Department of Pharmacy Policies & Procedures

Number: 5:33

Effective Date: 2/09

Revisions:

Approval: 2/09

Subject: DISPENSING OF CLOZAPINE TO INPATIENTS

A. PURPOSE

To establish a uniform procedure within the Department of Pharmacy for dispensing clozapine and to meet the federal requirements of monitoring therapy.

B. POLICY

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.

C. PROCEDURE

1. 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.

2. 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

50 NW 176th Street, Butler Building

Miami, Florida 33169

Phone: 800/507-8334

Fax: 800/507-8339

Email: Clozapine.Registry@TevaUSA.com

Website: www.ClozapineRegistry.com

3. Once the prescriber and the patient are registered, the prescriber must obtain and supply the pharmacy with the patient’s Eligibility Code/Patient ID and a 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. Follow the examples below on how to calculate an ANC.

ANC equals the Total WBC multiplied by the total percentage of neutrophils (segs plus bands).

Example 1:
WBC = 4.3
Segs = 48%
Bands = 2%
4300 x (0.48 + 0.02) = 4300 x 0.5 = ANC of 2,150

Example 2:
WBC = 2.4
Neutrophils = 34%
2400 x 0.34 = ANC of 816

4. In order to start clozapine, the WBC count must be at least 3500/mm³ and the ANC must be at least 2000/mm³.

5. 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.

6. 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.

7. 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:

WBC > 3000/mm^3 but < 3500/mm^3or ANC > 1500/mm^3 but < 2000/mm^3 and	Continue clozapine; increase monitoring to twice weekly
WBC > 2000/mm^3 but < 3000/mm^3 or ANC > 1000/mm^3 but < 1500/mm^3	Stop clozapine; start daily counts; may re-challenge with clozapine if counts return to normal

8. 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.

9. Initial and weekly blood work will be reported by the pharmacy to the Clozapine Patient Registry (within 7 days of dispensing) by using the form entitled “Single Patient WBC/ANC Reporting Form”. The form will be faxed to the Clozapine Patient Registry at 1-800-507-8339 then placed in the clozapine binder. The patient's initials, social security number, date of birth and gender may be obtained from the WebChart tab within Sunrise Medication Manager.

10. The staff pharmacists will be in charge of ensuring that appropriate monitoring of blood work is being done in order to continue dispensing clozapine.

11. 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 “Single Patient WBC/ANC Reporting Form”. The form is faxed to the Clozapine Patient Registry at 1-800-507-8339.