Pharmacy 151 Introduction to Pharmacy Law

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Pharmacy 151Introduction to Pharmacy Law

• US Legal System

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Why Regulate Medications?

• Potential risks to users
• Free market not always efficient
• Market inefficiency leads to Market Failure

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Market Failures

• Public Goods
• National Defense Programs
• Orphan Drugs and Vaccines
• Externalities
• Purchasing product from company that pollutes the
  air
• Over use of antibiotics

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Market Failures (cont)

• Natural Monopolies
• Utilities that provide electricity and water
• Exclusive right to market the drug
• Information Asymmetry
• See true value of good on examination
• Medications true values can not be seen

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Sources of United States Law

• LEGISLATIVE
• EXECUTIVE
• JUDICIAL
• ADMINISTRATIVE

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Federal and Legislative Process

• Constitution
• Federal Statutes
• State Constitution
• State Legislation
• Ordinances
• Administrative Law

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American Judicial System

• Courts
• Procedures
• Selection of a Court
• The Parties
• Complaint, Summons, and Answer
• Discovery
• Pretrial Motions
• Jury Selection

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American Judicial System (Cont)

• Witnesses
• Trial
• Verdict
• Appeal

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Administrative Agency Responsibilities

• Rulemaking
• Investigative
• Adjudicatory
• Enforcement

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Administrative Procedure Act

• Requires agency to
• Prepare written regulations
• Publish them in Federal Register
• Hold hearings on proposed regulations
• Publish modified regulations
• Hold 2nd hearings on modifications
• Publish final regulations before implementation

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Advantages of Administrative Agencies

• Develop expertise (legislature/executive lack)
• Public better served by use of experts
• Enhanced communications between regulators and
  regulated
• Have long-term knowledge on which to base
  decisions

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Advantages of Administrative Agencies (Cont)

• Can closely supervise judgment against regulated
• High profile discourages improper behavior
• Administrative process faster than trial
• Reduces court case load (costs)

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Disadvantages of Administrative Agencies

• High cost of operation
• Cost/benefit may be poor
• Salaries too low to attract true experts
• Government/private sector interchanges may not
  always serve the public interest (special
  interests)
• Too much power (judge, jury, executioner
• Slow, inefficient, and poor results

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Divisions of Law Civil

• Relates to disputes between two or more private
  parties
• Object is to compensate the injured party
• Penalties include damage awards, enforcement of
  contracts, or injunctions against action
• Tried before a court
• Torts, Contracts

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Divisions of Law Criminal

• Society punishes individuals who commit crimes by
  violating specific statutes
• Object is to deter future behavior, punish the
  wrong doer (retributive justice), and/or
  rehabilitate the wrong doer
• Penalties involve fines and/or prison sentences,
  sometime capital punishment (death)
• Misdemeanors, Gross Misdemeanors, Felonies

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Divisions of Law Administrative

• Investigations of violations of rules or
  regulation made by administrative agencies
• Directly affects only those individuals subject
  to the agencys jurisdiction
• Object is to correct professional or business
  behavior, and/or to remove a person from a
  profession if he or she poses a danger to the
  public
• Involves hearings before the agency
• Results in payments of fines and/or probation,
  suspension, or revocation of license or other
  permit
• May be appealed to a court

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Relationship among Divisions

• Trials or hearings and penalties, conducted in
  one division of the law do not preclude trials,
  hearings, and penalties in another division
• In some cases, evidence in one division may be
  used in cases from an other division
• Example Robert Ray Courtney

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Example Robert Ray Courtney

• 20 Criminal Charges
• Tampering with consumer products (8)
• Adulteration (6)
• Misbranding (6)
• Unknown number of patients injured, who may sue
• MO Board of Pharmacy received surrendered license

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Two major objectives of law

• Substantive
• Creates, defines, and regulates rights
• Procedural
• Prescribes methods for enforcing rights and
  obtaining redress