What is a REMS?
A REMS or Risk Evaluation and Mitigation Strategy is an FDA required risk management plan that uses risk minimization strategies beyond the professional labeling to ensure that the benefits of prescription drugs outweigh their risk.
What is the Clozapine REMS Program?
The Clozapine REMS Program is an FDA-mandated program implemented by the manufacturers of clozapine. It is intended to help Healthcare Providers (HCPs) ensure the safety of patients taking clozapine. The Clozapine REMS Program is a single shared patient registry with requirements for prescribers, pharmacists, patients, and distributors, and replaces the multiple individual clozapine patient registries.
What are the goals of the Clozapine REMS Program?
The goals of the Clozapine REMS Program are to mitigate the risk of severe neutropenia associated with the use of clozapine by:
  • Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements
  • Informing patients about the risk of severe neutropenia and appropriate monitoring requirements
  • Ensuring compliance with the monitoring frequency for absolute neutrophil count (ANC) prior to dispensing clozapine
  • Ensuring the prescriber documents a risk-benefit assessment when the patient's ANC falls below the acceptable range as described in the Prescribing Information
  • Establishing long-term safety and safe-use of clozapine by enrolling all patients who receive clozapine in the registry
Download program enrollment forms here
Where can I obtain the Prescribing Information for clozapine?
For current Prescribing Information for clozapine, visit the Resources page on the Clozapine REMS Program Website at www.clozapinerems.com.
What are the different roles of healthcare staff in the Clozapine REMS Program?
There are 4 different roles in the Clozapine REMS Program:
  • Prescriber
  • Prescriber Designee
  • Pharmacy Staff
  • Pharmacy Authorized Representative
Please refer to the description of each of these roles and determine which one best describes your duties in the Clozapine REMS Program. There are instances where a Healthcare Provider can serve in more than one role in the Clozapine REMS Program (click here for details). The high-level enrollment and/or certification requirements for each role are presented in the table below.

Role Certify or Enroll? Description
Prescriber Certify Prescriber Certification Process
  • Complete the Clozapine REMS Prescriber Enrollment Form online at www.clozapinerems.com or by faxing it to the Clozapine REMS Program Contact Center at 844-404-8876
  • Pass the Clozapine REMS Knowledge Assessment for Healthcare Providers via the Clozapine REMS Program Website, or by completing and faxing it to the Clozapine REMS Program Contact Center
Prescriber Designee Enroll Prescriber Designee Enrollment Process
  • Complete the Clozapine REMS Prescriber Designee Enrollment Form online at www.clozapinerems.com or by faxing it to the Clozapine REMS Program Contact Center at 844-404-8876
  • Become associated in the system with a certified prescriber
  • Be approved by a certified prescriber
Authorized Representative (Non-chain Pharmacy) Certify Authorized Representative Certification Process
  • Complete the Clozapine REMS Outpatient Pharmacy Enrollment Form or the Clozapine REMS Inpatient Pharmacy Enrollment Form online at www.clozapinerems.com or by faxing it to the Clozapine REMS Program Contact Center at 844-404-8876
  • Pass the Clozapine REMS Knowledge Assessment for Healthcare Providers via the Clozapine REMS Program Website, or by completing and faxing it to the Clozapine REMS Program Contact Center
  • Renew certification of their pharmacy in the Clozapine REMS Program every two years from initial enrollment
Authorized Representative (Chain Pharmacy) Certify Chain Pharmacy Authorized Representative Certification Process
  • Work with an account manager from your pharmacy network system (i.e., the "switch") provider to complete the certification process
  • Pass the Clozapine REMS Knowledge Assessment for Healthcare Providers via the Clozapine REMS Program Website, or by completing and faxing it to the Clozapine REMS Program Contact Center at 844-404-8876
  • Renew certification of their pharmacies in the Clozapine REMS Program every two years from initial enrollment
Pharmacy Staff Enroll Pharmacy Staff Enrollment Process
  • Enroll online as pharmacy staff at www.clozapinerems.com
  • Become associated in the system with a pharmacy

Prescriber

Definition Responsibilities
A prescriber is any healthcare professional who prescribes clozapine to a patient Certification Process
  • A prescriber must certify in the Clozapine REMS Program:
    • Review the Prescribing Information for clozapine
    • Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
    • Complete the Clozapine REMS Prescriber Enrollment Form
    • Pass the Clozapine REMS Knowledge Assessment for Healthcare Providers
  • Prescribers who order clozapine to be dispensed from an inpatient pharmacy** are not required to become certified in the Clozapine REMS Program
**An inpatient pharmacy operates within a facility dispensing clozapine only to patients receiving inpatient medical care and other related services for surgery, acute medical conditions or injuries (usually for a short-term illness or condition). Responsibilities
  • Prescribers who order clozapine to be dispensed from an outpatient pharmacy are required to become certified in the Clozapine REMS Program and must adhere to the following requirements:
    • Enroll every new patient in the Clozapine REMS Program
    • Counsel each patient (or their caregiver) about the risk of severe neutropenia which can lead to serious infection and death
    • Check the ANC for each patient according to the monitoring requirements
    • Submit and verify ANC according to the patient's monitoring frequency on file with the Clozapine REMS Program:
      • For weekly monitoring frequency, ANC must be submitted within 7 days of the lab draw* date
      • For every two weeks monitoring frequency, ANC must be submitted within 15 days of the lab draw* date
      • For monthly monitoring frequency, ANC must be submitted within 31 days of the lab draw* date
      • *Assumes the lab draw date is day 0
In the future1, a lab that is not current according to the patient's monitoring frequency will prevent a patient from receiving clozapine. The Clozapine REMS Program will then require the ANC to be aligned with the patient's monitoring frequency. In the interim, warning messages will alert the pharmacy if the ANC is overdue
  • Provide a "Treatment Rationale" to authorize the continuation of clozapine therapy for patients with moderate or severe neutropenia if it is determined that:
    • The benefits of clozapine therapy outweigh the risks
    • The patient has documented benign ethnic neutropenia (BEN)
1Once the date for full program implementation has been confirmed, updated information will be provided to prescribers and pharmacies and will also be available on the Clozapine REMS Program Website.

Prescriber Designee

Definition Responsibilities
A Healthcare Provider, office staff member, or pharmacist designated by a certified prescriber to act on their behalf Enrollment Process
  • Complete the Clozapine REMS Prescriber Designee Enrollment Form online at www.clozapinerems.com or by faxing it to the Clozapine REMS Program Contact Center at 844-404-8876.
  • Become associated in the system with a certified prescriber
  • Be approved by the associated prescriber
Responsibilities
  • A prescriber designee can:
    • Enroll general population patients
    • Counsel patients
    • Check ANCs
    • Submit ANCs on the prescriber's behalf
    • Change a patient's monitoring frequency
  • A prescriber designee cannot:
    • Enroll a patient with benign ethnic neutropenia (BEN)
    • Provide a Treatment Rationale for a patient
    • Designate a patient as a hospice patient

Authorized Representative for Outpatient Pharmacy

Definition Responsibilities
For outpatient pharmacies with a single location, the authorized representative may be a:
  • Pharmacy Manager, or
  • Staff Pharmacist
If your pharmacy has more than one pharmacy location and your organization would like to coordinate staff training and implement processes for all the pharmacies in your organization, the authorized representative may be a:
  • Director of Pharmacy Services, or
  • Corporate Executive over-seeing Pharmacy Service
The authorized representative represents the Pharmacy and is responsible for ensuring the processes and procedures within the Pharmacy are in place to comply with the Clozapine REMS Program requirements.
Certification Process
  • An authorized representative for an outpatient pharmacy must certify in the Clozapine REMS Program by:
    • Reviewing the Prescribing Information for clozapine
    • Certifying their pharmacy in the Clozapine REMS Program by:
      • Reviewing Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
      • Completing the Clozapine REMS Outpatient Pharmacy Enrollment Form
      • Passing the Clozapine REMS Knowledge Assessment for Healthcare Providers
    • Ensuring training for all relevant staff involved in the dispensing of clozapine on the Clozapine REMS Program requirements
    • Putting processes and procedures in place to verify:
      • The prescriber is certified in the Clozapine REMS Program prior to dispensing clozapine
      • The patient is enrolled in the Clozapine REMS Program prior to dispensing clozapine
      • The ANC result is current according to the patient's monitoring frequency:
        • For weekly monitoring frequency, the submitted ANC result must have been drawn* within 7 days prior to the "Predispense Authorization" (PDA) transaction date
        • For every two weeks monitoring frequency, the submitted ANC result must have been drawn* within 15 days prior to the PDA transaction date
        • For monthly monitoring frequency, the submitted ANC result must have been drawn* within 31 days prior to the PDA transaction date
        • *Assumes the lab draw date is day 0
      • The submitted ANC is within acceptable range or a certified prescriber has provided a Treatment Rationale to authorize the continuation of clozapine treatment
    • Renewing certification of their pharmacy in the Clozapine REMS Program every two years from initial enrollment
Responsibilities
  • Coordinate the activities required in the Clozapine REMS Program
  • Establish and implement processes and procedures to ensure compliance with the safe-use conditions required in the Clozapine REMS Program

Authorized Representative for Inpatient Pharmacy

Definition Responsibilities
For inpatient pharmacies with a single location, the authorized representative may be a:
  • Pharmacy Manager, or
  • Staff Pharmacist
If your pharmacy has more than one pharmacy location and your organization would like to coordinate staff training and implement processes for all the pharmacies in your organization, the authorized representative may be a:
  • Director of Pharmacy Services, or
  • Corporate Executive overseeing Pharmacy Service
The authorized representative represents the pharmacy and is responsible for ensuring the processes and procedures within the pharmacy are in place to comply with the Clozapine REMS Program requirements.
Certification Process
  • An authorized representative for an inpatient pharmacy must certify in the Clozapine REMS Program by:
    • Reviewing the Prescribing Information for clozapine
    • Certifying their pharmacy in the Clozapine REMS Program by:
      • Reviewing Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
      • Completing the Clozapine REMS Inpatient Pharmacy Enrollment Form
      • Passing the Clozapine REMS Knowledge Assessment for Healthcare Providers
    • Ensuring training for all relevant staff involved in the dispensing of clozapine on the Clozapine REMS Program requirements
    • Putting processes and procedures in place to verify the patient is enrolled in the Clozapine REMS Program prior to dispensing clozapine
    • Renewing certification of their pharmacy in the Clozapine REMS Program every two years from initial enrollment
Responsibilities
  • Coordinate the activities required in the Clozapine REMS Program
  • Establish and implement processes and procedures to ensure compliance with the safe-use conditions required in the Clozapine REMS Program
  • Verify every patient receiving clozapine is enrolled in the Clozapine REMS Program prior to dispensing
  • Before dispensing clozapine, inpatient pharmacies can:
    • Verify the ANC is current (within 7 days of the "Eligibility Check" date for weekly monitoring, 15 days for every 2 weeks monitoring, and 31 days for monthly monitoring)
    • Verify ANC is within the acceptable range or a certified prescriber has provided a Treatment Rationale to authorize the continuation of clozapine treatment
    • Inpatient pharmacists are encouraged to submit the patient's ANC to the Clozapine REMS Program at intervals consistent with the patient's monitoring frequency.

Pharmacy Staff

Definition Responsibilities
Any pharmacist or pharmacy employee may assume the role of pharmacy staff member associated with a pharmacy to conduct basic program functions Enrollment Process
  • Enroll online as pharmacy staff
  • Associate with a pharmacy
Responsibilities
  • Outpatient pharmacy staff must:
    • Verify a prescriber is certified in the Clozapine REMS Program
    • Verify the pharmacy is certified
    • Verify a patient is enrolled in the Clozapine REMS Program
    • Obtain a PDA before dispensing clozapine to a patient
    • May submit an ANC for a patient
  • Inpatient pharmacy staff must:
    • Verify a patient is enrolled in the Clozapine REMS Program using the Eligibility Check
    • Verify patient has an ANC on file and the ANC is current and within acceptable range via an Eligibility Check and/or review of the patient's medical record
    • Dispense clozapine to patients only after verifying safe-use conditions have been met
    • May submit an ANC for a patient
Can a Healthcare Provider fulfill multiple roles in the Clozapine REMS Program?
Yes; the Clozapine REMS Program allows Healthcare Providers with multiple roles in the Clozapine REMS Program to create multiple website user accounts using the same email address.

One example of multiple roles a Healthcare Provider might have in the Clozapine REMS Program includes being a pharmacy authorized representative and a prescriber designee.

If you have any questions, call the Clozapine REMS Program Contact Center at 844-267-8678 for assistance.
How does a Healthcare Provider certify in more than one role in the Clozapine REMS Program (i.e., as a pharmacy staff and a prescriber designee)? Can the same email address be used for multiple roles in the Clozapine REMS Program?
Yes; to certify in more than one role in the Clozapine REMS Program, you must create a Clozapine REMS Program Website user account for each role. The same email address may be used for each role. If you have any questions, call the Clozapine REMS Program Contact Center at 844-267-8678 for assistance.
Why are white blood cell (WBC) counts no longer being collected?
FDA has determined that the absolute neutrophil count (ANC) is more relevant to drug-induced neutropenia than is the white blood cell (WBC) count. Therefore, WBC counts are no longer required. An ANC calculator is available on the Clozapine REMS Program Website.
How frequently should a patient's ANC be monitored?
A patient's monitoring frequency depends on the patient's ANC and the amount of time a patient has been on treatment. For details regarding what monitoring frequency a patient should be on, refer to the Prescribing Information.

The ANC Monitoring Table can be found on the Clozapine REMS Program Website:
  • Home Page → Resources → Program Materials → Prescriber Tab → ANC Monitoring Table
When should I submit a patient's ANC to the Clozapine REMS Program?
Patient ANC information should be submitted to the Clozapine REMS Program as soon as possible after the patient blood draw occurs but must be submitted according to the table below, which is consistent with patient monitoring frequency.

The monitoring frequency and corresponding blood draw dates can be found in the table below:

Monitoring Frequency ANC Blood Draw Date
Weekly ANC must be submitted within 7 days of the lab draw* date
Every two weeks ANC must be submitted within 15 days of the lab draw* date
Monthly ANC must be submitted within 31 days of the lab draw* date
*Assumes the lab draw date is day 0

Presently, although the 'Lab Not Current' will not prevent a patient from receiving medication, i.e., will not prevent a PDA from being provided; a warning message will be sent to the pharmacy advising that the lab is not current and to contact the prescriber for a current ANC. In the future when the Clozapine REMS Program is fully implemented, a lab that is not current with the patient's monitoring frequency will prevent the patient from receiving clozapine. (Once the date for full program implementation has been confirmed, updated information will be provided to prescribers and pharmacies and will be available on the Clozapine REMS Program Website.) In the interim, warning messages will be provided if the ANC is overdue.
A prescriber must ensure patients are on the appropriate monitoring frequency and adhere to the appropriate corresponding blood draw dates in order for the patient to receive clozapine.
How do I contact the Clozapine REMS Program?
For additional information about the Clozapine REMS Program, please call 844-267-8678. For additional contact methods, please see the Contact Us page.
How does a Healthcare Provider report an adverse event, product complaint, or obtain medical information about clozapine?
Promptly report suspected adverse events associated with the use of a clozapine directly to the Clozapine REMS Program Contact Center at 844-267-8678. You should also report adverse event information to the FDA MedWatch Reporting System by telephone at (800) FDA-1088, by mail using Form 3500, or online. Downloadable reporting forms and online reporting forms are available at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.

To report a product complaint, or if you require medical information, you may also call the Clozapine REMS Program Contact Center at 844-267-8678.
What is the new certification deadline for prescribers and outpatient pharmacies?
The decision to extend the deadlines was made in consultation with the FDA to minimize treatment disruption for patients while allowing more time for pharmacies and prescribers to complete certification. Please refer to the categories below for specific dates.

Pharmacies
All pharmacies are required to become certified in the Clozapine REMS Program by 02/28/2019.

Outpatient Prescribers
All prescribers who prescribe clozapine only to patients treated on an outpatient or chronic basis including, but not limited to, retail drug-stores, ambulatory care pharmacies, and pharmacies dispensing to long-term care, rehabilitation facilities and prison systems must be certified in the Clozapine REMS Program by 02/28/2019.

Inpatient Prescribers
In 02/28/2019, prescribers who prescribe clozapine only to patients receiving inpatient medical care and other related services for surgery, acute medical conditions or injuries (usually for a short-term illness or condition) will not be required to become certified in the Clozapine REMS Program. However, in order to initiate clozapine therapy in an inpatient setting, a certified prescriber must enroll the patient in the Clozapine REMS Program before the first dose can be dispensed.

For more information on this program change for prescribers who prescribe clozapine in an inpatient setting, please visit the Clozapine REMS Program Website at www.clozapinerems.com or call the Clozapine REMS Program Contact Center at 844-267-8678.
How is monitoring frequency determined in the Clozapine REMS Program?
Monitoring frequency is calculated by the Clozapine REMS Program automatically, based on the patient's history of consistently acceptable ANC values submitted to the program. The guidelines for determining monitoring frequency are described in the Prescribing Information.

If a patient's monitoring frequency is incorrect, the prescriber can modify a patient's monitoring frequency by attesting in the patient's profile via the Clozapine REMS Program Website. Prescribers and prescriber designees can also modify a patient's monitoring frequency by calling the Clozapine REMS Program Contact Center at 844-267-8678 or by faxing the update via the Clozapine REMS ANC Lab Reporting Form to the Clozapine REMS Program Contact Center for processing.

Note: A pharmacy cannot update a patient's monitoring frequency. Pharmacies should work with the patient's prescriber to update a patient's monitoring frequency.

The ANC Monitoring Table can be found on the Clozapine REMS Program Website:
  • Home Page → Resources → Program Materials → Prescriber Tab → ANC Monitoring Table
Why did established patients with monthly monitoring frequency get converted to weekly monitoring frequency?
The Clozapine REMS Program made every effort to consolidate ANC data for patients with laboratory data in multiple individual manufacturer registries to create complete patient records. Patients with complete profile information in the individual manufacturer registries were migrated to the Clozapine REMS Program successfully, but may have had different monitoring frequencies across multiple individual manufacturer registries and/or had a significant gap in ANC data when patient data was consolidated from the multiple individual manufacturer registries.

In accordance with the approved clozapine Prescribing Information, if the patient had consistent ANCs submitted over the previous 12-month period, the patient was migrated with a monthly monitoring frequency.

If a patient's ANCs were inconsistently submitted to the registries in the previous 12-month period and/or there was a time-frame longer than 56 days between blood draw dates, the patient was migrated with a weekly monitoring frequency.

The guidelines outlined above for assigning a new monitoring frequency are consistent with the clozapine Prescribing Information.

If a prescriber needs to change a patient's monitoring frequency, the prescriber can do so on the prescriber dashboard on the Clozapine REMS Program Website. The prescriber or a prescriber designee may also update a patient's monitoring frequency by calling the Clozapine REMS Program Contact Center at 844-267-8678.
My existing clozapine patient was not migrated from the individual manufacturer registries and therefore the Clozapine REMS Program identifies this patient as new and has aligned this patient to a weekly monitoring frequency. How can I update the system so my patient is correctly returned to monthly monitoring frequency?
The Clozapine REMS Program made every effort to consolidate ANC data for patients with laboratory data in multiple individual manufacturer registries to create complete patient records. In some instances, data was incomplete, creating gaps in ANC histories. These gaps resulted in some patients who were previously on a monthly monitoring frequency in an individual manufacturer registry to revert to a weekly monitoring frequency in the Clozapine REMS Program.

If a prescriber needs to change a patient's monitoring frequency, the prescriber can do so on the prescriber dashboard on the Clozapine REMS Program Website. The prescriber or the prescriber designee can also update a patient's monitoring frequency by calling the Clozapine REMS Program Contact Center at 844-267-8678, or by faxing the update via the Clozapine REMS ANC Lab Reporting Form to the Clozapine REMS Program Contact Center for processing.
How can a prescriber become certified in the single shared Clozapine REMS Program?
Any prescriber who wants to initiate clozapine therapy in a patient must be certified in order for the patient to be enrolled in the Clozapine REMS Program.

Prescribers who prescribe clozapine only to patients treated on an outpatient or chronic basis including, but not limited to, retail drug-stores, ambulatory care pharmacies, and pharmacies dispensing to long-term care, rehabilitation facilities and prison systems must certify in the Clozapine REMS Program and adhere to the Clozapine REMS Program requirements. Prescribers may certify online through the Clozapine REMS Program Website or by submitting the Clozapine REMS Prescriber Enrollment Form and Clozapine REMS Knowledge Assessment for Healthcare Providers via fax to the Clozapine REMS Program Contact Center at 844-404-8876.

To complete certification on the Clozapine REMS Program Website:

  • From the Home Page, use the "Start Prescriber Certification" button. You will be taken to the Prescriber Certification page, which will explain what is expected and required in the Clozapine REMS Program.
  • From that certification page, use the "Begin Now!" button to begin certification in the Clozapine REMS Program.
Prescribers who have completed the Clozapine REMS Program certification requirements will receive notification that they are certified in the program.

During the 02/2019 Clozapine REMS Program Modification, prescribers who prescribe clozapine only to patients receiving inpatient medical care and other related services for surgery, acute medical conditions or injuries (usually for a short-term illness or condition) will not be required to become certified in the Clozapine REMS Program. Patients in this setting are required to be enrolled in the Clozapine REMS Program in order to receive clozapine. If a patient in this setting is not enrolled, they must be enrolled by a certified prescriber before they will be allowed to receive clozapine.

For further information, please visit the Clozapine REMS Program Website at www.clozapinerems.com or call the Clozapine REMS Program Contact Center at 844-267-8678. For a faxed copy of the certification forms, call the Clozapine REMS Program Contact Center at 844-267-8678.
When do I need to complete certification?
The new deadline for prescriber certification is 02/28/2019. If you are not certified by this date your patient may not be eligible to receive clozapine. Prescribers are highly encouraged to certify in the Clozapine REMS Program as soon as possible.

For further information on this change for prescribers who prescribe clozapine in an inpatient setting, please visit the Clozapine REMS Program Website at www.clozapinerems.com or call the Clozapine REMS Program Contact Center at 844-267-8678.
What are the changes for prescribers in an inpatient setting with the 02/2019 Clozapine REMS Program Modification?
During the 02/2019 Clozapine REMS Program Modification, prescribers who prescribe clozapine only to patients receiving inpatient medical care and other related services for surgery, acute medical conditions or injuries (usually for a short-term illness or condition) will not be required to become certified in the Clozapine REMS Program.

Patients in this setting are required to be enrolled in the Clozapine REMS Program in order to receive clozapine. If a patient in this setting is not enrolled, they must be enrolled by a certified prescriber before they will be allowed to receive clozapine.

For further information on prescribers who prescribe clozapine in an inpatient setting, please call the Clozapine REMS Program Contact Center at 844-267-8678.
If a prescriber is going to be out of the office for an extended period of time, can another prescriber cover during the absence?
Yes; however, the covering prescriber must be certified in the Clozapine REMS Program and it may be beneficial for the new prescriber to associate themselves with those patients in the program or call the Clozapine REMS Program Contact Center at 844-267-8678 to have the patient assigned to that covering prescriber.
If a prescriber is going to be out of the office for a short period of time, can another prescriber write a prescription for the patient during the absence?
Yes; the covering prescriber can write a prescription for another prescriber's patient as long as the covering prescriber is certified in the Clozapine REMS Program. When the eligibility of the patient to receive clozapine is checked, it does not look for an established relationship between the prescriber and patient.
Can a nurse practitioner, physician assistant, resident, or intern certify as a prescriber in the Clozapine REMS Program?
Yes; any medical professional with prescribing privileges can become certified in the Clozapine REMS Program.
Can a member of the prescriber's office staff help manage patients in the Clozapine REMS Program?
Yes; the Clozapine REMS Program allows a certified prescriber to identify a prescriber designee to perform some duties or functions on behalf of the prescriber. The prescriber's designee(s) will need to enroll in the Clozapine REMS Program and become certified before they can perform any duties or functions for their associated prescriber(s). A prescriber may have more than one prescriber designee.

A notification will be sent to the prescriber when the designee enrolls. Before a designee can act on behalf of a prescriber, the prescriber will need to approve the person acting on his or her behalf. Once the designee has been approved by the certified prescriber, they will be able to engage in patient management through the Clozapine REMS Program Website.
How can a prescriber find a list of pharmacies that are certified in the Clozapine REMS Program?
A prescriber can obtain a list of participating pharmacies by calling the Clozapine REMS Program Contact Center at 844-267-8678.

If a prescriber knows the pharmacy's DEA, or NPI, or NCPDP number, the prescriber can also confirm that a pharmacy is certified by using the feature "Certification Lookup" on the Resources tab of the Clozapine REMS Program Website at www.clozapinerems.com.
Where can I find the Patient ID for the Clozapine REMS ANC Lab Reporting Form?
The Patient ID can be found on the Prescriber Dashboard on the patient tab. The Patient ID is also known as the Patient Enrollment ID.

Note: The Patient ID is an optional field on the Clozapine REMS ANC Lab Reporting Form.
What actions can a prescriber designee perform in the Clozapine REMS Program?
A prescriber designee can perform the following actions on behalf of the prescriber:

  • Enroll general population patients
  • Counsel patients
  • Submit ANCs on the prescriber's behalf
  • View patient lists and patient ANC history
  • Change monitoring frequency
A prescriber designee cannot perform the following actions on behalf of a prescriber:

  • Enroll patients with documented benign ethnic neutropenia
  • Provide a Treatment Rationale for a patient
  • Designate a patient as a hospice patient
To download the Clozapine REMS Prescriber Designee Enrollment Form or Clozapine REMS Patient Enrollment Form, visit the Clozapine REMS Program Website.

Download program enrollment forms here
Do patients need to be enrolled in the Clozapine REMS Program in order to receive clozapine?
Yes; any patient prescribed clozapine, whether in an inpatient or outpatient setting must be enrolled in the Clozapine REMS Program by the patient's prescriber or the prescriber designee. To enroll a patient, please visit www.clozapinerems.com or fax the completed Clozapine REMS Patient Enrollment Form to the Clozapine REMS Program Contact Center at 844-404-8876.

Note: An acceptable ANC or Treatment Rationale must also be on file with the Clozapine REMS Program for patients to receive clozapine in an outpatient setting
How are patients enrolled into the Clozapine REMS Program?
Prescribers and prescriber designees can enroll patients into the Clozapine REMS Program. General population patients can be enrolled by both prescribers and prescriber designees online, by phone, or by faxing the Clozapine REMS Patient Enrollment Form.

Only a prescriber can enroll patients with benign ethnic neutropenia (BEN). The prescriber must indicate BEN status as part of the enrollment process on the Clozapine REMS Program Website or on the Clozapine REMS Patient Enrollment Form to be faxed; patients with BEN cannot be enrolled by phone. Phone enrollment is only available for general population patients.

For assistance in enrolling your patient please call the Clozapine REMS Program Contact Center at 844-267-8678.

To download the Clozapine REMS Patient Enrollment Form, visit the Clozapine REMS Program Website.

Download program enrollment forms here
Can a Healthcare Provider not certified in the Clozapine REMS Program submit an ANC?
If you are a Healthcare Provider directly involved in the treatment of a clozapine patient, you can call the Clozapine REMS Program Contact Center at 844-267-8678 and submit an ANC over the phone even if you aren't certified in the Clozapine REMS Program. You may be required to provide specific identifying patient information when you submit the ANC results.

An ANC can also be faxed to the Clozapine REMS Program Contact Center at 844-404-8876 for data entry.

For organizations with high laboratory volumes, a simple automated interface can be implemented to electronically send ANC data for entry into the Clozapine REMS Program. Please call the Clozapine REMS Program Contact Center at 844-267-8678 for more information on this process.
Will the program send notices if the patient experiences a low ANC or substantial drop?
The Clozapine REMS Program uses an automated system that will notify the patient's associated prescriber if a patient experiences mild, moderate, or severe neutropenia as defined in the approved clozapine Prescribing Information for both patients in the general population and for patients with documented benign ethnic neutropenia.

Substantial drops are not defined in the clozapine Prescribing Information, so safety notices will not be sent if the patient experiences such a drop. Notice will be sent if the ANC meets criteria for mild, moderate, or severe neutropenia.
What is a Treatment Status?
A patient's Treatment Status describes a patient's status in the clozapine treatment process.

There are four Treatment Statuses in the Clozapine REMS Program:
  • Pre-Treatment: new patient with no baseline ANC submitted who has not started clozapine
  • Active: receiving clozapine at regular intervals consistent with their monitoring frequency
  • Interrupted: clozapine usage has stopped temporarily pending next actions before resuming therapy or being permanently discontinued
  • Discontinued: clozapine usage has stopped
Treatment Status is automatically updated based on the ANC values entered into the system.
  • For general population patients:
    • An ANC between 500 and 999/μL (moderate neutropenia) will cause Treatment Status to update to Interrupted
    • An ANC below 500/μL (severe neutropenia) will cause Treatment Status to update to Discontinued
  • For patients with documented benign ethnic neutropenia (BEN):
    • An ANC below 500/μL (severe neutropenia) will cause Treatment Status to update to Interrupted
A Treatment Status of Interrupted or Discontinued will prevent a PDA from being provided and could result in a disruption of a patient's clozapine therapy. If a prescriber determines that the benefits of continuing clozapine outweigh the risks when a patient's Treatment Status was changed to Interrupted, the prescriber can provide a Treatment Rationale into the system and change the patient's Treatment Status back to Active thereby allowing clozapine to be dispensed.

If a patient's Treatment Status was changed to Discontinued because of a low ANC value, the Treatment Status will automatically return to Active only when a new/current lab is submitted with the patient's ANC value within acceptable range.
What is a Treatment Rationale?
A Treatment Rationale is required from a prescriber when he or she determines that a patient should continue clozapine treatment despite a low ANC.

To authorize the continuation of clozapine therapy for any patient with a Treatment Status of Interrupted or Discontinued because of a low ANC indicating severe neutropenia, the prescriber must take action by providing a Treatment Rationale to update the patient's Treatment Status back to Active to allow a PDA request to be approved.

The Clozapine REMS Program will alert the prescriber via the Clozapine REMS Program Website dashboard if a submitted ANC is below the recommended thresholds for a patient. Clozapine will not be dispensed to the patient unless the prescriber then provides a Treatment Rationale to authorize continued treatment. There are two Treatment Rationale options in the Clozapine REMS Program:

  1. "Benefits outweigh risks" → In the prescriber's clinical judgment; the benefits of continuing clozapine treatment outweigh the risk of neutropenia
  2. "Patient with documented BEN" → The ANC is within a range where treatment can continue for a patient with benign ethnic neutropenia (BEN)
Information provided in the Clozapine REMS Program is not a substitute for appropriate documentation in the patient's medical record regarding the prescriber's decision to continue, interrupt, or discontinue clozapine treatment.
How can I provide a Treatment Rationale?
Providing a Treatment Rationale confirms that the benefits of continuing clozapine treatment outweigh the risks of developing severe neutropenia when the prescriber wishes to continue clozapine treatment in a patient whose ANC value is low. The Treatment Rationale returns the patient's Treatment Status in the Clozapine REMS Program to Active and allows the Clozapine REMS Program to provide a PDA which permits the pharmacy to dispense clozapine.

Prescribers may confirm treatment continuation with a Treatment Rationale in the Clozapine REMS Program by:
  1. Faxing a signed Clozapine REMS ANC Lab Reporting Form to 844-404-8876 containing a completed Treatment Rationale section, or
  2. Accessing the Clozapine REMS Program Website to provide a Treatment Rationale online. To do so, perform the following steps:
    1. Log in to the Clozapine REMS Program Website at www.clozapinerems.com.
    2. Access the dashboard.
    3. Select 'Change Treatment Rationale' from the drop-down menu and click the GO button.
    4. Enter the lab information on the 'Lab Information' screen and click Next. The user will be redirected back to the Dashboard after this step is complete.
What happened to patients previously on the National Non-Rechallenge Master File (NNRMF)?
The NNRMF was developed by the Novartis Pharmaceuticals Corporation to ensure that patients at risk of developing severe neutropenia (previously referred to as agranulocytosis) while on clozapine, regardless of the manufacturer, could not be restarted on clozapine. Due to updates to the clozapine Prescribing Information, the NNRMF is no longer applicable. Patients who were previously identified in the NNRMF will be identified in the Clozapine REMS Program with a flag on the Prescriber Dashboard.

Patients who were previously identified in the NNRMF may restart clozapine in certain circumstances as defined in the Prescribing Information. Monitoring requirements for patients previously identified in the NNRMF are the same as for patients new to clozapine.
How are patient ANCs submitted to the Clozapine REMS Program?
Patient ANCs can be submitted to the Clozapine REMS Program in a variety of ways:
  • Prescribers and prescriber designees can log in to the Clozapine REMS Program Website and enter ANCs for a patient using their dashboard
  • Pharmacy staff and pharmacy authorized representatives can submit an ANC via their dashboard on the Clozapine REMS Program Website
  • All program roles can call the Clozapine REMS Program Contact Center at 844-267-8678
  • All program roles can fax ANCs to the Clozapine REMS Program Contact Center at 844-404-8876
Download Clozapine REMS ANC Reporting Form
Does the Clozapine REMS Program need to be advised when a patient is admitted to or discharged from an acute or long-term healthcare setting?
No; the Clozapine REMS Program does not track when patients are admitted or discharged. Patient association to a prescriber is updated automatically when a new prescriber enrolls a patient. There is no action required on the part of the previous prescriber.

If a prescriber wishes to remove a patient from their list, they can deactivate the patient via their dashboard.
When discontinuing treatment, does the patient's ANC need to be monitored for 4 weeks?
No; the duration and frequency of all patient ANC monitoring after discontinuation is dependent on that patient's ANC and clinical status (see Section 2.4 in the clozapine Prescribing Information for more details).
If a patient is eligible to reduce their monitoring frequency does the Clozapine REMS Program need to be notified?
No; the monitoring frequency recommendations are described in the Prescribing Information. In the Clozapine REMS Program, monitoring frequency is a calculated value, based on the patient's ANC history. Thus, if the patient is eligible to reduce their monitoring frequency, the system will automatically adjust their monitoring frequency.

If a patient's monitoring frequency is incorrect, the prescriber can modify the patient's monitoring frequency to monthly by performing an attestation in the patient's profile via the Clozapine REMS Program Website. Prescribers and prescriber designees can modify a patient's monitoring frequency to monthly by calling the Clozapine REMS Program Contact Center at 844-267-8678.

A prescriber can move a patient from monthly or every two weeks monitoring frequency to weekly by faxing the update via the Clozapine REMS ANC Lab Reporting Form to the Clozapine REMS Program Contact Center for processing.
If the patient or caregiver will not provide the required information needed to complete Patient Enrollment (i.e., Name, Date of Birth) can they still receive clozapine?
This information is needed in order for prescribers and pharmacies to identify the patient in the Clozapine REMS Program to submit ANCs and provide authorization to receive clozapine. If a patient and/or their caregiver will not provide the required information, the patient will not be able to receive clozapine therapy.
How does a patient in an inpatient setting become enrolled if prescribers in this setting are not required to be certified in the Clozapine REMS Program?
All patients are required to be enrolled in the Clozapine REMS Program in order to receive clozapine. If a patient in this setting is not enrolled, they must be enrolled by a certified prescriber before they will be allowed to receive clozapine.
What are the different pharmacy certification types in the Clozapine REMS Program?
All pharmacies must certify in the Clozapine REMS Program to purchase and dispense clozapine.

Pharmacies participating in the Clozapine REMS Program must determine their pharmacy type based on the definitions below. The certification requirements are different for different pharmacy types.

Pharmacy Type Definition
Chain Pharmacy
  • A chain of retail pharmacies has an authorized representative located at a chain headquarters who is responsible for ensuring certification and training in the Clozapine REMS Program across all stores in the chain.
  • A chain pharmacy is contracted to participate with a pharmacy network provider.
  • Chain pharmacies must adjudicate claims through their Pharmacy Benefit Management System (PBMS) via electronic communication with the Clozapine REMS Program using established telecommunications standards (i.e., "the switch").
Outpatient Pharmacy
  • Pharmacies are considered outpatient if the pharmacy dispenses clozapine only to patients treated on an outpatient or chronic basis including, but not limited to, retail drug-stores, ambulatory care pharmacies, and pharmacies dispensing to long-term care, rehabilitation facilities and prison systems.
  • An outpatient pharmacy is an individual location or multiple stores with an authorized representative associated to the independent stores. The authorized representative is responsible for ensuring certification and training in the Clozapine REMS Program within the individual or multiple stores.
  • Even if a pharmacy has multiple locations, it is not considered a chain for the purposes of the REMS unless it has a single authorized representative at a corporate headquarters that is responsible for ensuring certification and training in the Clozapine REMS Program across all stores in the chain.
  • An Outpatient Pharmacy may be able to adjudicate claims via electronic communication with the Clozapine REMS Program using established telecommunications standards (i.e., "the switch").
  • Outpatient Pharmacies that cannot adjudicate claims via the switch must obtain a PDA via the Clozapine REMS Program Website, or by calling the Clozapine REMS Program Contact Center.
Inpatient Pharmacy
  • Pharmacies are considered inpatient if the pharmacy is within a facility dispensing clozapine only to patients receiving inpatient medical care and other related services for surgery, acute medical conditions or injuries (usually for a short-term illness or condition).
  • Inpatient pharmacies are required to perform an Eligibility Check to verify a patient is eligible to receive clozapine before dispensing. If the patient is found to not yet have been enrolled in the Clozapine REMS Program, he/she must be enrolled by a certified prescriber before being allowed to receive clozapine.
What is a Predispense Authorization (PDA)?
A Predispense Authorization (PDA) determines if a patient is eligible to receive clozapine and provides an authorization for an outpatient pharmacy to dispense.

The PDA currently evaluates that the:
  • Prescriber is certified; and,
  • Pharmacy is certified; and,
  • Patient is enrolled; and,
  • Patient has an ANC on file; and,
  • Patient's ANC is within acceptable range according to the Prescribing Information, or has a valid Treatment Rationale on file from the prescriber.
In addition, PDA responses provide the dispensing pharmacy with the following information:
  • The most recent ANC value and the associated blood draw date
  • Patient monitoring frequency
If the ANC is not current (i.e., within 7/15/31 days of the ANC draw date) based on the patient's monitoring frequency (either weekly, every 2 weeks or monthly), this will not prevent a PDA.

Upon full implementation of the Clozapine REMS Program, pharmacies will be required to verify the patient ANC is current. At that time, if the ANC is not current based on the patient's monitoring frequency, a PDA will not be provided and the patient will not be allowed to receive clozapine. (Once the date for full program implementation has been confirmed, updated information will be provided to prescribers and pharmacies and available on the Clozapine REMS Program Website.)

Click here to access the Clozapine REMS PDA Fact Sheet.
What is an Eligibility Check?
The Eligibility Check (EC) determines if a patient is eligible to receive clozapine and provides an authorization for an inpatient pharmacy to dispense.

The EC evaluates the criteria of patient enrollment in the Clozapine REMS Program to determine if it is safe to dispense clozapine to the patient. Patients who are not enrolled in the Clozapine REMS Program are not "eligible" to receive clozapine and must be enrolled by a certified prescriber prior to their first dose of clozapine.

In addition, the EC will provide a warning message informing the pharmacy if the patient's ANC is not on file, is not within acceptable ranges according to the Prescribing Information; or, when the ANC on file indicates moderate or severe neutropenia there is no valid Treatment Rationale on file from the prescriber. This warning message will not prevent a dispense for a patient as long as the patient is enrolled in the Clozapine REMS Program.

All EC responses will provide the following information:
  • The most recent ANC value and the associated blood draw date
  • Patient monitoring frequency
Pharmacy authorized representatives and pharmacy staff in an inpatient pharmacy can perform an EC from their dashboard. To perform an EC, the user enters the following data:
  • Patient data: First Name, Last Name, Date of Birth, Zip Code (Required)
  • Prescriber identifier: DEA or NPI (at least one identifier is required)
  • Patient ANC data: ANC, Blood Draw Date (Optional)
  • Dispense data: Date of Service, NDC, Days' Supply, Quantity (Optional)
Click here to access a Clozapine REMS Eligibility Check Fact Sheet.
How is an Eligibility Check different from a Predispense Authorization?
The Eligibility Check is primarily used by inpatient pharmacies, whereas the PDA is used by outpatient pharmacies. Further specifics about the use of each and the steps required to perform each one can be obtained from the Clozapine REMS Program Website at www.clozapinerems.com by downloading and reviewing the Clozapine REMS PDA Fact Sheet and/or Clozapine REMS Eligibility Check Fact Sheet.
What is a "Dispense Rationale"?
The Clozapine REMS Program provides certified outpatient pharmacies with an opportunity to apply clinical judgment and continue to dispense clozapine to enrolled patients when a patient's prescriber is not certified in the Clozapine REMS Program. In order to dispense to a patient who does not have an associated certified prescriber, the pharmacist must provide a Dispense Rationale.

The Clozapine REMS Program will alert the pharmacy if the prescriber is not certified in the Clozapine REMS Program when a PDA is requested. A PDA will not be provided for a clozapine dispense unless the pharmacy provides a Dispense Rationale to authorize a dispense.

In order for a patient to be eligible for a Dispense Rationale, that patient must:
  • Be enrolled in the Clozapine REMS Program; and,
  • Have an acceptable ANC value on file; or,
  • Have a Treatment Rationale on file if the ANC on file is low indicating moderate or severe neutropenia.
The Dispense Rationale is valid for 72 hours (3 calendar days).

The Dispense Rationale will be limited to no more than three (3) Dispense Rationales for an individual patient within a rolling six (6) month period of time.

Pharmacies must fill and dispense no more than the amount of clozapine necessary to treat the patient until the next blood draw/ANC or as directed by the prescriber.
How can I provide a Dispense Rationale?
Certified authorized representatives and enrolled pharmacy staff for certified pharmacies can provide a Dispense Rationale through the Clozapine REMS Program Website. The process varies slightly for providing a Dispense Rationale depending on whether your pharmacy requests a Predispense Authorization (PDA) by using the Clozapine REMS Program Website (see Section A. below) or by using the pharmacy network system, i.e., "switch" (see Section B. below). Alternatively, a Dispense Rationale may be provided via calling the Clozapine REMS Program Contact Center at 844-267-8678.

A. A Pharmacy using the Clozapine REMS Program Website to request a PDA, should:
  1. Log in to the Clozapine REMS Program Website.
    Note: You must be enrolled as a pharmacy staff or certified as an authorized representative for the pharmacy.
  2. Access the dashboard.
  3. Select 'Predispense Authorization' from the drop-down menu and click the Go button.
  4. Enter the patient information on the 'Predispense Authorization' screen and click Submit (see screenshot below). The 'Predispense Authorization Result' screen will appear with a reject message.



  5. Click on the 'Provide a Dispense Rationale for this patient' check box at the bottom of the 'Predispense Authorization Result' screen and click the Submit button. (see screenshot below)



  6. If the Dispense Rationale was provided successfully, you will be taken to a success screen. (see screenshot below)



B. A pharmacy using the pharmacy network system (i.e., "switch") to request a PDA should:
  1. Log in to the Clozapine REMS Program Website.
    Note: You must be enrolled as a pharmacy staff or certified as an authorized representative for the switch pharmacy.
  2. Access the dashboard.
  3. Select 'Dispense Rationale' from the drop-down menu and click the Go button. (see screenshot below)



  4. Enter the patient information on the Dispense Rationale screen and click Submit. (see screenshot below)



  5. The "Dispense Rationale Result" screen will appear with a reject message similar to the switch reject message.
  6. Click on the 'Provide Dispense Rationale for this patient' check box at the bottom of the 'Dispense Rationale Result' screen and click the Submit button. (see screenshot below)



  7. If the Dispense Rationale is provided successfully, you will be taken to a success screen. (see screenshot below)



  8. Reprocess the claim transaction through the pharmacy switch system.
    Note: Please wait approximately 2 minutes before going back to the switch to reprocess the claim transaction.
If you experience any issues, please call the Clozapine REMS Program Contact Center at 844-267-8678.
How does a pharmacy certify in the Clozapine REMS Program?
To certify in the Clozapine REMS Program, the authorized representative of a pharmacy must:

  • Complete the Clozapine REMS Inpatient Pharmacy Enrollment Form or the Clozapine REMS Outpatient Pharmacy Enrollment Form
  • Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
  • Complete the Clozapine REMS Knowledge Assessment for Healthcare Providers
Non-chain pharmacies can also certify online through the Clozapine REMS Program Website at www.clozapinerems.com, or by submitting the completed Clozapine REMS Inpatient Pharmacy Enrollment Form or the Clozapine REMS Outpatient Pharmacy Enrollment Form via fax to the Clozapine REMS Program Contact Center at 844-404-8876.

Chain pharmacies should work with their account managers from their pharmacy management system (i.e., "switch") provider to become certified.

For additional information, call the Clozapine REMS Program Contact Center at 844-267-8678.
How often must pharmacies recertify?
Pharmacies are required to recertify in the Clozapine REMS Program every two (2) years from the date of the pharmacy's original certification to maintain ability to order and dispense clozapine.
How does a pharmacy recertify in the Clozapine REMS Program?
Recertification requires that the authorized representative of the pharmacy has (re)certified by reviewing of the Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers, (re)attesting to the program requirements on the appropriate Clozapine REMS Enrollment Form for the pharmacy type, and successful completion of the Clozapine REMS Knowledge Assessment for Healthcare Providers. Pharmacy recertification may then be completed after the authorized representative is (re)certified. Recertification tasks may be completed on the Clozapine REMS Program Website at www.clozapinerems.com; or, by downloading and completing the appropriate type of Clozapine REMS Pharmacy Enrollment Form (Inpatient, Outpatient, or Chain Headquarters) and the Clozapine REMS Knowledge Assessment for Healthcare Providers, and faxing the completed/signed forms to 844-404-8876.

Note: Chain Headquarters Pharmacies may recertify only by completing and faxing the Clozapine REMS Chain Headquarters Pharmacy Enrollment Form and Clozapine REMS Knowledge Assessment for Healthcare Providers to the Clozapine REMS Program Contact Center at 844-404-8876.

Additional assistance for questions or problem resolution may be obtained by calling the Clozapine REMS Contact Center at 844-267-8678.
What happens if a pharmacy does not recertify every 2 years?
Pharmacies that do not recertify every two years from the date of their original certification in the Clozapine REMS Program will be deactivated and will be unable to order or dispense clozapine.
What happens if a pharmacy is deactivated?
Deactivated pharmacies will be unable to order or dispense clozapine. Previously certified pharmacies will be unable to obtain a Predispense Authorization from the Clozapine REMS Program until recertified.
If my pharmacy is "deactivated", what must be done?
If your pharmacy has been deactivated from the Clozapine REMS Program due to failure to recertify every 2 years, the pharmacy authorized representative should immediately recertify online at www.clozapinerems.com; or, download and complete the appropriate type of Clozapine REMS Pharmacy Enrollment Form (Inpatient, Outpatient, or Chain Headquarters) and the Clozapine REMS Knowledge Assessment for Healthcare Providers, and fax the completed/signed forms to 844-404-8876.

Additional assistance for questions or problem resolution may be obtained by calling the Clozapine REMS Program Contact Center at 844-267-8678.
What is an authorized representative?
Please refer to the FAQ on different roles of healthcare staff in the Clozapine REMS Program in the General Section of the FAQs.
Who should act as the authorized representative in the pharmacy?
Please refer to the FAQ on different roles of healthcare staff in the Clozapine REMS Program in the General Section of the FAQs.
When does certification need to be completed?
The new deadline for pharmacy certification is 02/28/2019. If you are not certified by this date your patient may not be eligible to receive clozapine from a pharmacy.

Pharmacies are required to verify and/or update their pharmacy classification upon recertification in the program. This pharmacy reclassification may change prescriber certification and patient safety requirements.

For more information, visit the Clozapine REMS Program Website at www.clozapinerems.com or call the Clozapine REMS Program Contact Center at 844-267-8678.
What is the difference between an inpatient pharmacy and an outpatient pharmacy?
  • A pharmacy that dispenses clozapine only to patients receiving inpatient medical care and other related services for surgery, acute medical conditions or injuries (usually for a short-term illness or condition), the pharmacy will be classified as an "inpatient pharmacy".
  • A pharmacy that dispenses clozapine only to patients treated on an outpatient or chronic basis including, but not limited to, retail drug-stores, ambulatory care pharmacies, and pharmacies dispensing to long-term care, rehabilitation facilities and prison systems, the pharmacy will be classified as an "outpatient pharmacy".
If you feel your pharmacy is incorrectly classified or if your pharmacy dispenses to both patient groups, please call the Clozapine REMS Program Contact Center for further instructions at 844-267-8678.
What if I am in a pharmacy that dispenses clozapine for both inpatient and outpatient use?
The authorized representative will need to complete both the inpatient pharmacy enrollment and outpatient pharmacy enrollment. The authorized representative can complete enrollment through the Clozapine REMS Program Website or by completing the Clozapine REMS Inpatient Pharmacy Enrollment Form and the Clozapine REMS Outpatient Pharmacy Enrollment Form and faxing them to the Clozapine REMS Program at 844-404-8876.

For additional questions, please call the Clozapine REMS Program Contact Center at 844-267-8678.
What is "the switch"?
The term "the switch" refers to a technical solution that allows pharmacies to adjudicate prescription information simultaneously through both the Clozapine REMS Program to obtain the PDA and their Pharmacy Management System (PMS) to obtain insurance claim payments via electronic communication using established telecommunications standards.
What happens to patients who try to fill a prescription at a pharmacy that is not certified?
Beginning on 02/28/2019, if a pharmacy is not certified in the Clozapine REMS Program, a patient presenting a clozapine prescription at that pharmacy location will not receive clozapine regardless if the patient meets other program element requirements as defined by the Clozapine REMS Program (patient is enrolled and has ANC on file with acceptable values per the Prescribing Information).

Pharmacies must become certified in the Clozapine REMS Program by 02/28/2019 in order to obtain clozapine from a wholesaler.
Will pharmacies that are not certified be able to order and receive clozapine?
Starting on 02/28/2019, if a pharmacy is not certified in the Clozapine REMS Program, the pharmacy will not be able to order and receive clozapine, regardless if they were in any of the previous individual manufacturer registries.

Access the pharmacy certification procedure here
The pharmacy has been certified but the system is reporting that the pharmacy is not certified. What are the next steps?
Please ensure you have completed the steps listed on the certification page. If you are still experiencing issues, please call the Clozapine REMS Program Contact Center at 844-267-8678 for assistance.
Will patients still need to have blood draws?
Yes; blood draws for ANC monitoring are required prior to dispensing. Monitoring frequency (i.e., weekly, every 2 weeks, or monthly) is determined by the patient's prescriber based on criteria in the clozapine Prescribing Information.
Can clozapine be dispensed to a patient without bloodwork?
No; patients must have ANCs that are current according to their monitoring frequency and in the acceptable range. If there is no ANC on file in the patient's lab history, an ANC will be required before a PDA is provided. After the Clozapine REMS Program is fully implemented, if the ANC on file is not current based on the patient's monitoring frequency, a more recent ANC will be required before dispensing clozapine. (Once the date for full program implementation has been confirmed, updated information will be provided to prescribers and pharmacies and available on the Clozapine REMS Program Website.)

If the ANC meets the criteria for moderate or severe neutropenia, a patient must have an appropriate Treatment Rationale provided to the Clozapine REMS Program prior to dispensing clozapine.
What actions are required if the prescribing physician isn't certified?
Prescribers who prescribe clozapine for outpatient use must be certified in the Clozapine REMS Program by 02/28/2019.

Prescribing clozapine for patients receiving inpatient care does not require prescriber certification in the Clozapine REMS Program if the patient is already enrolled in the program. If the patient is to be initiated on clozapine while admitted to an inpatient setting, a certified prescriber must enroll the patient in the Clozapine REMS Program prior to receiving their first dose of clozapine.

We encourage you to contact the prescriber to advise him or her of the need to certify in the Clozapine REMS Program. The Clozapine REMS Program Dispense Rationale provides certified outpatient pharmacies with an opportunity to apply clinical judgment and continue to dispense clozapine to enrolled patients when a patient's prescriber is not certified in the Clozapine REMS Program.
What should a pharmacist do with the patient's ANC Lab Reporting Form?
The pharmacist should enter the patient's ANC via the Clozapine REMS Program Website or fax it to the Clozapine REMS Program Contact Center at 844-404-8876. Once the information has been entered, the pharmacist may keep the form for his or her records, if desired. The length of time these records are kept is based on the policies implemented by each individual pharmacy or organization.
The pharmacy just certified and needs to order clozapine today. What are the next steps?
The Pharmacy should contact its wholesaler/distributor to inform them that the pharmacy just certified in the Clozapine REMS Program. If the wholesaler needs to verify certification, they can access the Certification Look-up on the Clozapine REMS Program Website or call the Clozapine REMS Program Contact Center at 844-267-8678 to verify the pharmacy's certification in the program.
What if the authorized representative leaves the pharmacy?
If the authorized representative leaves the pharmacy, the new authorized representative must notify the Clozapine REMS Program of the change in the authorized representative by certifying in the Clozapine REMS Program as soon as possible.
If the patient's prescription is denied or the Eligibility Check indicates "do not dispense", will the Clozapine REMS Program system explain the reason?
Yes; when a prescription is denied (i.e., a PDA is not generated), an appropriate message will be displayed to the pharmacy staff member.

There are several rejection reasons that could be provided for a patient. The following are examples of the most common rejection messages (actual messages may vary):

Outpatient Pharmacy using the pharmacy management system:
"*REMS* - ANC results out of range. Results Last ANC: 400 01/12/16; MF=7d"
"*REMS* - Patient not enrolled. Call 844-267-8678 for additional information and to enroll patient."
"*REMS* - ANC results not on file. Contact prescriber"

Outpatient Pharmacy using web-based PDA:
"*REMS* - ANC results out of acceptable range"
"*REMS* - Patient not enrolled. Call 844-267-8678 for additional information and to enroll patient."
"*REMS* - ANC results not on file. Contact prescriber"

Inpatient Pharmacy:
"*REMS* - Patient not enrolled. Call 844-267-8678 for additional information and to enroll patient."
Does a distributor have to enroll in the Clozapine REMS Program?
Yes; clozapine is only available through the Clozapine REMS Program. As part of a restricted distribution REMS program, distributors will need to enroll in the Clozapine REMS Program in order to be able to purchase and distribute clozapine.
How can a distributor enroll in the Clozapine REMS Program?
To enroll in the Clozapine REMS Program, a distributor should contact info@clozapinedistributor.com to have a Clozapine REMS Distributor Enrollment Form sent to via email.

A Customer Manager will help the distributor to complete a Clozapine REMS Distributor Enrollment Form. In completing the enrollment form, the distributor is required to indicate that they understand that clozapine is available only through the Clozapine REMS Program and they will comply with the program requirements.
How can enrolled distributors access a list of pharmacies that participate in the Clozapine REMS Program?
After enrollment, distributors can access the current list of certified pharmacies by:
  • Downloading a current list of certified pharmacies from a secure FTP site
  • Using the "Certification Look-up" feature on the Resources tab of the Clozapine REMS Program Website at www.clozapinerems.com to verify a pharmacy
  • Calling the Clozapine REMS Program Contact Center at 844-267-8678
A pharmacy has requested clozapine, but they are not yet certified in the Clozapine REMS Program. Can my company still distribute clozapine to them?
Starting 02/28/2019, a pharmacy is only eligible to receive clozapine if the pharmacy has certified in the Clozapine REMS Program. If the pharmacy is not on the current list of certified pharmacies, you must not ship clozapine to that pharmacy.
If a pharmacy has requested clozapine but is not eligible to receive clozapine, how do I notify them?
If a Pharmacy orders clozapine, but is not certified in the Clozapine REMS Program, distributors should reject the order per their standard procedures. At that point, the pharmacy can contact the Clozapine REMS Program and start the certification process.
What if I need help using the Clozapine REMS Program Website?
Call the Clozapine REMS Program Contact Center for assistance at 844-267-8678.
What browser types and versions does the Clozapine REMS Program Website support?
We support the latest and previous releases of all major browsers on a rolling basis. Each time a new version is released; we begin supporting that version and typically stop supporting the third most recent version. Major browsers include Internet Explorer, Chrome, Firefox, and Safari.
How does the Clozapine REMS Program Website use cookies?
Our technical cookies are used to display the correct alerts and notifications on your dashboard that assist you in complying with the Clozapine REMS Program requirements.

We never store your unencrypted sensitive information in a cookie. Refer to our privacy policy to find more information about how we use cookies.
What do I do if I can't view a document on the Clozapine REMS Program Website?
If you are attempting to open a document but nothing appears, you may have a pop-up blocker installed on your browser or, if you're unable to open a .pdf file, you may not have the Adobe Reader software installed. To rectify this, disable the feature in your browser for pop-up blockers. To install Adobe Reader, visit the Adobe site here.
How do I report a problem with the Clozapine REMS Program Website?
If you experience an outage or need to report a problem with the Clozapine REMS Program Website, please call the Clozapine REMS Program Contact Center at 844-267-8678.
Why does the Clozapine REMS Program Website use Captcha?
The Captcha on the Create Account page is used to ensure that only humans obtain accounts on the Clozapine REMS Program Website. The Captcha has been implemented to prevent abuse by automated scripts. To complete the Captcha, the user must type the letters of a distorted image that appears on the screen. If the Captcha image is difficult to read, the user can reload the Captcha image.
How do I obtain a username and password for the Clozapine REMS Program Website?
You can create a user account for the Clozapine REMS Program Website. You will be asked to provide your contact information and create a username and password. Once the information is submitted online, you will be sent an email with a link to use in order to verify your account.
What if I do not receive the verification email after I created my account?
If you did not receive the email with the verification link, please check your junk mail folder or call the Clozapine REMS Program Contact Center at 844-267-8678.
What do I do if I forgot my password?
If you forgot your password, you can use the "Forgot Password?" option in the upper right-hand corner of the page in the sign in section. Fill in the requested information and submit it online. A temporary password will be sent to your email address on file.
What do I do if I forgot my username?
If you forgot your username, you can use the "Forgot Username?" option in the upper right-hand corner of the page in the sign in section. Fill in the requested information and submit it online. Your username will be sent to your email address on file.
What do I do if my user account is locked?
If your user account is locked, please call the Clozapine REMS Program Contact Center at 844-267-8678 so a Clozapine REMS Program support agent can assist you in unlocking it.
How do I change my username and/or password?
To change your username and/or password select the drop-down arrow displayed next to your name in the upper right corner and select "My Profile". Select the appropriate tab and enter the information in the fields and submit the information online. You will be sent either your username or a temporary password.
How does a Healthcare Provider create multiple accounts with the same email address?
If you are a Healthcare Provider with multiple roles in the Clozapine REMS Program, you may create multiple accounts by following this procedure:
  • In the Create an Account screen, you may enter the same email address in the My Information section for each account being set up. (see screenshot below)




In the Sign In section, do not use your email address as the username or select the checkbox to use email address as username. Please create a unique username for each account you create.
  • You will need to log in to each account separately in order to access applicable role functionality.
    • For example, if you have an account as a prescriber designee and an account as a pharmacy staff, you would have to log out of one in order to access the other.
    • A single log in for multiple roles is not available at this time.
  • You will receive Clozapine REMS Program communications to a single email address if these steps are followed.
If you have any questions, call the Clozapine REMS Program Contact Center at 844-267-8678 for assistance.
How does a Healthcare Provider change a website username if they wish to create multiple accounts and have already used their email address as the username previously?
You may change your username by signing in to your account on the Clozapine REMS Program Website and selecting the Change Username option from the links below your account link in the upper right corner of the website. (see screenshot below)



How does a Healthcare Provider change the email address on their REMS profile if they previously created an account with an email address they no longer wish to use?
You may change your email address by signing in to your account on the Clozapine REMS Program Website and selecting the Change Email Address option from the links below your account link in the upper right corner of the website. (see screenshot below)



I am a clozapine patient. How do I know if I'm enrolled in the Clozapine REMS Program? If I'm not enrolled, how do I become enrolled in the Clozapine REMS Program?
Please contact your Healthcare Provider for information on whether you are currently enrolled or how to become enrolled in the Clozapine REMS Program.
Where do I find a list of local pharmacies that participate in the Clozapine REMS Program?
Your Healthcare Provider can help you find a participating pharmacy. Please contact your Healthcare Provider for additional information about the Clozapine REMS Program.
For additional information about the Clozapine REMS Program, please call 844-267-8678.