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Question 1

What are the four types of market failures?

Answer 1

1. Public goods
2. Externalities
3. Natural monopolies
4. Information asymmetry

Question 2

Public Goods

Answer 2

Necessary and beneficial commodities that private entities will not supply because there is no incentive
Examples: orphan drugs; vaccines

Question 3

Externality

Answer 3

When the production or consumption of a good affects someone who does not fully consent to the effect
Example: indiscriminate use of antibiotics

Question 4

Monopoly

Answer 4

When the fixed costs of providing a good are high, relative to the variable costs of producing the good
Example: patents and market exclusivity for new drugs

Question 5

Information Asymmetry

Answer 5

When the consumer is uninformed about the true value of a good
Examples: prescription only drugs; written consumer information for certain drugs

Question 6

Criminal Actions

Answer 6

Government v. private party
Objectives: deter, punish, rehabilitate

Question 7

Civil Actions

Answer 7

Private party v. private party
Objectives: compensation to injured party

Question 8

Administrative Actions

Answer 8

Agency v. private party
Objectives:

Question 9

Federal Authority

Answer 9

Regulate drug distribution comes primarily from the Interstate Commerce Clause

Question 10

State Authority

Answer 10

Regulate pharmacy practice and drug distribution comes primarily from the Tenth Amendment and the inherent authority of a state’s police powers

Question 11

Pure Food and Drug Act (1906)

Answer 11

Prohibited interstate commerce of adulterated (not pure) food and drugs

Question 12

Food, Drug, and Cosmetic Act (1938)

Answer 12

Scientific proof of safety before a drug could be marketed (sulfanilamide
disaster)

Question 13

Durham-Humphrey Amendment (1951)

Answer 13

Created 2 classes of products, prescription and OTC, created “Legend Drugs”

Question 14

Kefauver-Harris Amendment (1962)

Answer 14

Scientific proof of efficacy (effectiveness)

Question 15

Orphan Drug Act (1983)

Answer 15

Gave economic and tax incentives for pharmaceutical manufacturers to develop drugs for rare disease

Question 16

Drug Price Competition and Patent Restoration Act (1984)

Answer 16

Created the ANDA for generic drugs (prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval

Question 17

Prescription Drug Marketing Act (1987)

Answer 17

Regulated samples, cannot re-import drugs from other countries, regulates who hospitals can sell to

Question 18

Dietary Supplement Health and Education Act (1994)

Answer 18

Made herbals officially dietary supplements

Question 19

What is considered evidence that a product is a drug?

Answer 19

Labeling, advertising, and nature of a product

Question 20

DSHEA

Answer 20

Created a new special category of food called “dietary supplements” (DSs), do not require premarket approval

Question 21

Adulteration

Answer 21

A drug is adulterated if its strength, quality, or purity differs from label.

Question 22

Misbranding

Answer 22

A drug is misbranded unless its labeling contains a list of any active ingredient and the quantity of each, in most situations the labeling must
also contain a list of inactive ingredients in alphabetical order

Question 23

Black Box Warnings

Answer 23

Required in labeling when use of a drug may lead to death or serious injury

Question 24

“New drug”

Answer 24

A drug that is not generally
recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling and has been used for a material extent and time for conditions recommended in labeling

Question 25

An approved drug can become a "new drug" under what certain conditions?

Answer 25

Addition of new substance, new combination of approved drugs, change in proportion of ingredients, new intended use, dosage, method, or duration of administration or application is changed

Question 26

“Change Being Effected (CBE)”

Answer 26

SNDA allows the sponsor to make the change before FDA approval and is important for labeling changes

Question 27

Drug Efficacy Study Implementation (DESI)

Answer 27

Applies to prescription and OTC drugs - only requires evidence of bioequivalence and manufacturing methods rather than proof of safety and efficacy

Question 28

505(b)(2) application

Answer 28

Allows a manufacturer to use published or other existing information to establish safety and efficacy without extensive clinical trials

Question 29

MedWatch

Answer 29

Voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues

Question 30

What are the minimum prescription dispensing label requirements?

Answer 30

- Dispenser name and address - Serial number - Date of prescription or filled date - Prescriber name - Patient name - Directions for use - Cautionary statements

Question 31

The FDA can authorize a switch of a drug from prescription to OTC status by means of an ______ ___ or _____.

Answer 31

Approved NDA, SNDA

Question 32

Manufacturing

Answer 32

Mass production of drug products that have been approved by the FDA (through IND/NDA)

Question 33

Compounding

Answer 33

USP definition: preparation, mixing, assembly, packaging, and labeling of one or more drugs. - not FDA approved, regulated by state boards of pharmacy

Question 34

Drug Quality and Security Act 2013

Answer 34

Passed in effort to increase regulatory requirements of compounding pharmacies, ensuring safe production of compounded drugs

Question 35

503A compounding pharmacy

Answer 35

Dispense patient specific medications pursuant to prescriptions for individual patients - Regulated by the states

Question 36

503B outsourcing facility

Answer 36

Produce large batches of sterile products for multiple patients with or without a prescription - Subject to Current Good Manufacturing Practices

Question 37

Prescription Drug Marketing Act

Answer 37

Establish legal framework for safe and effective distribution of prescription drugs

Question 38

Drug Supply Chain Security Act (DSCSA 2013)

Answer 38

Established timeline for trading partners toward implementation of a track and trace system

Question 39

Poison Prevention Packaging Act

Answer 39

Intent of act to protect children from accidental poisonings due to “household substances”

Question 40

Federal Controlled Substances Act

Answer 40

Creates a closed system via registration, enforced by the DEA

Question 41

State law must be _____ than federal law to not conflict.

Answer 41

stricter, pharmacists must follow stricter law

Question 42

Combat Methamphetamine Epidemic Act of 2005 and Methamphetamine Prevention Act of 2008

Answer 42

Places restrictions on OTC drugs used to manufacture methamphetamine including pseudoephedrine - No more than 3.6 g of ephedrine, PSE, or PPA base to a single purchaser per day