,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:
8
Clayton’s Basic Pharmacology for Nurses, 20th Edition 8
MULTIPLE CHOICE
1. Which name identifies a drug listed by the US Food andD
8
rug Administration (FDA)?
8
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is listed by t 8
he FDA. The brand name, or trademark, is the name given to a 8
drug by its manufacturer. The nonproprietary, or generic, nam
e is provided by the United States Adopted Names Council.
8 8
DIF: Cognitive Level: Knowledge
8 REF: p. 9
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care
Environment TOP: Nursing Process Step: Assessment
8 8
CON:
Patient Education
2. Whichsource contains information specific to nutritional supplements?
8
a. USPDictionary of USAN &International Drug Names
b. Natural Medicines Comprehensive Database
c. United States Pharmacopoeia/National Formulary(USPNF)
d. Drug Interaction Facts
ANS: C
United States Pharmacopoeia/National Formulary contains informationspecificto nutritional s 8
upplements. USP Dictionary of USAN & International Drug Names is a compilation of drug na 8
mes, pronunciation guide, and possible future FDA approved drugs; it does not include nutrition
8 8 8
al supplements. Natural Medicines Comprehensive Database contains
evidence-
based information onherbal medicines and herbal combination products; it does notinclude infor
8 8 8
mation specific to nutritional supplements. Drug Interaction Facts contains comprehensive info
8
rmation on drug interaction facts; it does not include nutritional supplements.
8 8
DIF: Cognitive Level: Knowledge
8 REF: p. 4
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Integri
ty
TOP: Nursing Process Step: Assessment
8 8 CON: Nutrition |Patient Education 8
3. Which drugreference contains drug monographs that describe all drugs in a therapeutic class?
8 8 8
a. Drug Factsand Comparisons
,Test Bank For Clayton’s Basic Pharmacology for Nurses 20th Edition 8 3
b. Drug Interaction Facts
c. Handbook on Injectable Drugs
8
d. Martindale—The Complete Drug Reference
ANS: A
Drug Facts and Comparisons contains drug monographs that describe all drugs in ather
8 8
apeutic class. Monographs are formatted as tables to allow comparison ofsimilarproduct
8
s, brand names, manufacturers, cost indices, and available dosage forms Online version
is available.
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 8
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment
8 CON: Safety|Patient Education |Clinical Judgment
8
4. Which drug reference contains monographs about virtuallyeverysingle-
8
entitydrug availablein the United States and describes therapeutic uses of drugs, including app
8
roved and unapproved uses?
a. Martindale: The Complete Drug Reference
b. AHFSDrug Information
c. Drug Reference
d. Drug Facts and Comparisons
ANS: B
AHFS Drug Information contains monographs about virtually every single-
entity drug available in the United States and describes therapeutic uses ofdrugs, including appro
ved andunapproved uses. 8
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 8
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Planning CON: Safety|Patient Education |Clinical Judgment
8
5. Which online drug reference makes available to healthcare providers and the public a standa
8 8 8
rd, comprehensive, up-to-datelookupanddownloadable resource about medicines?
a. American Drug Index
b. American Hospital Formulary
c. DailyMed
d. Drug Reference
ANS: C
DailyMed makes available to healthcare providers and the public astandard, comprehensive,up
8 8
-to-
datelook up and downloadable resource about medicines. The American Drug Index is not appr
8 8
opriate for patient use. The American Hospital Formulary is not appropriate for patient use. Th
8
e drug reference is not appropriate for patient use. 8
DIF: Cognitive Level: Knowledge
8 REF: p. 3 | p. 4
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Integri
ty
TOP: Nursing Process Step: Implementation
8
CON: Safety |Patient Education |Clinical Judgment
8
6. Which legislation authorizes the FDA to determine the safetyofa drug before its marketing?
8
a. Federal Food, Drug, and Cosmetic Act (1938)
b. Durham HumphreyAmendment (1952)
, Test Bank For Clayton’s Basic Pharmacology for Nurses 20th Edition
8 4
c. Controlled Substances Act (1970)
8 8
d. Kefauver Harris Drug Amendment (1962)
8
ANS: A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety
8
of all drugs before marketing. Later amendments and acts helped tighten FDA control and ensur
e drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be use
d safely without medical supervision and restricts their sale to prescription by a licensed practiti
8 8 8
oner. The Controlled Substances Act addresses only controlled substances and their categorizatio
8 8
n. The Kefauver Harris Drug Amendment ensures drug efficacyand greaterdrug safety. Drug m 8
anufacturers are required to prove to the FDA the effectiveness of their products before marketin
g them.
8
DIF: Cognitive Level: Knowledge REF: p. 5Table l.3
OBJ: 5
NAT: NCLEX Client Needs Category: Physiological Integrity
8
TOP: Nursing Process Step: Assessment
CON: Safety |Patient Education |Evidence |Health Care Law 8
7. Whichclassification does meperidine (Demerol) fall under?
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 tosev
8 8
erepsychological and physical dependence. Schedule I drugs have high potential for abuseand n
8 8 8
o recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to lo
w to moderate physical dependence or high psychological dependence. Schedule IVdrugs have
8
low potential for abuse. Use may lead to limited physical or psychological dependence.
8
DIF: Cognitive Level: Knowledge
8 REF: p. 10
OBJ: 2NAT: NCLEX Client Needs Category: Safe, Effective Care
Environment
TOP: Nursing Process Step: Assessment CON: Patient Education |Addiction |Pain
8 8
8. Which action would the FDA taketo expedite drugdevelopment and approval for an outbreakof
smallpox?
a. List smallpox as a health orphandisease.
8
b. Omit thepreclinical researchphase.
c. Extend the clinicalresearch phase.
d. Fast trackthe investigational drug.
ANS: D
Once the Investigational New Drug Application has been approved, the drug can receive highest
8 8
priority within the agency, which is called fast tracking. A smallpox outbreak would become a p 8
riority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
8
research is not omitted. Extending any phase of the research would meanalonger time to develo
p avaccine. The FDAmust ensurethat all phases of the preclinical andclinical research phase hav
8 8
e been completed in a safe manner.
8
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 5
8
Clayton’s Basic Pharmacology for Nurses, 20th Edition 8
MULTIPLE CHOICE
1. Which name identifies a drug listed by the US Food andD
8
rug Administration (FDA)?
8
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is listed by t 8
he FDA. The brand name, or trademark, is the name given to a 8
drug by its manufacturer. The nonproprietary, or generic, nam
e is provided by the United States Adopted Names Council.
8 8
DIF: Cognitive Level: Knowledge
8 REF: p. 9
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care
Environment TOP: Nursing Process Step: Assessment
8 8
CON:
Patient Education
2. Whichsource contains information specific to nutritional supplements?
8
a. USPDictionary of USAN &International Drug Names
b. Natural Medicines Comprehensive Database
c. United States Pharmacopoeia/National Formulary(USPNF)
d. Drug Interaction Facts
ANS: C
United States Pharmacopoeia/National Formulary contains informationspecificto nutritional s 8
upplements. USP Dictionary of USAN & International Drug Names is a compilation of drug na 8
mes, pronunciation guide, and possible future FDA approved drugs; it does not include nutrition
8 8 8
al supplements. Natural Medicines Comprehensive Database contains
evidence-
based information onherbal medicines and herbal combination products; it does notinclude infor
8 8 8
mation specific to nutritional supplements. Drug Interaction Facts contains comprehensive info
8
rmation on drug interaction facts; it does not include nutritional supplements.
8 8
DIF: Cognitive Level: Knowledge
8 REF: p. 4
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Integri
ty
TOP: Nursing Process Step: Assessment
8 8 CON: Nutrition |Patient Education 8
3. Which drugreference contains drug monographs that describe all drugs in a therapeutic class?
8 8 8
a. Drug Factsand Comparisons
,Test Bank For Clayton’s Basic Pharmacology for Nurses 20th Edition 8 3
b. Drug Interaction Facts
c. Handbook on Injectable Drugs
8
d. Martindale—The Complete Drug Reference
ANS: A
Drug Facts and Comparisons contains drug monographs that describe all drugs in ather
8 8
apeutic class. Monographs are formatted as tables to allow comparison ofsimilarproduct
8
s, brand names, manufacturers, cost indices, and available dosage forms Online version
is available.
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 8
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment
8 CON: Safety|Patient Education |Clinical Judgment
8
4. Which drug reference contains monographs about virtuallyeverysingle-
8
entitydrug availablein the United States and describes therapeutic uses of drugs, including app
8
roved and unapproved uses?
a. Martindale: The Complete Drug Reference
b. AHFSDrug Information
c. Drug Reference
d. Drug Facts and Comparisons
ANS: B
AHFS Drug Information contains monographs about virtually every single-
entity drug available in the United States and describes therapeutic uses ofdrugs, including appro
ved andunapproved uses. 8
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 8
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Planning CON: Safety|Patient Education |Clinical Judgment
8
5. Which online drug reference makes available to healthcare providers and the public a standa
8 8 8
rd, comprehensive, up-to-datelookupanddownloadable resource about medicines?
a. American Drug Index
b. American Hospital Formulary
c. DailyMed
d. Drug Reference
ANS: C
DailyMed makes available to healthcare providers and the public astandard, comprehensive,up
8 8
-to-
datelook up and downloadable resource about medicines. The American Drug Index is not appr
8 8
opriate for patient use. The American Hospital Formulary is not appropriate for patient use. Th
8
e drug reference is not appropriate for patient use. 8
DIF: Cognitive Level: Knowledge
8 REF: p. 3 | p. 4
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Integri
ty
TOP: Nursing Process Step: Implementation
8
CON: Safety |Patient Education |Clinical Judgment
8
6. Which legislation authorizes the FDA to determine the safetyofa drug before its marketing?
8
a. Federal Food, Drug, and Cosmetic Act (1938)
b. Durham HumphreyAmendment (1952)
, Test Bank For Clayton’s Basic Pharmacology for Nurses 20th Edition
8 4
c. Controlled Substances Act (1970)
8 8
d. Kefauver Harris Drug Amendment (1962)
8
ANS: A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety
8
of all drugs before marketing. Later amendments and acts helped tighten FDA control and ensur
e drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be use
d safely without medical supervision and restricts their sale to prescription by a licensed practiti
8 8 8
oner. The Controlled Substances Act addresses only controlled substances and their categorizatio
8 8
n. The Kefauver Harris Drug Amendment ensures drug efficacyand greaterdrug safety. Drug m 8
anufacturers are required to prove to the FDA the effectiveness of their products before marketin
g them.
8
DIF: Cognitive Level: Knowledge REF: p. 5Table l.3
OBJ: 5
NAT: NCLEX Client Needs Category: Physiological Integrity
8
TOP: Nursing Process Step: Assessment
CON: Safety |Patient Education |Evidence |Health Care Law 8
7. Whichclassification does meperidine (Demerol) fall under?
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 tosev
8 8
erepsychological and physical dependence. Schedule I drugs have high potential for abuseand n
8 8 8
o recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to lo
w to moderate physical dependence or high psychological dependence. Schedule IVdrugs have
8
low potential for abuse. Use may lead to limited physical or psychological dependence.
8
DIF: Cognitive Level: Knowledge
8 REF: p. 10
OBJ: 2NAT: NCLEX Client Needs Category: Safe, Effective Care
Environment
TOP: Nursing Process Step: Assessment CON: Patient Education |Addiction |Pain
8 8
8. Which action would the FDA taketo expedite drugdevelopment and approval for an outbreakof
smallpox?
a. List smallpox as a health orphandisease.
8
b. Omit thepreclinical researchphase.
c. Extend the clinicalresearch phase.
d. Fast trackthe investigational drug.
ANS: D
Once the Investigational New Drug Application has been approved, the drug can receive highest
8 8
priority within the agency, which is called fast tracking. A smallpox outbreak would become a p 8
riority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
8
research is not omitted. Extending any phase of the research would meanalonger time to develo
p avaccine. The FDAmust ensurethat all phases of the preclinical andclinical research phase hav
8 8
e been completed in a safe manner.
8
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 5
