Lect 1. Intro to Law Flashcards
Reqs for NC licensure
- Graduated from an accredited program
- passed the NAPLEX/MPJE
- Proof of age
- Rotation hours (1500) submitted via affidavit
MPJE
- 90 questions
- 2 hour computer exam
- 75 is passing (not 75%)
MPJE breakdown
- Pharmacy practice (84%)
- Licensure registration, certification, and operational requirements (13%)
- Regulatory structure and terms (3%)
Hierarchy of Law
1) Constitutional law
2) Statutory Law
2a) Federal Statutes
2b) State constitutions
2c) State statutes
2d) Ordinances
3) Common
4) Administrative
Statutory Law process
1) bill drafted/introduced
2) bill referred to committee
3) considered by first chamber
4) considered by second chamber
5) amendments
6) ratified, published, and signed
Administrative law at the federal level
- CMS (DHHS)
- FDA (DHHS)
- DEA (DOJ)
Administrative law at the state level
- BOP
- Health department
- State medicaid department
State BOP authorities
- License pharmacy/ists
- Registering/licensing techs
- Inspect pharmacies
- Issuing rules/regs
- Investigating complaints
- Disciplinary actions
- Promulgate regs (notice of comment and rulemaking)
In order for an agency reg to be valid…
1) reg is within scope of agency’s authority
2) reg must be based on a statute to promulgate the reg
3) reg must bear a relationship to the public health, safety, and welfare
Market failures
- Public good
- Externalities
- Natural monopoly
- Information asymetry
Public Good
Necessary/beneficial commodities that private entities will not supply because of lack of incentive (vaccines, orphan drugs)
Externalities
exist when production or consumption of a good affects someon who does not fully consent to the effect (overuse of antibiotics)
Natural Monopoly
Fixed costs are inhibitive (costs decline over time)
Information Asymmetry
- Consumer uninformed (don’t know what they don’t know)
- OBRA ‘90 (mandatory counseling)
Cost of overly proactive laws
- “parade of horribles”
- limit positive effect
- limit innovation
