The Geezer’s Smartphone Search and Clozapine REMS Saga Goes On

So the smartphone shopping saga continues with guidance from my wife to look under the “Offers” tab on our carrier’s website. She’s always looking for the best deal. On the other hand, I’m just looking for the path of least resistance ($650? No problem, put it in my shopping cart!).

Dr Jim Amos MD iPhone Right

Picture credit–Dr. Aubrey Chan, UIHC Med-Psych resident!

I saw some phones for a penny…which is technically not correct if we’re strict about the distinction between pennies and cents in the U.S. The trouble is low selection–no iphones for a cent.

The search for smarter technology reminds me of technology which has been not so smart lately and that’s the Clozapine REMS Program. The FDA is again announcing the shortcomings of the program:

If you have the free login for Medscape, you can take a look at the few comments (including mine, of course) other doctors have about the issues. But if you don’t, here you go:

Dr. Jim Amos, MD: I agree with others who have criticized the Clozapine REMS Program. The FDA directs me to the REMS program to address my ongoing difficulties with “Alerts” about overdue labs for patients who are not my own. On the other hand, the REMS program tells me that the FDA is responsible for the prescriber misidentification flaws in the system.

Who is truly accountable for this mess?

firehydrant2Some of us still cannot even register. It is ironic for the FDA to claim that this program will do a better job of protecting patient safety from severe neutropenia and persuading clinicians to use clozapine more frequently for their patients with treatment-resistant schizophrenia.

In fact, so far it has done nothing to achieve either of these goals and, if anything, is providing doctors with a disincentive to prescribe clozapine.

Other de-identified commenters said:

The program is a fiasco. Website was not tested prior to go live date, phone support is difficult to access, and I’m already receiving bogus emails directing me to “notifications” that I cannot review due to lack if access to the website. I have wasted 5 hours to complete my certification and they still have me listed at a phone which has been disconnected, from a now defunct agency I worked fro 13 years ago. Why should we trust them to maintain a data base?

I agree. The online registration is a mess. Calls to the help line go unanswered. They instruct you to leave a message for a callback that never comes. They probably used the same vendor that nailed the healthcare.gov rollout.

And what about that DRISK response I got November 16, 2015? Recall I got a message from the FDA after the Clozapine REMS Program told me to contact the FDA about the all the Overdue lab Alerts (I have several, which I’m now not removing):

“Dear Dr. James J. Amos,

Thank you for writing to the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

We greatly appreciate your comments and suggestions for the Clozapine REMS program.  We have forwarded your email to the Division of Risk Management (DRISK) for evaluation. DRISK serves as the focal point for risk management activities in CDER. DRISK provides risk management expertise on development and implementation of programs and initiatives to support the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS) authorities under the Food and Drug Administration Amendments Act (FDAAA) of 2007. DRISK reviews all proposed REMS, REMS modifications, and REMS assessments for all products with approved REMS for conformance with current FDA standards.

If you have additional questions or concerns about the Clozapine REMS Program or its website, please contact FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400; Monday – Friday, 8am – 4:30pm EDT.”

Apparently the response might have been a “brisk” move shortly thereafter to postpone the registration deadline dates, including the one in mid-December. As of November 20, 2015, the “Important Program Update”:

“The deadline for Prescriber certification in the Clozapine REMS Program has been extended.

  • The Clozapine REMS Program is working with the FDA to determine a new timeline.
  • In the upcoming weeks you will receive additional communication outlining the new timeline for certification and full program implementation.
  • Please click on this link for a letter to Prescribers explaining the extension.

FAQs

  • What happens to my patients if I do not enroll? Patients who meet safe use conditions will be able to continue clozapine therapy even if the Prescriber is not certified in the Clozapine REMS Program. Continue prescribing clozapine to patients with an ANC within the acceptable ranges.Patient registration and lab monitoring is still required for patients on therapy. Continue to submit ANC labs to the Clozapine REMS Program.Use clinical judgment, determine what is in the best interest for the patient and, as appropriate, continue clozapine therapy for patients with an ANC within the acceptable ranges. Work with the dispensing pharmacy to continue treatment for patients with an ANC within acceptable ranges.
  • When do I need to complete certification? Prescribers are still highly encouraged to certify in the Clozapine REMS Program as soon as possible.The Clozapine REMS Program is working with the FDA to determine a new timeline. In the upcoming weeks you will receive additional communication outlining the new timeline for certification and full program implementation.If you have encountered enrollment-related issues, please try again. The most common technical issues have been addressed and we’re continuing to make changes to improve the stakeholder experience.We also understand that long call hold times have caused frustration and are working hard to resolve these issues.”

On the one hand, Clozapine REMS Program directs you to the FDA with questions about the wacky structure of the program–while the FDA redirects back to the REMS program, hence my uncertainty about who’s ultimately accountable.

There are other REMS programs. Most of them are for drugs I’ve never even heard of, much less about the kind of disaster that has characterized the Clozapine REMS Program since its inception on October 12, 2015.

So tell me again, is it the FDA or the Clozapine REMS Program administrators (whoever they are; I’ve never spoken to any of them as far as I know) who is accountable for addressing all of the technical and other snafus here? One thing is for sure; it’s not the “prescribers.”

I don’t think a smartphone will help.

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