Pharmacies' Certification Deadline Extended for Clozapine REMS Program

As a result of implementation difficulties, the FDA announced that it will extend the pharmacy certification deadline for the clozapine risk evaluation and mitigation strategy (REMS) program.

The deadlines, which had been set for December 14, 2015, for pharmacists, and November 23, 2015, for prescribers, were extended so that health care professionals could have enough time to complete the certification process in order to maintain patient access to the schizophrenia drug Clozaril.

The FDA said it would announce the new deadlines and more information about the pre-dispense authorization launch as soon as possible.

In the meantime, pharmacists should continue to dispense clozapine to patients with an absolute neutrophil count within the acceptable ranges.

The FDA also recommended that pharmacists continue to resolve issues with clozapine REMS program administrators, work toward their certification, and update patient information in line with the program.

Technical issues, data migration problems, and long call wait times have plagued health care professionals since the program launched on October 12, 2015.

“We understand this has caused frustration and take these concerns seriously,” the FDA stated on November 13, 2015. “We are working closely with the Clozapine REMS program administrators to address the challenges, many of which are a result of merging data from 6 registries encompassing more than 50,000 prescribers, 28,000 pharmacies, and 90,000 patient records.”

In order for a pharmacy to become certified, it must review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers and pass a knowledge assessment.

Pharmacies must also implement staff training and processes to comply with the clozapine REMS program requirements.