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Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Complete
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,Chapter 01: Drug Definitions, Standards, and Information Sources
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Willihnganz: Clayton’s Basic Pharmacology for Nurses, 20th Edition
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MULTIPLE CHOICE b-g
1. Which name identifies a drug listed bythe US Food and Drug
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Administration (FDA)?
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a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C b- g
The official name is the name under which a drug is listed by
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the FDA. The brand name, or trademark, is the name given to a
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drug by its manufacturer. The nonproprietary, or generic, name
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is provided by the United States Adopted Names Council.
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DIF: Cognitive Level: Knowledge REF: p. 9 b-g b-g b - g b-g
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care b-g b-g b-g b-g b-g b-g b-g b-g b-
Environment TOP: Nursing Process Step: Assessment
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Patient Education
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2. Whichsource contains information specific to nutritional supplements?
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a. USP Dictionary of USAN &International Drug Names b-g b-g b-g b-g b-g b-g b-g
b. Natural Medicines Comprehensive Database b-g b-g b-g
c. United States Pharmacopoeia/National Formulary (USP NF) b-g b-g b-g b-g b-g
d. Drug Interaction Facts b-g b-g
ANS: C b- g
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
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evidence-based information on herbal medicines and herbal combination products; it does not b-g b-g b-g b-g b-g b-g b-g b-g b-g b-g b-g b-
include 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. 4 OBJ: 3 b-g b-g b - g b-g b-g b-
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Assessment CON: Nutrition |Patient Education
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3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
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a. Drug Facts and Comparisons b-g b-g b-g
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b. Drug Interaction Facts b-g b-g
c. Handbook on Injectable Drugs b-g b-g b-g
d. Martindale—The Complete Drug Reference b-g b-g b-g
ANS: A b-g
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
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therapeutic class. Monographs are formatted as tables to allow comparison ofsimilar
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products, brand names, manufacturers, cost indices, and available dosage forms
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Online version is available.
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DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 b-g b-g b - g b- g b-g b-g
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Assessment CON: Safety |Patient Education |Clinical Judgment
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4. Which drug reference contains monographs about virtuallyeverysingle-entitydrug available in
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the United States and describes therapeutic uses of drugs, including approved and
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unapproved uses?
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a. Martindale: The Complete Drug Reference b-g b-g b-g b-g
b. AHFS Drug Information b-g b-g
c. DrugReference b-g
d. DrugFacts and Comparisons b-g b-g b-g
ANS: B b-g
AHFS Drug Information contains monographs about virtually every single-entity drug
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available in the United States and describes therapeutic uses ofdrugs, including approved and
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unapproved uses.
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DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 b-g b-g b - g b- g b-g b-g
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Planning
b - g CON: Safety |Patient Education |Clinical Judgment b-g b-g b-g b - g b-g b-g b-g b-g b-g b-g
5. Which online drug reference makes available to healthcare providers and the public a
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standard, comprehensive, up-to-date look up and downloadable resource about medicines?
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a. American Drug Index b-g b-g
b. American Hospital Formulary b-g b-g
c. DailyMed
d. Drug Reference b-g
ANS: C b- g
DailyMed makes available to healthcare 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 drug reference is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 b-g b-g b - g b-g b-g b-g b-g OBJ: 3 b-g b-
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Implementation
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CON: Safety |Patient Education | Clinical Judgment
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6. Which legislation authorizes the FDA to determine the safetyof a drug before its marketing?
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a. Federal Food, Drug, and Cosmetic Act (1938) b-g b-g b-g b-g b-g b-g
b. Durham HumphreyAmendment (1952) b-g b-g b-g
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c. Controlled Substances Act (1970) b-g b-g b-g
d. Kefauver Harris Drug Amendment (1962) b-g b-g b-g b-g
ANS: A b-g
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 onlycontrolled 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. 5Table l.3 b-g b-g b - g b- g b-g b-g
OBJ: b - g 5 NAT: NCLEX Client Needs Category: Physiological Integrity b-g b-g b-g b-g b-g b-g b-
TOP:
g b - gNursing Process Step: Assessment b-g b-g b-g
CON: b - g Safety |Patient Education |Evidence | Health Care Law b-g b-g b-g b-g b-g b-g b-g b-g b-g
7. Whichclassification does meperidine (Demerol) fall under?
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a. I
b. II
c. III
d. IV
ANS: B b-g
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 Idrugs 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: Knowledge REF: p. 10 OBJ: 2 b-g b-g b - g b-g b-g b-
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
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TOP: Nursing Process Step: Assessment CON: Patient Education |Addiction |Pain
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8. Which action would the FDA take to expedite drug development and approval for an outbreak of
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smallpox?
g
a. List smallpox as a health orphan disease.
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b. Omit the preclinical research phase. b-g b-g b-g b-g
c. Extend the clinical research phase. b-g b-g b-g b-g
d. Fast track the investigational drug. b-g b-g b-g b-g
ANS: D b- g
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 mean a
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longer time to develop a vaccine. The FDA must ensure that all phases of the preclinical and
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clinical research phase have been completed in a safe manner.
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DIF: Cognitive Level: Knowledge b-g b-g REF: b - g b - g p. 7 b-g OBJ: 5 b-g