Clozapine REMS Program, Are You Threatening Me?

I got a notice from PDR Drug Alerts about the Clozapine REMS Program yesterday. It’s about that deadline extension for prescribers and pharmacies regarding certification in the program.The letter announces the Initial Pre-Dispense Authorization (PDA) launch for May 2016 and foreshadows what may happen later this year when the full PDA launches. The bottom line? The program will let prescribers and pharmacies slide for a while, but:

“When the the full PDA launch occurs later in the year, if prescribers and/or pharmacies are not certified in the Clozapine REMS Program, or a patient’s ANC is not current, this will impact the pharmacy’s ability to dispense clozapine, negatively affecting patient care.”

The information was sent by regular mail and I could not find it on the Clozapine REMS Program or FDA websites.

Clozapine REMS PDA

Some of my colleagues and residents are still unable to certify because of ongoing glitches with the website or other problems. I’m still getting notices about delinquent Absolute Neutrophil Counts (ANC) on patients for whom I am not the clozapine prescriber. This indicates that many prescribers are unable to certify and I suspect some long-time prescribers probably were either never certified in the old registries or the mass migration of the data in those registries to the Clozapine REMS Program were corrupted in the process. This means that it’s virtually impossible to identify who some of the prescribers are.

The program started last October with spectacular failures in access and troubleshooting, either by telephone or the website. These have been acknowledged and improvements have been made. Because of the glitches, the deadlines were indefinitely extended starting last fall and I remember asking one program representative how they would eventually enforce certification if they could not locate the prescribers. He wasn’t sure but guessed that access to clozapine might be interrupted.

The move to deny access of patients to clozapine is troubling. Some prescribers will probably feel threatened although the bottom line in the paperwork is easy to miss in a cursory reading because of an excess of fine print. What’s even more troubling is that patients and families could also feel threatened.

I’m not sure threatening to deny patients access to clozapine will be an acceptable method of encouraging prescribers and pharmacies to certify in the Clozapine REMS Program. My understanding is that the program is run by an independent contractor hired by the Clozapine manufacturer. It’s difficult for me to imagine a conflict of interest would be at work here. If the manufacturer were trying to say, increase its profits by getting more customers to buy their product, would it make sense for them to try to achieve that with this clunky REMS program or by prohibiting pharmacies from dispensing the product because they and the prescribers are not in their registry?

And does the manufacturer have the authority to prevent dispensing the clozapine? If some prescribers are, for example, willfully refusing to comply with the certification requirement, could that imply a question about the prescriber’s competence to practice? In that case wouldn’t that mean this is a question for the state medical board or other regulatory agency to address?

On the other hand, could we ask, as I already have in a previous post, if we really need the Clozapine REMS Program? How can it be proven that prescribers are not actually obtaining the ANCs on time just because they’re not being reported on a website which has earned a reputation for being dysfunctional?

On the whole, I suspect the great majority of prescribers and pharmacies are making a gallant effort to get through the certification process and I doubt that the Clozapine REMS Program will penalize their patients because they know who they are and the program is trying to help them with it.

Still, there are obviously a few who are not making the effort. Would it make more sense to reach out to this small group as it might be more productive than denying clozapine to the patients most in need of a treatment which has probably saved many lives over the decades that it has been available. Threatening patients and families won’t work.

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