Ch3. Pharmacy Law and Ethics of Technicians

Question 1

Legislative

Answer 1

congress

Question 2

executive

Answer 2

president

Question 3

FDA

Answer 3

Food and Drug Administration

Question 4

Judicial

Answer 4

Supreme Court

Question 5

Kefauver-Harris Amendment of 1962

Answer 5

Effective and safe

Question 6

Durham-Humphrey Amendment of 1951

Answer 6

Prescription and nonprescription drugs

Question 7

Food, Drug, and Cosmetic Act of 1938

Answer 7

new drug application

Question 8

Controlled Substances Act of 1970

Answer 8

drug schedule

Question 9

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

Answer 9

seven digits

Question 10

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

Answer 10

Consumer Product Safety Commission (CPSC)

Question 11

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

Answer 11

deposition

Question 12

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

Answer 12

2 years

Question 13

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

Answer 13

a manufacturer could not make false statements about a drug

Question 14

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

Answer 14

food and drug administration

Question 15

creates standards for child-resistant packaging

Answer 15

consumer product safety commission (CPSP)

Question 16

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

Answer 16

Center for Disease control and prevention (CDC)

Question 17

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

Answer 17

Drug Enforcement Administration (DEA)

Question 18

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

Answer 18

Occupational Safety and Health Administration (OSHA)

Question 19

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

Answer 19

Combat Methamphetamine Epidemic Act

Question 20

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

Answer 20

Both Electronic Transactions and Privacy Standards

Question 21

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

Answer 21

10

Question 22

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

Answer 22

the name and description of the drug

Question 23

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

Answer 23

Food and Drug Administration (FDA)

Question 24

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

Answer 24

Centers for Disease Control and Prevention (CDC)

Question 25

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

Answer 25

Medical Device Amendment

Question 26

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

Answer 26

legislative branch

Question 27

A Class II Drug Recall is one in which

Answer 27

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

Question 28

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

Answer 28

National Associations of Boards of Pharmacy (NABP)

Question 29

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?

Answer 29

106

Question 30

A pharmacist must be registered with the DEA if he

Answer 30

owns a pharmacy as a sole proprietor

Question 31

A pharmacist must be registered with the DEA if he

Answer 31

owns a pharmacy as a sole proprietor

Question 32

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

Answer 32

DEA-41

Question 33

The study of values or principles governing personal relationships is called

Answer 33

Ethics

Question 34

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

Answer 34

Lomotil

Question 35

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?

Answer 35

isotretinoin (Accutane)

Question 36

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

Answer 36

Prescription Drug Marketing Act

Question 37

Prescriptions for Schedule II controlled substances can be refilled

Answer 37

No refills are allowed.

Question 38

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

Answer 38

fraud

Question 39

defamatory spoken words

Answer 39

slander

Question 40

improper use of equipment, a substance, or a service

Answer 40

abuse

Question 41

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

Answer 41

negligence

Question 42

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

Answer 42

libel

Question 43

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

Answer 43

60 days

Question 44

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

Answer 44

Schedule II

Question 45

Schedule IV controlled substances include drugs with

Answer 45

a low abuse potential such as certain hypnotics and minor tranquilizers

Question 46

laws that result from court decisions

Answer 46

judicial law

Question 47

governs the relationship of the individual to society as a whole

Answer 47

criminal law

Question 48

governs the relationship between individuals within society

Answer 48

civil law

Question 49

results from action by the legislature

Answer 49

statutes

Question 50

the rules and regulations established by agencies of the federal government

Answer 50

Administrative law

Question 51

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

Answer 51

Kefauver-Harris Amendment 1962

Question 52

controls the manufacture, distribution, and dispensing of controlled substances

Answer 52

Comprehensive drug abuse prevention and control act 1970

Question 53

prohibits dispensing of legend drugs without a prescription

Answer 53

durham-humphrey amendment 1951

Question 54

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

Answer 54

Supplemental Health and education act 1994

Question 55

prohibits the reimportation of a drug into the United States

Answer 55

prescription drug marketing act of 1987

Question 56

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

Answer 56

pure food and drug act 1906

Question 57

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

Answer 57

orphan drug act of 1983

Question 58

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

Answer 58

food, drug, and cosmetic act of 1983

Question 59

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

Answer 59

peptic ulcer

Question 60

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

Answer 60

social security number

Question 61

An example of an intentional tort is

Answer 61

battery

Question 62

Prescriptions for Schedules III and IV controlled substances can be refilled

Answer 62

up to five times in 6 months