Week 1 Lecs (1-2)

Describe the general nature and role of law

Laws= Requirements for human conduct applying to all persons within their jurisdiction 

• Commanding what SHOULD be done

• Prohibiting what SHOULD NOT be done 

• Imposing penalties for violations 

Often Intentionally vague 

Describe the four market failures that provide the basis for government regulation of drugs

and provide a pharmacy-related example of each

1. Public goods

   1. Necessary and beneficial things that private companies will not supply bc they have no incentive to

      1. Ex; vaccines, orphan drugs

2. Externalities

   1. Production or consumption of the good affects someone else who doesnt fully consent to the effect

      1. Ex: resistance due to antibiotic overuse

3. Natural Monopoly

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

      1. Ex; drug manufacturing 

4. Information Asymmetry 

   1. Consumer is uninformed about the true value fo the good

      1. Medication info to pts 

Describe the relationship between laws and professional judgment

Laws do not substitute for good professional judgement 

Describe the roles of the three branches of government

Legislative- Makes the laws

Executive- enforces the laws

Judicial- interprets the laws

Identify the four sources of law

1. Laws made by legislatures

2. Constitution 

3. Laws made by administrative agencies 

4. Common Law

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

How a Bill Becomes a Law (Statute):

A member of Congress writes and introduces the bill.

Congress votes on it.

If both the House and Senate approve it, the President signs it to make it a law.

How a Regulation (Rule)  is Approved:

A government agency creates the regulation based on a law.

The public gets to give feedback on it.

The agency finalizes it and puts it into action.

Explain the Preemption Doctrine and apply it to a scenario

The Preemption Doctrine states that federal law takes priority over state law when the two conflict

List federal agencies that are relevant to pharmacy practice

Centers for Medicare and Medicaid

Food and Drug Administration

Drug Enforcement Administration

List state agencies that are relevant to pharmacy practice

State Board of Pharmacy

State Department of Health Services

State Medicaid Agency

Explain how administrative agencies serve both legislative and judicial functions

Administrative agencies have two jobs: legislative and judicial. They create rules (regulations) that work like laws, and they also hold hearings to decide if someone broke those rules, like a court does.

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

1. Violation of statute- Criminal action brought by the government 

2. Violation of regulation or statute- Administrative action (fines ; license suspension)

3. Injury to private party- lawsuit