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Pharmacy Tech > Pharmacy Law: Module 2 Review > Flashcards

Pharmacy Law: Module 2 Review Flashcards

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1
Q

These sources must be ________ and up to date; most give ________ information; some are very ________; they are ________ or printed.

A

current, basic, technical, computerized

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2
Q

The PDR is updated each year with 6 sections: Manufacturer ________, Generic and ________ Names, Product ________ Index, Product ________ Guide, Product Information, and Diagnostic Product Information.

A

Indexing, Trade, Category, Identification

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3
Q

Each drug listed in the PDR has a complete ________; it compiles official drug ________ inserts; manufacturers pay a ________ to list drugs; only ________-approved drugs are included.

A

monograph, package, fee, FDA

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4
Q

Drug Facts and Comparisons is divided into five sections: ________, Keeping ________, Drug ________, Drug ________, and ________.

A

Index, Up, Monographs, Identification, Appendix

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5
Q

Drug Facts and Comparisons includes ________, dosage ________, dosage ________, sizes, and ________.

A

Indications, strengths, forms, manufacturers

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6
Q

The Orange Book is officially titled Approved Drug Products with Therapeutic ________ Evaluations; it is provided by the ________ and updated ________.

A

Equivalence, FDA, annually

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7
Q

The Orange Book is the best source for determining whether a ________ drug is equivalent to a brand name drug; it includes discontinued products and orphan designations, and can be searched by ________ ingredient, ________ name, applicant holder, and application number.

A

generic, active, proprietary

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8
Q

The Drug Topics Red Book is more common in ________ pharmacies than hospital pharmacies; it includes ________ sections like emergency info, drug ________, product ID, ________ products, and herbals.

A

community, ten, reimbursement, OTC

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9
Q

The Drug Topics Red Book contains charts for drugs excreted in ________ milk, drugs that shouldn’t be ________, and those that are ________ or alcohol-free; it also includes Spanish-language dosing instructions and PharmD program info.

A

breast, crushed, sugar

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10
Q

The U.S. Pharmacopeia–National Formulary lists new ________, helps pharmacies stay in ________, and includes ________ control and pharmaceutical ________ standards.

A

products, compliance, quality, manufacturing

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11
Q

Trissel’s ‘Handbook on Injectable Drugs’ is used primarily in __________.

A

Hospitals

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12
Q

Trissel’s handbook provides information on parenteral drugs such as: administration, stability, drug products, and __________.

A

compatability

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13
Q

The U.S. Pharmacists’ Pharmacopeia includes information on compounding products and __________.

A

Ingredients

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14
Q

The U.S. Pharmacists’ Pharmacopeia also includes safety information, dietary supplements, and __________ laws.

A

related

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15
Q

: The American Hospital Formulary Service Drug Information is favored in __________ pharmacies.

A

hospital

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16
Q

Drug monographs from AHFS include uses, adverse reactions, compounding info, and __________.

A

pharmacokinetics

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17
Q

Martindale’s ‘The Complete Drug Reference’ provides global clinical drug info including herbal medicines and __________ substances.

A

toxic

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18
Q

The Pediatric and Neonatal Dosage Handbook provides info on suggested dosages for __________ patients.

A

Pediatric

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19
Q

The Geriatric Dosage Handbook provides info on suggested dosages for __________ patients.

A

Geriatric

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20
Q

Goodman & Gilman’s focuses on pharmacogenomics, pharmacokinetics, and principles of __________.

A

therapeutics

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21
Q

The American Drug Index lists over 22,000 prescription and __________ drugs.

A

otc

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22
Q

The American Drug Index lists over 22,000 prescription and __________ drugs.

A

Requirements

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23
Q

The Handbook of Nonprescription Drugs provides options for self-care and info on __________ medications.

A

nonprescription

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24
Q

Remington’s textbook covers all pharmacy areas including history, ethics, and patient __________.

A

care

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25
This publication is known for computer-related content: ________.
Computer Talk for the Pharmacist
26
A publication by the American Pharmacists Association: ________.
Pharmacy Today (JAPhA)
27
Which of the following drugs are listed in the Physician’s Desk Reference? Schedule drugs b. Herbal and OTC drugs Only trade names Only FDA-approved drugs
Only FDA-approved drugs
28
Which of the following is one of the oldest sources of drug information published? Drug Topics Red Book U.S. Pharmacists’ Pharmacopeia The Complete Drug Reference d. Orange Book
Drug Topics Red Book
29
Comprehensive listing of approved drug products and therapeutic equivalence evaluations are found in which of the following reference sources?
Orange book
30
How many sections are contained in the Drug Topics Red Book?
10
31
Contains information for drug metabolism, pharmacokinetics, and pharmacodynamics.
Goodman Gilmans The Pharmacological Basis of Therapeutics
32
It provides information on suggested current dosages for elderly patients.
Geriatric Dosage Handbook
33
It contains information about parenteral drugs.
Trissels Handbook
34
It includes compounding products and ingredient information.
United States Pharmacists Pharmacopeia
35
The best source to use in determining whether a generic drug is equivalent to a brand name drug.
Orange Book
36
It lists over 22,000 prescription and over-the-counter drugs.
American Drug Index
37
The most popular sources of drug information used by pharmacists; it is organized into five sections.
Drug Facts and Comparisons
38
It contains manufacturer indexing, generic and trade name, product category index, product identification guide, produce information, and diagnostic product information.
physicians Desk Reference
39
It provides information on suggested current dosages for children.
Pediatric and Neonatal Dosage Handbook
40
More commonly used in community pharmacies than in hospital pharmacies.
Red Book
41
Which of the following publishes the Handbook of Nonprescription Drugs?
American Pharmacists Association
42
Which of the following pharmaceutical references helps pharmacy personnel comply with official standards and lists new products being developed and approved?
United States Pharmacopeia
43
The electronic version of the Orange Book is updated: Correct!
every day
44
Which of the following lists many prescription and over-the-counter drugs?
American Drug Index
45
The FDA is a branch of the U.S. Department of Health and ____________________ Services.
human
46
When a controlled substance is stolen or lost from a pharmacy, the nearest DEA office must be notified using which of the following DEA forms?
106
47
The DEA is part of the U.S. Department of ____________________.
Justice
48
An ___________ is one that is intended for use in a few patients with a rare disease or condition affecting less than 200,000 people.
Orphan Drug Act
49
Which act prohibits the reimportation of a drug into the United States by anyone but the manufacturer?
Prescription Drug Marketing Act
50
Patient counseling, as required by the Omnibus Budget Reconciliation Act (OBRA) of 1990, should include:
the name and description of the drug.
51
The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires that pharmacists offer to discuss information about new and refill prescriptions with Medicare and ____________________ recipients.
medicaid
52
requires that drug products—both prescription and nonprescription—must be effective and safe
KefauverHarris Amendment of 1962
53
controls the manufacture, distribution, and dispensing of controlled substances
Comprehensive Drug Abuse Prevention and Control Act of 1970
54
prohibits dispensing of legend drugs without a prescription
DurhamHumphrey Amendment of 1951
55
placed the burden of proof squarely on FDA with regard to the safeness of dietary supplements
Supplemental Health and Educational Act of 1994
56
prohibits the reimportation of a drug into the United States
Prescription Drug Marketing Act of 1987
57
prohibits the interstate distribution or sale of adulterated and misbranded food and drugs
Pure Food and Drug Act of 1906
58
offers tax breaks for companies to undertake the development and manufacture of drugs for uncommon diseases
Orphan Drug Act of 1983
59
created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a New Drug Application with the FDA
Food, Drug, and Cosmetic Act of 1938
60
branch of the Department of Health and Human Services that controls all drugs for legal use
Food and Drug Administration (FDA)
61
creates standards for child-resistant packaging Consumer Product Safety Commission (CPSC
Consumer Product Safety Commission (CPSC)
62
federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease
Centers for Disease Control and Prevention (CDC)
63
federal agency whose mission is to enforce the controlled substance laws and regulations
Drug Enforcement Administration (DEA)
64
mission is to ensure workplace safety and a healthy environment within the workplace
Occupational Safety and Health Administration (OSHA)
65
The mission of the DEA is to enforce ____________________ laws and regulations.
controlled substance
66
Prescriptions for Schedules III and IV controlled substances can be refilled:
up to five times in six months
67
HIPAA stands for:
Health Insurance Portability and Accountability Act
68
The study of values or principles governing personal relationships is called:
ethics
69
Doctors and pharmacists are now required by the FDA to register and use a specific Web site in order to receive which of the following medications?
Isotretinoin (Accutane)
70
The official DEA form that pharmacies use to document the destruction of controlled substances is form:
DEA-41.
71
The Poison Prevention Packaging Act specifies that the majority of OTC and legend drugs cannot be opened by ____________________% of children under 5 years of age.
80
72
The ____________________ are administrative agencies that are authorized to make rules and regulations for the enforcement and administration of pharmacy law.
Boards of pharmacy
73
Drug standards that set the requirements for the formulation of drug substances, ingredients, and dosage forms are contained in the United States Pharmacopeia and the ____________________.
National Formulary
74
T or F The Medicare Prescription Drug, Improvement, and Modernization Act was designed to provide senior citizens and disabled individuals with a prescription drug benefit.
True
75
An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony is called:
deposition.
76
A Class II Drug Recall is one in which:
the use or exposure to the product may cause temporary or medically reversible adverse health hazards.
77
Pharmacies utilize DEA form ____________________ to report loss or theft of significant amounts of controlled substances.
DEA-106
78
Which of the following amendments or acts required manufacturers to register and list their products?
Medical Device Amendment
79
T or F The Accutane iPledge Program is intended to prevent use of the drug during pregnancy due to the high risk of birth defects.
Tue
80
The ____________________ is a unique and permanent product code that identifies the manufacturer or distributor, the drug formulation, and the size and type of packaging.
National Drug Code
81
aws that result from court decisions
Judicial law
82
governs the relationship of the individual to society as a whole
criminal law
83
governs the relationship between individuals within society
civil law
84
results from action by the legislature
statutes
85
the rules and regulations established by agencies of the federal government
administrative law
86
What regulatory agency is responsible for the approval of drugs, over-the-counter (OTC) and prescription labeling, and standards for drug manufacturing?
Food and Drug Administration (FDA)
87
When the use of or exposure to a drug will cause severe adverse reactions or death, and the drug is recalled, it is classified as a(n) ____________________ drug recall.
class 1
88
Applications for re-registration for a DEA license should be mailed approximately how many days prior to the expiration date?
60 days
89
Dishonest and deceitful practices undertaken in order to induce someone to part with something valuable or a legal right
fraud
90
defamatory spoken words
slander
91
improper use of equipment, a substance, or a service
abuse
92
failure to use a reasonable amount of care to prevent injury or damage to another
negligence
93
defamatory writing such as published material that injures the reputation of another
libel
94
Which schedule is the opiate morphine, which may result in severe psychological and physical dependence when abused?
schedule II
95
T or F The Durham–Humphrey Amendment prohibits dispensing of legend drugs without a prescription.
True
96
Orphan drugs are developed to be used for diseases that affect fewer than ____________________ people in the country.
two hundred thousand
97
Guidelines for practice of a profession developed by professional organizations are also called ____________________.
standards
98
Which of the following laws is an extension of the Patriot Act?
Combat Methamphetamine Epidemic Act
99
The Model State Pharmacy Practice Act (MSPPA), which can provide a greater degree of uniformity between states with regard to the practice of pharmacy, was developed by the:
National Associations of Boards of Pharmacy (NABP).
100
A pharmacy must maintain records of controlled substances dispensed for ____________________ years, although some states require pharmacies to maintain records for at least five years.
2
101
A pharmacy must maintain records of controlled substances dispensed for ____________________ years, although some states require pharmacies to maintain records for at least five years.
Drug Topics Red Book
102
Which of the following pharmaceutical references helps pharmacy personnel comply with official standards and lists new products being developed and approved?
United States Pharmacopeia
103
Which of the following drugs are listed in the Physician’s Desk Reference?
Only FDA-approved drugs
104
Comprehensive listing of approved drug products and therapeutic equivalence evaluations are found in which of the following reference sources?
Orange Book
105
Which of the following lists many prescription and over-the-counter drugs?
American Drug Index
106
How many sections are contained in the Drug Topics Red Book?
10
107
The electronic version of the Orange Book is updated:
every day.
108
Drug Facts and Comparisons is organized into five sections; which of the following is not one of these?
Glossary
109
Contains information for drug metabolism, pharmacokinetics, and pharmacodynamics. Goodman Gilmans The
Pharmacological Basis of Therapeutics
110
It provides information on suggested current dosages for elderly patients.
Geriatric Dosage Handbook
111
It contains information about parenteral drugs.
Trissels Handbook
112
It includes compounding products and ingredient information.
United States Pharmacists Pharmacopeia
113
The best source to use in determining whether a generic drug is equivalent to a brand-name drug is.
Orange Book
114
It lists over 22,000 prescription and over-the-counter drugs.
American Drug Index
115
The most popular sources of drug information used by pharmacists; it is organized into five sections.
Drug Facts and Comparisons
116
It contains manufacturer indexing, generic and trade name, product category index, product identification guide, produce information, and diagnostic product information.
Physicians Desk Reference
117
It provides information on suggested current dosages for children.
Pediatric and Neonatal Dosage Handbook
118
More commonly used in community pharmacies than in hospital pharmacies.
Red Book
119
Which of the following publishes the Handbook of Nonprescription Drugs?
American Pharmacists Association
120

Pharmacy Tech (12 decks)

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