Edition by Michelle J. Willihnganz Test Bank newest
edition
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18THEDITION
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,Y Chapter 1: Drug Definitions, Standards, and Information Sources Test Bank
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MULTIPLE CHOICE fh
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
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(FDA)?
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a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C fh
The official name is the name under which a drug is listed by the FDA. The brand name, or
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trademark, is the name given to a drug by its manufacturer. The nonproprietary, or
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generic, name is provided by the U.S. Adopted Names Council.
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DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2 fh fh f h fh fh
TOP: Nursing Process Step: Assessment
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MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
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2. Which source contains information specific to nutritional supplements?
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a. USP Dictionary of USAN & International Drug Names
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b. Natural Medicines Comprehensive Database fh fh fh
c. United States Pharmacopoeia/National Formulary (USP NF)
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d. Drug Interaction Facts fh fh
ANS: C fh
United States Pharmacopoeia/National Formulary contains information specific to nutritional
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supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
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names, pronunciation guide, and possible future FDA approved drugs; it does not include
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nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
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information on herbal medicines and herbal combination products; it does not include
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information specific to nutritional supplements. Drug Interaction Facts contains
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comprehensive information on drug interaction facts; it does not include nutritional
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supplements.
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DIF: Cognitive Level: Knowledge REF: p. 2 fh fh f h fh OBJ: 4 fh
TOP: Nursing Process Step: Assessment
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MSC: NCLEX Client Needs Category: Physiological Integrity
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3. What is the most comprehensive reference available to research a drug interaction?
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a. Drug Facts and Comparisons fh fh fh
b. Drug Interaction Facts fh fh
c. Handbook on Injectable Drugs fh fh fh
d. Martindale—The Complete Drug Reference fh fh fh
ANS: B fh
, First published in 1983, Drug Interaction Facts is the most comprehensive book available on
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drug interactions. In addition to monographs listing various aspects of drug interactions, this
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information is reviewed and updated by an internationally renowned group of physicians and
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pharmacists with clinical and scientific expertise.
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DIF: Cognitive Level: Comprehension REF: p. 3 fh fh f h fh OBJ: 3 fh
TOP: Nursing Process Step: Assessment
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MSC: NCLEX Client Needs Category: Physiological Integrity
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4. The physician has written an order for a drug with which the nurse is unfamiliar. Which
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section of the Physicians’ Desk Reference (PDR) is most helpful to get information about
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this drug?
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a. Manufacturer‟s section fh
b. Brand and Generic Name section fh fh fh fh
c. Product Category section fh fh
d. Product Information section fh fh
ANS: B fh
A physician‟s order would include the brand and/or generic name of the drug. The alphabetic
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index in the PDR would make this section the most user friendly. Based on a physician‟s
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order, manufacturer‟s information and classification information would not be known. The
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Manufacturer‟s section is a roster of manufacturers. The Product Category section lists
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products subdivided by therapeutic classes, such as analgesics, laxatives, oxytocics, and
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antibiotics. The Product Information section contains reprints of the package inserts for the
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major products of manufacturers.
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DIF: Cognitive Level: Comprehension REF: p. 3 fh fh f h fh OBJ: 4 fh
TOP: Nursing Process Step: Planning
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MSC: NCLEX Client Needs Category: Physiological Integrity
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5. Which online drug reference makes available to health care providers and the public a
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fh standard, comprehensive, up to date look up and downloadable resource about medicines?
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a. American Drug Index fh fh
b. American Hospital Formulary fh fh
c. DailyMed
d. Physicians’ Desk Reference (PDR) fh fh fh
ANS: C fh
DailyMed makes available to health care providers and the public a standard, comprehensive,
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up to date look up and downloadable resource about medicines. The American Drug Index is
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not appropriate for patient use. The American Hospital Formulary is not appropriate for
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patient use. The PDR is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 4 fh fh f h fh OBJ: 5 fh
TOP: Nursing Process Step: Implementation
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MSC: NCLEX Client Needs Category: Physiological Integrity
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6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
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a. Federal Food, Drug, and Cosmetic Act (1938) fh fh fh fh fh fh
b. Durham Humphrey Amendment (1952) fh fh fh
c. Controlled Substances Act (1970) fh fh fh
, d. Kefauver Harris Drug Amendment (1962) fh fh fh fh
ANS: A fh
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
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safety of all drugs before marketing. Later amendments and acts helped tighten FDA control
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and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that
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cannot be used safely without medical supervision and restricts their sale to prescription by a
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licensed practitioner. The Controlled Substances Act addresses only controlled substances and
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their categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater
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drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their
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products before marketing them.
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DIF: Cognitive Level: Knowledge REF: p. 4 fh fh f h fh OBJ: 8 fh
TOP: Nursing Process Step: Assessment
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MSC: NCLEX Client Needs Category: Physiological Integrity
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7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
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fh dependency. Under which classification does this drug fall? fh fh fh fh fh fh fh
a. I
b. II
c. III
d. IV
ANS: B fh
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to
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severe psychological and physical dependence. Schedule I drugs have high potential for abuse
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and no recognized medical use. Schedule III drugs have some potential for abuse. Use may
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lead to low to moderate physical dependence or high psychological dependence. Schedule IV
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drugs have low potential for abuse. Use may lead to limited physical or psychological
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dependence.
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DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7 fh fh f h fh fh fh fh fh
TOP: Nursing Process Step: Assessment
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MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
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8. What would the FDA do to expedite drug development and approval for an outbreak of
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smallpox, for which there is no known treatment?
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a. List smallpox as a health orphan disease.
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b. Omit the preclinical research phase. fh fh fh fh
c. Extend the clinical research phase. fh fh fh fh
d. Fast track the investigational drug.
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ANS: D fh
Once the Investigational New Drug Application has been approved, the drug can receive
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highest priority within the agency, which is called fast tracking. A smallpox outbreak would
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become a priority concern in the world. Orphan diseases are not researched in a priority
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manner. Preclinical research is not omitted. Extending any phase of the research would
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mean a longer time to develop a vaccine. The FDA must ensure that all phases of the
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preclinical and clinical research phase have been completed in a safe manner.
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DIF: Cognitive Level: Knowledge REF: fh fh f h p. 7 fh OBJ: 8 fh
TOP: Nursing Process Step: Assessment
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