Lecture 1 Flashcards
Why are there laws? (4)
- A form of social control
- Permits, prohibits, or requires action
- Enforceable by government power
- Specifies penalties for violation
Civil penalties vs. Criminal penalties
- Civil: Usual ends up being fines
- Criminal penalties: Usually end up being jail time
Where do laws come from?
5
- Constitution
- Treaties
- Legislation (Statutes - ORS)
- Government Agencies (Rules OARS)
- Common Law (written opinion by the courts)
How are laws created?
- Acts of the US Congress/State Legislatures
- Decisions of administrative agencies
- Decisions in courts
What are types of laws made by the US Congress/ State Legislatures? (3)
Examples?
– Statutes
– Constitutional amendments
– Treaties (federal only)
– DEA, FDA, Boards
What are types of laws made by administrative agencies?
– Regulations
– Advisory opinions
– Enforcement guides
What are examples of federal agencies that deal with pharmacy laws?
– US Congress
– US Drug Enforcement Administration (DEA)
– US Food and Drug Administration (FDA)`
What are examples of state agencies that deal with pharmacy laws?
– State Legislature (Statutes - ORS)
– Oregon Board of Pharmacy (Rules - OAR)
What is the mission of the Oregon Board of Pharmacy?
…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.
Pharmacy is a ____________________ profession.
Pharmacy is a “self-regulated” profession
Board of Pharmacy enforces _________.
Board of Pharmacy enforces regulations.
How are the State Legislature and Board of Pharmacy Related?
- Legislature grants power to the board
- Legislature controls the Board’s budget
How do members get on the board?
Board members are appointed by the governor and approved by the Senate
Who does the Board of Pharmacy report to?
The Governor
What are the two categories that practice of pharmacy laws fall in Oregon?
-Statutes and Rules
What are Statutes in Oregon?
(with regards to pharmacy)
Also known as?
- 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
What is an example of a recent statute in Oregon? (with regards to pharmacy)
New Oregon Birth Control Law
Where are rules found for pharmacy in Oregon?
Chapter 855
What are Rules in Oregon?
(with regards to pharmacy)
Also known as?
- 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
What are the procedures for the Board of Pharmacy making laws?
- Notice
- Hearing
- Filing and Publication
What are some important things to remember with Pharmacy Statutes and Rules?
- 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
Pharmacy is a healthcare profession and
responsible for _____, ______, ______, and
________.
Pharmacy is a healthcare profession and
responsible for buying, storing, preparing, and
dispensing drugs
Drugs require special ________ and_______.
Drugs require special storage and handling
What are the three categories of legal processes?
- criminal
- civil
- administrative
Criminal legal processes.
Who vs. who?
What usually has occurred?
Criminal legal processes.
- Government vs. “person”
- Violation of a statute
Civil legal processes.
Who vs. who?
What usually has occurred?
Civil legal processes.
- “Person” vs. “Person” lawsuit
- Usually involves injury and compensation
Administrative legal processes.
Who vs. who?
What usually has occurred?
Administrative legal processes.
- Agency vs. licensee (Board vs. Pharmacist)
- Usually involves investigation and discipline
Liability
Actions or conduct creating civil liability may
result in criminal liability, and actions or
conduct creating criminal liability may result in
civil liability.
Vicarious liability
Pharmacists responsible for technician actions
Who required Tamper Resistant Prescription Pads in 2008?
Medicare & Medicaid prescriptions
What is the goal with requiring Tamper Resistant Prescription Pads?
– Unauthorized copying of a completed or blank Rx
– Erasure or modification of information
– Use of counterfeit pads
What has actually happened with prescriptions since requiring Tamper Resistant Prescription Pads?
Appears to have had little impact on
fraudulent prescriptions
What do Medicare and Medicaid do with regards to insurance?
Set the precedent.
Prescription drug market is ______________.
Prescription drug market is hyper-competitive.
Why does pharmacy need trust laws?
2
- Many entities involved and complex pricing, discount, and rebate schemes
- Goal is to promote competition
How does the Sherman Antitrust Act effect pharmacy?
2
-Prohibits competitors from entering into agreements that inhibit competition
-Helps markets remain competitive and keep prices
low through competition
How does the Robinson-Patman Act effect pharmacy?
- 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
Slide 44
Slide 44
