Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
Test Bank Lehne's Pharmacology for Nursing Care,11th Ed by Jacqueline Burchum,
Laura Rosenthal
Chapter 3: Drug Regulation, Development, Names, and Information
Test Bank
3. A nursing student asks a nurse about pharmaceutical research and wants to know the purpose
of randomization in drug trials. The nurse explains that randomization is used to:
a. ensure that differences in outcomes are the result of treatment and not differences in
subjects.
b. compare the outcome caused by the treatment to the outcome caused by no treatment.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
c. make sure that researchers are unaware of which subjects are in which group.
d. prevent subjects from knowing which group they are in and prevent preconception
bias.
ANS: A
Randomization helps prevent allocation bias, which can occur when researchers place subjects
with desired characteristics in the study group and other subjects in the control group so that
differences in outcome are actually the result of differences in subjects and not treatment.
Comparing treatment outcome to no treatment outcome is the definition of a controlled study.
The last two options describe the use of blinding in studies; blinding ensures that researchers
or subjects (or both) are unaware of which subjects are in which group so that preconceptions
about benefits and risks cannot bias the results.
DIF: Cognitive Level: Comprehension REF: The Randomized Drug Trial
TOP: Nursing Process: Implementation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
MULTIPLE CHOICE
1. A nurse educator is conducting a continuing education class on pharmacology. To evaluate
the learning of the nurses in the class, the nurse educator asks, ―Which drug name is a
generic drug name?‖ Which is the correct response? a. Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS: A
Acetaminophen is the generic name. Tylenol, Cipro, and Motrin are all trade names.
DIF: Cognitive Level: Comprehension REF: Table 3-3: The Three Types of Drug Names
TOP: Nursing Process: Diagnosis
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
2. The FDA Amendments Act (FDAAA) was passed in 2007 to address which aspect of drug
safety?
a. Allowing pharmaceutical companies to identify off-label uses of medications
approved for other uses
b. Evaluating drug safety information that emerges after a drug has been approved and is
in use
c. Expediting the approval process of the U.S. Food and Drug Administration (FDA) so
that needed drugs can get to market more quickly
d. Requiring manufacturers to notify patients before removing a drug from the market
ANS: B
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
The FDAAA was passed to enable the Food and Drug Administration to continue oversight of
a drug after granting it approval so that changes in labeling could be made as necessary and
postmarketing risks could be tracked and identified. A provision of the FDA Modernization
Act (FDAMA), passed in 1997, allows drug companies to promote their products for off-label
uses as long as they promise to conduct studies to support their claims. Regulations to permit
accelerated approval of drugs for life-threatening diseases were adopted in 1992 by the FDA.
The requirement that drug companies notify patients 6 months before removing a drug from
the market is a provision of the FDAMA.
DIF: Cognitive Level: Comprehension REF: Landmark Drug Legislation
TOP: Nursing Process: Evaluation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
4. Someone asks a nurse about a new drug that is in preclinical testing and wants to know why it
cannot be used to treat a friend‘s illness. Which statement by the nurse is correct?
a. ―A drug at this stage of development can be used only in patients with serious disease.‖
b. ―At this stage of drug development, the safety and usefulness of the medication is
unknown.‖
c. ―Clinical trials must be completed to make sure the drug is safe to use in humans.‖
d. ―Until postmarketing surveillance data are available, the drug cannot be used.‖
ANS: B
Preclinical testing must be completed before drugs can be tested in humans. In this stage,
drugs are evaluated for toxicities, pharmacokinetic properties, and potentially useful effects.
Some drugs can be used in patients before completion of Phase III studies, but this is after
preclinical testing is complete. Clinical trials proceed in stages, and each stage has guidelines
defining how a new drug may be used and which patients may receive it. Postmarketing
surveillance takes place after a drug is in general use.
DIF: Cognitive Level: Comprehension
REF: Landmark Drug Legislation | Stages of Drug Development
TOP: Nursing Process: Implementation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Reduction of Risk Potential
5. A patient asks a nurse why drugs that have been approved by the FDA still have unknown
side effects. The nurse tell the patient that:
a. testing for all side effects of a medication would be prohibitively expensive.
b. patients in drug trials often are biased by their preconceptions of a drug‘s benefits.
c. researchers tend to conduct studies that will prove the benefits of their new drugs.
d. subjects in drug trials do not always represent the full spectrum of possible patients.
ANS: D
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
All drug trials are limited by a relatively small group of subjects who may not have all the
characteristics of people who will be using the drug; therefore, some side effects go
undetected until the drug is in use. Although drug trials are very expensive, this is only an
indirect reason they do not detect all side effects before approval. In theory, well-designed
drug trials, using blinded studies, minimize or eliminate subject bias. Designing studies to
prove desired results is unethical.
DIF: Cognitive Level: Analysis REF: Failure to Detect All Adverse Effects
TOP: Nursing Process: Implementation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
6. A nurse is teaching nursing students about the use of nonproprietary names for drugs. The
nurse tells them which fact about nonproprietary names?
a. They are approved by the FDA and are easy to remember.
b. They are assigned by the U.S. Adopted Names Council.
c. They clearly identify the drug‘s pharmacological classification.
d. They imply the efficacy of the drug and are less complex.
ANS: B
Nonproprietary, or generic, names are assigned by the U.S. Adopted Names Council, which
ensures that each drug has only one name. Trade names, or brand names, are approved by the
FDA and are easier to remember. Some nonproprietary names contain syllables that identify
the classification, although not all do. Drug names are not supposed to identify the use for the
drug, although some brand names do so.
DIF: Cognitive Level: Comprehension REF: Drug Names: The Three Types of Drug Names TOP:
Nursing Process: Diagnosis
MSC: NCLEX Client Needs Category: Physiologic Integrity: Reduction of Risk Potential
Chapter 4: Pharmacokinetics
Test Bank
MULTIPLE CHOICE
1. A patient tells the nurse that the oral drug that has been prescribed has caused a lot of stomach
discomfort in the past. What will the nurse ask the prescriber?
a. Whether a sublingual form of the medication can be given
b. Whether the medication can be given by a parenteral route instead
c. To order an enteric-coated form of the drug
d. Whether the patient can receive a sustained-release preparation of the drug
ANS: C
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
Test Bank Lehne's Pharmacology for Nursing Care,11th Ed by Jacqueline Burchum,
Laura Rosenthal
Chapter 3: Drug Regulation, Development, Names, and Information
Test Bank
3. A nursing student asks a nurse about pharmaceutical research and wants to know the purpose
of randomization in drug trials. The nurse explains that randomization is used to:
a. ensure that differences in outcomes are the result of treatment and not differences in
subjects.
b. compare the outcome caused by the treatment to the outcome caused by no treatment.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
c. make sure that researchers are unaware of which subjects are in which group.
d. prevent subjects from knowing which group they are in and prevent preconception
bias.
ANS: A
Randomization helps prevent allocation bias, which can occur when researchers place subjects
with desired characteristics in the study group and other subjects in the control group so that
differences in outcome are actually the result of differences in subjects and not treatment.
Comparing treatment outcome to no treatment outcome is the definition of a controlled study.
The last two options describe the use of blinding in studies; blinding ensures that researchers
or subjects (or both) are unaware of which subjects are in which group so that preconceptions
about benefits and risks cannot bias the results.
DIF: Cognitive Level: Comprehension REF: The Randomized Drug Trial
TOP: Nursing Process: Implementation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
MULTIPLE CHOICE
1. A nurse educator is conducting a continuing education class on pharmacology. To evaluate
the learning of the nurses in the class, the nurse educator asks, ―Which drug name is a
generic drug name?‖ Which is the correct response? a. Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS: A
Acetaminophen is the generic name. Tylenol, Cipro, and Motrin are all trade names.
DIF: Cognitive Level: Comprehension REF: Table 3-3: The Three Types of Drug Names
TOP: Nursing Process: Diagnosis
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
2. The FDA Amendments Act (FDAAA) was passed in 2007 to address which aspect of drug
safety?
a. Allowing pharmaceutical companies to identify off-label uses of medications
approved for other uses
b. Evaluating drug safety information that emerges after a drug has been approved and is
in use
c. Expediting the approval process of the U.S. Food and Drug Administration (FDA) so
that needed drugs can get to market more quickly
d. Requiring manufacturers to notify patients before removing a drug from the market
ANS: B
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
The FDAAA was passed to enable the Food and Drug Administration to continue oversight of
a drug after granting it approval so that changes in labeling could be made as necessary and
postmarketing risks could be tracked and identified. A provision of the FDA Modernization
Act (FDAMA), passed in 1997, allows drug companies to promote their products for off-label
uses as long as they promise to conduct studies to support their claims. Regulations to permit
accelerated approval of drugs for life-threatening diseases were adopted in 1992 by the FDA.
The requirement that drug companies notify patients 6 months before removing a drug from
the market is a provision of the FDAMA.
DIF: Cognitive Level: Comprehension REF: Landmark Drug Legislation
TOP: Nursing Process: Evaluation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
4. Someone asks a nurse about a new drug that is in preclinical testing and wants to know why it
cannot be used to treat a friend‘s illness. Which statement by the nurse is correct?
a. ―A drug at this stage of development can be used only in patients with serious disease.‖
b. ―At this stage of drug development, the safety and usefulness of the medication is
unknown.‖
c. ―Clinical trials must be completed to make sure the drug is safe to use in humans.‖
d. ―Until postmarketing surveillance data are available, the drug cannot be used.‖
ANS: B
Preclinical testing must be completed before drugs can be tested in humans. In this stage,
drugs are evaluated for toxicities, pharmacokinetic properties, and potentially useful effects.
Some drugs can be used in patients before completion of Phase III studies, but this is after
preclinical testing is complete. Clinical trials proceed in stages, and each stage has guidelines
defining how a new drug may be used and which patients may receive it. Postmarketing
surveillance takes place after a drug is in general use.
DIF: Cognitive Level: Comprehension
REF: Landmark Drug Legislation | Stages of Drug Development
TOP: Nursing Process: Implementation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Reduction of Risk Potential
5. A patient asks a nurse why drugs that have been approved by the FDA still have unknown
side effects. The nurse tell the patient that:
a. testing for all side effects of a medication would be prohibitively expensive.
b. patients in drug trials often are biased by their preconceptions of a drug‘s benefits.
c. researchers tend to conduct studies that will prove the benefits of their new drugs.
d. subjects in drug trials do not always represent the full spectrum of possible patients.
ANS: D
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
All drug trials are limited by a relatively small group of subjects who may not have all the
characteristics of people who will be using the drug; therefore, some side effects go
undetected until the drug is in use. Although drug trials are very expensive, this is only an
indirect reason they do not detect all side effects before approval. In theory, well-designed
drug trials, using blinded studies, minimize or eliminate subject bias. Designing studies to
prove desired results is unethical.
DIF: Cognitive Level: Analysis REF: Failure to Detect All Adverse Effects
TOP: Nursing Process: Implementation
MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Therapies
6. A nurse is teaching nursing students about the use of nonproprietary names for drugs. The
nurse tells them which fact about nonproprietary names?
a. They are approved by the FDA and are easy to remember.
b. They are assigned by the U.S. Adopted Names Council.
c. They clearly identify the drug‘s pharmacological classification.
d. They imply the efficacy of the drug and are less complex.
ANS: B
Nonproprietary, or generic, names are assigned by the U.S. Adopted Names Council, which
ensures that each drug has only one name. Trade names, or brand names, are approved by the
FDA and are easier to remember. Some nonproprietary names contain syllables that identify
the classification, although not all do. Drug names are not supposed to identify the use for the
drug, although some brand names do so.
DIF: Cognitive Level: Comprehension REF: Drug Names: The Three Types of Drug Names TOP:
Nursing Process: Diagnosis
MSC: NCLEX Client Needs Category: Physiologic Integrity: Reduction of Risk Potential
Chapter 4: Pharmacokinetics
Test Bank
MULTIPLE CHOICE
1. A patient tells the nurse that the oral drug that has been prescribed has caused a lot of stomach
discomfort in the past. What will the nurse ask the prescriber?
a. Whether a sublingual form of the medication can be given
b. Whether the medication can be given by a parenteral route instead
c. To order an enteric-coated form of the drug
d. Whether the patient can receive a sustained-release preparation of the drug
ANS: C
