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FAQs Important Safety Information |
FREQUENTLY ASKED QUESTIONS WBC Count and ANC Information Can the pharmacy dispense the medication without blood work? No. Results must be reviewed by the pharmacist prior to dispensing. No Blood, No Drug! What is an acceptable White Blood Cell (WBC) count and Absolute Neutrophil Count (ANC) for dispensing? An acceptable WBC count for dispensing is ≥ 3000/mm3 and an acceptable ANC is ≥ 1500/mm3. A WBC Count < 3500/mm3 or an ANC < 2000/mm3 is an indication of leukopenia or granulocytopenia, and patients should be monitored closely. Click here to review the treatment parameters for CPAS. When is a WBC count or ANC too high to dispense clozapine? There is no set value for a WBC count that is too high for a patient to receive clozapine. The Prescribing Information defines an “acceptable” WBC or ANC as a WBC ≥ 3000/mm3, or an ANC ≥ 1500/mm3. What should a pharmacist do with his or her copy of the patient’s WBC count and ANC form? The pharmacist should keep the form for his or her records. The length of time these records are kept is based on the policies implemented by each individual pharmacy or organization. How long does a pharmacist have from the blood draw date to the time he or she dispenses the drug? Reports should be sent within 7 days of collection for patients who are monitored weekly, within 14 days of collection for patients who are monitored every 2 weeks and within 28 days for patients who are monitored every 4 weeks. Drug dispensing should be contingent upon receipt of WBC Count and ANC test results that are within normal limits and timeframe according to the guideline outlined in the Clozapine Prescribing Information. When does a pharmacist need a new WBC count and ANC? A new WBC count and ANC should be done within 7 days of the last blood draw date for patients monitored weekly, within 14 days of the last blood draw date for patients monitored every 2 weeks, and within 28 days from the last blood draw date for patient’s monitored every 4 weeks. Registration Information What do I need to do to register with the Clozapine Prescription Access System (CPAS)? Pharmacies currently dispensing Clozaril®*/clozapine and enrolled in a patient monitoring program of another manufacturer may complete Pharmacy Stocking Form A. The completion of this form and acceptance by CPAS will enable the pharmacy to order The Mylan Brand of Clozapine and dispense to patients continuing treatment prior to registering as an access group. After this occurs, the physician and patient need to be registered prior to the next supply of medication. Physicians wishing to register without a patient should complete the top portion of the Registration Form B, including signature, and fax it to CPAS at 1-800-843-9916. Pharmacies that have never dispensed Clozaril/clozapine and are not enrolled in a patient monitoring program of another manufacturer must register with the physician by completing Registration Form B. The pharmacy and physician form the patient’s access group. What is an access group? An access group is a physician and pharmacist jointly enrolled and associated within CPAS. The physician and pharmacist who register with the monitoring program agree to adhere to the CPAS program requirements and become jointly responsible for the treatment of patients receiving The Mylan Brand of Clozapine. How soon after a patient is registered can the pharmacy dispense The Mylan Brand of Clozapine? When first blood draw results indicate that the WBC count and ANC values are acceptable. Can the pharmacist order the drug from the wholesaler after he or she has registered with CPAS? Yes. Once CPAS receives the Pharmacy Stocking Form A and the form is CPAS accepted, the pharmacy is registered to stock The Mylan Brand of Clozapine. Wholesalers receive immediate notification as well as monthly lists of newly registered pharmacies. Once the wholesaler receives notification of the newly registered pharmacy, the wholesaler will supply that pharmacy with its clozapine order. When a pharmacy calls to register with CPAS, how soon can it order The Mylan Brand of Clozapine? As soon as CPAS registers the pharmacy, CPAS provides a registration notification to the wholesaler via fax, thus providing immediate authorization for the pharmacy to order The Mylan Brand of Clozapine. Why do a pharmacist and/or physician need to register with CPAS if they are already registered with another clozapine monitoring system? Each manufacturer must track patients who receive their product. CPAS communicates with Novartis to check the National Non-Rechallenge Master File (NNRMF) to ensure that patients who begin therapy are eligible. When does CPAS need a physician’s signature? CPAS requires a physician’s signature when the physician is registering a new patient or an interrupted therapy patient. The physician must also sign when registering with the CPAS registry without a patient. Note: The physician’s signature is needed only once. Once the physician’s signature is on file with CPAS, no additional signatures are needed unless an identification number is assigned. What if a pharmacy is unable to register a patient on the Internet? A patient can not be registered online if: a. the patient is the first patient to be registered with the pharmacy. b. the physician and pharmacy have not formed an access group for a patient. c. the patient is a new patient. d. the patient is registered with another access group. As long as the patient is continuing therapy not registered with another healthcare provider, and both the physician and pharmacy are registered as an access group, the pharmacy can register the patient online. Other Questions If a pharmacist receives a prescription for Clozaril®*, can he or she substitute The Mylan Brand of Clozapine? Yes. The Mylan Brand of Clozapine is FDA rated “AB” (bioequivalent or therapeutically equivalent) to Clozaril. The FDA has approved The Mylan Brand of Clozapine tablets in both the 25 mg and 100 mg strengths. As long as the physician has not written Brand Medically Necessary (or comparable language) on the prescription, The Mylan Brand of Clozapine may be substituted. However, the pharmacy must first be registered with CPAS. What is a quality assurance committee? A quality assurance committee consists of individuals within the treatment community who are willing to oversee prescribing and dispensing of clozapine. CPAS encourages the development and use of an independent quality assurance committee to ensure good clinical practice by the access group. CPAS will not audit or monitor the committee. When does the CPAS Registry communicate with Novartis? The Novartis National Non-Rechallenge Master File (NNRMF) is contacted to confirm treatment eligibility for all new and interrupted therapy patient registrations. In addition, the CPAS Registry reports any patient who becomes non-rechallengeable on The Mylan Brand of Clozapine to the NNRMF. How does a pharmacist get a patient reclearance code? A reclearance code is the patient-specific code necessary for participation in CPAS. This code must be reissued if the treating physician changes. A pharmacist can get a patient reclearance code by calling CPAS to register the patient. If the patient is already registered, the pharmacist can contact CPAS via phone or log on to the telephone remote access system or the CPAS database to find out the patient’s reclearance code. The reclearance code provides confirmation that the patient is registered with CPAS and eligible to receive The Mylan Brand of Clozapine. Why are some Courtesy Reminders sent to the pharmacist instead of the physician? Some Courtesy Reminders are sent to the physician and pharmacy while some are only sent to the pharmacy. Ultimately the pharmacist is the last entity to review the blood work prior to dispensing. Click here to learn about Reminders and Alerts. Does Mylan send Form Ds automatically? Yes. Once the patient is registered with CPAS, the pharmacy and physician will be mailed the Patient-Specific WBC Count and ANC Reporting Forms (Form D) automatically with each patient registration. To request that no reporting forms be sent, or to request Multiple Patient WBC Count and ANC Reporting Forms (Form E) to be sent automatically, contact CPAS at 1-800-843-9915. Information about the revised Prescribing Information
Are there treatment parameters in the prescribing information?
Yes. Click here to view the treatment parameters.
Are Absolute Neutrophil Count (ANC) values now required according to the Prescribing Information? Yes, the prescribing information requires the monitoring of both WBC counts and ANC values. Below is information on how to calculate an ANC and to make this process easier for you, we have provided an ANC calculator. There are two main groups of white blood cells or leukocytes: granulocytes and nongranulocytes. Granulocytes: neutrophils, eosinophils and basophils have multilobed nuclei and may also be called polymorphonuclear leukocytes, “PMNs” or “polys”. Nongranulocytes: monocytes and lymphocytes have nonlobular nuclei and may also be called mononuclear leukocytes. Neutrophils: nuclei of mature neutrophils appear segmented and may also be called segmented neutrophils or “segs”, “PMNs” or “polys”. Nuclei of less mature neutrophils are not segmented, but have a band or rod-like shape, and may also be called “bands” or “stabs”.
With the monitoring guidelines, will CPAS provide Courtesy Reminders or Alerts? Yes. The table below outlines the Courtesy Reminders and Alerts that CPAS will provide to the patient’s access group.
How is a patient monitored after a treatment break?
When can a patient begin every 4 week testing?
* Registered trademark of Novartis Pharmaceuticals Corporation. † Note: Do not initiate in patients with 1) history of myeloproliferative disorder or 2) clozapine induced agranulocytosis or granulucytopenia. |
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