Test Bank for
m m
Essentials of Phar m m
macology for Healt m m
h Professions, 8th E
m m m
dition, Bruce Colbe
m m
rt, Ruth Woodrow
m m
,CHAPTERm1:m CONSUMERmSAFETYmAND mDRUG mREGULATIONS
TRUE/FALSE
1. Thempharmaceuticalmmanufacturer mhas mthemauthority mtomaddmadditionalmacti
vemingredients mtomampreviously m approved mpharmaceuticalmproduct.
ANS:m F
Accordingmtomthem1938mFederalm Food,mDrug,mandmCosmetic mActmandmAmend
ments mofm1951mandm1962,mallm labels mmustmbemaccuratemand mincludemam listingm
ofmallmactivemandm inactivem ingredients.
PTS:m 1
2. Drugmstrengthmmay mvary mwithmeachmlotmnumbermofmammedication.
ANS:m F
Them1906mPuremFood mand mDrugmActmestablishedmthatmallmdrugs mmarketedmin mth
emUnitedmStates mmeetmminimalmstandards mofmstrength,mpurity,mandmquality.
PTS:m 1
3. ThemPuremFoodmandmDrugmActmofm1906mestablishedmdrugmstandards mand moffi
cialmdrugmreferences.
ANS:m T
This mactmestablishedmthatmallm drugs mmarketedminmthemUnitedm States mmeetmmin
imalmstandards mofmstrength,mpurity,mandmquality.m Itmalsom establishedmtwomoffici
almreferences mthatmestablishedmthe mstandards mformmakingmeach mdrug:m The
U.S.mPharm acopeiam(USP)m andmthem National m Form ulary m (NF).
PTS:m 1
4. Them1906mPuremFoodm and mDrugmActmestablishedmconsumermprotections mto
mprevent mtheminclusionm of m“dangerous mingredients” mwithout mthemknowledge
mof mthemconsumer.
ANS:m T
Morphinemis monemexample mof ma mdangerous mingredientmthatmmaymhavembeenm in
cludedmwithoutmthemknowledgem ofmthe mconsumer.
PTS:m 1
5. Medicationmlabels mneedm only mincludemthemtrademnamemof mthemdrug.
ANS:m F
Labels mmustmincludemamlistingm ofmallmactivemandm inactivemingredients, mwarning m
labels monmcertainmpreparations, mandm generic mnamesmformthemmedication
, PTS:m 1
6. Themprescribermofmthemmedication mis mthe monly mhealth mcaremprofessionalmwh
omismresponsiblemformbeing mawaremofm new mmedications,m laws,mandmrestricti
ons.
ANS:m F
Themhealthmcaremworkerminvolved minm administrationmofm ammedicationm alsombea
rs mthemresponsibility mofmbeing mawarem ofmthe mlaws mandmrestrictions mpertinentmto
mthat mmedication.
PTS:m 1
7. Amdouble-
lockedmsystem mismthemrecommendedmmethodmformmaintaining msecurity mofmcont
rolledmsubstances.
ANS:m T
Amdouble-
lockedmsystem mmay mincludemtwomseparatemkey mentries morman melectronic muserm i
dentificationmandm passwordmaccess msystem.
PTS:m 1
8. Healthmcaremworkers maremresponsiblemformmaintainingmrecords mof mallmcontroll
edmsubstances mreceived,mdispensed,mand mdestroyed.
ANS:m T PTS:m 1
9. Controlledmsubstancemrecords maremtombe mkeptmform10 myears.
ANS:m F
Records mformthemprevious m2myears mmustmbemavailablematmallmtimes mforminspecti
on.mPTS:m 1
MULTIPLEmCHOICE
1. Identify mthemdrugmstandardminmthe mfollowingm list.
a. Color c. Shape
b. Strength d. Taste
ANS:m B
Feedback
A Colormismnotmamstandard.
B Correct!
C Shapemismnotmamstandard.
D Tastemismnotmamstandard.
, PTS:m 1
2. Themrisk mofmdeathmfrom mthemusemofmstreetmdrugsmversus mprescripti
onmmedicationsmismmostly mduemto:
a. amlack mofmcontrolmovermquality,mpurity,
mandmstrengthmmakes mstreet mdrugs md
angerous.
b. themrisk mis mthemsamemformboth msource
smofmthemsamemsubstance.
c. streetmdrugs maremapprovedmformuse.
d. themneedmformamprescriptionmmakes md
rugs mhardmtomobtain.
ANS:m A
Feedback
A Correct!
B Themlack mofmenforcementmofmdrugmsta
ndards minmillegalmstreetmdrugs mposes m
amsignificantmdangermformthemconsum
er.
C Themexactmcompositionmofmamstreetmd
rugmismunknown,mandmitmmay mcontainm
dangerous mcontaminants mormundiscl
osedmadditionalmdrugs.
D Streetmdrugs maremillegal.
PTS:m 1
3. Drugmstandards mregulatemdrugmmanufacturemsomthatmmedications mofmthemsa
memnamemwillmbemofmthemsame:
a. strength,mpurity,mandmquality.
b. shape,mcolor,mandmtaste.
c. purity,mshape,mandmcolor.
d. quality,mcolor,mandmshape.
ANS:m A
Drugmstandards mstatemthatmallmpreparations mofmthemsamemdrugmnamemmustmbe
mof muniform mstrength, mpurity, mandmquality.
PTS:m 1
4. Them1906mPuremFood mandmDrugmActmincludes mwhich mofmthe mfollowingmprovision
s?
m m
Essentials of Phar m m
macology for Healt m m
h Professions, 8th E
m m m
dition, Bruce Colbe
m m
rt, Ruth Woodrow
m m
,CHAPTERm1:m CONSUMERmSAFETYmAND mDRUG mREGULATIONS
TRUE/FALSE
1. Thempharmaceuticalmmanufacturer mhas mthemauthority mtomaddmadditionalmacti
vemingredients mtomampreviously m approved mpharmaceuticalmproduct.
ANS:m F
Accordingmtomthem1938mFederalm Food,mDrug,mandmCosmetic mActmandmAmend
ments mofm1951mandm1962,mallm labels mmustmbemaccuratemand mincludemam listingm
ofmallmactivemandm inactivem ingredients.
PTS:m 1
2. Drugmstrengthmmay mvary mwithmeachmlotmnumbermofmammedication.
ANS:m F
Them1906mPuremFood mand mDrugmActmestablishedmthatmallmdrugs mmarketedmin mth
emUnitedmStates mmeetmminimalmstandards mofmstrength,mpurity,mandmquality.
PTS:m 1
3. ThemPuremFoodmandmDrugmActmofm1906mestablishedmdrugmstandards mand moffi
cialmdrugmreferences.
ANS:m T
This mactmestablishedmthatmallm drugs mmarketedminmthemUnitedm States mmeetmmin
imalmstandards mofmstrength,mpurity,mandmquality.m Itmalsom establishedmtwomoffici
almreferences mthatmestablishedmthe mstandards mformmakingmeach mdrug:m The
U.S.mPharm acopeiam(USP)m andmthem National m Form ulary m (NF).
PTS:m 1
4. Them1906mPuremFoodm and mDrugmActmestablishedmconsumermprotections mto
mprevent mtheminclusionm of m“dangerous mingredients” mwithout mthemknowledge
mof mthemconsumer.
ANS:m T
Morphinemis monemexample mof ma mdangerous mingredientmthatmmaymhavembeenm in
cludedmwithoutmthemknowledgem ofmthe mconsumer.
PTS:m 1
5. Medicationmlabels mneedm only mincludemthemtrademnamemof mthemdrug.
ANS:m F
Labels mmustmincludemamlistingm ofmallmactivemandm inactivemingredients, mwarning m
labels monmcertainmpreparations, mandm generic mnamesmformthemmedication
, PTS:m 1
6. Themprescribermofmthemmedication mis mthe monly mhealth mcaremprofessionalmwh
omismresponsiblemformbeing mawaremofm new mmedications,m laws,mandmrestricti
ons.
ANS:m F
Themhealthmcaremworkerminvolved minm administrationmofm ammedicationm alsombea
rs mthemresponsibility mofmbeing mawarem ofmthe mlaws mandmrestrictions mpertinentmto
mthat mmedication.
PTS:m 1
7. Amdouble-
lockedmsystem mismthemrecommendedmmethodmformmaintaining msecurity mofmcont
rolledmsubstances.
ANS:m T
Amdouble-
lockedmsystem mmay mincludemtwomseparatemkey mentries morman melectronic muserm i
dentificationmandm passwordmaccess msystem.
PTS:m 1
8. Healthmcaremworkers maremresponsiblemformmaintainingmrecords mof mallmcontroll
edmsubstances mreceived,mdispensed,mand mdestroyed.
ANS:m T PTS:m 1
9. Controlledmsubstancemrecords maremtombe mkeptmform10 myears.
ANS:m F
Records mformthemprevious m2myears mmustmbemavailablematmallmtimes mforminspecti
on.mPTS:m 1
MULTIPLEmCHOICE
1. Identify mthemdrugmstandardminmthe mfollowingm list.
a. Color c. Shape
b. Strength d. Taste
ANS:m B
Feedback
A Colormismnotmamstandard.
B Correct!
C Shapemismnotmamstandard.
D Tastemismnotmamstandard.
, PTS:m 1
2. Themrisk mofmdeathmfrom mthemusemofmstreetmdrugsmversus mprescripti
onmmedicationsmismmostly mduemto:
a. amlack mofmcontrolmovermquality,mpurity,
mandmstrengthmmakes mstreet mdrugs md
angerous.
b. themrisk mis mthemsamemformboth msource
smofmthemsamemsubstance.
c. streetmdrugs maremapprovedmformuse.
d. themneedmformamprescriptionmmakes md
rugs mhardmtomobtain.
ANS:m A
Feedback
A Correct!
B Themlack mofmenforcementmofmdrugmsta
ndards minmillegalmstreetmdrugs mposes m
amsignificantmdangermformthemconsum
er.
C Themexactmcompositionmofmamstreetmd
rugmismunknown,mandmitmmay mcontainm
dangerous mcontaminants mormundiscl
osedmadditionalmdrugs.
D Streetmdrugs maremillegal.
PTS:m 1
3. Drugmstandards mregulatemdrugmmanufacturemsomthatmmedications mofmthemsa
memnamemwillmbemofmthemsame:
a. strength,mpurity,mandmquality.
b. shape,mcolor,mandmtaste.
c. purity,mshape,mandmcolor.
d. quality,mcolor,mandmshape.
ANS:m A
Drugmstandards mstatemthatmallmpreparations mofmthemsamemdrugmnamemmustmbe
mof muniform mstrength, mpurity, mandmquality.
PTS:m 1
4. Them1906mPuremFood mandmDrugmActmincludes mwhich mofmthe mfollowingmprovision
s?
