Clozapine Monitors The Problem But Does It Fix The Problem?

OK, are you ready for the new Clozapine REMS Program rules for dispensing clozapine? First go to the website and click on the red update icon, which right now is dated April 29, 2016. There are notices about the Initial Pre-Dispense Authorization (PDA) Launch Plan (which starts this month) and a Full PDA Launch Plan to begin sometime later this year.

One item that is not covered is psychologist prescribing. Apparently, psychologists were left out of the Frequently Asked Questions (FAQ) section which answers the question, “Can a nurse practitioner, physician’s assistant, resident, or intern certify as a prescriber in the Clozapine REMS PRogram [sic]?” The answer is “Yes. Any medical professional prescribing professional prescribing clozapine must become certified in the Clozapine REMS Program.”

Unless a prescribing psychologist is definable as a “medical professional,” that leaves them unable to certify.

But apparently the program does not yet recognize psychologists as prescribers. This will be relevant for those states which have passed legislation allowing psychologist to prescribe psychotropic medications, which now includes Iowa as of last month, assuming Governor Terry Branstad signs the bill into law. According to Iowa Senator Joe Bolkcom, psychologists will be able to write prescriptions for over 400 drugs. It doesn’t look like clozapine will be one of them.

Another important caveat to that rule is, while a resident “must” certify, that doesn’t necessarily mean they’ll learn how to manage clozapine independently. For example, our residency program strongly encourages residents to certify (some have not yet done so) but they still are not allowed to write the initial prescription for clozapine, which must be done by a faculty member.

Furthermore, at our academic medical center, only psychiatrists and neurologists can certify in the Clozapine REMS Program. It’s only when patients are being managed in non-academic settings (the real world), that medical professionals who are not psychiatrists and neurologists prescribe clozapine. Examples of settings like that include skilled nursing facilities, long term acute care hospitals, and nursing homes.

The Initial PDA Launch Plan takes it easy on prescribers and pharmacies and the bottom line here is that patients can still get their clozapine even if their prescribers and prescribers are not yet certified. But later in the year, a tough love approach is foreshadowed although the message is in fine print–the patient will not get clozapine if the certification process is not yet completed by both prescriber and pharmacy. The Clozapine REMS Program tries to soft sell the understated warning:

“When the full PDA launch occurs later in the year, if prescribers and/or pharmacies are not certified in the Clozapine REMS Program, or a patient’s ANC is not current, this will impact the pharmacy’s ability to dispense Clozapine [sic], negatively affecting patient care.”

There will be a new deadline at that time and it’s not hard to appreciate the threat to patient care this strategy may pose. Punishing the patients for the presumed sins of the prescribers could be a tough pill to swallow, especially in the setting of the barely acknowledged technical and procedural flaws of the Clozapine REMS Program since its inception October 12, 2015.

It cannot even locate the prescribers. I’m still getting warnings about missing Absolute Neutrophil Counts (ANC) on patients for whom I’m not prescribing clozapine because when the original registry databases were migrated to the Clozapine REMS Program, the names of many prescribers were apparently either never in them or the data got corrupted.

Which is the higher risk, a psychotic break if the patient doesn’t get clozapine or severe neutropenia if she does get it from an uncertified prescriber? The former carries a much higher risk. I still don’t see how threatening the patients and their families will encourage prescribers to certify. The only way that might happen is if pharmacists do the heavy lifting by telling prescribers that they’re the ones who are the problem because both pharmacists and prescribers have to be certified.

The pharmacist can say, “My hands are tied; help me out here.” And the prescriber can say, “I don’t need no stinking Clozapine REMS Program” or “Tell me about it, I can’t certify in that glitchy monitoring system.” Why is the ultimate solution to negatively affect patient care?

Because the Clozapine REMS Program is a monitoring system, not a fixing system. It reminds me of the TV commercial about the “monitor” that doesn’t fix a problem.

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