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PHA 454 - Pharmacy Law (Federal and Nebraska Law) > Exam 1 - The Legal System of the US > Flashcards

Exam 1 - The Legal System of the US Flashcards

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1
Q

Which type of government, federal or state, deals with those items important to the country as a whole?

A

FEDERAL government

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2
Q

Which type of government, federal or state, deals with items not proscribed in the constitution?

A

STATE government

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3
Q

____ _____ involves business transactions across state lines.

A

INTERSTATE COMMERCE involves business transactions across state lines.

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4
Q

T/F: Pharmacy operations in federal facilities (military bases and VA hospitals) are subject only to federal statutes and regulations.

A

TRUE

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5
Q

T/F: Pharmacies not operated under federal jurisdiction are subject at only the state level.

A

FALSE - pharmacies not operated under federal jurisdiction are subjection regulation at both the federal and state levels

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6
Q

Name the highest type of law.

A

Constitutional law

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7
Q

T/F: Constitutional law is the highest type of law in the US.

A

TRUE

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8
Q

What type of law forms the framework for all other types of law and regulation?

A

CONSTITUTIONAL LAW

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9
Q

Name the three branches of government established under the US constitution.

A

1) Legislative
2) Executive
3) Judicial

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10
Q

Which branch of the government develops and passes statutory laws?

A

Legislative branch

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11
Q

What does the legislative branch of government do/accomplish?

A

It develops and passes statutory laws - makes the laws

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12
Q

What type of law further defines Statutory Laws?

A

Regulatory laws

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13
Q

T/F: Statutory laws and Regulatory laws are viewed the same in court.

A

TRUE

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14
Q

Which branch of the government executes statutory laws, develops and implements regulatory laws and signs all the laws?

A

EXECUTIVE BRANCH

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15
Q

What does the executive branch of the government do?

A

This branch executes statutory laws, develops and implements regulatory laws, and signs all laws

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16
Q

Which branch of the government is charged with enforcing the law?

A

Executive branch

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17
Q

T/F: The executive branch can sign or veto a law, but the legislative branch, with a majority vote of its members can override the veto of the chief executive.

A

TRUE

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18
Q

Which branch of the government interprets the law?

A

JUDICIAL BRANCH

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19
Q

Which type of laws are enacted by the legislative branch with agreement of the executive branch?

A

STATUTORY LAWS

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20
Q

___ ___ are enacted by the legislative branch with agreement of the executive branch.

A

STATUTORY LAWS are enacted by the legislative branch with agreement of the executive branch.

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21
Q

Which type of law provides the details that the broad framework provided by statutory laws may leave out?

A

ADMINISTRATIVE LAWS

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22
Q

T/F: The Nebraska Board of Pharmacy operates under the Nebraska Department of Health and Human Services (DHHS).

A

TRUE

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23
Q

T/F: The DHHS regulates health care facilities (including pharmacies) in Nebraska.

A

TRUE

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24
Q

Which type of law is made by courts based on judicial opinion?

A

COMMON LAW

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25
Q

___ ___ is made by courts based on judicial opinion.

A

COMMON LAW is made by courts based on judicial opinion.

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26
Q

What does stare decisis mean?

A

To stand by things decided

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27
Q

What does the concept of stare decisis in common law mean?

A

That judicial opinions serve as precedent and are binding on lower courts within the same jurisdiction.

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28
Q

Contract and Tort law make up what type of law?

A

Civil law

29
Q

Negligence falls under which type of law?

A

TORT LAW

30
Q

Which type of law regulates the relationship between the individual and society?

A

CRIMINAL LAW

31
Q

_____ ____ regulates the relationship between the individual and society.

A

CRIMINAL LAW regulates the relationship between the individual and society.

32
Q

Name an example of criminal law that falls under state statutes.

A

Pharmacy Practice Acts

33
Q

Name an example of criminal law that deals with federal statutes regulating drugs in interstate commerce.

A

Federal Food, Drug, and Cosmetic Act

34
Q

What is the type of law that governs relationships between/among individuals?

A

CIVIL LAW

35
Q

What is required in criminal law?

A

INTENT

-Have to prove intent to cause harm

36
Q

What 3 sources do laws come from?

A

1) Federal
2) State
3) Regulatory agencies

37
Q

What is the name of the law that ordered states to establish minimum standards (via state statutes and/or regulations) for pharmacists to provide the offer to counsel Medicaid patients about their prescriptions?

A

OBRA 90

-The Omnibus Budget Reconciliation Act of 1990

38
Q

What did OBRA 90 establish?

A

The requirement of pharmacists to OFFER to counsel Medicaid patients on their prescriptions

39
Q

What does OBRA 90 stand for?

A

The Omnibus Budget Reconciliation Act of 1990

40
Q

What does HCFA stand for?

A

Health Care Financing Administration

41
Q

What did the HCFA change its name to?

A

Centers for Medicare and Medicaid Services (CMS)

42
Q

What does CMS stand for?

A

Centers for Medicare and Medicaid Services

43
Q

Who was charged with the responsibility of setting up the framework for states to use in developing their OBRA 90 equivalent statutes and/or regulations at the state level?

A

HCFA (now CMS)

44
Q

HCFA = ?

A

Health Care Financing Administration

45
Q

T/F: States were free to ignore the standards made by the HCFA (now CMS) for OBRA 90.

A

TRUE - but would no longer have qualified for any federal Medicaid funds

46
Q

When did OBRA 90 go into effect?

A

January 1993

47
Q

Name the 6 agencies that affect pharmacists at federal and state levels.

A

1) US Consumer Product Safety Commission (CPSC)
2) Centers for Medicare and Medicaid Services (CMS) of the US Department of Health and Human Services (DHHS)
3) Food and Drug Administration (FDA) - also in the in the DHHS
4) Federal Trade Commission (FTC)
5) Drug Enforcement Administration (DEA)
6) Health Information Portability and Accountability Act (HIPAA)

48
Q

What does CPSC stand for?

A

Consumer Product Safety Commission

49
Q

CPSC = ?

A

Consumer Product Safety Commission

50
Q

What does PPPA stand for?

A

Poison Prevention Packaging Act of 1970

51
Q

PPPA = ?

A

Poison Prevention Packaging Act of 1970

52
Q

What agency administers the PPPA?

A

CPSC

-The US Consumer Product Safety Commission

53
Q

What act requires special (child-resistant and adult-friendly) packaging of a wide range of hazardous products including most oral prescription drugs?

A

PPPA

-Poison Prevention Packaging Act of 1970

54
Q

What does CMS stand for?

A

Centers for Medicare and Medicaid Services

55
Q

T/F: The CMS is apart of the DHHS.

A

TRUE

56
Q

What is the agency that controls reimbursement policies and procedures for entities (pharmacies and providers) working with Medicare and Medicaid programs?

A

CMS

-Centers for Medicare and Medicaid Services

57
Q

What does FDCA stand for?

A

Food, Drug, and Cosmetic Act

58
Q

What does FDA stand for?

A

Food and Drug Administration

59
Q

T/F: The FDA is also in the DHHS.

A

TRUE

60
Q

Which act is the FDA responsible for?

A

The FDA is responsible for the administration of the Food, Drug, and Cosmetic Act (FDCA)

61
Q

What does FTC stand for?

A

Federal Trade Commission

62
Q

What does the FTC oversee?

A

The FTC oversees business practices with medications involved

63
Q

What does DEA stand for?

A

Drug Enforcement Administration

64
Q

What does CSA stand for?

A

Controlled Substances Act

65
Q

What act does DEA administer?

A

The DEA of the US Justice Department administers the Controlled Substances Act (CSA)

66
Q

What does HIPPA stand for?

A

Health Insurance Portability and Accountability Act

67
Q

Which act authorizes the DHHS to enact regulations to protect the privacy and security of personal health information?

A

HIPPA

68
Q

T/F: The Office for Civil Rights is also involved in HIPPA.

A

TRUE

PHA 454 - Pharmacy Law (Federal and Nebraska Law) (2 decks)

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