TestBankfor
f f
EssentialsofPhar f f
macologyforHealt f f
hProfessions,8thE
f f f
dition,BruceColbe
f f
rt,RuthWoodrow
f f
,CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
f f f f f f
TRUE/FALSE
1. Thefpharmaceuticalfmanufacturerfhasfthefauthorityftofaddfadditionalfactivefin
gredientsftofafpreviouslyfapprovedfpharmaceuticalfproduct.
ANS:f F
Accordingftofthef1938fFederalfFood,fDrug,fandfCosmeticfActfandfAmendmentsfo
ff1951fandf1962,fallflabelsfmustfbefaccuratefandfincludefaflistingfoffallfactivefandfin
activefingredients.
PTS:f 1
2. Drugfstrengthfmayfvaryfwithfeachflotfnumberfoffafmedication.
ANS:f F
Thef1906fPurefFoodfandfDrugfActfestablishedfthatfallfdrugsfmarketedfinfthefUnite
dfStatesfmeetfminimalfstandardsfoffstrength,fpurity,fandfquality.
PTS:f 1
3. ThefPurefFoodfandfDrugfActfoff1906festablishedfdrugfstandardsfandfofficialfdru
gfreferences.
ANS:f T
ThisfactfestablishedfthatfallfdrugsfmarketedfinfthefUnitedfStatesfmeetfminimalfst
andardsfoffstrength,fpurity,fandfquality.f Itfalsofestablishedftwofofficialfreferences
fthatfestablishedfthefstandardsfforfmakingfeachfdrug:f The
U.S.fPharmacopeiaf(USP)fandfthefNationalfFormularyf(NF).
PTS:f 1
4. Thef1906fPurefFoodfandfDrugfActfestablishedfconsumerfprotectionsftofpreve
ntfthefinclusionfoff“dangerousfingredients”fwithoutfthefknowledgefoffthefcons
umer.
ANS:f T
Morphinefisfonefexamplefoffafdangerousfingredientfthatfmayfhavefbeenfincludedf
withoutfthefknowledgefoffthefconsumer.
PTS:f 1
5. Medicationflabelsfneedfonlyfincludeftheftradefnamefoffthefdrug.
ANS:f F
Labelsfmustfincludefaflistingfoffallfactivefandfinactivefingredients,fwarningflabelsf
onfcertainfpreparations,fandfgenericfnamesfforfthefmedication
, PTS:f 1
6. Thefprescriberfoffthefmedicationfisfthefonlyfhealthfcarefprofessionalfwhofisfres
ponsiblefforfbeingfawarefoffnewfmedications,flaws,fandfrestrictions.
ANS:f F
Thefhealthfcarefworkerfinvolvedfinfadministrationfoffafmedicationfalsofbearsfthefr
esponsibilityfoffbeingfawarefofftheflawsfandfrestrictionsfpertinentftofthatfmedicati
on.
PTS:f 1
7. Afdouble-
lockedfsystemfisfthefrecommendedfmethodfforfmaintainingfsecurityfoffcontrolled
fsubstances.
ANS:f T
Afdouble-
lockedfsystemfmayfincludeftwofseparatefkeyfentriesforfanfelectronicfuserfidentific
ationfandfpasswordfaccessfsystem.
PTS:f 1
8. Healthfcarefworkersfarefresponsiblefforfmaintainingfrecordsfoffallfcontrolledfsu
bstancesfreceived,fdispensed,fandfdestroyed.
ANS:f T PTS:f 1
9. Controlledfsubstancefrecordsfareftofbefkeptfforf10fyears.
ANS:f F
Recordsfforfthefpreviousf2fyearsfmustfbefavailablefatfallftimesfforfinspection.fPTS
:f 1
MULTIPLEfCHOICE
1. Identifyfthefdrugfstandardfinftheffollowingflist.
a. Color c. Shape
b. Strength d. Taste
ANS:f B
Feedback
A Colorfisfnotfafstandard.
B Correct!
C Shapefisfnotfafstandard.
D Tastefisfnotfafstandard.
, PTS:f 1
2. Thefriskfoffdeathffromfthefusefoffstreetfdrugsfversusfprescriptionfme
dicationsfisfmostlyfduefto:
a. aflackfoffcontrolfoverfquality,fpurity,fan
dfstrengthfmakesfstreetfdrugsfdanger
ous.
b. thefriskfisfthefsamefforfbothfsourcesfofft
hefsamefsubstance.
c. streetfdrugsfarefapprovedfforfuse.
d. thefneedfforfafprescriptionfmakesfdrug
sfhardftofobtain.
ANS:f A
Feedback
A Correct!
B Theflackfoffenforcementfoffdrugfstand
ardsfinfillegalfstreetfdrugsfposesfafsign
ificantfdangerfforfthefconsumer.
C Thefexactfcompositionfoffafstreetfdrugf
isfunknown,fandfitfmayfcontainfdanger
ousfcontaminantsforfundisclosedfaddi
tionalfdrugs.
D Streetfdrugsfarefillegal.
PTS:f 1
3. Drugfstandardsfregulatefdrugfmanufacturefsofthatfmedicationsfoffthefsamefna
mefwillfbefoffthefsame:
a. strength,f purity,f andf quality.
b. shape,fcolor,fandftaste.
c. purity,fshape,fandfcolor.
d. quality,fcolor,fandfshape.
ANS:f A
Drugfstandardsfstatefthatfallfpreparationsfoffthefsamefdrugfnamefmustfbefoffunifo
rmfstrength,fpurity,fandfquality.
PTS:f 1
4. Thef1906fPurefFoodfandfDrugfActfincludesfwhichfofftheffollowingfprovisions?
a. Regulationfoffdrugsfsoldfinfthe
f f
EssentialsofPhar f f
macologyforHealt f f
hProfessions,8thE
f f f
dition,BruceColbe
f f
rt,RuthWoodrow
f f
,CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
f f f f f f
TRUE/FALSE
1. Thefpharmaceuticalfmanufacturerfhasfthefauthorityftofaddfadditionalfactivefin
gredientsftofafpreviouslyfapprovedfpharmaceuticalfproduct.
ANS:f F
Accordingftofthef1938fFederalfFood,fDrug,fandfCosmeticfActfandfAmendmentsfo
ff1951fandf1962,fallflabelsfmustfbefaccuratefandfincludefaflistingfoffallfactivefandfin
activefingredients.
PTS:f 1
2. Drugfstrengthfmayfvaryfwithfeachflotfnumberfoffafmedication.
ANS:f F
Thef1906fPurefFoodfandfDrugfActfestablishedfthatfallfdrugsfmarketedfinfthefUnite
dfStatesfmeetfminimalfstandardsfoffstrength,fpurity,fandfquality.
PTS:f 1
3. ThefPurefFoodfandfDrugfActfoff1906festablishedfdrugfstandardsfandfofficialfdru
gfreferences.
ANS:f T
ThisfactfestablishedfthatfallfdrugsfmarketedfinfthefUnitedfStatesfmeetfminimalfst
andardsfoffstrength,fpurity,fandfquality.f Itfalsofestablishedftwofofficialfreferences
fthatfestablishedfthefstandardsfforfmakingfeachfdrug:f The
U.S.fPharmacopeiaf(USP)fandfthefNationalfFormularyf(NF).
PTS:f 1
4. Thef1906fPurefFoodfandfDrugfActfestablishedfconsumerfprotectionsftofpreve
ntfthefinclusionfoff“dangerousfingredients”fwithoutfthefknowledgefoffthefcons
umer.
ANS:f T
Morphinefisfonefexamplefoffafdangerousfingredientfthatfmayfhavefbeenfincludedf
withoutfthefknowledgefoffthefconsumer.
PTS:f 1
5. Medicationflabelsfneedfonlyfincludeftheftradefnamefoffthefdrug.
ANS:f F
Labelsfmustfincludefaflistingfoffallfactivefandfinactivefingredients,fwarningflabelsf
onfcertainfpreparations,fandfgenericfnamesfforfthefmedication
, PTS:f 1
6. Thefprescriberfoffthefmedicationfisfthefonlyfhealthfcarefprofessionalfwhofisfres
ponsiblefforfbeingfawarefoffnewfmedications,flaws,fandfrestrictions.
ANS:f F
Thefhealthfcarefworkerfinvolvedfinfadministrationfoffafmedicationfalsofbearsfthefr
esponsibilityfoffbeingfawarefofftheflawsfandfrestrictionsfpertinentftofthatfmedicati
on.
PTS:f 1
7. Afdouble-
lockedfsystemfisfthefrecommendedfmethodfforfmaintainingfsecurityfoffcontrolled
fsubstances.
ANS:f T
Afdouble-
lockedfsystemfmayfincludeftwofseparatefkeyfentriesforfanfelectronicfuserfidentific
ationfandfpasswordfaccessfsystem.
PTS:f 1
8. Healthfcarefworkersfarefresponsiblefforfmaintainingfrecordsfoffallfcontrolledfsu
bstancesfreceived,fdispensed,fandfdestroyed.
ANS:f T PTS:f 1
9. Controlledfsubstancefrecordsfareftofbefkeptfforf10fyears.
ANS:f F
Recordsfforfthefpreviousf2fyearsfmustfbefavailablefatfallftimesfforfinspection.fPTS
:f 1
MULTIPLEfCHOICE
1. Identifyfthefdrugfstandardfinftheffollowingflist.
a. Color c. Shape
b. Strength d. Taste
ANS:f B
Feedback
A Colorfisfnotfafstandard.
B Correct!
C Shapefisfnotfafstandard.
D Tastefisfnotfafstandard.
, PTS:f 1
2. Thefriskfoffdeathffromfthefusefoffstreetfdrugsfversusfprescriptionfme
dicationsfisfmostlyfduefto:
a. aflackfoffcontrolfoverfquality,fpurity,fan
dfstrengthfmakesfstreetfdrugsfdanger
ous.
b. thefriskfisfthefsamefforfbothfsourcesfofft
hefsamefsubstance.
c. streetfdrugsfarefapprovedfforfuse.
d. thefneedfforfafprescriptionfmakesfdrug
sfhardftofobtain.
ANS:f A
Feedback
A Correct!
B Theflackfoffenforcementfoffdrugfstand
ardsfinfillegalfstreetfdrugsfposesfafsign
ificantfdangerfforfthefconsumer.
C Thefexactfcompositionfoffafstreetfdrugf
isfunknown,fandfitfmayfcontainfdanger
ousfcontaminantsforfundisclosedfaddi
tionalfdrugs.
D Streetfdrugsfarefillegal.
PTS:f 1
3. Drugfstandardsfregulatefdrugfmanufacturefsofthatfmedicationsfoffthefsamefna
mefwillfbefoffthefsame:
a. strength,f purity,f andf quality.
b. shape,fcolor,fandftaste.
c. purity,fshape,fandfcolor.
d. quality,fcolor,fandfshape.
ANS:f A
Drugfstandardsfstatefthatfallfpreparationsfoffthefsamefdrugfnamefmustfbefoffunifo
rmfstrength,fpurity,fandfquality.
PTS:f 1
4. Thef1906fPurefFoodfandfDrugfActfincludesfwhichfofftheffollowingfprovisions?
a. Regulationfoffdrugsfsoldfinfthe
