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