By Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton
Complete
,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnga
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nz: Clayton’s Basic Pharmacology for Nurses, 19th Edition
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MULTIPLE CHOICE ws
1. Which name identifies a drug listed by the US Food a
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nd Drug Administration (FDA)?
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a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C ws
The official name is the name under which a drug is list
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ed by the FDA. The brand name, or trademark, is the na
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me given to a drug by its manufacturer. The nonproprieta
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ry, or generic, name is provided by the United States Ado
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pted Names Council.
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DIF: Cognitive Level: Knowledge REF: p. 9 ws ws ws ws
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective C
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are Environment TOP: Nursing Process Step: Assessment
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CON: ws
Patient Education ws
2. Which source contains information specific to nutritional supplements?
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a. USP Dictionary of USAN & International Drug Names
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b. Natural Medicines Comprehensive Database ws ws ws
c. United States Pharmacopoeia/National Formulary (USP NF)
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d. Drug Interaction Facts ws ws
ANS: C ws
United States Pharmacopoeia/National Formulary contains information specific to nutrition
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al supplements. USP Dictionary of USAN & International Drug Names is a compilation of
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drug names, pronunciation guide, and possible future FDA approved drugs; it does not in
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clude nutritional supplements. Natural Medicines Comprehensive Database contains
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evidence-
based information on herbal medicines and herbal combination products; it does not include
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information specific to nutritional supplements. Drug Interaction Facts contains compreh
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ensive information on drug interaction facts; it does not include nutritional supplements.
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DIF: Cognitive Level: Knowledge REF: p. 4 ws ws w s ws
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological I
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ntegrity
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
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3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
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a. Drug Facts and Comparisons ws ws ws
,Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Editi
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on
b. Drug Interaction Facts ws ws
c. Handbook on Injectable Drugs ws ws ws
d. Martindale—The Complete Drug Reference ws ws ws
ANS: A ws
Drug Facts and Comparisons contains drug monographs that describe all drugs in
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a therapeutic class. Monographs are formatted as tables to allow comparison of simi
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lar products, brand names, manufacturers, cost indices, and available dosage form
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s Online version is available.
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DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 ws ws w s ws ws ws
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment
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4. Which drug reference contains monographs about virtually every single-
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entity drug available in the United States and describes therapeutic uses of drugs, includi
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ng approved and unapproved uses?
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a. Martindale: The Complete Drug Reference ws ws ws ws
b. AHFS Drug Information ws ws
c. Drug Reference ws
d. Drug Facts and Comparisons ws ws ws
ANS: B ws
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, including
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approved and unapproved uses. ws ws ws
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 ws ws w s ws ws ws
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: Nursing Process Step: Planning
w s CON: Safety | Patient Education | Clinical Judgment
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5. Which online drug reference makes available to healthcare providers and the public a
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standard, comprehensive, up-to- ws ws
date look up and downloadable resource about medicines?
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a. American Drug Index ws ws
b. American Hospital Formulary ws ws
c. DailyMed
d. Drug Reference ws
ANS: C ws
DailyMed makes available to healthcare providers and the public a standard, comprehensi
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ve, up-to- ws
date look up and downloadable resource about medicines. The American Drug Index is not
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appropriate for patient use. The American Hospital Formulary is not appropriate for pat
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ient use. The drug reference is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 ws ws w s ws ws ws ws
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological I
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ntegrity
TOP: Nursing Process Step: Implementation
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CON: Safety | Patient Education | Clinical Judgment
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6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
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a. Federal Food, Drug, and Cosmetic Act (1938)
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b. Durham Humphrey Amendment (1952) ws ws ws
, Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Editi
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on
c. Controlled Substances Act (1970) ws ws ws
d. Kefauver Harris Drug Amendment (1962) ws ws ws ws
ANS: A ws
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
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safety of all drugs before marketing. Later amendments and acts helped tighten FDA cont
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rol and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drug
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s that cannot be used safely without medical supervision and restricts their sale to prescri
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ption by a licensed practitioner. The Controlled Substances Act addresses only controlled s
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ubstances and their categorization. The Kefauver Harris Drug Amendment ensures drug eff
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icacy and greater drug safety. Drug manufacturers are required to prove to the FDA the e
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ffectiveness of their products before marketing them. ws ws ws ws ws ws
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 ws ws w s ws ws ws
OBJ: 5 w s
NAT: NCLEX Client Needs Category: Physiological Integri ws ws ws ws ws ws
ty TOP: Nursing Process Step: Assessment
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CON: Safety | Patient Education | Evidence | Health Care Law
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7. Which classification does meperidine (Demerol) fall under?
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a. I
b. II
c. III
d. IV
ANS: B ws
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lea
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d to severe psychological and physical dependence. Schedule I drugs have high potential fo
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r abuse and no recognized medical use. Schedule III drugs have some potential for abuse.
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Use may lead to low to moderate physical dependence or high psychological dependence.
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Schedule IV drugs have low potential for abuse. Use may lead to limited physical or psy
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chological dependence. ws
DIF: Cognitive Level: Knowledge REF: p. 10 ws ws w s ws
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective
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Care Environment ws
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain
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8. Which action would the FDA take to expedite drug development and approval for an outbr
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eak of smallpox?
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a. List smallpox as a health orphan disease.
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b. Omit the preclinical research phase. ws ws ws ws
c. Extend the clinical research phase. ws ws ws ws
d. Fast track the investigational drug.
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ANS: D ws
Once the Investigational New Drug Application has been approved, the drug can receive
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highest priority within the agency, which is called fast tracking. A smallpox outbreak wo
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uld become a priority concern in the world. Orphan diseases are not researched in a prior
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ity manner. Preclinical research is not omitted. Extending any phase of the research woul
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d mean a longer time to develop a vaccine. The FDA must ensure that all phases of the pr
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eclinical and clinical research phase have been completed in a safe manner.
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DIF: Cognitive Level: Knowledge ws ws REF: wsws p. 7 ws OBJ: 5 ws