Respectfully Helping The Clozapine REMS Program

You know, I heard about former Speaker of The House John Boehner’s struggle to adapt to his new retirement from Congress. I guess Mr. Boehner likes to vacuum, although I don’t know how long he’ll keep it up. A couple of comments had suggestions for him on adjusting to retirement. I have a couple:

He went from 100 mph to zero in nothing flat…and he’s tearing up about it. I’m having apprehensions about this because I’m starting to actively look into retirement options now. I especially get preoccupied with this when issues like the Clozapine REMS Program continues to send me notices about labs I’m failing to update on patients who are not my responsibility.

starts-with-a-stopYesterday I sent an email to the FDA  about it and they replied the same day. We’ll see if the Division of Risk Management (DRISK) will act, although maybe they should STOP first. This is another wrinkle on the “STOP The Line” message in yesterday’s post. I was watching Iowa Public Television (IPTV) last night and noticed a commercial about an organization called Character Counts in Iowa, which upon further investigation turns out to have been renamed (How did IPTV miss this?) The Robert D. and Billie Ray Center. Some of us may remember Bob Ray; he served as Iowa Governor for 5 terms from 1963-1983 (is there a message for another Iowa Governor here?). I was browsing the site and noticed this blog post “Every good decision starts with a stop.”

Maybe there’s a message here for the FDA. A little foresight and reflection would have been a good thing. Sending the wrong doctors messages implying we’re not protecting the safety of patients is misleading at best and at worst potentially puts patients safety at risk because the patients’ actual clinicians are not being notified of such issues as important lab values not being updated.

It makes no sense to send Alerts to the wrong doctors. Paraphrasing Michael Josephson’s blog post:

“Wait, what does the FDA really want to accomplish here?”

“How will the FDA’s decision to design the Clozapine REMS Program in its current form affect patients, prescribers, and pharmacists?”

“What are the FDA’s alternatives?”

“What could go wrong?”

Maybe it wouldn’t hurt for all stakeholders to contact the Clozapine REMS Program (sorry, you can’t email them) and the FDA. If you call the Clozapine REMS Program and ever manage to connect with a real person, be aware one of the first things the representative will say is “This conversation is being recorded…” Consider beginning with something like,

“I’m so glad we’re being recorded; that may help ensure the right people will hear what you and I discuss today. I feel like these Alert messages I get about patients for whom I’m not the prescriber are falsely accusing me of neglecting their safety. I realize that’s not your intent although I have to admit it has an impact on me. I’m also concerned about the impact this may have on patients because these Alerts ought to be sent to the prescribing clinician, not someone who has, in many cases, not seen them in many years. Can we work on solving this together? If you are not the right person to talk to, can you direct me to somebody who can help me?”

Remember to be civil.

Would they listen? I’m not sure…yet, and I’ll tell you why. I just read another thought-provoking article entitled “See? I was right.” According to a new study from the University of Iowa, “…once people reach a conclusion, they aren’t likely to change their minds, even when new information shows their initial belief is likely wrong and clinging to that belief costs real money.”

How about when the belief might cost real health consequences which could be harmful?

Need contact information for the FDA? Here you go:

“If you have additional questions or concerns about the Clozapine REMS Program or its website, please contact FDA at, 1-855-543-3784 or 301-796-3400; Monday – Friday, 8am – 4:30pm EDT.”



  1. At least you’re IN the system. I’m one of those sorry SOBs who tried to register on 10/12. As of today (11/17), I STILL can’t complete my pharmacy registration and when I DO get through to them (averaging about 35 minutes on hold these days), they have no idea when they’re going to fix it.


    • I hear you. I was also one of those who tried to register on 10/12/15 and my saga about that is on this blog under the Clozapine REMS Program menu item subtitled “Clozapine REMS Program Joke Fodder.” One of my colleagues just got registered–and is now hassled by the ridiculous Alerts that are not relevant to his practice because the patients he’s getting those Alerts on are not his. There’s no doubt this circus is in no position to protect patient safety when it can’t even identify who the patients’ doctors are. The Clozapine REMperor has no clothes.


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