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P1: Pharmacy Law- Exam 1 > Pharmacy Practice and the Law- Exam 1 > Flashcards

Pharmacy Practice and the Law- Exam 1 Flashcards

Chapter 1

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1
Q

******Federal vs. State Law

A
  • When a State law conflicts with either the US Constitution and/or Federal law, the Federal law will preempt (=displaces) State law under the Supremacy Clause of the U.S. Constitution
  • Conflicts generally exist when state law is less strict than federal law
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2
Q

******Stare Decisis- Law Made By Courts: Common Law Cont.

A
  • Stare decisis
    • ​Opinions are binding on lower courts in the same jurisdiction and serve as precedent
    • Not an inflexible principle
      • ​Reasons for deviating from precedent include factual distinctions and changing times or circumstances
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3
Q

*****Law Made By Administrative Agencies

A
  • Infamous 4th branch of Govt
    • ​Administrative Agencies
      • ​Admin agencies are created by legislature to:
      1. ​implement desired changes in policies
      2. administer a body of substantive law
      3. usually have considerable and broad authority ​
        ​► to perform legislative, judicial, and executive functions
    • Create “law” (with the effect of law passed by the legislature and signed by executrive) by
      • ​enacting policies, rules, procedures, and regulations►Notice and Comments
      • rendering decisions at hearings
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4
Q

*****Law Made By Courts:

Common Law

A
  • Common law refers to judicial opinions and was adopted from the English judicial system
    • Story: mortalcombat with prosecutor
  • Judicial opinions: Decisions of the court
    • Enforceable legal opinions as if legislative created law
      • Expanding the common law
      • Interpreting statutes and regulations
    • Binding on lower courts in the same jurisdiction
      • Persuasive in other jurisdictions
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5
Q

*****Law Made of Administrative Agencies-

Legislative Function

A
  • Promulgate Regulations- Legislative function
    • Regulations interpret, define, and add detail to statuses
  • Regulations enacted via notice and comment rulemaking
  • Validity tests of a regulation
    • Within the scope of Board’s authority
      • ultra vires
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6
Q

*****Law Made of Administrative Agencies-

Judicial Function

A
  • Exercise Judicial Fx thru enforcement actions
    • these are discretionary with the agency
      • FDA would not institute action for lethal injection
  • Render decisions pursuant to “hearings” resembling court proceedings
    • Resemble Civil and Criminal proceedings
      • evidence is presented, arguements made, judgment rendered and “sentencing” imposed
      • Loosely bound by state decisis
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7
Q

*****Law Made of Administrative Agencies-

Legislative Function Continued

A
  • Based upon statutory authority
    • Can’t create new law without statute allowing
    • OR Board to discipline technicians
  • Reasonable relationship to public health safety and welfare
    • Eg- dress code or north facing front door = invalid
      • Like all pharmacists must wear lab coats
    • But when would a “dress” code be vaild??
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8
Q

*****Nature and Role of Law

A
  • Stare Decics- the doctrine of precedent
    • to stand by decisions and not disturb the undisturbed
      • The law is still flexible enough to create a new outcome for different fact patterns
    • ALL lower courts are required to follow decisions from higher courts
    • US Supreme Court should follow past SCOTUS decisions
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8
Q

*****Relationship of Common Law to Statutory Law

A
  • Virtually impossible to write a law that is NOT ambiguous, vague, or confusing when applied to specific situations
    • Deliberately written this way to provide flexibility in settling disputes
    • Void for vagueness
    • Courts do not like to invalidate statues unless they have no choice
      • Presume the constitutionality of a statute and make every attempt to interpret the statute in a way that results in a resonable and fair application of the law to the facts of the case
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9
Q

*****Resonable Doubt

A
  • Proof of such a convincing character that you would be willing to rely and act upon it without hesitation in the most important of your own affairs
  • Why do criminal cases require it- deprivation of a defendant’s liberty or even his or her life
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10
Q

****Civil Court Procedures Statute of Limitations

A
  • Limits the period of time in which a case can be filed
    • Generally, the SoL is usually 1-6 years
    • In Colorado the SoL for
      • Contract (oral or written) issues- 6 yrs
      • Injury claims- 2 yrs
      • Property damage- 2 yrs
    • NO SoL for exceptionally heinous crimes like murder
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11
Q

****Civil Court Procedures: The Trial

A
  • All evidence must be
    • relevant to the case
    • more probative (affording proof or evidence) than prejudicial
  • Burden of Proof- level of legal proof required
  • Objections
    • attempt to restrict the introduction of evidence or testimony
    • might constitute issues of law for appeal
  • After all evidence is presented, the judge instructs the jury as to the applicable law to apply
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12
Q

****Civil Court Procedures Discovery

A
  • Pretrial process where each side must give the other side all the facts, evidence, and names of witnesses upon which it will rely to present its case
    • Should be no surprises at trial
  • **Deposition: **Out of court testimony by a witness under oath
  • Interrogatory: List of written questions that witness must respond to under oath
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13
Q

****Federal vs. State Law

A
  • Federal authority to regulate drugs generally arise from the Interstate Commerce Clause of the U.S. Constitution
    • Regulation of drug distribution often results in professional regulation as well
    • Still needs to bear some relationship to Interstate commerce
  • State authority to regulate generally derives from the Tenth Amendment to the U.S. Constitution and under its inherent State police powers
  • State laws must bear a reasonable relationship to the public health safety and welfare
    • Eg: OTC drugs only sold in licensed pharmacies
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14
Q

****Law Made by Administrative Agencies

A
  • Infamous 4th branch of Govt
    • Administrative Agencies
      • Agency “direction” is “controlled” by Exectutive branch (and sometimes Legislative branch) via top executive appointments (with Legistlative confirmation) by Executive branch
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15
Q

******Legislatures: Statutory Law **

A
  • U.S. Congress (federal laws)
  • State Constitutions
  • State Legislatures (state laws)
  • Political Subdivisions (ordinances)
    • Cities, towns, etc.
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16
Q

****Limits of the Law

A
  • Certain human relationships
    • families, professions, religious groups
      • courts lack the expertise to deal with these specialized relationships
  • De minimis violations
    • Overly harsh punishments
    • NO pharmacy can operate withour occasional, very minor technical legal violations
      • no real advantage to pursuing infrequent and De minimis violations
      • BUT boards will take action for multiple repeats of same or similar offense
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18
Q

***Civil Court Procedures Parties

A
  • Plantiff- Person bringing the action
  • Defendant: Person action is brought against
  • In the initial proceedings, the Plaintiff’s name appears first in title of case
    • Plaintiff v. Defendant
  • ​Plaintiff must prove “standing”: that the challenged conduct has caused the plaintiff injury and that there is a legally protectable interest
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18
Q

***Civil Court Procedures: Pre-Trial Motions

A
  • Each party may file various motions with the Court
    • Motion to Dismiss (12b action)- failure to state a claim for which relief can be granted
    • Motion for summary judgment: One party attempts to convince the judge that the other sides claims have no merit even if correct
    • Motions in limine (a motion made at the start of a trial requesting that the judge rule that certain evidence may not be introduced in trial)
      • Exclusions/ inclusions of certain evidence
        • Exclusions- that evidence can’t be brought up in trial and if so, could be grounds for mistrial
        • Inclusions- that evidence does not have to go through the same admission of evidnce procedure
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19
Q

***Criminal Court Procedures

A
  • A criminal defendant can be either indicted or arrested
  • Indictments are issued by a grand jury when it determines that enought evidence (probable cause) exists for an arrest and trial
  • If arrested, at a preliminary hearing the judge must determine if there is enough probably cause for an arrest; and if so, defendant must enter a plea at an arraignment
    • nolo contendere- “I do not wish to contend”
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20
Q

***Criminal Court Procedures

A
  • The parties may agree to a “plea bargain” where the defendant agrees to a lesser charge rather than face a trial
  • Burden of proof for all evidence in a criminal proceeding- beyond a reasonable doubt
  • Defendant has many rights
    • # 1- not to self incriminate
    • right to a speedy trial
    • right to jury trial (generally)
    • Etc, etc
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21
Q

***Limits of the Law Continued

A
  • Protecting individual freedoms while preventing harm to others
  • “The only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others”
21
Q

***Law Made of Administrative Agencies-

Judicial Function Continued

A
  • Decisions subject to judicial review
    • Exhaustion of remedies
    • Court will review record to determine if decision was based upon substantial evidence
      • reviews appropriateness of decision in light of evid
    • De novo: If substantial evidence lacking, court will conduct an entirely new trial
22
Q

***Nature and Role of Law Continued

A
  • Factors courts commonly apply in researching decisions
    • Fundmantal notions of fairness/fair play
    • Custom or history involved
    • Command of a politcal entity
    • Best balance between conflicting societal interests
23
Q

***Relationship of Common Law to Statutory Law

A
  • Courts often must interpret the meaning and application of statutes
  • Principles of interpretation include:
    • Determining legislative intent if possible
    • Ordinary meaning of words
    • Best fit with current social policy
    • Due process rights of the individual
      • A reasonable person would be expected to know that this law does or doesn’t apply to the particular activity in question
      • Does not excuse ignorance of the law
24
Q

***Summons, Complaint, and Answer

A
  • Complaint: Contains all material facts of case and remedy requested
  • **Summons: **Issued by court notifying defendant of suit and commanding defendant to file an answer
  • Answer: Admitting to or denying ALL allegations in the complaint
  • IF YOU GET SERVED- SEEK LEGAL ADVICE IMMEDIATELY
25
Q

**Civil Court Procedures Selection of Court

A
  • Court is an adversarial process
    • To bring out all possible legal arguments and rationale that are relevant to the issue so that an impartial judge or jury may apply the best ones to the situation and render a judgment
  • State court likely unless a federal issue is involved or the parties are from different states
26
Q

**Civil Court Procedures: Verdict and Appeal

A
  • For an appeal, attorney’s for each side submit a “brief” to the court citing the legal principles and precedent involved and why the lower court erred
    • Appellant: party who lost an “issue” below
    • Appellee: party defending the appeal
  • Appellant must convince the appellate court that the trial court committed an error of law that was material to the decision in the case
27
Q

**Distinguishing Criminal, Civil, and Administrative Actions

A
  • Criminal: Government v. Private party
    • Charged with a crime as prohibited by a statute and subject to penalties (fines/prison) specified by statute
    • Objectives: Deter, punish, rehabilitate
  • Civil: Private party v. Private party
    • May be based upon statute or common law
    • Objective: Compensation to injured party
  • Administrative: Agenvy v. Private party
    • Disciplinary determination which may include warning, fines, licensure revocation or suspension, probation
27
Q

**Criminal Court Procedures

A
  • Right to a legal attest
    • valid search warrant
    • valid seizure of physical evidence
  • Evidence may not be “strong” enough to find guilty in a criminal case but may be strong enough in a civil case
    • Ex: OJ Simpson case
28
Q

**General Definition of Law

A
  • Requirements for human conduct applying to all persons within their jurisdiction
  • It is a framework thru which people in a society resolve their disputes in a peaceful manner acceptable to society
    • Consistently???
30
Q

**Sources of Law

A
  • U.S. Constitution- Original Source
    • Supremacy Clause (Art VI, CI 2)
      • No federal or state law may conflict
    • 14th Amendment
      • Applies the Bill of Rights to state governments
31
Q

**Sources of Law Continued

A
  • Tripartite system
    • Executive, Legislative, Judicial
  • Legislature
    • US Congress- Art I, Sec8- make all laws “necessary and proper” for carrying out its responsibilities
    • State have own Constitutions
      • Federal Law is Supreme Law over State
      • 10th Amendment allows state to legistale in all areas except those prohibited or given to Congress by the US Constitution
        • State Legislatures have extremely broad “police” powers to pass laws to protect the “health, safety, and welfare” of the public
32
Q

**State Court Systems

A
  • State Supreme Court
    • Each state has one
  • Intermediate appellate courts
    • In more populated states
  • Trial courts
    • Often called county courts, superior courts, district courts or circuit courts
    • Nearly unlimited jurisdiction
  • Limited Jurisdiction Courts
    • ie: Probate, family, juvenile
  • Very limited jurisdiction courts
    • ie: traffic, small claims
33
Q

**The Judicial Process: Federal Court System

A
  • U.S. Supreme Court
    • Directly created by US Constitution
    • Highest U.S. court, 9 justices with lifetime appointment
    • Original jurisdiction only in cases involving ambassadors, other public ministers, consuls, and when a state is a party
    • Other cases heard by writ of certiorari (orders a lower court to deliver its records in a case so that the higher court can review it)
  • Court of Appeals
    • Created by Congress via Article III
    • 12 judicial circuits and courts primarily hear appeals
34
Q

*Federal Agencies

A
  • Where to find proposed and final regulations that affect Pharmacy Practice
    • Regulations published in Federal Register (Fed. Reg.) and Code of Federal Regulations (CFR)
    • Federal Register: Daily publication of proposed and final regulations and notices
    • CFR: Compilation of final regulations divided and indexed by subject matter
    • Board Website
35
Q

*The Judicial Process: Federal Court System

A
  • District Courts
    • Created by Congree via Article III
    • Jurisdiction primarily based upon whether there is a:
      • Federal law or constitutional issue
      • diversity citizenship
      • if a state or the U.S. is a party
      • Admiralty and maritime issues
      • Ambassadors of consuls
36
Q

*The Judicial Process: Federal Court System Continued

A
  • Specialty Courts
    • Tax
    • Customs and Patent
    • Court of Claims
38
Q

Case Citation

A
  • State and federal appellate court decisions are often reported and have citations
  • From the citation one can tell the names of the parties, which court decided the case and the volume and page number where the case can be found
39
Q

CFR

A

Code of Federal Regulations

40
Q

Civil Court Procedures: Jury Selection

A
  • Voir Dire (used to determine if any juror is biased and/or cannot deal with the issues fairly) examination: the questioning by each side of potential jurors
  • Jury’s role is to determine questions of fact
  • Judge must determine questions of law
41
Q

Civil Court Procedures: The Trial

A
  • Motion for directed verdict
    • After the introduction of evidence, the parties allege that the other lacks sufficient evidence
42
Q

Civil Court Procedures: Verdict and Appeal

A
  • Judgement notwithstanding the verdict (JNOV): The judge may rule contrary to the jury if the jury clearly reached the wrong verdict
  • Mistrial may be granted if a major error or violation of law or procedure occurred during the trial
  • Either party may appeal the final verdcit on the basis that the court committed an error or law
44
Q

Externality

A
  • When the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of the good are not fully incorporated in the price of the good
    • Ex: Indiscriminate use of anitbiotics
44
Q

Civil Court Procedures: Witnesses

A
  • Witnesses may be subject to subpoena
    • which is an order to appear in court
    • failure to appear may result in contempt of court resulting in fines or jail time
  • Expert witnesses will be called when the factual subject matter is beyond the scope of jurors
46
Q

Information Asymmetry

A
  • When the consumer is uninformed about the true value of a good
  • Ex: Prescription only drugs; written consumer information for certain drugs
47
Q

Jurisdiction

A

The official power to make legal decisions and judgments

48
Q

Legislative Process: Federal Level

A
  • After bill leaves committee, majority leadership place bill on a calendar
  • Bill must be debated and passed in one chamber before being sent to other chamber for debate and passage
  • Conference committee must rectify differences
  • Role of the President
    • Approve or veto bill
  • Congress can override veto with 2/3 vote
49
Q

Legislative Process:

State Level

A
  • State legislatures generally modeled after Congress
  • Legislative history generally harder to deterime because fewer written recirds of committee hearings and reports
50
Q

Legislative Process:

Federal Level

A
  • Congree
    • Senate
    • House of Representatives
  • Sponsor of a bill must be a legislator
  • Bill is sent to appropriate congressional committee
    • Holds hearings, conducts investigations
    • Determines whether bill will go to Senate or House floor
51
Q

Monopoly

A
  • When the fixed costs of providing a good are high relative to the variable costs of producing the good
  • Ex: Patents and market exclusivity for new drugs
52
Q

Public Goods

A
  • Necessart and beneficial commodities that private entities will not supply because there is no incentive
    • Ex: Orphan drugs, vaccines
53
Q

Reason To Regulate Drugs

A
  • Potential risk to users
  • Free market is not always society friendly
  • MARKET FAILURES
  • Public goods
  • Externalities
  • Natural monopolies
  • Information asymmetry
54
Q

Role of Law in Pharmacy Practice

A
  • Pharmacy laws have been drafted to:
    • Describe the best general approach to specific pharmacy practice situations
    • Guidance for pharmacists be establishing rules that reflect societal value choices
  • It is not the role of law to dicate:
    • Practice stategy- (within reason)
      • Eg. Where laws do dictate- use UDP approved chemicals​
    • Professional judgment
      • ​Laws CAN NOT substitue for good professional judgment

P1: Pharmacy Law- Exam 1 (3 decks)

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