Pharm Law Lecture 2

Front 1

Which statue allows the US Congress and federal administrative agencies toregulate drug distribution?

Back 1

Interstate Commerce Clause of the US Constitution

Front 2

Who regulates medication manufacturing?

Back 2

Federal government

Front 3

Who regulates controlled substances?

Back 3

Federal government

Front 4

Who regulates the practice of pharmacy?

Back 4

State government

Front 5

Are intrastate pharmaceutical transactions still under the Interstate Commerce Clause?

Back 5

Yes; Clause is designed to protect all people living in the US

Front 6

This law was mainly intended to address unsafe foods

Back 6

Pure Food and Drug Act of 1906

Front 7

This law prohibited the adulteration and misbranding of foods and drugs

Back 7

Pure Food and Drug Act of 1906

Front 8

Drug regulation remained secondary under this law

Back 8

Pure Food and Drug Act of 1906

Front 9

What was the catalyst for the FDCA of 1938?

Back 9

Sulfanilamide elixir tragedy of 1937

Front 10

This law regulates drug development, manufacturing, and marketing (with the focus on quality)

Back 10

FDCA of 1938

Front 11

Under this law, only safe and properly labed drugs may be introduced into interstate commerce

Back 11

FDCA of 1938

Front 12

This law defined label and labeling

Back 12

FDCA of 1938

Front 13

Under this law, labels must contain adequte directions for use and warning if habit-forming

Back 13

FDCA of 1938

Front 14

This law expanded the definition of misbranding and adulteration

Back 14

FDCA of 1938

Front 15

This law established the FDA

Back 15

FDCA of 1938

Front 16

This law defines what is considered a food, drug, cosmetic, dietary supplement and devices

Back 16

FDCA of 1938

Front 17

Under this law, some drugs were grandfathered in

Back 17

FDCA of 1938

Front 18

What is Adulteration?

Back 18

Regarding a drug's strength, purity, and quality (See Lecture 2 Handout pg 16)

Front 19

What is Misbranding?

Back 19

Regarding representations made by the manufacturer on the label or labeling (See Lecture 2 Handout pg 16)

Front 20

What is the other name for Durham-Humphrey Amendment of 1951?

Back 20

Prescription Drug Amendment

Front 21

This law established two classes of drugs (Rx and OTC)

Back 21

Durham-Humphrey Amendment of 1951

Front 22

Under this law, prescriptions may be orally-transmitted

Back 22

Durham-Humphrey Amendment of 1951

Front 23

Under this law, prescribers may authorize refills of the prescription order

Back 23

Durham-Humphrey Amendment of 1951

Front 24

True or False: Prescription drugs in cemmercial containers are exempt from the [adequate directions for use] requirement

Back 24

True; They must contain the legend statement: [Caution: Federal law prohibits dispensing w/o a prescription] or [Rx only]

Front 25

What is the other name for Kefauver-Harris Amendment of 1962?

Back 25

Drug Efficacy Amendment

Front 26

What prompted the Kefauver-Harris Amendment?

Back 26

Thalidomide drug tragedy of the late 50's (flipper babies)

Front 27

This law established that drugs must be both safe and effective

Back 27

Kefauver-Harris Amendment of 1962

Front 28

This law established CGMP

Back 28

Kefauver-Harris Amendment of 1962

Front 29

This law switched jurisdiction over drug advertising from the FTC to the FDA

Back 29

Kefauver-Harris Amendment of 1962

Front 30

Under this law, DESI drugs were reviewed for efficacy

Back 30

Kefauver-Harris Amendment of 1962

Front 31

This law classifies devices according to their function

Back 31

Medical Device Amendment of 1976

Front 32

How many classifications are there for medical devices?

Back 32

3

Front 33

What is the other name for Prescription Drug Marketing Act of 1987?

Back 33

Dingle Bill or PDMA

Front 34

What are the reasons for the passing of the PDMA?

Back 34

(1) Protection of the public health (2) Secondary whoulesale distribution schemes (3) Unfair competition (4) Re-importation of prescription drugs (5) Distribution of Rx samples

Front 35

Under this law, states must license drug wholesalers

Back 35

PDMA of 1987

Front 36

This law banned the re-importation of drugs, except by the manufacturer

Back 36

PDMA of 1987

Front 37

This law banned the sale, trade, purchase of Rx drug samples

Back 37

PDMA of 1987

Front 38

This law set the standards for distribution, storage, records or Rx drug samples

Back 38

PDMA of 1987

Front 39

This law banned trafficking in Rx drug coupons

Back 39

PDMA of 1987

Front 40

This law prohibited the resale of drugs purchased by hospitals or health care facilities

Back 40

PDMA of 1987

Front 41

What are Rx drug samples?

Back 41

A unit of drug intended not to be sold but used to promote sales

Front 42

Who enforces the PDMA?

Back 42

State boards of pharmacy and the FDA

Front 43

What are the consequences for breaking PDMA?

Back 43

up to 10 years imprisonment/$250,000 fine

Front 44

What is a disadvantage of the Dietary Supplement Health and Education Act of 1994?

Back 44

It may blur the line between foods and drugs, and may complicate any of the FDA's enforcement over dietary supplements [See Lecture 2 Handout pg 20]

Front 45

What would it take for a supplement to be considered a drug?

Back 45

If there are drug claims in the item's promotion (i.e. cure, treatment, prevention)

Front 46

What is FDAMA?

Back 46

Food and Drug Administration Modernization Act of 1997

Front 47

Why was FDAMA passed?

Back 47

(1) Primarily to streamline regulatory procedures at the FDA (2) Extended the FDA's authority over OTC drugs and new labeling requirements

Front 48

What is FDAAA?

Back 48

Food and Drug Administration Amendments of 2007

Front 49

What does the FDAAA do?

Back 49

(1) Reauthorized and amended many of the drug and medical device provisions that were set to expire (2) Increased funding for the FDA (3) Enhanced the FDA's responsibilities and authority to regulate drug safety (i.e. can require post-marketing clinical studies or REMS)

Front 50

What does the PPPA do?

Back 50

Poison Prevention Packaging Act of 1970; Protect children from accidental poisonings with household substances [See Lecture 2 Handout pg 21]

Front 51

What is considered Child-resistant packaging?

Back 51

80% of children less than 5 CANNOT open it, but 90% of adults CAN open it

Front 52

What are the provisions concerning blanket requests for child-resistant packaging?

Back 52

Individual patients MAY make a blanket request that all of their prescriptions be filled in non-safe containers; Prescribers may request for individual prescription, but they CANNOT make blanket requests

Front 53

Who enforces the PPPA?

Back 53

CPSC - Consumer Product Safety Commission

Front 54

Who may use tax-free alcohol?

Back 54

(1) Political subdivisions (2) Educational institutions, research, etc (3) Hospitals, pathology labs, non-profit clinics [Medicines compounded on hospital premises for inpatients may be sold if a separate charge is made; Outpatient charity clinics may furnish medicines made with tax-free alcohol to outpatients if they do not charge]

Front 55

Who CANNOT legally obtain tax-free alcohol?

Back 55

Community pharmacies

Front 56

This law requires pharmacists to provide DUR

Back 56

OBRA '90

Front 57

This law required manufacturer rebates to Medicaid

Back 57

OBRA '90

Front 58

What are the different parts of a DUR?

Back 58

(1) Retrospective review (i.e. duplicate therapy, drug interactions, therapy duration) (2) Educational programs (i.e. continuing education) (3) Prospective review (i.e. new data about medications, screen of medications before dispensing, patient counseling, pharmacist documentation of relevant information)

Front 59

Which agency creates OTC monographs?

Back 59

FDA

Front 60

Which agency creates patient package inserts and MedGuides?

Back 60

FDA

Front 61

What does the FDA regulate?

Back 61

(1) Biologicals (2) Drugs (3) Cosmetics (4) Food (5) Medical Devices (6) Veterinary Products (7) Radiation Emitting Electronic Products [See Lecture 2 Handout pg 25]

Front 62

What are the responsibilities of the FTC?

Back 62

FTC = Federal Trade Commission (1) Regulates OTC drug advertising (2) Enforces unfair business practices and anti-trust violations

Front 63

What is the CMS and what established it?

Back 63

CMS = Centers for Medicare and Medicaid Services; Established by the 1965 Medicare Act; Housed in the DHHS (US Department of Health and Human Services)\

Front 64

What is the purpose of the ASBP?

Back 64

ASBP = Arizona State Board of Pharmacy; To protect public health, safety, and welfare

Front 65

Who are the members of ASBP?

Back 65

1 technician, 6 pharmacists (at least 1 each of hospital and community), 2 consumers that are not married to a pharmacist

Front 66

Does the executive director fo the ASBP need to be a pharmacist?

Back 66

No

Front 67

How long are ASBP board member appointments, and who appoints them?

Back 67

5-year terms, the governor

Front 68

Describe the roles of ASBP

Back 68

(1) Licensing (2) Establishing standards of practice (3) Investigations and disciplinary action against license and permit holders [See Lecture 2 handout pg 28]

Front 69

If a complaint is filed by a patient about a pharmacist/pharmacy/technician/permittee, how long must a written response be submitted by?

Back 69

Usually within 10 days

Front 70

How often are pharmacies inspected in Arizona?

Back 70

Annually

Front 71

Pharmacy records must be readily retrievable, within _____ of a request by ASBP

Back 71

72 hours

Front 72

What is the PAPA Program?

Back 72

PAPA = Pharmacists Assisting Pharmacist Program; 5-year program for impaired pharmacists; Those who enter voluntarily are not subject to discipline, those who are forced to enter are subject to discipline (i.e. Must relinquish pharmacist license, name is listed in monthly newsletter)

Front 73

Who has reponsibility over hospital pharmacies?

Back 73

State Board of Health (not Pharmacy Board)