Deck 2: Pharmacy Law, Ethics, and Regulatory Agencies

Question 1

DUEs required under OBRA 90 must include all of the following except:

A) Possible drug interactions
B) Appropriateness of dosage and duration of therapy
C) Evaluation of lower cost therapies
D) Contraindications

Answer 1

Evaluation of lower cost therapies

Question 2

Which of the following is a U.S. government-managed entity that oversees safety in the workplace?

A) Health and Human Services
B) Occupational Safety and Health Administration (OSHA)
C) Food and Drug Administration
D) Material safety data sheet (MSDS)

Answer 2

Occupational Safety and Health Administration (OSHA)

Question 3

The FDA is currently under the authority of the:

A) Department of Health, Education, and Welfare (HEW).
B) Public Health Service.
C) Department of Health and Human Services.
D) Department of Agriculture.

Answer 3

Department of Health and Human Services.

Question 4

Which of the following required the labeling, "Caution: Federal law prohibits dispensing without a prescription"?

A) 1951 Durham-Humphrey Amendment
B) 1962 Kefauver-Harris Amendments
C) 1970 Comprehensive Drug Abuse Prevention and Control Act
D) 1972 Drug Listing Act

Question 5

OBRA originally addressed problems regarding the quality of health care for:

A) Infants and children
B) Older adults
C) Disabled individuals
D) Patients with acquired immunodeficiency syndrome (AIDS)

Question 6

Which set(s) of numbers in the NDC code is(are) assigned by the drug company?

A) First set (labeler code)
B) Second set (product code)
C) Third set (package code)
D) B and C

Question 7

Which agency within the U.S. Department of Health and Human Services is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, the national food supply, cosmetics, and radioactive products?

A) DEA
B) FDA
C) DUE
D) USDA

Question 8

Which of the following is not considered a HIPAA-covered entity?

A) Health care provider
B) Family member
C) Health plan
D) Health care clearinghouse

Question 9

The first set of numbers of a National Drug Code (NDC) number, which is assigned by the FDA, is the:

A) Labeler code
B) Product code
C) Package code
D) None of the above

Question 10

Which of the following statements is(are) true of patient counseling?

A) Most individual states have set higher standards than those in OBRA 90.
B) A patient can refuse counseling.
C) A pharmacy technician cannot counsel.
D) All of the above statements are true.

Question 11

Which of the following are exceptions to the childproof cap requirement set into place by the Poison Prevention Packaging Act of 1970?

A) Emergency medications such as sublingual nitroglycerin
B) Hospitalized patients' medications
C) Patient or physician's request
D) All of the above

Question 12

Medicare insures individuals:

A) Over 65 years of age
B) Under 65 years of age with long-term disabilities
C) With end-stage renal disease
D) All of the above

Question 13

Which schedule of medication is considered an exempt controlled substance?

A) C-II
B) C-III
C) C-IV
D) C-V

Question 14

The OBRA of 1990 federal counseling rules specifically state that the pharmacist must offer to counsel all:

A) Insured persons with new prescriptions
B) Persons with new prescriptions
C) Persons with new prescriptions or new instructions for old prescriptions
D) Medicaid patients who receive new prescriptions

Question 15

Drug diversion can be defined as the:

A) Intentional misuse of a drug intended for medical purposes.
B) Mishandling of a medication that can lead to contamination or impurity, falsification of contents, or loss of drug quality or potency.
C) Recreational use of a prescription or a scheduled drug.
D) A and C.

Question 16

DUE stands for:

A) Drug under evaluation
B) Data use evaluation
C) Data usage evaluation
D) Drug utilization evaluation

Question 17

Drug errors can be reported to:

A) MedWatch
B) The Joint Commission (TJC)
C) United States Pharmacopeia (USP)
D) Health and Human Services

Question 18

PHI stands for:

A) Public health institution
B) Personal health information
C) Private health institution
D) Protected health information

Question 19

Which of the following involved the setup of the five-level schedule of controlled substances?

A) 1951 Durham-Humphrey Amendment
B) 1962 Kefauver-Harris Amendments
C) 1970 Comprehensive Drug Abuse Prevention and Control Act
D) 1972 Drug Listing Act

Question 20

Which one of the following product recalls is the most serious?

A) Class 1
B) Class 2
C) Class 3
D) Class 4

Question 21

What is the first letter in the DEA number of prescribers who are qualified to prescribe medication to treat opioid addiction?

A) B
B) F
C) M
D) X

Question 22

Individual states cannot establish which of the following?

A) Storage of certain controlled substances
B) Record keeping of certain controlled substances
C) OTC status of some schedule C-V medications
D) Schedule under which a drug should be placed

Question 23

No special prescribing requirement exists for which of the following medications?

A) Methadone
B) Isotretinoin
C) Heroin
D) Suboxone

Question 24

Form 222 consists of three copies. Which copy is ultimately sent to the DEA?

A) Top copy (1)
B) Middle copy (2)
C) Bottom copy (#)
D) B and C

Question 25

In which of the following forms can prescriptions for schedules C-II through C-V drugs be accepted by the pharmacy?

A) Written
B) Orally
C) Facsimile
D) All of the above

Question 26

How often does the DEA require a narcotic inventory?

A) Every month
B) Every 6 months
C) Every year
D) Every 2 years

Question 27

Which DEA form is needed to destroy damaged, outdated, or unwanted controlled substances?

A) DEA Form 41
B) DEA Form 224
C) DEA Form 225
D) DEA Form 363

Question 28

Which of the following drug classification require package inserts to be provided with the prescription?

A) Estrogens
B) Fertility drugs
C) Retinoids
D) All of the above

Question 29

How many years does the pharmacy need to retain invoices for scheduled drug purchases?

A) 1
B) 2
C) 3
D) 7

Question 30

Which of the following statements is not true regarding a boxed warning?

A) A boxed warning is encased in a black border in the manufacturer's insert.
B) It is required on any medication or product that carries a high risk potential to the consumer.
C) A boxed warning is required on all medication package inserts.
D) It is sometimes referred to as a "black box warning."

Question 31

What is the maximum number of refills allowed for schedules C-III and C-IV prescriptions?

A) Whatever the physician writes
B) None
C) Five refills within 6 months of the date the prescription was written
D) Six refills within 6 months of the date of the original fill

Question 32

Which of the following is not required on a prescription label?

A) Date the prescription was filled
B) Name, address, and telephone number of the pharmacy
C) License or DEA number of the prescriber
D) Name of the prescriber

Question 33

Which of the following statements is(are) true of record keeping as it/they apply to controlled substances?

A) Federal law allows the choice of one of three different prescription-filing methods.
B) Controlled substances must be logged in and out of the pharmacy stock.
C) A perpetual inventory must be maintained until an item is no longer stocked.
D) All of the above statements are true.

Question 34

Which of the following would be a correct DEA number for Dylan Brown, MD?

A) MB1234563
B) BB1234564
C) AB1234563
D) MD1234563

Question 35

How many times can schedules C-III, C-IV, and C-V prescriptions be transferred?

A) None
B) One
C) Until the refills have expired
D) None of the above

Question 36

Schedule C-II prescriptions cannot be:

A) Refilled
B) Partially filled
C) Transferred
D) A and C

Question 37

Which of the following is(are) true of schedule C-I drugs?

A) C-I drugs have no approved medicinal use.
B) These medications include lysergic acid diethylamide (LSD) and heroin.
C) C-I drugs are not stocked in pharmacies.
D) All of the above statements are true.

Question 38

What does the abbreviation REMS mean?

A) Rapid eye movement study
B) Risk evaluation and mitigation strategy
C) Risk examination and management study
D) Restricted evaluation and management strategy

Question 39

The purchase of pseudoephedrine is limited to:

A) 3.6 g per calendar day.
B) 9 g per 30 days from a retailer.
C) 7.5 g per 30 days by mail order.
D) all of the above.

Question 40

Who can sign DEA Form 222 to order schedule C-II narcotics?

A) Pharmacist who signed DEA Form 224 or the person who has been the legally designated Power of Attorney by that pharmacist
B) Pharmacist on duty
C) Store manager
D) PTCB certified pharmacy technician

Question 41

Which act defined adulteration and misbranding?

A) Pure Food and Drug Act of 1906
B) Federal Food, Drug and Cosmetic Act of 1938
C) Comprehensive Drug Abuse Prevention and Control Act of 1970
D) Poison Prevention Packaging Act

Question 42

When a state law conflicts with a federal law, which law must be followed?

A) Federal law
B) State law
C) The most stringent law
D) The oldest law

Question 43

By what means is a patient's information protected in an information system?

A) Backing up files
B) Use encryption technology
C) Use of biometrics
D) Only licensed pharmacists and certified pharmacy technicians have access to it

Question 44

Which DEA form must a pharmacy possess in order to dispense controlled substances?

A) DEA Form 41
B) DEA Form 106
C) DEA Form 222
D) DEA Form 224

Question 45

Which medication is covered under the I-Pledge program?

A) Clozaril
B) Ciprofloxacin
C) Isotretinoin
D) Thalidomide

Question 46

Which of the following is considered a patient's right under HIPAA?

A) The right to ask to see and obtain a copy of their health records.
B) The right to have corrections added to their health information.
C) The right to obtain a report on when and why their health information was shared for certain purposes.
D) All of the above.

Question 47

Which of the following was NOT covered in OBRA'87?

A) Individual Privacy Rights
B) Establishing a minimum standard of care was required
C) Providing a higher quality of care in nursing homes
D) Requirements for facilities participating in Medicare and Medicaid programs

Question 48

A medication is packaged in a container that is defective; what type of drug recall would it be?

A) Class 1
B) Class 2
C) Class 3
D) Class 4

Question 49

Which government agency created Safety Data Sheet requirements?

A) CMS
B) DEA
C) FDA
D) OSHA