Test Bank
for Clayton's Basic Pharmacology for Nurses 18th Edition by Michelle J.
Willihnganz, Samuel L. Gurevitz & Bruce D. Clayton ISBN 9780323550611
Chapter 1-48 | Complete Guide A+
,Chapter 1: Drug Definitions, Standards, and Information Sources
p1 p1 p1 p1 p1 p1 p1
Test Bank
p1 p1
MULTIPLE CHOICE p1
1. What is the name under which a drug is listed by the U.S. Food and Drug
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Administration (FDA)?
p1 p1
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: p 1 C
The official name is the name under which a drug is listed by the FDA. The brand name,
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
or trademark, is the name given to a drug by its manufacturer. The nonproprietary, or
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
generic, name is provided by the U.S. Adopted Names Council.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: p1 p1 p 1 p1
p 2 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
p 1 p1 p1 p1 p1 p1 p1 p1
2. Which source contains information specific to nutritional supplements?
p1 p1 p1 p1 p1 p1 p1
a. USP Dictionary of USAN & International Drug Names
p1 p1 p1 p1 p1 p1 p1
b. Natural Medicines Comprehensive Database p1 p1 p1
c. United States Pharmacopoeia/National Formulary (USP NF) p1 p1 p1 p1 p1
d. Drug Interaction Facts p1 p1
ANS: p 1 C
United States Pharmacopoeia/National Formulary contains information specific to
p1 p1 p1 p1 p1 p1 p1
nutritional supplements. USP Dictionary of USAN & International Drug Names is a
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
compilation of drug names, pronunciation guide, and possible future FDA approved drugs;
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
it does not include nutritional supplements. Natural Medicines Comprehensive Database
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
contains evidence based information on herbal medicines and herbal combination products;
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
it does not include information specific to nutritional supplements. Drug Interaction Facts
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
contains comprehensive information on drug interaction facts; it does not include
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
nutritional supplements.
p1 p1
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: p1 p1 p 1 p1
p 4 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
3. What is the most comprehensive reference available to research a drug interaction?
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
a. Drug Facts and Comparisons p1 p1 p1
b. Drug Interaction Facts p1 p1
c. Handbook on Injectable Drugs p1 p1 p1
d. Martindale—The Complete Drug Reference p1 p1 p1
ANS: p 1 B
, First published in 1983, Drug Interaction Facts is the most comprehensive book available on
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
drug interactions. In addition to monographs listing various aspects of drug interactions,
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
this information is reviewed and updated by an internationally renowned group of
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
physicians and pharmacists with clinical and scientific expertise.
p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: p1 p1 p 1 p1
p 3 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
section of the Physicians’ Desk Reference (PDR) is most helpful to get information about
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
this drug?
p1 p1
a. Manufacturer‟s section p1
b. Brand and Generic Name section p1 p1 p1 p1
c. Product Category section p1 p1
d. Product Information section p1 p1
ANS: p 1 B
A physician‟s order would include the brand and/or generic name of the drug. The alphabetic
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
index in the PDR would make this section the most user friendly. Based on a physician‟s
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
order, manufacturer‟s information and classification information would not be known. The
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Manufacturer‟s section is a roster of manufacturers. The Product Category section lists
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
products subdivided by therapeutic classes, such as analgesics, laxatives, oxytocics, and
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
antibiotics. The Product Information section contains reprints of the package inserts for the
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
major products of manufacturers.
p1 p1 p1 p1
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: p1 p1 p 1 p1
p 4 TOP: Nursing Process Step: Planning
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
5. Which online drug reference makes available to health care providers and the public a
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
standard, comprehensive, up to date look up and downloadable resource about
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
medicines?
p1
a. American Drug Index p1 p1
b. American Hospital Formulary p1 p1
c. DailyMed
d. Physicians’ Desk Reference (PDR) p1 p1 p1
ANS: p 1 C
DailyMed makes available to health care providers and the public a standard, comprehensive,
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
up to date look up and downloadable resource about medicines. The American Drug Index
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
is not appropriate for patient use. The American Hospital Formulary is not appropriate for
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
patient use. The PDR is not appropriate for patient use.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: p1 p1 p 1 p1
p 5 TOP: Nursing Process Step: Implementation
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
a. Federal Food, Drug, and Cosmetic Act (1938) p1 p1 p1 p1 p1 p1
b. Durham Humphrey Amendment (1952) p1 p1 p1
c. Controlled Substances Act (1970) p1 p1 p1
, d. Kefauver Harris Drug Amendment (1962) p1 p1 p1 p1
ANS: p 1 A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
safety of all drugs before marketing. Later amendments and acts helped tighten FDA
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
control and ensure drug safety. The Durham Humphrey Amendment defines the kinds of
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
drugs that cannot be used safely without medical supervision and restricts their sale to
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
prescription by a licensed practitioner. The Controlled Substances Act addresses only
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
controlled substances and their categorization. The Kefauver Harris Drug Amendment
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
ensures drug efficacy and greater drug safety. Drug manufacturers are required to prove to
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
the FDA the effectiveness of their products before marketing them.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: p1 p1 p 1 p1
p 8 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
7. Meperidine (Demerol) is a narcotic with a high potential for physical and
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
p1 psychological dependency. Under which classification does this drug fall? p1 p1 p1 p1 p1 p1 p1 p1
a. I
b. II
c. III
d. IV
ANS: p 1 B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
to severe psychological and physical dependence. Schedule I drugs have high potential for
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
abuse and no recognized medical use. Schedule III drugs have some potential for abuse.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Use may lead to low to moderate physical dependence or high psychological dependence.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Schedule IV drugs have low potential for abuse. Use may lead to limited physical or
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
psychological dependence.
p1 p1
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: p1 p1 p 1 p1 p1 p1 p1
p 7 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
p 1 p1 p1 p1 p1 p1 p1 p1
8. What would the FDA do to expedite drug development and approval for an outbreak
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
of smallpox, for which there is no known treatment?
p1 p1 p1 p1 p1 p1 p1 p1 p1
a. List smallpox as a health orphan disease.
p1 p1 p1 p1 p1 p1
b. Omit the preclinical research phase. p1 p1 p1 p1
c. Extend the clinical research phase. p1 p1 p1 p1
d. Fast track the investigational drug.p1 p1 p1 p1
ANS: p 1 D
Once the Investigational New Drug Application has been approved, the drug can receive
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
highest priority within the agency, which is called fast tracking. A smallpox outbreak
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
would become a priority concern in the world. Orphan diseases are not researched in a
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
priority manner. Preclinical research is not omitted. Extending any phase of the research
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
would mean a longer time to develop a vaccine. The FDA must ensure that all phases of the
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
preclinical and clinical research phase have been completed in a safe manner.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p1 p1 p 1 p. 7 p1 OBJ:
p 8 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
for Clayton's Basic Pharmacology for Nurses 18th Edition by Michelle J.
Willihnganz, Samuel L. Gurevitz & Bruce D. Clayton ISBN 9780323550611
Chapter 1-48 | Complete Guide A+
,Chapter 1: Drug Definitions, Standards, and Information Sources
p1 p1 p1 p1 p1 p1 p1
Test Bank
p1 p1
MULTIPLE CHOICE p1
1. What is the name under which a drug is listed by the U.S. Food and Drug
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Administration (FDA)?
p1 p1
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: p 1 C
The official name is the name under which a drug is listed by the FDA. The brand name,
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
or trademark, is the name given to a drug by its manufacturer. The nonproprietary, or
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
generic, name is provided by the U.S. Adopted Names Council.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: p1 p1 p 1 p1
p 2 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
p 1 p1 p1 p1 p1 p1 p1 p1
2. Which source contains information specific to nutritional supplements?
p1 p1 p1 p1 p1 p1 p1
a. USP Dictionary of USAN & International Drug Names
p1 p1 p1 p1 p1 p1 p1
b. Natural Medicines Comprehensive Database p1 p1 p1
c. United States Pharmacopoeia/National Formulary (USP NF) p1 p1 p1 p1 p1
d. Drug Interaction Facts p1 p1
ANS: p 1 C
United States Pharmacopoeia/National Formulary contains information specific to
p1 p1 p1 p1 p1 p1 p1
nutritional supplements. USP Dictionary of USAN & International Drug Names is a
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
compilation of drug names, pronunciation guide, and possible future FDA approved drugs;
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
it does not include nutritional supplements. Natural Medicines Comprehensive Database
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
contains evidence based information on herbal medicines and herbal combination products;
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
it does not include information specific to nutritional supplements. Drug Interaction Facts
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
contains comprehensive information on drug interaction facts; it does not include
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
nutritional supplements.
p1 p1
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: p1 p1 p 1 p1
p 4 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
3. What is the most comprehensive reference available to research a drug interaction?
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
a. Drug Facts and Comparisons p1 p1 p1
b. Drug Interaction Facts p1 p1
c. Handbook on Injectable Drugs p1 p1 p1
d. Martindale—The Complete Drug Reference p1 p1 p1
ANS: p 1 B
, First published in 1983, Drug Interaction Facts is the most comprehensive book available on
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
drug interactions. In addition to monographs listing various aspects of drug interactions,
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
this information is reviewed and updated by an internationally renowned group of
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
physicians and pharmacists with clinical and scientific expertise.
p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: p1 p1 p 1 p1
p 3 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
section of the Physicians’ Desk Reference (PDR) is most helpful to get information about
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
this drug?
p1 p1
a. Manufacturer‟s section p1
b. Brand and Generic Name section p1 p1 p1 p1
c. Product Category section p1 p1
d. Product Information section p1 p1
ANS: p 1 B
A physician‟s order would include the brand and/or generic name of the drug. The alphabetic
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
index in the PDR would make this section the most user friendly. Based on a physician‟s
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
order, manufacturer‟s information and classification information would not be known. The
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Manufacturer‟s section is a roster of manufacturers. The Product Category section lists
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
products subdivided by therapeutic classes, such as analgesics, laxatives, oxytocics, and
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
antibiotics. The Product Information section contains reprints of the package inserts for the
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
major products of manufacturers.
p1 p1 p1 p1
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: p1 p1 p 1 p1
p 4 TOP: Nursing Process Step: Planning
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
5. Which online drug reference makes available to health care providers and the public a
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
standard, comprehensive, up to date look up and downloadable resource about
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
medicines?
p1
a. American Drug Index p1 p1
b. American Hospital Formulary p1 p1
c. DailyMed
d. Physicians’ Desk Reference (PDR) p1 p1 p1
ANS: p 1 C
DailyMed makes available to health care providers and the public a standard, comprehensive,
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
up to date look up and downloadable resource about medicines. The American Drug Index
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
is not appropriate for patient use. The American Hospital Formulary is not appropriate for
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
patient use. The PDR is not appropriate for patient use.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: p1 p1 p 1 p1
p 5 TOP: Nursing Process Step: Implementation
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
a. Federal Food, Drug, and Cosmetic Act (1938) p1 p1 p1 p1 p1 p1
b. Durham Humphrey Amendment (1952) p1 p1 p1
c. Controlled Substances Act (1970) p1 p1 p1
, d. Kefauver Harris Drug Amendment (1962) p1 p1 p1 p1
ANS: p 1 A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
safety of all drugs before marketing. Later amendments and acts helped tighten FDA
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
control and ensure drug safety. The Durham Humphrey Amendment defines the kinds of
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
drugs that cannot be used safely without medical supervision and restricts their sale to
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
prescription by a licensed practitioner. The Controlled Substances Act addresses only
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
controlled substances and their categorization. The Kefauver Harris Drug Amendment
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
ensures drug efficacy and greater drug safety. Drug manufacturers are required to prove to
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
the FDA the effectiveness of their products before marketing them.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: p1 p1 p 1 p1
p 8 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Physiological Integrity
p 1 p1 p1 p1 p1 p1
7. Meperidine (Demerol) is a narcotic with a high potential for physical and
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
p1 psychological dependency. Under which classification does this drug fall? p1 p1 p1 p1 p1 p1 p1 p1
a. I
b. II
c. III
d. IV
ANS: p 1 B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
to severe psychological and physical dependence. Schedule I drugs have high potential for
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
abuse and no recognized medical use. Schedule III drugs have some potential for abuse.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Use may lead to low to moderate physical dependence or high psychological dependence.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
Schedule IV drugs have low potential for abuse. Use may lead to limited physical or
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
psychological dependence.
p1 p1
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: p1 p1 p 1 p1 p1 p1 p1
p 7 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
p 1 p1 p1 p1 p1 p1 p1 p1
8. What would the FDA do to expedite drug development and approval for an outbreak
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
of smallpox, for which there is no known treatment?
p1 p1 p1 p1 p1 p1 p1 p1 p1
a. List smallpox as a health orphan disease.
p1 p1 p1 p1 p1 p1
b. Omit the preclinical research phase. p1 p1 p1 p1
c. Extend the clinical research phase. p1 p1 p1 p1
d. Fast track the investigational drug.p1 p1 p1 p1
ANS: p 1 D
Once the Investigational New Drug Application has been approved, the drug can receive
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
highest priority within the agency, which is called fast tracking. A smallpox outbreak
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
would become a priority concern in the world. Orphan diseases are not researched in a
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
priority manner. Preclinical research is not omitted. Extending any phase of the research
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
would mean a longer time to develop a vaccine. The FDA must ensure that all phases of the
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
preclinical and clinical research phase have been completed in a safe manner.
p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1 p1
DIF: Cognitive Level: Knowledge REF: p1 p1 p 1 p. 7 p1 OBJ:
p 8 TOP: Nursing Process Step: Assessment
1 p1 p 1 p1 p1 p1
