FDA Pauses Clozapine REMS Program Enforcement Due to High Volume of Patient Delays

The program was put in place to prevent cases of neutropenia, which was leaving patients vulnerable to severe and sometimes deadly infections.

Delays in patients receiving treatment have led to federal regulators to put on hold a program that was intended to reduce the risk of adverse side effects from Clozapine; an antipsychotic known to cause neutropenia, which may leave patients vulnerable to infection.

On December 2, the FDA announced it was temporarily suspending enforcement of some aspects of the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program, allowing pharmacists and wholesalers to provide easier access to the drug for patients in the interim.

Clozapine is used to treat patients diagnosed with severe schizophrenia whose symptoms cannot be controlled by standard antipsychotic treatment or therapies. The antipsychotic medication has also been used to treat reoccurring suicidal behavior in patients with schizophrenia or schizoaffective disorder. The drug is used to block various receptors in the brain and restore balance in patient’s dopamine and serotonin level. However, it also can decrease the neutrophil count, lowering the body’s resistance to infections.

The Clozapine REMS program was put in place to manage the risk of severe neutropenia, which can result in serious injury or death. It required pharmacies and prescribers to be certified before receiving, dispensing or prescribing the drug.

Pharmacists and prescribers were required to be certified by November 15 if they were to be allowed to dispense the drug.

However, the FDA reports that healthcare professionals began to alert the agency about problems with the program, including high call volume and long call wait times for patients. As a result, many healthcare professionals were unable to meet the November 15 deadline for the program.

As a result, the FDA announced it will place certain aspects of the program to be on temporary hold.

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The FDA will not object if pharmacists dispense clozapine without a REMS dispense authorization. The agency will also not object if wholesalers ship clozapine to pharmacies and healthcare settings without confirming enrollment in the REMS program.

The agency noted it is invested in the continuity of care, patient access to clozapine, and patient safety priority. Abruptly stopping clozapine can lead to complications for patients, and the FDA indicates doctors should use their clinical judgement with regard to prescribing the drug to patients with an absolute neutrophil count within the acceptable range.

The clozapine REMS regulations required patients to undergo absolute neutrophil count monitoring. Due to the issues with hold and wait times, those requirements are also on hold.

REMS is a drug safety program instituted by the FDA to monitor medications with a high potential for serious adverse effects. It applies to specific prescription drugs and can carry specific requirements, such as for clozapine.

The FDA indicates it is working with the clozapine REMS program administrators to address the high call volume and long wait time challenges to avoid interruption in patient care. While certain aspects of the clozapine REMS program are on hold, the FDA also encourages pharmacists and prescribers to continue working with the clozapine REMS program to complete certification and patient enrollment.

“We understand that this has caused frustration and has led to patient access issues for clozapine,” the agency said in its statement. “The FDA takes these concerns seriously.”


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