KATZUNG'S BASIC AND
CLINICAL PHARMACOLOGY
16TH EDITION
• AUTHOR(S)TODD W.
VANDERAH
TEST BANK
,Question 1
A nurse is participating in a clinical trial for a new medication.
Which statement best describes the primary purpose of a phase
III clinical trial?
A. To determine whether the drug causes toxicity in laboratory
animals
B. To evaluate safety and effectiveness in a large population
before regulatory review
C. To identify the chemical structure of the medication
D. To monitor rare adverse effects after the drug has been
marketed
Correct Answer: B
Rationale:
Phase III clinical trials involve large groups of participants and
are designed to confirm therapeutic effectiveness, compare the
drug with existing therapies when appropriate, and further
evaluate safety before regulatory approval is considered. Option
A describes preclinical testing. Option C occurs during drug
discovery and development rather than clinical trials. Option D
describes postmarketing (phase IV) surveillance.
Question 2
,A nurse is reviewing a newly prescribed medication that carries
a boxed warning. Which nursing action is most appropriate?
A. Assume the medication should never be administered.
B. Verify the indication, review required monitoring, and
educate the patient about significant risks.
C. Substitute an over-the-counter medication without
contacting the prescriber.
D. Administer the medication without additional assessment
because approval indicates complete safety.
Correct Answer: B
Rationale:
A boxed warning highlights serious or life-threatening risks that
require careful consideration, patient selection, monitoring, or
specific precautions. The nurse should verify that the
medication is appropriate, perform required assessments, and
provide patient education. Option A is incorrect because boxed
warnings do not automatically prohibit use. Option C is outside
the nurse's scope of practice. Option D ignores the purpose of
the warning.
Question 3
, A patient asks why a newly approved medication continues to
be monitored after it becomes available for prescription use.
What is the nurse's best response?
A. "Postmarketing surveillance helps identify uncommon or
delayed adverse effects that may not have appeared during
clinical trials."
B. "The medication remains experimental until several years
have passed."
C. "Approval means the medication has not yet been tested in
humans."
D. "The purpose is to determine the drug's chemical
composition."
Correct Answer: A
Rationale:
Postmarketing surveillance collects information on rare,
delayed, or population-specific adverse effects that may not be
detected during preapproval clinical trials. Option B is incorrect
because approved drugs are no longer considered
investigational. Option C is false because human testing
precedes approval. Option D relates to drug development, not
postmarketing monitoring.
Question 4
CLINICAL PHARMACOLOGY
16TH EDITION
• AUTHOR(S)TODD W.
VANDERAH
TEST BANK
,Question 1
A nurse is participating in a clinical trial for a new medication.
Which statement best describes the primary purpose of a phase
III clinical trial?
A. To determine whether the drug causes toxicity in laboratory
animals
B. To evaluate safety and effectiveness in a large population
before regulatory review
C. To identify the chemical structure of the medication
D. To monitor rare adverse effects after the drug has been
marketed
Correct Answer: B
Rationale:
Phase III clinical trials involve large groups of participants and
are designed to confirm therapeutic effectiveness, compare the
drug with existing therapies when appropriate, and further
evaluate safety before regulatory approval is considered. Option
A describes preclinical testing. Option C occurs during drug
discovery and development rather than clinical trials. Option D
describes postmarketing (phase IV) surveillance.
Question 2
,A nurse is reviewing a newly prescribed medication that carries
a boxed warning. Which nursing action is most appropriate?
A. Assume the medication should never be administered.
B. Verify the indication, review required monitoring, and
educate the patient about significant risks.
C. Substitute an over-the-counter medication without
contacting the prescriber.
D. Administer the medication without additional assessment
because approval indicates complete safety.
Correct Answer: B
Rationale:
A boxed warning highlights serious or life-threatening risks that
require careful consideration, patient selection, monitoring, or
specific precautions. The nurse should verify that the
medication is appropriate, perform required assessments, and
provide patient education. Option A is incorrect because boxed
warnings do not automatically prohibit use. Option C is outside
the nurse's scope of practice. Option D ignores the purpose of
the warning.
Question 3
, A patient asks why a newly approved medication continues to
be monitored after it becomes available for prescription use.
What is the nurse's best response?
A. "Postmarketing surveillance helps identify uncommon or
delayed adverse effects that may not have appeared during
clinical trials."
B. "The medication remains experimental until several years
have passed."
C. "Approval means the medication has not yet been tested in
humans."
D. "The purpose is to determine the drug's chemical
composition."
Correct Answer: A
Rationale:
Postmarketing surveillance collects information on rare,
delayed, or population-specific adverse effects that may not be
detected during preapproval clinical trials. Option B is incorrect
because approved drugs are no longer considered
investigational. Option C is false because human testing
precedes approval. Option D relates to drug development, not
postmarketing monitoring.
Question 4
