In an effort to ensure patients that are prescribed Clozapine REMS can continue to have access to the drug, the U.S. Food and Drug Administration (FDA) has extended the deadline for prescriber certification to Nov. 23 and the deadline for pharmacy certification to Dec. 14. A new Clozapine REMS program was recently launched, and health care providers have experienced some challenges.
Dec. 14 is also the date for a pre-dispense authorization (PDA) deadline, a date that may be extended as well.
The REMS program replaced the six clozapine registries that were established by the manufacturers of the drug. The program mandates that prescribers, pharmacies and patients must enroll in one centralized place.
FDA officials encouraged health care providers to continue prescribing Clozapine, as needed. The drug is indicated for treatment of patients with an absolute neutrophil count -- a condition that may indicate inflammation, infection, stress, reaction to medication or the presence of cancer -- within acceptable ranges.
