fMichelleJ.Willihnganz,SamuelL.Gurevitz,BruceClaytonComplete
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,Chapter 01: Drug Definitions, Standards, and Information Sources
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Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition
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MULTIPLE CHOICE fg
Which name identifies a drug listed by the US Food and
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Drug Administration (FDA)?
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Brand
Nonproprietary
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Official
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Trademark
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ANS: C fg
The official name is the name under which a drug is
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listed by the FDA. The brand name, or trademark, is the
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name gi ven to a drug by its manufacturer. The
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nonproprietary, or g eneric, name is provided by the
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United States Adopted Na mes Council.
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DIF: Cognitive Level: Knowledge REF: p. 9 fg fg fg fg
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective
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Care Environment TOP: Nursing Process Step: Assessment CON:
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Patient Education
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Which source contains information specific to nutritional supplements?
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USP Dictionary of USAN & International Drug Names
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Natural Medicines Comprehensive Database
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United States Pharmacopoeia/National Formulary (USP NF)
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Drug Interaction Facts
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ANS: C fg
United States Pharmacopoeia/National Formulary contains information specific to
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nutrition al supplements. USP Dictionary of USAN & International Drug Names is a
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compilation of d rug names, pronunciation guide, and possible future FDA approved
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drugs; it does not includ e nutritional supplements. Natural Medicines Comprehensive
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Database contains evidence- based information on herbal medicines and herbal
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combination products; it does not include information specific to nutritional supplements.
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Drug Interaction Facts contains comprehen sive information on drug interaction facts; it
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does not include nutritional supplements.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 3 fg fg f g fg fg
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Assessment
f g CON: Nutrition | Patient Education
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Which drug reference contains drug monographs that describe all drugs in a therapeutic
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cla ss? a. Drug Facts and Comparisons
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,TestABank For Clayton’s Basic Pharmacology for Nurses 19th Edition
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Drug Interaction Facts
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Handbook on Injectable
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Drugs
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Martindale—The Complete Drug Reference fg fg fg
ANS: A fg
Drug Facts and Comparisons contains drug monographs that describe all drugs
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in
fg a therapeutic class. Monographs are formatted as tables to allow
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comparison of si milar products, brand names, manufacturers, cost indices, and
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available dosage for ms Online version is available.
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DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 fg fg fg fg fg fg
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity fg fg fg fg fg fg
CON: Safety | Patient Education | Clinical fg fg fg fg fg fg
TOP: Nursing Process Step: Judgme nt fg fg fg fg
Assessment fg
Which drug reference contains monographs about virtually every single-
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entity drug available in the United States and describes therapeutic uses of drugs,
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includin g approved and unapproved uses?
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Martindale: The Complete Drug Reference fg fg fg fg
AHFS Drug Information
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Drug Reference fg
Drug Facts and Comparisons fg fg fg
ANS: B fg
AHFS Drug Information contains monographs about virtually every single-
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entity drug available in the United States and describes therapeutic uses of drugs, including
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approved and unapproved uses.
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DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 fg fg fg fg fg fg
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity fg fg fg fg fg fg
CON: Safety | Patient Education | Clinical fg fg fg fg fg fg
TOP: Nursing Process Step: Planning Judgme fg fg fg fg
nt
Which online drug reference makes available to healthcare providers and the public a
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stand ard, comprehensive, up-to-date look up and downloadable resource about
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medicines?
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American Drug Index fg fg
American Hospital Formulary
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DailyMed
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Drug Reference fg
ANS: C fg
DailyMed makes available to healthcare providers and the public a standard,
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comprehensiv e, up-to-
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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
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for patie nt use. The drug reference is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 OBJ: 3 fg fg f g fg fg fg fg fg
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Implementation
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CON: Safety | Patient Education | Clinical Judgment
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Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
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Federal Food, Drug, and Cosmetic Act (1938)
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Durham Humphrey Amendment (1952)
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, TestABank For Clayton’s Basic Pharmacology for Nurses 19th Edition
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Controlled Substances Act (1970) fg fg fg
Kefauver Harris Drug Amendment
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(1962)
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ANS: A fg
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
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sa fety of all drugs before marketing. Later amendments and acts helped tighten FDA
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control a nd ensure drug safety. The Durham Humphrey Amendment defines the kinds of
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drugs that cannot be used safely without medical supervision and restricts their sale
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to prescription by a licensed practitioner. The Controlled Substances Act addresses only
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controlled substances and their categorization. The Kefauver Harris Drug Amendment
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ensures drug efficacy and g reater drug safety. Drug manufacturers are required to
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prove to the FDA the effectiveness o f their products before marketing them.
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DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 fg fg f g fg fg fg
OBJ: 5 NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Assessment
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CON: Safety | Patient Education | Evidence | Health Care Law
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Which classification does meperidine (Demerol) fall under?
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I
I f g
I
II fg
I
I fg
V
ANS: B fg
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may
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lead
fg to severe psychological and physical dependence. Schedule I drugs have high
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potential for abuse and no recognized medical use. Schedule III drugs have some
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potential for abuse. Us e may lead to low to moderate physical dependence or high
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psychological dependence. Sch edule IV drugs have low potential for abuse. Use may
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lead to limited physical or psycholog ical dependence.
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DIF: Cognitive Level: Knowledge REF: p. 10 OBJ: 2 fg fg f g fg fg
NAT: NCLEX Client Needs Category: Safe, Effective Care
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Environment
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TOP: Nursing Process Step: Assessment
f g CON: Patient Education | Addiction | Pain
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Which action would the FDA take to expedite drug development and approval for an
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outbr eak of smallpox?
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List smallpox as a health orphan disease.
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Omit the preclinical research phase.
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Extend the clinical research phase. fg fg fg fg
Fast track the investigational
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drug. fg
ANS: D fg
Once the Investigational New Drug Application has been approved, the drug can receive
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hi ghest priority within the agency, which is called fast tracking. A smallpox outbreak
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would become a priority concern in the world. Orphan diseases are not researched in a
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priority ma nner. Preclinical research is not omitted. Extending any phase of the
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research would mean a longer time to develop a vaccine. The FDA must ensure that
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all phases of the preclinical and clinical research phase have been completed in a safe
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manner.
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DIF: Cognitive Level: Knowledge fg fg REF: f g p. 7 fg OBJ: 5 fg