FDA Puts Clozapine REMS on Hold

Megan Brooks

November 02, 2022

To ensure continuity of care for patients taking clozapine, the US Food and Drug Administration (FDA) will temporarily exercise "enforcement discretion" with respect to certain clozapine risk evaluation and mitigation strategy (REMS) program requirements.

In a November 2 notice on its website, the FDA said it is aware that healthcare professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.

A chief concern is that inpatient pharmacies are only allowed to dispense a 7-days' supply of clozapine to the patient upon discharge.

To address this issue, the FDA said it will now (temporarily) not object if inpatient pharmacies dispense a days' supply of clozapine that aligns with the patient's monitoring frequency.

For example, a 7-days' supply for weekly monitoring, a 14-days' supply for twice-monthly monitoring, and a 30-days' supply for monthly monitoring upon discharge from an inpatient facility.

Clozapine is a second-generation (atypical) antipsychotic used to treat schizophrenia that is not well controlled with standard antipsychotics.

While clozapine can be highly effective in some patients, it also carries serious risks, including a decrease in neutrophil count, which can lead to severe neutropenia, serious infections, and death.

As a result, those taking the drug must undergo regular absolute neutrophil count monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The FDA says it will continue to exercise earlier enforcement discretion regarding the clozapine REMS program announced back in November 2021.

As reported by Medscape Medical News, this includes allowing pharmacists to dispense clozapine without a REMS dispense authorization and allowing wholesalers to ship clozapine to pharmacies and healthcare settings without confirming enrollment in the REMS.

"We understand that difficulties with the clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities," the FDA says.

The agency is working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.

The FDA encourages pharmacists and prescribers to continue working with the clozapine REMS to complete certification, and prescribers to enroll patients in the program.

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