Lecture 1

Question 1

Why are there laws? (4)

Answer 1

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

Question 2

Civil penalties vs. Criminal penalties

Answer 2

• Civil: Usual ends up being fines

- Criminal penalties: Usually end up being jail time

Question 3

Where do laws come from?

5

Answer 3

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

Question 4

How are laws created?

Answer 4

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

Question 5

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

Examples?

Answer 5

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

Question 6

What are types of laws made by administrative agencies?

Answer 6

– Regulations
– Advisory opinions
– Enforcement guides

Question 7

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

Answer 7

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

Question 8

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

Answer 8

– State Legislature (Statutes - ORS)

– Oregon Board of Pharmacy (Rules - OAR)

Question 9

What is the mission of the Oregon Board of Pharmacy?

Answer 9

…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.

Question 10

Pharmacy is a ____________________ profession.

Answer 10

Pharmacy is a “self-regulated” profession

Question 11

Board of Pharmacy enforces _________.

Answer 11

Board of Pharmacy enforces regulations.

Question 12

How are the State Legislature and Board of Pharmacy Related?

Answer 12

• Legislature grants power to the board

- Legislature controls the Board’s budget

Question 13

How do members get on the board?

Answer 13

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

Question 14

Who does the Board of Pharmacy report to?

Answer 14

The Governor

Question 15

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

Answer 15

-Statutes and Rules

Question 16

What are Statutes in Oregon?

(with regards to pharmacy)

Also known as?

Answer 16

• 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

Question 17

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

Answer 17

New Oregon Birth Control Law

Question 18

Where are rules found for pharmacy in Oregon?

Answer 18

Chapter 855

Question 19

What are Rules in Oregon?

(with regards to pharmacy)

Also known as?

Answer 19

• 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

Question 20

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

Answer 20

• Notice
• Hearing
• Filing and Publication

Question 21

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

Answer 21

• 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

Question 22

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

Answer 22

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

Question 23

Drugs require special ________ and_______.

Answer 23

Drugs require special storage and handling

Question 24

What are the three categories of legal processes?

Answer 24

• criminal
• civil
• administrative

Question 25

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

Answer 25

Criminal legal processes. - Government vs. "person" - Violation of a statute

Question 26

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

Answer 26

Civil legal processes. - "Person" vs. "Person" lawsuit - Usually involves injury and compensation

Question 27

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

Answer 27

Administrative legal processes. - Agency vs. licensee (Board vs. Pharmacist) - Usually involves investigation and discipline

Question 28

Liability

Answer 28

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

Question 29

Vicarious liability

Answer 29

Pharmacists responsible for technician actions

Question 30

Who required Tamper Resistant Prescription Pads in 2008?

Answer 30

Medicare & Medicaid prescriptions

Question 31

What is the goal with requiring Tamper Resistant Prescription Pads?

Answer 31

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

Question 32

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

Answer 32

Appears to have had little impact on | fraudulent prescriptions

Question 33

What do Medicare and Medicaid do with regards to insurance?

Answer 33

Set the precedent.

Question 34

Prescription drug market is ______________.

Answer 34

Prescription drug market is hyper-competitive.

Question 35

Why does pharmacy need trust laws? | 2

Answer 35

- Many entities involved and complex pricing, discount, and rebate schemes - Goal is to promote competition

Question 36

How does the Sherman Antitrust Act effect pharmacy? | 2

Answer 36

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

Question 37

How does the Robinson-Patman Act effect pharmacy?

Answer 37

- 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

Question 38

Slide 44

Answer 38

Slide 44