Deck 1: Consumer Safety and Drug Regulations

Question 1

Match each example to the names listed below.
Drug that treats a disease affecting a very small number of people

A)Orphan drug
B)Drug standards
C)NDC
D)USP/NF
E)OTC

Answer 1

Orphan drug

Question 2

The NDC contains the manufacturer, product, and package information for all commercially available products.

Answer 2

True

Question 3

Match each example to the names listed below.
Directory listing of officially approved drugs (was originally two references)

A)Orphan drug
B)Drug standards
C)NDC
D)USP/NF
E)OTC

Answer 3

USP/NF

Question 4

Match each example to the names listed below.
These drugs require no prescription.

A)Orphan drug
B)Drug standards
C)NDC
D)USP/NF
E)OTC

Question 5

Match each example to the names listed below.
Directory listing drugs by manufacturer and packaging type(s).

A)Orphan drug
B)Drug standards
C)NDC
D)USP/NF
E)OTC

Question 6

Match each name to the definition listed below.
These were established by the 1906 Pure Food and Drug Act

A)Standards
B)Controlled (schedule) drug
C)Legend drug
D)FDA
E)DEA

Question 7

The pharmaceutical manufacturer has the authority to add additional active ingredients to a previously approved pharmaceutical product.

Question 8

Controlled substance records are to be kept for 10 years.

Question 9

The prescriber of the medication is the only health care professional who is responsible for being aware of new medications, laws, and restrictions.

Question 10

The 1906 Pure Food and Drug Act established consumer protections to prevent the inclusion of "dangerous ingredients" without the knowledge of the consumer.

Question 11

Match each name to the definition listed below.
Approval agency established by the 1938 Federal Food, Drug and Cosmetic Act

A)Standards
B)Controlled (schedule) drug
C)Legend drug
D)FDA
E)DEA

Question 12

Match each name to the definition listed below.
Requires a prescription and DEA number

A)Standards
B)Controlled (schedule) drug
C)Legend drug
D)FDA
E)DEA

Question 13

Match each example to the names listed below.
Uniform strength, purity and quality

A)Orphan drug
B)Drug standards
C)NDC
D)USP/NF
E)OTC

Question 14

Match each name to the definition listed below.
Requires a prescription but not a DEA number

A)Standards
B)Controlled (schedule) drug
C)Legend drug
D)FDA
E)DEA

Question 15

A double-locked system is the recommended method for maintaining security of controlled substances.

Question 16

Health care workers are responsible for maintaining records of all controlled substances received, dispensed, and destroyed.

Question 17

The Pure Food and Drug Act of 1906 established drug standards and official drug references.

Question 18

Match each name to the definition listed below.
Enforcement agency established by the 1970 Controlled Substances Act

A)Standards
B)Controlled (schedule) drug
C)Legend drug
D)FDA
E)DEA

Question 19

Drug strength may vary with each lot number of a medication.

Question 20

Medication labels need only include the trade name of the drug.

Question 21

DEA numbers appear on the _____.

A) prescriber's professional license
B) prescription for a controlled substance
C) medication bottle that contains the controlled substance
D) receipt for the medication

Question 22

The Food and Drug Administration was created to _____.

A) oversee testing of all proposed new drugs prior to release into the U.S.market
B) inspect plants where food, drugs, medical devices, and cosmetics are made
C) remove unsafe drugs from the market
D) All of the above.

Question 23

NF is the official abbreviation for _______.

A) National Football
B) National Fortress
C) National Food
D) National Formulary

Question 24

Identify a provision of the Federal Food, Drug, and Cosmetic Act and its Amendments _____.

A) new products are required to be approved by the Food and Drug Administration
B) defined schedules for substances that require specific controls
C) it set limitations on the use of prescriptions
D) established USP

Question 25

Drug standards regulate drug manufacture so that medications of the same name will be of the same ____.

A) strength, purity, and quality
B) shape, color, and taste
C) purity, shape, and color
D) quality, color, and smell

Question 26

The Controlled Substances Act may limit _________.

A) the number of refills that can be filled in a 6-month time frame
B) at which pharmacies the patient may get the prescription filled
C) the level of pain control to be maintained
D) how the patient may maintain or store the medication

Question 27

Which act required that drug preparations containing morphine have a label indicating the presence of morphine?

A) Federal Food, Drug, and Cosmetic Act of 1938
B) Federal Food, Drug, and Cosmetic Act Amendment of 1965
C) Controlled Substances Act of 1970
D) Pure Food and Drug Act of 1906

Question 28

USP is the official abbreviation for _____.

A) U.S.Post office
B) U.S.Patrol
C) U.S.Police
D) U.S.Pharmacopoeia

Question 29

The Pure Food and Drug Act of 1906 was formulated ______.

A) to control use of drugs being abused by society
B) as the first government attempt to establish consumer protection in the manufacture of drugs and foods
C) in order to make drug manufacturing profitable for the drug companies
D) as a means to identify addicting or abused drugs

Question 30

Identify the drug standard in the following list.

A) Color
B) Strength
C) Shape
D) Taste

Question 31

The 1906 Pure Food and Drug Act includes which of the following provisions?

A) Regulation of drugs sold in the United States and Canada
B) Requires labeling to indicate if a medication contained a "dangerous ingredient"
C) Regulates illicit (illegal) drugs
D) Requires information regarding medications to be handed down from one practitioner to the next

Question 32

Which of the following is required to have a DEA number?

A) The provider writing the prescription
B) The person receiving the prescription
C) All providers working in the physician's office or clinic
D) All providers working in the pharmacy

Question 33

Prior to the 1906 establishment of the U.S.Pharmacopeia, drug information was related by _______.

A) the Internet
B) encyclopedias
C) passing to the next generation
D) schools of medicine and pharmacology

Question 34

The Controlled Substances Act of 1970 set much tighter controls on a specific group of drugs that are _______.

A) at risk of being abused by society
B) listed in the USP/NF
C) those that contain herbal components
D) available over the counter

Question 35

The Controlled Substances Act sets tighter controls on _______.

A) common analgesics such as Tylenol or aspirin
B) depressants, stimulants, psychedelics, narcotics, and anabolic steroids
C) antibiotics, diuretics, antihypertensives, and diabetic medications
D) common cold/allergy medications

Question 36

The USP/NF (U.S.Pharmacopeia/National Formulary) was established to _____.

A) provide a reference for all officially approved medications
B) legalize the manufacture of medications.
C) give the public the information needed to safely make their own drugs.
D) All of the above.

Question 37

What drugs are referred to as "legend" drugs?

A) Drugs that work so well they become "legendary."
B) Drugs that have been available for over 100 years.
C) Drugs that must carry the legend "Caution-federal law prohibits dispensing without a prescription."
D) Drugs that are mentioned in urban legends.

Question 38

The risk of death from the use of street drugs versus prescription medications is mostly due to___.

A) a lack of control over quality, purity, and strength makes street drugs dangerous
B) the risk is the same for both sources of the same substance
C) street drugs are approved for use
D) the need for a prescription makes drugs hard to obtain

Question 39

Professionals needing a DEA number are _________.

A) registered nurses (RNs), licensed (vocational) nurses (LPN/LVNs), and certified medication assistants (CMAs)
B) pharmacists, physicians, and veterinarians
C) clients who have a professional license
D) administrators of nursing care facilities, acute care hospitals, and home health care associations

Question 40

Which bureau of the Department of Justice was established by the Controlled Substances Act of 1970?

A) USP
B) DEA
C) FDA
D) NF

Question 41

An orphan drug is defined as a(n) _____.

A) drug used only in children
B) drug used to treat a disease that affects only a small number of people
C) lone drug in a specific class of drugs
D) unapproved drug used to treat a rare disease

Question 42

Which act established the USP and NF?

A) 1938 Federal Food, Drug, and Cosmetic Act
B) 1906 Pure Food and Drug Act
C) 1965 Pharmaceutical Consumer Protection Act
D) 1962 Amendment to the 1938 Federal Food, Drug, and Cosmetic Act

Question 43

The schedule of controlled substances that has the highest risk of abuse potential is ______.

A) Schedule C 2
B) Schedule C 3
C) Schedule C 4
D) Schedule C 5

Question 44

Drugs listed in Schedule 1 of Controlled Substances _______.

A) are not approved for medical use in the United States
B) may be refilled up to five times in 6 months
C) may have prescriptions phoned in by health care workers
D) have low abuse potential compared to other schedules

Question 45

A DEA number represents _____.

A) the number of times the DEA has cited the person
B) the phone number for the local DEA office
C) registration with the Drug Enforcement Agency
D) the prescriber's professional state license number

Question 46

You're waiting in line at the pharmacy to get your medication, and decide to take a look at your doctor's handwriting on the prescription.You notice the phrase "DEA Number" followed by a code.What does the phrase "DEA Number" represent?

A) The code required to determine whether the drug is reimbursable
B) The physician's license number for your state
C) The drug standards met by the medication prescribed for you
D) The registration number for physicians who prescribe controlled substances

Question 47

Ian, a registered nurse, maintains that he is not a drug abuser, so the 1970 Controlled Substances Act has no relevance for him.Is he right?

A) Yes, except that his state licensing board may place additional restrictions on him.
B) No, as long as he is careful to avoid the appearance of impropriety and is generally responsible in his all aspects of life.
C) Yes, as long as he does not abuse drugs, this act does not impact him.
D) No, because the act lays out his responsibilities with respect to record keeping and administration of controlled substances.

Question 48

The least desirable information source regarding drugs is a _______.

A) current drug reference
B) pharmacist
C) coworker
D) pharmaceutical company representative

Question 49

The National Drug Code Directory (NDC) was established in 1972 and provides the FDA with the following information for all drugs commercially distributed ______.

A) the drug name
B) packaging information
C) the manufacturer of the product
D) All of the above are included in the NDC.

Question 50

Quinn hears on the news that the FDA has asked a company to withdraw a medication.Under what circumstances can the FDA do this?

A) When more effective alternatives are available
B) When it is no longer profitable
C) Never, because only the DEA can do this
D) When the benefits of a drug outweigh its risks

Question 51

Your friend, Thomas, had a serious adverse reaction to an over-the-counter medication and found that a number of other individuals had similar adverse reactions.Which agency is most likely to investigate this situation and take action if a problem is found?

A) Food and Drug Administration
B) United States Pharmacopeia
C) National Formulary Enforcement
D) Drug Enforcement Agency

Question 52

Prescriptions of the controlled substances listed in these schedules have restrictions about phoning them into the pharmacy _____.

A) Schedule 1
B) Schedule 2
C) Schedule 3
D) All of the above.

Question 53

The Sunshine Act, which is part of the Affordable Care Act, requires reporting of ______.

A) monetary payment a physician receives from a pharmaceutical representative
B) any compensation or gifts paid to physicians by pharmaceutical representatives
C) gifts worth over one-hundred dollars a physician receives from pharmaceutical representatives
D) all samples a physician receives from pharmaceutical representatives

Question 54

What new requirements were mandated by the Omnibus Budget Reconciliation Act of 1990?

A) All prescriptions are to be included as part of the permanent medical record.
B) Over-the-counter medications are to be entered into the permanent medical record.
C) Pharmacists are required to provide drug use review and patient counseling prior to dispensing prescriptions to patients.
D) Both B and C are correct.
E) All of the above.

Question 55

Prescriptions of the controlled substances listed in these schedules may be refilled up to five times in 6 months ________.

A) Schedules 1 and 2
B) Schedules 3 and 4
C) Schedules 3, 4, and 5
D) Schedules 1, 2, 3, 4, and 5

Question 56

Agencies/persons that are required to have a DEA number are _______.

A) acute care hospitals and nursing homes
B) pharmacies, grocery stores, and convenience stores
C) drug manufacturers and packaging facilities, pharmacists, and physicians
D) schools of nursing, medical assisting, and radiology

Question 57

Which legislation provides for financial incentives to be provided to pharmaceutical companies for the development of medications that would otherwise be unprofitable because they are designed to treat diseases that affect only a small number of people?

A) 1965 Pure Food and Drug Act
B) 1938 Orphan Drug and Cosmetic Act
C) 1983 Orphan Drug Act
D) OBRA of 1990

Question 58

The FDA needs to identify all the packaging options available for a drug, the best reference to locate this information would be ________.

A) U.S.Pharmacopoeia
B) National Drug Code Directory
C) National Formulary
D) National Drug Registration Database

Question 59

Prescriptions of the controlled substances listed in which of these schedules MAY be called into the pharmacy by health care workers other than the prescriber ______.

A) Schedules 1 and 2 only
B) Schedules 2 through 4
C) Schedules 4 and 5 only
D) Schedules 1 through 3

Question 60

Once a drug or device has been approved for use in the United States, the _____.

A) DEA may withdraw approval if a safety concern exists
B) only action that can be taken is requirement of additional warnings to be added to the labeling and recommendation for voluntary withdrawal by the manufacturer
C) FDA may reconsider its approval and withdraw it from the market to protect the public safety
D) DEA may demand withdrawal from the market