Clozapine REMS Program Essentials

I’ve been looking at the FDA web links to educate myself about the new Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program. Here’s a list of important links:

Dr. Jim Amos Happy HalloweenThe REMS website where you can see the “No blood, no drug” welcome logo; seriously there is an FDA Black Box Warning about severe neutropenia which clozapine can cause. The website is currently under construction, but prescribers can certify in the REMS program starting October 12, 2015.

The Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers, which prescribers need to read to learn about the new guidelines on monitoring for neutropenia.

The Knowledge Assessment for Healthcare Providers which is the final exam over which you need not sweat bullets.

The Prescriber Enrollment Form.

You can certify on line, by fax, or by telephone as long as you remember not to be surprised by common customer service messages:

  1. “The fax machine is out of order.”
  2. “Your call is important to us, please remain on the line and our service representative will be with you shortly…current hold times are 4 billion years at which time dinosaurs will again rule the earth.”
  3. Microsoft syntax error 01189: “Your connection has been interrupted and any information entered has been lost…hahahahahahahaha.”
  4. “The server is down for system maintenance and will be up again from 1:32 a.m.-1:33 a.m. in your time zone.”
  5. “All service representatives are assisting other callers; please consider picking your nose.”

Get the REMS essentials.


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