Old Material Flashcards
What are the four types of market failures?
- Public goods
- Externalities
- Natural monopolies
- Information asymmetry
Public Goods
Necessary and beneficial commodities that private entities will not supply because there is no incentive
Examples: orphan drugs; vaccines
Externality
When the production or consumption of a good affects someone who does not fully consent to the effect
Example: indiscriminate use of antibiotics
Monopoly
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
Information Asymmetry
When the consumer is uninformed about the true value of a good
Examples: prescription only drugs; written consumer information for certain drugs
Criminal Actions
Government v. private party
Objectives: deter, punish, rehabilitate
Civil Actions
Private party v. private party
Objectives: compensation to injured party
Administrative Actions
Agency v. private party
Objectives:
Federal Authority
Regulate drug distribution comes primarily from the Interstate Commerce Clause
State Authority
Regulate pharmacy practice and drug distribution comes primarily from the Tenth Amendment and the inherent authority of a state’s police powers
Pure Food and Drug Act (1906)
Prohibited interstate commerce of adulterated (not pure) food and drugs
Food, Drug, and Cosmetic Act (1938)
Scientific proof of safety before a drug could be marketed (sulfanilamide
disaster)
Durham-Humphrey Amendment (1951)
Created 2 classes of products, prescription and OTC, created “Legend Drugs”
Kefauver-Harris Amendment (1962)
Scientific proof of efficacy (effectiveness)
Orphan Drug Act (1983)
Gave economic and tax incentives for pharmaceutical manufacturers to develop drugs for rare disease
Drug Price Competition and Patent Restoration Act (1984)
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
Prescription Drug Marketing Act (1987)
Regulated samples, cannot re-import drugs from other countries, regulates who hospitals can sell to
Dietary Supplement Health and Education Act (1994)
Made herbals officially dietary supplements
What is considered evidence that a product is a drug?
Labeling, advertising, and nature of a product
DSHEA
Created a new special category of food called “dietary supplements” (DSs), do not require premarket approval
Adulteration
A drug is adulterated if its strength, quality, or purity differs from label.
Misbranding
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
Black Box Warnings
Required in labeling when use of a drug may lead to death or serious injury
“New drug”
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
An approved drug can become a “new drug” under what certain conditions?
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
“Change Being Effected (CBE)”
SNDA allows the sponsor to make the change before FDA approval and
is important for labeling changes
Drug Efficacy Study Implementation (DESI)
Applies to prescription and OTC drugs - only requires evidence of bioequivalence and manufacturing methods rather than proof of
safety and efficacy
505(b)(2) application
Allows a manufacturer to use published or other existing information to establish safety and efficacy without extensive clinical trials
MedWatch
Voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues
What are the minimum prescription dispensing label requirements?
- Dispenser name and address
- Serial number
- Date of prescription or filled date
- Prescriber name
- Patient name
- Directions for use
- Cautionary statements
The FDA can authorize a switch of a drug from prescription to OTC status
by means of an ______ ___ or _____.
Approved NDA, SNDA
Manufacturing
Mass production of drug products that have been approved by the FDA (through IND/NDA)
Compounding
USP definition: preparation, mixing, assembly, packaging, and labeling of one or more drugs. - not FDA approved, regulated by state boards of pharmacy
Drug Quality and Security Act 2013
Passed in effort to increase regulatory requirements of compounding pharmacies, ensuring safe production of compounded drugs
503A compounding pharmacy
Dispense patient specific medications pursuant to prescriptions for
individual patients
- Regulated by the states
503B outsourcing facility
Produce large batches of sterile
products for multiple patients with or without a prescription
- Subject to Current Good Manufacturing Practices
Prescription Drug Marketing Act
Establish legal framework for safe and
effective distribution of prescription drugs
Drug Supply Chain Security Act
(DSCSA 2013)
Established timeline for trading partners toward implementation of a track and trace system
Poison Prevention Packaging Act
Intent of act to protect children from accidental poisonings due to “household substances”
Federal Controlled Substances Act
Creates a closed system via registration, enforced by the DEA
State law must be _____ than federal law to not conflict.
stricter, pharmacists must follow stricter law
Combat Methamphetamine Epidemic Act of 2005 and Methamphetamine Prevention Act of 2008
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
