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Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:
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Clayton’sBasicPharmacology forNurses,19thEdition
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MULTIPLECHOICE c3
1. Whichnameidentifies adruglisted 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 c 3
The official name is the name under which a drug is listed by the
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FDA. The brand name, or trademark, is the name given to a drug
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by its manufacturer. The nonproprietary, or generic, name is
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provided by the United States Adopted Names Council.
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DIF: CognitiveLevel:Knowledge REF: p. 9 c3 c3 c 3 c3
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care c3 c3 c3 c3 c3 c3 c3 c3
Environment TOP: Nursing Process Step: Assessment
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Patient Education
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2. Whichsourcecontains information specificto nutritional supplements?
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a. USPDictionary of USAN &International Drug Names c3 c3 c3 c3 c3 c3 c3
b. NaturalMedicinesComprehensiveDatabase c3 c3 c3
c. UnitedStatesPharmacopoeia/NationalFormulary (USPNF) c3 c3 c3 c3 c3
d. DrugInteractionFacts c3 c3
ANS: C c 3
UnitedStatesPharmacopoeia/NationalFormularycontainsinformationspecifictonutritional
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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 informationonherbalmedicines andherbal combinationproducts;itdoesnot c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3
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 c3 c3 c 3 c3 c3
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Assessment
c CON: Nutrition |Patient Education
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3. Whichdrugreference contains drugmonographs that describe all drugs ina therapeutic class?
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a. DrugFactsandComparisons c3 c3 c3
TestBank For Clayton’s Basic Pharmacology for Nurses 19th Edition c3 c3 c3 c3 c3 c3 c3 c3 c3
,TestBank For Clayton’s Basic PharmacologyforNurses 19th Edition
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b. DrugInteractionFacts c3 c3
c. Handbookon Injectable Drugs c3 c3 c3
d. Martindale—TheCompleteDrugReference c3 c3 c3
ANS: A c 3
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
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therapeuticclass.Monographsareformattedastablestoallowcomparison 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 c3 c3 c 3 c3 c3 c3
OBJ: 3 NAT: NCLEXClientNeedsCategory:PhysiologicalIntegrity
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TOP: NursingProcess Step: Assessment CON: Safety|Patient Education |Clinical Judgment
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4. Whichdrugreference contains monographs about virtuallyeverysingle-entitydrugavailable 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:TheCompleteDrugReference c3 c3 c3 c3
b. AHFSDrugInformation c3 c3
c. DrugReference c3
d. DrugFactsandComparisons c3 c3 c3
ANS: B c 3
AHFS Drug Information contains monographs about virtually every single-entity drug available
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intheUnitedStatesanddescribes therapeuticusesofdrugs, includingapproved and unapproved
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uses.
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DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 c3 c3 c 3 c3 c3 c3
OBJ: 3 NAT: NCLEXClientNeedsCategory:PhysiologicalIntegrity
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TOP: NursingProcess Step: Planning CON: Safety|Patient Education |Clinical Judgment
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5. Which online drug reference makes available to healthcare providers and the public a standard,
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comprehensive, up-to-datelookupanddownloadableresourceaboutmedicines?
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a. AmericanDrugIndex c3 c3
b. AmericanHospitalFormulary c3 c3
c. DailyMed
d. DrugReference c3
ANS: C c 3
DailyMed makes available tohealthcareproviders and thepublic astandard,comprehensive, up- c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3
to-datelook upanddownloadableresourceabout medicines. TheAmericanDrugIndexis 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 c3 c3 c 3 c3 c3 c3 c3 OBJ:3 c3
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcessStep: Implementation
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CON: Safety|PatientEducation |ClinicalJudgment
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6. Whichlegislation authorizes theFDA to determinethesafetyof adrugbeforeits marketing?
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a. FederalFood,Drug,and CosmeticAct(1938) c3 c3 c3 c3 c3 c3
b. DurhamHumphreyAmendment (1952) c3 c3 c3
TestBank For Clayton’s Basic Pharmacology for Nurses 19th Edition c3 c3 c3 c3 c3 c3 c3 c3 c3 c 3
,TestBank For Clayton’s Basic PharmacologyforNurses 19th Edition
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c. ControlledSubstancesAct(1970) c3 c3 c3
d. KefauverHarrisDrugAmendment(1962) c3 c3 c3 c3
ANS: A c 3
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 ControlledSubstancesActaddressesonlycontrolledsubstances and their
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categorization. The Kefauver Harris Drug Amendment ensures drug efficacyand 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 c3 c3 c 3 c3 c3 c3
OBJ: c 3 5 NAT: NCLEX Client NeedsCategory: Physiological Integrity c3 c3 c3 c3 c3 c3
TOP:
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CON: c Safety|Patient Education|Evidence |Health Care Law
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7. Whichclassification doesmeperidine(Demerol)fall under?
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a. I
b. II
c. III
d. IV
ANS: B c 3
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3
psychological and physical dependence. Schedule Idrugs havehigh potentialforabuse and no
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recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to
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moderate physical dependence or high psychological dependence. Schedule IV drugs have low
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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 c3 c3 c 3 c3 c3
NAT: NCLEX Client NeedsCategory: Safe, EffectiveCare Environment
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TOP: NursingProcess Step: Assessment
c CON: Patient Education |Addiction|Pain
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8. Whichaction would theFDAtaketo expeditedrugdevelopment and approval foran outbreak of
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smallpox?
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a. Listsmallpox asahealth orphandisease. c3 c3 c3 c3 c3 c3
b. Omitthepreclinical researchphase. c3 c3 c3 c3
c. Extendtheclinicalresearchphase. c3 c3 c3 c3
d. Fasttracktheinvestigationaldrug. c3 c3 c3 c3
ANS: D c 3
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. Preclinical
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research is not omitted. Extending any phase of the research would mean alongertimeto develop a
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vaccine.The FDAmust ensurethatall phasesof thepreclinical and clinical research phase have been
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completed in a safe manner.
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DIF: Cognitive Level: Knowledge c3 c3 REF: p. 7 c 3 c 3 c3 OBJ: c 3 5
TestBank For Clayton’s Basic Pharmacology for Nurses 19th Edition c3 c3 c3 c3 c3 c3 c3 c3 c3 c 3
, TestBank For Clayton’s Basic PharmacologyforNurses 19th Edition
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NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
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TOP: Nursing Process Step: Assessment
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CON: HealthCareLaw|Health Care Policy|Infection |Care Coordination
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9. Whichstatement is trueabout over-the-counter(OTC) drugs? c3 c3 c3 c3 c3 c3 c3
a. Theyare not listed in theUSPNF. c3 c3 c3 c3 c3 c3 c3
b. Aprescription froma healthcareprovideris needed.
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c. Theyaresold without aprescription. c3 c3 c3 c3 c3
d. Theyare known onlybytheir brand names. c3 c3 c3 c3 c3 c3 c3
ANS: C c 3
OTC medications do not require a prescription. A variety of names, both generic and trade, canbe
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used forindividualdrugs sold OTC. OTC drugs arelisted inthe USP NF. Prescription drugs require
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an order by a health professional who is licensed to prescribe, such as a physician, nurse
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practitioner, physician assistant, or dentist.
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DIF: Cognitive Level: Comprehension REF: p. 2 OBJ:2 c3 c3 c 3 c3 c3
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Planning c CON: PatientEducation
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10. Whichisthemost authoritativereference formedications thatareinjected?
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a. Martindale:TheComplete c3 c3
b. Handbookon Injectable Drugs c3 c3 c3
c. DailyMed
d. Handbookof Nonprescription Drugs c3 c3 c3
ANS: B c 3
The Handbook on Injectable Drugs is the most comprehensive reference available on the topicof
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compatibilityofinjectabledrugs. It isacollection ofmonographs formorethan 300 injectable drugs
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that are listed alphabetically by generic name.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ:3 c3 c3 c 3 c3 c3
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Assessmentc CON: ClinicalJudgment |Safety
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11. Whichstatement istrueabout Lomotil? c3 c3 c3 c3 c3
a. Abusepotential forthis drugis low. c3 c3 c3 c3 c3 c3
b. Psychologicaldependencyislikely. c3 c3 c3
c. Thereis ahigh potential forabuse. c3 c3 c3 c3 c3 c3
d. This drugis not acontrolled substance. c3 c3 c3 c3 c3 c3
ANS: A c 3
Lomotil, a Schedule V drug, has an abuse potential of limited physical or psychological c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3 c3
dependenceliabilitycompared with drugs inSchedule IV. Because abusepotential islowwith a
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Schedule Vdrug, a prescription maynot be required. Psychological dependencyis not likely with a
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Schedule V drug. Schedule V drugs are classified as controlled substances.
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DIF: Cognitive Level: Knowledge REF: p. 5 Box 1.1 OBJ:2 c3 c3 c 3 c3 c3 c3 c3
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcess Step: Assessmentc CON: ClinicalJudgment |Safety|Patient Education
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