Dr. Frownin’ Willie Morgan On The New Clozapine REMS Program…Arrr!

Dr. Frownin' Willie Morgan

Dr. Frownin’ Willie Morgan

So, in honor of today being International Talk Like A Pirate Day, my official name for September 19 is Dr. Frownin’ Willie Morgan after conversion of “The Practical Psychosomaticist” on the pirate name generator site. I know, I’m not frowning.

Arrr! would be an appropriate way to start this post about the new update to the clozapine post, in view of the upcoming new FDA prescribing rules for clozapine known as the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program.

Arrr!

This reminded me of a recent article in Psychiatric News entitled “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?” by Mark Moran (Rough Sailin’ Quinn Drake just for today) who interviewed Deanna Kelly, Pharm.D. (who, according to the pirate name generator, should be called Scurv-aceous Guidiana Bellamy which of course is the feminized version of the name which actually came up–Guideon).

Anyway, according to Scurv-aceous Guidiana, “All the data suggest this is a superior medication, particularly for treatment-resistant schizophrenia…” There is plenty of evidence for its effectiveness across several studies and it’s the only FDA-approved antipsychotic for treatment-resistant schizophrenia.

pirate-sword-973700Also, in the aptly named trial in view of today’s holiday, Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS), “…clozapine treatment was associated with significantly greater improvement in Positive and Negative Symptom Scale (PANSS) total scores and higher patient subjective ratings compared with risperidone, olanzapine, quetiapine, and amisulpiride.”

But only about 5% of patients got clozapine last year in America. Cost isn’t the main issue because clozapine is available as a generic. So why do we avoid it? Without hesitation, most of us would say it’s the stringent restrictions on blood monitoring–which some might say will get much easier under the new REMS Program. It’ll be different–but for now I’m deferring judgment on whether it’ll be truly that much easier.

Arrr! Until now, five companies offer generic clozapine, each with a separate registration system for clinicians and pharmacists. That’s all going to change come October 12, 2015 when they are replaced by just one system, the REMS Program. Under the new program, only the absolute neutrophil count (ANC) will be recognized as the blood monitoring parameter of interest. That’s right, the total white blood cell count (WBC) is going away.

Shiver me timbers!

As clinicians, we’re also leery of the side effects including but not limited to agranulocytosis. There are other adverse events such as myocarditis, weight gain, seizures, sialorrhea, hypotension, clozapine-induced gastrointestinal hypomotility leading to bowel obstruction sometimes resulting in death, to name a few.

Scurv-aceous Guidiana lists the definitions of the various blood parameters in the article–which you can just forget now because it will all be different as of October 12, 2015. However, she mentions “benign ethnic neutropenia” (BEN) which has complicated access for some African Americans and Africans who can have lower WBC. That may be less of a barrier now with the REMS Program.

She also mentions the effort to reduce the administrative burden by “…several researchers…” who had petitioned the FDA to develop a centralized registry system.

Wow, which incidentally translates to “Wow” on the pirate name generator. That centralized registry system is now upon us and it’s one way experts hope to promote the culture change which could persuade more clinicians to prescribe clozapine.

Well, that brings me to the updated WordPress Presentation Shortcode slide set on clozapine in the general hospital. This is by no means an exhaustive review and barely scratches the surface of the complexity involved in using clozapine for the treatment of schizophrenia. The Disclaimer certainly applies to this short slide set on the use of clozapine in the general hospital.

Them that certify will be the lucky ones–maybe.

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Comments

  1. So, if you let your ABPN certification lapse, and/or if you only have NBAPS Board certification, can you still approve a clozapine orderer written by a resident? Or prescribe it yourself in an outpatient setting?

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    • Good question. I think “certify” in this case refers to the REMS Program itself rather than with specialty certification boards, but it’s worth clarifying.

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