up the order appropriately. o Prior to discharge, patient should also be set-up with a local laboratory for the required blood monitoring. The lab test can be done at a local community laboratory as long as the review and reporting of results and “no blood result, This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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no drug” policy is preserved. Some community laboratories can arrange a blood draw in the patient’s home, but patient should expect an additional charge for this service. The laboratory must fax the lab test results to the dispensing community pharmacy, managing psychiatrist, and/or to CSAN or alternative program as well. Some laboratories may not fax the results directly to CSAN or an alternative program and the responsibility will lie upon the community pharmacy and managing psychiatrist. 

Scenario # 2: If the patient does NOT have a drug plan/coverage OR cannot afford the co-payment on a drug plan and lives Halifax area in close proximity to Dartmouth General Hospital Pharmacy: o The attending psychiatrist must make application to the Nova Scotia Clozapine Committee. A Clozapine Application for Outpatient Funding must be completed and signed by the physician prior to initiation of clozapine therapy. The pharmacist involved may assist in completing the application (Application for Outpatient Funding - Appendix B). The final application should be faxed to Dartmouth General Hospital Pharmacy at 902-465-8548 (Refer to Section C). o The team/pharmacist can confirm patient approval by calling Dartmouth General Hospital Pharmacy at 902-465-8544. Alternatively the program may fax/email a confirmation. o Dartmouth General Hospital Pharmacy will be responsible for the monitoring of labs for the patient in addition to the dispensing of Clozapine. o Once the patient is approved, for most cases he/she will generally receive the dispensed drug from Dartmouth General Hospital Pharmacy location.  Alternatively, the patients may coordinate with their local pharmacy, if possible, to have a driver pick up the medication. In this scenario, the pharmacy picking up the medication is only responsible for housing the drug safely and NOT for the monitoring of therapy. Dartmouth General Hospital Pharmacy would communicate with the pharmacy to release the drug at the time that the lab test is normal. There may be a charge from the community pharmacy to the patient for this service.  Alternatively, Dartmouth General Hospital Pharmacy can, in some situations, send the drug to the institution where the lab is located (example: Early Psychosis Program or to the Halifax Infirmary clinic)  It is the responsibility of the patient and/or their family to coordinate alternative options with Dartmouth General Hospital Pharmacy. IWK team may assist with this coordination. o Prior to discharge, IWK pharmacist in coordination with the coordinator at Dartmouth General Hospital pharmacy should ensure that the patient is setup with a laboratory. (Most patients will get their lab work done at Dartmouth General Hospital where they will also pick up their medication.)  Depending on the individual situation, a patient may be set-up with This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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one of the NSHA Central Zone laboratories if it is more of a convenience to them (refer to the following website for a list of laboratories: http://www.cdha.nshealth.ca/pathology-laboratorymedicine-17) 

Scenario # 3: If the patient does NOT have a drug plan/coverage OR cannot afford the co-payment on a drug plan and DOES NOT live in the metro area, but are located close to another major hospital (e.g., Cape Breton Regional) o The attending psychiatrist must make application to the Nova Scotia Clozapine Committee. A Clozapine Application for Outpatient Funding must be completed and signed by the physician prior to initiation of clozapine therapy. The pharmacist involved may assist in completing the application (Application for Outpatient Funding - Appendix B). The final application should be faxed to Dartmouth General Hospital Pharmacy at 902-465-8548 (Refer to Section C). o The team/pharmacist can confirm patient approval by calling Dartmouth General Hospital Pharmacy at 902-465-8544. Alternatively, the program may fax/email a confirmation. o Generally, the hospital will take the responsibility of monitoring of labs for the patient in addition to the dispensing of clozapine. o The funding for the drug will be set up with the Nova Scotia Clozapine Program through Provincial Drug Distribution Program (PDDP) so that the local hospital pharmacy can order the drug without cost to the hospital. PDDP will not have knowledge of the patient name in order to preserve confidentiality. This will be set up by the Dartmouth General Hospital Pharmacy. o The IWK pharmacist and team should ensure that the patient is set-up with the hospital laboratory for ongoing monitoring. o The exception to this is in Truro where clozapine is managed by retail pharmacy

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Scenario # 4: If the patient has NO drug plan/coverage OR cannot afford the co-payment on the drug plan AND lives in a rural remote area with no access to a major hospital o The attending psychiatrist must make application to the Nova Scotia Clozapine Committee. A Clozapine Application for Outpatient Funding must be completed and signed by the physician prior to initiation of clozapine therapy. The pharmacist involved may assist in completing the application (Application for Outpatient Funding - Appendix B). The final application should be faxed to Dartmouth General Hospital Pharmacy at 902-465-8548 (Refer to Section C). o The team/pharmacist can confirm patient approval calling Dartmouth General Hospital Pharmacy at 902-465-8544. Alternatively the program may fax/email This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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a confirmation. o A local community pharmacy will be identified that agrees to dispense and monitor lab test results for the patient. o To assist the pharmacy in making an informed decision, the IWK pharmacist involved in coordination with the Dartmouth General Hospital coordinator will provide the community pharmacy with the necessary information required to register with CSAN in addition to information about clozapine and the necessary monitoring requirements. o The IWK pharmacist should fax the document in Appendix F “Guideline to Dispending Clozapine to Outpatients by Community Pharmacy” to help guide the community pharmacy. o The funding for the drug will be set up with the Nova Scotia Clozapine Program through Provincial Drug Distribution Program (PDDP) so that the local community pharmacy can order the drug without cost to the pharmacy. PDDP will not have knowledge of the patient name in order to preserve confidentiality. This will be set up by the Dartmouth General Hospital Pharmacy. The IWK pharmacist should alert Dartmouth General Hospital Pharmacy of the name and location of the community pharmacy that was chosen by the patient. o IWK pharmacist in coordination with the coordinator at Dartmouth General Hospital pharmacy should ensure that the patient is set-up with a community laboratory for ongoing monitoring. The laboratory monitoring can be done at a local community laboratory as long as the review and reporting of results and “no blood result, no drug” policy is preserved. Some community laboratories can arrange a blood draw in the patient’s home but there may be a charge for this. The laboratory can be set up to fax the lab test result to the community pharmacy, managing psychiatrist and/or to CSAN as well. Some laboratories may not fax the results directly to CSAN and the responsibility will lie upon the pharmacy and managing psychiatrist. 

Prior to discharge the IWK team including the treating psychiatrist and pharmacists involved must ensure the following for ALL patients:  Patient has an outpatient psychiatrist that will be following his treatment and progress  Patient has been set-up with a local laboratory for hematological monitoring  Patient has been set-up with a pharmacy (community or hospital) to receive the drug  Latest laboratory results have been faxed to the outpatient psychiatrist and pharmacy where the drug will be dispensed (retail or hospital)  Patient has enough drug supply to last during the transition period. The IWK pharmacy may dispense up to 10 days of clozapine with the initial outpatient prescription (an extended supply can be discussed depending on the patient circumstance). This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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APPENDIX G Guidelines for Discharge and Coordination of Clozapine Therapy for Patients Living OUTSIDE Nova Scotia   

Follow the general guidelines described in Section I. The outpatient funding set-up for clozapine is different in each province. Every effort should be made to contact the local funding program in order to get the patient registered. The patient may require an extended drug supply upon discharge to last during the transition period.

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APPENDIX H Guidelines/Fax to Community Pharmacy Dispensing Clozapine 

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Patients must be registered with the Clozaril® Support and Assistance Network (CSAN) monitoring program and have an active CSAN registration number. The registration with CSAN must include the current treating psychiatrist and the dispensing pharmacist/pharmacy and laboratory. Changes in either are made by completing the registration form and faxing it to CSAN at 1-800-465-1312. The registration/enrollment form can be found on the CSAN website at www.csan.ca. The responsibility of setting up your pharmacy will be conducted in collaboration with the IWK pharmacist involved. If your pharmacy accepts the responsibility of clozapine dispensing, a prescription for clozapine will be sent your pharmacy by the managing psychiatrist at IWK Health Centre or the patient/family member will provide you with a written prescription. In regards to funding, patients who are NOT covered by a private insurance must also be approved and registered with the Nova Scotia Clozapine Program for funding purposes. This generally is already done for all patients by the IWK pharmacist in collaboration with the IWK mental health team. For more information regarding the application process, please contact the Dartmouth General Hospital Pharmacy at 902-465-8544 and liaise with the IWK pharmacist involved to ensure that patient has been approved for outpatient funding. If the patient is NOT covered under private insurance and has been approved by the Nova Scotia Clozapine Program, your pharmacy can order the drug at no cost to you or the patient by following the steps listed below: 1. Call the Provincial Drug Distribution Program (PDDP) at 902-473-8589 and provide your pharmacy details including, name of pharmacy, location, contact information and any other information required to get an account set up. 2. To order the drug, fax PDDP at 902-473-8574 a request detailing the number of bottles, and strengths of clozapine, specifying the brand name, depending on the patient’s treatment dose and needs and include that the drug is for a patient that has been approved by the Nova Scotia Clozapine Outpatient Program. Exclude mention of the specific name of the patient for confidentiality purposes. Dartmouth General Hospital Pharmacy who administers the Nova Scotia Clozapine Program would have already informed PDDP that your pharmacy will be dispensing clozapine to an approved outpatient. 3. The order needs to be placed before 2 pm so that it arrives next business day to your pharmacy. No courier charges apply. It is best to alow at least This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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two business days to ensure the drug arrives to the pharmacy in time for the patient’s dose. 4. Once the order is received, reserve the bottle/bottles for that specific patient’s use. 5. A running inventory of clozapine dispensed should be maintained and faxed to Dartmouth General Hospital Pharmacy at 902-465-8548 when a new supply is ordered from PDDP. An inventory sheet may be requested from Dartmouth General Hospital Pharmacy at 902-465-8544. Make copies of it for future use. 

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Your pharmacy can make arrangements for compensation with Pharmacare if the patient is receiving clozapine as an approved outpatient through the Nova Scotia Clozapine Program. Pharmacare will often contact Dartmouth General Hospital Pharmacy to confirm if the patient has been approved for the provincial clozapine program in order to allow your community pharmacy to bill a fee for dispensing, prepacking, etc. The compensation set up should be coordinated by your pharmacy directly with Pharmacare. If the patient is covered by a private insurance, your pharmacy can purchase the specific brand of Clozapine that the patient is taking through your assigned distributer. A supply of clozapine may only be dispensed upon verification of a blood test for a CBC and differential. A supply of clozapine may then be dispensed to last until the next blood test is due. Patients treated less than 6 months require a lab test every week (a seven day supply) and those over six months every two weeks. After 12 months of therapy, many patients are able to have blood monitoring done every four weeks. The treating psychiatrist must authorize any changes in the frequency of blood monitoring upon notification of eligibility from CSAN. The dispensing pharmacist should familiarize him/herself with the current CPS monograph monitoring guidelines. CSAN can provide your pharmacy with a binder and other useful information on Clozaril® including a laminated hematologic monitoring quick reference chart. Contact CSAN at 1800- 267-2726 to request the information to be mailed to your pharmacy. An initial guideline is provided to you below:

A. GREEN: a. Criteria for Green i. WBC greater than or equal to 3.5 AND ii. ANC greater than or equal to 2.0 (and patient feels well and is afebrile). b. Response to Green i. Continue to dispense Clozaril® ii. Monitor as follows for eligible patients This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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1. Weekly for the first 26 weeks 2. Every 2 weeks for the subsequent 26 weeks 3. Every 4 weeks as of 52 weeks B. AMBER: a. Criteria for Amber i. WBC between 2.0 and 3.5 ii. ANC (granulocytes) between 1.5 and 2.0 iii. Flu-like complaints or other signs or symptoms that might suggest infection (e.g., fever) iv. Single fall or sum of falls in WBC greater than or equal to 3.0 is measured in the last 4 weeks, reaching a value of lower than 4.0 v. Single fall or sum of falls in ANC of greater than or equal to 1.5 is measured in the last 4 weeks reaching a value of less than 2.5 b. Response for Amber i. Monitor twice weekly until results turn to GREEN ii. Continue to dispense Clozaril®. C. RED a. Criteria for Red i. WBC below 2.0 and/or ANC below 1.5 ii. A second red result (from a new blood sample) is considered a “confirmed” RED b. Response for Red i. Notify CSAN at 1-800-267-2726 ii. Confirm laboratory results by drawing another sample within 24 hours! iii. STOP CLOZAPINE THERAPY IMMEDIATELY IF RESULTS ARE CONFIRMED. Monitor for 4 weeks. 1. Monitor for flu-like complaints or other symptoms that might suggest infection. 2. Patient should be treated for potential agranulocytosis. iv. DO NOT RESUME CLOZARIL® THERAPY (unless exceptions are made in consultation with CSAN) 

The WBC and granulocyte lab results will be faxed to your pharmacy, CSAN, and the managing psychiatrist. All are responsible for ensuring that the lab test is ok prior to the patient getting clozapine. In most circumstances, the results with be faxed directly by the chosen laboratory to all three parties. The IWK pharmacist and mental health team take responsibility of that coordination. It is your pharmacy’s responsibility however to ensure that the lab test is ok prior to dispensing the next week’s supply of clozapine (or biweekly or monthly depending on the circumstance) by assessing the WBC and ANC numbers. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server version prior to use

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Please follow the recommendations placed fourth in the Clozaril® monograph and CSAN hematologic monitoring guidelines. If you choose, CSAN can notify you as a pharmacy when the clozapine may be released to guide this process. You will need to take the necessary arrangements to set this up by calling CSAN at 1-800-267-2726. Please provide the patient’s CSAN # and date of birth as they are used as identifiers in any correspondence with CSAN. The Clozaril® website, www.clozaril.ca, can be used as an educational tool. The website includes useful information that can be related to the patient and/or family as well as illustrative videos that can guide the educational session. To enter the site, the patient and/or family member will need the Drug Identification Number located on the Clozaril® package, alternatively any healthcare provider can enter the site by inputting “123456” in the license number field requested. Please feel free to contact the IWK Pharmacy Team at 902-470-8134 for any questions. You can specifically request to speak with the Clinical Pharmacy Specialist dedicated for mental health. If he/she is not available, the pharmacist involved with the particular patient’s discharge can assist you.

Regards, IWK Pharmacy 902-470-8134

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IWK Policies Being Replaced

*** Version History Major Revisions (e.g. Standard 4 year review)

Minor Revisions (e.g. spelling correction, wording changes, etc.

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