Deck 3: Pharmacy Law and Ethics for Technicians

Question 1

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

A) Food and Drug Administration (FDA)
B) Drug Enforcement Agency (DEA)
C) Consumer Product Safety Commission (CPSC)
D) United States Pharmacopeia (USP)

Answer 1

Consumer Product Safety Commission (CPSC)

Question 2

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

A) this act did not extend to cosmetics
B) this act did not permit the authority to ban unsafe drugs
C) a manufacturer could not make false statements about a drug
D) labels were not required to identify the contents

Answer 2

a manufacturer could not make false statements about a drug

Question 3

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

A) executive branch
B) legislative branch
C) judicial branch
D) court branch

Answer 3

legislative branch

Question 4

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

A) Lomotil
B) morphine
C) cough syrup with codeine (10 mg/5 ml)
D) Imodium

Question 5

A pharmacist must be registered with the DEA if he

A) works in a pharmacy that dispenses controlled drugs
B) owns a pharmacy that is incorporated
C) owns a pharmacy as a sole proprietor
D) A pharmacist never needs to be registered with the DEA.

Question 6

Prescriptions for Schedule II controlled substances can be refilled

A) one time in 6 months
B) up to five times in 6 months
C) an unlimited number of times for up to a year
D) No refills are allowed.

Question 7

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

A) Board of Pharmacy
B) United States Pharmacopeia (USP)
C) Drug Enforcement Administration (DEA)
D) Food and Drug Administration (FDA)

Question 8

The study of values or principles governing personal relationships is called

A) laws
B) standards
C) ethics
D) etiquette

Question 9

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

A) DEA-222
B) DEA-41
C) DEA-106
D) DEA-510

Question 10

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

A) month
B) year
C) 2 years
D) 3 years

Question 11

Prescriptions for Schedules III and IV controlled substances can be refilled

A) one time in 6 months
B) up to five times in 6 months
C) an unlimited number of times for up to a year
D) No refills are allowed.

Question 12

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

A) Food and Drug and Administration (FDA)
B) Centers for Disease Control and Prevention (CDC)
C) Drug Enforcement Agency (DEA)
D) Department of Health and Human Services (HHS)

Question 13

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

A) 14 days
B) 30 days
C) 60 days
D) 120 days

Question 14

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

A) the name and description of the drug
B) all possible side effects of the drug
C) the name of the manufacturer
D) the pharmacokinetics of the drug

Question 15

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

A) Electronic Health Transaction Standards
B) Standards for setting insurance premiums
C) Privacy and Confidentiality Standards
D) Both a and c

Question 16

Schedule IV controlled substances include drugs with

A) a high abuse potential and no accepted medical use
B) a high abuse potential with a legitimate medical use
C) a low abuse potential such as certain hypnotics and minor tranquilizers
D) the lowest abuse potential such as some narcotic drugs generally for their antitussive properties

Question 17

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) subpoena
B) deposition
C) litigation
D) summons

Question 18

A Class II Drug Recall is one in which

A) the use or exposure to the product will cause severe adverse reactions or death
B) the use or exposure to the product may cause temporary or medically reversible adverse health hazards
C) the use or exposure to the product is not likely to cause adverse health hazards
D) none of the above

Question 19

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) Boards of Pharmacy
B) Food and Drug Administration (FDA)
C) National Associations of Boards of Pharmacy (NABP)
D) Department of Health and Human Services

Question 20

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

A) Schedule I
B) Schedule II
C) Schedule IV
D) Schedule V

Question 21

Most Schedule V drugs are ____________________ preparations that may be sold without a prescription.

Question 22

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) ibuprofen (Motrin)
B) isoniazid (Isoniazid)
C) isotretinoin (Accutane)
D) isoflurane (Forane)

Question 23

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

A) snakebite
B) cystic fibrosis
C) peptic ulcer
D) blepharospasm

Question 24

A court order that requires the individual to appear as a witness in court or to make herself available to be deposed is called a(n) ____________________.

Question 25

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

A) Medicare Modernization Act
B) Combat Methamphetamine Epidemic Act
C) Dietary Supplement Health and Education Act
D) Anabolic Steroid Control Act

Question 26

Pharmacies utilize DEA form ____________________ to report loss or theft of significant amounts of controlled substances.

Question 27

The ____________________ are administrative agencies that are authorized to make rules and regulations for the enforcement and administration of pharmacy law.

Question 28

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) 222
B) 224
C) 106
D) 41

Question 29

An example of an intentional tort is

A) negligence
B) malpractice
C) libel
D) battery

Question 30

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

A) three digits
B) five digits
C) seven digits
D) nine digits

Question 31

The federal regulatory agency for the field of pharmacy is the ____________________.

Question 32

A pharmacy must maintain records of controlled substances dispensed for ____________________ years, although some states require pharmacies to maintain records for at least 5 years.

Question 33

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

A) 3
B) 5
C) 10
D) 15

Question 34

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

A) Prescription Drug Marketing Act
B) Anabolic Steroids Control Act
C) Drug Price Competition and Patent Term Restoration Act
D) Orphan Drug Act

Question 35

A crime in a pharmacy in which the pharmacist was illegally selling prescription drugs without a prescription would be classified as a(n) ____________________.

Question 36

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

A) company name and address
B) social security number
C) ordering date
D) signature of purchaser

Question 37

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

A) Medical Device Amendment
B) Kefauver-Harris Amendment
C) Durham-Humphrey Amendment
D) Omnibus Budget Reconciliation Act

Question 38

Schedule ____________________ control substances have no accepted medical use in the United States and can only be used for research purposes by properly registered people.

Question 39

The relationship between individuals within society is governed by ____________________ law.

Question 40

The ____________________ code is a unique and permanent product code that identifies the manufacturer or distributor, the drug formulation, and the size and type of packaging.

Question 41

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.

Question 42

It is unlawful for any person to provide nuclear pharmaceutical services unless under the supervision of a(n) ____________________.

Question 43

The DEA is part of the U.S. Department of ____________________.

Question 44

Controlled substances have been categorized according to their potential for ____________________ and their ____________________ abilities.

Question 45

Retail pharmacies may request DEA permission to destroy outdated or damaged controlled substances ____________________ per year.

Question 46

The Medicare Prescription Drug, Improvement, and Modernization Act was designed to provide senior citizens and ____________________ individuals with a prescription drug benefit.

Question 47

The FDA is a branch of the U.S. Department of ____________________ and ____________________ Services.

Question 48

Drug standards that set the requirements for the formulation of drug substances, ingredients, and dosage forms are contained in the ____________________ and the ____________________.

Question 49

The regulation of the practice of pharmacy is primarily a function of the ____________________ and not the federal government.

Question 50

The Accutane iPledge Program is intended to prevent use of the drug during ____________________ due to the high risk of ____________________.

Question 51

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.

Question 52

Anabolic steroids are hormonal substances that are related to ____________________, ____________________, ____________________, and corticosteroids.

Question 53

The Durham-Humphrey Amendment prohibits dispensing of ____________________ drugs without a(n) ____________________.

Question 54

Orphan drugs are developed to be used for diseases that affect fewer than ____________________ people in the country.

Question 55

Guidelines for practice of a profession developed by professional organizations are also called ____________________.

Question 56

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.

Question 57

The mission of the DEA is to enforce ____________________ laws and regulations.

Question 58

The discipline dealing with the ethical and moral implications of biological research and applications, especially as they relate to life and death is called ____________________.

Question 59

The Food, Drug, and Cosmetic Act created the ____________________ and required pharmaceutical manufacturers to file New Drug Applications with the FDA.

Question 60

Schedule V agents have the ____________________ abuse potential of all the controlled substances.

Question 62

The Anabolic Steroids Control Act of 1990 places anabolic steroids under the regulatory provisions of the CSA. Why is this significant as it relates to the regulation of controlled substances?

Question 63

The patient asks that he have counseling with the pharmacist regarding the prescription. What law requires that the pharmacist consult with the patient regarding this medication?

Question 64

What control drug schedule is morphine?

Question 65

Explain the Privacy and Confidentiality Standards found in The Health Insurance Portability and Accountability (HIPAA) Act. What is "protected health information"?