By Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton
Complete
,Chapter 01: Drug Definitions, Standards, and Information Sources
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Willihnganz:Clayton’sBasicPharmacology forNurses,19thEdition
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MULTIPLECHOICE i
1. Whichname identifies a druglisted bythe US Food and
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Drug Administration (FDA)?
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a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C i
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,
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name is provided by the United States Adopted Names
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Council.
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DIF: Cognitive Level: Knowledge REF: p. 9 i i i i
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care i i i i i i i i
Environment TOP: Nursing Process Step: Assessment
i CON: i i i i i
Patient Education
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2. Whichsourcecontains information specific to nutritional supplements?
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a. USPDictionary of USAN &International Drug Namesi i i i i i i
b. Natural Medicines Comprehensive Database i i i
c. UnitedStatesPharmacopoeia/National Formulary (USPNF) i i i i i
d. DrugInteraction Facts i i
ANS: C i
UnitedStatesPharmacopoeia/National Formulary contains information specificto 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 onherbal medicines and herbal combination products; it doesnot i i i i i i i i i i i
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 supplements.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ:3 i i i i i
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Assessment
i CON: Nutrition |Patient Education i i i i i i i
3. Whichdrug reference contains drug monographs that describe all drugs in a therapeutic class?
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a. Drug Facts and Comparisons i i i
,Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
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b. DrugInteraction Facts i i
c. Handbook on Injectable Drugs i i i
d. Martindale—TheComplete Drug Reference i i i
ANS: A i
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
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therapeutic class. Monographs are formatted astablesto allow comparison ofsimilar
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products, brand names, manufacturers, cost indices, and available dosage forms Online
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version is available.
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DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 i i i i i i
OBJ: 3 i NAT: NCLEXClient NeedsCategory:Physiological Integrity
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TOP: NursingProcess Step: Assessment
i CON: Safety|Patient Education |Clinical Judgment i i i i i i i i i i
4. Whichdrugreference contains monographs about virtuallyeverysingle-entitydrug available in
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the United States and describes therapeutic uses of drugs, including approved and unapproved
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uses?
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a. Martindale:TheComplete DrugReference i i i i
b. AHFSDrug Information i i
c. DrugReference i
d. DrugFacts and Comparisons i i i
ANS: B i
AHFS Drug Information contains monographs about virtually every single-entity drug available
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in the United States and describes therapeuticuses ofdrugs, including approved and unapproved
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uses.
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DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 i i i i i i
OBJ: 3 i NAT: NCLEXClient NeedsCategory:Physiological Integrity
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TOP: NursingProcess Step: Planning
i CON: Safety|Patient Education |Clinical Judgment i i i i i i i i i i
5. Which online drug reference makes available to healthcare providers and the public a
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standard, comprehensive, up-to-datelook upanddownloadable resource about medicines?
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a. AmericanDrug Index i i
b. AmericanHospital Formulary i i
c. DailyMed
d. DrugReference i
ANS: C i
DailyMed makes available to healthcare providers and the public astandard, comprehensive, up-
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to-datelook up and downloadable resource about medicines. The American Drug Indexis not
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appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
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The drug reference is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 i i i i i i i OBJ:3 i
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Implementation
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CON: Safety |Patient Education |ClinicalJudgment
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6. Which legislation authorizes the FDA to determine the safetyofadrug before its marketing?
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a. FederalFood, Drug, and Cosmetic Act (1938) i i i i i i
b. DurhamHumphreyAmendment (1952) i i i
, Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
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c. ControlledSubstances Act (1970) i i i
d. KefauverHarrisDrugAmendment (1962) i i i i
ANS: A i
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of
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all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure
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drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used
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safely without medical supervision and restricts their sale to prescription by a licensed
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practitioner. The Controlled Substances Act addresses onlycontrolled substances and their
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categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug
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safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products
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before marketing them.
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DIF: Cognitive Level: Knowledge REF: p. 5Table l.3 i i i i i i
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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7. Whichclassificationdoes meperidine (Demerol) fallunder?
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a. I
b. II
c. III
d. IV
ANS: B i
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to
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severepsychological and physical dependence. Schedule Idrugs have high potential forabuse and
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no recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to
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low to moderate physical dependence or high psychological dependence. Schedule IV drugs have
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low potential for abuse. Use may lead to limited physical or psychological dependence.
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DIF: Cognitive Level: Knowledge REF: p. 10 OBJ:2 i i i i i
NAT: NCLEX Client Needs Category: Safe, Effective CareEnvironment
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TOP: NursingProcess Step: Assessment
i CON: Patient Education |Addiction |Pain i i i i i i i i i
8. Which action would the FDAtake to expedite drugdevelopment and approval for an outbreak of
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smallpox?
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a. List smallpox as a health orphandisease. i i i i i i
b. Omit thepreclinical researchphase. i i i i
c. Extendthe clinicalresearchphase. i i i i
d. Fasttrackthe investigationaldrug. i i i i
ANS: D i
Once the Investigational New Drug Application has been approved, the drug can receive highest
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priority within the agency, which is called fast tracking. A smallpox outbreak would become a
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priority concern in the world. Orphan diseases are not researched in a priority manner.
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Preclinical research is not omitted. Extending any phase of the research would mean alonger time
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to develop avaccine. The FDAmust ensurethat all phases of the preclinical and clinical research
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phase have been completed in a safe manner.
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DIF: Cognitive Level: Knowledge i i REF: p. 7 i i i OBJ: 5 i