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PHT101 > Ch3. Pharmacy Law and Ethics of Technicians > Flashcards

Ch3. Pharmacy Law and Ethics of Technicians Flashcards

1
Q

Legislative

A

congress

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2
Q

executive

A

president

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3
Q

FDA

A

Food and Drug Administration

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4
Q

Judicial

A

Supreme Court

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5
Q

Kefauver-Harris Amendment of 1962

A

Effective and safe

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6
Q

Durham-Humphrey Amendment of 1951

A

Prescription and nonprescription drugs

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7
Q

Food, Drug, and Cosmetic Act of 1938

A

new drug application

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8
Q

Controlled Substances Act of 1970

A

drug schedule

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9
Q

A DEA number consists of a two-letter prefix followed by

A

seven digits

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10
Q

Who creates the standards for child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA)?

A

Consumer Product Safety Commission (CPSC)

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11
Q

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

A

deposition

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12
Q

Pharmacies should make a complete and accurate record of all stocks of controlled substances on hand every

A

2 years

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13
Q

The Pure Food and Drug Act of 1906 was believed inadequate for the following reasons, EXCEPT

A

a manufacturer could not make false statements about a drug

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14
Q

branch of the Department of Health and Human Services that controls all drugs for legal use

A

food and drug administration

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15
Q

creates standards for child-resistant packaging

A

consumer product safety commission (CPSP)

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16
Q

federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease

A

Center for Disease control and prevention (CDC)

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17
Q

federal agency whose mission is to enforce the controlled substance laws and regulations

A

Drug Enforcement Administration (DEA)

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18
Q

mission is to ensure workplace safety and a healthy environment within the workplace

A

Occupational Safety and Health Administration (OSHA)

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19
Q

Which of the following laws is an extension of the Patriot Act?

A

Combat Methamphetamine Epidemic Act

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20
Q

The “Administrative Simplification” provision of the Health Insurance Portability and Accountability Act (HIPAA) consists of

A

Both Electronic Transactions and Privacy Standards

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21
Q

The maximum amount of items that may be ordered on DEA Form 222 is

A

10

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22
Q

Patient counseling, as required by the Omnibus Budget Reconciliation Act (COBRA) of 1990, should include

A

the name and description of the drug

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23
Q

What regulatory agency is responsible for the approval of drugs, over-the-counter (OTC) and prescription labeling, and standards for drug manufacturing?

A

Food and Drug Administration (FDA)

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24
Q

The agency deeply involved in the war against the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is the

A

Centers for Disease Control and Prevention (CDC)

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25
Q

Which of the following amendments or acts required manufacturers to register and list their products?

A

Medical Device Amendment

26
Q

The branch of the government that is responsible for creating laws is the

A

legislative branch

27
Q

A Class II Drug Recall is one in which

A

the use or exposure to the product may cause temporary or medically reversible adverse health hazards

28
Q

The Model State Pharmacy Practice Act (MSPPA), which can provide a greater degree of uniformity between states in regards to the practice of pharmacy, was developed by the

A

National Associations of Boards of Pharmacy (NABP)

29
Q

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?

A

106

30
Q

A pharmacist must be registered with the DEA if he

A

owns a pharmacy as a sole proprietor

31
Q

A pharmacist must be registered with the DEA if he

A

owns a pharmacy as a sole proprietor

32
Q

The official DEA form that pharmacies use to document the destruction of controlled substances is form

A

DEA-41

33
Q

The study of values or principles governing personal relationships is called

A

Ethics

34
Q

Which drug is an example of a Schedule V drug that requires a prescription?

A

Lomotil

35
Q

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?

A

isotretinoin (Accutane)

36
Q

Which act prohibits the reimportation of a drug into the United States by anyone but the manufacturer?

A

Prescription Drug Marketing Act

37
Q

Prescriptions for Schedule II controlled substances can be refilled

A

No refills are allowed.

38
Q

Dishonest and deceitful practices undertaken in order to induce someone to part with something valuable or a legal right

A

fraud

39
Q

defamatory spoken words

A

slander

40
Q

improper use of equipment, a substance, or a service

A

abuse

41
Q

failure to use a reasonable amount of care to prevent injury or damage to another

A

negligence

42
Q

defamatory writing such as published material that injures the reputation of another

A

libel

43
Q

Applications for re-registration for a DEA license should be mailed approximately how many days prior to the expiration date?

A

60 days

44
Q

Which schedule is the opiate morphine, which may result in severe psychological and physical dependence when abused?

A

Schedule II

45
Q

Schedule IV controlled substances include drugs with

A

a low abuse potential such as certain hypnotics and minor tranquilizers

46
Q

laws that result from court decisions

A

judicial law

47
Q

governs the relationship of the individual to society as a whole

A

criminal law

48
Q

governs the relationship between individuals within society

A

civil law

49
Q

results from action by the legislature

A

statutes

50
Q

the rules and regulations established by agencies of the federal government

A

Administrative law

51
Q

requires that drug products—both prescription and nonprescription—must be effective and safe

A

Kefauver-Harris Amendment 1962

52
Q

controls the manufacture, distribution, and dispensing of controlled substances

A

Comprehensive drug abuse prevention and control act 1970

53
Q

prohibits dispensing of legend drugs without a prescription

A

durham-humphrey amendment 1951

54
Q

placed the burden of proof squarely on FDA in regard to the safeness of dietary supplements

A

Supplemental Health and education act 1994

55
Q

prohibits the reimportation of a drug into the United States

A

prescription drug marketing act of 1987

56
Q

prohibits the interstate distribution or sale of adulterated and misbranded food and drugs

A

pure food and drug act 1906

57
Q

offers tax breaks for companies to undertake the development and manufacture of drugs for uncommon diseases

A

orphan drug act of 1983

58
Q

created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a New Drug Application with the FDA

A

food, drug, and cosmetic act of 1983

59
Q

Orphan drugs are used for all of the following disorders or conditions, EXCEPT

A

peptic ulcer

60
Q

Which information does not have to be included on a DEA Form 222 when ordering controlled substances?

A

social security number

61
Q

An example of an intentional tort is

A

battery

62
Q

Prescriptions for Schedules III and IV controlled substances can be refilled

A

up to five times in 6 months

PHT101 (10 decks)

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