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The Marketed Health Products Directorate (MHPD), Therapeutic Products
Directorate (TPD) and Biologics and Genetic Therapies Directorate
(BGTD) post safety alerts, public health advisories, press releases
and other notices from industry as a service to health professionals,
consumers, and other interested parties. Although MHPD, TPD and
BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse
either the product or the company. Any questions regarding product
information should be discussed with your health professional.
This is issued by the Marketed Health Products
Directorate and the Therapeutic Products Directorate.
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IMPORTANT SAFETY INFORMATION REGARDING
THE DISPENSING OF CLOZAPINE
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November 11, 2003
Dear Pharmacist,
The Marketed Health Products and Therapeutic Products Directorates (MHPD
and TPD) seek your collaboration by drawing your attention to an essential
element in the dispensing of the currently marketed clozapine brands,
as set out in the INDICATIONS1 Section of
the approved Product Monographs;
The switching of a patient from one brand of clozapine to another
should not be done unless the pharmacist obtains a new,
registry-specific patient registration form filled out by the
prescribing physician.
This is necessary because the monitoring systems for the clozapine
products are independent, one for each sponsor. Since it is the prescribing
physician who is ultimately responsible for verifying a patient's
hematological/non-rechallengable status as stated in the "Indications"
section of the PM1, the physician must
know which monitoring system the patient is registered in, so as to
be able to send and/or request a patient's hematological / non-rechallengable
status to the appropriate system.
In addition, when starting a new patient on clozapine, Health Canada
encourages the dispensing pharmacist to verify the patient's hematological/non-rechallengeable
status with all existing clozapine registries2. |
Health Canada's regulatory role is to establish conditions and essential
safety requirements for the use of drugs, which are indicated in the official
Canadian Product Monograph (PM). In contrast to most other drug products,
the safe dispensation of clozapine requires registration of treating physicians,
dispensing pharmacists and patients in manufacturer-specific distribution
systems1. Therefore, the switching of clozapine
brands in a multi-source environment necessitates specific steps to ensure
safety. The principles behind these steps have been set out in the PM,
with the statement that details on distribution systems can be obtained
from the manufacturers who administer these systems.
It is Health Canada's position that the safe dispensing of clozapine
in the context of multiple distribution registries relies on the cooperation
of prescribing physicians, dispensing pharmacists and on an efficient
exchange of information between Health Professionals and the registries.
The need for this DHPL, which identifies the specific area in the PM where
expansion is required, was recognized following actual marketing experience
with clozapine in a multisource environment.
original signed by
Robert Peterson, MD MPH PhD
Director General
Therapeutic Products Directorate
original signed by
David Clapin, BSc, PhD for
Christopher Turner, MD FRCPC
Director General
Marketed Health Products Directorate
- "INDICATIONS
. . . BRAND-NAME clozapine is available only through a distribution
system (SYSTEM NAME) that ensures weekly or every-fwo-week hematological
testing prior to the dispensing of the next period's supply of BRAND
NAME clozapine (see WARNINGS).
This requires.
- registration of the patient, their current location, treating
physician, testing laboratory and dispensing pharmacist in the SYSTEM
NAME.
- maintenance of a national SPONSOR-specific database that enables
the monitoring of the hematological results of all patients on BRAND-NAME
clozapine and provides timely feedback (within 24 hours of receipt
of the blood test results) to the treating physician and dispensing
pharmacist/or pharmacy.
- the ability to identify patients who have been assigned "Non-rechallengeable
Status" (see WARNINGS). This requires that SPONSOR both provide
to. and obtain from all other approved suppliers*
of clozapine, the Non-rechallengeable Status/Hematological Status
of all patients (see DOSAGE AND ADMINISTRATION). SPONSOR must be
able to provide this information within 24 hours of receiving a
written request. "
"Physicians should not prescribe BRAND NAME clozapine until the non-rechallengeable
status and the hematological status of the patient has been verified.
For the distribution system to be effective, treating physicians
must ensure that the hematological testing is performed at the required
frequency (see WARNINGS) and that the hematological results are sent
to SYSTEM NAME ."
* : " approved supplier" is a manufacturer who
holds a valid Notice of Compliance (NOC) for clozapine
- Novartis Canada Inc. CSAN® - distribution
registry 1-800-267-2726 Genpharm Inc. GenCAN®-distribution
registry 1-866-501-3338, http://www.gencan.ca
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Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR
Guidelines can be found on the TPD web site or in The Canadian
Compendium of Pharmaceuticals and Specialties.
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