j j j j j j j j j j j
Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Complete
j j j j j j j j
,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:
j j j j j j j j j
Clayton’s Basic Pharmacology for Nurses, 19th Edition
j j j j j j
MULTIPLEjCHOICE
1. WhichjnamejidentifiesjajdrugjlistedjbyjthejUSjFoodjandjDr
ugjAdministrationj(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:j C
Thejofficialjnamejisjthej namejunderjwhichjajdrugjisjlistedjbyjth
ejFDA.jThejbrandjname,jorjtrademark,jisjthejnamejgivenjtojajdr
ugjbyjitsjmanufacturer.jThejnonproprietary,jorjgeneric,jnamejis
jprovidedjbyjthejUnitedjStatesjAdoptedjNamesjCouncil.
DIF: CognitivejLevel:jKnowledge REF:j p.j9
OBJ:j1NAT:jNCLEXjClientjNeedsjCategory:jSafe,jEffectivejCarejE
nvironmentjTOP:j NursingjProcessjStep:jAssessment
CON:j
PatientjEducation
2. Whichjsourcejcontainsjinformationjspecificjtojnutritionaljsupplements?
a. USPjDictionaryjofjUSANj &jInternationaljDrugjNames
b. NaturaljMedicinesjComprehensivejDatabase
c. UnitedjStatesjPharmacopoeia/NationaljFormularyj(USPjNF)
d. DrugjInteractionjFacts
ANS:j C
UnitedjStatesjPharmacopoeia/NationaljFormularyjcontainsjinformationjspecificjtojnutritionaljsu
pplements.jUSPjDictionaryjofjUSANj&jInternationaljDrugjNamesjisjajcompilationjofjdrugjnames
,jpronunciationjguide,jandjpossiblejfuturejFDAjapprovedjdrugs;jitjdoesjnotjincludejnutritionaljsup
plements.jNaturaljMedicinesjComprehensivejDatabasejcontains
evidence-
basedjinformationjonjherbaljmedicinesjandjherbaljcombinationjproducts;jitjdoesjnotjincludejinfor
mationjspecificjtojnutritionaljsupplements.jDrugjInteractionjFactsjcontainsjcomprehensivejinfor
mationjonjdrugjinteractionjfacts;jitjdoesjnotjincludejnutritionaljsupplements.
DIF: CognitivejLevel:jKnowledge REF:j p.j4
OBJ:j3jNAT:j NCLEXjClientjNeedsjCategory:jPhysiologicaljIntegrit
y
TOP:j NursingjProcessjStep:jAssessment CON:j Nutritionj|jPatientjEducation
3. Whichjdrugjreferencejcontainsjdrugjmonographsjthatjdescribejalljdrugsjinjajtherapeuticjclass?
a. DrugjFactsjandjComparisons
,TestjBankjForjClayton’sjBasicjPharmacologyjforjNursesj19thjEdition 3
b. DrugjInteractionjFacts
c. HandbookjonjInjectablejDrugs
d. Martindale—ThejCompletejDrugjReference
ANS:j A
DrugjFactsjandjComparisonsjcontainsjdrugjmonographsjthatjdescribejalljdrugsjinjajthera
peuticjclass.jMonographsjarejformattedjasjtablesjtojallowjcomparisonjofjsimilarjproducts,j
brandjnames,jmanufacturers,jcostjindices,jandjavailablejdosagejformsjOnlinejversionjisja
vailable.
DIF: CognitivejLevel:jKnowledge REF:j p.j4jTablej1.2
OBJ:jjj 3 NAT:j NCLEXjClientjNeedsjCategory:jPhysiologicaljIntegrity
TOP:j NursingjProcessjStep:jAssessment CON:j Safetyj|jPatientjEducationj|jClinicaljJudgment
4. Whichjdrugjreferencejcontainsjmonographsjaboutj virtuallyjeveryjsingle-
entityjdrugjavailablejinjthejUnitedjStatesjandjdescribesjtherapeuticjusesjofjdrugs,jincludingjappro
vedjandjunapprovedjuses?
a. Martindale:jThejCompletejDrugjReference
b. AHFSjDrugjInformation
c. DrugjReference
d. DrugjFactsjandjComparisons
ANS:j B
AHFSjDrugjInformationjcontainsjmonographsjaboutjvirtuallyjeveryjsingle-
entityjdrugjavailablejinjthejUnitedjStatesjandjdescribesjtherapeuticjusesjofjdrugs,jincludingjapprov
edjandjunapprovedjuses.
DIF: CognitivejLevel:jKnowledge REF:j p.j4jTablej1.2
OBJ:jjj 3 NAT:j NCLEXjClientjNeedsjCategory:jPhysiologicaljIntegrity
TOP:j NursingjProcessjStep:jPlanning CON:j Safetyj|jPatientjEducationj|jClinicaljJudgment
5. Whichjonlinejdrugjreferencejmakesjavailablejtojhealthcarejprovidersjandjthejpublicjajstandar
d,jcomprehensive,jup-to-datejlookjupjandjdownloadablejresourcejaboutjmedicines?
a. AmericanjDrugjIndex
b. AmericanjHospitaljFormulary
c. DailyMed
d. DrugjReference
ANS:j C
DailyMedjmakesjavailablejtojhealthcarejprovidersjandjthejpublicjajstandard,jcomprehensive,jup-
to-
datejlookjupjandjdownloadablejresourcejaboutjmedicines.jThejAmericanjDrugjIndexjisjnotjapprop
riatejforjpatientjuse.jThejAmericanjHospitaljFormularyjisjnotjappropriatejforjpatientjuse.jThejdr
ugjreferencej isjnotjappropriatejforjpatientjuse.
DIF: CognitivejLevel:jKnowledge REF:j p.j3j|jp.j4
OBJ:j3jNAT:j NCLEXjClientjNeedsjCategory:jPhysiologicaljIntegrit
y
TOP:j NursingjProcessjStep:jImplementation
CON:j Safetyj|jPatientjEducationj|jClinicaljJudgment
6. WhichjlegislationjauthorizesjthejFDAjtojdeterminejthejsafetyjofjajdrugjbeforejitsjmarketing?
a. FederaljFood,jDrug,jandjCosmeticjActj(1938)
b. DurhamjHumphreyjAmendmentj(1952)
, TestjBankjForjClayton’sjBasicjPharmacologyjforjNursesj19thjEdition 4
c. ControlledjSubstancesjActj(1970)
d. KefauverjHarrisjDrugjAmendmentj(1962)
ANS:j A
ThejFederaljFood,jDrug,jandjCosmeticjActjofj1938jauthorizedjthejFDAjtojdeterminejthejsafetyjofj
alljdrugsjbeforejmarketing.jLaterjamendmentsjandjactsjhelpedjtightenjFDAjcontroljandjensurejdru
gjsafety.jThejDurhamjHumphreyjAmendmentjdefinesjthejkindsjofjdrugsjthatjcannotjbejusedjsafel
yjwithoutjmedicaljsupervisionjandjrestrictsjtheirjsalejtojprescriptionjbyjajlicensedjpractitioner.jThe
jControlledjSubstancesjActjaddressesjonlyjcontrolledjsubstancesjandjtheirjcategorization.jThejKef
auverjHarrisjDrugjAmendmentjensuresjdrugjefficacyjandjgreaterjdrugjsafety.jDrugjmanufacturersj
arejrequiredjtojprovejtojthejFDAjthejeffectivenessjofjtheirjproductsjbeforejmarketingjthem.
DIF: CognitivejLevel:jKnowledge REF:jp.j5jTablejl.3
OBJ:j 5
NAT:jNCLEXjClientjNeedsjCategory:jPhysiologicaljIntegrityjT
OP:j NursingjProcessjStep:jAssessment
CON:j Safetyj|jPatientjEducationj|jEvidencej|jHealthjCarejLaw
7. Whichjclassificationjdoesjmeperidinej(Demerol)jfalljunder?
a. I
b. II
c. III
d. IV
ANS:j B
Meperidinej(Demerol)jisjajSchedulejIIjdrug;jitjhasjajhighjpotentialjforjabusejandjmayjleadjtojsever
ejpsychologicaljandjphysicaljdependence.jSchedulejIjdrugsjhavejhighjpotentialjforjabusejandjnojre
cognizedjmedicaljuse.jSchedulejIIIjdrugsjhavejsomejpotentialjforjabuse.jUsejmayjleadjtojlowjtojm
oderatejphysicaljdependencejorjhighjpsychologicaljdependence.jSchedulejIVjdrugsjhavejlowjpot
entialjforjabuse.jUsejmayjleadjtojlimitedjphysicaljorjpsychologicaljdependence.
DIF: CognitivejLevel:jKnowledge REF:j p.j10
OBJ:j2jNAT:j NCLEXjClientjNeedsjCategory:jSafe,jEffectivejCarejE
nvironment
TOP:j NursingjProcessjStep:jAssessment CON:j PatientjEducationj|jAddictionj|jPain
8. WhichjactionjwouldjthejFDAjtakejtojexpeditejdrugjdevelopmentjandjapprovaljforjanjoutbreakjofjs
mallpox?
a. Listjsmallpoxjasjajhealthjorphanjdisease.
b. Omitjthejpreclinicaljresearchjphase.
c. Extendjthejclinicaljresearchjphase.
d. Fastjtrackjthejinvestigationaljdrug.
ANS:j D
OncejthejInvestigationaljNewjDrugjApplicationjhasjbeenjapproved,jthejdrugjcanjreceivejhighestjp
riorityjwithinjthejagency,jwhichjisjcalledjfastjtracking.jAjsmallpoxjoutbreakjwouldjbecomejajprior
ityjconcernjinjthejworld.jOrphanjdiseasesjarejnotjresearchedjinjajpriorityjmanner.jPreclinicaljresea
rchjisjnotjomitted.jExtendingjanyjphasejofjthejresearchjwouldjmeanjajlongerjtimejtojdevelopjajvacci
ne.jThejFDAjmustjensurejthatjalljphasesjofjthejpreclinicaljandjclinicaljresearchjphasejhavejbeenjco
mpletedjinjajsafejmanner.
DIF: CognitivejLevel:jKnowledge REF:jjjp.j7 OBJ:j 5