Stop, In The Name Of Patient Safety!

OK, so I repeatedly get Patient Alerts, now called “Overdue” from the Clozapine REMS Program. I called my contact there and it looks like there is no thought being given to stop sending Alerts to the wrong clinicians, despite the complaints from several of us. Even though he agrees with our view of the problem, he’s powerless to address it because it’s a top-down decision to continue this feature of the program–from the FDA itself.

I think it’s potentially a patient safety issue and sent an email message to the FDA about it:

Regarding the Clozapine REMS Program website, I continue to receive notices of overdue labs in my email inbox on patients that are not under my care . I have already spoken with a responsible Clozapine REMS Program representative who tells me that this extraordinary feature was built into the program and is unlikely to change because it is based on guidelines from the FDA. In my opinion, this is a fundamental flaw because it is an ineffective way to ensure the safety of patients taking clozapine. Simply sending the wrong doctors notices marked “Overdue Patient Lab” fails absolutely to protect the patient because they repeatedly bypass the clinician who could correct the problem. Relying on the pharmacist to notify that clinician in an effort to address the problem misses the point, although that is exactly what I’m told is the expectation.

What happens if the clinician fails to register by November 23, 2015? Will you keep sending the wrong doctors messages that clozapine will not be dispensed? That attempt at corrective action will go nowhere. I’m already registered. I have no patients under my care who are taking clozapine. You can’t contact the clinicians who are responsible for these patients because, in fact, you don’t even know who they are, demonstrated by repeatedly sending messages to the last clinician who saw the patients—in some cases many years ago.

One of the ironies here is that the program so far actually has been telling prescribers and pharmacies that they should do the right thing clinically by dispensing clozapine when the blood work is within safe parameters even if they are not registered. This may be unintentionally encouraging a tendency to ignore the registration requirement altogether. The chief reason for this maneuver were the many technical problems with the website, especially at the outset.

My contact at the Clozapine REMS Program tells me that he’s not in a position to correct this problem in the program because you are in charge of it and are unwilling to change it. Simply saying that the Alert messages have to go to someone does not solve the real problem—the clinician who fails to register with the Clozapine REMS Program.

I regularly get these misdirected Alerts. My contact at the Clozapine REMS Program tells me he agrees with my position and, in fact, he’s receiving similar complaints from other clinicians about this issue. He says he just sends it up the line, presumably to the FDA because he lacks the authority to change it.

When do we “Stop The Line”? We actually have such a policy at our hospital which is called “Protection of Patient Safety: Stop The Line” which is “the empowerment of all staff members to clarify or interrupt a process when a potential risk to patient safety is perceived.” This encourages all members of the healthcare team to speak up whenever something is perceived to be inconsistent with safe practices. This helps draw attention to the potential problem so that all stakeholders can acknowledge the concern and address it. There is even a funny acronym for it: C-U-S-S:


Concern: I need to communicate my concern


Understanding: “I don’t fully understand the process here”


Safety: “I believe patients’ safety might be placed at risk”


Stop: “Please stop and let’s review the process together.”


Obviously by now, many clinicians would like to “cuss” out the Clozapine REMS Program and whoever cobbled it together. My contact at the program tells me that he’s attempted to escalate this issue several times, based on expressions of concern by many prescribers about this situation. The escalation appears to stop at the top of the call-tree—which is the FDA.


Can we stop the line, please?



  1. Hmmm…I’ve got a reply already from the FDA:

    “Dear Dr. James J. Amos,

    Thank you for writing to the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

    We greatly appreciate your comments and suggestions for the Clozapine REMS program. We have forwarded your email to the Division of Risk Management (DRISK) for evaluation. DRISK serves as the focal point for risk management activities in CDER. DRISK provides risk management expertise on development and implementation of programs and initiatives to support the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS) authorities under the Food and Drug Administration Amendments Act (FDAAA) of 2007. DRISK reviews all proposed REMS, REMS modifications, and REMS assessments for all products with approved REMS for conformance with current FDA standards.

    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.”

    Will DRISK be brisk addressing the issue?

    Wait and see…


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