NGA
NZ
,Chapter .1: .Drug .Definitions, .Standards, .and .Information .Sources
.Test .Bank
MULTIPLE .CHOICE
1. What .is .the .name .under .which .a .drug .is .listed .by .the .U.S. .Food .and .Drug
.Administration .(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: . C
The .official .name .is .the .name .under .which .a .drug .is .listed .by .the .FDA. .The .brand .name,
.or .trademark, .is .the .name .given .to .a .drug .by .its .manufacturer. .The .nonproprietary, .or
.generic, .name .is .provided .by .the .U.S. .Adopted .Names .Council.
DIF: Cognitive .Level: .Knowledge REF: . p. .1 OBJ: .2
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Safe, .Effective .Care .Environment
2. Which .source .contains .information .specific .to .nutritional .supplements?
a. USP .Dictionary .of .USAN .& .International .Drug .Names
b. Natural .Medicines .Comprehensive .Database
c. United .States .Pharmacopoeia/National .Formulary .(USP .NF)
d. Drug .Interaction .Facts
ANS: . C
United .States .Pharmacopoeia/National .Formulary .contains .information .specific .to
.nutritional .supplements. .USP .Dictionary .of .USAN .& .International .Drug .Names .is .a
.compilation .of .drug .names, .pronunciation .guide, .and .possible .future .FDA .approved .drugs;
.it .does .not .include .nutritional .supplements. .Natural .Medicines .Comprehensive .Database
.contains .evidence .based .information .on .herbal .medicines .and .herbal .combination .products;
.it .does .not .include .information .specific .to .nutritional .supplements. .Drug .Interaction .Facts
.contains .comprehensive .information .on .drug .interaction .facts; .it .does .not .include
.nutritional .supplements.
DIF: Cognitive .Level: .Knowledge REF: . p. .2 OBJ: .4
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
3. What .is .the .most .comprehensive .reference .available .to .research .a .drug .interaction?
a. Drug .Facts .and .Comparisons
b. Drug .Interaction .Facts
c. Handbook .on .Injectable .Drugs
d. Martindale—The .Complete .Drug .Reference
ANS: . B
, First .published .in .1983, .Drug .Interaction .Facts .is .the .most .comprehensive .book .available
.on .drug .interactions. .In .addition .to .monographs .listing .various .aspects .of .drug .interactions,
.this .information .is .reviewed .and .updated .by .an .internationally .renowned .group .of
.physicians .and .pharmacists .with .clinical .and .scientific .expertise.
DIF: Cognitive .Level: .Comprehension REF: . p. .3 OBJ: .3
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
4. The .physician .has .written .an .order .for .a .drug .with .which .the .nurse .is .unfamiliar. .Which
.section .of .the .Physicians’ .Desk .Reference .(PDR) .is .most .helpful .to .get .information .about
.this .drug?
a. Manufacturer‟s .section
b. Brand .and .Generic .Name .section
c. Product .Category .section
d. Product .Information .section
ANS: . B
A .physician‟s .order .would .include .the .brand .and/or .generic .name .of .the .drug. .The
.alphabetic .index .in .the .PDR .would .make .this .section .the .most .user .friendly. .Based .on .a
.physician‟s .order, .manufacturer‟s .information .and .classification .information .would .not .be
.known. .The .Manufacturer‟s .section .is .a .roster .of .manufacturers. .The .Product .Category
.section .lists .products .subdivided .by .therapeutic .classes, .such .as .analgesics, .laxatives,
.oxytocics, .and .antibiotics. .The .Product .Information .section .contains .reprints .of .the
.package .inserts .for .the .major .products .of .manufacturers.
DIF: Cognitive .Level: .Comprehension REF: . p. .3 OBJ: .4
.TOP: . Nursing .Process .Step: .Planning
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
5. Which .online .drug .reference .makes .available .to .health .care .providers .and .the .public .a
.standard, .comprehensive, .up .to .date .look .up .and .downloadable .resource .about
.medicines?
a. American .Drug .Index
b. American .Hospital .Formulary
c. DailyMed
d. Physicians’ .Desk .Reference .(PDR)
ANS: . C
DailyMed .makes .available .to .health .care .providers .and .the .public .a .standard,
.comprehensive, .up .to .date .look .up .and .downloadable .resource .about .medicines. .The
.American .Drug .Index .is .not .appropriate .for .patient .use. .The .American .Hospital .Formulary
.is .not .appropriate .for .patient .use. .The .PDR .is .not .appropriate .for .patient .use.
DIF: Cognitive .Level: .Knowledge REF: . p. .4 OBJ: .5
.TOP: . Nursing .Process .Step: .Implementation
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
6. Which .legislation .authorizes .the .FDA .to .determine .the .safety .of .a .drug .before .its .marketing?
a. Federal .Food, .Drug, .and .Cosmetic .Act .(1938)
b. Durham .Humphrey .Amendment .(1952)
c. Controlled .Substances .Act .(1970)
, d. Kefauver .Harris .Drug .Amendment .(1962)
ANS: . A
The .Federal .Food, .Drug, .and .Cosmetic .Act .of .1938 .authorized .the .FDA .to .determine .the
.safety .of .all .drugs .before .marketing. .Later .amendments .and .acts .helped .tighten .FDA
.control .and .ensure .drug .safety. .The .Durham .Humphrey .Amendment .defines .the .kinds .of
.drugs .that .cannot .be .used .safely .without .medical .supervision .and .restricts .their .sale .to
.prescription .by .a .licensed .practitioner. .The .Controlled .Substances .Act .addresses .only
.controlled .substances .and .their .categorization. .The .Kefauver .Harris .Drug .Amendment
.ensures .drug .efficacy .and .greater .drug .safety. .Drug .manufacturers .are .required .to .prove .to
.the .FDA .the .effectiveness .of .their .products .before .marketing .them.
DIF: Cognitive .Level: .Knowledge REF: . p. .4 OBJ: .8
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
7. Meperidine .(Demerol) .is .a .narcotic .with .a .high .potential .for .physical .and
.psychological .dependency. .Under .which .classification .does .this .drug .fall?
a. I
b. II
c. III
d. IV
ANS: . B
Meperidine .(Demerol) .is .a .Schedule .II .drug; .it .has .a .high .potential .for .abuse .and .may .lead
.to .severe .psychological .and .physical .dependence. .Schedule .I .drugs .have .high .potential .for
.abuse .and .no .recognized .medical .use. .Schedule .III .drugs .have .some .potential .for .abuse.
.Use .may .lead .to .low .to .moderate .physical .dependence .or .high .psychological .dependence.
.Schedule .IV .drugs .have .low .potential .for .abuse. .Use .may .lead .to .limited .physical .or
.psychological .dependence.
DIF: Cognitive .Level: .Comprehension REF: . p. .4 .| .p. .5 OBJ: .7
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Safe, .Effective .Care .Environment
8. What .would .the .FDA .do .to .expedite .drug .development .and .approval .for .an .outbreak
.of .smallpox, .for .which .there .is .no .known .treatment?
a. List .smallpox .as .a .health .orphan .disease.
b. Omit .the .preclinical .research .phase.
c. Extend .the .clinical .research .phase.
d. Fast .track .the .investigational .drug.
ANS: . D
Once .the .Investigational .New .Drug .Application .has .been .approved, .the .drug .can .receive
.highest .priority .within .the .agency, .which .is .called .fast .tracking. .A .smallpox .outbreak
.would .become .a .priority .concern .in .the .world. .Orphan .diseases .are .not .researched .in .a
.priority .manner. .Preclinical .research .is .not .omitted. .Extending .any .phase .of .the .research
.would .mean .a .longer .time .to .develop .a .vaccine. .The .FDA .must .ensure .that .all .phases .of
.the .preclinical .and .clinical .research .phase .have .been .completed .in .a .safe .manner.
DIF: Cognitive .Level: .Knowledge REF: . p. .7 OBJ: .8
.TOP: . Nursing .Process .Step: .Assessment
NZ
,Chapter .1: .Drug .Definitions, .Standards, .and .Information .Sources
.Test .Bank
MULTIPLE .CHOICE
1. What .is .the .name .under .which .a .drug .is .listed .by .the .U.S. .Food .and .Drug
.Administration .(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: . C
The .official .name .is .the .name .under .which .a .drug .is .listed .by .the .FDA. .The .brand .name,
.or .trademark, .is .the .name .given .to .a .drug .by .its .manufacturer. .The .nonproprietary, .or
.generic, .name .is .provided .by .the .U.S. .Adopted .Names .Council.
DIF: Cognitive .Level: .Knowledge REF: . p. .1 OBJ: .2
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Safe, .Effective .Care .Environment
2. Which .source .contains .information .specific .to .nutritional .supplements?
a. USP .Dictionary .of .USAN .& .International .Drug .Names
b. Natural .Medicines .Comprehensive .Database
c. United .States .Pharmacopoeia/National .Formulary .(USP .NF)
d. Drug .Interaction .Facts
ANS: . C
United .States .Pharmacopoeia/National .Formulary .contains .information .specific .to
.nutritional .supplements. .USP .Dictionary .of .USAN .& .International .Drug .Names .is .a
.compilation .of .drug .names, .pronunciation .guide, .and .possible .future .FDA .approved .drugs;
.it .does .not .include .nutritional .supplements. .Natural .Medicines .Comprehensive .Database
.contains .evidence .based .information .on .herbal .medicines .and .herbal .combination .products;
.it .does .not .include .information .specific .to .nutritional .supplements. .Drug .Interaction .Facts
.contains .comprehensive .information .on .drug .interaction .facts; .it .does .not .include
.nutritional .supplements.
DIF: Cognitive .Level: .Knowledge REF: . p. .2 OBJ: .4
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
3. What .is .the .most .comprehensive .reference .available .to .research .a .drug .interaction?
a. Drug .Facts .and .Comparisons
b. Drug .Interaction .Facts
c. Handbook .on .Injectable .Drugs
d. Martindale—The .Complete .Drug .Reference
ANS: . B
, First .published .in .1983, .Drug .Interaction .Facts .is .the .most .comprehensive .book .available
.on .drug .interactions. .In .addition .to .monographs .listing .various .aspects .of .drug .interactions,
.this .information .is .reviewed .and .updated .by .an .internationally .renowned .group .of
.physicians .and .pharmacists .with .clinical .and .scientific .expertise.
DIF: Cognitive .Level: .Comprehension REF: . p. .3 OBJ: .3
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
4. The .physician .has .written .an .order .for .a .drug .with .which .the .nurse .is .unfamiliar. .Which
.section .of .the .Physicians’ .Desk .Reference .(PDR) .is .most .helpful .to .get .information .about
.this .drug?
a. Manufacturer‟s .section
b. Brand .and .Generic .Name .section
c. Product .Category .section
d. Product .Information .section
ANS: . B
A .physician‟s .order .would .include .the .brand .and/or .generic .name .of .the .drug. .The
.alphabetic .index .in .the .PDR .would .make .this .section .the .most .user .friendly. .Based .on .a
.physician‟s .order, .manufacturer‟s .information .and .classification .information .would .not .be
.known. .The .Manufacturer‟s .section .is .a .roster .of .manufacturers. .The .Product .Category
.section .lists .products .subdivided .by .therapeutic .classes, .such .as .analgesics, .laxatives,
.oxytocics, .and .antibiotics. .The .Product .Information .section .contains .reprints .of .the
.package .inserts .for .the .major .products .of .manufacturers.
DIF: Cognitive .Level: .Comprehension REF: . p. .3 OBJ: .4
.TOP: . Nursing .Process .Step: .Planning
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
5. Which .online .drug .reference .makes .available .to .health .care .providers .and .the .public .a
.standard, .comprehensive, .up .to .date .look .up .and .downloadable .resource .about
.medicines?
a. American .Drug .Index
b. American .Hospital .Formulary
c. DailyMed
d. Physicians’ .Desk .Reference .(PDR)
ANS: . C
DailyMed .makes .available .to .health .care .providers .and .the .public .a .standard,
.comprehensive, .up .to .date .look .up .and .downloadable .resource .about .medicines. .The
.American .Drug .Index .is .not .appropriate .for .patient .use. .The .American .Hospital .Formulary
.is .not .appropriate .for .patient .use. .The .PDR .is .not .appropriate .for .patient .use.
DIF: Cognitive .Level: .Knowledge REF: . p. .4 OBJ: .5
.TOP: . Nursing .Process .Step: .Implementation
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
6. Which .legislation .authorizes .the .FDA .to .determine .the .safety .of .a .drug .before .its .marketing?
a. Federal .Food, .Drug, .and .Cosmetic .Act .(1938)
b. Durham .Humphrey .Amendment .(1952)
c. Controlled .Substances .Act .(1970)
, d. Kefauver .Harris .Drug .Amendment .(1962)
ANS: . A
The .Federal .Food, .Drug, .and .Cosmetic .Act .of .1938 .authorized .the .FDA .to .determine .the
.safety .of .all .drugs .before .marketing. .Later .amendments .and .acts .helped .tighten .FDA
.control .and .ensure .drug .safety. .The .Durham .Humphrey .Amendment .defines .the .kinds .of
.drugs .that .cannot .be .used .safely .without .medical .supervision .and .restricts .their .sale .to
.prescription .by .a .licensed .practitioner. .The .Controlled .Substances .Act .addresses .only
.controlled .substances .and .their .categorization. .The .Kefauver .Harris .Drug .Amendment
.ensures .drug .efficacy .and .greater .drug .safety. .Drug .manufacturers .are .required .to .prove .to
.the .FDA .the .effectiveness .of .their .products .before .marketing .them.
DIF: Cognitive .Level: .Knowledge REF: . p. .4 OBJ: .8
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Physiological .Integrity
7. Meperidine .(Demerol) .is .a .narcotic .with .a .high .potential .for .physical .and
.psychological .dependency. .Under .which .classification .does .this .drug .fall?
a. I
b. II
c. III
d. IV
ANS: . B
Meperidine .(Demerol) .is .a .Schedule .II .drug; .it .has .a .high .potential .for .abuse .and .may .lead
.to .severe .psychological .and .physical .dependence. .Schedule .I .drugs .have .high .potential .for
.abuse .and .no .recognized .medical .use. .Schedule .III .drugs .have .some .potential .for .abuse.
.Use .may .lead .to .low .to .moderate .physical .dependence .or .high .psychological .dependence.
.Schedule .IV .drugs .have .low .potential .for .abuse. .Use .may .lead .to .limited .physical .or
.psychological .dependence.
DIF: Cognitive .Level: .Comprehension REF: . p. .4 .| .p. .5 OBJ: .7
.TOP: . Nursing .Process .Step: .Assessment
MSC: . NCLEX .Client .Needs .Category: .Safe, .Effective .Care .Environment
8. What .would .the .FDA .do .to .expedite .drug .development .and .approval .for .an .outbreak
.of .smallpox, .for .which .there .is .no .known .treatment?
a. List .smallpox .as .a .health .orphan .disease.
b. Omit .the .preclinical .research .phase.
c. Extend .the .clinical .research .phase.
d. Fast .track .the .investigational .drug.
ANS: . D
Once .the .Investigational .New .Drug .Application .has .been .approved, .the .drug .can .receive
.highest .priority .within .the .agency, .which .is .called .fast .tracking. .A .smallpox .outbreak
.would .become .a .priority .concern .in .the .world. .Orphan .diseases .are .not .researched .in .a
.priority .manner. .Preclinical .research .is .not .omitted. .Extending .any .phase .of .the .research
.would .mean .a .longer .time .to .develop .a .vaccine. .The .FDA .must .ensure .that .all .phases .of
.the .preclinical .and .clinical .research .phase .have .been .completed .in .a .safe .manner.
DIF: Cognitive .Level: .Knowledge REF: . p. .7 OBJ: .8
.TOP: . Nursing .Process .Step: .Assessment
