Question

Failure to report __________ or __________ can result in an adverse event and an increase of patient injury.

Answer 1

Failure to report adverse drug experiences or patients' overdoses of illegal drugs can result in an adverse event and an increase of patient injury.

Step-by-step explanation:

Failure to report adverse drug experiences or patients' overdoses of illegal drugs can result in an adverse event and an increase of patient injury. After NDA approval, the sponsor must review and report to the FDA every patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis.