Nokea
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, didn't they know this adverse effect could occur? What is the nurse's best response? (Select one that does not apply.)
Correct Answer: B
Rationale: When a new and unexpected adverse effect occurs, especially one of a serious nature, it is reported to the drug company who reports it to the FDA immediately. When a large number of people begin using the drug in phase III studies, it is not unusual to identify adverse effects not previously noted. It would be both unprofessional and inaccurate to imply that pharmaceutical companies put profit ahead of patient concern because lawsuits would remove any potential profit if a drug proves harmful. The FDA is responsible for weighing risk versus benefit in deciding whether to allow the drug to move to the next phase of testing. Drugs found to have serious adverse effects can be removed from the market at any time.