Drugs

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

[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: 12/09/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.