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Frequently Asked Questions
  1. What information did the FDA use to make the decision to reduce the monitoring frequency for eligible patients?
  2. Can a prescriber write a standing order for Clozaril?
  3. What happens if a patient is going on vacation or is unable to obtain blood work during an emergency?
  4. What does ANC stand for? How is it calculated?
  5. How do I report blood work?
  6. How long do I need to keep the reporting forms?
  7. Why does the patient have only 7 days from the blood draw to obtain medication? Is this FDA mandated or a Novartis policy?
  8. What is CARE and how do I access it?
  9. Do I always need to call the Clozaril National Registry to request registration and reporting forms?
  10. If my patient is taking a generic form of clozapine, do I still register them with Novartis?
  11. My patient is eligible to reduce their monitoring frequency. Do I need to call the registry?

  1. What information did the FDA use to make the decision to reduce the monitoring frequency for eligible patients?

    In 2001, the FDA reviewed the 1997 Psychopharmacologic Drugs Advisory Committee (PDAC) recommendation to evaluate the impact of the current monitoring system on the rate of agranulocytosis and whether further monitoring frequency reductions were warranted based on the data from the CNR regarding the new monitoring rules. The following information has been taken from the presentation at PDAC on June 16, 2003. The following link is the website where all presented information can be reviewed:

    http://www.fda.gov/ohrms/dockets/ac/03/briefing/3959b1.htm.

    If you prefer to navigate through the site, start at www.fda.gov/

    On the upper left side of the FDA homepage, under "search" see "A-Z Index" and left click once. Screen displays columns A, B, and C. In the "A" column, scroll down to "Advisory Committees", the last bullet is called "Transcripts". Left click once. Screen displays Documents by Center, with years starting with 1997 to current year. Left click on 2003 "Meeting Documents by Center". Under the second subheading "Center for Drug Evaluation and Research", click on third from the last entry "Psychopharmacology Drugs Advisory Committee (updated 7/30/03)". Left click once. Screen opens to date on top of June 16, 2003. Left click on "June 16, 2003 Briefing Information". Choose a document to review.

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  2. Can a prescriber write a standing order for Clozaril?

    Yes, a prescriber may write a prescription which includes refills. The pharmacist must receive the current (drawn within 7 days irrespective of monitoring frequency) blood work prior to dispensing Clozaril, for each refill.

  3. What happens if a patient is going on vacation or is unable to obtain blood work during an emergency?

    A one-week supply of Clozaril may be dispensed without a blood work in the event of an emergency/vacation, known as an emergency/vacation supply. Upon initiation of therapy, up to a one-week supply of additional Clozaril tablets may be provided to the patient to be held for emergencies (e.g. weather, holidays). Clozaril prescribing information (2005).

    Two common circumstances that may require an emergency supply of drug include:

    - the patient is unable to get to the laboratory for their normally scheduled blood draw.

    - vacations or holidays interfere with their normal routine.

    The patient must be eligible for weekly, biweekly or monthly blood draws and their white blood counts and absolute neutrophil counts should be stable, relative to the patient's normal values. It is possible that a patient entitled to a one week supply of medication to receive a 2-week supply which would include their vacation/emergency supply of the drug. A patient entitled to a 2-week supply could receive a total of a 3-week supply which would include their vacation/emergency supply of the drug.

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  4. What does ANC stand for? How is it calculated?

    The term ANC stands for Absolute Neutrophil Count. The ANC is the real or actual number of white blood cells that a patient has to fight an infection. The ANC can is determined through a WBC (White Blood Cell) count with differential. The ANC can be calculated using the formula below: ANC = WBC x Neutrophil %

  5. How do I report blood work?

    Blood work may be reported using the following methods:

    a) by visiting www.clozarilregistry.com and registering on-line for electronic submission

    b) by faxing/mailing the form entitled "White Blood Cell / Absolute Neutrophil Count Reporting Form"

    Mailing address:
    Novartis Pharmaceuticals Corporation
    Clozaril National Registry
    One Health Plaza
    East Hanover, NJ 07936
    Phone: 1-800-448-5938
    Fax: 1-800-648-6015
    www.clozaril.com

    c) by calling the Clozaril National Registry at 1-800-528-2877 to speak with an associate.

  6. How long do I need to keep the reporting forms?

    The reporting forms should be kept for at least 1 year.

  7. Why does the patient have only 7 days from the blood draw to obtain medication? Is this FDA mandated or a Novartis policy?

    This is a Novartis policy used to ensure patient safety. If the blood work is older than 7 days when the prescription is to be filled, another blood draw must be done.

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  8. What is CARE and how do I access it?

    The CARE application is an online tool for handling the administrative aspects of your Clozaril patients' therapy. With CARE, the user has the ability to register patients, create patient groups, report blood work, and much more. The CARE application may be accessed at www.clozarilregistry.com.

  9. Do I always need to call the Clozaril National Registry to request registration and reporting forms?

    No, registration and reporting forms may be downloaded from the Healthcare Professional section of the Clozaril website (www.clozaril.com). However, you may still call the CNR at 1-800-448-5938 to request forms.

  10. If my patient is taking a generic form of clozapine, do I still register them with Novartis?

    Each company that manufactures clozapine has it's own registry. Only patients taking brand Clozaril are to be registered with the Novartis Clozaril National Registry. To ensure patient safety, please register your patient(s) with the appropriate registry.

  11. My patient is eligible to reduce their monitoring frequency. Do I need to call the registry?

    We recommend contacting the registry whenever you are changing a patient's monitoring frequency or Clozaril status. A CNR associate will review your patient's history to ensure that all FDA requirements are met, as well as update our database.

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