Drugs

FDA working with manufacturers to resolve challenges with the Clozapine REMS Program

[Updated 12/16/2016] Full launch for the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program will not be implemented in 2016

Although the FDA announced in May 2016 that the full REMS program launch would occur in December 2016, recent technical and logistical challenges necessitate that we postpone the launch. The Clozapine Product Manufacturers’ Group and the FDA are continuing to work to ensure that patients relying on clozapine have continued access to this medication and appropriate management of associated risks. We are planning a phased approach to implementing the Clozapine REMS Program in order to carefully balance patient access and ensuring the safe use of clozapine during the transition to a fully implemented Clozapine REMS Program. 

Prescribers and pharmacies that have not certified in the Clozapine REMS Program are encouraged to use this additional time to certify in the program before the full launch, which includes a fully implemented predispense authorization (PDA) for pharmacies. In addition, prescribers should submit absolute neutrophil count (ANC) results to the Clozapine REMS Program according to the patients monitoring frequency (i.e. within 7, 15, or 31 days) to ensure the ANC is current. If prescribers and/or pharmacies are not certified in the Clozapine REMS Program and the ANC in the Clozapine REMS Program is not current after the full launch, this will impact the pharmacy’s ability to dispense clozapine, negatively affecting patient care.

Updated information will be sent to prescribers and pharmacies once an implementation date has been confirmed.

During this extension, prescribers and pharmacies should continue to adhere to the current Clozapine REMS Program requirements:

1.      Current prescriber requirements:

  • Enroll patients in the Clozapine REMS Program
    • Patient enrollment in the Clozapine REMS Program is confirmed prior to dispensing clozapine
    • You can enroll patients through  your account on www.clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678
    • If the patient is not enrolled in the Clozapine REMS Program, a dispense will not be authorized
  • Obtain an absolute neutrophil count (ANC) for patients in accordance with the clozapine Prescribing Information and aligned with the patients monitoring frequency
  • Submit the ANC directly to the Clozapine REMS Program according to the patients monitoring frequency (i.e. within 7, 15, or 31 days) so the current ANC is in the REMS Program database prior to the dispense
    • ANCs should be submitted directly to the REMS Program and not to the pharmacy to ensure timely data entry into the system
      • ANCs may be submitted to the program by logging into your account on www.clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678
      • ANCs may also be submitted using the ANC reporting form (available under the Resources tab on www.clozapinerems.com). However it will take up to 48 hours to process this form
    • If a patient does not have an ANC on file with the REMS, a dispense will not be authorized
    • If the last ANC on file for a patient indicates moderate or severe neutropenia, a dispense will not be authorized
    • A patient with an ANC that indicates moderate or severe neutropenia must have a Treatment Rationale on file before the dispense can be authorized
      • A Treatment Rationale can be submitted by logging into your account at www.clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678
      • The ANC reporting form can also be used to submit a Treatment Rationale. However, it will take up to 48 hours to process this form

2.      Current pharmacy requirements:

  • Outpatient pharmacies must obtain a PDA prior to dispensing clozapine and inpatient pharmacies are required to complete an eligibility check prior to dispensing clozapine
    • A PDA will not be issued or the eligibility check will not be successful if the patient is not enrolled in the Clozapine REMS Program, if an ANC is not on file, or if a patient has an ANC that indicates moderate or severe neutropenia (without a prescriber Treatment Rationale)
    • Pharmacies may still enroll patients in the Clozapine REMS Program by calling the Clozapine REMS Program Contact Center at 844-267-8678

3.      Currently, the following will not prevent a patient from receiving clozapine from the pharmacy:

  • Prescribers and Pharmacies not certified
    • Because there are technical problems with the system that have not yet been resolved, we encourage adherence to the requirements though the absence of prescriber and pharmacy certification will not preclude a patient being dispensed clozapine. In the future, patients that are not associated with a certified prescriber and pharmacy will not be allowed to receive clozapine.
    • ANC not current (i.e. within 7, 15, or 31 days of the dispense date) based on the patient’s monitoring frequency (MF)
      • Although not required, pharmacies are encouraged to contact the prescriber to acquire the most recent patient ANC information for patient safety purposes. In the future, patients that do not have a current ANC on file may not be allowed to receive clozapine.

For additional information about the Clozapine REMS Program, please call at the Clozapine REMS Program Contact Center at 844-267-8678.


[Updated 11/19/2015] Clozapine REMS deadlines for prescribers and pharmacies extended

Due to ongoing implementation challenges with the new Clozapine REMS Program, FDA is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. We are also carefully evaluating next steps regarding the December 14, 2015 pre-dispense authorization (PDA) launch. We will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible.

Healthcare providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators. Prescribers and pharmacies should continue to work with the Clozapine REMS Program administrators to resolve any issues and continue their efforts to complete certification and update patient information to meet the requirements of the program.


[Updated 11/13/2015] FDA working with manufacturers to resolve challenges with the Clozapine REMS Program

Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS Program, including technical issues with the website, data migration problems, and long call wait times since the launch of the program on October 12, 2015. We understand this has caused frustration and take these concerns seriously. We are working closely with the Clozapine REMS program administrators to address the challenges, many of which are a result of merging data from six registries encompassing more than 50,000 prescribers, 28,000 pharmacies, and 90,000 patient records. 

During this transition to the new shared Clozapine REMS program, continuity of care, patient access to clozapine, and patient safety are our highest priorities. Healthcare providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators. Prescribers and pharmacies should continue to work with the Clozapine REMS Program to resolve any issues.  

FDA has asked the Clozapine REMS Program administrators to continue posting updated information and to help answer frequently asked questions under the “Important Program Update” section of the Clozapine REMS Program homepage.

Prescribers and pharmacists who encounter issues with the Clozapine REMS Program should contact the Clozapine REMS Contact Center at 1-844-267-8678; Monday – Friday, 8am – 10pm EST. Because of the challenges mentioned above, the Contact Center has been extremely busy. However, the Clozapine REMS program administrators have informed FDA that wait times are improving.  We encourage pharmacists and prescribers to continue their efforts to complete certification and update patient information to meet the requirements of the program. 

If you have questions or concerns about the Clozapine REMS Program or its website please contact FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or  301-796-3400. 


[10/20/2015] FDA alerts prescribers and pharmacists to continue clozapine prescribing and dispensing if they encounter online Clozapine REMS certification issues

Program launched October 12, 2015;  technical issues resolved as of October 16, 2015

The FDA is aware that in recent days, technical difficulties with the new Clozapine REMS websitedisclaimer icon have prevented some pharmacies and prescribers from completing their required online Clozapine REMS certification. This has resulted in patient access issues in some cases. The clozapine manufacturers, who are the REMS program administrators, have notified FDA that these technical issues have been resolved as of October 16, 2015. If prescribers and pharmacists continue to experience any issues, they should use clinical judgment and consider the best interests of the patient. Continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved.

Prescribers and authorized representatives for pharmacies who encountered certification difficulties should resume the online certification process. Pharmacists at chain pharmacies will be receiving additional communication from their authorized representative.   

Prescribers or pharmacists who continue to encounter technical issues with the Clozapine REMS Program should contact the Clozapine REMS Contact Center at 1-844-267-8678; Monday – Friday, 8am – 10pm EDT.

We are also aware that there is confusion about the new Clozapine REMS Program requirements. Clozapine manufacturers are working to answer these questions and have posted additional information that is available by clicking on the “Important Program Update” button on the Clozapine REMS websitedisclaimer icon homepage.

If you have questions or concerns about the Clozapine REMS Program or its website please contact FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400.

Page Last Updated: 12/16/2016
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