What is a REMS?
A REMS or Risk Evaluation and Mitigation Strategy is a required risk management plan that uses risk minimization strategies beyond the professional labeling to ensure that the benefits of prescription drugs outweigh their risks.
What is the Clozapine REMS Program?
The Clozapine REMS (Risk Evaluation and Mitigation Strategy) 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 schedule for absolute neutrophil count (ANC) prior to dispensing clozapine
  • Ensuring the prescriber documents a risk-benefit assessment when a 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
Has the Prescribing Information been updated?
Yes.

For updated Prescribing Information visit the Resources page on the Clozapine REMS Program website at www.clozapinerems.com.
How is the new Clozapine REMS Program different from the Clozapine registries that were used in the past?
The CPMG is working on a detailed Fact Sheet that outlines the differences between the Clozapine REMS Program and the individual manufacturer registries. When that Fact Sheet is available (targeted for shortly after initial PDA launch), there will be a link posted within this FAQ.
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 more than one role in the Clozapine REMS Program. 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 to the Clozapine REMS Program Contact Center at 1-844-404-8876
  • Pass the Knowledge Assessment for Healthcare Providers via the website, or faxing in 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 to the Clozapine REMS Program Contact Center at 1-844-404-8876
  • Associate with and be approved by a certified prescriber
Authorized Representative (Non-chain Pharmacy) Certify Authorized Representative Certification Process
  • Complete the Clozapine REMS Pharmacy Enrollment Form online at www.clozapinerems.com or by faxing to the Clozapine REMS Program Contact Center at 1-844-404-8876
  • Pass the Knowledge Assessment for Healthcare Providers via the website, or faxing in 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 switch provider to complete the certification process.
  • Pass the Knowledge Assessment for Healthcare Providers via the website, or faxing in to the Clozapine REMS Program Contact Center
  • Renew certification of their pharmacy in the Clozapine REMS Program every two years from initial enrollment
Pharmacy Staff Enroll Pharmacy Staff Enrollment Process

Prescriber

Definition Responsibilities
A prescriber is any healthcare professional who prescribes clozapine to a patient Certification Process Responsibilities
  • Enroll every new patient in the Clozapine REMS Program
  • Counsel each patient (or their caregiver) about the risk of severe neutropenia
  • Check the ANC for each patient according to the monitoring requirements
  • Report each ANC for each patient to the Clozapine REMS Program as soon as possible after the blood draw
  • Provide a Treatment Rationale to authorize the continuation of clozapine therapy for patients with moderate or severe neutropenia if they determine that:
    • The benefits of clozapine therapy outweigh the risks, or
    • The patient has Benign Ethnic Neutropenia (BEN)

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 to the Clozapine REMS Program Contact Center at 1-844-404-8876.
  • Associate with and be approved by a certified prescriber
Responsibilities
  • A Prescriber Designee can:
    • Enroll general population patients
    • Counsel patients
    • Check ANCs
    • Submit ANCs on the prescriber's behalf
  • A Prescriber Designee cannot:
    • Enroll patient with Benign Ethnic Neutropenia (BEN)
    • Submit a Treatment Rationale for a patient
    • Designate a patient as Hospice

Authorized Representative for Pharmacy

Definition Responsibilities
For outpatient or inpatient pharmacies with a single location, the authorized representative may be a:
  • Pharmacy Manager
  • 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
  • Corporate Executive overseeing Pharmacy Service
The Authorized Representative represents the Pharmacy and is responsible for ensuring processes and procedures within Pharmacy are in place to comply with the Clozapine REMS Program.
Certification Process
  • An Authorized Representative for a Pharmacy must certify in the Clozapine REMS Program:
    • Review the full Prescribing Information for clozapine
    • Certify their pharmacy in the Clozapine REMS Program by
    • Ensure training for all relevant staff involved in the dispensing of clozapine on the Clozapine REMS Program requirements
    • Put 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 is current and acceptable according to the patient's monitoring schedule, or a certified prescriber has provided a treatment rationale to authorize the continuation of clozapine treatment
    • Renew certification of their pharmacy in the Clozapine REMS Program every two years from initial enrollment
Responsibilities
  • Coordinates the activities required in the Clozapine REMS Program
  • Establishes and implements processes and procedures to ensure compliance with the safe use conditions required in the Clozapine REMS Program

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
  • May enter an ANC for a patient
  • May verify a prescriber is certified in the Clozapine REMS Program
  • May verify a patient is enrolled in the Clozapine REMS Program
  • Outpatient Pharmacy Staff may obtain a PDA
  • Inpatient Pharmacy staff may perform an eligibility check since they do not obtain PDA
Can a healthcare provider fulfill multiple roles in the Clozapine REMS Program?
Yes, as of December 10th 2015, the Clozapine REMS Program made changes to allow health care 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 (e.g., as a Pharmacy Staff and a Prescriber Designee)? Can the same email address be used for multiple roles in the Clozapine REMS Program?
Yes, as of December 10th 2015, the Clozapine REMS Program made changes to allow health care 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.
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.
How do I contact the 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 contact the Clozapine REMS Program Contact Center using the number provided above.
There are extensions to the deadlines for Prescribers and Pharmacies to certify. Why is that? When are the new deadlines?
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. Once a new timeline is established, a new deadline for certification will be communicated.
How do I manage my patients until the new deadlines are communicated?
Prescribers and pharmacies should continue to get certified in the Clozapine REMS Program as soon as possible.

The initial Pre-Dispense Authorization (PDA) launch is scheduled for May 2016. The initial PDA launch evaluates some of the program elements that the Clozapine REMS Program has defined, and provides an authorization for the pharmacist to dispense accordingly.

As part of a 2-phase implementation, the initial PDA launch will provide warning messages if a prescriber and/or a pharmacy is not certified - but it will not prevent a dispense from being authorized. Similarly, if the most recent Absolute Neutrophil Count (ANC) is not current based on the patient's Monitoring Frequency (MF), this will not prevent a dispense from being authorized.

When the full PDA launch occurs later in the year, if prescribers and/or pharmacies are not certified in the Clozapine REMS Program, or a patient's ANC is not current, this will impact the pharmacy's ability to dispense Clozapine, negatively affecting patient care.

Until the initial PDA launch occurs, pharmacies should be performing the eligibility check to ensure that the patient has already been enrolled in the Clozapine REMS Program. If a patient is not enrolled, the pharmacy should contact the prescriber to ensure the patient becomes enrolled in the Clozapine REMS Program.

Also, until the initial PDA launch occurs, prescribers and pharmacies should continue to use clinical judgment, determine what is in the best interest of the patient and, as appropriate, continue clozapine therapy for patients with ANCs within the acceptable ranges.
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 ANC history. The guidelines for determining monitoring frequency are described in the updated Prescribing Information.

If a patient's monitoring frequency is incorrect, the Prescriber can modify a patient's Monitoring Frequency to monthly by performing an attestation in the patient's profile via the Website. Prescribers and Prescriber Designees can also 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 bi-weekly monitoring to weekly by faxing the update via the ANC Lab Reporting form to the Clozapine REMS Contact Center for processing.

Note: A pharmacy cannot update a patient's Monitoring Frequency. Pharmacies should work with the Prescriber to update a patient's Monitoring Frequency.

The ANC Monitoring Table can be found on the website:
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 new shared 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 newly approved clozapine Prescribing Information, if the patient had consistent ANCs reported over the previous 12 month period, the patient was migrated with a monthly monitoring frequency.
  • If patient's ANCs were inconsistently reported to the registries in the previous 12 month period and there was a timeframe 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 new Prescribing Information.

If a Prescriber needs to change a patient's monitoring frequency, the Prescriber can do that on the Prescriber dashboard.

The Prescriber or a Prescriber Designee can 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 be reverted back 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 that on the Prescriber dashboard. 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.
How can a prescriber become certified in the single shared Clozapine REMS Program?
Prescribers can certify online through the Clozapine REMS Program website or by submitting the Prescriber Enrollment forms and Knowledge Assessment via fax to the Clozapine REMS Program Contact Center at 1-844-404-8876.

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

For a faxed copy of the certification forms, call the Clozapine REMS Program Contact Center at 1-844-267-8678
When do I need to complete certification?
The deadline for Pharmacy and Prescriber certification in the Clozapine REMS Program has been extended. This is to allow more time for both Pharmacies and Prescribers to complete certification and to minimize treatment disruption for patients.

Prescribers are highly encouraged to certify in the Clozapine REMS Program as soon as possible.

The Clozapine REMS Program is working with the FDA to determine a new timeline. You will receive additional communication outlining the new timeline for certification and full program implementation when that information is available.

If you have encountered certification-related issues, please try again. The most common technical issues have been addressed and the Clozapine manufacturers are continuing to make changes to improve the HCP or HC staff experience.
What happens to the patients of a prescriber who does not certify into the Clozapine REMS Program?
Until the new certification deadlines are finalized: Patients who meet the appropriate criteria, defined in the Clozapine REMS Program elements will be able to continue clozapine therapy even if the Prescriber is not yet certified in the Clozapine REMS Program. Continue prescribing clozapine to patients with an ANC within the acceptable ranges.

Patient enrollment and ANC monitoring is still required for patients on therapy. Continue to submit ANCs to the Clozapine REMS Program.

Use clinical judgment, determine what is in the best interest of the patient and, as appropriate, continue clozapine therapy for patients with an ANC within the acceptable ranges. Work with the dispensing pharmacy to continue treatment for patients with an ANC within acceptable ranges.
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 contact Clozapine REMS Program Contact Center at 1-844-267-8678 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 as long as they are certified in the Clozapine REMS Program. When the eligibility of the patient to receive clozapine is checked, it does not check for an established relationship between the prescriber and patient.
Can a nurse practitioner, physician's assistant, resident, or intern certify as a prescriber in the Clozapine REMS Program?
Yes. Any medical professional prescribing clozapine must 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 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 before they can perform any duties or functions for their 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?
If a Prescriber wants to obtain a list of participating pharmacies, they can call the Clozapine REMS Program Contact Center at 1-844-267-8678.

If a Prescriber knows the pharmacy's DEA, or NPI, or NCPDP number, the Prescriber can also confirm that a pharmacy is certified pharmacy by using the feature "Certification Lookup" on the Resources tab of the Clozapine REMS Program website at www.clozapinerems.com.
What actions can a Prescriber Designees perform in the Clozapine REMS Program?
A Prescriber Designee can perform the following actions on behalf of the prescriber:
  • Enroll General Population patients
  • Report ANCs
  • 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 BEN,
  • Provide a treatment rationale for a patient, or
  • Change a patient to a hospice patient.
Download program enrollment forms
Do patients need to be enrolled in the Clozapine REMS Program in order to receive Clozapine?
Yes. Any patient prescribed clozapine, whether inpatient or outpatient must be enrolled in the Clozapine REMS Program by the patient's Prescriber or the Prescriber's Designee. To enroll a patient please visit www.clozapinerems.com or fax the completed enrollment forms to the Clozapine REMS Program Contact Center at 1-844-404-8876.
How are patients enrolled into the Clozapine REMS Program?
During the initial PDA launch, Prescribers, Prescriber Designees and Pharmacy Staff can enroll patients. Once the full PDA is implemented, a patient must be enrolled by a Prescriber or a Prescriber Designee to ensure that the patient receives the appropriate counseling.

General population patients can be enrolled by both Prescribers and Prescriber Designees online, by phone, or by faxing the Patient Enrollment form. During the initial PDA launch, Pharmacists can enroll patients by phone or fax.

Only Prescribers can enroll patients with Benign Ethnic Neutropenia (BEN). The Prescriber must indicate BEN status as part of the enrollment process on the Clozapine REMS website or on the 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.

Download Patient Enrollment form
Can a healthcare provider not certified in the Clozapine REMS Program enter 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 provide 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 report 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 current 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 BEN.

Substantial drops are not defined in the new clozapine Prescribing Information so safety notices will not be sent if the patient experiences such a drop, unless the ANC itself meets criteria for mild, moderate or severe neutropenia, in which case the notice will be sent.
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 reported who has not started clozapine)
  • Active (actively on clozapine treatment)
  • Interrupted (clozapine treatment interrupted due to suspected clozapine induced neutropenia or no ANC reported)
  • Discontinued (clozapine treatment discontinued due to severe neutropenia, or prescriber updates Treatment Status to Discontinued)
Treatment Status is automatically updated based on the ANC 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 (severe neutropenia) will cause Treatment Status to update to Discontinued
  • For patients with Benign Ethnic Neutropenia (BEN):
    • An ANC below 500 (severe neutropenia) will cause Treatment Status to update to Interrupted
A Treatment Status of Interrupted or Discontinued will prevent a PDA from being issued. If a Prescriber determines that the benefits of continuing clozapine outweigh the risks, the Prescriber can enter a Treatment Rationale (see below) into the system and change a patient's Treatment Status back to Active.

If a patient's Treatment Status is set to interrupted because of a low ANC, that patient's Treatment Status will return to Active when ANC values reach a normal level without the Prescriber entering a Treatment Rationale. If a patient's Treatment Status is set to interrupted because of a low ANC indicating severe Neutropenia, and the Prescriber wishes to continue therapy, the Prescriber must take action and enter a Treatment Rationale to update the patient's Treatment Status back to active.
What is a Treatment Rationale?
A Treatment Rationale is required by a prescriber if he or she determines that a patient should continue clozapine treatment despite a low ANC.

If a patient's Treatment Status has been updated to Interrupted or Discontinued due to a low ANC (see above), a Treatment Rationale must be entered by a Prescriber to change a patient's treatment status back to Active.

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 therapy outweigh the risks.
  2. "Patient with BEN"
    • The ANC result is within a range where treatment can continue for a patient with Benign Ethnic Neutropenia (BEN).
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 as such in the Clozapine REMS Program with a flag on the Prescriber Dashboard (see screenshot, below).

Patients who were previously identified in the NNRMF may restart clozapine in certain circumstances as defined in the current Prescribing Information. Monitoring requirements for patients previously identified in the NNRMF are the same as for patients new to clozapine.

How are patient ANCs reported to the Clozapine REMS Program?
Patient ANCs can be reported to the Clozapine REMS Program in a variety of ways:
  • Prescribers and Prescriber Designees can log into the Clozapine REMS website and enter ANCs for a patient using My Dashboard.
  • Pharmacy Staff and Pharmacy Authorized Representatives can enter an ANC via the website as part of process for checking a patient's eligibility.
  • All program roles can call the Clozapine REMS Program Contact Center at 844-267-8678.
  • All program roles can fax ANCs into the Clozapine REMS Program Contact Center at 844-404-8876.
Download ANC Reporting form
Does the Clozapine REMS Program need to be advised when a patient is admitted or discharged in an acute or long-term inpatient healthcare setting?
No. The Clozapine REMS Program is not tracking 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 de-activate 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?
The monitoring frequency recommendations are described in the updated Prescribing Information. In the Clozapine REMS Program, monitoring frequency is a calculated value, based on the patient's ANC history.

If a patient's monitoring frequency is incorrect, the Prescriber can modify a patient's Monitoring Frequency to monthly by performing an attestation in the patient's profile via the 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 bi-weekly monitoring to weekly by faxing the update via the ANC Lab Reporting form to the Clozapine REMS Contact Center for processing.
If the patient or caregiver will not provide the required information needed to complete Patient Enrollment (e.g., 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.
What are the different pharmacy certification types in the Clozapine REMS Program?
All inpatient and outpatient 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 that 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 (a.k.a. "the switch").
Outpatient Pharmacy
  • 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 (a.k.a. "the switch").
  • Outpatient Pharmacies that cannot adjudicate claims via the switch can perform an eligibility check and/or obtain a pre-dispense authorization (PDA) via the Clozapine REMS Program website when the PDA is implemented.
Inpatient Pharmacy
  • An inpatient Pharmacy is usually located within an larger facility, such as a hospital or long-term care facility, in which the prescriber and pharmacy work together within a single organization to manage patient care.
  • Inpatient pharmacies are required to perform an eligibility check to verify a patient is eligible to receive clozapine before the initial dispense.
Can a pharmacy enroll a patient?
Yes. A pharmacy can enroll a patient, as long as the Prescriber is certified in the Clozapine REMS Program, by calling the Clozapine REMS Program Contact Center at 844-267-8678.

Once the full PDA is implemented, a patient must be enrolled by a Prescriber or a Prescriber Designee to ensure that the patient receives the appropriate counseling.
How does a pharmacy certify in the Clozapine REMS Program?
To certify in the Clozapine REMS Program, the authorized representative of a pharmacy must: Non-Chain Pharmacies can certify online through the Clozapine REMS Program website at www.clozapinerems.com, or by submitting the pharmacy enrollment forms via fax to the Clozapine REMS Program Contact Center at 1-844-404-8876.

Chain Pharmacies should work with Account Managers from their switch provider to become certified.

For additional information call the Clozapine REMS Program Contact Center at 1-844-267-8678.
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 deadline for Pharmacy and Prescriber certification in the Clozapine REMS Program has been extended. This is to allow more time for both Pharmacies and Prescribers to complete certification and to minimize treatment disruption for patients.

Pharmacies are still highly encouraged to certify in the Clozapine REMS Program as soon as possible.

You will receive communication about the revised certification deadlines and additional information about the PDA launch as soon as possible.

If you have encountered enrollment- or certification-related issues, please try again. The most common technical issues have been addressed and improvements are being made to improve the user's experience.
What is a Pre-Dispense Authorization (PDA)?
A Pre-Dispense Authorization (PDA) determines if a patient is eligible to receive clozapine and provides an authorization to dispense.

When implemented in May 2016, the PDA will evaluate that:
  • Patient is enrolled
  • Patient has an ANC on file
  • Patient's ANC is within acceptable ranges according to the updated Prescribing Information or there is a valid Treatment Rationale on file from the Prescriber
  • Prescriber is certified (will provide a warning message if Prescriber is not certified, but will not prevent an authorization to dispense)
  • Pharmacy is certified (will provide a warning message if Pharmacy is not certified, but will not prevent an authorization to dispense)
  • All PDA claim responses will provide the dispensing pharmacy with the following information:
    • The 2 most recent ANC values and the associated blood draw dates
    • Patient Monitoring Frequency (MF)
    • If the last ANC draw date is not current based on the patient's Monitoring Frequency (MF), this will not prevent a PDA
Click here for a Fact Sheet on the PDA.
What is an Eligibility Check?
Through May 2016

The Eligibility Check uses the following criteria to determine if it is safe to dispense clozapine to the patient
  • Patient is enrolled
  • Patient has a ANC on file with values that are within acceptable ranges according to the updated Prescribing Information, or there is a valid Treatment Rationale on file from the Prescriber
  • Patient has an ANC with a blood draw date within the last 56 days
  • Prescriber is certified (informational message only, will not stop dispense if prescriber is not certified)
  • Pharmacy is certified (informational message only, will not stop dispense if pharmacy is not certified)
The Eligibility Check currently returns a simple result of patient is eligible to receive clozapine or a patient is not eligible to receive clozapine.

An Eligibility Check can be performed online by a Pharmacy Authorized Representative or Pharmacy Staff. Eligibility Checks can also be obtained by calling the Clozapine REMS Program Contact Center.

Starting in May 2016

The Eligibility Check will use the following criteria to determine if it is safe to dispense clozapine to the patient:
  • Patient is enrolled
  • Patient has an ANC on file
  • Patient's ANC is within acceptable ranges according to the updated Prescribing Information or there is a valid Treatment Rationale on file from the Prescriber
  • Prescriber is certified (will provide a warning message if Prescriber is not certified, but will not prevent an authorization to dispense)
  • Pharmacy is certified (will provide a warning message if Pharmacy is not certified, but will not prevent an authorization to dispense)
  • All Eligibility Check responses will provide the following information:
    • The 2 most recent ANC values and the associated blood draw dates
    • Patient Monitoring Frequency (MF)
    • If the last ANC draw date is not current based on the patient's Monitoring Frequency (MF), this will not prevent a patient from being eligible to receive clozapine.
Prescribers and Prescriber Designees can perform an eligibility check from their dashboard. To perform an eligibility check, they would enter the following data:
  • Patient data: First Name, Last Name, Date of Birth, Zip Code (Required)
  • Pharmacy identifier: DEA, NPI, NCPDP (at least one identifier is required)
  • Dispense data: Date of Service, NDC, Days Supply, Quantity (Optional)
Pharmacy Authorized Representatives and Pharmacy Staff can perform an eligibility check from their dashboard. To perform an eligibility check, they would enter 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)
How is an Eligibility Check different from a Pre-Dispense Authorization (PDA)?
The following graphic explains the differences between an Eligibility Check and a PDA.

What is the "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 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?
Until the new pharmacy certification deadlines are determined, patients who meet program element requirements as defined by the Clozapine REMS Program (patient enrolled, ANC on file with acceptable values per the Prescribing Information) will be able to receive clozapine - even if the dispensing Pharmacy is not certified in the Clozapine REMS Program.

Pharmacies should use clinical judgment, determine what is in the best interest for the patient and, as appropriate, continue dispensing clozapine to patients with an ANC within the acceptable ranges.
Will Pharmacies that are not certified be able to order and receive clozapine?
The deadline for Pharmacy Certification was extended for pharmacies currently dispensing clozapine to minimize treatment disruption for patients while allowing more time for Pharmacies to complete certification. Once a new timeline is established, a new deadline for certification will be communicated.

Currently, if a Pharmacy is not certified in the new Clozapine REMS Program, but was approved to order and receive clozapine in any of the individual manufacturer registries, that Pharmacy is eligible to order and receive clozapine. If a Pharmacy was not previously approved to order and receive clozapine in any of the individual manufacturer registries, they must first become certified in the Clozapine REMS Program to order and receive clozapine.

While the deadline for Pharmacy certification for pharmacies currently dispensing clozapine has been extended, those pharmacies not already certified are encouraged to become certified as soon as possible if they wish to dispense a clozapine product.

Distributors can continue to ship clozapine to pharmacies previously participating in the individual manufacturer registries (regardless of the registry they were associated to) and to pharmacies certified in the Clozapine REMS Program.

Once the new Pharmacy certification deadlines are determined, additional communication will be provided about the process for Pharmacies to order and receive clozapine.
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 having issues, please contact the Clozapine REMS Program Contact Center at 844-267-8678.
Will patients still need to have blood draws?
Yes. Blood draws for ANC monitoring are required prior to dispensing. Monitoring frequency is determined by the patient's prescriber based on details in the clozapine Prescribing Information.
Can clozapine be dispensed to a patient without bloodwork?
No. Patients must have ANCs that are current and in the acceptable range. Between the initial PDA launch in May and the full PDA launch later this year, if there is no ANC on file in the patient's lab history, an ANC will be required before a PDA is issued. After full PDA launch, if the last ANC on file is not current based on the patient's monitoring frequency, a more recent ANC will be required before dispensing clozapine.

If the ANC meets the criteria for moderate or severe neutropenia, a patient must have an appropriate Treatment Rationale documented in the Clozapine REMS Program prior to dispensing clozapine.
How does a pharmacy enroll a patient into the Clozapine REMS Program?
Until the new certification deadlines are finalized, a pharmacy can enroll a patient, as long as the Prescriber is certified in the Clozapine REMS Program, by calling the Clozapine REMS Program Contact Center at 844-267-8678.

When the full PDA launch occurs (later in the year), a patient must be enrolled by a Prescriber or a Prescriber Designee to ensure that the patient receives the appropriate counseling.
What actions are required if the prescribing physician isn't certified?
Until the new certification deadlines are finalized, patients with acceptable ANCs can receive drug even if a Prescriber or a Pharmacy has not completed certification.

Use clinical judgment, determine what is in the best interest of the patient and, as appropriate, continue dispensing clozapine to patients with an ANC within the acceptable ranges.

We encourage you to contact the prescriber's office to advise him or her of the need to certify in the Clozapine REMS Program since once the program is fully implemented, they must be certified in order for the patient to continue receiving clozapine.
What should a pharmacist do with the patient's ANC form?
The pharmacist should enter the patient's ANC into the system or fax to 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 contact 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, will the Clozapine REMS system explain the reason?
When a prescription is denied (i.e., a PDA is not generated), an appropriate message will be displayed to the pharmacy staff member.

When the PDA launched in May 2016, patients with acceptable ANCs will still be able to receive clozapine even if a Prescriber or a Pharmacy has not completed certification. In this case, the Clozapine REMS system will also display an appropriate message.

Use clinical judgment, determine what is in the best interest of the patient and, as appropriate, continue dispensing clozapine to patients with an ANC within the acceptable ranges.
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.

A Customer Manager will help the distributor to complete a 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 Lookup" 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 1-844-267-8678
A pharmacy has requested clozapine, but they are not yet certified in the Clozapine REMS Program, can my company still distribute clozapine to them?
Until the new certification deadlines are finalized, a pharmacy is eligible to receive clozapine if either of the following conditions apply:
  • The pharmacy was enrolled in a previous clozapine registry
  • The pharmacy has certified in the Clozapine REMS Program
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 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 website?
Call the Clozapine REMS Program Contact Center for assistance at 1-844-267-8678.
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 and you can find more information about how we use cookies in our privacy policy.
What do I do if I can't view a document on the website?
If you are attempting to open a document, but nothing appears you may have a pop-up blocker installed on your PC or, in the case of a PDF file, you may not have the Adobe Reader software installed. To rectify this, you can disable the feature in your browser for pop-up blockers. To install Adobe Reader, you can 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 1-844-267-8678.
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 in order 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 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 that you must 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 contact 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 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 health care 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.
  • 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 into 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 login 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 into your account on the Clozapine REMS website and selecting the Change Username option from the links below your account link in the upper right corner of the website.

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 into your account on the Clozapine REMS website and selecting the Change Email Address option from the links below your account link in the upper right corner of the website.
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.