The Geezer’s Final Countdown to the Clozapine REMS Program

So here’s the Geezer’s final countdown to the Clozapine REMS Program. I’m still getting “Final Overdue Lab Notices” although none of the patients I’m getting these notices for are under my care. Obviously by now everyone realizes that the Clozapine manufacturer has likely abandoned the final deadline of December 14, 2015 so it’s pointless to emphasize it. However, the final countdown was too funny to resist.

The reason why there is no firm deadline is probably the low likelihood the drug manufacturer will really refuse to dispense clozapine to pharmacies because the REMS program itself has failed to effectively demonstrate that it can levy any meaningful penalty to clinicians who don’t register. That may be why the website carries the message:

  • “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.”

Any new timeline would be difficult to enforce. The message doesn’t mention what would happen to clinicians who do not enroll. That’s because the program can’t locate them. They’re essentially invisible. Furthermore, in the real world, clinicians and pharmacists are continuing to safely provide clozapine to many patients with treatment-resistant schizophrenia.

Even if the manufacturer could find the prescribers who aren’t registering, why would they penalize them by not dispensing clozapine? They would lose money. It looks like this could be a case of the fox guarding the hen house–except the fox can’t find the chickens.

“No Blood, No Drug?” How about a slogan which encourages using clozapine for patients with treatment-resistant schizophrenia rather than for threatening clinicians?

“Clozapine, Finally a Path to Recovery.”

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