Clozapine REMS and Other Barriers: A Conversation With Peter J. Weiden, MD

Peter J. Weiden, MD

(This is the second part of a video interview on the recent US Food and Drug Administration’s joint advisory committees vote to dismiss the clozapine REMS protocols. The first video discussed what the dismissal may mean for clinical care.)

Peter J. Weiden, MD, a clinical professor of psychiatry at SUNY Stony Brook School of Medicine, shared critical insights into the challenges surrounding Clozapine prescribing in the wake of the FDA advisory committee’s recommendations to overhaul its REMS (Risk Evaluation and Mitigation Strategies) system. The committee’s 14-1 vote to reduce barriers could profoundly impact access to this life-saving medication, but significant hurdles for prescribers remain.

“Clozapine is a tough medicine. It’s like [it needs] its own psychopharmacology textbook,” Weiden told Psychiatric Times, emphasizing the complexity of prescribing and managing this medication. Despite its efficacy, he explained that clozapine requires intensive monitoring, which can be burdensome for clinicians already strained by limited time and resources. When reflecting on REMS and the importance of clozapine as a resource, he thinks of the support that should be provided to clinicians to make prescribing clozapine easier for them, including providing real-time training as needed.

Weiden explained the systemic issues that disincentivize the use of clozapine, such as inadequate training and logistical barriers. “If you have not trained in it or had experience with it, it’s scary to then get started,” he said. He empathizes with clinicians who are tempted to avoid using clozapine while acknowledging these challenges often leading to both underprescribing of clozapine and general overprescribing, with the lure of relying on relatively quick polypharmacy. “Not to say that polypharmacy never works,” Weiden said, “but it’s not clozapine. But it’s easier.”

Weiden posed a case situation that may be common to a busy practice, and how the REMS may be problematic for getting a patient on clozapine. “If I have 15 minutes per patient and I have a treatment resistant patient who might be a candidate for clozapine, am I really able to get that patient on clozapine [in that short time?” he said. “Even if I have the discussion [with the patient], I have to call the family. I have to schedule extra visits, because they're going to have a tough time likely with sedation or the up titration. I'm going to have to train them as to how to get the blood tests. There are going to be hassles and mishaps. And am I getting any extra RVUs [relative value unites] or credit or anything else, besides that I know I'm doing the right thing? No, I in many places, I won't. And what will I do instead? Well, I have that 15 minutes, its just much easier for me to add a second medicine for treatment.”

Fortunately, the recent joint advisory committees have recommended significant changes to the REMS system, including removing the requirement for absolute neutrophil count (ANC) documentation and simplifying pharmacy dispensing protocols. These changes aim to address what Weiden described as “hassles and mishaps” that have discouraged widespread clozapine use.

However, Weiden argues that reform must go beyond regulatory adjustments to address clinician education and support. “We need to understand more the human factors among us that make it harder to prescribe,” he said, calling for a cultural shift that reduces blame on clinicians and prioritizes practical assistance.

As the FDA considers the committees’ recommendations, the psychiatric community has a unique opportunity to advocate for reforms that both simplify clozapine prescribing and enhance outcomes for patients with treatment-resistant schizophrenia. Weiden’s insights underscore the urgency of these changes, as well as the potential for systemic improvements to unlock the full benefits of this critical medication.

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