Updated/Latest Lehne’s Pharmacology for Nursing Care 11th Edition Burchum Rosenthal Psychopharmacology Final Exam Test Bank Comprehensive Examination Questions and Answers Study Guide for Nursing Pharmacology Drug Therapy Psychopharmacology Medication Adm

Tes Bank Lehne's Pharmacology for Nursing Care, 11th
J




Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+

Psychopharmacology FINAL EXAM 3


Chapter 3: Drug Regulation, Development, Names, and Information
Tes Bank
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MULTIPLE CHOICE

1. A nurse educator is conducting a continuing education class on pharmacology. To evaluate the J J J J J J J J J J J J




learning of the nurses in the class, the nurse educator asks, ―Which drug name is a generic drug
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name?‖ Which is the correct response? a. Acetaminophen
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b. Tylenol
c. Cipro
d. Motrin
ANS: A J




Acetaminophen is the generic name. Tylenol, Cipro, and Motrin are all trade names. J J J J J J J J J J J J




DIF: Cognitive Level: Comprehension
J REF: Table 3-3: The Three Types of DrugNames J J J J J J J J J J J




TOP: Nursing Process: Diagnosis
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MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic andParenteralTherapies
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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 identifyoff-label uses of medications
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approved for other uses J J J




b. Evaluating drug safety information that emerges after a drug has been approved and is in J J J J J J J J J J J J J J J




use
c. Expediting the approval process ofthe U.S. Food and Drug Administration (FDA) so that J J J J J J J J J J J J J J




needed drugs can get to market more quickly J J J J J J J




d. Requiring manufacturers to notify patients before removing a drug from the market
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ANS: B J




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 Act
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(FDAMA), passed in 1997, allows drug companies to promote their products for off-label uses as
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long as they promise to conduct studies to support their claims. Regulations to permit accelerated
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approval of drugs for life-threatening diseases were adopted in 1992 by the FDA.
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, Tes Bank Lehne's Pharmacology for Nursing Care, 11th
J




Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
The requirement that drug companies notifypatients 6 months before removing a drug from the
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market is a provision of the FDAMA.J J J J J J




DIF: Cognitive Level: Comprehension
J REF:LandmarkDrugLegislation J J J J J J




TOP: Nursing Process: Evaluation
J J J




MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic andParenteralTherapies
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3. A nursing student asks a nurse about pharmaceutical research and wants to know the purpose of
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randomization in drug trials. The nurse explains that randomization is used to: J J J J J J J J J J J




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. J J J J J J J J J J J J J




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 theyare in and prevent preconception bias. J J J J J J J J J J J J




ANS: A J




Randomization helps prevent allocation bias, which can occur when researchers place subjects with J J J J J J J J J J J J J




desired characteristics in the study group and other subjects in the control group so that differences in
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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. The J J J J J J J J J J J J J J J




last two options describe the use of blinding in studies; blinding ensures that researchers or
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subjects (or both) are unaware of which subjects are in which group so that preconceptions about
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benefits and risks cannot bias the results. J J J J J J




DIF: Cognitive Level: Comprehension
J REF:TheRandomizedDrugTrial J J J J J J J




TOP: Nursing Process: Implementation
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MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic andParenteralTherapies
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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 safetyand 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.‖ J J J J J J J J J J J J J J J




d. ―Until postmarketing surveillance data are available, the drug cannot be used.‖ J J J J J J J J J J




ANS: B J




Preclinical testing must be completed before drugs can be tested in humans. In this stage, drugs are
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evaluated for toxicities, pharmacokinetic properties, and potentially useful effects. Some drugs
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can be used in patients before completion of Phase III studies, but this is after preclinical testing is
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complete. Clinical trials proceed in stages, and each stage has guidelines defining how a new drug
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may be used and which patients may receive it. Postmarketing surveillance takes place after a drug
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is in general use.
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DIF: Cognitive Level: Comprehension
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REF: Landmark Drug Legislation |Stages of Drug Development TOP:
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, Tes Bank Lehne's Pharmacology for Nursing Care, 11th
J




Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
Nursing Process: Implementation J J




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 bythe FDA still have unknown side
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effects. The nurse tell the patient that: J J J J J J




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. J J J J J J J J J J J J J




d. subjects in drug trials do not always represent the full spectrum of possible patients. J J J J J J J J J J J J J




ANS: D J




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 undetected J J J J J J J J J J J J J J J




until the drug is in use. Although drug trials are very expensive, this is onlyan indirect reason they
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do not detect all side effects before approval. In theory, well-designed drug trials, using blinded
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studies, minimize or eliminate subject bias. Designing studies to prove desired results is unethical.
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DIF: Cognitive Level: Analysis J REF: Failure to Detect All Adverse Effects J J J J J J J J J




TOP: Nursing Process: Implementation
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MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic andParenteralTherapies
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6. A nurse is teaching nursing students about the use of nonproprietary names for drugs. The nurse
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tells them which fact about nonproprietary names?
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a. They are approved by the FDA and are easy to remember.J J J J J J J J J J




b. They are assigned by the U.S. Adopted Names Council. J J J J J J J J




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 J




Nonproprietary, or generic, names are assigned by the U.S. Adopted Names Council, which J J J J J J J J J J J J J




ensures that each drug has only one name. Trade names, or brand names, are approved by the FDA
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and are easier to remember. Some nonproprietary names contain syllables that identify the
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classification, although not all do. Drug names are not supposed to identifythe use for the drug,J J J J J J J J J J J J J J J J J




although some brand names do so. J J J J J




DIF: Cognitive Level: Comprehension REF: Drug Names: The Three Types of Drug Names TOP: Nursing
J J J J J J J J J J J J J J J




Process: Diagnosis J




MSC: NCLEX Client Needs Category: Physiologic Integrity: Reduction of Risk Potential
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Chapter4:Pharmacokinetics Test
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Bank



MULTIPLE CHOICE J




1. A patient tells the nurse that the oral drug that has been prescribed has caused a lot of stomach
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discomfort in the past. What will the nurse ask the prescriber? J J J J J J J J J J




a. Whether a sublingual form of the medication can be given J J J J J J J J J

, Tes Bank Lehne's Pharmacology for Nursing Care, 11th
J




Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
b. Whether the medication can be given by a parenteral route instead J J J J J J J J J J




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 J J J J J J J J J J




ANS: C J




Enteric-coated drugs are preparations that have been coated with a material that dissolves in the J J J J J J J J J J J J J J J




intestines, not the stomach. This coating is used either to protect the drug from stomach acid and
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pepsin or to protect the stomach from a drug that can cause gastric upset. Sublingual forms often are
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used for drugs that undergo rapid inactivation during the first pass through the hepatic circulation so
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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 a
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specific period to reduce the number of daily doses required to sustain therapeutic drug levels.
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DIF: Cognitive Level: Application
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REF: ComparingOral Administration with Parenteral Administration
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TOP: Nursing Process: Implementation
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MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic andParenteralTherapies
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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 Brand
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Y of the same drug. Both brands contain the same amount of the active ingredient. What does the
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nurse know to be most likely? J J J J J




a. Advertising bypharmaceutical companies can enhance patient expectations of one brand J J J J J J J J J J J




over another, leading to a placebo effect. J J J J J J




b. Because the drug preparations are chemically equivalent, the effects of the two brands J J J J J J J J J J J J J




must be identical. J J




c. Tablets can differ in composition and can have differing rates of disintegration and J J J J J J J J J J J J




dissolution, which can alter the drug‘s effects in the body. J J J J J J J J J




d. The bioavailability of a drug is determined by the amount of the drug in each dose.
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ANS: C J




Even if two brands of a drug are chemically equivalent (i.e., they have identical amounts of the
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same chemical compound), they can have different effects in the body if they differ in
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bioavailability. Tablets made bydifferent manufacturers contain different binders and fillers, J J J J J J J J J J J




which disintegrate and dissolve at different rates and affect the bioavailability of the drug.
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Two brands may be chemicallyequivalent and still differ in bioavailability, which is not determined
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by the amount of drug in the dose.
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DIF: Cognitive Level: Application
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REF: Pharmaceutical Preparations for Oral Administration
J TOP: Nursing Process: Diagnosis J J J J J J J J




MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and ParenteralTherapies
J J J J J J J J J J