Block 3 Flashcards
ATT
Authorization to Test
NAPLEX
North American Pharmacist Licensure Examination
How many questions and how long is the NAPLEX?
185, 4.25 h
How many questions and how long is the MPJE?
adaptive 90 questions, 2 h
What is the breakdown of the NAPLEX?
56% pharmacotherapy, 33% compounding/dispensing, 11% stats
What is a passing score on the NAPLEX?
75
What is a passing score on the MPJE?
75
What is the breakdown of the MPJE?
84% pharmacy practice
13% licensure
3% regulatory structure
Where is the MPJE not required?
AR, VA, CA
How long is the waiting period for NAPLEX?
91 days, 5 chances per state
How long is the waiting period after failure of MPJE?
30 days, 5 chances per state
What is needed to submit to the board to receive an ATT?
1) pharmacist licensure application
2) passport photo
3) certification of intern hours
4) certification of graduation
5) certificate of HIV/AIDS education
6) criminal background check with fingerprints
What defines “readily retrievable” prescription records?
retrievable within 48 hours
How long are wholesaler and manufacturer records (POs) kept?
2 years
How long are prescription records kept?
5 years from date of last activity
What does signing the daily report signify?
everything you dispensed was accurate
Who must sign the daily report?
every pharmacist who verified an rx
What are the federal requirements regarding the daily report log?
must sign in 72 hours, all 3 signing options are allowed
What are the 3 ways to sign a daily report?
1) physically sign
2) sign log referenced to a report
3) sign electronically
How are e-rx records maintained?
maintained for all 5 years electronically
How are oral prescription records retained?
reduced, entered, and kept on physical paper for 3 years
then can scan electronically x 2 years
How are faxed prescription records retained?
paper x 3 years, then can scan for additional 2 years
KASPER:
Kentucky All Schedule Prescription Electronic Reporting System
PMP / PDMP:
Prescription Monitoring Program / Prescription Drug Monitoring Program
MPJE
Multistate Pharmacy Jurisprudence Examination
How soon must a pharmacy report data to KASPER and when will it appear in the database?
1 day to report
7 days to appear
What if patient doesn’t have a SSN and has rx for CS?
use DL
if no DL, use 000-00-0000
Can you disclose the KASPER report?
yes, if you make it a pharmacy record
- can disclose pursuant to HIPAA
- old rule: only person who requested report could view it
To what does KASPER apply?
all CS dispensed to or in KY
– mail order
– dispensed by practitioners in licensed facilities
NOT institutional/LTCF
Who implements KASPER?
CHFS
- only electronic
- can only give data to certain people
How do you report theft/loss of CS?
Form 106
– to CHFS, DEA, local law enforcement, BoP
How are C-II records maintained?
separately, including rx records
How are C-III, IV, V records maintained?
can be intermixed but must be identifiable
– or can be filed separately
When should the initial CS inventory be done?
on the date first rx (CS or not) is dispensed
How often should inventory be done for CS?
every 2 years, completed on a single date
- complete and accurate
- perpetual not required
What are inventory requirements for CS?
1) inventory q 2 years
2) exact count for C-II (law requires C-II inventory to be complete and accurate)
How are C-III, IV, V’s counted for biennial inventory?
- if bottle less than 1000, can estimate
- if bottle greater than 1000, then exact count needed
What is DEA Form 222
special triplicate PO for C-IIs and for more DEA Forms 222
– brown on top, green, blue on bottom
How long should DEA 222s be kept?
5 years according to KY law
CSOS:
Controlled Substance Ordering System
What is DEA Form 41?
Form that asks DEA how you should dispose of CS
– you receive a 1-time blanket response
What are the 2 ways to help patients dispose of CS?
1) mail order form
2) place container in pharmacy
What are the 3 purposes of CSOS?
1) authentication
2) nonrepudiation
3) verification/integrity
What are the requirements for reporting theft/compromise of digital certificate or signature of CSOS?
– within 24 hours
– if POA revoked, 6 hours
How soon must a CSOS order be filled?
60 days
What do you do when you receive a C-II order?
1) pull copy 3 (blue)
2) note products and quantity received
3) sign and date
What do you do if wholesaler refuses your messy DEA 222?
file your copy and re-do
What do you do if you think your DEA 222 is too messy?
1) void it
2) file it
3) re-do
What do you do if you need to cancel all or part of a C-II order?
make written statement to manufacturer and attach a copy to filed 222
Formal name for FDA Orange Book:
“Approved Drug Products with Therapeutic Equivalence Evaluations”
What must be written on Medicaid rx for DAW brand?
BMN/brand medically necessary
What is an authorized generic?
generic product produced under the innovator’s NDA
- not rated
- FDA and KY BoP says they’re therapeutically equivalent
What is the FDA Purple Book?
therapeutic equivalence book for biosimilars
What are the 4 categories for biosimilars?
1) not similar
2) similar
3) highly similar
4) highly similar with fingerprint
What is the Kentucky Formulary Compliance Law?
if doc gives permission, can change drug and dose in a class to preferred product on formulary -- must tell doc after you do this
What is a contract?
set of promises that is legally enforceable
What are the requirements of a contract?
1) agreement
2) supported by consideration
3) made for lawful purpose
4) between competent parties
What are the remedies for a contract breach?
1) compensatory damages
2) liquidated damages
3) specific performance
4) restitution
When are written contracts required?
1) promise to pay debt of another
2) agreements for sale of real estate or interest in real estate, including leases over 1 year
3) agreement longer than 1 year
4) agreement to sale of personal property (5000+ in ky)
What is the parole evidence rule?
if written contract exists, court won’t hear oral evidence about different terms
What is the statute of limitations?
legal action must be commenced in certain time frame
When must legal action be commenced according to KY law?
10 years
- 4 years if sale contract
- 1 year if professional negligence
- clock starts over if debtor acknowledges by partial payment or written statement
UCC
Uniform Commercial Code
what is duress:
threat of force
what is undue influence:
taking unfair advantage of a confidential relationship
When is assent to an agreement not genuine?
1) mutual mistake
2) fraud
3) duress or undue influence
- - voidable by injured party
What is an option?
contract to keep offer open for a specified period of time
What is an express warranty?
affirmation of fact or promise made by seller that induces a purchase reliant on the statement
What is an implied warranty?
when a warranty is implied by a matter of law (not expressly made by seller)
What are the types of implied warranties?
1) of merchantability
2) of fitness for a particular purpose
3) of sale by description or sample
4) of title
What is privity of contract?
only parties to a contract have a right to sue
What are exceptions to privity of contract?
1) potentially dangerous articles (food, drugs)
2) consumer goods when use by individuals other than purchaser is likely
When is a warranty breached?
when goods deviate from express or implied warranties
What can the buyer do when a warranty is breached?
1) accept goods and sue for damages
- - not if he knew of breach of implied warranty
2) refuse to accept goods
What are reasonable searches?
1) pursuant to search warrant
2) emergency
3) incidental to lawful arrest
4) for general police power
5) after consent
6) stop and frisk
searches cew fap
What is the exclusionary rule?
evidence from an illegal search can’t be used in court
Who administers the Occupational Safety and Health Act?
OSH Administration
What are the Miranda warnings?
1) absolute right to remain silent
2) anything you say can be used against you
3) right to presence of attorney during questioning
4) if you can’t afford attorney, one will be appointed for you
When are miranda warnings required?
when. ..
1) subjected to questioning
2) taking into custody OR deprived of freedom
What are the 3 ways intern can get 1500 hours?
1) work in pharmacy
2) approved academic experience
3) research project pre-approved by BoP and limited to 400 hours
What are the requirements on getting intern hours regarding school weeks?
limited to 20 h/wk during school
– 500 hours max
limited to 48 h/wk when not in school
What can interns NOT do?
1) assist in transfer of CS
2) verify as final check
What are the requirements for a preceptor?
1) licensed and in good standing
2) 1+ year of licensure
3) actively practicing at site
How does a tech become certified?
- PTCB or ICPT
- - nuclear techs must take approved nuclear program
ITCP:
Institute for Certification of Pharmacy Technicians
PTCB
Pharmacy Technician Certification Board
What are the meth precursors?
1) pseudoephedrine
2) ephedrine
3) phenylpropanolamine
ODCP
Office for Drug Control Policy
KEMPT
Kentucky Electronic Methamphetamine Precursor Tracking
CGMP
current good manufacturing practices
Pseudoephedrine limits
- 3 pkg/transaction
- 3.6 g/day
- 7.2 g per 30 days
- 7.5 g per rolling 30 days or mail order
- 24 g per year
When do manufacturing permits expire?
9/30
When do tech registrations expire?
3/31
What is the tech registration fee?
$25
What is OSHAct’s view on searches?
says it’s illegal to deny entry
– in conflict with Constitution and Constitution is the higher law
What is the highly regulated industry exception?
exception to 4th amendment
- manufacture/sale/dist of firearms
- m/s/d of alcoholic beverages
- nuclear power plants
How long does a patent apply?
for 20 years from application filing date
How long does a copyright apply?
author’s life plus 70 years
What is a patent?
grant made by federal government to investors to convey and secure exclusive right to make, use, and sell an invention;
authorized by constitution
What is a copyright?
exclusive ownership right granted by statute to authors and originators of literary or artistic works
What is a trademark?
word, name, symbol, device (or any combo) used by seller for distinguishing products from those of others
What are the forms of intellectual property?
1) trademark
2) copyright
3) patent
4) trade secret
What is the purpose of the blue copy of the 222?
ordering party’s copy
What is the purpose of the brown copy of the 222?
wholesaler copy
What is the purpose of the green copy of the 222?
DEA copy, filled out by wholesaler
T/F: only person on DEA registration can sign 222
false, can authorize others (even non-pharmacists) via a PoA
