So, I found this short article on line in which the Clozapine REMS site issues are identified but are not solved as the author states. They continue to pretend things are fine. It is now October 22, 2015 and statements about the continuing dysfunction of the Clozapine REMS are still misleading. The message reads in part:
“The Food and Drug Administration (FDA) announced that there have been technical difficulties with the new clozapine risk evaluation and mitigation strategy (REMS) website that may have prevented some pharmacies and prescribers from completing their required certification, resulting in problems with patient access.
Clozapine manufacturers, the REMS program administrators, notified the FDA of these technical issues; the issues have been resolved as of October 16, 2015 [NOT!]. However, if prescribers and pharmacists continue to experience any issues, they are advised to use clinical judgment, consider the best interests of the patient, and to continue prescribing and dispensing clozapine to patients with an with an absolute neutrophil count (ANC) within the acceptable ranges until the issues are fully resolved.”
I have tried every day since October 12, 2015 to certify and cannot. I note that the phone number 844-267-8678 has a new recorded message essentially telling doctors and pharmacists to do what they have to in order to safely care for their patients taking clozapine. The new phone message also gets rid of the long hold times (over an hour according to one of my pharmacists who was only to able to certify yesterday)–by asking for our phone numbers and promising to call us back; like that’s gonna happen! I’ve been waiting since about 3:30 PM today. It’s now about 5:00 PM.
This means non-certified clinicians and pharmacists can dispense clozapine to patients with treatment-resistant schizophrenia. We’re just not certified because the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program is a spectacular failure.
Things are not hunky dory as of October 16, 2015. And I have yet to hear a public apology from the Clozapine REMS Program to patients, pharmacists, and prescribers. Do they need an example?