Deck 2: Pharmacy Law, Ethics, and Regulatory Agencies

Question 1

PHI stands for:

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

Answer 1

D
Protected health information (PHI) is a phrase used to describe a patient's personal health data. Under HIPAA, this information is protected from being shared or distributed without the patient's permission.

Question 2

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

Answer 2

C
The 1970 Comprehensive Drug Abuse Prevention and Control Act is also known as the Controlled Substance Act. The DEA was formed to enforce the laws concerning controlled substances and their distribution. A stair-step schedule of controlled substances was introduced, based on a drug's intended medical use, the propensity of the drug to be abused, and safety and dependency concerns.

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

C
The FDA was under the authority of the U.S. Department of Agriculture until 1940, when the agency became part of the Federal Security Agency. As the FDA continued to regulate new applications for drugs, devices, and other products, the agency was transferred to the Department of HEW in 1953 and was eventually placed under the authority of the U.S. Public Health Service within the Department of HEW in 1968. Ultimately the FDA's final destination occurred in 1980 when it was moved from the Department of HEW to the newly created U.S. Department of Health and Human Services, where it remains today.

Question 4

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 5

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 6

Drug errors can be reported to:

A)MedWatch
B)The Joint Commission (TJC)
C)United States Pharmacopeia (USP)
D)DEA

Question 7

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 8

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

Question 9

DUE stands for:

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

Question 10

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 11

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 12

What 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 13

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

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

Question 14

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 15

Which schedule of medication is considered an exempt controlled substance?

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

Question 16

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 17

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 18

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 19

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

A)Omnibus Budget Reconciliation Act (OBRA)
B)Occupational Safety and Health Administration (OSHA)
C)Health Insurance Portability and Accountability Act (HIPAA)
D)Material safety data sheet (MSDS)

Question 20

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 21

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 22

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 23

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 24

Schedule C-II prescriptions cannot be:

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

Question 25

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)Five refills within 6 months of the date of the original fill

Question 26

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

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

Question 27

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

A)41
B)106
C)225
D)363

Question 28

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 29

How often does the DEA require a narcotic inventory?

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

Question 30

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

A)Pharmacist who signed 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)Pharmacy technician

Question 31

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 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

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 34

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 35

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

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

Question 36

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 37

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

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

Question 38

What does the abbreviation REMS mean?

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

Question 39

Which pregnancy category has the highest risk of teratogenicity?

A)X
B)B
C)C
D)D

Question 40

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