Clozapine REMS Program Update: Take A Breath

OK, remember the FDA new certification process for the glitchy Clozapine Risk Evaluation and Mitigation Strategy (REMS)? I have not been able to get through the long hold times on the telephone. Allow me to stop and take a breath while I ponder the maniacal inscrutability of a program that will not allow me to get through the dysfunctional endless loop of what I’ll call the non- certification process online. I just repeatedly get the following message:

REMS Error Message

But the REMS telephone number will get you an automated message that finally acknowledges the technical problems and says they’ll be fixed in “24-48 hours.” That message is now at least 3 days old. And there is a REMS website message announcing an update:

REMS update message

And the new message is (click in the gallery below):

So the new information is that prescribers are now not required to be enrolled in REMS to prescribe clozapine and pharmacies are not required to certify in REMS in order to dispense clozapine to patients with an Absolute Neutrophil Count (ANC) in the acceptable range.

This is what we were forced to do anyway this past Monday, the dreaded and cursed October 12, 2015. No apologies, no explanation other than “technical difficulties,” and no solution yet in sight. Enrollment and certification are not required because it’s impossible to accomplish them.

There is a laughable message claiming that the technical issues for prescribers have been resolved. They have not been resolved and this is just more evidence that the FDA Clozapine REMS Program is close to being a complete failure and that the leaders of this farce do not have the integrity to admit their incompetence and simply apologize to the physicians, pharmacies, and patients they have inconvenienced and possibly put at risk for harm by delays in access to the only antipsychotic available and approved for treatment-resistant schizophrenia.

If you have problems with the website, call the program at 844-267-8678? Go ahead. Be sure to have plenty of food and water and a port-a-potty handy.

You’ll be waiting a long time.

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