Lehne's91Pharmacology91for91Nursing91Care9110th91Edition91T
EST91BANK(Chapter911-110).
Chapter913:91Drug91Regulation,91Development,91Names,91and91Inform
ation91Test91Bank
MULTIPLE91CHOICE
1. A91nurse91educator91is91conducting91a91continuing91education91class91on91pharmacology.91T
o91evaluate91the91learning91of91the91nurses91in91the91class,91the91nurse91educator91asks,91
―Which91drug91name91is91a91generic91drug91name?‖91Which91is91the91correct91response?9
1a.91Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:91A
Acetaminophen91is91the91generic91name.91Tylenol,91Cipro,91and91Motrin91are91all91trade91names.
DIF:91Cognitive91Level:91Comprehension REF:91Table913-
3:91The91Three91Types91of91Drug91Names91TOP:91Nursing91Process:91Diagnosis
MSC:91NCLEX91Client91Needs91Category:91Physiologic91Integrity:91Pharmacologic91and91Parenteral91Ther
apies
2. The91FDA91Amendments91Act91(FDAAA)91was91passed91in91200791to91address91which91
aspect91of91dr91ug91safety?
a. Allowing91pharmaceutical91companies91to91identify
91off-
91label91uses91of91medications91approved91for91other
91uses
b. Evaluating91drug91safety91information91that91emerges91after91a91drug91has91been91ap
proved91and91is91in91use
c. Expediting91the91approval91process91of91the91U.S.91Food91and91Drug91Administratio
n91(FDA)91s91o91that91needed91drugs91can91get91to91market91more91quickly
d. Requiring91manufacturers9 1 to91 notify91patients9 1 before91 removing91 a91 drug91 from91 the9 1 mar
ket
ANS:91 B
The91FDAAA91was91passed91to91enable91the91Food9 1 and9 1 Drug91Administration91to91continu
e91oversight9 1 of91a91drug91after91granting91it91approval91so91that91changes91in91labeling91coul
d91be9 1 made91as91necessary9 1 and91postmarketing91risks91could91be91tracked91and91identified
.91A91provision91of91the91FDA91Moderniza91tion91 Act91(FDAMA),91passed91in9 1 1997,91allow
s91drug91companies91to91promote91their91products91for91of9 1 f-
label91uses91as91long91as91they91promise91to91conduct91studies91to91support91their91claims.91Re
gulations91to9 1 permit91accelerated91approval91of91drugs91for91life-
threatening91diseases91were91adopted91in91199291by91the91FDA.91The91requirement91that91dru
g91compani9 1 es91notify91patients91691months91before91removing91a91drug91from91the91market
91is91a91provision91of91the91F91DAMA.
,Test91Bank91Lehne's91Pharmacology91for91Nursing91Care,9111th91
Edi91tion91by91Jacqueline91Burchum,91Laura91Rosenthal91Chapt
er911-91112|Complete91Guide91A+
DIF:9 1 Cognitive9 1 Level:9 1 Comprehen
sion REF:91Landmark91Drug91Legislation
TOP:9 1 Nursing91 Process:9 1 Evaluation
MSC:91NCLEX91Client91Needs91Category:91 Physiologic91 Integrity:91 Pharmacologic91and91Parenteral91
Therapies
, Lehne's91Pharmacology91for91Nursing91Care9110th91Edition91T
EST91BANK(Chapter911-110).
3. A91nursing91student91asks91a91nurse91about91pharmaceutical91research91and91wants91to91kno
w91the91purpo91se91of9 1 randomization91in9 1 drug9 1 trials.9 1 The9 1 nurse9 1 explains91that9 1 ra
ndomization9 1 is91used9 1 to:
a. ensure91that91differences91in91outcomes91are91the91result91of91treatment91and91not9
1differences91in91subjects.
b. compare91 the9 1 outcome9 1 caused9 1 by91the91 treatment9 1 to9 1 the91 outcome91 caused9 1 by91no9 1 trea
tment.
, Test91Bank91Lehne's91Pharmacology91for91Nursing91Care,9111th91
Edi91tion91by91Jacqueline91Burchum,91Laura91Rosenthal91Chapt
er911-91112|Complete91Guide91A+
c. make91 sure91 that9 1 researchers9 1 are91 unaware91 of9 1 which9 1 subjects9 1 are91 in9 1 which9 1 group.
d. prevent91subjects91from91knowing91which91group91they91are91in91and91prevent91pr
econceptio91n91bias.
ANS:91 A
Randomization91helps91prevent91allocation91bias,91which91can91occur91when91researchers91pla
ce91subjec91ts91with91desired91characteristics91in91the91study91group91and91other91subjects91in9
1the91control91group91so91t91hat91 differences9 1 in91 outcome91 are91 actually91the9 1 result91 of91 di
fferences9 1 in9 1 subjects9 1 and91 not91 treatmen91t.
Comparing91treatment91 outcome91 to91 no91 treatment91 outcome91 is91 the91 definition91 of91 a91 contro
lled91 stud
y.91The91last91two91options91describe91the91use91of91blinding91in91studies;91blinding91ensures9
1that91researc91hers91or91subjects91(or91both)91are91unaware91of91which91subjects91are91in91wh
ich91group91so91that91preconc91eptions91about91benefits91and91risks91cannot91bias91the91results
.
DIF:9 1 Cognitive9 1 Level:9 1 Comprehensi
on REF:91The91Randomized91Drug91Tria
l9 1 TOP:9 1 Nursing9 1 Process:9 1 Implemen
tation
MSC:91NCLEX91Client91Needs91Category:91 Physiologic91 Integrity:91 Pharmacologic91and91Parenteral91
Therapies
4. Someone91asks91 a91nurse91 about91a91new91drug91that91is91 in91preclinical91 testing91and9 1 wan
ts91to91know91 wh9 1 y91it9 1 cannot9 1 be9 1 used9 1 to9 1 treat9 1 a9 1 friend‘s9 1 illness.9 1 Which9 1 st
atement9 1 by9 1 the9 1 nurse9 1 is9 1 correct?
a. ―A91 drug91 at91 this91 stage91 of91 development9 1 can9 1 be91 used91 only91in91 patients91 with91 seri
ous91 disease.‖
b. ―At91this91stage91of91drug91development,91the91safety91and91usefulness91of91the91
medication91is91unknown.‖
c. ―Clinical91 trials91 must91 be91 completed91 to91 make91 sure9 1 the91 drug91 is91 safe91 to91 use91 in9 1
humans.‖
d. ―Until91 postmarketing91 surveillance91 data91 are91 available,91 the91 drug91 cannot9 1 be91 used.‖
ANS:91 B
Preclinical91testing91must91be91completed91before91drugs91can91be91tested91in91humans.91In9
1this91stage,91drugs9 1 are9 1 evaluated9 1 for91 toxicities,91 pharmacokinetic9 1 properties,9 1 and9 1
potentially91 useful9 1 effect
s.91Some91drugs91can91be91used91in91patients91before91completion91of91Phase91III91studies,91
but91this91is91af9 1 ter91preclinical91testing91is91complete.91Clinical91trials91proceed91in91stage
s,91and91each91stage91has91guid91elines91defining91how91a91new91drug91may91be91used91and91
which91patients91may91receive91it.91Postmark91eting91surveillance91takes91place91after91a91dr
ug91is91in91general91use.
DIF:91 Cognitive91 Level:91 Comprehension
REF:91Landmark91Drug91Legislation91|91Stages91of91Drug91Develop
ment91T91OP:91Nursing91Process:91Implementation
EST91BANK(Chapter911-110).
Chapter913:91Drug91Regulation,91Development,91Names,91and91Inform
ation91Test91Bank
MULTIPLE91CHOICE
1. A91nurse91educator91is91conducting91a91continuing91education91class91on91pharmacology.91T
o91evaluate91the91learning91of91the91nurses91in91the91class,91the91nurse91educator91asks,91
―Which91drug91name91is91a91generic91drug91name?‖91Which91is91the91correct91response?9
1a.91Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:91A
Acetaminophen91is91the91generic91name.91Tylenol,91Cipro,91and91Motrin91are91all91trade91names.
DIF:91Cognitive91Level:91Comprehension REF:91Table913-
3:91The91Three91Types91of91Drug91Names91TOP:91Nursing91Process:91Diagnosis
MSC:91NCLEX91Client91Needs91Category:91Physiologic91Integrity:91Pharmacologic91and91Parenteral91Ther
apies
2. The91FDA91Amendments91Act91(FDAAA)91was91passed91in91200791to91address91which91
aspect91of91dr91ug91safety?
a. Allowing91pharmaceutical91companies91to91identify
91off-
91label91uses91of91medications91approved91for91other
91uses
b. Evaluating91drug91safety91information91that91emerges91after91a91drug91has91been91ap
proved91and91is91in91use
c. Expediting91the91approval91process91of91the91U.S.91Food91and91Drug91Administratio
n91(FDA)91s91o91that91needed91drugs91can91get91to91market91more91quickly
d. Requiring91manufacturers9 1 to91 notify91patients9 1 before91 removing91 a91 drug91 from91 the9 1 mar
ket
ANS:91 B
The91FDAAA91was91passed91to91enable91the91Food9 1 and9 1 Drug91Administration91to91continu
e91oversight9 1 of91a91drug91after91granting91it91approval91so91that91changes91in91labeling91coul
d91be9 1 made91as91necessary9 1 and91postmarketing91risks91could91be91tracked91and91identified
.91A91provision91of91the91FDA91Moderniza91tion91 Act91(FDAMA),91passed91in9 1 1997,91allow
s91drug91companies91to91promote91their91products91for91of9 1 f-
label91uses91as91long91as91they91promise91to91conduct91studies91to91support91their91claims.91Re
gulations91to9 1 permit91accelerated91approval91of91drugs91for91life-
threatening91diseases91were91adopted91in91199291by91the91FDA.91The91requirement91that91dru
g91compani9 1 es91notify91patients91691months91before91removing91a91drug91from91the91market
91is91a91provision91of91the91F91DAMA.
,Test91Bank91Lehne's91Pharmacology91for91Nursing91Care,9111th91
Edi91tion91by91Jacqueline91Burchum,91Laura91Rosenthal91Chapt
er911-91112|Complete91Guide91A+
DIF:9 1 Cognitive9 1 Level:9 1 Comprehen
sion REF:91Landmark91Drug91Legislation
TOP:9 1 Nursing91 Process:9 1 Evaluation
MSC:91NCLEX91Client91Needs91Category:91 Physiologic91 Integrity:91 Pharmacologic91and91Parenteral91
Therapies
, Lehne's91Pharmacology91for91Nursing91Care9110th91Edition91T
EST91BANK(Chapter911-110).
3. A91nursing91student91asks91a91nurse91about91pharmaceutical91research91and91wants91to91kno
w91the91purpo91se91of9 1 randomization91in9 1 drug9 1 trials.9 1 The9 1 nurse9 1 explains91that9 1 ra
ndomization9 1 is91used9 1 to:
a. ensure91that91differences91in91outcomes91are91the91result91of91treatment91and91not9
1differences91in91subjects.
b. compare91 the9 1 outcome9 1 caused9 1 by91the91 treatment9 1 to9 1 the91 outcome91 caused9 1 by91no9 1 trea
tment.
, Test91Bank91Lehne's91Pharmacology91for91Nursing91Care,9111th91
Edi91tion91by91Jacqueline91Burchum,91Laura91Rosenthal91Chapt
er911-91112|Complete91Guide91A+
c. make91 sure91 that9 1 researchers9 1 are91 unaware91 of9 1 which9 1 subjects9 1 are91 in9 1 which9 1 group.
d. prevent91subjects91from91knowing91which91group91they91are91in91and91prevent91pr
econceptio91n91bias.
ANS:91 A
Randomization91helps91prevent91allocation91bias,91which91can91occur91when91researchers91pla
ce91subjec91ts91with91desired91characteristics91in91the91study91group91and91other91subjects91in9
1the91control91group91so91t91hat91 differences9 1 in91 outcome91 are91 actually91the9 1 result91 of91 di
fferences9 1 in9 1 subjects9 1 and91 not91 treatmen91t.
Comparing91treatment91 outcome91 to91 no91 treatment91 outcome91 is91 the91 definition91 of91 a91 contro
lled91 stud
y.91The91last91two91options91describe91the91use91of91blinding91in91studies;91blinding91ensures9
1that91researc91hers91or91subjects91(or91both)91are91unaware91of91which91subjects91are91in91wh
ich91group91so91that91preconc91eptions91about91benefits91and91risks91cannot91bias91the91results
.
DIF:9 1 Cognitive9 1 Level:9 1 Comprehensi
on REF:91The91Randomized91Drug91Tria
l9 1 TOP:9 1 Nursing9 1 Process:9 1 Implemen
tation
MSC:91NCLEX91Client91Needs91Category:91 Physiologic91 Integrity:91 Pharmacologic91and91Parenteral91
Therapies
4. Someone91asks91 a91nurse91 about91a91new91drug91that91is91 in91preclinical91 testing91and9 1 wan
ts91to91know91 wh9 1 y91it9 1 cannot9 1 be9 1 used9 1 to9 1 treat9 1 a9 1 friend‘s9 1 illness.9 1 Which9 1 st
atement9 1 by9 1 the9 1 nurse9 1 is9 1 correct?
a. ―A91 drug91 at91 this91 stage91 of91 development9 1 can9 1 be91 used91 only91in91 patients91 with91 seri
ous91 disease.‖
b. ―At91this91stage91of91drug91development,91the91safety91and91usefulness91of91the91
medication91is91unknown.‖
c. ―Clinical91 trials91 must91 be91 completed91 to91 make91 sure9 1 the91 drug91 is91 safe91 to91 use91 in9 1
humans.‖
d. ―Until91 postmarketing91 surveillance91 data91 are91 available,91 the91 drug91 cannot9 1 be91 used.‖
ANS:91 B
Preclinical91testing91must91be91completed91before91drugs91can91be91tested91in91humans.91In9
1this91stage,91drugs9 1 are9 1 evaluated9 1 for91 toxicities,91 pharmacokinetic9 1 properties,9 1 and9 1
potentially91 useful9 1 effect
s.91Some91drugs91can91be91used91in91patients91before91completion91of91Phase91III91studies,91
but91this91is91af9 1 ter91preclinical91testing91is91complete.91Clinical91trials91proceed91in91stage
s,91and91each91stage91has91guid91elines91defining91how91a91new91drug91may91be91used91and91
which91patients91may91receive91it.91Postmark91eting91surveillance91takes91place91after91a91dr
ug91is91in91general91use.
DIF:91 Cognitive91 Level:91 Comprehension
REF:91Landmark91Drug91Legislation91|91Stages91of91Drug91Develop
ment91T91OP:91Nursing91Process:91Implementation
