The nurse is caring for a patient who had a severe, acute, previously unseen adverse effect of a drug in Phase III testing. The patient asks, After all the testing done on this drug, didnt they know this adverse effect could occur? What is the nurses best response? (Select all that apply.)
Correct Answer: C
Rationale: Phase III testing involves a large population, uncovering rare effects . Preclinical animal studies don't fully predict human responses (B is false). Phase I uses healthy volunteers, missing disease-specific effects (C is false). Rare effects emerge post-approval , potentially leading to further action .