Author Question: While reading a medication package insert, the nurse notes the information contained within the ... (Read 14 times)

go.lag · **on:** Jul 23, 2018

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.

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.

Question 2

A drug manufacturer that is performing the effects of a drug on laboratory animals would be in which phase of the new drug development timeline?

1. Clinical Investigation
2. Preclinical Investigation
3. New Drug Application Review
4. Post-marketing Studies

kaylee05 · **Reply #1 on:** Jul 23, 2018

Answer to Question 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.

Answer to Question 2

2
Rationale 1: Clinical investigation involves testing the drug on human subjects.
Rationale 2: Preclinical investigation involves laboratory research on nonhuman subjects.
Rationale 3: New Drug Application review occurs during human clinical trials.
Rationale 4: Post-marketing Studies occur after the drug is being used by the general population.
Global Rationale: Clinical investigation involves testing the drug on human subjects. Preclinical investigation involves laboratory research on nonhuman subjects. New Drug Application review occurs during human clinical trials. Post-marketing Studies occur after the drug is being used by the general population.