Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Complete
,Chapter01:Drug Definitions,Standards, andInformationSourcesWillihnganz
l. l.
:Clayton’s Basic Pharmacology forNurses, 19th Edition
l. l. l. l.
MULTIPLE CHOICE l.
1. Whichnameidentifiesadrug listedbythe US Foodan
d 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 giv
en to a drug by its manufacturer. The nonproprietary, or gen
eric, name is provided by the United States Adopted Names
Council.
DIF: CognitiveLevel:Knowledge REF: p. 9
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Car
e Environment TOP: Nursing Process Step: Assessment
l.
CON:
Patient Education
2. Which source containsinformation specifictonutritional supplements?
l. l. l. l.
a. USPDictionaryof USAN &International Drug Names
b. NaturalMedicines Comprehensive Database
c. UnitedStatesPharmacopoeia/National Formulary (USPNF)
d. DrugInteraction Facts
ANS: C
United States Pharmacopoeia/National Formulary contains information specific to nutritional s
upplements. USP Dictionary of USAN & International Drug Names is a compilation of drug n
ames, pronunciation guide, and possible future FDA approved drugs; it does not include nutri
tional 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
information on drug interaction facts; it does not include nutritional supplements.
DIF: CognitiveLevel:Knowledge REF: p. 4
OBJ:3 NAT: NCLEXClient Needs Category:Physiological Inte l.
grity
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
l. l.
3. Which drug reference contains drug monographs that describealldrugsina therapeuticclass?
l. l. l. l.
a. DrugFactsand Comparisons l.
,TestBank For Clayton’s Basic Pharmacology forNurses 19thEdition 3
b. DrugInteraction Facts
c. Handbook on Injectable Drugs
d. Martindale—TheComplete Drug Reference
ANS: A
Drug Facts and Comparisons contains drug monographs that describe all drugs in a t
herapeutic class. Monographs are formatted as tables to allow comparison ofsimilarpr
oducts, brand names, manufacturers, cost indices, and available dosage forms Online
version is available.
DIF: Cognitive Level:Knowledge REF: p. 4 Table 1.2
l.
OBJ: 3 NAT: NCLEX Client Needs Category:PhysiologicalIntegrity
TOP: Nursing Process Step: Assessment CON: Safety|Patient Education |Clinical Judgment
4. Which drug reference contains monographs about virtuallyeverysingle-
entitydrug available in the United States and describestherapeutic uses of drugs, including a
pproved and unapproved uses?
a. Martindale: The Complete Drug Reference l.
b. AHFSDrug Information
c. Drug Reference
l.
d. Drug Factsand Comparisons
l. l.
ANS: B
AHFS Drug Information contains monographs about virtually every single-
entitydrug available inthe UnitedStatesand describes therapeuticusesof drugs, includingap
l. l. l. l.
proved and unapproved uses.
DIF: Cognitive Level:Knowledge REF: p. 4 Table 1.2
l.
OBJ: 3 NAT: NCLEX Client Needs Category: PhysiologicalIntegrity l. l.
TOP: Nursing Process Step: Planning CON: Safety|Patient Education |Clinical Judgment
l.
5. Which online drug reference makes available to healthcare providers and the public a sta
ndard, comprehensive, up-to-datelook upand downloadable resource about medicines?
a. AmericanDrugIndex
b. American Hospital Formulary l.
c. DailyMed
d. DrugReference
ANS: C
DailyMed makes available to healthcareproviders and the public a standard, comprehensive, l. l.
up-to-
date look up and downloadable resourceabout medicines. TheAmericanDrugIndexis not ap
l. l. l. l. l.
propriate for patient use. The American Hospital Formulary is not appropriate for patient us
e. The drug reference is not appropriate forpatient use.
DIF: CognitiveLevel:Knowledge REF: p. 3 |p. 4 l.
OBJ:3 NAT: NCLEXClient Needs Category:Physiological Inte l. l.
grity
TOP: Nursing Process Step:Implementation l.
CON: Safety|Patient Education | Clinical Judgment l. l. l.
6. Which legislation authorizes theFDA to determinethesafetyofa drug beforeits marketing?
l. l. l. l. l.
a. Federal Food,Drug, and Cosmetic Act (1938)
l. l. l. l.
b. Durham HumphreyAmendment (1952)
l.
, TestBank For Clayton’s Basic Pharmacology forNurses 19thEdition 4
c. Controlled Substances Act (1970)
d. KefauverHarrisDrug Amendment (1962)
ANS: A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the saf
ety of all drugs before marketing. Later amendments and acts helped tighten FDA control an d
ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that can not
be used safely without medical supervision and restricts their sale to prescription by a lic ensed
practitioner.TheControlledSubstancesAct addressesonlycontrolled substancesand th eir l. l.
categorization. The Kefauver Harris Drug Amendment ensuresdrugefficacyand greaterdr ug
safety. Drug manufacturers are required to prove to the FDA the effectiveness of their pro
ducts before marketing them.
DIF: Cognitive Level:Knowledge l. REF: p. 5Table l.3 l.
OBJ: 5
NAT: NCLEX Client Needs Category: Physiological Integrit
yTOP: Nursing Process Step: Assessment
CON: Safety|Patient Education |Evidence | Health Care Law l. l.
7. Which classification doesmeperidine(Demerol) fall under?
l. l. l.
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 maylead to l.
severe psychological and physical dependence.Schedule I drugshavehigh potential for abuse
l. l. l. l. l. l. l.
and no recognized medical use. Schedule III drugs have some potential for abuse. Use may l
ead 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 depen
dence.
DIF: CognitiveLevel:Knowledge REF: p. 10
OBJ: 2 NAT: NCLEX Client Needs Category:Safe,Effective Car l. l. l.
e Environment
l.
TOP: Nursing Process Step: Assessment
l. CON: Patient Education |Addiction|Pain
8. Which action would the FDA take toexpedite drug development and approval foran outbreak
l. l. l. l. l. l. l. l. l. l. l. l. of
smallpox?
a. List smallpox as a health orphan disease.
l. l. l. l.
b. Omit the preclinical research phase. l. l.
c. Extendtheclinical research phase. l.
d. Fast track the investigational drug.
l. l.
ANS: D
Once the Investigational New Drug Application has been approved, the drug can receive hig
hest priority within the agency, which is called fast tracking. A smallpox outbreak would bec
ome 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 alonger
time to develop a vaccine. The FDA must ensure that all phases of the preclinical and clinical re yi
search phase have been completed in a safe manner.
DIF: Cognitive Level:Knowledge
l. REF: p. 7 OBJ: 5