Clozapine REMS Program Progress–Maybe; And A Poll!

This morning I was just going to add a comment on yesterday’s post about today’s latest close (or more properly, near miss) encounter with the hilariously incomprehensible Clozapine REMS Program, but it was too long. I might as well add a new post. See the new update at the preceding link (but you have to be quick because it changes frequently…so see it below):

  • If I’m not able to complete certification for myself (prescriber) or my pharmacy (Pharmacy Authorized Representative) in the Clozapine REMS Program, can my patients get clozapine? How can I avoid an interruption in therapy?
    While the technical issues are being resolved, use clinical judgment, determine what is in the best interest for the patient and, as appropriate, continue dispensing clozapine to patients with an ANC within the acceptable ranges.
  • I get a message that the Clozapine REMS Program phone/fax is not in service? (Note from Dr. Amos; I have not gotten any such message…yet)
    As of October 21, 2015, based on initial findings, we believe that 844-prefix numbers are potentially being blocked by some organizations’ telecommunication services. (Note from Dr. Amos; my organization is not blocking them because I got a message on my voice mail today!)
    If you are experiencing this problem, in order to contact the Clozapine REMS Program please try using a phone or fax number from a previous registry (listed below). All phone and fax numbers from the previous registries are forwarded to the Clozapine REMS Program.

    • Voice: 800-507-8334 (Note from Dr. Amos; this will not be an improvement over the 844 number…but you’re welcome to try)
    • Fax: 800-507-8339 (Note from Dr. Amos; I double-dog dare you!)
  • Do I need a DEA number to certify as a Prescriber?
    No. Prescribers must provide either a DEA or NPI number. Both are not required. (Note from Dr. Amos; The website still requires both, although I still can’t get past the intake portion of the certification process)
    Keep in mind, to dispense clozapine to patients, pharmacies must verify the Prescriber is certified and will need a Prescriber’s unique identifier. Pharmacies may try to use either the prescriber’s DEA or NPI number. Therefore, Prescribers should provide both a DEA and NPI during the certification process, if available.
    Prior to October 24th, online Prescriber certification required a Prescriber to enter both a DEA and NPI number.
    As of October 24th, the website will permit Prescribers to certify by providing an NPI or DEA number. If a Prescriber does not provide a DEA number, he/she will select the “No DEA” checkbox on the Prescriber Intake screen to indicate they do not have a DEA number and proceed through the online certification process.
  • Please click on this link (Note from Dr. Amos; This takes you a page which claims the website is functional as of 10/16/2015–not true; I still can’t certify, even with an alternate username for login) for a communication to Non-Chain Outpatient Pharmacies
  • If you are a Pharmacy Authorized Representative that has completed your certification, but have not yet added pharmacies for which you are responsible, please log into your account and:
    • Navigate to your dashboard
    • Go to the “Pharmacies” tab
    • Click on the “Add Pharmacy” button and add pharmacy information

So today is Saturday, October 24, 2015. I’m on call and just finished rounding. I had a voice mail message and–miraculous–it was from the Clozapine REMS Program, finally returning my call…yesterday evening at 6:45 PM long after I’d left my office. The caller seemed to have a bad connection, or was stuck for words a couple of times.

She invited me to call back between 8 AM and 10 PM and left the same dysfunctional phone number, 1-844-267-8678. I tried calling that number, obeying the caller’s instructions, and–ridiculous–got the same original message telling me to leave my phone number so that somebody could call me back. I left yet another message like that at noon today.

I’m not going to wait very long because it’s Saturday, I’m not sure anyone is there and I’ve got other things I would like to do today rather than wait however long it would take for REMS to call me back again.

I’ve tried two usernames to log in to the website, which is still dysfunctional.

It’s all been circular, with no end in sight. One of my pharmacists was able to get through after waiting on hold for an hour (before they abandoned the hold forever thing and promised to return calls). He asked them if they are FDA employees. Turns out they’re an outside agency that the FDA hired as a subcontractor for this debacle.

It’s about 12:30 now (a half hour since I left my phone number again); they have not returned my call and I’m getting a little hungry.

I’m going to try to give them another half hour. I’m considering making an opinion poll about this, although polls and surveys on my blog have typically gotten low response rates. I fully acknowledge that some prescribers and pharmacists have been able to certify, a few of them without notable difficulties. On the other hand, other people are having a heck of a time.

So here’s the poll and I’m asking that only prescribers, pharmacists, and patients respond (in other words, true stakeholders who are familiar with the issue). Thanks. It’s close enough to 1:00 PM that I think I can safely leave. I wonder if there’ll be another voice mail from them tomorrow?



  1. Rats! The Clozapine REMS Program and I are playing phone tag. They again called when I was unable to pick up the phone, at around twenty minutes past noon today judging from the voice mail message. I again had to leave my “10 digit phone number starting with the area code.” At this rate, it could be a while before we connect. I can’t leave a message of any kind–just my phone number (which I left around 1:30 PM today). I guess that prevents the hacked off caller from giving anyone a piece of his mind.


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