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53 Cards in this Set
- Front
- Back
Public Goods
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Necessary and beneficial commodities that private entities will not supply because there is no incentive for a private entity to provide them
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Externality
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exists when the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of a good are not fully incorporated into the price a consumer pays for it - parties who are directly involved in using the good may not consider the indirect impact of the production/consumption of the good for a party that is NOT involved in the use of that good
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Natural Monopoly
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occurs when the fixed costs of providing a good are high relative to the variable costs, so the average cost declines over the time that the good is provided
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Government Regulation when it comes to Monopolies
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Governments regulate natural monopolies to promote efficiency. In drug therapy, the cost of demonstrating the safety and efficacy of a new drug is usually much greater than the cost of providing the new drug once it has been shown to be safe and effective
Government regulation ensures that there is an incentive to develop new drugs by INITIALLY providing an EXCLUSIVE right to market them. After the period of exclusivity expires, regulation promotes efficiency by permitting competition by generic manufacturers |
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Information Asymmetry
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leads to market failures when the consumer in uninformed about the true value of a good. Government regulation requires the provision of information and input by educated professionals into decisions about drug use
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de minimis
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very minor or trifling
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Young Vs Board of Pharmacy
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The Supreme Court of New Mexico substituted its judgement for that of the enforcement authorities. Court reacted to what it believe was "excessive punishment" ruling that charges made against a pharmacist for sloppy record keeping were arbitrary, unlawful, and unsupported. It was not as charged "unprofessional conduct". Court did not see how record keeping should be a test of a person's professional character
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Individuals in a free society are permitted to act in ways....
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that they deem best for themselves, as long as their actions do not interfere with another individual's right of action
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Administrative Agencies
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Can be considered a 4th Branch of Government where all three branches make law together
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What is the Supreme Law of the U.S.?
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the Constitution
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Fourteenth Amendment
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passed in 1870, applies the Bill of Rights to STATE governments
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legislature
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an elected body of persons with the primary responsibility to enact laws, also called "statutes". These statutes can be organized in a hierarchical order: Federal Statutes --> State constitutions --> State Legislation --> Ordinances
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Article 1, Section 1 of the US Constitution
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Provides that all legislative powers of the federal government shall be vested in a Congress, which shall be composed of a Senate and a House of Representatives
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Article 1, Section 8 of the US Constitution
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Provides that Congress shall have the power to make all laws "necessary and proper" for carrying out its responsibilities. Thus Congress enacts laws that apply nationwide
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What do states have under the 10th Amendment?
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States have the power to legislate in all areas except those prohibited or given to Congress by the US Constitution, As a result, state legislatures have extremely broad powers to pass laws to protect the health, safety, and welfare of the public
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When can legislatures create administrate agencies?
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A legislature may create administrative agencies to implement desired changes in policies or to administer a body of substantive law when the legislature itself cannot perform these functions **although they may be created by legislature, such agencies are house in the EXECUTIVE branch of government
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CMS
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Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration - HCFA) which is housed in the Department of Health and Human Services (DHHS) is responsible for reimbursement polices and procedures for pharmacies and other health care providers participating in said programs
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FDA
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The Food and Drug Administration, also housed in DHHS, administers the federal Food, Drug, and Cosmetic Act (FDCA)
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DHHS
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Department of Health and Human Services
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FTC
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Federal Trade Commission, in administering the Federal Trade Commission Act, enforces unfair business practices and antitrust violations.
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DEA. What does the "A" stand for? **
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Administration
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DEA
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Drug Enforcement Administration is under the jurisdiction of the U.S. Justice Department, and administers the federal Controlled Substances Act
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promulgate
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to make
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How do administrative agencies accomplish their legislative function?
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through the promulgation (to make) of REGULATIONS
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administrative regulations interpret and define ____
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statutes
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Notice and Comment Period
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the statutory timeframe during which an agency publishes a proposed regulation; published in Federal Register or Code of Federal Regulations, received public feedback on the regulation, after this period expires, the regulation can take effect **Although regulations are NOT statutes, they have the legal force of statutes and must be obeyed as such
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pursuant
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in accordance with
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In order to be deemed "valid", a regulation must meet THREE legal tests
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1. must be within the scope of the agency's authority
2. must be based on a statute that gives the agency the authority to promulgate the regulation 3. it must bear a reasonable relationship to the public health, safety, and welfare |
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RRC
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Rule Review Commission - it must approve state agency regulations
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Notice and Comment Rulemaking has replaced what unfair approach?
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case-by-case enforcement
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Exhaustion of Remedies
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Agency decisions are subject to judicial review only after the individual has taken advantage of every available administrative option
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Title 21 of the CFR
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Where ALL FDA regulations are contained
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Federal Register (FR)
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daily publication in which US administrative agencies publish: federal actions, proposed regulations, final regulations, governmental notices
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Code of Federal Regulations (CFR)
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the annual collection of executive agency regulations published in the daily Federal Register, combined with previously issued regulations that are still in effect it has 50 Titles --> we will focus on Title 21
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Courts make law through _____
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Judicial opinions, these opinions aka rules are enforceable as law!! they are binding on lower courts within the same jurisdiction and are persuasive in other jurisdictions
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Judicial Opinions establish enforceable legal principles either by....
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expanding the common law OR by interpreting statutes and regulations
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common law
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law developed from judicial opinions
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Stare Decisis
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"to abide by decided cases" It serves 2 purposes: 1. establishing continuity of decisions 2. expediting judicial decision making, not an inflexible principle
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Stare decisis applies only to
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lower courts within the jurisdiction in which the precedent has been established
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What principles do courts apply when interpreting legislation?
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determine the legislative intent...in other words, the court attempts to put itself in the mind of the legislature and ask "Did the legislature mean for the law to apply to the specific fact situation that the court is now considering?"
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Primary function of Congress?
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to enact statutes through vote of the full membership (senate and house of representatives)
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sponsor of a bill must be either....
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a senator or representative
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civil action
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lawsuit in which one private party sues another private party alleging an injury, may be based on common law, statutory law, or BOTH, objective of a civil action is to compensate the injured party for the damages caused by the wrongdoer
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administrative action
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may occur when a pharmacist has violated a statute or regulation or has committed an act that, in the opinion of the agency, warrants an investigation
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Article 3 of US Constitution
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authorizes the Supreme Court and authorizes Congress to establish additional federal courts as necessary
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District courts have jurisdiction over controversies that include
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1. US Constitution or a federal law
2. ambassadors or consuls 3. admiralty and maritime issues 4. the United States as a party 5. a state as a party against another state 6. a state as one party and a citizen of another state as the other party 7. a citizen of one state against a citizen of a different state |
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State Court System
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one highest review court --> state supreme court (then many of the more densely populated states like FL and CA have an additional INTERMEDIATE APPELLATE COURT below the state supreme court) -->trial courts with very broad jurisdiction --> limited jurisdiction trial courts (ex probate, family, juvenile) -->very limited jurisdiction (ex police courts, traffic, small claims)
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an action can be filed in a court only if that court has jurisdiction over both...
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the subject matter of the dispute and the parties involved
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plantiff
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person who BRINGS the lawsuit
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DMA
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Department of Medical Assistance, medicaid policy and reimbursement
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DPH
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Department of Public Health, Board of Registration in Pharmacy (BOP) --> Pharmacy Practice Acts
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example of a criminal action by pharmacist
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pharmacist sells a controlled substance (CIV) without a prescription
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example of a administrative action by a pharmacist
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pharmacist appears in front of Board of Pharmacy for unprofessional conduct
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