Clozapine REMS Program Day of Reckoning: Post On The Run

Right, so as of about 6:00 AM this morning Central Standard Time, the Clozapine REMS Program website welcome page looked like this:

Clozapine REMS Program doubts

Yesterday, it looked like this:

Clozapine-REMS-program

Is it just a temporary glitch? Do they now mean they don’t even know what year the program will be operational? It’s Monday and I’ve checked what my day as a general hospital psychiatric consultant is going to look like. I need that Clozapine REMS Program to “become operational” today at about 8:00 AM CST.

My firetruckThis post will be a running account of my first day of using the Clozapine REMS Program, both online and (most likely) by telephone and fax. You will know, first hand, about my satisfaction or lack thereof with this rollout–in between my rushing around the hospital taking care of patients.

Here’s the link to the site and readers will probably see it evolve before I do as I’m putting out fires all over UIHC. Check back frequently for updates.

Update: I’ve successfully faxed my paperwork including the test and the enrollment form. I’m waiting to hear back from the FDA Clozapine REMS Program. The website still looks the same as above.

Update: Problems with the website that I’ve paged our pharmacists about. Message from the pharmacist: “I will look into this and get back to you this morning. I hope the website works today.”

Update: Website looks like it’s up but can’t finish the online certification process because I haven’t got an email verification yet (even though it says the email was sent). I’ve tried calling REMS but get the forever on hold message beginning with “All of our representatives are assisting other callers…” or “We’re experiencing exceptionally long wait times…” I did get an automated email message from REMS notifying me that “RE: Action Required–Prescriber Certification in the New Clozapine REMS Program.” It essentially tells me that I must certify.

Update: Now I’m in an endless loop of trying to certify on line. It keeps telling me I must “resume my certification from the dashboard” but then won’t let me do that.

Update: Still can’t certify, just keep getting the message: “It appears your certification is already in progress based on the information provided. Please resume your certification from the dashboard.” Then I have to start all over. I’m still in an endless loop. Pharmacist still unable to act as my designee…because he can’t finish the certification process on line either.

Update: It’s now going on 3:00 PM and no one in my department can certify because of the above glitch in the website and the REMS Program restriction to certifying until today. The system is probably swamped and the website is hopelessly dysfunctional. The pharmacists can’t certify either. There is no way to comply with the program’s requirements. So in order to protect patients’ safety in view of their treatment resistant schizophrenia, we’re going to have to break the rules and dispense the clozapine anyway, despite our not being able to certify.

Last Update: It’s almost 5:00 PM and I’m resigned to waiting for the Clozapine REMS Program to catch up with all the prescribers and pharmacists who tried to access the system today. At least they have my paperwork I faxed this morning. I think I predicted this disaster in an earlier post.

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Comments

  1. One of my colleagues compared the rollout of the FDA Clozapine REMS Program to the initial rollout of Healthcare.gov. I had the same thought!

    It’s ironic that an agency purporting to promote the safety of clozapine actually puts patients’ safety at risk by interfering with prescriber and pharmacist certification, thereby defeating the purpose of the program.

    I’m reminded of the July 17, 2015 Psychiatric News article “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?” in which the solutions are outlined, one of which is:

    “In an effort to reduce the administrative burden associated with clozapine registration and monitoring, several researchers have petitioned the FDA to develop a centralized registry system.”

    Like

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