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NAPLEX > Law > Flashcards

Law Flashcards

1
Q

how long do records need to be kept via Ohio law

A

3 years

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2
Q

how long do records need to be kept via FDA law

A

2 years

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3
Q

when is it legal to send a rx from computer to fax machine

A

rx operates within a closed system

computer to computer system is down

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4
Q

when does a pharmacist not have to disclose the price of a drug

A

schedule 2 drugs

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5
Q

How long does a pharmacy have to retrieve records to be reviewed

A

3 business days

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6
Q

At what point does a pharmacy need a wholesaler license

A

5% rule

  • if a pharmacy buys $$$ worth of drug and sells 5% to someone other than their own patients they need a wholesaler license
  • anything less than 5% is considered occasional sale
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7
Q

Define prescription drug

A

habit forming

unsafe for use except under the supervision of a practicioner

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8
Q

What will be the expiration date on a prescription

A

1 year from the dispensing date
or
manufacturer’s expiration date whichever is shorter

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9
Q

how long is a consult agreement effective for

A

2 years

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10
Q

who can participate in a consult agreement

A

ohio licensed pharmacists
ohio licensed physicians
no PAs
no APNs

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11
Q

how long do you have to notify the board if the pharmacists in a consult agreement is no longer authorized to prescribed controlled substances

A

5 days

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12
Q

once a pharmacist obtains a valid DEA registration to prescribe how many days to they have to notify the board

A

30 days

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13
Q

when does an OARRs report need checked when prescribinh

A

adding a controlled substance

adjusting a controlled substance

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14
Q

how often can a pharmacists provide an emergency prescription

A

once per prescription
or
once per year if it’s a 30 day supply

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15
Q

what is the amount of drug that can be given in an emergency prescription

A

72-hour, except C2

30-day if it’s a consistent drug

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16
Q

how many attempts do you have to pass the NAPLEX and MJPE

A

5

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17
Q

when must an intern notify the board and employer when they are no longer enrolled in a school of pharmacy

A

72 hours

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18
Q

after an intern is no longer enrolled when must they return their intern certificate to the board

A

10 days

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19
Q

intern and pharmacist license renewal date

A

september 15

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20
Q

how many days do you have to notify the board of a name change

A

30

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21
Q

how many days do you have to notify the board of a change of address

A

30

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22
Q

how many days do you have to notify the board of a change of employment

A

30

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23
Q

how many days do you have to notify the board for a change in responsible pharmacist

A

10

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24
Q

how many days in advance must you notify the board to discontinue business

A

30

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25
Q

what date do terminal distributers renew licenses

A

april 1

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26
Q

what date do wholesaler’s renew licenses

A

july 1

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27
Q

what date do laboratory terminal distributors renew licenses

A

april 1

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28
Q

what date must a rx be filled from issuance

A

6 months

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29
Q

max number of non-controlled substances that can be written on one rx

A

3

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30
Q

drugs encompassed by a category 1 license for terminal distributors

A

single dose injections of IV fluids

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31
Q

Drugs encompassed by a category 2 license for terminal distributors

A

any dangerous drug

+ category 1 drugs

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32
Q

Drugs encompassed by a category 3 license for terminal distributors

A

controlled substances

+ category 1 & 2 drugs

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33
Q

how many CE hours are required

A

40 hours every 2 years

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34
Q

how many hours are required of patient safety/medication errors

A

2 hours

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35
Q

When do CE hours need to be reported

A

sept 15 of the year they are due

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36
Q

how many CE hours of law are required

A

2 hours

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37
Q

how long can your license lapse before you have to retake the naplex and mjpe

A

3 years

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38
Q

how many days does a pharmacist have to notify the MD of interchangeable biological product is substituted

A

5 days

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39
Q

what does the orange book include

A

FDA generic bioequivalence

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40
Q

What does the purple book include

A

FDA list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations

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41
Q

can you transfer a c2 escript if its never been filled

A

yes

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42
Q

What are the items required on an outpatient label (10)

A 
name and address of dispenser
directions
full name of patient
full name of prescriber
date of dispensing
cautions
Rx number
drug name and strength
quantity
state if compounded
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43
Q

What 2 items are required on a small container within a prescription

A

rx number

patient name

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44
Q

What items are required on an inpatient unit dose prescription (6)

A 
name of drug
route of administration if not oral
strength
lot number and expiration date
manufacturer or repacker
special storage conditions
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45
Q

requirements for IV bags inpatient (6)

A 
patient name
name and amount of solution
name and amount of drug
expiration date or BUD
name and address of pharmacy
cautionary statements
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46
Q

requirements for IV bags outpatient (11)

A 
name and address of pharmacy and phone number
full patient name
full name of prescriber
directions and route
date of dispensing
any cautions
name and volume of solution
name and amount of drug
quantity of the drug dispensed
expiration date
storage condition
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47
Q

what 3 things are required on a label for a sample

A

name of prescriber
patient name
directions

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48
Q

what 3 things on a C2 prescription that cannot be changed

A

patient name
doctor
drug name

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49
Q

how long does a pharmacy have to get rid of an outdated drug

A

1 year

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50
Q

how long does a wholesaler have to get rid of an outdated drug

A

2 years

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51
Q

What is an adulterated drug

A

1) physical conditions of the drugs, environment in which they were manufactured, anything unsanitary or damaged
2) if a drug leaves teh pharmacy and is then re-dispensed
3) outdated drugs

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52
Q

What needs to be completed on the date of discontinuing business of a pharmacy

A

complete controlled substance inventory

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53
Q

if missing/stolen drugs are controlled what must the pharmacist do

A

notify DEA immediately
file form 106
within 1 business day

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54
Q

how many days does a pharmacy have to report a stolen controlled substance to the board

A

30 days

55
Q

Can a patient donate drugs

A

no

a person donating an eligible drug may not have taken custody of the drug prior to the donation

56
Q

can controlled substances be donated

A

no

57
Q

What is the expiration date of a drug that can be donated

A

6 months or greater

58
Q

who is eligible to receive donated drug

A

resident of ohio
no 3rd party reimbursement
or
patient of a nonprofit clinic

59
Q

what age can a pharmacist give an immunization to without a prescription

A

13

60
Q

what age can a pharmacist give an immunization to with a prescription

A

7

61
Q

what age can a pharmacist give a flu shot

A

7

62
Q

what two records does a pharmacist need to give immunizations

A

successful completion of immunization course

BLS

63
Q

anabolic steroids are what schedule of drug

A

3

64
Q

can a practicioner request the drug name be omitted from the label

A

yes

65
Q

records dating back to how long must be immediately retrievable

A

12 months

66
Q

how many days do you have to retrieve records for the past 36 months

A

3 days

67
Q

what happens to refills once a physician dies

A

patient can have one more refill

68
Q

correct temperature for refrigerated products

A

2-8 degrees celsius

69
Q

how many minutes do you have to submit a medical marijuana sale to oarrs

A

5 minutes

70
Q

do naltrexone prescriptions need submitted to OARRS

A

only ones that are indicated for treatment of alcohol dependence or prevention of relapse to opioid dependence

71
Q

when does OARRS need checked

A

adds a new/different OARRS substances to therapy
OARRS has not been reviewed for 12 months
prescriber from outside area
patient from outside area
rph beleives pt got more than one md in past 3 months
pt showing s/sx of abuse

72
Q

can you give an OARRS report copy to a MD?

A

no they must request their own

but you can talk to them about it and show them they just can’t keep it

73
Q

can an IPPE or an APPE be an OARRS delegate of the pharmacy

A

no, they must be a paid internship

74
Q

what is ohio’s MED threshold

A

80

75
Q

what is USP 797

A

sterile products compounding chapter

76
Q

What is USP 795

A

non-sterile products compounding chapter

77
Q

any USP # under what is federally enforceable

A

1000

78
Q

is it ok to bulk compound products and sell to other pharmacies

A

no it is illegal

79
Q

when can a pharmacist compound a commercially available product

A

drug shortage
pt needs med made without certain item
pt needs a different dosage form

80
Q

what is them max that a prescriber can have on hand of a compounded drug

A

72 hour supply limit

81
Q

when can pharmacies compound for physicians use in office

A

treat emergency situations
unanticipated procedures for which a time delay would negatively affect patient outcomes
diagnostic purposes

82
Q

what is the max MDs can have for in office use of a compounded topical product

A

60 grams or 60 mL

and only one container at a time

83
Q

BUD for low risk compounds

A

48 hours at room temp
14 days when refrigerated
45 days frozen solid state

84
Q

BUD for medium risk compounds

A

30 hours room temp
9 days when refrigerated
45 days frozen solid states

85
Q

BUD for high risk compounds

A

24 hours room temp
3 days when refrigerated
45 days when frozen solid states

86
Q

what 2 unique things are on a label for a compounded product

A

for direct patient administration only

not for resale

87
Q

what is the days supply a vet can supply to a patient of a compounded product

A

7 days

88
Q

Define charitable pharmacies

A

has terminal distributors’ license
is exempt from federal taxation
is not a hospital

89
Q

how much continuing education does a registered pharmacy technician need

A

10 hours total every 2 years
2 hours in pharmacy law
2 hours in medication safety

90
Q

how many pharmacy technician trainees can a pharmacist supervise at one time

A

3

91
Q

what must be done prior to prescribing opioids to minors

A

get informed consent

92
Q

when does a MD not need informed consent when prescribing opioids to a minor

A

emergency
treatment for surgery
in a hospital

93
Q

how long does a pharmacy have to notify the board if they start dispensing naloxone

A

30 days

94
Q

what must a pharmacy have in order to provide lab testing or POC testing

A

certification through CLIA

95
Q

how long does a pharmacist have to notify a MD that they gave a long term injectable drug

A

7 days

96
Q

for an injectable drug (Not vaccine) is the pharmacy where it is dispensed also where the patient is required to get the inejection

A

No

97
Q

how many days from the written date do you have to fill an opioid prescription

A

14 days

98
Q

what is the max number of days an opioid Rx can be filled for

A

90 days

99
Q

can you change the date on an opioid prescription

A

yes after calling the doctor

100
Q

what is the supply limit a MD can prescribe opioids for acute pain

A

7 days

101
Q

what is the supply limit a MD can prescribe opioids for acute pain for a minor

A

5 days

102
Q

if an opioid is partially filled how long does a patient have to fill the rest of the prescription

A

30 days

103
Q

what form is needed to order C2 drugs

A

DEA form 222

104
Q

how many refills are allowed for C3s and C4s

A

5 refills or 6 months

105
Q

what is the limit on selling a C5 as OTC when it was previously written as an RX

A

cannot sell if it was written as an rx in the past 6 months

106
Q

What is DEA form 222

A

C2 ordering

107
Q

What is DEA form 224

A

original registration for DEA license

108
Q

What is DEA form 225

A

license to manufacture controlled substances

109
Q

What is DEA form 224a

A

DEA re-registration form

110
Q

What is DEA form 41

A

disposal of controlled substances

111
Q

What is DEA form 106

A

theft or loss of controlled substances

112
Q

how long does a pharmacy have to complete an annual inventory of controlled substances

A

13 months since previous inventory

113
Q

When does a C 3,4,5 need to be estimated versus exact

A

<1000 can be estimated

>1000 must be exact

114
Q

when a non-controlled substance becomes a controlled substance how long does the pharmacy have to do an inventory

A

10 days

115
Q

what are reasons a pharmacy can partially fill a C2 and how long do they have to fill it

A

in a LTC, terminally ill = 6 months

requested = 30 days

116
Q

what is the max number of pt a MD can treat how many pt with buprenorphine the first year and then years after

A

30 first year

100 after that

117
Q

what is the max number of days a MD can write a rx for weight reduction

A

30 days

118
Q

what is required on label of OTC drugs

A 
name of product
name and address of manufacturer
net contents
name and amount of all active ingredients
name of any habit-forming drug included
cautions and warnings
directions
119
Q

what is a class 1 drug recall

A

will cause either serious AE or death

120
Q

what is a class 2 drug recall

A

may cause temporary or medically reversible AE on health or where the probability of serious AE is remote

121
Q

What is a class 3 drug recall

A

exposure is not likely to cause AE

122
Q

max PSE allowed to be sold per day

A

3.6g

123
Q

max PSE allowed to be sold per month

A

9 g

124
Q

what is the 1906 pure food and drug act

A

prohibited the interstate commerce of adulterated foods and drugs

125
Q

what is the 1911 shirley amendments

A

prohibited false and misleading claims for drug products

126
Q

what is the 1938 federal food, drug, and cosmetic act

A

scientific proof of safety before a drug could be marketed

127
Q

what is the 1951 durham-humphrey amendment

A

created two classes of products prescription and over the counter

128
Q

what is the 1962 harris-kefauver amendments

A

scientific proof of efficacy

129
Q

what is the 1983 orphan drug act

A

gave economic tax incentives for pharmaceutical manufacturers to develop drugs for rare diseases

130
Q

what is the 1984 drug price competition patent restoration act

A

created the ANDA for generic drugs (prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval

131
Q

What is the prescription drug marketing act of 1984

A

regulated samples
cannot re-import drugs from other countries
regulates who hospitals can sell to

132
Q

what is the 1994 dietary supplement health and education act

A

made herbals officially dietary supplements

133
Q

for immunizations what is the pharmacist to intern ratio

A

6:1

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