Updated Clozapine REMS Program Requires Certification With Few Exceptions
Abstract
The updated Risk Evaluation and Mitigation Strategy Program limits enrolling patients to prescribers and designees but allows slight leeway on absolute neutrophil counts.
Modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program went into effect on February 28. Going forward, all prescribers who write clozapine prescriptions on an outpatient basis and all pharmacies that dispense clozapine must be certified in the REMS program. Prescribers who write clozapine prescriptions on an inpatient basis are not required to be certified if they are prescribing for patients who are already enrolled in the program. Inpatients must be enrolled in the REMS program before receiving their first dose if clozapine is initiated in an inpatient setting.
Ryan S. Sultan, M.D., says that the changes in the Clozapine REMS Program are likely to benefit patients and reduce missed doses.
Pharmacies are no longer permitted to enroll patients in the REMS program. Only prescribers and their designees may enroll patients.
“While this change may create additional administrative work for providers, individuals on clozapine require a relationship with a provider for regular lab work and prescriptions regardless,” said Ryan S. Sultan, M.D., a psychiatrist at New York-Presbyterian Hospital and Columbia University College of Physicians and Surgeons.
Another key change is that if a patient’s absolute neutrophil count (ANC) is not current, this will not prevent clozapine from being dispensed. Kristofer Baumgartner, an FDA spokesperson, told Psychiatric News that if an ANC is not current, pharmacists should use their best judgment on dispensing.
Clozapine REMS Program Resources
APA has posted online information about the Clozapine REMS Program for prescribers here.
APA also administers the SMI Adviser Clozapine Center of Excellence listserv, which provides updates on new resources, education, and other information related to clozapine. The sign-up link is located here. The listserv is part of the larger, overarching SMI Adviser Clinical Support System for Serious Mental Illness initiative, which is funded by the Substance Abuse and Mental Health Services Administration.
Prescribers and pharmacists who wish to become certified in the Clozapine REMS Program may do so at https://www.clozapinerems.com. Those with questions for the FDA may call (844) 267-8678.
A history of FDA updates to the Clozapine REMS Program can be accessed here.
An ANC lab is considered current if reported within seven days of the lab draw for patients monitored weekly, 15 days for patients monitored every two weeks, and 31 days for patients monitored monthly, Baumgartner said.
“Pharmacists are instructed to use their clinical judgment, making a decision that is best for the patient in which the benefits outweigh the risks, when dispensing clozapine when the predispense authorization indicates that the ANC on file with the Clozapine REMS Program is not current,” he said.
Sultan stressed the importance of considering the risks of neutropenia against the backdrop of treatment-resistant schizophrenia.
“Monitoring of ANCs for neutropenia is important. It is our method for identifying potential agranulocytosis. The drop in [ANC] lab values is unpredictable and may indicate a clozapine-treated patient’s immune system is not working correctly. Conversely, as psychiatrists, we want to limit treatment barriers for those who need clozapine,” Sultan said. “Allowing pharmacies some ‘wiggle room’ on the most recent ANC values is likely to be beneficial and reduce missed doses.” ■
