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MPJE > KY Law > Flashcards

KY Law Flashcards

1
Q

what makes up KY legislature

A

BOP, CHFS (cabinet for health and family services), OIG/Drug control

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2
Q

how many members in BOP

A

6 members (1 nonpharmacy and NO two from the same county)

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3
Q

BOP member requirements for serving

A

serve 4 years
can be reappointed ONCE by governor
elect president on annual basis - each officer can serve 2 years

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4
Q

BOP duties

A

exams
approve approved COP
pharmacy regulations
schedule hearings
issue licenses
employ executive director - MUST be a pharmacist

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5
Q

who can complain to the board - and how to file complaint

A

anyone can give oral, electronic, written complaint about anything

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6
Q

if BOP receives a complaint, what must they do

A

conduct an investigation - inspector MUST be a pharmacist

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7
Q

what are the outcomes of an investigation from BOP after a complaint is made

A

1 - agreed order
2 - settlement conference
3 - hearing

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8
Q

how long before a pharmacist can request to the BOP to expunge minor violations from their record

A

3 years

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9
Q

pharmacist recovery network requirements

A

can self-report and surrender license and remain unknown to the BOP
board MUST return license if PRN requirements are met

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10
Q

pharmacist license renewal

A

every year on Feb 28

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11
Q

requirements for pharmacist license

A

same as IN including:
graduate from approved COP
register with KASPER
register with CPE monitor

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12
Q

CE requirements for pharmacist

A

15 CE or 1.5 CEU from Jan 1 to Dec 31
maintain record for 3 years
1 hour MUST be on opioid epidemic

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13
Q

internship requirements for pharmacist licensure

A

1500 hours - 400 hours max from research
registered ID card on hand at all times - good for 6 years
HAVE to act as tech during P1 year then starting P2 year they can do pharmacist duties

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14
Q

requirements to be a preceptor

A

licensed for 1 year
supervise 1 student at a time unless one student and one hire

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15
Q

requirements for PIC

A

MUST be designated on pharmacy permit
1 PIC per pharmacy - except medical gas
be present 10 hours a week - except medical gas and manufacturer (quarterly inspections)
notify BOP within 14 days with changes

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16
Q

PIC responsibilities

A

QA
storage, security of drugs
reports required by law
responding to BOP

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17
Q

what is the pharmacist’s duty for any felonies or violations to law

A

report to BOP
self-report within 30 days of conviction

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18
Q

when MUST an offer to counsel be made

A

new rx and when professional discretion dictates for refills
offer made for deliveries with phone counseling
discharge medications for inpatient

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19
Q

counseling requirements

A

names, dosage form, ROA, storage, common & clinical AE, interactions, CI
document refusal to counsel and keep for 1 year

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20
Q

TB health department requirements

A

report if you see a patient with TB
also measles, cholera, E. coli, rabies, rubella, diphtheria

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21
Q

immunization requirements

A

anyone above age 9
technicians CANNOT give vaccines

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22
Q

technician requirements

A

noncertified are under IMMEDIATE supervision
certified are under GENERAL supervision
renew certification yearly on March 31

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23
Q

technician responsibilities

A

certify med carts
initiate or receive refills
receive diagnostic orders in nuclear
non-judgmental duties

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24
Q

what are the BOP authorized protocols for pharmacists WITH written protocol approval from prescriber

A

acute influenza
opioid use disorder
allergic rhinitis
self-care diabetes testing
tobacco cessation
TB skin testing
travel health therapy
colorectal screening
anaphylaxis treatment
strep A pharyngitis
probiotics
naloxone
alcohol use disorder
self-care dietary supplements
acute uncomplicated UTI
self-care emergency contraceptives

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25
Q

what must BOP authorized protocols have in order for pharmacist to prescribe/dispense

A

prescriber written approval
pharmacist education and training
criteria for identifying eligible patients
list of medications for dispensing
care plan that prescriber reviews

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26
Q

pharmacy permit requirements

A

renew yearly on June 30

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27
Q

out of state pharmacy requirements

A

have KY permit
retrieve records within 72 hours
toll-free number
PIC is licensed in KY
can get BOP waiver if rx # sent to KY is minimal

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28
Q

what reference material MUST pharmacies have

A

category I-IV
I - pharmacology
II - drug interactions
III - drug product composition
IV - laws and regulations

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29
Q

what equipment MUST pharmacies have

A

class A balance
weight set
graduates
mortar and pestle
spatula
fridge
ointment slab
heating unit
filtration funnel
sink

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30
Q

permanent closure of pharmacies

A

sign notice 30 days prior to closing and kept 30 days after closure - states where rx is transferred unless <5 miles away
written notice to BOP, CHFS, DEA within 15 days
maintain records for 2 years
remove pharmacy stuff
return permit to BOP

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31
Q

involuntary closure requirements - acute illness, death, natural disaster, BOP action

A

written notice to BOP within 5 days
may maintain premises for 60 days - if no sale within that time BOP MAY seize drugs

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32
Q

voluntary closure requirements - chronic illness, abandonment, deviation from posted hours over 5 days

A

BOP MUST close store and seize drugs if failure to resume normal operations within 60 days

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33
Q

temporary closure requirements

A

MUST close and no one can enter
floor to ceiling locked

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34
Q

how must pharmacists maintain rx filling activities

A

daily printout or log book - BOP must give permission for daily log if printout is wanted
keep record for 5 years

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35
Q

charitable pharmacy requirements

A

can petition to be exempt from requirements pertaining to operation of pharmacy
NO CONTROLS KEPT
may NOT charge fee
can accept rx for distribution if unbroken and in original package

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36
Q

hospital pharmacy requirements

A

MUST have PIC and director of pharmacy
MUST have written job descriptions
MUST have pharmacist in every decentralized pharmacy location
MUST be available at all times
MUST be a member of P&T
may stock drug samples

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37
Q

what references MUST a hospital pharmacy have

A

category I-IV
drug identification
toxicology
parenteral drug compatibility
microbiology

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38
Q

emergency room drugs

A

does not exceed 72 hours for patient

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39
Q

emergency box requirements in LTCF

A

only 10 controls in <6 dosage units
policy & procedure
physician MUST write order
notify pharmacy within 24 hours
inventory done monthly

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40
Q

nuclear pharmacy requirements

A

pharmacist is certified
exempt from space requirements

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41
Q

medical gas pharmacy requirements

A

oxygen & nitrous oxide
special pharmacy permit + regular permit
PIC inspect quarterly
policy & procedure
requires rx - refill up to 1 year

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42
Q

clinical pharmacy requirements

A

does not fill rx
PIC
category I-IV references
can be exempt from sanitation and equipment requirements
policy & procedure
records maintained for 5 years
MUST have physical address

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43
Q

what drugs can hospice and home health have if PIC approves

A

SWFI
sterile saline
heparine
diphenhydramine
epinephrine
glucagon
flu and pneumonia vaccines
maintain records for 5 years

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44
Q

requirements for manufacturers and wholesalers

A

license (including CHFS license)
log books
pharmacist supervises manufacturing
alarm system
procedures
returns policy

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45
Q

what happens when you sell a pharmacy

A

return permit to BOP
inventory is done by outgoing and incoming PIC
inspected by BOP before opening
list of all pharmacy staff given to BOP

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46
Q

how long must rx records be kept

A

5 years - can be stored off-site but MOST RECENT (last 2 years) MUST be maintained on site

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47
Q

formulary compliance dispensing requirements to change without contacting prescriber

A

prescriber notes “formulary compliance approval” on rx
pharmacist adjudicates rx and third party rejects
third party gives formulary change notice
preferred product is in same drug class
change name on rx blank - can directions if needed
notify prescriber within 24 hours in writing - can fax

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48
Q

what MUST be on rx blank to be valid from prescriber

A

name, address, phone number of physician, DEA if controlled

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49
Q

emergency refill requirements

A

can be done 1 time within 3 days for maintenance meds NO CONTROLS
dispense 72 hours
can dispense 30 days if governor declares disaster

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50
Q

requirements for transferring pharmacy to have

A

name of receiving pharmacist
date
name, address of receiving pharmacy
DEA if control

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51
Q

requirements for receiving pharmacy to have

A

transferring pharmacy info
original date filled
last fill
date of issue
refills remaining
original refills
name of pharmacy

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52
Q

transferring rx requirements

A

keep record for 5 years
only by pharmacists and interns for non controls
CONTROLS IS RPH ONLY
on hold - needs to be filled once then transferred or forwarded to pharmacy with common database

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53
Q

what can a pharmacist do if a rx is unlawful

A

CAN give back to patient
MUST ascertain validity within reasonable time
MUST report to authorities if unlawful

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54
Q

changing dosage forms for legend drugs - contact prescriber prior?

A

YES

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55
Q

BUD for unit dose

A

either 6 months OR 25% of time remaining between date of repacking and original expiration date

56
Q

unit dose labeling requirements

A

name, strength
BUD
manufacturer name
lot or control number
number of units per container

57
Q

can you return a rx drug to pharmacy?

A

NO - unless unopened/sealed unit dose, tamper-resistant and MUST be within 14 days of sale and not require refrigeration and NOT CONTROLLED

58
Q

med synch requirements for medicaid

A

for chronic illness
NO CII
must have refills
full fee dispensing

59
Q

prescription eye drop requirements for health benefits

A

can refill 30 ds from day 25 OR refill 90 ds from day 80
prescriber MUST authorize refills
covers 1 additional bottle

60
Q

when can 1 additional bottle of rx eye drops be given?

A

requested by patient or prescriber when original is dispensed
prescriber indicates on rx
limits to 1 additional q3 months
has same copay

61
Q

stock bottle label requirements

A

name, strength, quantity
ingredients per dose
manufacturer name and address
expiration
lot number
package insert
storage
required warnings
NDC
CII-IV if controlled

62
Q

rx label requirements

A

pharmacy name, address, number
serial number
patient name
drug name, strength, quantity
directions
date filled
original fill date
expiration
pharmacist name or initials
prescriber name
refill information

63
Q

otc bottle label requirements

A

drug name, strength, quantity
lot number
expiration
warnings
directions
manufacturer name and address
storage
ID number (can be NDC)

64
Q

thalidomide requirements for prescribing/dispensing

A

prescriber is certified
patient enrolled in program
prescriber MUST counsel on risks
rx limits 28 ds

65
Q

isotretinoin requirements for prescribing/dispensing

A

iPledge
negative pregnancy test monthly
void after 7 days or 30 days if not picked up
rx limits 30 ds, no refills
two forms of bc

66
Q

which drugs need MedGuides

A

estrogen
NSAIDs
antidepressants
misoprostol
isotretinoin

67
Q

what makes a drug hazardous - NIOSH

A

teratogenicity
carcinogenicity
reproductive toxicity
organ toxicity
genetotoxicity

68
Q

examples of hazardous drugs from NIOSH list

A

antineoplastics
hormones
fluconazole
clonazepam
paroxetine
AEDs
spironolactone
warfarin

69
Q

when MUST you substitute brand for generic

A

if it is a lower price
is in stock

70
Q

requirements for generic substitution

A

sign in front of pharmacy “this pharmacy is required to dispense lowest price generic…ask your pharmacist”
BOP has the right to say you CANNOT substitute even if in orange book (negative formulary)

71
Q

AA generic code = ?

A

substitute

72
Q

AB generic code = ?

A

meets bioequivalence requirements

73
Q

EE generic code = ?

A

evaluated by FDA but rating is not available

74
Q

ZZ generic code = ?

A

FDA standard with no orange book code

75
Q

what are the requirements to prescribe controls

A

patient has to be seen first
patient signs agreement for prescriber to write
prescriber has KASPER report
patient seen on periodic basis

76
Q

CII rx requirements

A

written or electronic - faxed for LTCF, hospice, parenteral for compounding
no refills
valid for 60 days

77
Q

what modifications can you make to a CII rx WITHOUT contacting prescriber

A

patient address
dosage form
prescriber address or number
prescriber DEA

78
Q

what modifications can you make to a CII rx AFTER contacting prescriber

A

date of issue can be ADDED
drug strength if obviously wrong
quantity to match strength
quantity check box not marked
directions
refills
prescriber printed NOT SIGNED

79
Q

what can you NEVER change on a CII rx that requires a new rx

A

patient name
prescriber signature
drug name

80
Q

what additional law is made with CII ADD drugs for children

A

can have two labeled bottles - put all medication in one bottle and let the parent put however much into the second bottle for school

81
Q

what are the CII opioid prescribing limits for acute pain

A

3 days

82
Q

partial fill requirements for CII

A

1 - fill remaining within 72 hours or else void
2 - LTCF/hospice: up to 60 days and note terminally ill or LTCF and contact prescriber PRIOR to dispensing
3 - requests: no dispensing beyond 30 days of issue date

83
Q

CII rx requirements for LTCF/hospice patients

A

fax can suffice as original
oral rx allowed IF for immediate use (communicated by prescriber and MUST send written or electronic rx within 7 days NO FAX)
central fill CANNOT dispense oral CII rx

84
Q

when should you notify the DEA if a prescriber does not send immediate use rx to pharmacy for LTCF/hospice patient

A

after 7 days

85
Q

who may NOT write multiple CII rx at a time

A

KY APRNs

86
Q

CIII-V rx requirements

A

sign daily log for refills, date, quantity
oral or fax rx MUST have rph signature and date NO INITIALS
faxed rx MUST be on security blank

87
Q

what is the days supply that insurances will cover controls?

A

90 days - BOP can permit up to 1 year

88
Q

what schedule are butalbital and barbiturate drugs

A

CIII

89
Q

what schedule is gabapentin

A

CV

90
Q

what schedule is carisoprodol

A

CIV

91
Q

what schedule is nalbuphine

A

CIV

92
Q

what schedule is pentazocine

A

CIII

93
Q

requirements for prescribing anorexiants

A

BMI 27 or 25 with comorbidities (qsymia is 30 or 27 with comorbidities)
NO CII for weight loss

94
Q

control rx blank requirements

A

pantone green
opaque rx in upper right
watermark on back
quantity check boxes
one rx per blank
no advertising
not pre-printed
MUST be signed by prescriber

95
Q

does KY require legend drug rx to be signed by prescriber

A

NO

96
Q

who can fill out a 222 form

A

PIC or POA

97
Q

who do you report form 106 to?

A

DEA, CHFS, BOP

98
Q

when does the DEA require control inventory

A

biennial - any inventory that meets DEA requirements can push back DEA required date
new drugs added MUST be inventoried within 30 days and added to last inventory

99
Q

what are the requirements for control rx written for animals

A

list owner’s name and species of animal

100
Q

what purchase records do you need for controls

A

222 and invoice for CII
invoice for CIII-V

101
Q

when do you use KASPER for controls

A

prior to dispensing and reported daily- need patient’s SSN or driver’s license (can use 0s if no SSN but they need a SSN before next fill)
hospital or institution patients do not need to be reported to KASPER

102
Q

who can make the sale for guaifenesin with codeine or opium-containing anti-diarrheals

A

anyone can make the sale AFTER the pharmacist okays it

103
Q

limits for pseudoephedrine - records maintained for 2 years

A

3.6g per day
7.2g per 30 days
24g per year

104
Q

requirements to sell dextromethorphan

A

18+
given affirmative defense
ID with DOB
$25 fine for first offense then $200

105
Q

requirements for prescribing buprenorphine and naloxone for addiction

A

X DEA and regular DEA (physician or APRN)
no off-label prescribing (not for butrans or belbucca)
no BZD, hypnotic, sedative prescribing without consulting addictionologist or psychiatrtist - can prescribe 30 days without consult
dose once daily

106
Q

when can an X DEA practitioner prescribe single entity buprenorphine

A

pregnant females
breastfeeding females
naloxone hypersensitivity
injectable given in office

107
Q

can telehealth prescribers prescribe controls

A

NO

108
Q

APRN prescribing restrictions - physician does not have to be on premises

A

can prescribe only to collaborative agreement - maintain CCA for 5 years
72 hour supply of CII - 30 days for psychostimulants if associated with psychiatrist or mental health AND 30 days hydrocodone
30 days CIII no refills
30 days CIV-V with 5 refills

109
Q

PA-C prescribing restrictions - physician MUST be on premises

A

only specialized to what physician is
NO CII
30 days CIII no refills
30 days CIV-V with 5 refills

110
Q

OD prescribing restrictions

A

need additional training to prescribe PO drugs
72 hour supply for controls NO refills
NO CII - except 72 hours of hydrocodone
can administer diagnostic agents only - can administer adrenaline and benadryl
only purchase drugs that are administered

111
Q

physician dispensing requirements

A

no more than 48 hour supply of controls
MUST be on premises

112
Q

what happens with the death of a prescriber

A

controls IMMEDIATELY void
legend can be reasonable for patient to find another prescriber

113
Q

can prescriber request office supply for drugs

A

YES - fill out invoice or 222 form for CII
CANNOT use rx blank

114
Q

what are the requirements for prescribers that partake in DATA prescribing

A

limit 30 or 100 patients to start - may increase to 275 after a year
write for suboxone, subutex or other CIII-V that will treat addiction
methadone administered ON SITE - no rx unless for pain

115
Q

when can a prescriber prescribe methadone without a X DEA

A

a hospitalist or attending can TEMPORARILY prescribe if the addict is hospitalized - CANNOT take home rx

116
Q

what is USP 825 for

A

nuclear

117
Q

compound rx requirements

A

name, address
drug name, strength, quantity
date
directions
prescriber name, address, DEA if controlled
refill info
BUD

118
Q

compounded rx label requirements

A

name, address, number of pharmacy
patient name
active ingredients and ratio
directions
“this is compounded”
generic or chemical name of ingredients
strength, quantity
lot number
date of compounding
BUD
storage

119
Q

how long should you keep compounding records

A

2 years

120
Q

is flavoring considered compounding

A

NO - unless >5% of the total volume

121
Q

what references must be kept on hand for compounding

A

handbook of injectable drugs
king’s guide
micromedex
lexicomp
USP

122
Q

BUD for non preserved aqueous compounding

A

14 days

123
Q

BUD for preserved aqueous compounding

A

35 days

124
Q

BUD for nonaqueous dosage forms compounding

A

90 days

125
Q

BUD for solid dosage forms compounding

A

180 days

126
Q

BUD for water containing compounded drugs requiring refrigeration

A

14 days

127
Q

BUD for NON water containing compounded drugs requiring refrigeration

A

30 days

128
Q

BUD for single use vials in compounding

A

6 hours

129
Q

BUD for multi dose vials in compounding

A

2 days

130
Q

how long to maintain HIPPA records

A

6 years

131
Q

requirements for poisonous drugs

A

state poison on label if likely to cause death in 60 grains or less
record sale if can cause death in 5 grains or less
64.8 mg = 1 grain

132
Q

what was the pure food and drug act

A

lead to creation of FDA (DID NOT CREATE FDA)
accurately labeled drugs and contents

133
Q

what was the food, drug and cosmetic act

A

created FDA
safety for drugs

134
Q

what was the humphrey-durham act

A

rx vs otc

135
Q

what was the kefauver-harris act

A

manufacturer must prove safety and efficacy

136
Q

which insulins can be bought otc

A

beef and beef/pork insulins

MPJE (4 decks)

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