Edition
ByMichelleJ.Willihnganz,SamuelL.Gurevitz,BruceClayton
Complete
,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:
Clayton’s Basic Pharmacology for Nurses, 19th Edition
MULTIPLE CHOICE
1. Which name identifies avdrug listed bythe US Foodvand
Drug Administration (FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under whichva drug is listed by
the FDA. The brand name, or trademark, is the namevgiven t
ova drug by its manufacturer. The nonproprietary, or generic,
name is provided by the United States Adopted Names Coun
cil.
DIF: Cognitive Level: Knowledge REF: p. 9
OBJ: 1NAT: 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. 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 information specific to nutritional s
upplements. USP Dictionaryvof USAN & International Drug Names is a compilation of drug na
mes, pronunciation guide, and possible future FDA approved drugs; it does not include nutritio
nal supplements. Natural Medicines Comprehensive Database contains
evidence-
based information on herbal medicines and herbal combination products; it does not include inf
ormation specific to nutritional supplements. Drug Interaction Facts contains comprehensive i
nformation on drug interaction facts; it does not includevnutritional supplements.
DIF: Cognitive Level: Knowledge REF: p. 4
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integ
rity
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
,Test Bank ForvClayton’s Basic PharmacologyvforvNurses 19th Edition 3
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 describevall drugs in a th
erapeutic class. Monographs are formatted as tables to allow comparison of similar pro
ducts, brand names, manufacturers, cost indices, and available dosage forms Onlinevve
rsionvis available.
DIF: Cognitive Level: Knowledge REF: p. 4vTable 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 aboutvvirtually everysingle-
entitydrug available in thevUnited States and describes therapeutic uses of drugs, including ap
proved and unapproved uses?
a. Martindale: The Complete Drug Reference
b. AHFS Drug Information
c. Drug Reference
d. Drug Facts andvComparisons
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 appr
oved and unapproved uses.
DIF: Cognitive Level: Knowledge REF: p. 4vTable 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 stand
ard, 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 app
ropriate 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 Integ
rity
TOP: Nursing Process Step: Implementation
CON: Safety | Patient Education | Clinical Judgment
6. Which legislation authorizes the FDA to determine the safetyof a drug before its marketing?
a. Federal Food, Drug, and Cosmetic Act (1938)
b. Durham Humphrey Amendment (1952)
, Test Bank ForvClayton’s Basic PharmacologyvforvNurses 19th Edition 4
c. Controlled Substances Act (1970)
d. Kefauver Harris Drug Amendment (1962)
ANS: A
The Federal Food, Drug, and Cosmetic Actvof 1938 authorized the FDA to determinevthe safet
y of all drugsvbefore marketing. Later amendments and acts helped tighten FDA control and en
surevdrug 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 pr
actitioner. The Controlled Substances Act addresses only controlled substances and their catego
rization. The Kefauver Harris Drug Amendment ensures drugvefficacy and greater drug safety.
Drug manufacturers are required to provevto thevFDA 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 se
vere psychological and physical dependence. Schedule I drugs have high potential for abuse and
no recognized medical use. Schedule III drugs havevsome potential for abuse. Use may lead to
low to moderate physical dependence or high psychological dependence. SchedulevIV drugs ha
ve 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 Car
e Environment
TOP: Nursing Process Step: Assessment CON: PatientvEducation | Addiction | Pain
8. Which action would the FDA take tovexpedite drugvdevelopment and approval for an outbreak o
f smallpox?
a. List smallpox as a health orphan disease.
b. Omit the preclinical research phase.
c. Extendvthe clinical research phase.
d. Fast track the investigational drug.
ANS: D
Once the Investigational New Drug Application has been approved, the drug can receive high
est priority within the agency, which is called fast tracking. A smallpox outbreak would beco
me a priority concern in the world. Orphan diseases are not researched in a priority manner. Pr
eclinical research is not omitted. Extendingvany phase of the research would mean a longer tim
e to develop a vaccine. The FDA must ensure that all phases of the preclinical and clinical resea
rch phasevhave been completed in a safe manner.
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 5