Health care professionals continue to alert FDA about ongoing difficulties with the clozapine REMS program external link disclaimer, including a high call volume and long call wait times for stakeholders since the program launched on Nov. 15. This has caused frustration and has led to patient access issues for clozapine, causing concern because continuity of care, patient access to clozapine, and patient safety are among the FDA’s highest priorities. Because of these issues, FDA is temporarily suspending certain clozapine REMS program requirements, allowing pharmacists to dispense clozapine without a REMS dispense authorization. Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range. If you have questions or concerns about the clozapine REMS program or its website, please contact FDA at [email protected], 1-855-543-3784, or 301-796-3400.
NCPA
