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What is an educational/promotional initiative that was designed to emphasize the responsibility of healthcare providers to identify and report adverse events related to the use of medical products to the Food and Drug Administration?

A. Operation Safe Medicine
B. MedWatch
C. PharmaGuard
D. HealthAlert

User NTyler
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Final answer:

MedWatch is the initiative that requires healthcare providers to report adverse events to the FDA, playing a key role in postmarket safety surveillance of medical products.

Step-by-step explanation:

The educational/promotional initiative designed to emphasize the responsibility of healthcare providers to identify and report adverse events related to the use of medical products to the Food and Drug Administration (FDA) is MedWatch. MedWatch, also known as the FDA Safety Information and Adverse Event Reporting Program, serves as a primary tool for the postmarket safety surveillance of medical products. After a new drug application (NDA) approval, sponsors must report any adverse drug experiences to the FDA.

Reports of unexpected serious and fatal events must be communicated within 15 days, and other events on a quarterly basis. Through MedWatch, the FDA receives these voluntary 'spontaneous reports' from consumers and health professionals, allowing for ongoing monitoring and increased safety in pharmaceutical care.

User Sanmiguel
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