Midterm Laws

Question 1

1890 Sherman Antitrust

Answer 1

applies to all competitive markets and prohibits competitors from price fixing, boycotting. Complex law but maintains competition and low prices.

Question 2

1936 Robinson Antitrust

Answer 2

allows volume med discounts: large purchasers get lower prices (hospitals, HMOs). These institutions cannot compete with retail pharmacys using discounted drug prices

Question 3

4 elements of negligence

Answer 3

1. Duty owed
2. Breach of Cuty
3. Causation
4. Damages

Question 4

Tort

Answer 4

A civil wrong that unfairly causes someone to suffer loss/harm resulting in legal liability

Question 5

Laws of contract

Answer 5

1. mutual agreement between more than 2 people
2. legally competent parties
3. consideration of anything valuable promised in another contract
4. lawful purpose or object

Question 6

express warranty

Answer 6

written and available to buyer

Question 7

implied of merchantibilty

Answer 7

not written

Question 8

exclusion of implied warranties

Answer 8

sold as is

Question 9

1906 Pure Food and Drug Act

Answer 9

address the ineffective and unsafe remedies

protection from adulterated/misbranded food/drugs

Question 10

1938 Food Drug and Cosmetic Act

Answer 10

FDA regulates drug safety, quality regulations
no drug is marketed until proved safe
need adequate directions for use

Question 11

1951 Durham-Humphrey Administration

Answer 11

RX only/established OTC drugs

based on public use safely with adequate directions for use

Question 12

1962 Kefauver-Harris Administration

Answer 12

Proof of safety and efficacy
established good manufacturing practices=GMP
clinical trial safeguards and adverse reaction reporting

Question 13

1983 Orphan Drug Act

Answer 13

tax/licensing incentives for drugs that have little/no commercial values for rare diseases
applies when drug development costs much more than returns

Question 14

1984 Drug Price Competition

Answer 14

aka Waxman Hatch Administration
generic drug approval to make more readily available
the FDA determines the bio-equivalence, lists in Orange Book

Question 15

1992 Prescription Drug User Fee Act

Answer 15

drug/biologic manufacturers pay a fee for product applications and those funds are used to hire more reviewers to speed up the review and approval process

Question 16

1994 Dietary Supp Health and Education Act

Answer 16

specific labeling requirements and GMP for dietary supplements. The manufacturer is responsible for ensuring dietary supplements is safe. No disease prevention claims allowed

Question 17

1997 Food and Drug Modernization Act

Answer 17

reauthorizes prescription drug use act to accelerate review of devices, regulate the unapproved uses of drugs and devices and deals with health claims for foods.

Question 18

2007 FDA Administration Act

Answer 18

$1.2 M for New Drug Application. Encourages research on children and pediatric medicines.
Pediatric Research Equity Act
medication guide/pkg inserts

Question 19

2013 Drug Quality and Security Act

Answer 19

large compounding pharmacies must register as outsourcing facilities
Drug supply chain security act-track and trace all Rx drug sales

Question 20

product claims ad

Answer 20

drug, indication, claims of safety and efficacy

Question 21

reminder ad

Answer 21

drug, dosage form, and cost

Question 22

help-seeking ad

Answer 22

describes disease

Question 23

NDC number

Answer 23

first 4-labeler
middle 4-product code
last 3-pkg code

Question 24

1970 Poison Prevention Act

Answer 24

child resistant pkging for OTC and RX meds
pt can opt out in writing
exceptions: nitroglycerin and some medications for the elders

Question 25

Controlled Substances Act of 1970

Answer 25

closed system for manufacturing/distributing/dispensing narcs
rehab for addicts, research in chemical dependency

Question 26

1965 Drug Abuse Control Admin

Answer 26

deal with problems caused by abuse of depressants, stimulants, hallucinogens

Question 27

1990 Anabolic Steroids

Answer 27

C3 steroids

Question 28

1996 Methamphetamine control

Answer 28

C3 OTC sale of ephedrine/pseudo-ephedrine

In Oregon: street meth C1, medical: C2

Question 29

Requirements for C2 Rxs

Answer 29

Date of date written
signed by practitioners
cannot be refilled “do not fill until ___” ok
patient address and DEA of practitioner

Question 30

DEA # verification

Answer 30

Second letter=first letter of last name
1st, 3rd, 5th numbers add
2 times add 2nd, 4th, and 6th numbers
last number of addition is last number of DEA

Question 31

electronic orders needs…

Answer 31

authentication, non repudiation, message integrity