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Chapter 2_ Drug Development and Ethical Considerations Questions &Exam (elaborations) answers 100% satisfaction guarantee

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  • August 11, 2024
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  • 2024/2025
  • Exam (elaborations)
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STUVIA 2024/2025
Chapter 2: Drug Development and Ethical
Considerations
A clinical drug trial is concluding a study of pharmacokinetics and safety of a drug in healthy
individuals. The nurse will assist enrollment of participants into the next phase of the study and will
include which subjects?
a. Healthy subjects
b. Healthy and ill subjects
c. Subjects with the disease the drug will treat
d. Subjects with other diseases - ✔✔ANS: C

Rationale: After Phase I studies demonstrating drug safety and pharmacokinetics have been
completed, the drug is tested on subjects who have the disease the drug will treat.

A patient is prescribed a medication and asks the nurse if the drug is available in a generic form. The
nurse understands that a generic drug name is:
a. a registered trademark.
b. always capitalized.
c. related to the drug's chemical structure.
%


d. nonproprietary. - ✔✔ANS: D

Rationale: The generic name is the official, nonproprietary name for a drug. The brand name is the
trademark name and is always capitalized. The chemical name describes the chemical structure of
the drug.

A patient is taking methadone as part of a heroin withdrawal program. The nurse understands that, in
this instance, methadone is classified as which drug schedule?
a. C-I
b. C-II
c. C-III
d. C-V - ✔✔ANS: B

Rationale: Methadone is a category II drug, with a high potential for drug abuse.

A patient receives a prescription on which the provider has noted that a generic medication may be
given. The patient asks the nurse what this means. What will the nurse tell the patient about generic
drugs?
a. They contain the same inert ingredients as brand-name drugs.
b. They have chemical structures that are different from proprietary drugs.


stuvia

, STUVIA 2024/2025
c. They tend to be less expensive than brand-name drugs.
d. They undergo extensive testing before they are marketed. - ✔✔ANS: C

Rationale: Generic drugs are approved by the FDA if they are proved to be bioequivalent to the
brand-name drug. They tend to be less expensive because manufacturers of these drugs do not have
to do the extensive testing required of brand-name drugs before marketing. They are not identical to
brand-name drugs and often have different inert ingredients.

Before marketing a new drug that has been approved for use based on clinical effectiveness and
safety, the manufacturer wishes to study the potential new uses for the drug. This is an example of
which phase of study?a. Phase I
b. Phase II
c. Phase III
d. Phase IV - ✔✔ANS: D

Rationale: Phase IV studies are performed, in part, to examine potential new indications for approved
drugs.

During a clinical drug trial for a new medication, researchers note a previously unknown serious
adverse effect occurring in more than 50% of subjects. The study is discontinued. Which ethical
%

principle is being exercised?
a. Beneficence
b. Justice
c. Respect for persons
d. Veracity - ✔✔ANS: A

Rationale: Beneficence is the duty to protect subjects from harm. Once a serious adverse effect is
noted and it is determined that the benefits do not outweigh the risks of the study, researchers have
an ethical obligation to stop the study.

In a 5-year experimental clinical trial to investigate a new cancer treatment, researchers in the second
year note overwhelming improvement in almost all of the subjects in the treatment group. It is decided
to stop the trial early and report the findings due to the overwhelmingly beneficial effects. This
decision was made based on which ethical principle?
a. Beneficence
b. Justice
c. Respect for persons
d. Veracity - ✔✔ANS: B




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