TEST BANK LEHNE'S PHARMACOLOGY FOR NURSING CARE 10TH EDITION Author: Jacqueline Burchum| Laura

Lehne's Pharmacology for Nursing Care 10th Edition TEST
BANK(Chapter 1-110).

Chapter 3: Drug Regulation, Development, Names, and Inform
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at ion Test Bank
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MULTIPLE CHOICE 8 l




1. A nurse educator is conducting a continuing education class on pharmacology.
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To evaluate the learning of the nurses in the class, the nurse educator
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lasks, ―Whi ch drug name is a generic drug name?‖ Which is the cor
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rect response? a. Acet aminophen
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b. Tylenol
c. Cipro
d. Motrin
ANS: A 8 l


Acetaminophen is the generic name. Tylenol, Cipro, and Motrin are all trade names.
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DIF: Cognitive Level: Comprehension REF: Table 3-
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3: The Three Types ofs2Drug Names TOP: Nursing Process: Diagnosis
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MSC: NCLEX Client Needs Category: Physiologic Integrity: Pharmacologic and Parenteral Th
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erap ies 8 l




2. The FDA Amendments
8 l Act (FDAAA) was passed in 2007 to address
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which as pect of dr ug safety?
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a. Allowing pharmaceutical companies to identify 8 l 8 l 8 l 8 l


off- 8l


label uses ofs2medications approved for other
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s uses 8 l


b. Evaluating drug safety information that emerges after a drug has be 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l


en appr oved and is in use
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c. Expediting the approval process of the U.S. Food and Drug Admin 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l


istration (FDA) s o that needed drugs can get to market more qui
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ckly
d. Requiring manufacturers to notify patients before removing a drug from
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e mark et 8 l 8l




ANS: 8 l B
The FDAAA was passed to enable the Food and Drug Administration to
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lcontinue oversight 8l


ofs2a drug after granting it approval so that changes in labeling 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8 l


could be 8 l


made as necessary 8 l 8 l


and postmarketing risks could be tracked and identified. 8 l 8 l 8 l 8 l 8 l 8 l 8 l 8

,l A pr ovision ofs2the FDA Moderniza tion Act (FDAMA), passed in 1997,
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l allows drug c ompanies to promote their products for of
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label uses as long as they promise to conduct studies to support their cla
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ims. Regu lations to
8 l permit accelerated approval ofs2drugs for life-
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, Test Bank Lehne's Pharmacology for Nursing Care, 11th E di
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tion by Jacqueline Burchum, Laura Rosenthal Chapter
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threatening diseasess2weres2adopteds2ins21992s2bys2thes2FDA.s2The requirement that drug
compani
1- 112|Complete Guide A+ 8 l
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es notify patientss26 months before removing a drug from the m
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arket is a provision ofs2the F DAMA.
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DIF: Cognitive 8 l 8 l Level: Comprehe
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ns ion8l REF: Landmark Drug Legislation
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TOP: Nursing Process: Evaluation
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MSC: NCLEX Client Needs Category:
8 l 8 l 8 l 8 l 8 l Physiologic 8 l Integrity: 8 l Pharmacologic 8 l and Parent
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eral Th erapies
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, 3. A nursing student
8 l asks a nurse about pharmaceutical research and wants t
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o know the purpo se of
8 l 8l randomization in
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drug trials. The nurse explains that
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randomi zation is used to: 8l 8 l


a. ensure that differences in outcomes are the result ofs2treatment and
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not di fferences in subjects.
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b. compare the outcome caused by the treatment to the outcome caused
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8


no treat ment.
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