FDA Updates Pharmacists on Clozapine REMS Program Rollout


The FDA is continuing to work with clozapine manufacturers to develop a timeline for the program's full implementation.

The FDA is reminding pharmacists and other health care providers that patients taking clozapine (Clozaril) need to have their absolute neutrophil count (ANC) monitored on a regular basis as part of the antipsychotic drug’s new shared risk evaluation and mitigation strategy (REMS).

In its latest update about the ongoing rollout of the Clozapine REMS Program, the FDA said it’s continuing to work with clozapine manufacturers to develop a timeline for the program’s full implementation, including the pre-dispense authorization (PDA) and prescriber and pharmacy certification requirements. The agency believes this will all be completed in a phased approach beginning in May 2016.

Technical issues, data migration problems, and long call wait times have plagued health care professionals since the Clozapine REMS Program launched back in October 2015. In light of these implementation difficulties, the FDA extended the program certification deadline that had originally been set for December 14, 2015, for pharmacists, and November 23, 2015, for prescribers.

At this point, the goal is to have the program fully operational by the end of this year, the FDA said. Once it is, prescribers and pharmacies will need to be certified in the Clozapine REMS Program in order to prescribe and dispense the drug.

In the meantime, the FDA is encouraging pharmacies and prescribers to get certified before the new deadlines for certification have been established.

To become certified, a pharmacy must designate an authorized representative to:

  • Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • Pass the Knowledge Assessment for Healthcare Providers.
  • Complete and submit the appropriate Clozapine REMS Pharmacy Enrollment Form.
  • Implement the necessary staff training and processes to comply with the Clozapine REMS Program requirements.

Pharmacies with multiple locations must certify on behalf of each pharmacy location, and add each pharmacy location as that pharmacy completes the necessary training.

Unless they’re prescriber designees, pharmacists will no longer be able to enroll patients in the Clozapine REMS Program or view a list of patients taking clozapine.

Prescribers and pharmacies that experience problems while attempting to become certified should contact the Clozapine REMS Call Center at 844-267-8678.

Meanwhile, outpatient pharmacies will be required to obtain a PDA from the Clozapine REMS Program before clozapine can be dispensed.

A PDA is an electronic code that indicates the Clozapine REMS Program has verified that the prescriber and pharmacy are certified and the patient is enrolled, and that the patient’s ANC is acceptable or the certified prescriber has authorized the patient to continue taking clozapine.

A PDA can be obtained by enabling the pharmacy management system to support electronic communication with the Clozapine REMS Program, signing into the REMS program’s website, or calling the program at 844-267-8678.

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