Clozapine REMS Program Paused After Problems With Re-Certification
Executive Summary
US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.
The US Food and Drug Administration has temporarily suspended requirements of the modified Clozapine Risk Evaluation and Mitigation Strategy so pharmacists can dispense the antipsychotic without a REMS dispense authorization and wholesalers may continue to ship it to pharmacies and health care settings without confirming enrollment in the program.
The agency announced on 19 November that it had been alerted by health care professionals of difficulties, including a high call volume and long call wait times, since the modification to the REMS requiring re-certification was launched on 15 November.
“We understand that this has caused frustration and has led to patient access issues for clozapine,” FDA said. “Continuity of care, patient access to clozapine and patient safety are our highest priorities. We are working closely with the Clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”
The clozapine Risk Evaluation and Mitigation Strategy was required by FDA to manage the risk of severe neutropenia associated with clozapine treatment. Neutropenia is a life-threatening condition in which patients have dangerously low levels of white blood cells that help fight infections. The REMS requires healthcare providers and pharmacists to be certified in the REMS to prescribe, receive and dispense clozapine and for patients to be enrolled in the REMS program by a certified doctor.
In July, FDA approved a modification to the REMS, which states that all prescribers and pharmacies must be re-certified by 15 November or they will no longer be able to prescribe and dispense clozapine. The REMS also requires prescribers to re-enroll their patients by that date or patients will no longer be able to receive the drug.
The new program also requires pharmacies to obtain authorization to dispense either through the contact center or online via the REMS website. They can no longer use the telecommunication verification system to verify safe use conditions. In addition, the REMS has a new patient status form to document absolute neutrophil count monitoring for all outpatients.
The FDA has previously had problems with the REMS. In 2015, there were technical glitches when six individual clozapine registries were merged into a shared REMS. There were problems with the website, data migration and long call wait times. (Also see "FDA Working To Smooth Snags In Shared Clozapine REMS" - Pink Sheet, 19 Nov, 2015.)
And in December 2016, the agency postponed the full launch of the REMS program due to technical and logistical challenges.
Manufacturers with approved clozapine medicines include HLS Therapeutics, Inc., Jazz Pharmaceuticals plc, Sun Pharmaceutical Industries Ltd., and Teva Pharmaceuticals USA Inc. HLS distributes Clozaril and Jazz sells FazaClo.