serious adverse drug event
defined as an action that's life threatening, requires intervention to prevent death/permanent impairment, and/or leads to death, hospitalization, disability, or congenital anomaly. RNs and HC professionals are encouraged to complete a form that provides info on a med/medical product that they suspect either has caused harm and submit the form to the MEDWATCH prog. Provides a national report of all serious adv drug reactions. Reporting is necessary for corrective action to take place to protect pts. This info is used to revise drug labels, add warning to HC providers, create pt med guides, or withdraw a drug from the market.