Clozapine, USP ODT Patient Registry
Healthcare Practitioner Enrollment Form
This form is used to enroll a health care practitioner in the Clozapine, USP ODT Patient Registry.
Submitting this completed form indicates you have read and agree to the Statement of OBLIGATIONS below. All forms
must be signed and dated by the health care practitioner.
Health Care Practitioner Statement of OBLIGATIONS:
I have reviewed the Clozapine, USP ODT package insert and agree to participate in prescribing and monitoring only according to product labeling and only with a pharmacy/pharmacist enrolled in the Clozapine, USP ODT Patient Registry.
I understand the risk of death associated with agranulocytosis and granulocytopenia when prescribing Clozapine, USP ODT and agree to register all applicable patients in the Clozapine, USP ODT Patient Registry to support early detection of WBC and ANC suppression and ensure that no patient is inappropriately rechallenged with a clozapine product.
I agree to prescribe Clozapine, USP ODT only after receiving a Patient Registration Number (PRN) from the Clozapine, USP ODT Patient Registry subsequent to the Clozapine, USP ODT Patient Registry verifying patient rechallenge status and an acceptable baseline WBC count (≥ 3500/mm3) and ANC (≥2000/mm3) test results are obtained.*
I agree to provide the Clozapine, USP ODT Patient Registry with all WBC count and ANC test results for all registered patients within:
7 days of blood draw for patients on weekly monitoring schedule**
14 days of blood draw for patients on an every-2-weeks monitoring schedule**
28 days of blood draw for patients on an every-4-weeks monitoring schedule**
I agree to notify the Clozapine, USP ODT Patient Registry of all patients permanently discontinued on Clozapine, USP ODT and submit the required WBC count and ANC test results until they return to normal and for at least 4 weeks from day of discontinuation of therapy.
I understand the Clozapine, USP ODT Patient Registry will verify rechallenge status against the Clozapine National Non- Rechallenge Masterfile and will update this list with all patients permanently discontinued on Clozapine, USP ODT due to an abnormal blood event as defined by product labeling.
I understand the Clozapine, USP ODT Patient Registry will be internally audited and will monitor adherence to prescribing, monitoring, and timeliness requirements and will promptly notify registered health care practitioners and pharmacies of any discrepancies or missing information.
*If the patient is being switched to Clozapine, USP ODT from another formulation of clozapine, Clozapine, USP ODT may be dispensed before a PRN is obtained. In this case, the PRN will be issued when the pharmacist reports the WBC count and ANC test results to the CPR.
Health Care Practitioner Acknowledgement:
Health Care Practitioner Name
Health Care Practitioner ID#
Medical Facility Information
Please answer the following question:
Are you currently enrolled in any other clozapine registry?
If yes, please indicate the name of the registry:
Please mail or Fax completed form to:
Clozapine, USP ODT Patient Registry
1818 Market Street, Suite 2350
Philadelphia, PA 19103
**The blood work draw date may not be more than 7 days old in order for the pharmacist
to dispense the drug, regardless of the patients’ monitoring schedule.
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