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Pharmacy Law 728 > Lecture 1 > Flashcards

Lecture 1 Flashcards

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1
Q

Why are there laws? (4)

A
  • A form of social control
  • Permits, prohibits, or requires action
  • Enforceable by government power
  • Specifies penalties for violation
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2
Q

Civil penalties vs. Criminal penalties

A
  • Civil: Usual ends up being fines

- Criminal penalties: Usually end up being jail time

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3
Q

Where do laws come from?

5

A
  • Constitution
  • Treaties
  • Legislation (Statutes - ORS)
  • Government Agencies (Rules OARS)
  • Common Law (written opinion by the courts)
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4
Q

How are laws created?

A
  • Acts of the US Congress/State Legislatures
  • Decisions of administrative agencies
  • Decisions in courts
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5
Q

What are types of laws made by the US Congress/ State Legislatures? (3)

Examples?

A

– Statutes
– Constitutional amendments
– Treaties (federal only)
– DEA, FDA, Boards

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6
Q

What are types of laws made by administrative agencies?

A

– Regulations
– Advisory opinions
– Enforcement guides

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7
Q

What are examples of federal agencies that deal with pharmacy laws?

A

– US Congress
– US Drug Enforcement Administration (DEA)
– US Food and Drug Administration (FDA)`

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8
Q

What are examples of state agencies that deal with pharmacy laws?

A

– State Legislature (Statutes - ORS)

– Oregon Board of Pharmacy (Rules - OAR)

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9
Q

What is the mission of the Oregon Board of Pharmacy?

A

…to promote, preserve and protect public health, safety and welfare by ensuring high standards in the practice of pharmacy and by regulating the quality, manufacture, sale and distribution of drugs.

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10
Q

Pharmacy is a ____________________ profession.

A

Pharmacy is a “self-regulated” profession

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11
Q

Board of Pharmacy enforces _________.

A

Board of Pharmacy enforces regulations.

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12
Q

How are the State Legislature and Board of Pharmacy Related?

A
  • Legislature grants power to the board

- Legislature controls the Board’s budget

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13
Q

How do members get on the board?

A

Board members are appointed by the governor and approved by the Senate

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14
Q

Who does the Board of Pharmacy report to?

A

The Governor

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15
Q

What are the two categories that practice of pharmacy laws fall in Oregon?

A

-Statutes and Rules

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16
Q

What are Statutes in Oregon?

(with regards to pharmacy)

Also known as?

A
  • Enacted by a vote of the legislature
  • Any changes require vote of the legislature
  • The Board of Pharmacy is responsible for implementing and regulating
  • Oregon Revised Statutes - ORS
17
Q

What is an example of a recent statute in Oregon? (with regards to pharmacy)

A

New Oregon Birth Control Law

18
Q

Where are rules found for pharmacy in Oregon?

A

Chapter 855

19
Q

What are Rules in Oregon?

(with regards to pharmacy)

Also known as?

A
  • Written and adopted by the Board of Pharmacy
  • Must be allowed by a statute
  • Usually more specific to a specific area of practice

-Oregon Administrative Rules - OAR

20
Q

What are the procedures for the Board of Pharmacy making laws?

A
  • Notice
  • Hearing
  • Filing and Publication
21
Q

What are some important things to remember with Pharmacy Statutes and Rules?

A
  • Not a “How to Practice Pharmacy” manual
  • Minimum requirements
  • Board relies on voluntary compliance
  • Pharmacists must hold themselves and employers to high standard
  • ITS THE PHARMACISTS LICENSE AFTER ALL
22
Q

Pharmacy is a healthcare profession and
responsible for _____, ______, ______, and
________.

A

Pharmacy is a healthcare profession and
responsible for buying, storing, preparing, and
dispensing drugs

23
Q

Drugs require special ________ and_______.

A

Drugs require special storage and handling

24
Q

What are the three categories of legal processes?

A
  • criminal
  • civil
  • administrative
25
Q

Criminal legal processes.
Who vs. who?
What usually has occurred?

A

Criminal legal processes.

  • Government vs. “person”
  • Violation of a statute
26
Q

Civil legal processes.
Who vs. who?
What usually has occurred?

A

Civil legal processes.

  • “Person” vs. “Person” lawsuit
  • Usually involves injury and compensation
27
Q

Administrative legal processes.
Who vs. who?
What usually has occurred?

A

Administrative legal processes.

  • Agency vs. licensee (Board vs. Pharmacist)
  • Usually involves investigation and discipline
28
Q

Liability

A

Actions or conduct creating civil liability may
result in criminal liability, and actions or
conduct creating criminal liability may result in
civil liability.

29
Q

Vicarious liability

A

Pharmacists responsible for technician actions

30
Q

Who required Tamper Resistant Prescription Pads in 2008?

A

Medicare & Medicaid prescriptions

31
Q

What is the goal with requiring Tamper Resistant Prescription Pads?

A

– Unauthorized copying of a completed or blank Rx
– Erasure or modification of information
– Use of counterfeit pads

32
Q

What has actually happened with prescriptions since requiring Tamper Resistant Prescription Pads?

A

Appears to have had little impact on

fraudulent prescriptions

33
Q

What do Medicare and Medicaid do with regards to insurance?

A

Set the precedent.

34
Q

Prescription drug market is ______________.

A

Prescription drug market is hyper-competitive.

35
Q

Why does pharmacy need trust laws?

2

A
  • Many entities involved and complex pricing, discount, and rebate schemes
  • Goal is to promote competition
36
Q

How does the Sherman Antitrust Act effect pharmacy?

2

A

-Prohibits competitors from entering into agreements that inhibit competition
-Helps markets remain competitive and keep prices
low through competition

37
Q

How does the Robinson-Patman Act effect pharmacy?

A
  • Prevents discriminatory pricing to like competitors
  • Allows volume discounts
  • Large purchasers usually get lower prices
  • Hospitals and HMOs can not compete with retail pharmacies using discounted drug purchases
38
Q

Slide 44

A

Slide 44

Pharmacy Law 728 (1 decks)

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