,
,
,
, b. It is not measurable.
c. It is not patient-centered.
d. It is not realistic.
ANS: D
The expected outcome is not realistic because the patient is not usually on room air and should
not be expected to attain that expected outcome by discharge from this hospitalization.
DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Planning
MSC: NCLEX: Management of Client Care
10. The nurse is developing a teaching plan for an elderly patient who will begin taking an
antihypertensive drug that causes dizziness and orthostatic hypotension. Which hypothesis
(problem) documented by the nurse is appropriate for this patient?
a. Deficient knowledge related to drug side effects.
b. Ineffective health maintenance related to age.
c. Readiness for enhanced knowledge related to medication side effects.
d. Risk for injury related to side effects of the medication.
ANS: D
This patient has an increased risk for injury because of drug side effects, so this is an appropriate
hypothesis (problem) to direct the type of care and follow-up the patient will receive.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Nursing Diagnosis
MSC: NCLEX: Management of Client Care
11. An older patient must learn to administer a medication using a device that requires manual
dexterity. The patient becomes frustrated and expresses lack of self-confidence in performing
this task. Which action will the nurse perform next?
a. Ask the patient to keep trying until the skill is learned.
b. Provide written instructions with illustrations showing each step of the skill.
c. Schedule multiple sessions and practice each step separately.
d. Teach the procedure to family members who can administer the medication for the
patient.
ANS: C
Nurses should be sensitive to patient’s level of frustration when teaching skills. In this case,
breaking the steps down into individual parts will help with this patient’s frustration level.
DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Planning
MSC: NCLEX: Management of Client Care
12. A school-age child will begin taking a medication to be administered at 5 mL three times daily.
The child’s parent tells the nurse that, with a previous use of the drug, the child repeatedly forgot
to bring the medication home from school, resulting in missed evening doses. What will the
nurse recommend?
a. Encourage the child to be more responsible and that it is important to take the
medication as prescribed.
, b. Putting a note on the child’s locker to encourage the child to take responsibility for
medication administration.
c. Asking the provider if 7.5 mL may be taken in the morning and 7.5 mL may be
taken in the evening so that the correct amount is given daily.
d. Taking the noon dose to school every day and giving it to the school nurse to
administer.
ANS: C
For busy families with school-age children, it may be necessary to adjust the medication
schedule to one that fits their schedule. The nurse should ask the provider if a revised schedule is
possible. In this case, the most effective revised schedule would involve not taking the
medication while at school. Putting a note on the locker is not likely to be effective. It is not
correct to adjust the dose.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Nursing Intervention | Nursing Process: Planning
MSC: NCLEX: Management of Client Care
13. A high-school student regularly forgets to use a twice-daily inhaled corticosteroid to prevent
asthma flares and is repeatedly admitted to the hospital. The child’s parent tells the nurse that the
child has been told that forgetting to take the medication causes frequent hospitalizations. The
nurse will
a. encourage the child to take responsibility for taking the medication.
b. reinforce the need to take prescribed medications to avoid hospitalizations.
c. suggest putting the inhaler with the child’s toothbrush to use before brushing teeth.
d. suggest that the child’s parents administer the medication to increase compliance.
ANS: C
It is important to empower patients to take responsibility for managing medications. Putting the
medication with the toothbrush can help this child remember to use it. Telling the child to take
medications and reminding the child that failure to do so results in hospitalization is not working.
Asking the child’s parents to administer the medication does not empower the adolescent to take
responsibility.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Planning | Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
14. An adolescent patient who has acne is given a regimen of topical medications and an oral
antibiotic that generally clears up lesions to fewer than 10 within 6 to 8 weeks. At a 2-month
follow-up, the patient continues to have more than 25 lesions. The child’s parent affirms that the
child is using the medications as prescribed. Which statement below is correct for this patient to
evaluate the outcome?
a. “Goal of fewer than 10 lesions in 6 to 8 weeks is not met.”
b. “Goal that the medication will be effective is not met.”
c. “Goal that the patient will take medications as prescribed is not met.”
d. “Goal that the patient understands the medication regimen is not met.”
ANS: A
, All indications are that this patient is taking the medications and they are not effective. The first
statement is correct because it identifies a measurable desired outcome and a specific time frame.
DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Evaluation
MSC: NCLEX: Management of Client Care
15. Which of the following would not be considered an important element of health teaching in drug
therapy?
a. Assess the patients’ health literacy skills.
b. Assess all of the drugs on the patients’ profile for possible drug interactions.
c. Avoid discussing potential side effects and adverse reactions with the patient to
avoid nonadherence.
d. Determine if the patient needs laboratory monitoring.
ANS: C
Potential side effects and adverse reactions should always be discussed with the patient so they
know what to report to their health care team should they occur. All other factors considerations
listed are important elements of health teaching.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Assessment | Nursing Process: Nursing Intervention
MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies
Chapter 02: Drug Development and Ethical Considerations
McCuistion: Pharmacology: A Patient-Centered Nursing Process Approach, 11th Edition
MULTIPLE CHOICE
1. The nurse is obtaining consent from a subject newly recruited for a clinical drug trial that will
last for 6 months. All subjects will be given gift certificates for participating. One subject says,
“Well, I guess if the drug doesn’t work, I’ll just have to put up with the symptoms for 6 months.”
What will the nurse tell the subject?
a. “Participation for the duration of the study is required.”
b. “Participation may end at any time without penalty.”
c. “Withdrawal from the study may end at any time, but the gift certificate will not be
given.”
d. “You can request placement in the treatment group.”
ANS: B
All participants have the right to autonomy, which is the right to self-determination. Patients
have the right to refuse to participate or to withdraw from a study at any time without penalty.
Patients generally are not allowed to choose participation in either the treatment or the control
group.
DIF: Cognitive Level: Understanding (Comprehension)
TOP: Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
,2. The nurse is assisting with a clinical drug trial in which the side effects of two effective drugs are
being compared. A patient who would benefit from either drug has elected to withdraw from the
study, and the nurse assists with the paperwork to facilitate this. This is an example of
a. autonomy.
b. beneficence.
c. justice.
d. veracity.
ANS: A
All participants have the right to autonomy, which is the right to self-determination. Patients
have the right to refuse to participate or to withdraw from a study at any time without penalty
even if the health care provider disagrees with that choice.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
3. 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
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.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
4. In a 5-year clinical trial investigating a new cancer treatment, researchers note overwhelming
improvement in almost all of the subjects in the treatment group during the second year of the
trial. 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
The principle of justice requires that all people be treated fairly. Because the findings were
overwhelmingly positive, an ethical decision was made to stop the study early and report
findings so that additional people could gain benefit from the treatment.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
,5. The nurse is enrolling subjects for a double-blind experimental study. One patient asks the nurse
to explain the role of the experimental group. The nurse will explain that subjects in the
experimental group in this type of study
a. are selected for participation in that group.
b. have unique baseline characteristics.
c. receive a placebo.
d. receive the experimental treatment being evaluated.
ANS: D
In a double-blind experimental study, subjects in the experimental group receive the treatment or
drug under study. They are randomly assigned and not selected. They should have similar
baseline characteristics to those in the control group. They do not receive a placebo.
DIF: Cognitive Level: Understanding (Comprehension)
TOP: Nursing Process: Nursing Intervention: Patient Teaching
MSC: NCLEX: Management of Client Care
6. The nurse is obtaining signatures on consent forms for participation in a clinical drug trial. One
patient says, “I’m not sure I want to do this, but I need the cash.” The nurse will take which
action?
a. Ask the patient to clarify concerns.
b. Reinforce that cash is given to all subjects equally.
c. Report this statement to the lead investigator.
d. Review the elements of the study and obtain consent.
ANS: C
If a nurse suspects that a patient is being coerced to participate in the study, the nurse should
report this to the principal investigator. When a patient verbalizes participation based on a
financial reward, there is a potential element of coercion.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
7. Which of the following best describes preclinical in vivo testing?
a. A comparison of experimental and control data in animals.
b. A study conducted in a test tube in a laboratory.
c. A study that determines the effects of the experimental product in human
participants.
d. A study to assess the seriousness of the disease to be treated.
ANS: A
Preclinical in vivo testing is performed in animals or other non-human living organisms. In vitro
studies occur in test tubes. Safe therapeutic dose studies are part of clinical research. Prior to
clinical trials, an assessment is made of the disease and its seriousness.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
, 8. Drugs approved to the market in the 1980s may not be proven effective in a large portion of the
population. The nurse understands that this is because these drugs
a. did not pass through the appropriate phases of clinical trials.
b. did not require human subject protections and are invalid.
c. were not always tested in women, minorities, or children.
d. were tested on healthy subjects only.
ANS: C
Drug research was historically performed primarily in Caucasian males, causing uncertainty as to
the validity of the research results in the broader population. The NIH Revitalization Act passed
by Congress in 1993 helped establish guidelines to include women and minorities in clinical
research.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
9. The nurse is assisting with data collection in a study of drug effects in a small group of healthy
subjects. The nurse assists with blood and urine collection to determine serum drug levels and
the presence of metabolites in urine. Which phase of drug development does this best represent?
a. Phase I
b. Phase II
c. Phase III
d. Phase IV
ANS: A
Phase I drug trials are performed to assess safety and to identify the pharmacokinetics, such as
metabolism and elimination, of drugs in healthy subjects.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
10. The nurse is enrolling subjects for a clinical drug trial in which subjects will be randomly
assigned to either a treatment or a placebo group. The pills in both groups will be in identical
packaging with identical appearance. The group that receives the intervention is the
a. control group.
b. experimental group.
c. dependent group.
d. independent group.
ANS: B
The experimental group in a drug trial is the group that receives the drug being tested. The
control group may receive no drug, a different drug, a placebo, or the same drug with a different
dose, route, or frequency of administration. Dependent and independent are not terms to describe
groups in a study; they denote the variables.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
,
,
, b. It is not measurable.
c. It is not patient-centered.
d. It is not realistic.
ANS: D
The expected outcome is not realistic because the patient is not usually on room air and should
not be expected to attain that expected outcome by discharge from this hospitalization.
DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Planning
MSC: NCLEX: Management of Client Care
10. The nurse is developing a teaching plan for an elderly patient who will begin taking an
antihypertensive drug that causes dizziness and orthostatic hypotension. Which hypothesis
(problem) documented by the nurse is appropriate for this patient?
a. Deficient knowledge related to drug side effects.
b. Ineffective health maintenance related to age.
c. Readiness for enhanced knowledge related to medication side effects.
d. Risk for injury related to side effects of the medication.
ANS: D
This patient has an increased risk for injury because of drug side effects, so this is an appropriate
hypothesis (problem) to direct the type of care and follow-up the patient will receive.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Nursing Diagnosis
MSC: NCLEX: Management of Client Care
11. An older patient must learn to administer a medication using a device that requires manual
dexterity. The patient becomes frustrated and expresses lack of self-confidence in performing
this task. Which action will the nurse perform next?
a. Ask the patient to keep trying until the skill is learned.
b. Provide written instructions with illustrations showing each step of the skill.
c. Schedule multiple sessions and practice each step separately.
d. Teach the procedure to family members who can administer the medication for the
patient.
ANS: C
Nurses should be sensitive to patient’s level of frustration when teaching skills. In this case,
breaking the steps down into individual parts will help with this patient’s frustration level.
DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Planning
MSC: NCLEX: Management of Client Care
12. A school-age child will begin taking a medication to be administered at 5 mL three times daily.
The child’s parent tells the nurse that, with a previous use of the drug, the child repeatedly forgot
to bring the medication home from school, resulting in missed evening doses. What will the
nurse recommend?
a. Encourage the child to be more responsible and that it is important to take the
medication as prescribed.
, b. Putting a note on the child’s locker to encourage the child to take responsibility for
medication administration.
c. Asking the provider if 7.5 mL may be taken in the morning and 7.5 mL may be
taken in the evening so that the correct amount is given daily.
d. Taking the noon dose to school every day and giving it to the school nurse to
administer.
ANS: C
For busy families with school-age children, it may be necessary to adjust the medication
schedule to one that fits their schedule. The nurse should ask the provider if a revised schedule is
possible. In this case, the most effective revised schedule would involve not taking the
medication while at school. Putting a note on the locker is not likely to be effective. It is not
correct to adjust the dose.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Nursing Intervention | Nursing Process: Planning
MSC: NCLEX: Management of Client Care
13. A high-school student regularly forgets to use a twice-daily inhaled corticosteroid to prevent
asthma flares and is repeatedly admitted to the hospital. The child’s parent tells the nurse that the
child has been told that forgetting to take the medication causes frequent hospitalizations. The
nurse will
a. encourage the child to take responsibility for taking the medication.
b. reinforce the need to take prescribed medications to avoid hospitalizations.
c. suggest putting the inhaler with the child’s toothbrush to use before brushing teeth.
d. suggest that the child’s parents administer the medication to increase compliance.
ANS: C
It is important to empower patients to take responsibility for managing medications. Putting the
medication with the toothbrush can help this child remember to use it. Telling the child to take
medications and reminding the child that failure to do so results in hospitalization is not working.
Asking the child’s parents to administer the medication does not empower the adolescent to take
responsibility.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Planning | Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
14. An adolescent patient who has acne is given a regimen of topical medications and an oral
antibiotic that generally clears up lesions to fewer than 10 within 6 to 8 weeks. At a 2-month
follow-up, the patient continues to have more than 25 lesions. The child’s parent affirms that the
child is using the medications as prescribed. Which statement below is correct for this patient to
evaluate the outcome?
a. “Goal of fewer than 10 lesions in 6 to 8 weeks is not met.”
b. “Goal that the medication will be effective is not met.”
c. “Goal that the patient will take medications as prescribed is not met.”
d. “Goal that the patient understands the medication regimen is not met.”
ANS: A
, All indications are that this patient is taking the medications and they are not effective. The first
statement is correct because it identifies a measurable desired outcome and a specific time frame.
DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Evaluation
MSC: NCLEX: Management of Client Care
15. Which of the following would not be considered an important element of health teaching in drug
therapy?
a. Assess the patients’ health literacy skills.
b. Assess all of the drugs on the patients’ profile for possible drug interactions.
c. Avoid discussing potential side effects and adverse reactions with the patient to
avoid nonadherence.
d. Determine if the patient needs laboratory monitoring.
ANS: C
Potential side effects and adverse reactions should always be discussed with the patient so they
know what to report to their health care team should they occur. All other factors considerations
listed are important elements of health teaching.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Assessment | Nursing Process: Nursing Intervention
MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies
Chapter 02: Drug Development and Ethical Considerations
McCuistion: Pharmacology: A Patient-Centered Nursing Process Approach, 11th Edition
MULTIPLE CHOICE
1. The nurse is obtaining consent from a subject newly recruited for a clinical drug trial that will
last for 6 months. All subjects will be given gift certificates for participating. One subject says,
“Well, I guess if the drug doesn’t work, I’ll just have to put up with the symptoms for 6 months.”
What will the nurse tell the subject?
a. “Participation for the duration of the study is required.”
b. “Participation may end at any time without penalty.”
c. “Withdrawal from the study may end at any time, but the gift certificate will not be
given.”
d. “You can request placement in the treatment group.”
ANS: B
All participants have the right to autonomy, which is the right to self-determination. Patients
have the right to refuse to participate or to withdraw from a study at any time without penalty.
Patients generally are not allowed to choose participation in either the treatment or the control
group.
DIF: Cognitive Level: Understanding (Comprehension)
TOP: Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
,2. The nurse is assisting with a clinical drug trial in which the side effects of two effective drugs are
being compared. A patient who would benefit from either drug has elected to withdraw from the
study, and the nurse assists with the paperwork to facilitate this. This is an example of
a. autonomy.
b. beneficence.
c. justice.
d. veracity.
ANS: A
All participants have the right to autonomy, which is the right to self-determination. Patients
have the right to refuse to participate or to withdraw from a study at any time without penalty
even if the health care provider disagrees with that choice.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
3. 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
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.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
4. In a 5-year clinical trial investigating a new cancer treatment, researchers note overwhelming
improvement in almost all of the subjects in the treatment group during the second year of the
trial. 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
The principle of justice requires that all people be treated fairly. Because the findings were
overwhelmingly positive, an ethical decision was made to stop the study early and report
findings so that additional people could gain benefit from the treatment.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
,5. The nurse is enrolling subjects for a double-blind experimental study. One patient asks the nurse
to explain the role of the experimental group. The nurse will explain that subjects in the
experimental group in this type of study
a. are selected for participation in that group.
b. have unique baseline characteristics.
c. receive a placebo.
d. receive the experimental treatment being evaluated.
ANS: D
In a double-blind experimental study, subjects in the experimental group receive the treatment or
drug under study. They are randomly assigned and not selected. They should have similar
baseline characteristics to those in the control group. They do not receive a placebo.
DIF: Cognitive Level: Understanding (Comprehension)
TOP: Nursing Process: Nursing Intervention: Patient Teaching
MSC: NCLEX: Management of Client Care
6. The nurse is obtaining signatures on consent forms for participation in a clinical drug trial. One
patient says, “I’m not sure I want to do this, but I need the cash.” The nurse will take which
action?
a. Ask the patient to clarify concerns.
b. Reinforce that cash is given to all subjects equally.
c. Report this statement to the lead investigator.
d. Review the elements of the study and obtain consent.
ANS: C
If a nurse suspects that a patient is being coerced to participate in the study, the nurse should
report this to the principal investigator. When a patient verbalizes participation based on a
financial reward, there is a potential element of coercion.
DIF: Cognitive Level: Applying (Application)
TOP: Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
7. Which of the following best describes preclinical in vivo testing?
a. A comparison of experimental and control data in animals.
b. A study conducted in a test tube in a laboratory.
c. A study that determines the effects of the experimental product in human
participants.
d. A study to assess the seriousness of the disease to be treated.
ANS: A
Preclinical in vivo testing is performed in animals or other non-human living organisms. In vitro
studies occur in test tubes. Safe therapeutic dose studies are part of clinical research. Prior to
clinical trials, an assessment is made of the disease and its seriousness.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
, 8. Drugs approved to the market in the 1980s may not be proven effective in a large portion of the
population. The nurse understands that this is because these drugs
a. did not pass through the appropriate phases of clinical trials.
b. did not require human subject protections and are invalid.
c. were not always tested in women, minorities, or children.
d. were tested on healthy subjects only.
ANS: C
Drug research was historically performed primarily in Caucasian males, causing uncertainty as to
the validity of the research results in the broader population. The NIH Revitalization Act passed
by Congress in 1993 helped establish guidelines to include women and minorities in clinical
research.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
9. The nurse is assisting with data collection in a study of drug effects in a small group of healthy
subjects. The nurse assists with blood and urine collection to determine serum drug levels and
the presence of metabolites in urine. Which phase of drug development does this best represent?
a. Phase I
b. Phase II
c. Phase III
d. Phase IV
ANS: A
Phase I drug trials are performed to assess safety and to identify the pharmacokinetics, such as
metabolism and elimination, of drugs in healthy subjects.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
10. The nurse is enrolling subjects for a clinical drug trial in which subjects will be randomly
assigned to either a treatment or a placebo group. The pills in both groups will be in identical
packaging with identical appearance. The group that receives the intervention is the
a. control group.
b. experimental group.
c. dependent group.
d. independent group.
ANS: B
The experimental group in a drug trial is the group that receives the drug being tested. The
control group may receive no drug, a different drug, a placebo, or the same drug with a different
dose, route, or frequency of administration. Dependent and independent are not terms to describe
groups in a study; they denote the variables.
DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A
MSC: NCLEX: Management of Client Care
