While reading a medication package insert, the nurse notes the information contained within the "black box." What is the significance of this information to the nurse? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Standard Text: Select all that apply

Question

1. The drug can cause "special problems."
2. It identifies extreme adverse drug reactions.
3. It differentiates a prescribed medication from an over-the-counter medication.
4. It highlights the cost of the medication.
5. It signifies the medication is generic.

Answer 1

1,2
Rationale 1: The FDA created boxed warnings in order to regulate drugs with "special problems."
Rationale 2: The black box warning is a primary alert for identifying extreme adverse drug reactions.
Rationale 3: Black box warnings are not a mechanism to differentiate a prescribed medication from an over-the-counter medication.
Rationale 4: It does not highlight the cost of the medication.
Rationale 5: It does not signify the medication as being generic.
Global Rationale: The FDA created boxed warnings in order to regulate drugs with "special problems." The black box warning is a primary alert for identifying extreme adverse drug reactions. Black box warnings are not a mechanism to differentiate a prescribed medication from an over-the-counter medication, do not highlight the cost of the medication, and do not signify the medication as being generic.