Clozapine REMS Program Saga: Is It Worth It?

Well, I’m getting a new error message up on the FDA Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program website.

Clozapine REMS Error Message

That’s not exactly the apology I was hoping for. Obviously, the breathtaking ineptitude of the program leadership continues, without a public apology which even the architects of Healthcare.gov finally delivered in its early rollout.

How anyone can believe this spectacular failure to communicate will persuade more psychiatrists to prescribe clozapine is beyond comprehension. I am still unable to certify as a prescriber, although REMS now doesn’t require it, precisely because the man behind the curtain is dimly aware that it’s impossible for prescribers to certify or enroll.

They have my paperwork. I faxed it to them at 8:00 AM on the apocalyptic day of October 12, 2015. They still have not certified me. I cannot get through to any real human by calling their phone number, 844-267-8678, just their infernal automated messages advertising their incompetence. I sometimes daydream about how an actual conversation might go with one of the representatives who are always “busy assisting other callers.”

et-phoneREMS Rep: Hello, Farcical Drug Administration Clozapine REMS Program, helping Americans spend more time in the restorative Rapid Eye Movement Sleep (REMS) stage. Your pain is our pleasure! My name is E.T. Barnum; how can I be of no service? This phone call may be recorded for teaching or training purposes when the equipment is working properly–which is never. With whom am I talking today?

 

Dr. Amos on phoneDr. Amos: I’m Dr. Amos. Thank goodness, a real live person at last. Can you help me get certified? Wait, did you say something about REM sleep? I thought this was the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program.

 

 

 

et-phoneE.T.: Yes, I believe I said REMS, which can be improved significantly with Remeron (catchy name huh, REM-er-ron?), otherwise known by the generic name mirtazapine, although it can cause weight gain, dizziness, dry mouth, and severe and potentially life-threatening neutropenia occurring with a risk of approximately 1 in a 1,000 cases. This is why the FDA is centralizing the dispensing of this extremely beneficial drug for insomnia and depression, though it could kill you dead by rendering you incapable of fighting serious infections.

 

Dr. Amos on phoneDr. Amos: No, I think I may have the wrong number…but I’m pretty sure there’s a REMS for clozapine, a drug which also can cause potentially life-threatening neutropenia.

 

 

 

et-phoneE.T.: (noise of paper shuffling and hurried whispers to someone in the background)…Yes, Dr. Amos, this is in fact the REMS Program and your mother can relax now that, as of October 12, 2015, the Rest Easy Mom Strategy is underway for monitoring the drug Valium, otherwise known as Mother’s Little Helper in the classic song by the Rolling Stones.

 

Dr. Amos on phoneDr. Amos: No, no. I’m talking about the Clozapine REMS Program, you know, the Risk Evaluation and Mitigation Strategy?

 

 

 

 

et-phoneE.T.: Wow, am I off base this morning or what? Sorry, Dr. Amos, you bet our Really Empty Music Solutions has been developed in consultation with Dave Barry, Pulitzer Prize-winning columnist for the Miami Herald and New York Times bestselling author, based on his acclaimed classic, Dave Barry’s Book of Bad Songs. Unquestionably we believe that weeny music is a risk to young minds everywhere in this country and…

 

Dr. Amos on phoneDr. Amos: Wrong, wrong, wrong. I’m not talking about “weeny music,” I’m talking about neutroPENIA. I need help certifying in the REMS program, for crying out loud.

 

 

 

et-phoneE.T.: You betcha, Dr. Amos! And when I say to you I believe in our Risky Ergonomic Mumbo Satanism, you can rely on that based on my personal experience. My chronic low back pain issues arise from the ergonomic nightmare of the FDA workplace environment. Frankly though, my real problem is the terrestrial abduction program of this planet of which I’m a victim and if I could get any other work besides this I would, although fat chance that any earthlings will do this job but I know that oxycodone and clonazepam are the only drugs that help and if I could find a certified physician who would write me a year’s prescription…

Dr. Amos on phoneDr. Amos: Certified, yes, I’m talking about getting certified in the Clozapine REMS Program, could we do that now please!

 

 

 

 

et-phoneE.T.: And then you’ll write me a prescription for clonazepam?

 

 

 

Dr. Amos on phoneDr. Amos: Clozapine, clozapine…don’t you understand?

 

 

 

 

et-phoneE.T.: I’m sorry, Dr. Amos; clozapine is not a pain medication.

 

 

 

On second thought, I think I”ll pass on trying to call REMS today. I don’t think I’m strong enough.

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Comments

  1. I am having problems with the link provided in the email. I have tried it twice already. This is a joke.

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  2. this is just so hard to believe that they messed up this big. I hope patients do not have to suffer because of their faults and shortcomings.

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    • I hope patients don’t have to suffer either. Common sense and practicality will be the most useful tools–and a willingness to break the rules to protect patients.

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