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 all that apply.) A) "Pharmaceutical companies sometimes underreport problems to make more money."
B) "Your response to this medication will be reported to the drug company and the Food and Drug Administration (FDA)."
C) "When a drug begins to be used by a large clinical market, new adverse effects may be found."
D) "The pharmaceutical company weighs the benefits of the drug with the severity of adverse effects."
E) After a drug reaches phase III testing it is considered an accepted drug and will not be recalled."
B, C
Feedback:
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.
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