,TestBank iFor iiClayton’s iiBasicP
i harmacology iiforNurses1
i 9thEdition 3
b. DrugInteraction iiFacts
c. Handbook iioniInjectable i i Drugs
d. Martindale—TheCompleteiDrugiReference
ANS: ii i i A
Drug iiFacts iiand iiComparisons iicontains iidrug iimonographs iithat iidescribe iiall
ii drugs ii in ii a iit i i herapeutic iclass. iiMonographs iiare iiformatted ii as itables ito
iiallow ii comparison ii ofsimilarpr i i oducts, iibrand ii names, iimanufacturers,
iicost ii indices, ii and iiavailable iidosage iiforms iiOnline i i version iiis iiavailable.
DIF: ii ii ii ii Cognitive Level:Knowledge
l. REF: ii ii ii i i p. i i 4 iiTablei1.2
OBJ: ii ii ii ii 3 NAT: ii ii ii i i NCLEX iiClient iiNeeds iiCategory:PhysiologicalIntegrity
TOP: ii ii ii ii Nursing iiProcess iiStep: iiAssessment ii ii ii i i CON: ii ii ii i i Safety|Patient i i Education i|Clinical
iJudgment
4. Which idrug iireference iicontains imonographs iiabout iivirtuallyeverysingle-
entitydrug iiavailable iiinitheiUnitediStates iandidescribestherapeuticiuses of drugs,
iincluding a i i pproved iiand iiunapproved iiuses?
a. Martindale: iiThe CompleteiDrug iiReference l.
b. AHFSDrugiInformation
c. Drug Reference
l.
d. Drug Factsand Comparisons
l. l.
ANS: ii i i B
AHFS iiDrug iiInformation iicontains iimonographs iiabout iivirtuallyieveryisingle-
entitydrugiavailable iiinthe UnitedStatesand describes therapeuticusesof drugs,
l. l. l. l.
ii includingap i i proved iiand iiunapproved iiuses.
DIF: ii ii ii ii Cognitive Level:Knowledge
l. REF: ii ii ii i i p. i i 4 iiTablei1.2
OBJ: ii ii ii ii 3 NAT: ii ii ii i i NCLEX iiClient iiNeeds Category: PhysiologicalIntegrity l. l.
TOP: ii ii ii i i Nursing Process iiStep: iiPlanning ii ii ii ii ii ii ii ii i i CON: ii ii ii
l. i i Safety|Patient
i i Education |ClinicaliJudgment
5. Whichionlineidrug ireference iimakes iiavailable iito iihealthcare iiproviders iiand iithe
public iia ista i i ndard, iicomprehensive, iiup-to-datelook up and downloadable
i
resource iiabout iimedicines?
ii
a. AmericanDrugIndex
b. American HospitaliFormulary l.
c. DailyMed
d. DrugReference
ANS: i i C
DailyMed imakesiavailableito iihealthcareproviders iandithe publicia standard, l. l.
icomprehensive, i i up-to-
date look up and downloadable resourceaboutimedicines.iTheAmericanDrugIndexis
l. l. l. l. l.
iinot iiap i i propriate iifor ipatient iiuse. iiTheiAmericaniHospital iFormularyiis inot
iiappropriate iifor iipatient iius
e. iiThe iidrug ireference i i is i i not i i appropriate ii forpatient i i use.
DIF: ii ii ii ii CognitiveLevel:Knowledge REF: ii ii ii i i p. ii3 i i |p. i i 4 l.
OBJ:3 ii NAT: ii i i NCLEXClient Needs iiCategory:Physiological Inte l. l.
grity
TOP: i i Nursing iiProcess Step:Implementation l.
CON: Safety|Patient iiEducation | Clinical Judgment l. l. l.
6. Which legislationiauthorizes theFDA to iideterminethesafetyofa drug beforeits imarketing?
l. l. l. l. l.
a. Federal Food,Drug, and Cosmetic Acti(1938)
l. l. l. l.
dr.j
,TestBank iFor iiClayton’s iiBasicP
i harmacology iiforNurses1
i 9thEdition 4
b. Durham HumphreyAmendment ii(1952)
l.
dr.j
, TestBank iFor iiClayton’s iiBasicP
i harmacology iiforNurses1
i 9thEdition 5
c. ControllediSubstances iiAct ii(1970)
d. KefauverHarrisDrug iiAmendment i(1962)
ANS: ii i i A
The iiFederal iiFood, iiDrug, iiand iiCosmetic iiAct iiof ii1938 iiauthorized iithe iiFDA iito iidetermine
iithe iisaf i i ety iiof iiall iidrugs iibefore iimarketing. iiLater iiamendments iiand iiacts iihelped
iitighten iiFDA iicontrol iian iid i i ensure iidrug isafety. iiThe iiDurham iiHumphrey
iAmendment iidefines iithe iikinds iiof iidrugs iithat iican iinot i i be iiused iisafely iwithout
iimedical iisupervision iiand iirestricts iitheir iisale iito iiprescription iby iia iilic iiensed
i i practitioner.TheControlledSubstancesAct addressesonlycontrolled substancesand l. l.
iith iieir i i categorization. iiThe iiKefauveriHarrisiDrugiAmendment
iiensuresdrugefficacyand igreaterdr iiug i i safety. iiDrug iimanufacturers iiare iirequired iito
iiprove iito iithe iiFDA iithe iieffectiveness iiof iitheir iipro i i ducts iibefore iimarketing it hem.
DIF: Cognitive Level:Knowledge l. REF: iip.
i i 5Table l.3 i i OBJ:
l. 5
NAT:iNCLEX iClient iiNeedsiCategory:iPhysiological
iIntegrit i i yTOP: ii ii iiNursing iiProcess iiStep: iiAssessment
CON: Safety|Patient i i Education |Evidence ii| Health iiCareiLaw l. l.
7. Which classification doesmeperidine(Demerol) iifall under?
l. l. l.
a. I
b. II
c. III
d. IV
ANS: ii i i B
Meperidinei(Demerol)iis iia iiSchedule iiIIidrug;iitihasia highipotentialiforiabuseiand l.
im aylead ito i i severe psychological and physical dependence.ScheduleiI
l. l. l. l.
iidrugshavehigh potential for abuse l. i i and iino iirecognized iimedical iiuse. iiSchedule
l. l.
iiIII iidrugs iihave iisome iipotential iifor iiabuse. iiUse iimay iil i i ead iito iilow iito iimoderate
iiphysical iidependence iior iihigh iipsychological iidependence. iiSchedule iiIV i i drugs
iihave iilow iipotential iifor iiabuse. iiUse iimay iilead iito iilimited iiphysical iior iipsychological
iidepen i i dence.
DIF: CognitiveLevel:Knowledge REF: p. ii10
OBJ:i2 ii NAT: ii i i NCLEX Client l.
iNeeds Category:Safe,Effective Car
l. i i e Environment l. l.
TOP: Nursing ProcessiStep: iiAssessment CON: Patient i i Education ii|Addiction|Pain
l.
8. Which action would the FDA take toexpedite drug development and approval foran out
l. l. l. l. l. l. l. l. l. l. l. l.
break of
i i smallpox?
a. List smallpoxias a health orphan iidisease.
l. l. l. l.
b. Omit ithe iipreclinical research phase. l. l.
c. Extendtheclinical iiresearch phase. l.
d. Fast iitrack the iiinvestigational drug.
l. l.
ANS: i i D
Once ii the ii Investigational i i New iiDrug iiApplication ii has iibeen ii approved, ii the ii drug
ii can ii receive ii hig i i hest iipriority iiwithin iithe iiagency, iiwhich ii is iicalled ii fast
iitracking. ii A iismallpox iioutbreak ii would iibec i i ome iia iipriority iiconcern iiin iithe
ii world. iiOrphan iidiseases iiare iinot iiresearched ii in iia iipriority iimanner. i i Preclinical
iiresearch ii is ii not ii omitted. ii Extending iiany ii phase ii of ii the ii research ii would ii mean
ii a longer i i time ito iidevelop i i a ivaccine. iiThe iiFDA imust iiensure ithat ii all iphases iiof
ithe iipreclinicaliand clinical iire i i search iiphase iihave iibeen iicompleted iiin iia iisafe iimanner.
yi
dr.j
i harmacology iiforNurses1
i 9thEdition 3
b. DrugInteraction iiFacts
c. Handbook iioniInjectable i i Drugs
d. Martindale—TheCompleteiDrugiReference
ANS: ii i i A
Drug iiFacts iiand iiComparisons iicontains iidrug iimonographs iithat iidescribe iiall
ii drugs ii in ii a iit i i herapeutic iclass. iiMonographs iiare iiformatted ii as itables ito
iiallow ii comparison ii ofsimilarpr i i oducts, iibrand ii names, iimanufacturers,
iicost ii indices, ii and iiavailable iidosage iiforms iiOnline i i version iiis iiavailable.
DIF: ii ii ii ii Cognitive Level:Knowledge
l. REF: ii ii ii i i p. i i 4 iiTablei1.2
OBJ: ii ii ii ii 3 NAT: ii ii ii i i NCLEX iiClient iiNeeds iiCategory:PhysiologicalIntegrity
TOP: ii ii ii ii Nursing iiProcess iiStep: iiAssessment ii ii ii i i CON: ii ii ii i i Safety|Patient i i Education i|Clinical
iJudgment
4. Which idrug iireference iicontains imonographs iiabout iivirtuallyeverysingle-
entitydrug iiavailable iiinitheiUnitediStates iandidescribestherapeuticiuses of drugs,
iincluding a i i pproved iiand iiunapproved iiuses?
a. Martindale: iiThe CompleteiDrug iiReference l.
b. AHFSDrugiInformation
c. Drug Reference
l.
d. Drug Factsand Comparisons
l. l.
ANS: ii i i B
AHFS iiDrug iiInformation iicontains iimonographs iiabout iivirtuallyieveryisingle-
entitydrugiavailable iiinthe UnitedStatesand describes therapeuticusesof drugs,
l. l. l. l.
ii includingap i i proved iiand iiunapproved iiuses.
DIF: ii ii ii ii Cognitive Level:Knowledge
l. REF: ii ii ii i i p. i i 4 iiTablei1.2
OBJ: ii ii ii ii 3 NAT: ii ii ii i i NCLEX iiClient iiNeeds Category: PhysiologicalIntegrity l. l.
TOP: ii ii ii i i Nursing Process iiStep: iiPlanning ii ii ii ii ii ii ii ii i i CON: ii ii ii
l. i i Safety|Patient
i i Education |ClinicaliJudgment
5. Whichionlineidrug ireference iimakes iiavailable iito iihealthcare iiproviders iiand iithe
public iia ista i i ndard, iicomprehensive, iiup-to-datelook up and downloadable
i
resource iiabout iimedicines?
ii
a. AmericanDrugIndex
b. American HospitaliFormulary l.
c. DailyMed
d. DrugReference
ANS: i i C
DailyMed imakesiavailableito iihealthcareproviders iandithe publicia standard, l. l.
icomprehensive, i i up-to-
date look up and downloadable resourceaboutimedicines.iTheAmericanDrugIndexis
l. l. l. l. l.
iinot iiap i i propriate iifor ipatient iiuse. iiTheiAmericaniHospital iFormularyiis inot
iiappropriate iifor iipatient iius
e. iiThe iidrug ireference i i is i i not i i appropriate ii forpatient i i use.
DIF: ii ii ii ii CognitiveLevel:Knowledge REF: ii ii ii i i p. ii3 i i |p. i i 4 l.
OBJ:3 ii NAT: ii i i NCLEXClient Needs iiCategory:Physiological Inte l. l.
grity
TOP: i i Nursing iiProcess Step:Implementation l.
CON: Safety|Patient iiEducation | Clinical Judgment l. l. l.
6. Which legislationiauthorizes theFDA to iideterminethesafetyofa drug beforeits imarketing?
l. l. l. l. l.
a. Federal Food,Drug, and Cosmetic Acti(1938)
l. l. l. l.
dr.j
,TestBank iFor iiClayton’s iiBasicP
i harmacology iiforNurses1
i 9thEdition 4
b. Durham HumphreyAmendment ii(1952)
l.
dr.j
, TestBank iFor iiClayton’s iiBasicP
i harmacology iiforNurses1
i 9thEdition 5
c. ControllediSubstances iiAct ii(1970)
d. KefauverHarrisDrug iiAmendment i(1962)
ANS: ii i i A
The iiFederal iiFood, iiDrug, iiand iiCosmetic iiAct iiof ii1938 iiauthorized iithe iiFDA iito iidetermine
iithe iisaf i i ety iiof iiall iidrugs iibefore iimarketing. iiLater iiamendments iiand iiacts iihelped
iitighten iiFDA iicontrol iian iid i i ensure iidrug isafety. iiThe iiDurham iiHumphrey
iAmendment iidefines iithe iikinds iiof iidrugs iithat iican iinot i i be iiused iisafely iwithout
iimedical iisupervision iiand iirestricts iitheir iisale iito iiprescription iby iia iilic iiensed
i i practitioner.TheControlledSubstancesAct addressesonlycontrolled substancesand l. l.
iith iieir i i categorization. iiThe iiKefauveriHarrisiDrugiAmendment
iiensuresdrugefficacyand igreaterdr iiug i i safety. iiDrug iimanufacturers iiare iirequired iito
iiprove iito iithe iiFDA iithe iieffectiveness iiof iitheir iipro i i ducts iibefore iimarketing it hem.
DIF: Cognitive Level:Knowledge l. REF: iip.
i i 5Table l.3 i i OBJ:
l. 5
NAT:iNCLEX iClient iiNeedsiCategory:iPhysiological
iIntegrit i i yTOP: ii ii iiNursing iiProcess iiStep: iiAssessment
CON: Safety|Patient i i Education |Evidence ii| Health iiCareiLaw l. l.
7. Which classification doesmeperidine(Demerol) iifall under?
l. l. l.
a. I
b. II
c. III
d. IV
ANS: ii i i B
Meperidinei(Demerol)iis iia iiSchedule iiIIidrug;iitihasia highipotentialiforiabuseiand l.
im aylead ito i i severe psychological and physical dependence.ScheduleiI
l. l. l. l.
iidrugshavehigh potential for abuse l. i i and iino iirecognized iimedical iiuse. iiSchedule
l. l.
iiIII iidrugs iihave iisome iipotential iifor iiabuse. iiUse iimay iil i i ead iito iilow iito iimoderate
iiphysical iidependence iior iihigh iipsychological iidependence. iiSchedule iiIV i i drugs
iihave iilow iipotential iifor iiabuse. iiUse iimay iilead iito iilimited iiphysical iior iipsychological
iidepen i i dence.
DIF: CognitiveLevel:Knowledge REF: p. ii10
OBJ:i2 ii NAT: ii i i NCLEX Client l.
iNeeds Category:Safe,Effective Car
l. i i e Environment l. l.
TOP: Nursing ProcessiStep: iiAssessment CON: Patient i i Education ii|Addiction|Pain
l.
8. Which action would the FDA take toexpedite drug development and approval foran out
l. l. l. l. l. l. l. l. l. l. l. l.
break of
i i smallpox?
a. List smallpoxias a health orphan iidisease.
l. l. l. l.
b. Omit ithe iipreclinical research phase. l. l.
c. Extendtheclinical iiresearch phase. l.
d. Fast iitrack the iiinvestigational drug.
l. l.
ANS: i i D
Once ii the ii Investigational i i New iiDrug iiApplication ii has iibeen ii approved, ii the ii drug
ii can ii receive ii hig i i hest iipriority iiwithin iithe iiagency, iiwhich ii is iicalled ii fast
iitracking. ii A iismallpox iioutbreak ii would iibec i i ome iia iipriority iiconcern iiin iithe
ii world. iiOrphan iidiseases iiare iinot iiresearched ii in iia iipriority iimanner. i i Preclinical
iiresearch ii is ii not ii omitted. ii Extending iiany ii phase ii of ii the ii research ii would ii mean
ii a longer i i time ito iidevelop i i a ivaccine. iiThe iiFDA imust iiensure ithat ii all iphases iiof
ithe iipreclinicaliand clinical iire i i search iiphase iihave iibeen iicompleted iiin iia iisafe iimanner.
yi
dr.j
