Karch’s Focus on Nursing
Pharmacology
9th Edition
Author(s)Rebecca G. Tucker
TEST BANK
Question 1
Clinical Scenario
A nursing student is reviewing the drug approval process and
learns that a new cardiovascular medication has just completed
,Phase III clinical trials. The pharmaceutical company has
submitted a New Drug Application (NDA) to the FDA.
Question
The nurse recognizes that which of the following best describes
the primary purpose of Phase IV studies for this medication
after it receives FDA approval?
Options
A. To determine the medication's therapeutic index in a small
group of healthy volunteers.
B. To evaluate the medication's safety and efficacy in a large,
diverse patient population over an extended period.
C. To gather preliminary data on the medication's
pharmacokinetics and pharmacodynamics.
D. To confirm the medication's effectiveness and monitor for
adverse effects in patients with the specific condition it is
intended to treat.
Correct Answer
B. To evaluate the medication's safety and efficacy in a large,
diverse patient population over an extended period.
Rationale
Phase IV studies, also known as postmarketing surveillance,
occur after FDA approval. Their primary purpose is to monitor
the drug's long-term safety and effectiveness in a much larger
and more diverse population than was studied in clinical trials.
,This phase can detect rare or long-term adverse effects that
were not apparent in earlier phases.
Why the Other Options Are Incorrect
A. Determining the therapeutic index in healthy volunteers is a
function of Phase I studies, which are the first stage of human
testing.
C. Gathering preliminary pharmacokinetic and
pharmacodynamic data is also a primary objective of Phase I
studies.
D. Confirming effectiveness and monitoring for adverse effects
in a specific patient population is the primary objective of Phase
III studies, which are large-scale trials conducted before FDA
approval.
Learning Objective
Differentiate between the phases of the drug approval process
and their specific purposes.
Bloom's Taxonomy
Understand
Difficulty
Easy
NCLEX Client Needs Category
Pharmacological and Parenteral Therapies
, NCJMM Clinical Judgment Skill
Recognize Cues
Question 2
Clinical Scenario
A nurse is preparing to administer a medication to a patient.
The nurse notes that the drug label includes the information
"NDC 12345-678-90."
Question
The nurse understands that the National Drug Code (NDC)
number on a medication label is primarily used to identify
which of the following?
Options
A. The manufacturer, the drug product, and the package size.
B. The drug's generic name and its therapeutic classification.
C. The drug's expiration date and lot number for safety tracking.
D. The route of administration and the recommended dosage.
Correct Answer
A. The manufacturer, the drug product, and the package size.
Rationale
The National Drug Code (NDC) is a unique, three-segment
number assigned to each medication. The first segment
identifies the labeler (manufacturer), the second identifies the
Pharmacology
9th Edition
Author(s)Rebecca G. Tucker
TEST BANK
Question 1
Clinical Scenario
A nursing student is reviewing the drug approval process and
learns that a new cardiovascular medication has just completed
,Phase III clinical trials. The pharmaceutical company has
submitted a New Drug Application (NDA) to the FDA.
Question
The nurse recognizes that which of the following best describes
the primary purpose of Phase IV studies for this medication
after it receives FDA approval?
Options
A. To determine the medication's therapeutic index in a small
group of healthy volunteers.
B. To evaluate the medication's safety and efficacy in a large,
diverse patient population over an extended period.
C. To gather preliminary data on the medication's
pharmacokinetics and pharmacodynamics.
D. To confirm the medication's effectiveness and monitor for
adverse effects in patients with the specific condition it is
intended to treat.
Correct Answer
B. To evaluate the medication's safety and efficacy in a large,
diverse patient population over an extended period.
Rationale
Phase IV studies, also known as postmarketing surveillance,
occur after FDA approval. Their primary purpose is to monitor
the drug's long-term safety and effectiveness in a much larger
and more diverse population than was studied in clinical trials.
,This phase can detect rare or long-term adverse effects that
were not apparent in earlier phases.
Why the Other Options Are Incorrect
A. Determining the therapeutic index in healthy volunteers is a
function of Phase I studies, which are the first stage of human
testing.
C. Gathering preliminary pharmacokinetic and
pharmacodynamic data is also a primary objective of Phase I
studies.
D. Confirming effectiveness and monitoring for adverse effects
in a specific patient population is the primary objective of Phase
III studies, which are large-scale trials conducted before FDA
approval.
Learning Objective
Differentiate between the phases of the drug approval process
and their specific purposes.
Bloom's Taxonomy
Understand
Difficulty
Easy
NCLEX Client Needs Category
Pharmacological and Parenteral Therapies
, NCJMM Clinical Judgment Skill
Recognize Cues
Question 2
Clinical Scenario
A nurse is preparing to administer a medication to a patient.
The nurse notes that the drug label includes the information
"NDC 12345-678-90."
Question
The nurse understands that the National Drug Code (NDC)
number on a medication label is primarily used to identify
which of the following?
Options
A. The manufacturer, the drug product, and the package size.
B. The drug's generic name and its therapeutic classification.
C. The drug's expiration date and lot number for safety tracking.
D. The route of administration and the recommended dosage.
Correct Answer
A. The manufacturer, the drug product, and the package size.
Rationale
The National Drug Code (NDC) is a unique, three-segment
number assigned to each medication. The first segment
identifies the labeler (manufacturer), the second identifies the
