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Pharmacy Law > Old Material > Flashcards

Old Material Flashcards

1
Q

What are the four types of market failures?

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

Public Goods

A

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

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3
Q

Externality

A

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

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4
Q

Monopoly

A

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

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5
Q

Information Asymmetry

A

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

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6
Q

Criminal Actions

A

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

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7
Q

Civil Actions

A

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

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8
Q

Administrative Actions

A

Agency v. private party
Objectives:

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9
Q

Federal Authority

A

Regulate drug distribution comes primarily from the Interstate Commerce Clause

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10
Q

State Authority

A

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

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11
Q

Pure Food and Drug Act (1906)

A

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

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12
Q

Food, Drug, and Cosmetic Act (1938)

A

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

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13
Q

Durham-Humphrey Amendment (1951)

A

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

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14
Q

Kefauver-Harris Amendment (1962)

A

Scientific proof of efficacy (effectiveness)

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15
Q

Orphan Drug Act (1983)

A

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

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16
Q

Drug Price Competition and Patent Restoration Act (1984)

A

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

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17
Q

Prescription Drug Marketing Act (1987)

A

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

18
Q

Dietary Supplement Health and Education Act (1994)

A

Made herbals officially dietary supplements

19
Q

What is considered evidence that a product is a drug?

A

Labeling, advertising, and nature of a product

20
Q

DSHEA

A

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

21
Q

Adulteration

A

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

22
Q

Misbranding

A

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

23
Q

Black Box Warnings

A

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

24
Q

“New drug”

A

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

25
Q

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

A

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

26
Q

“Change Being Effected (CBE)”

A

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

27
Q

Drug Efficacy Study Implementation (DESI)

A

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

28
Q

505(b)(2) application

A

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

29
Q

MedWatch

A

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

30
Q

What are the minimum prescription dispensing label requirements?

A
  • Dispenser name and address
  • Serial number
  • Date of prescription or filled date
  • Prescriber name
  • Patient name
  • Directions for use
  • Cautionary statements
31
Q

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

A

Approved NDA, SNDA

32
Q

Manufacturing

A

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

33
Q

Compounding

A

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

34
Q

Drug Quality and Security Act 2013

A

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

35
Q

503A compounding pharmacy

A

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

36
Q

503B outsourcing facility

A

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

37
Q

Prescription Drug Marketing Act

A

Establish legal framework for safe and
effective distribution of prescription drugs

38
Q

Drug Supply Chain Security Act
(DSCSA 2013)

A

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

39
Q

Poison Prevention Packaging Act

A

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

40
Q

Federal Controlled Substances Act

A

Creates a closed system via registration, enforced by the DEA

41
Q

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

A

stricter, pharmacists must follow stricter law

42
Q

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

A

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

Pharmacy Law (2 decks)

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