In regard to the Clozapine REMS Program, the “go live” date for Prescriber Enrollment (11/23) and Pharmacy Enrollment (12/14) have been extended. The new dates are not yet available, but more information will be forthcoming.
Read more at: http://www.fda.gov/Drugs/DrugSafety/ucm467560.htm
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 [email protected], 1-855-543-3784 or 301-796-3400.