FDA: Technical problem with Clozapine REMS Program certification resolved

Prescribers and pharmacies who were unable to complete online certification for the new Clozapine Risk Evaluation and Mitigation Strategy Program due to technical issues should try again because the problem was resolved as of Friday, the Food and Drug Administration announced yesterday. FDA last month announced changes to the requirements for monitoring, prescribing, dispensing and receiving the schizophrenia medicine to address continuing safety concerns about a serious blood condition called severe neutropenia. Prescribers or pharmacists who continue to encounter technical issues with the Clozapine REMS Program should contact the program at 844-267-8678, FDA said. “If prescribers and pharmacists continue to experience any issues, they should use clinical judgment and consider the best interests of the patient,” the agency said. “Continue prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable ranges while the issues are being resolved.”