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a body of principles, values, morals, and ethics that governs conduct
- Deals with those items important to the country as a whole –
- national defense, foreign relations, minting currency, and interstate commerce
Deals with items not proscribed in the constitution to be dealt with by the federal government.
________________ is the highest type of law. It forms the framework for all other types of law and regulation.
Three branches of government are established in the constitution:
Legislative does what?
legislative branch develops and passes statutory laws.
Executive does what?
- Executes statutory laws
- Develops and implements regulatory laws
- Signs all laws
- Charged with enforcing the law
- Legislative branch with ⅔ majority vote of its members can override the veto of the chief executive.
Judicial does what?
- Interprets the law when situations/conflicts arise
- This process then establishes a precedent for the interpretation and enforcement of a law.
Statutory laws are enacted by the __________________with agreement of the_____________________.
- legislative branch
- executive branch
Federal statutes pertinent to pharmacy include:
- Food, Drug and Cosmetic Act and the Poison Prevention Packaging Act (brought us child-resistant containers)
- Pharmacy Practice Act (governing conduct of pharmacy professionals) is a state law or federal law?
Statutory law provides a broad or narrow framework?
Administrative Law provides____________.
Administrative agencies, such as boards of pharmacy, are created by legislatures to _____________ passed by the legislature.
In Nebraska, _________________ and _________________combine to create a Board of Pharmacy that operates within the Nebraska Department of Health and Human Services (DHHS).
The Pharmacy Practice Act and the Uniform Credentialing Act
The Board of Pharmacy regulates___________________________________________. The DHHS regulates___________________________________________.
- Pharmacists engaged in the practice of pharmacy
- Health care facilities (including pharmacies)
Any regulation promulgated by a Board of Pharmacy must:
- Be within the scope of authority given to the Board by the legislature
- Have a reasonable relationship to protecting the public health, safety and welfare
Common Law is law made by courts based on_________________________.
- Judicial opinion
- What do 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
What types of civil law are there?
Contract and Tort
What type of Tort laws are there?
- Without fault
What 2 main types of laws exist?
Criminal and Civil
Criminal law regulates_____________________________________________.
- the relationship between the individual and society
- what is and what is not appropriate conduct within society
Federal statutes regulating drugs in interstate commerce (such as the federal Food, Drug and Cosmetic Act) and state statutes (such as Pharmacy Practice Acts) are examples of_____________________.
Federal statutes regulating drugs in interstate commerce (such as_____________________________) and state statutes (such as) are examples of criminal law.
- The federal Food, Drug and Cosmetic Act
- Pharmacy Practice Acts
Civil law governs:
- Relationships between/among individuals
- If a murder takes place, _______________ charges the defendant with murder to protect society from the accused. A ______________could then be taken against the murderer as well.
- criminal law
- civil action
People v. Stuart
- Owner of the pharmacy purchased the pharmacy with all its contents
- Bottle of sodium nitrite that had been mislabeled as sodium citrate
- The compounding pharmacist used the mislabeled nitrite rather than the citrate and unknowingly poisoned the child who later died.
- A charge of criminal manslaughter was filed against the pharmacist who was found guilty and then appealed
- INTENT is required in criminal law. The pharmacist’s attorney established that there was no intent to harm. Civil liability is a separate issue.
The best standards of care in practice are usually________________________________.
Well beyond what the law requires
Laws are the legal minimum for______________________.
The Omnibus Budget Reconciliation Act of 1990 (OBRA 90) 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
- The ________________________________ 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.
- Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
The _______________________________________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.
Director of the Health Care Financing Administration (HCFA, now the Centers for Medicare and Medicaid Services, or CMS)
Why was OBRA 90 not an intrusion on states ability to govern pharamcists?
States were free to ignore these standards, but would then no longer have qualified for any federal Medicaid funds
OBRA 90 finally went into effect in_______________.
A drawback with the implementation and comment period (2 years) associated with OBRA 90 included what?
- States were unsure what would apply
- Pharmacies and related businesses didn’t know what kind of software to get to comply with the new regulations
What is the composition of the federal legislative branch?
- Senate (100)
- House of Representatives (435)
What is the composition of the federal Executive branch?
- Dept. of Health and Human Services
- Public Health Service
- Food and Drug Administration (FDA)
- Centers for Disease Control (CDC)
- National Institutes of Health (NIH)
- Indian Health Service (IHS)
- Centers for Medicare & Medicaid Services (CMS)
- Dept. of Justice
- Drug Enforcement Administration (DEA)
- Dept. of Veterans Affairs (DVA)
- Non-Cabinet Agencies (partial list)
- Consumer Product Safety Commission (CPSC)
- Federal Trade Commission (FTC)
What is the composition of the Federal Judicial branch?
- Supreme Court
- Circuit Court of Appeals (12)
- (Nebraska is in 8th Circuit)
- District Courts (100)
- Nebraska is one district
What is the composition of the Nebraska legislative branch?
Nebraska Unicameral Legislature
What is the composition of the Nebraska Executive branch?
- Governor & Lieutenant Governor
- Agencies not subject to Governor’s direct control
- Agencies subject to Governor’s direct control
- Nebraska Health and Human Services System
- Department of Health & Human Services
- Department of HHS Finance & Support
- Department of HHS Regulation & Licensure
- Nebraska Board of Pharmacy
The Nebraska Judical system includes:
- Nebraska Supreme Court: Chief Justice and 6 Judges (is the highest Appellate Court)
- Court of Appeals: 6 Judges, Panels of 3 judges hear appeals throughout state
- District Courts: 54 Judges serving 12 districts