TestBank
n
, Chapter1: Drug Definitions, Standards,and Information Sources Test Bank
n n n n n n n n n
MULTIPLE CHOICE n
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
n n n n n n n n n n n n n n n n
(FDA)?
n
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C n
The official name is the name under which a drug is listed by the FDA. The brand name, or
n n n n n n n n n n n n n n n n n n
trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
n n n n n n n n n n n n n n n
name is provided by the U.S. Adopted Names Council.
n n n n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
n n n n n n n n
2. Which source contains information specific to nutritional supplements?
n n n n n n n
a. USP Dictionary of USAN & International Drug Names
n n n n n n n
b. Natural Medicines Comprehensive Database n n n
c. United States Pharmacopoeia/National Formulary (USP NF) n n n n n
d. Drug Interaction Facts n n
ANS: C n
United States Pharmacopoeia/National Formulary contains information specific to nutritional
n n n n n n n n
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
n n n n n n n n n n n n n n
names, pronunciation guide, and possible future FDA approved drugs; it does not include
n n n n n n n n n n n n n
nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
n n n n n n n n n
information on herbal medicines and herbal combination products; it does not include information
n n n n n n n n n n n n n
specific to nutritional supplements. Drug Interaction Facts contains comprehensive information
n n n n n n n n n n
on drug interaction facts; it does not include nutritional supplements.
n n n n n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
3. What is the most comprehensive reference available to research a drug interaction?
n n n n n n n n n n n
a. Drug Facts and Comparisons n n n
b. Drug Interaction Facts n n
c. Handbook on Injectable Drugs n n n
d. Martindale—The Complete Drug Reference n n n
ANS: B n
First published in 1983, Drug Interaction Facts is the most comprehensive book available
n n n n n n n n n n n n
ondrug interactions. In addition to monographs listing various aspects of drug interactions, this
n n n n n n n n n n n n n
information is reviewed and updated by an internationally renowned group of physicians
n n n n n n n n n n n n
andpharmacists with clinical and scientific expertise.
n n n n n n
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
n n n n n n n n
, Nursing Process Step: Assessment n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which section of
n n n n n n n n n n n n n n n n n
the Physicians’ Desk Reference (PDR) is most helpful to get information about this drug?
n n n n n n n n n n n n n n
a. Manufacturer’s section n
b. Brand and Generic Name section n n n n
c. Product Category section n n
d. Product Information section n n
n ANS: B n
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
n n n n n n n n
Nursing Process Step: Planning n n n
MSC: NCLEX Client Needs Category: Physiological Integrity
n n n n n n
5. Which online drug reference makes available to health care providers and the public a
n n n n n n n n n n n n n
standard, comprehensive, up to date look up and downloadable resource about medicines?
n n n n n n n n n n n n
a. American Drug Index n n
b. American Hospital Formulary n n
c. DailyMed
d. Physicians’ Desk Reference (PDR) n n n
ANS: C n
DailyMed makes available to health care providers and the public a standard, comprehensive, up
n n n n n n n n n n n n n
to date look up and downloadable resource about medicines. The American Drug Index is not
n n n n n n n n n n n n n n n
appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
n n n n n n n n n n n n n n
The PDR is not appropriate for patient use.
n n n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
n n n n n n n n n
Process Step: Implementation
n n n
MSC: NCLEX Client Needs Category: Physiological Integrity
n n n n n n
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
n n n n n n n n n n n n n n
a. Federal Food, Drug, and Cosmetic Act (1938) n n n n n n
b. Durham Humphrey Amendment (1952) n n n
c. Controlled Substances Act (1970) n n n
d. Kefauver Harris Drug Amendment (1962) n n n n
ANS: A n
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of
n n n n n n n n n n n n n n n n
all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure
n n n n n n n n n n n n n n
drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used
n n n n n n n n n n n n n n n
safely without medical supervision and restricts their sale to prescription by a licensed
n n n n n n n n n n n n n
practitioner. The Controlled Substances Act addresses only controlled substances and their
n n n n n n n n n n n
categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug
n n n n n n n n n n n n
safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products
n n n n n n n n n n n n n n n
before marketing them.
n n n
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
n n n n n n n n n n n n
, dependency. Under which classification does this drug fall? n n n n n n n
a. I
b. II
c. III
d. IV
ANS: B n
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe
n n n n n n n n n n n n n n n n n n
psychological and physical dependence. Schedule Idrugs have high potential forabuse and no
n n n n n n n n n n n n n n
recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to
n n n n n n n n n n n n n n n n n
moderate physical dependence or high psychological dependence. Schedule IV drugs have low
n n n n n n n n n n n n
potential for abuse. Use may lead to limited physical or psychological dependence.
n n n n n n n n n n n n
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7TOP:
n n n n n n n n n n n
Nursing Process Step: Assessment
n n n n
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
n n n n n n n n
8. What would the FDA do to expedite drug development and approval for an outbreak of
n n n n n n n n n n n n n n
smallpox, for which there is no known treatment?
n n n n n n n n
a. List smallpox as a health orphan disease.
n n n n n n
b. Omit the preclinical research phase. n n n n
c. Extend the clinical research phase. n n n n
d. Fast track the investigational drug.
n n n n
ANS: D n
Once the Investigational New Drug Application has been approved, the drug can receive highest
n n n n n n n n n n n n n
priority within the agency, which is called fast tracking. A smallpox outbreak would become a
n n n n n n n n n n n n n n n
priority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
n n n n n n n n n n n n n n n
research is not omitted. Extending any phase of the research would mean a longer time to develop
n n n n n n n n n n n n n n n n n
a vaccine. The FDA must ensure that all phases of the preclinical and clinical research phase have
n n n n n n n n n n n n n n n n n
been completed in a safe manner.
n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
n n n n n n n n
9. Which statement is true about over the counter (OTC) drugs?
n n n n n n n n n
a. They are not listed in the USP NF. n n n n n n n
b. A prescription from a health care provider is needed.
n n n n n n n n
c. They are sold without a prescription. n n n n n
d. They are known only by their brand names. n n n n n n n
ANS: C n
OTC medications do not require a prescription. A variety of names, both generic and trade, can be
n n n n n n n n n n n n n n n n
used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription drugs
n n n n n n n n n n n n n n n n
require an order by a health professional who is licensed to prescribe, such as a physician, nurse
n n n n n n n n n n n n n n n n n
practitioner, physician assistant, or dentist.
n n n n n
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP: Nursing
n n n n n n n n n
Process Step: Planning
n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
10. Which is the most authoritative reference for medications that are injected?
n n n n n n n n n n
n
, Chapter1: Drug Definitions, Standards,and Information Sources Test Bank
n n n n n n n n n
MULTIPLE CHOICE n
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
n n n n n n n n n n n n n n n n
(FDA)?
n
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C n
The official name is the name under which a drug is listed by the FDA. The brand name, or
n n n n n n n n n n n n n n n n n n
trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
n n n n n n n n n n n n n n n
name is provided by the U.S. Adopted Names Council.
n n n n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
n n n n n n n n
2. Which source contains information specific to nutritional supplements?
n n n n n n n
a. USP Dictionary of USAN & International Drug Names
n n n n n n n
b. Natural Medicines Comprehensive Database n n n
c. United States Pharmacopoeia/National Formulary (USP NF) n n n n n
d. Drug Interaction Facts n n
ANS: C n
United States Pharmacopoeia/National Formulary contains information specific to nutritional
n n n n n n n n
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
n n n n n n n n n n n n n n
names, pronunciation guide, and possible future FDA approved drugs; it does not include
n n n n n n n n n n n n n
nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
n n n n n n n n n
information on herbal medicines and herbal combination products; it does not include information
n n n n n n n n n n n n n
specific to nutritional supplements. Drug Interaction Facts contains comprehensive information
n n n n n n n n n n
on drug interaction facts; it does not include nutritional supplements.
n n n n n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
3. What is the most comprehensive reference available to research a drug interaction?
n n n n n n n n n n n
a. Drug Facts and Comparisons n n n
b. Drug Interaction Facts n n
c. Handbook on Injectable Drugs n n n
d. Martindale—The Complete Drug Reference n n n
ANS: B n
First published in 1983, Drug Interaction Facts is the most comprehensive book available
n n n n n n n n n n n n
ondrug interactions. In addition to monographs listing various aspects of drug interactions, this
n n n n n n n n n n n n n
information is reviewed and updated by an internationally renowned group of physicians
n n n n n n n n n n n n
andpharmacists with clinical and scientific expertise.
n n n n n n
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
n n n n n n n n
, Nursing Process Step: Assessment n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which section of
n n n n n n n n n n n n n n n n n
the Physicians’ Desk Reference (PDR) is most helpful to get information about this drug?
n n n n n n n n n n n n n n
a. Manufacturer’s section n
b. Brand and Generic Name section n n n n
c. Product Category section n n
d. Product Information section n n
n ANS: B n
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
n n n n n n n n
Nursing Process Step: Planning n n n
MSC: NCLEX Client Needs Category: Physiological Integrity
n n n n n n
5. Which online drug reference makes available to health care providers and the public a
n n n n n n n n n n n n n
standard, comprehensive, up to date look up and downloadable resource about medicines?
n n n n n n n n n n n n
a. American Drug Index n n
b. American Hospital Formulary n n
c. DailyMed
d. Physicians’ Desk Reference (PDR) n n n
ANS: C n
DailyMed makes available to health care providers and the public a standard, comprehensive, up
n n n n n n n n n n n n n
to date look up and downloadable resource about medicines. The American Drug Index is not
n n n n n n n n n n n n n n n
appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
n n n n n n n n n n n n n n
The PDR is not appropriate for patient use.
n n n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
n n n n n n n n n
Process Step: Implementation
n n n
MSC: NCLEX Client Needs Category: Physiological Integrity
n n n n n n
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
n n n n n n n n n n n n n n
a. Federal Food, Drug, and Cosmetic Act (1938) n n n n n n
b. Durham Humphrey Amendment (1952) n n n
c. Controlled Substances Act (1970) n n n
d. Kefauver Harris Drug Amendment (1962) n n n n
ANS: A n
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of
n n n n n n n n n n n n n n n n
all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure
n n n n n n n n n n n n n n
drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used
n n n n n n n n n n n n n n n
safely without medical supervision and restricts their sale to prescription by a licensed
n n n n n n n n n n n n n
practitioner. The Controlled Substances Act addresses only controlled substances and their
n n n n n n n n n n n
categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug
n n n n n n n n n n n n
safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products
n n n n n n n n n n n n n n n
before marketing them.
n n n
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
n n n n n n n n n n n n
, dependency. Under which classification does this drug fall? n n n n n n n
a. I
b. II
c. III
d. IV
ANS: B n
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe
n n n n n n n n n n n n n n n n n n
psychological and physical dependence. Schedule Idrugs have high potential forabuse and no
n n n n n n n n n n n n n n
recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to
n n n n n n n n n n n n n n n n n
moderate physical dependence or high psychological dependence. Schedule IV drugs have low
n n n n n n n n n n n n
potential for abuse. Use may lead to limited physical or psychological dependence.
n n n n n n n n n n n n
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7TOP:
n n n n n n n n n n n
Nursing Process Step: Assessment
n n n n
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
n n n n n n n n
8. What would the FDA do to expedite drug development and approval for an outbreak of
n n n n n n n n n n n n n n
smallpox, for which there is no known treatment?
n n n n n n n n
a. List smallpox as a health orphan disease.
n n n n n n
b. Omit the preclinical research phase. n n n n
c. Extend the clinical research phase. n n n n
d. Fast track the investigational drug.
n n n n
ANS: D n
Once the Investigational New Drug Application has been approved, the drug can receive highest
n n n n n n n n n n n n n
priority within the agency, which is called fast tracking. A smallpox outbreak would become a
n n n n n n n n n n n n n n n
priority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
n n n n n n n n n n n n n n n
research is not omitted. Extending any phase of the research would mean a longer time to develop
n n n n n n n n n n n n n n n n n
a vaccine. The FDA must ensure that all phases of the preclinical and clinical research phase have
n n n n n n n n n n n n n n n n n
been completed in a safe manner.
n n n n n n
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
n n n n n n n n n
Process Step: Assessment
n n n
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
n n n n n n n n
9. Which statement is true about over the counter (OTC) drugs?
n n n n n n n n n
a. They are not listed in the USP NF. n n n n n n n
b. A prescription from a health care provider is needed.
n n n n n n n n
c. They are sold without a prescription. n n n n n
d. They are known only by their brand names. n n n n n n n
ANS: C n
OTC medications do not require a prescription. A variety of names, both generic and trade, can be
n n n n n n n n n n n n n n n n
used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription drugs
n n n n n n n n n n n n n n n n
require an order by a health professional who is licensed to prescribe, such as a physician, nurse
n n n n n n n n n n n n n n n n n
practitioner, physician assistant, or dentist.
n n n n n
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP: Nursing
n n n n n n n n n
Process Step: Planning
n n n
MSC: NCLEXClient Needs Category: Physiological Integrity
n n n n n n
10. Which is the most authoritative reference for medications that are injected?
n n n n n n n n n n
