Iphc Law Exam

Front 1

is the duty to fulfill both explicit and implicit promises/agreements into which one has entered (ex. contracts)

Back 1

Fidelity

Front 2

the duty to make up for wrongful acts previously done to others (make amends or compensate)

Back 2

Reparation

Front 3

the duty to thank those who help us

Back 3

Gratitude

Front 4

to prevent such a mismatch but recognizing merits (benefits should be distributed according to the merits)

Back 4

Justice

Front 5

improve these conditions of others in these respects

Back 5

Beneficence

Front 6

the duty to be good to our self, to improve our virtue and our intelligence

Back 6

Self-improvement

Front 7

the duty not to injure others

Back 7

Nonmaleficence

Front 8

An action is morally right if the consequences of that action are more favorable than unfavorable

Back 8

Consequentialism

Front 9

an action is morally right if the consequences are more favorable than unfavorable only to the agent performing the action

Back 9

Ethical egoism

Front 10

an action is morally right if the consequences are more favorable than unfavorable to everyone except the agent

Back 10

Ethical Altruism

Front 11

an action is morally right if the consequences of the action are more favorable than unfavorable to everyone

Back 11

Utilitarianism

Front 12

father of utilitarian theory

Back 12

Jeremy Bentham

Front 13

A behavioral code/rule is morally right if the cons of adopting that rule are more favorable than unfavorable for everyone

Back 13

Rule Utilitarianism

Front 14

Having the freedom to make choices about specific issues that affects someone's life thereby enabling one to makes informed and reasonable choices

Back 14

Autonomy

Front 15

Balancing benefits of treatments against risks/costs, the health care professional should act in the best interest of their patient

Back 15

Beneficence

Front 16

Avoid causing harm to patients

Back 16

Nonmaleficence

Front 17

Refers to the obligation to be fair to all people

Back 17

Justice

Front 18

focuses on the distribution of goods and services (goods and burdens are distributed evenly and fairly)

Back 18

Distributive justice

Front 19

legal rights

Back 19

Legal justice

Front 20

includes legal rights and more

Back 20

Rights based justice

Front 21

Regulate controlled substance

Back 21

Federal Comprehensive Drug Abuse Prevention and Control act of 1970 (“Controlled Substance Act (CSA))

Front 22

an agency of the US Dept of Justice is charged with administering all parts of the CSA

Back 22

DEA

Front 23

establishes rehabilitation programs for drug abusers

Back 23

Controlled Substance Act Title I

Front 24

provides for the registration and distribution of controlled substances

Back 24

Controlled Substance Act Title II

Front 25

addresses the importation and exportation of controlled substances

Back 25

Controlled Substance Act Title III

Front 26

protect health and safety associated with unsanitary and poorly labeled food and drugs

Back 26

Pure Food & Drug Act of 1906

Front 27

Required drugs to be safe as labeled & approved by the FDA
Label must contain adequate instructions for use and warnings about habit-forming drugs

Back 27

Food, Drug and Cosmetic Act of 1938

Front 28

Established prescription and OTC classes of drugs

Back 28

Durham-Humphrey Amendment of 1951

Front 29

Established the federal caution required on all prescription drug products

Back 29

Durham-Humphrey Amendment of 1951

Front 30

Labels on prescription drugs contain prescriber’s directions – complies with “adequate directions for use”

Back 30

Durham-Humphrey Amendment of 1951

Front 31

Establishes requirements for oral prescriptions

Back 31

Durham-Humphrey Amendment of 1951

Front 32

Establishes requirements for prescription refills

Back 32

Durham-Humphrey Amendment of 1951

Front 33

Strengthened drug approval process by requiring drugs be proved not only safe but effective

Back 33

Kefauver-Harris Amendment 1962

Front 34

Gave FDA control of prescription drug marketing and advertising

Back 34

Kefauver-Harris Amendment 1962

Front 35

Established good manufacturing practices

Back 35

Kefauver-Harris Amendment 1962

Front 36

Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug events

Back 36

Kefauver-Harris Amendment 1962

Front 37

Expanded access to drugs for rare diseases

Back 37

Orphan Drug Act of 1983

Front 38

Commonly referred to as the Hatch-Waxman Act

Back 38

Drug Price Competition and Patent Term Restoration Act of 1984

Front 39

Streamlined requirements for bringing generics to market

Back 39

Hatch-Waxman Act

Front 40

Generic manufacturers, no longer have to perform safety and efficacy tests

Back 40

Hatch-Waxman Act

Front 41

Established sales restriction and recordkeeping requirements for prescription drug samples

Back 41

Prescription Drug Marketing Act of 1987

Front 42

Establishes state licensure requirements for pharmaceutical wholesalers

Back 42

Prescription Drug Marketing Act of 1987

Front 43

FDA allowed to collect fees from companies that produce human drug/biological products

Back 43

The Prescription Drug User Fee Act

Front 44

Streamlined FDA drug approval process to allow expedited availability of drugs and devices

Back 44

FDA Modernization Act of 1997

Front 45

Required FDA to establish public standards regarding approval process and a mission statement

Back 45

FDA Modernization Act of 1997

Front 46

Established a fast-track approval process for drugs used for life-threatening diseases

Back 46

FDA Modernization Act of 1997

Front 47

Gives FDA full authority to establish labeling requirements for OTC agents

Back 47

FDA Modernization Act of 1997

Front 48

Established ingredient labeling requirements for inactive ingredients

Back 48

FDA Modernization Act of 1997

Front 49

Reauthorize PDUFA user fees for drugs and devices for fiscal years 2008‐2012

Back 49

FDA Amendment Act of 2007 (FDAAA)

Front 50

Requires collection of fees for review of direct‐to-consumer TV ads

Back 50

FDA Amendment Act of 2007 (FDAAA)

Front 51

Establishes Reagan‐Udall Foundation to promote FDA

Back 51

FDA Amendment Act of 2007 (FDAAA)

Front 52

Establishes NIH clinical trials registry data bank and clinical trials results database

Back 52

FDA Amendment Act of 2007 (FDAAA)

Front 53

Mandatory Risk Evaluation & Mitigation Strategies (REMS)

Back 53

FDA Amendment Act of 2007 (FDAAA)

Front 54

Programs to identify and reduce inappropriate/unnecessary care

Back 54

OBRA-90

Front 55

Each state provides DUR to improve quality of care

Back 55

OBRA-90