Block 2 Flashcards
When does pharmacy permit expire?
annually on june 30
What does VIPPS stand for?
verified internet pharmacy practice sites
4 reference categories required in a pharmacy:
pharmacology, drug interactions, drug product composition, legal (state and federal)
How many days notice required to notify DEA and state BOP if modifying DEA registration to include internet pharmacy
30
What are the 4 special pharmacy permits in KY?
nuclear, central refill, charitable pharmacy, clinical practice
When does DEA registration expire?
last day of specified expiration month after 3 years
When must DEA registration be renewed?
within 60 days of expiration
How are C-II’s transferred?
DEA Form 222
What kinds of notice are required for pharmacy closure?
30 days to patients (with name and address of new record site) and 15 days to BOP, DEA, CHAFS
What is DEA Form 106
form on which theft or significant loss is reported to DEA when circumstances are known
When is theft or significant loss reported?
within 1 day
What 3 things do you need to get into court?
standing, ripeness, exhaustion
What things do you need to win a case?
1) mistake of law, OR, 2) abuse of discretion, OR 3) arbitrary or capricious action
What is standing?
some interest of the plaintiff has been adversely affected
What is ripeness?
facts must be fully developed
What is exhaustion?
all remedies at the agency level have been exhausted
What is abuse of discretion?
inappropriate evidence/witness used by agency
What is arbitrary or capricious action?
whimsical decision-making by agency
What is ultra vires?
an agency is doing something that exceeds its authority
What 2 things show the agency’s authority?
in a statute: 1) statement of policy 2) standards or guidelines
What circuit court region is KY in?
6 (cincinnati)
What are the 2 ways to get into federal court?
1) federal question 2) diversity of citizenship + 75000
What are the reasons for appeal?
mistake of fact; mistake of law
Certiorari:
supreme court has certified that the case will be heard
arbitration vs mediation:
arbitration: 3rd party announces a binding decision; mediation: 3rd party has no authority to impose decision
3 options of an appellate court
remand, affirm, overturn
poison:
substance that hurts or kills at dose less than 5 grains
How long is the bound hypodermic syringe/needle record kept?
2 years
4 parts of hipaa
1) privacy of records, 2) security 3) enforcement 4) breach of data notification
CMS
centers for medicare and medicaid services
NOPP
notice of privacy practices
executor vs. administrator
should have court order of probate; executor if will; administrator if not
How soon must you acknowledge a patient’s request to inspect healthcare record?
30 days + 1-time 30-day extension
How soon must you aknowledge a patient’s request to amend healthcare record?
60 days + 1-time 30-day extension
How soon must you acknowledge the patient’s request to accounting of disclosures?
60 days + 1-time 30-day extension
What is the 4-part breach test?
1) nature and extent of PHI involved; 2) person to whom PHI was disclosed; 3) whether person reviewed the PHI; 4) whether you can mitigate the problem
What is the significance of a presumption?
must be rebutted with evidence
How long should refuse-to-counsel documentation be kept?
1 year
What are the 2 concerns with liability claims?
money damages, damage to professional reputation
What are the 2 ways to commit negligence?
doing and not doing something
How are policy limits stated?
1st number is max per claim or per lawsuit; 2nd number is max per incident or per year
What is in rem jurisdiction?
jurisdiction applying to things
What is in personam jurisdiction?
jurisdiction applying to natural persons
How are cases cited?
Plaintiff/Appealer v. Defendant
What are the 2 types of jurisdiction?
in rem and in personam
What report contains KY’s regional reports?
Southwestern Reporter (S.W., S.W.2d, S.W.3d)
What is stare decisis:
court ruling only binding in geographic area under court’s jurisdiction
How is KRS/KAR cited?
(Title) K.R.S. (Chapter).(Section)
Druggist versus clerk
druggist is owner, clerk is staff
What agency enforces the PPPA?
US CPSC
What agency enforces the KY Controlled Substances Act?
KY CHAFS Drug Enforcement and Professional Practices Branch
Where are US statutes located?
USC
Where are US regulations posted?
CFR (Title CFR Part.Section)
What is the locality rule?
can’t hold rural professional to same standards as urban professional (no longer applies)
What are the required components of OTC product labeling?
DAPUWDOIQ; Drug Facts, Active Ingredients, Purposes, Uses, Warnings, Directions, Other Information, Questions
An infant is generally assumed to be:
less than 2 yo
3 components of REMS requirements
1) patient education; 2) prescriber training; 3) assessment for effectiveness
REMS:
risk evaluation and mitigation strategy
