Final answer:
NCBOP requires pharmacies to have a continuous quality improvement program to monitor and prevent quality-related events. After NDA approval, drug sponsors must continuously monitor for adverse drug experiences and report them to the FDA, including serious events within 15 days.
Step-by-step explanation:
According to the North Carolina Board of Pharmacy (NCBOP), pharmacies are required to maintain a continuous quality improvement (CQI) program. These programs are essential to monitor and prevent quality-related events, including adverse drug events. The purpose of such programs is to ensure that pharmacies provide safe and effective services to patients. After a New Drug Application (NDA) approval, the drug sponsor must continuously review and report any adverse drug experiences to the FDA. Furthermore, serious and fatal adverse drug events must be reported within 15 days, and other events on a quarterly basis. Pharmacovigilance doesn't stop at FDA approval; it is a critical ongoing process that includes direct reports from health professionals and consumers through the FDA's MedWatch program.