Clozapine Therapy: Dispensing Procedures 12/10/10
All patients on clozapine must be registered with the Clozapine Patient Registry and monitored on an ongoing basis to prevent drug-induced neutropenia. All orders for clozapine will be dispensed based on the following procedure.
III. PROCEDURE
A. Any prescriber who wishes to prescribe clozapine must register with the Teva Clozapine Patient Registry online at www.ClozapineRegistry.com or by completing the form entitled "Physician Registration Form" and faxing to 800-507-8339.
B. The prescriber is responsible for registering any patient for whom he/she is prescribing clozapine. The prescriber will need the patient's initials, social security number, date of birth and gender. Registration can be done online, by phone, or by fax or mail (if by fax or mail, the prescriber must complete the form entitled "Patient Registration Form").
Teva Clozapine Patient Registry
74 NW 176th Street
Miami, Florida 33169
Phone 1-800-507-8334
Fax 1-800-507-8339
Email: Clozapine.Registry@TevaUSA.com
Website: www.ClozapineRegistry.com
C. Once the prescriber and the patient are registered, the prescriber must obtain the patient’s Eligibility Code/Patient ID and provide code and ID to Pharmacy along with the current (within the last seven days) White Blood Cell (WBC) count and Absolute Neutrophil Count (ANC) value for the patient prior to dispensing. The Eligibility Code/Patient ID and the WBC and ANC values (and corresponding dates these values were obtained) will be entered into the computerized physician order entry system (Sunrise Clinical Manager) at the time of order entry.
a. In order to start clozapine, the WBC count must be at least 3500/mm3 and the ANC must be at least 2000/mm3.
D. Before dispensing clozapine, the pharmacist will verify that the patient is eligible based on the current WBC and ANC values and that an Eligibility Code/Patient ID has been received. After verifying this information, the pharmacist will then verify the order and dispense clozapine to the patient.
E. Inpatients are required to have their blood work done at least every 7 days. If the blood work has not been done in the last seven days, clozapine may not be dispensed.
F. The ordering physician is responsible for ordering and monitoring the CBC with differential; however, the physician should be contacted by the pharmacist with any of the following results:
WBC < 3500/mm3
ANC < 2000/mm3
Clozapine may still be dispensed at the discretion of the treating physician based on the following critical values: SEE APPENDIX I for more information.
3500/mm3 > WBC ≥ 3000/mm3 |
Increase Monitoring to twice weekly |
3000/mm3 > WBC ≥ 2000/mm3 |
Interrupt therapy; Increase Monitoring to once daily |
G. If the WBC is less than 2000/mm3 or if the ANC is less than 1000/mm3, clozapine must be discontinued and the patient may not be re-challenged. The pharmacist will contact the treating physician to ensure that the order is discontinued.
WBC< 2000/mm3 |
Discontinue therapy |
H. Initial and weekly blood work will be reported by the Pharmacy to the Clozapine Patient Registry (within 7 days of dispensing) online at www.ClozapineRegistry.com or by completing the form entitled “WBC/ANC Lab Form for a Single Patient”" and faxing to 800-507-8339.
I. All forms should be filed in the clozapine binder located in the pharmacy. The patient's initials, social security number, date of birth and gender may be obtained from the Sunrise Clinical Manager and/or the units.
J. The staff pharmacists will be in charge of ensuring that appropriate monitoring of blood work is being done in order to continue dispensing clozapine.
K. In the event that clozapine is stopped, it will be the responsibility of the prescriber to report the weekly blood work to the Clozapine Patient Registry by using the form entitled “WBC/ANC Lab Form for a Single Patient”. The form is faxed to the Clozapine Patient Registry at 1-800-507-8339.
IV. References
Teva Clozapine Patient Registry
Related standard
Related to regulatory standards
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