Introduction to Pharmacy Law + The U.S Legal System

Define Law

Requirements for human conduct, applying to all person within their jurisdiction

Describe the general nature and role of law

• Social aspects of law

  • Socially prescribed process - people declare their collective will and express their norms and values

• Clarity in the Law (or Lack Thereof)

  • Common misperception that law is crystal clear

    • Law are often intentionally vague

List the four market failures that provide the basis for goverment regulation of drugs

1. Public goods

2. Externalities

3. Natural monopoly

4. Information Asymmetry

Describe “Public Goods” and provide a pharamcy-related example

Necessary and beneficial commodities that private entities will NOT supply because there is no incentive for a private entity to provide them

• Orphan drugs

• Vaccines

Describe “Externalities” and provide a pharamcy-related example

1. The production or consumption of a good affects someone who does not fully consent to the effect

2. The cost of a good are not fully incorporated into the consumer price

Example

• Resistance due to antibiotic overuse

Describe “Natural Monopoly” and provide a pharamcy-related example

Fixed cost of producing a good is high relative to the variable cost, so the average cost declines over the time that the good is provided

• Drug manufacturing

Describe “Information Asymmetry” and provide a pharamcy-related example

Consumer is uninformed about the true value of a good

• Dissemination of medication information to patients and health care providers

3) Describe the relationship between laws and professional judgment

• Following the law is NECESSARY but not SUFFICIENT for professional success

• Laws do not substitute for good professional judgment - they provide the framework within which pharmacists create their own strategies to provide patient care. 

1) Describe the roles of the three branches of government

• Legislative: makes the law

• Executive: enforces the law

• Judicial: interprets the law

  All create laws

Identify the four sources of law

1. Laws made by the legislatures (Legislative branch)

2. Constitution (the Supreme Law of the Land)

3. Laws made by administrative agencies

4. Common Law

3) Contrast how a bill becomes a statute with how a regulation is approved

• Statute = vigorous discussion and debate on both sides of the legislature, ending with approval by the governor or president

• Regulations become law typically through the “notice and comment” approach

4) Explain the Preemption Doctrine and apply it to a scenario

• Also known as the Supremacy Clause of the Constitution

• Says that when there are difference between federal and state law such that they cannot stand together, federal law always prevails

If Federal and State laws are the same….

Just follow the law

If State law is stricter…

• Follow the state law - unless federal law specifically says it preempts state law

If Federal law is stricter…

follow the federal law

5) List federal and state agencies that are relevant to pharmacy practice 

• Federal

  • Centers for Medicare and Medicaid

  • Food and Drug Administration

  • Drug Enforcement Administration

• State

  • State Board of Pharmacy

  • State Department of Health Services

  • State Medicaid Agency

• These are part of the Executive Branch

6) Explain how administrative agencies serve both legislative and judicial functions

• Legislative

  • Regulations: detailed rules that interpret and define the general statutes enacted by the legislative branch; same legal force as statutes

• Judicial

  • Agencies can institute proceedings by their own discretion - hold disciplinary hearings are similar to civil or criminal court proceedings

7) Describe the three types of legal action that can be taken against a pharmacist

• Violating a statute → criminal action

• Violating a regulation (or statute) → administration action

• Causing an injury to a private party → Civil action