Exam 1 - The Legal System of the US Flashcards
Which type of government, federal or state, deals with those items important to the country as a whole?
FEDERAL government
Which type of government, federal or state, deals with items not proscribed in the constitution?
STATE government
____ _____ involves business transactions across state lines.
INTERSTATE COMMERCE involves business transactions across state lines.
T/F: Pharmacy operations in federal facilities (military bases and VA hospitals) are subject only to federal statutes and regulations.
TRUE
T/F: Pharmacies not operated under federal jurisdiction are subject at only the state level.
FALSE - pharmacies not operated under federal jurisdiction are subjection regulation at both the federal and state levels
Name the highest type of law.
Constitutional law
T/F: Constitutional law is the highest type of law in the US.
TRUE
What type of law forms the framework for all other types of law and regulation?
CONSTITUTIONAL LAW
Name the three branches of government established under the US constitution.
1) Legislative
2) Executive
3) Judicial
Which branch of the government develops and passes statutory laws?
Legislative branch
What does the legislative branch of government do/accomplish?
It develops and passes statutory laws - makes the laws
What type of law further defines Statutory Laws?
Regulatory laws
T/F: Statutory laws and Regulatory laws are viewed the same in court.
TRUE
Which branch of the government executes statutory laws, develops and implements regulatory laws and signs all the laws?
EXECUTIVE BRANCH
What does the executive branch of the government do?
This branch executes statutory laws, develops and implements regulatory laws, and signs all laws
Which branch of the government is charged with enforcing the law?
Executive branch
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.
TRUE
Which branch of the government interprets the law?
JUDICIAL BRANCH
Which type of laws are enacted by the legislative branch with agreement of the executive branch?
STATUTORY LAWS
___ ___ are enacted by the legislative branch with agreement of the executive branch.
STATUTORY LAWS are enacted by the legislative branch with agreement of the executive branch.
Which type of law provides the details that the broad framework provided by statutory laws may leave out?
ADMINISTRATIVE LAWS
T/F: The Nebraska Board of Pharmacy operates under the Nebraska Department of Health and Human Services (DHHS).
TRUE
T/F: The DHHS regulates health care facilities (including pharmacies) in Nebraska.
TRUE
Which type of law is made by courts based on judicial opinion?
COMMON LAW
___ ___ is made by courts based on judicial opinion.
COMMON LAW is made by courts based on judicial opinion.
What does stare decisis mean?
To stand by things decided
What does the concept of stare decisis in common law mean?
That judicial opinions serve as precedent and are binding on lower courts within the same jurisdiction.
Contract and Tort law make up what type of law?
Civil law
Negligence falls under which type of law?
TORT LAW
Which type of law regulates the relationship between the individual and society?
CRIMINAL LAW
_____ ____ regulates the relationship between the individual and society.
CRIMINAL LAW regulates the relationship between the individual and society.
Name an example of criminal law that falls under state statutes.
Pharmacy Practice Acts
Name an example of criminal law that deals with federal statutes regulating drugs in interstate commerce.
Federal Food, Drug, and Cosmetic Act
What is the type of law that governs relationships between/among individuals?
CIVIL LAW
What is required in criminal law?
INTENT
-Have to prove intent to cause harm
What 3 sources do laws come from?
1) Federal
2) State
3) Regulatory agencies
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?
OBRA 90
-The Omnibus Budget Reconciliation Act of 1990
What did OBRA 90 establish?
The requirement of pharmacists to OFFER to counsel Medicaid patients on their prescriptions
What does OBRA 90 stand for?
The Omnibus Budget Reconciliation Act of 1990
What does HCFA stand for?
Health Care Financing Administration
What did the HCFA change its name to?
Centers for Medicare and Medicaid Services (CMS)
What does CMS stand for?
Centers for Medicare and Medicaid Services
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?
HCFA (now CMS)
HCFA = ?
Health Care Financing Administration
T/F: States were free to ignore the standards made by the HCFA (now CMS) for OBRA 90.
TRUE - but would no longer have qualified for any federal Medicaid funds
When did OBRA 90 go into effect?
January 1993
Name the 6 agencies that affect pharmacists at federal and state levels.
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)
What does CPSC stand for?
Consumer Product Safety Commission
CPSC = ?
Consumer Product Safety Commission
What does PPPA stand for?
Poison Prevention Packaging Act of 1970
PPPA = ?
Poison Prevention Packaging Act of 1970
What agency administers the PPPA?
CPSC
-The US Consumer Product Safety Commission
What act requires special (child-resistant and adult-friendly) packaging of a wide range of hazardous products including most oral prescription drugs?
PPPA
-Poison Prevention Packaging Act of 1970
What does CMS stand for?
Centers for Medicare and Medicaid Services
T/F: The CMS is apart of the DHHS.
TRUE
What is the agency that controls reimbursement policies and procedures for entities (pharmacies and providers) working with Medicare and Medicaid programs?
CMS
-Centers for Medicare and Medicaid Services
What does FDCA stand for?
Food, Drug, and Cosmetic Act
What does FDA stand for?
Food and Drug Administration
T/F: The FDA is also in the DHHS.
TRUE
Which act is the FDA responsible for?
The FDA is responsible for the administration of the Food, Drug, and Cosmetic Act (FDCA)
What does FTC stand for?
Federal Trade Commission
What does the FTC oversee?
The FTC oversees business practices with medications involved
What does DEA stand for?
Drug Enforcement Administration
What does CSA stand for?
Controlled Substances Act
What act does DEA administer?
The DEA of the US Justice Department administers the Controlled Substances Act (CSA)
What does HIPPA stand for?
Health Insurance Portability and Accountability Act
Which act authorizes the DHHS to enact regulations to protect the privacy and security of personal health information?
HIPPA
T/F: The Office for Civil Rights is also involved in HIPPA.
TRUE
