,Chapter 01: Drug Definitions, Standards, and Information Sources
Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition
MULTIPLE CHOICE
1. Which name identifies a drug listed by the US 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 United States Adopted Names Council.
DIF: Cognitive Level: Knowledge REF: p. 9 OBJ: 1
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
TOP: Nursing Process Step: Assessment CON: Patient Education
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. 4 OBJ: 3
NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
a. Drug Facts and Comparisons
b. Drug Interaction Facts
c. Handbook on Injectable Drugs
d. Martindale—The Complete Drug Reference
ANS: A
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
therapeutic class. Monographs are formatted as tables to allow comparison of similar
products, brand names, manufacturers, cost indices, and available dosage forms
, Online version is available.
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment
4. Which drug reference contains monographs about virtually every single-entity drug available
in the United States and describes therapeutic uses of drugs, including approved and
unapproved uses?
a. Martindale: The Complete Drug Reference
b. AHFS Drug 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 of drugs, including approved and
unapproved uses.
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Planning CON: Safety | Patient Education | Clinical Judgment
5. Which online drug reference makes available to healthcare 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. Drug Reference
ANS: C
DailyMed makes available to healthcare 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 drug reference is not appropriate for patient use.
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 OBJ: 3
NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Implementation
CON: Safety | Patient Education | Clinical Judgment
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. 5 Table l.3
OBJ: 5 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment
CON: Safety | Patient Education | Evidence | Health Care Law
7. Which classification 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 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: Knowledge REF: p. 10 OBJ: 2
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain
8. Which action would the FDA take to expedite drug development and approval for an outbreak
of smallpox?
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: 5
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
TOP: Nursing Process Step: Assessment
CON: Health Care Law | Health Care Policy | Infection | Care Coordination
Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition
MULTIPLE CHOICE
1. Which name identifies a drug listed by the US 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 United States Adopted Names Council.
DIF: Cognitive Level: Knowledge REF: p. 9 OBJ: 1
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
TOP: Nursing Process Step: Assessment CON: Patient Education
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. 4 OBJ: 3
NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
a. Drug Facts and Comparisons
b. Drug Interaction Facts
c. Handbook on Injectable Drugs
d. Martindale—The Complete Drug Reference
ANS: A
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
therapeutic class. Monographs are formatted as tables to allow comparison of similar
products, brand names, manufacturers, cost indices, and available dosage forms
, Online version is available.
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment
4. Which drug reference contains monographs about virtually every single-entity drug available
in the United States and describes therapeutic uses of drugs, including approved and
unapproved uses?
a. Martindale: The Complete Drug Reference
b. AHFS Drug 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 of drugs, including approved and
unapproved uses.
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Planning CON: Safety | Patient Education | Clinical Judgment
5. Which online drug reference makes available to healthcare 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. Drug Reference
ANS: C
DailyMed makes available to healthcare 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 drug reference is not appropriate for patient use.
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 OBJ: 3
NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Implementation
CON: Safety | Patient Education | Clinical Judgment
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. 5 Table l.3
OBJ: 5 NAT: NCLEX Client Needs Category: Physiological Integrity
TOP: Nursing Process Step: Assessment
CON: Safety | Patient Education | Evidence | Health Care Law
7. Which classification 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 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: Knowledge REF: p. 10 OBJ: 2
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain
8. Which action would the FDA take to expedite drug development and approval for an outbreak
of smallpox?
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: 5
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
TOP: Nursing Process Step: Assessment
CON: Health Care Law | Health Care Policy | Infection | Care Coordination
