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PPS 930 > Block 3 > Flashcards

Block 3 Flashcards

1
Q

ATT

A

Authorization to Test

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2
Q

NAPLEX

A

North American Pharmacist Licensure Examination

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3
Q

How many questions and how long is the NAPLEX?

A

185, 4.25 h

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4
Q

How many questions and how long is the MPJE?

A

adaptive 90 questions, 2 h

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5
Q

What is the breakdown of the NAPLEX?

A

56% pharmacotherapy, 33% compounding/dispensing, 11% stats

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6
Q

What is a passing score on the NAPLEX?

A

75

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7
Q

What is a passing score on the MPJE?

A

75

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8
Q

What is the breakdown of the MPJE?

A

84% pharmacy practice
13% licensure
3% regulatory structure

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9
Q

Where is the MPJE not required?

A

AR, VA, CA

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10
Q

How long is the waiting period for NAPLEX?

A

91 days, 5 chances per state

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11
Q

How long is the waiting period after failure of MPJE?

A

30 days, 5 chances per state

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12
Q

What is needed to submit to the board to receive an ATT?

A

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

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13
Q

What defines “readily retrievable” prescription records?

A

retrievable within 48 hours

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14
Q

How long are wholesaler and manufacturer records (POs) kept?

A

2 years

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15
Q

How long are prescription records kept?

A

5 years from date of last activity

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16
Q

What does signing the daily report signify?

A

everything you dispensed was accurate

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17
Q

Who must sign the daily report?

A

every pharmacist who verified an rx

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18
Q

What are the federal requirements regarding the daily report log?

A

must sign in 72 hours, all 3 signing options are allowed

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19
Q

What are the 3 ways to sign a daily report?

A

1) physically sign
2) sign log referenced to a report
3) sign electronically

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20
Q

How are e-rx records maintained?

A

maintained for all 5 years electronically

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21
Q

How are oral prescription records retained?

A

reduced, entered, and kept on physical paper for 3 years

then can scan electronically x 2 years

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22
Q

How are faxed prescription records retained?

A

paper x 3 years, then can scan for additional 2 years

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23
Q

KASPER:

A

Kentucky All Schedule Prescription Electronic Reporting System

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24
Q

PMP / PDMP:

A

Prescription Monitoring Program / Prescription Drug Monitoring Program

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25
Q

MPJE

A

Multistate Pharmacy Jurisprudence Examination

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26
Q

How soon must a pharmacy report data to KASPER and when will it appear in the database?

A

1 day to report

7 days to appear

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27
Q

What if patient doesn’t have a SSN and has rx for CS?

A

use DL

if no DL, use 000-00-0000

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28
Q

Can you disclose the KASPER report?

A

yes, if you make it a pharmacy record

    • can disclose pursuant to HIPAA
    • old rule: only person who requested report could view it
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29
Q

To what does KASPER apply?

A

all CS dispensed to or in KY
– mail order
– dispensed by practitioners in licensed facilities
NOT institutional/LTCF

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30
Q

Who implements KASPER?

A

CHFS

    • only electronic
    • can only give data to certain people
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31
Q

How do you report theft/loss of CS?

A

Form 106

– to CHFS, DEA, local law enforcement, BoP

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32
Q

How are C-II records maintained?

A

separately, including rx records

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33
Q

How are C-III, IV, V records maintained?

A

can be intermixed but must be identifiable

– or can be filed separately

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34
Q

When should the initial CS inventory be done?

A

on the date first rx (CS or not) is dispensed

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35
Q

How often should inventory be done for CS?

A

every 2 years, completed on a single date

    • complete and accurate
    • perpetual not required
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36
Q

What are inventory requirements for CS?

A

1) inventory q 2 years

2) exact count for C-II (law requires C-II inventory to be complete and accurate)

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37
Q

How are C-III, IV, V’s counted for biennial inventory?

A
  • if bottle less than 1000, can estimate

- if bottle greater than 1000, then exact count needed

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38
Q

What is DEA Form 222

A

special triplicate PO for C-IIs and for more DEA Forms 222

– brown on top, green, blue on bottom

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39
Q

How long should DEA 222s be kept?

A

5 years according to KY law

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40
Q

CSOS:

A

Controlled Substance Ordering System

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41
Q

What is DEA Form 41?

A

Form that asks DEA how you should dispose of CS

– you receive a 1-time blanket response

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42
Q

What are the 2 ways to help patients dispose of CS?

A

1) mail order form

2) place container in pharmacy

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43
Q

What are the 3 purposes of CSOS?

A

1) authentication
2) nonrepudiation
3) verification/integrity

44
Q

What are the requirements for reporting theft/compromise of digital certificate or signature of CSOS?

A

– within 24 hours

– if POA revoked, 6 hours

45
Q

How soon must a CSOS order be filled?

A

60 days

46
Q

What do you do when you receive a C-II order?

A

1) pull copy 3 (blue)
2) note products and quantity received
3) sign and date

47
Q

What do you do if wholesaler refuses your messy DEA 222?

A

file your copy and re-do

48
Q

What do you do if you think your DEA 222 is too messy?

A

1) void it
2) file it
3) re-do

49
Q

What do you do if you need to cancel all or part of a C-II order?

A

make written statement to manufacturer and attach a copy to filed 222

50
Q

Formal name for FDA Orange Book:

A

“Approved Drug Products with Therapeutic Equivalence Evaluations”

51
Q

What must be written on Medicaid rx for DAW brand?

A

BMN/brand medically necessary

52
Q

What is an authorized generic?

A

generic product produced under the innovator’s NDA

    • not rated
    • FDA and KY BoP says they’re therapeutically equivalent
53
Q

What is the FDA Purple Book?

A

therapeutic equivalence book for biosimilars

54
Q

What are the 4 categories for biosimilars?

A

1) not similar
2) similar
3) highly similar
4) highly similar with fingerprint

55
Q

What is the Kentucky Formulary Compliance Law?

A 
if doc gives permission, can change drug and dose in a class to preferred product on formulary
-- must tell doc after you do this
56
Q

What is a contract?

A

set of promises that is legally enforceable

57
Q

What are the requirements of a contract?

A

1) agreement
2) supported by consideration
3) made for lawful purpose
4) between competent parties

58
Q

What are the remedies for a contract breach?

A

1) compensatory damages
2) liquidated damages
3) specific performance
4) restitution

59
Q

When are written contracts required?

A

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)

60
Q

What is the parole evidence rule?

A

if written contract exists, court won’t hear oral evidence about different terms

61
Q

What is the statute of limitations?

A

legal action must be commenced in certain time frame

62
Q

When must legal action be commenced according to KY law?

A

10 years

    • 4 years if sale contract
    • 1 year if professional negligence
    • clock starts over if debtor acknowledges by partial payment or written statement
63
Q

UCC

A

Uniform Commercial Code

64
Q

what is duress:

A

threat of force

65
Q

what is undue influence:

A

taking unfair advantage of a confidential relationship

66
Q

When is assent to an agreement not genuine?

A

1) mutual mistake
2) fraud
3) duress or undue influence
- - voidable by injured party

67
Q

What is an option?

A

contract to keep offer open for a specified period of time

68
Q

What is an express warranty?

A

affirmation of fact or promise made by seller that induces a purchase reliant on the statement

69
Q

What is an implied warranty?

A

when a warranty is implied by a matter of law (not expressly made by seller)

70
Q

What are the types of implied warranties?

A

1) of merchantability
2) of fitness for a particular purpose
3) of sale by description or sample
4) of title

71
Q

What is privity of contract?

A

only parties to a contract have a right to sue

72
Q

What are exceptions to privity of contract?

A

1) potentially dangerous articles (food, drugs)

2) consumer goods when use by individuals other than purchaser is likely

73
Q

When is a warranty breached?

A

when goods deviate from express or implied warranties

74
Q

What can the buyer do when a warranty is breached?

A

1) accept goods and sue for damages
- - not if he knew of breach of implied warranty
2) refuse to accept goods

75
Q

What are reasonable searches?

A

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

76
Q

What is the exclusionary rule?

A

evidence from an illegal search can’t be used in court

77
Q

Who administers the Occupational Safety and Health Act?

A

OSH Administration

78
Q

What are the Miranda warnings?

A

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

79
Q

When are miranda warnings required?

A

when. ..
1) subjected to questioning
2) taking into custody OR deprived of freedom

80
Q

What are the 3 ways intern can get 1500 hours?

A

1) work in pharmacy
2) approved academic experience
3) research project pre-approved by BoP and limited to 400 hours

81
Q

What are the requirements on getting intern hours regarding school weeks?

A

limited to 20 h/wk during school
– 500 hours max
limited to 48 h/wk when not in school

82
Q

What can interns NOT do?

A

1) assist in transfer of CS

2) verify as final check

83
Q

What are the requirements for a preceptor?

A

1) licensed and in good standing
2) 1+ year of licensure
3) actively practicing at site

84
Q

How does a tech become certified?

A
    • PTCB or ICPT

- - nuclear techs must take approved nuclear program

85
Q

ITCP:

A

Institute for Certification of Pharmacy Technicians

86
Q

PTCB

A

Pharmacy Technician Certification Board

87
Q

What are the meth precursors?

A

1) pseudoephedrine
2) ephedrine
3) phenylpropanolamine

88
Q

ODCP

A

Office for Drug Control Policy

89
Q

KEMPT

A

Kentucky Electronic Methamphetamine Precursor Tracking

90
Q

CGMP

A

current good manufacturing practices

91
Q

Pseudoephedrine limits

A
    • 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
92
Q

When do manufacturing permits expire?

A

9/30

93
Q

When do tech registrations expire?

A

3/31

94
Q

What is the tech registration fee?

A

$25

95
Q

What is OSHAct’s view on searches?

A

says it’s illegal to deny entry

– in conflict with Constitution and Constitution is the higher law

96
Q

What is the highly regulated industry exception?

A

exception to 4th amendment

    • manufacture/sale/dist of firearms
    • m/s/d of alcoholic beverages
    • nuclear power plants
97
Q

How long does a patent apply?

A

for 20 years from application filing date

98
Q

How long does a copyright apply?

A

author’s life plus 70 years

99
Q

What is a patent?

A

grant made by federal government to investors to convey and secure exclusive right to make, use, and sell an invention;
authorized by constitution

100
Q

What is a copyright?

A

exclusive ownership right granted by statute to authors and originators of literary or artistic works

101
Q

What is a trademark?

A

word, name, symbol, device (or any combo) used by seller for distinguishing products from those of others

102
Q

What are the forms of intellectual property?

A

1) trademark
2) copyright
3) patent
4) trade secret

103
Q

What is the purpose of the blue copy of the 222?

A

ordering party’s copy

104
Q

What is the purpose of the brown copy of the 222?

A

wholesaler copy

105
Q

What is the purpose of the green copy of the 222?

A

DEA copy, filled out by wholesaler

106
Q

T/F: only person on DEA registration can sign 222

A

false, can authorize others (even non-pharmacists) via a PoA

PPS 930 (4 decks)

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