Clozapine REMS Program Saga Just Keeps Getting Funnier Every Single Time…

Dr. Amos on phone 1The latest in the Clozapine REMS Program debacle, which I probably should start calling The Geezer’s Legendary Clozapine REMS Program Circular Saga (TGLCREMSPCS) is that I am almost there–I think. I actually got through the process to get the message:

“Thank You! You are now certified in the Clozapine REMS Program.” No kidding, I actually printed the page and have a Certification ID number.

But when I called my Clozapine REMS Program contact (yes, I have a personal consultant now!), he could not replicate it. In fact, he found another endless circular loop, which led me to sign out and sign back in.

Sure enough, the web site was still making me do everything all over again starting from the intake! The first time it recognized my completion of the Knowledge Assessment for Healthcare Providers and I electronically completed the attestation on the Prescriber Enrollment Form.

When I signed in again, it not only took me back to the intake section…it wanted me to take the Knowledge Assessment for Healthcare Providers over again. Over and over and over…

So it’s definitely a recurring technical problem. I got a hunch this is likely to evolve throughout the day. You might want to check back periodically 🙂

UPDATE: Later, I got this voice mail message from my consultant, indicating very cautious optimism about my chances of success for certification after an adjustment in the website. I called him back and we went through it. Wow.

It still doesn’t work. In fact, there’s another loop. It still makes me take the Knowledge Assessment for Healthcare Providers repeatedly, but there is one difference. I now get an “Alert” box. It just tells me that I still have to complete certification.

Irony the opposite of wrinklyIronically, I also got this email from the American Psychiatric Association (APA) today, shortly after 1:00 PM. The title is:

Continued Low Rate of Clozapine Use and Wide Variability Found in State Medicaid Programs

medal-09

Dr. Mark Olfson MD MPH

Dr. Mark Olfson MD MPH

Clozapine continues to be dramatically underutilized—despite it being the only drug approved for treatment-resistant schizophrenia—and there appears to be significant variation among states in its use for patients in the Medicaid program.

That’s the finding from an analysis of Medicaid data in 46 states published Monday in Psychiatric Services in Advance. Mark Olfson, M.D., M.P.H. (pictured left), of Columbia University and colleagues updated a previous analysis from 2001 to 2005 to include data from 2006 to 2009. [Iowa is one of the lowest–J. Amos, MD]

Overall, clozapine accounted for 4.8% of antipsychotic use in schizophrenia from 2006 to 2009, with a slight decline during this period (5.7% in 2006 to 4.3% in 2009). Clozapine was least commonly used in the Deep South (Louisiana, Mississippi, and Alabama) and more commonly used in New England, the Rocky Mountain West, and Washington. The highest rate of clozapine prescribing was in South Dakota (15.6%) and the lowest was in Louisiana (2.0%).

The authors of the analysis noted several factors associated with low clozapine use: fiscal stress, inadequate staffing to monitor clozapine, patient reluctance about blood monitoring, and concerns over tolerability.

Recently, the Food and Drug Administration issued modifications to its requirements for blood monitoring for patients receiving clozapine in an effort to lessen the burden on clinicians and patients. “I think the new monitoring system will be quite helpful,” Olfson said in comments to Psychiatric News. “It simplifies the clinical evaluation of neutropenic events, increases access to clozapine for patients with benign neutropenia, and permits those who develop mild neutropenia to continue treatment.” (bold-face type mine)

firehydrant2“Lessen the burden”? You mean they can’t find out that a number of clinicians are having a little trouble certifying under the new “modifications”? Or maybe they don’t see the irony in the Psychiatric News article published July 17, 2015:

“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.” See publication:

So far the bottom line for many clinicians and pharmacists (though clearly not all) is that the new certification process is one of the barriers to utilizing a very effective agent for treatment-resistant schizophrenia. Maybe we should petition the FDA to rethink its centralized registry system.

 

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Comments

  1. You know how there are Ig Nobel Prizes? http://www.improbable.com/ig/winners/#ig2015
    There should be an equivalent Medical prize. Maybe the Meaningless Use Prize. I think you just won it.

    Like

    • You can’t make this stuff up. How are you doing with it? Are you having problems certifying? The one saving grace so far is that I have one very helpful contact at the Clozapine REMS Program who listens to me and actively tries to address the issues.

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  2. Psssst…it’s about 7 PM. I checked. I think I’m certified. Shhhhh…No loop. No alerts. No notifications. Several patients on my list?

    I’m not their doctor.

    But for now, I’m going to put up with that.

    Like

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