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Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Compl e te
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, Chapter 01: Drug Definitions, Standards, and Information Sources Willihnga nz:
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Clayton’s Basic Pharmacology for Nurses, 19th Edition
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MULTIPLE CHOICE sl
1. Which name identifies a drug listed by the US Food a nd
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Drug Administration (FDA)?
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a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C s l
The official name is the name under which a drug is liste d
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by the FDA. The brand name, or trademark, is the name give
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n to a drug by its manufacturer. The nonproprietary, or
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generic, name is provided by the United States Adopted Nam
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es Council. sl
DIF: Cognitive Level: Knowledge REF: p. 9 s l s l s l
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective C a sl sl sl sl sl sl sl sl sl
re Environment TOP: Nursing Process Step: Assessment
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CON:
Patient Education s l
2. Which source contains information specific to nutritional supplements?
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a. USP Dictionary of USAN &International Drug Names sl s l s l s l s l s l
b. Natural Medicines Comprehensive Database sl sl sl
c. United States Pharmacopoeia/National Formulary (USP NF) sl sl sl s l sl
d. Drug Interaction Facts sl sl
ANS: C s l
United States Pharmacopoeia/National Formulary contains information specific to nutrition a
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l supplements. USP Dictionary of USAN & International Drug Names is a compilation o f d
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rug names, pronunciation guide, and possible future FDA approved drugs; it does not i nclu d
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e nutritional supplements. Natural Medicines Comprehensive Database contains evidence-
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oducts; it does not include i
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nformation specific to nutritional supplements. Drug Interaction Facts contains comprehe n
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sive information on drug interaction facts; it does not include nutritional supplem e
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nts.
DIF: s l Cognitive Level: Knowledge REF: p. 4 s l s l s l s l
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Int
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egrity
TOP: Nursing Process Step: Assessment CON: sl sl s l Nutrition | Patient Education s l sl s l
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
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a. Drug Facts and Comparisons sl sl sl
,Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Editi
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b. Drug Interaction Facts sl sl
c. Handbook on Injectable Drugs sl s l s l
d. Martindale—TheComplete Drug Reference sl sl sl
ANS: A s l
Drug Facts and Comparisons contains drug monographs that describe all drugs i
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n a therapeutic class. Monographs are formatted as tables to allow comparison of simi
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l arproducts, brand names, manufacturers, cost indices, and available dosage forms Onl
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ine version is available. sl sl sl
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 sl sl s l sl s l
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity sl s l sl sl sl
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment sl sl s l sl sl s l s l sl s l
4. Which drug reference contains monographs about virtually everysingle-
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entitydrug available in the United States and describes therapeutic uses of drugs, includi
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n g approved and unapproved uses?
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a. Martindale: The Complete Drug Reference s l sl s l sl
b. AHFS Drug Information sl s l
c. Drug Reference sl
d. Drug Facts and Comparisons sl s l s l
ANS: B s l
AHFS Drug Information contains monographs about virtually every single-
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entity drug available in the United States and describes therapeutic uses of drugs, includi ng
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approved and unapproved uses. sl sl sl
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 sl sl s l sl s l
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity sl sl sl sl sl
TOP: Nursing Process Step: Planning CON: Safety | Patient Education | Clinical Judgment sl s l s l sl sl s l s l sl s l
5. Which online drug reference makes available to healthcare providers and the public a s tand
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ard, comprehensive, up-to- sl s l
date look up and downloadable resource about medicines?
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a. American Drug Index sl sl
b. American Hospital Formulary sl sl
c. DailyMed
d. Drug Reference sl
ANS: C s l
DailyMed makes available to healthcare providers and the public a standard, comprehensi v
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e , up -to-
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date look up and downloadable resource about medicines. The American Drug Index is n ot a
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ppropriate for patient use. The American Hospital Formulary is not appropriate for p atie nt
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s use. The drug reference is not appropriate for patient use.
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DIF: s l Cognitive Level: Knowledge REF: p. 3 | p. 4 s l s l s l s l s l sl s l
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Int
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egrity
TOP: Nursing Process Step: Implementation s l sl s l s l
CON: Safety | Patient Education | Clinical Judgment sl sl s l s l sl s l
6. Which legislation authorizes the FDA to determine the safetyof a drug before its marketing?
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a. Federal Food, Drug, and Cosmetic Act (1938) sl sl s l s l sl s l
b. Durham Humphrey Amendment (1952) sl sl s l
, Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Editi
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c. Controlled Substances Act (1970) sl sl s l
d. Kefauver Harris Drug Amendment (1962) sl sl sl s l
ANS: A s l
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine th
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es sl
afety of all drugs before marketing. Later amendments and acts helped tighten
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s FD A contro l and ensure drug safety. The Durham Humphrey Amendment defines the
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lkinds of drugs t sl sl sl
hat cannot be used safely without medical supervision and restricts their s ale to
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prescriptio n by a licensed practitioner. The Controlled Substances Act addresses o nly control sl sl sl sl sl sl sl sl sl sl sl s l sl
led subst ances and their categorization. The Kefauver Harris Drug Amendment ensures drug ef
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ficacy and greater drug safety. Drug manufacturers are required to prove to the FDA the effecti
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ve ness of their products before marketing them.
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DIF: Cognitive Level: Knowledge sl sl
REF: p. 5 Table l.3 OBJ: 5 s l s l sl sl s l
NAT: NCLEX Client Needs Category: Physiological Integrit y T sl sl sl sl sl sl sl sl
OP: Nursing Process Step: Assessment
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CON: Safety | Patient Education | Evidence | Health Care Law s l sl s l s l sl s l sl s l s l
7. Which classification does meperidine (Demerol) fall under? 5% sl s l s l s l sl
a. I
b. II
c. III
d. IV
ANS: B s l
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abu s l s l s l s l s l s l s l s l s l s l s l s l s l
se and may lea d to severe psychological and physical dependence. Schedule I drugs have hig
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h p otential for abuse and no recognized medical use. Schedule III drugs have some potential
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for abuse. Us sl sl
e may lead to low to moderate physical dependence or high psychological dep sl sl sl sl sl sl sl sl sl sl sl sl
endence. Sc hedule IVdrugs have low potential for abuse. Use may lead to limited ph ysical
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or psychol ogical dependence.
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DIF: Cognitive Level: Knowledge REF: p. 10 s l s l s l
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective sl sl s l sl sl sl sl sl s
lC are Environment sl sl
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain sl s l s l s l s l sl s l sl
8. Which action would the FDA take to expedite drug development and approval for an outb re
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ak of smallpox? sl sl
a. List smallpox as a health orphan disease. s l s l sl s l s l sl
b. Omit the preclinical research phase. s l sl sl sl
c. Extend the clinical research phase. sl sl sl sl
d. Fast track the investigational drug. sl sl sl sl
ANS: D s l
Once the Investigational New Drug Application has been approved, the drug can receive h ighe
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st priority within the agency, which is called fast tracking. A smallpox outbreak wou ld
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become a priority concern in the world. Orphan diseases are not researched in a priorit y
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manner. Preclinical research is not omitted. Extending any phase of the research would me sl sl sl sl sl sl sl sl sl sl sl sl s l
an a longer time to develop a vaccine. The FDA must ensure that all phases of the pre
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clinical and clinical research phase have been completed in a safe manner.
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DIF: Cognitive Level: Knowledge sl sl REF: p. 7 s l OBJ: 5