The Canadian Adverse Drug Reaction Monitoring Program has been renamed ’Canada Vigilance’, according to an announcement by Health Canada. Regional adverse reaction monitoring offices will now be referred to as Canada Vigilance Regional Offices, and reporting mechanisms will remain the same. User Guide to completion and submission of the AEFI reports Table of Contents Acknowledgements Acronyms and abbreviations. When did National Vaccine Post Marketing Surveillance begin in Canada? National monitoring of adverse events dates back to. Health Canada releases important information on the dispensation of CLOZAPINE products in Canada - For Health Professionals - Recalls & alerts. June 2. 3, 2. 00. Subject: Monitoring of patients taking clozapine in Canada. Dear Health Care Professional. The Marketed Health Products Directorate (MHPD) and the Therapeutic Products Directorate (TPD) would like to draw your attention to important upcoming revisions to the Product Monographs of all clozapine products marketed in Canada. These revisions will strengthen the labelling and address ongoing issues around patient consent for the sharing of information between registries. Canadian Adverse Drug Reaction Monitoring Program Health Canada, through the Canadian Adverse Drug Reaction Monitoring Program (CADRMP), is responsible for collecting and assessing adverse reaction reports for the following health. Health Canada produces the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Adverse Reaction (AR) Database, which provides access to information on suspected adverse reactions to Canadian marketed pharmaceuticals, biologic agents, natural health products, and radiopharmaceuticals. As you know, monitoring of patients with the use of registries is the risk mitigation strategy in place to address the known risk of agranulocytosis. Revisions to clozapine Product Monographs will emphasize the following: the switching of a patient from one brand of clozapine to another must not be done by a pharmacist unless he/she obtains a new, registry- specific patient registration form filled out by the prescribing physician. Patients must undergo regular haematological tests to monitor their total white blood- cell and absolute neutrophil counts. Between 1. 99. 1 and 2. The introduction of generic clozapine in the last year has led to the establishment of other registries. The inclusion of this text in the Patient Registration Form is necessary to overcome ongoing problems with the exchange of information between registries, caused in part by some potential implications of the . As a preventive measure and to avoid any confusion, physicians may also ask patients already on clozapine to fill out the updated Patient Registration Form. A . Any further questions on clozapine Products Monographs' updates should be adressed to the Therapeutic Products Directorate (TPD), by phone: (6. TPD- General- DPT- G. Any further questions related to this letter should be adressed to the Marketed Health Products Directorate (MHPD): (6. I understand that no pharmacy will dispense any brand of clozapine to my patient without my prior knowledge and permission regarding which brand is being dispensed. In this way I will be able to inform the laboratory to send my patient's results to the appropriate manufacturer's clozapine database. I will not prescribe clozapine until the non- rechallengeable status of this patient has been verified. ADVERSE DRUG REACTION REPORTING FORM. REPORT ON SUSPECTED SERIOUS ADVERSE DRUG REACTION 1. PARTICULARS OF PATIENT Name of patient. Age Weight (kg) Patient address Sex Male Race Female Pregnant Yes No Not. Canadian Adverse Events Following Immunization Surveillance System Entry into iPHIS/PARIS Local/Designated. Titre du document / Document title Canadian Adverse Drug Reaction Monitoring Program (CADRMP)-Adverse Reaction (AR) Database <http:// medeff /databasdon /index. Acronym Definition CADRMP Canadian Adverse Drug Reaction Monitoring Program. Disclaimer All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. The information which may be released includes, the non- rechallengeable/haematological status of the patient, white blood cell counts and absolute neutrophils counts, dates and other information as may be relevant to the safe treatment of the patient with clozapine. Why does my blood need to be monitored if I am taking clozapine? Due to the risk of developing this condition, regular blood testing of white blood cell counts must take place for individuals on clozapine, to ensure that the white blood cell counts remains within the normal range. Why does my doctor need my consent? Each supplier has a different monitoring system to ensure patient safety. Should your doctor and/or pharmacist (with the approval of your doctor) change the brand of clozapine you are taking, you will be transferred to a different monitoring system. If this happens, it is very important that your new supplier is able to access your past white blood cell counts results in order to help your doctor ensure that you are properly monitored. Your consent is needed to allow this verification and sharing of information to take place. Why is personal information such as my initials, birth date, gender and health card number being collected and used for identification purposes? Since this information is specific to you, it helps to ensure that your test results are not mixed up with those of another person on the same medication. Using this information also avoids the need to use your full name and therefore protects your privacy. Can my personal information be used for other purposes? Your information will only be used to ensure that you are properly monitored while using any brand of clozapine. Where can I find information on the protection of health related personal information in the private sector? Any occurrences of serious and/or unexpected adverse reactions in patients receiving clozapine should be reported to Health Canada at the following address. Canadian Adverse Drug Reaction Monitoring Program (CADRMP)Marketed Health Products Directorate. HEALTH CANADAAddress Locator: 0. COTTAWA, Ontario, K1. A 0. K9. Tel: (6. Fax: (6. 13) 9. 57- 0. To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 8. Fax: 8. 66 6. 78- 6. For other inquiries: please refer to contact information.
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