, Chapter 01: Drug Definitions, Standards, and Information Sources Willihnga nz
j# j# j# j# j# j# j# j# j#
: Clayton’s Basic Pharmacology for Nurses, 20th Edition
j# j# j# j # j# j# j#
MULTIPLE CHOICE
1. Which name identifies a drug listed by the US Food a
nd Drug Administration (FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is liste
d 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 United States Adopted
Names Council.
DIF: Cognitive Level: Knowledge REF: p. 9 j # j # j #
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Cj# j# j# j# j# j# j# j# j#
are Environment TOP: Nursing Process Step: Assessment
j# j# j# j# j# j#
CON:
Patient Education j #
2. Which source contains information specific to nutritional supplements?
5% j# j # j# j # j # j#
a. USP Dictionary of USAN &International Drug Namesj# j # j # j # j # j #
b. Natural Medicines Comprehensive Database j# j# j#
c. United States Pharmacopoeia/National Formulary (USP NF) j# j# j# j # j#
d. Drug Interaction Facts j# j#
ANS: j # C
United States Pharmacopoeia/National Formulary contains information specific to nutrition a
j# j# j# j# j# j# j# j# j# j
l supplements. USP Dictionary of USAN & International Drug Names is a compilation o f
# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j
d rug names, pronunciation guide, and possible future FDA approved drugs; it does not i ncl
# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j #
u de nutritional supplements. Natural Medicines Comprehensive Database contains evidence-
j# j# j# j# j# j# j# j# j#
oducts; it does not include i
j# j # j# j# j #
nformation specific to nutritional supplements. Drug Interaction Facts contains comprehe
j# j# j# j# j# j# j# j# j# j #
n sive information on drug interaction facts; it does not include nutritional supple
j# j # j# j# j # j # j # j # j# j # j # j #
m ents. j#
DIF: j # j # Cognitive Level: Knowledge REF: p. 4 j # j # j # j # j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Int
j # j# j # j # j # j # j # j # j #
egrity
TOP: Nursing Process Step: Assessment CON: j# j# j # Nutrition | Patient Education j # j# j #
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
j# j# j # j # j# j # j # j # j# j # j# j # j #
a. Drug Facts and Comparisons j# j# j#
,Test Bank For Clayton’s Basic Pharmacology for Nurses 20th 3
Editi
b. Drug Interaction Facts j# j#
c. Handbook on Injectable Drugs j# j # j #
d. Martindale—The Complete Drug Reference j# j# j#
ANS: j # j # A
Drug Facts and Comparisons contains drug monographs that describe all drugs i
j # j # j # j # j # j # j # j # j # j # j #
n a therapeutic class. Monographs are formatted as tables to allow comparison of sim
j# j# j# j# j# j# j# j# j# j# j# j# j#
i l arproducts, brand names, manufacturers, cost indices, and available dosage forms O
j# j# j# j# j# j# j# j# j# j# j# j#
nline version is available. j# j# j#
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 j# j# j # j# j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity j# j # j# j# j#
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment j# j# j # j# j# j # j # j# j #
4. Which drug reference contains monographs about virtually everysingle-
j# j# j # j # j # j # j# j#
entitydrug available in the United States and describes therapeutic uses of drugs, includi
j# j# j# j# j# j# j# j# j# j# j# j# j
n g approved and unapproved uses?
# j # j# j# j# j#
a. Martindale: The Complete Drug Reference j # j# j # j#
b. AHFS Drug Information j# j #
c. Drug Reference j#
d. Drug Facts and Comparisons j# j # j #
ANS: j # j # B
AHFS Drug Information contains monographs about virtually every single-
j # j # j # j # j # j # j # j #
entity drug available in the United States and describes therapeutic uses of drugs, includi n
j# j# j# j# j# j# j# j# j# j# j# j# j # j #
g approved and unapproved uses.
j# j# j# j#
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 j# j# j # j# j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity j# j# j# j# j#
TOP: Nursing Process Step: Planning CON: Safety | Patient Education | Clinical Judgment j# j # j # j# j# j # j # j# j #
5. Which online drug reference makes available to healthcare providers and the public a s tan
j# j# j# j# j# j# j# j# j# j# j# j# j# j #
dard, comprehensive, up-to- j# j #
date look up and downloadable resource about medicines?
j# j# j# j# j# j# j#
a. American Drug Index j# j#
b. American Hospital Formulary j# j#
c. DailyMed
d. Drug Reference j#
ANS: j # C
DailyMed makes available to healthcare providers and the public a standard, comprehensi v
j# j# j# j# j# j# j# j# j# j# j# j #
e , up - to-
j # l j# j# j#
date look up and downloadable resource about medicines. The American Drug Index is n ot
j# j# j# j# j# j# j# j# j# j# j# j# j# j # j#
appropriate for patient use. The American Hospital Formulary is not appropriate for p atie
j# j# j# j# j# j# j# j# j# j# j# j# j# j #
nt use. The drug reference is not appropriate for patient use.
j # j # j # j # j # j # j # j # j # j #
DIF: j # j # Cognitive Level: Knowledge REF: p. 3 | p. 4 j # j # j # j # j # j # j# j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Int
j # j# j # j # j # j # j # j # j #
egrity
TOP: Nursing Process Step: Implementation
j # j # j# j # j #
CON: Safety | Patient Education | Clinical Judgment j# j# j # j # j# j#
6. Which legislation authorizes the FDA to determine the safetyof a drug before its marketing?
j # j # j # j # j# j # j # j # j# j# j# j # j #
a. Federal Food, Drug, and Cosmetic Act (1938) j# j# j # j # j# j #
b. Durham Humphrey Amendment (1952) j# j# j #
, Test Bank For Clayton’s Basic Pharmacology for Nurses 20th 4
Editi
c. Controlled Substances Act (1970) j# j# j #
d. Kefauver Harris Drug Amendment (1962) j# j# j# j #
ANS: j # j # A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine t
j # j # j # j # j # j # j # j # j # j # j # j # j # j #
he s j#
afety of all drugs before marketing. Later amendments and acts helped tighte
j # j # j # j # j # j # j # j # j # j # j #
n FD A contro l and ensure drug safety. The Durham Humphrey Amendment defines t
j # j# j # j # j # j # j # j # j # j # j # j # j # j #
he kinds of drugs t j # j# j# j#
hat cannot be used safely without medical supervision and restricts their s ale to
j # j # j # j # j # j # j # j # j # j # j # j # j # j #
prescriptio n by a licensed practitioner. The Controlled Substances Act addresses o nly contro
j# j# j# j# j# j# j# j# j# j# j# j # j#
lled subst ances and their categorization. The Kefauver Harris Drug Amendment ensures drug
j# j# j# j# j# j# j# j# j# j# j# j# j#
efficacy and greater drug safety. Drug manufacturers are required to prove to the FDA the effe
j# j# j# j# j# j# j# j# j# j# j# j # j# j# j#
ctive ness of their products before marketing them.
j# j# j# j# j# j# j#
DIF: Cognitive Level: Knowledge j# j#
REF: p. 5 Table l.3 OBJ: 5 j # j # j# j# j#
NAT: NCLEX Client Needs Category: Physiological Integrit y T j# j# j# j# j# j# j# j#
OP: Nursing Process Step: Assessment
j # j# j # j#
CON: Safety | Patient Education | Evidence | Health Care Law j # j# j # j # j# j # j# j # j #
7. Which classification does meperidine (Demerol) fall under?
5% j# j # j # j # j#
a. I
b. II
c. III
d. IV
ANS: j # j # B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abu j # j # j # j # j # j # j # j # j # j # j # j # j #
se and may lea d to severe psychological and physical dependence. Schedule I drugs have hi
j # j# j # j# j# j# j# j# j# j# j# j# j# j# j#
gh p otential for abuse and no recognized medical use. Schedule III drugs have some potentia
j# j # j# j# j# j# j# j# j# j# j# j# j# j# j#
l for abuse. Us
j # j# j#
e may lead to low to moderate physical dependence or high psychological dep j# j# j# j# j# j# j# j# j# j# j# j#
endence. Sc hedule IVdrugs have low potential for abuse. Use may lead to limited ph ysica
j# j # j# j# j# j# j# j# j# j# j# j# j# j# j #
l or psychol
j# ogical dependence.
j# j#
DIF: Cognitive Level: Knowledge REF: p. 10 j # j # j #
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective j# j# j # j# j# j# j# j# j
#C are Environment j# j#
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain j# j # j # j # j # j# j # j#
8. Which action would the FDA take to expedite drug development and approval for an outb r
j# j# j# j# j# j# j# j# j# j # j# j# j# j# j#
e ak of smallpox?
j# j# j#
a. List smallpox as a health orphan disease. j # j # j# j # j # j#
b. Omit the preclinical research phase. j # j# j# j#
c. Extend the clinical research phase. j# j# j# j#
d. Fast track the investigational drug. j# j# j# j#
ANS: j # D
Once the Investigational New Drug Application has been approved, the drug can receive h igh
j# j# j# j# j# j# j# j# j# j# j# j# j# j #
est priority within the agency, which is called fast tracking. A smallpox outbreak wou l
j # j # j # j # j # j # j # j # j # j # j # j # j # j#
d become a priority concern in the world. Orphan diseases are not researched in a priori
j # j# j# j# j# j# j# j# j# j# j# j# j# j# j#
ty j#
manner. Preclinical research is not omitted. Extending any phase of the research would mej# j# j# j# j# j# j# j# j# j# j# j# j #
an a longer time to develop a vaccine. The FDA must ensure that all phases of the pre
j # j# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j#
clinical and clinical research phase have been completed in a safe manner.
j# j# j# j# j# j# j# j# j# j# j#
DIF: Cognitive Level: Knowledge j# j# REF: p. 7 j # OBJ: 5
j# j# j# j# j# j# j# j# j#
: Clayton’s Basic Pharmacology for Nurses, 20th Edition
j# j# j# j # j# j# j#
MULTIPLE CHOICE
1. Which name identifies a drug listed by the US Food a
nd Drug Administration (FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is liste
d 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 United States Adopted
Names Council.
DIF: Cognitive Level: Knowledge REF: p. 9 j # j # j #
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Cj# j# j# j# j# j# j# j# j#
are Environment TOP: Nursing Process Step: Assessment
j# j# j# j# j# j#
CON:
Patient Education j #
2. Which source contains information specific to nutritional supplements?
5% j# j # j# j # j # j#
a. USP Dictionary of USAN &International Drug Namesj# j # j # j # j # j #
b. Natural Medicines Comprehensive Database j# j# j#
c. United States Pharmacopoeia/National Formulary (USP NF) j# j# j# j # j#
d. Drug Interaction Facts j# j#
ANS: j # C
United States Pharmacopoeia/National Formulary contains information specific to nutrition a
j# j# j# j# j# j# j# j# j# j
l supplements. USP Dictionary of USAN & International Drug Names is a compilation o f
# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j
d rug names, pronunciation guide, and possible future FDA approved drugs; it does not i ncl
# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j #
u de nutritional supplements. Natural Medicines Comprehensive Database contains evidence-
j# j# j# j# j# j# j# j# j#
oducts; it does not include i
j# j # j# j# j #
nformation specific to nutritional supplements. Drug Interaction Facts contains comprehe
j# j# j# j# j# j# j# j# j# j #
n sive information on drug interaction facts; it does not include nutritional supple
j# j # j# j# j # j # j # j # j# j # j # j #
m ents. j#
DIF: j # j # Cognitive Level: Knowledge REF: p. 4 j # j # j # j # j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Int
j # j# j # j # j # j # j # j # j #
egrity
TOP: Nursing Process Step: Assessment CON: j# j# j # Nutrition | Patient Education j # j# j #
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
j# j# j # j # j# j # j # j # j# j # j# j # j #
a. Drug Facts and Comparisons j# j# j#
,Test Bank For Clayton’s Basic Pharmacology for Nurses 20th 3
Editi
b. Drug Interaction Facts j# j#
c. Handbook on Injectable Drugs j# j # j #
d. Martindale—The Complete Drug Reference j# j# j#
ANS: j # j # A
Drug Facts and Comparisons contains drug monographs that describe all drugs i
j # j # j # j # j # j # j # j # j # j # j #
n a therapeutic class. Monographs are formatted as tables to allow comparison of sim
j# j# j# j# j# j# j# j# j# j# j# j# j#
i l arproducts, brand names, manufacturers, cost indices, and available dosage forms O
j# j# j# j# j# j# j# j# j# j# j# j#
nline version is available. j# j# j#
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 j# j# j # j# j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity j# j # j# j# j#
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment j# j# j # j# j# j # j # j# j #
4. Which drug reference contains monographs about virtually everysingle-
j# j# j # j # j # j # j# j#
entitydrug available in the United States and describes therapeutic uses of drugs, includi
j# j# j# j# j# j# j# j# j# j# j# j# j
n g approved and unapproved uses?
# j # j# j# j# j#
a. Martindale: The Complete Drug Reference j # j# j # j#
b. AHFS Drug Information j# j #
c. Drug Reference j#
d. Drug Facts and Comparisons j# j # j #
ANS: j # j # B
AHFS Drug Information contains monographs about virtually every single-
j # j # j # j # j # j # j # j #
entity drug available in the United States and describes therapeutic uses of drugs, includi n
j# j# j# j# j# j# j# j# j# j# j# j# j # j #
g approved and unapproved uses.
j# j# j# j#
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 j# j# j # j# j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity j# j# j# j# j#
TOP: Nursing Process Step: Planning CON: Safety | Patient Education | Clinical Judgment j# j # j # j# j# j # j # j# j #
5. Which online drug reference makes available to healthcare providers and the public a s tan
j# j# j# j# j# j# j# j# j# j# j# j# j# j #
dard, comprehensive, up-to- j# j #
date look up and downloadable resource about medicines?
j# j# j# j# j# j# j#
a. American Drug Index j# j#
b. American Hospital Formulary j# j#
c. DailyMed
d. Drug Reference j#
ANS: j # C
DailyMed makes available to healthcare providers and the public a standard, comprehensi v
j# j# j# j# j# j# j# j# j# j# j# j #
e , up - to-
j # l j# j# j#
date look up and downloadable resource about medicines. The American Drug Index is n ot
j# j# j# j# j# j# j# j# j# j# j# j# j# j # j#
appropriate for patient use. The American Hospital Formulary is not appropriate for p atie
j# j# j# j# j# j# j# j# j# j# j# j# j# j #
nt use. The drug reference is not appropriate for patient use.
j # j # j # j # j # j # j # j # j # j #
DIF: j # j # Cognitive Level: Knowledge REF: p. 3 | p. 4 j # j # j # j # j # j # j# j #
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Int
j # j# j # j # j # j # j # j # j #
egrity
TOP: Nursing Process Step: Implementation
j # j # j# j # j #
CON: Safety | Patient Education | Clinical Judgment j# j# j # j # j# j#
6. Which legislation authorizes the FDA to determine the safetyof a drug before its marketing?
j # j # j # j # j# j # j # j # j# j# j# j # j #
a. Federal Food, Drug, and Cosmetic Act (1938) j# j# j # j # j# j #
b. Durham Humphrey Amendment (1952) j# j# j #
, Test Bank For Clayton’s Basic Pharmacology for Nurses 20th 4
Editi
c. Controlled Substances Act (1970) j# j# j #
d. Kefauver Harris Drug Amendment (1962) j# j# j# j #
ANS: j # j # A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine t
j # j # j # j # j # j # j # j # j # j # j # j # j # j #
he s j#
afety of all drugs before marketing. Later amendments and acts helped tighte
j # j # j # j # j # j # j # j # j # j # j #
n FD A contro l and ensure drug safety. The Durham Humphrey Amendment defines t
j # j# j # j # j # j # j # j # j # j # j # j # j # j #
he kinds of drugs t j # j# j# j#
hat cannot be used safely without medical supervision and restricts their s ale to
j # j # j # j # j # j # j # j # j # j # j # j # j # j #
prescriptio n by a licensed practitioner. The Controlled Substances Act addresses o nly contro
j# j# j# j# j# j# j# j# j# j# j# j # j#
lled subst ances and their categorization. The Kefauver Harris Drug Amendment ensures drug
j# j# j# j# j# j# j# j# j# j# j# j# j#
efficacy and greater drug safety. Drug manufacturers are required to prove to the FDA the effe
j# j# j# j# j# j# j# j# j# j# j# j # j# j# j#
ctive ness of their products before marketing them.
j# j# j# j# j# j# j#
DIF: Cognitive Level: Knowledge j# j#
REF: p. 5 Table l.3 OBJ: 5 j # j # j# j# j#
NAT: NCLEX Client Needs Category: Physiological Integrit y T j# j# j# j# j# j# j# j#
OP: Nursing Process Step: Assessment
j # j# j # j#
CON: Safety | Patient Education | Evidence | Health Care Law j # j# j # j # j# j # j# j # j #
7. Which classification does meperidine (Demerol) fall under?
5% j# j # j # j # j#
a. I
b. II
c. III
d. IV
ANS: j # j # B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abu j # j # j # j # j # j # j # j # j # j # j # j # j #
se and may lea d to severe psychological and physical dependence. Schedule I drugs have hi
j # j# j # j# j# j# j# j# j# j# j# j# j# j# j#
gh p otential for abuse and no recognized medical use. Schedule III drugs have some potentia
j# j # j# j# j# j# j# j# j# j# j# j# j# j# j#
l for abuse. Us
j # j# j#
e may lead to low to moderate physical dependence or high psychological dep j# j# j# j# j# j# j# j# j# j# j# j#
endence. Sc hedule IVdrugs have low potential for abuse. Use may lead to limited ph ysica
j# j # j# j# j# j# j# j# j# j# j# j# j# j# j #
l or psychol
j# ogical dependence.
j# j#
DIF: Cognitive Level: Knowledge REF: p. 10 j # j # j #
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective j# j# j # j# j# j# j# j# j
#C are Environment j# j#
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain j# j # j # j # j # j# j # j#
8. Which action would the FDA take to expedite drug development and approval for an outb r
j# j# j# j# j# j# j# j# j# j # j# j# j# j# j#
e ak of smallpox?
j# j# j#
a. List smallpox as a health orphan disease. j # j # j# j # j # j#
b. Omit the preclinical research phase. j # j# j# j#
c. Extend the clinical research phase. j# j# j# j#
d. Fast track the investigational drug. j# j# j# j#
ANS: j # D
Once the Investigational New Drug Application has been approved, the drug can receive h igh
j# j# j# j# j# j# j# j# j# j# j# j# j# j #
est priority within the agency, which is called fast tracking. A smallpox outbreak wou l
j # j # j # j # j # j # j # j # j # j # j # j # j # j#
d become a priority concern in the world. Orphan diseases are not researched in a priori
j # j# j# j# j# j# j# j# j# j# j# j# j# j# j#
ty j#
manner. Preclinical research is not omitted. Extending any phase of the research would mej# j# j# j# j# j# j# j# j# j# j# j# j #
an a longer time to develop a vaccine. The FDA must ensure that all phases of the pre
j # j# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j# j#
clinical and clinical research phase have been completed in a safe manner.
j# j# j# j# j# j# j# j# j# j# j#
DIF: Cognitive Level: Knowledge j# j# REF: p. 7 j # OBJ: 5
