KY Law Flashcards
what makes up KY legislature
BOP, CHFS (cabinet for health and family services), OIG/Drug control
how many members in BOP
6 members (1 nonpharmacy and NO two from the same county)
BOP member requirements for serving
serve 4 years
can be reappointed ONCE by governor
elect president on annual basis - each officer can serve 2 years
BOP duties
exams
approve approved COP
pharmacy regulations
schedule hearings
issue licenses
employ executive director - MUST be a pharmacist
who can complain to the board - and how to file complaint
anyone can give oral, electronic, written complaint about anything
if BOP receives a complaint, what must they do
conduct an investigation - inspector MUST be a pharmacist
what are the outcomes of an investigation from BOP after a complaint is made
1 - agreed order
2 - settlement conference
3 - hearing
how long before a pharmacist can request to the BOP to expunge minor violations from their record
3 years
pharmacist recovery network requirements
can self-report and surrender license and remain unknown to the BOP
board MUST return license if PRN requirements are met
pharmacist license renewal
every year on Feb 28
requirements for pharmacist license
same as IN including:
graduate from approved COP
register with KASPER
register with CPE monitor
CE requirements for pharmacist
15 CE or 1.5 CEU from Jan 1 to Dec 31
maintain record for 3 years
1 hour MUST be on opioid epidemic
internship requirements for pharmacist licensure
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
requirements to be a preceptor
licensed for 1 year
supervise 1 student at a time unless one student and one hire
requirements for PIC
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
PIC responsibilities
QA
storage, security of drugs
reports required by law
responding to BOP
what is the pharmacist’s duty for any felonies or violations to law
report to BOP
self-report within 30 days of conviction
when MUST an offer to counsel be made
new rx and when professional discretion dictates for refills
offer made for deliveries with phone counseling
discharge medications for inpatient
counseling requirements
names, dosage form, ROA, storage, common & clinical AE, interactions, CI
document refusal to counsel and keep for 1 year
TB health department requirements
report if you see a patient with TB
also measles, cholera, E. coli, rabies, rubella, diphtheria
immunization requirements
anyone above age 9
technicians CANNOT give vaccines
technician requirements
noncertified are under IMMEDIATE supervision
certified are under GENERAL supervision
renew certification yearly on March 31
technician responsibilities
certify med carts
initiate or receive refills
receive diagnostic orders in nuclear
non-judgmental duties
what are the BOP authorized protocols for pharmacists WITH written protocol approval from prescriber
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
what must BOP authorized protocols have in order for pharmacist to prescribe/dispense
prescriber written approval
pharmacist education and training
criteria for identifying eligible patients
list of medications for dispensing
care plan that prescriber reviews
pharmacy permit requirements
renew yearly on June 30
out of state pharmacy requirements
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
what reference material MUST pharmacies have
category I-IV
I - pharmacology
II - drug interactions
III - drug product composition
IV - laws and regulations
what equipment MUST pharmacies have
class A balance
weight set
graduates
mortar and pestle
spatula
fridge
ointment slab
heating unit
filtration funnel
sink
permanent closure of pharmacies
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
involuntary closure requirements - acute illness, death, natural disaster, BOP action
written notice to BOP within 5 days
may maintain premises for 60 days - if no sale within that time BOP MAY seize drugs
voluntary closure requirements - chronic illness, abandonment, deviation from posted hours over 5 days
BOP MUST close store and seize drugs if failure to resume normal operations within 60 days
temporary closure requirements
MUST close and no one can enter
floor to ceiling locked
how must pharmacists maintain rx filling activities
daily printout or log book - BOP must give permission for daily log if printout is wanted
keep record for 5 years
charitable pharmacy requirements
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
hospital pharmacy requirements
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
what references MUST a hospital pharmacy have
category I-IV
drug identification
toxicology
parenteral drug compatibility
microbiology
emergency room drugs
does not exceed 72 hours for patient
emergency box requirements in LTCF
only 10 controls in <6 dosage units
policy & procedure
physician MUST write order
notify pharmacy within 24 hours
inventory done monthly
nuclear pharmacy requirements
pharmacist is certified
exempt from space requirements
medical gas pharmacy requirements
oxygen & nitrous oxide
special pharmacy permit + regular permit
PIC inspect quarterly
policy & procedure
requires rx - refill up to 1 year
clinical pharmacy requirements
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
what drugs can hospice and home health have if PIC approves
SWFI
sterile saline
heparine
diphenhydramine
epinephrine
glucagon
flu and pneumonia vaccines
maintain records for 5 years
requirements for manufacturers and wholesalers
license (including CHFS license)
log books
pharmacist supervises manufacturing
alarm system
procedures
returns policy
what happens when you sell a pharmacy
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
how long must rx records be kept
5 years - can be stored off-site but MOST RECENT (last 2 years) MUST be maintained on site
formulary compliance dispensing requirements to change without contacting prescriber
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
what MUST be on rx blank to be valid from prescriber
name, address, phone number of physician, DEA if controlled
emergency refill requirements
can be done 1 time within 3 days for maintenance meds NO CONTROLS
dispense 72 hours
can dispense 30 days if governor declares disaster
requirements for transferring pharmacy to have
name of receiving pharmacist
date
name, address of receiving pharmacy
DEA if control
requirements for receiving pharmacy to have
transferring pharmacy info
original date filled
last fill
date of issue
refills remaining
original refills
name of pharmacy
transferring rx requirements
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
what can a pharmacist do if a rx is unlawful
CAN give back to patient
MUST ascertain validity within reasonable time
MUST report to authorities if unlawful
changing dosage forms for legend drugs - contact prescriber prior?
YES
BUD for unit dose
either 6 months OR 25% of time remaining between date of repacking and original expiration date
unit dose labeling requirements
name, strength
BUD
manufacturer name
lot or control number
number of units per container
can you return a rx drug to pharmacy?
NO - unless unopened/sealed unit dose, tamper-resistant and MUST be within 14 days of sale and not require refrigeration and NOT CONTROLLED
med synch requirements for medicaid
for chronic illness
NO CII
must have refills
full fee dispensing
prescription eye drop requirements for health benefits
can refill 30 ds from day 25 OR refill 90 ds from day 80
prescriber MUST authorize refills
covers 1 additional bottle
when can 1 additional bottle of rx eye drops be given?
requested by patient or prescriber when original is dispensed
prescriber indicates on rx
limits to 1 additional q3 months
has same copay
stock bottle label requirements
name, strength, quantity
ingredients per dose
manufacturer name and address
expiration
lot number
package insert
storage
required warnings
NDC
CII-IV if controlled
rx label requirements
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
otc bottle label requirements
drug name, strength, quantity
lot number
expiration
warnings
directions
manufacturer name and address
storage
ID number (can be NDC)
thalidomide requirements for prescribing/dispensing
prescriber is certified
patient enrolled in program
prescriber MUST counsel on risks
rx limits 28 ds
isotretinoin requirements for prescribing/dispensing
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
which drugs need MedGuides
estrogen
NSAIDs
antidepressants
misoprostol
isotretinoin
what makes a drug hazardous - NIOSH
teratogenicity
carcinogenicity
reproductive toxicity
organ toxicity
genetotoxicity
examples of hazardous drugs from NIOSH list
antineoplastics
hormones
fluconazole
clonazepam
paroxetine
AEDs
spironolactone
warfarin
when MUST you substitute brand for generic
if it is a lower price
is in stock
requirements for generic substitution
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)
AA generic code = ?
substitute
AB generic code = ?
meets bioequivalence requirements
EE generic code = ?
evaluated by FDA but rating is not available
ZZ generic code = ?
FDA standard with no orange book code
what are the requirements to prescribe controls
patient has to be seen first
patient signs agreement for prescriber to write
prescriber has KASPER report
patient seen on periodic basis
CII rx requirements
written or electronic - faxed for LTCF, hospice, parenteral for compounding
no refills
valid for 60 days
what modifications can you make to a CII rx WITHOUT contacting prescriber
patient address
dosage form
prescriber address or number
prescriber DEA
what modifications can you make to a CII rx AFTER contacting prescriber
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
what can you NEVER change on a CII rx that requires a new rx
patient name
prescriber signature
drug name
what additional law is made with CII ADD drugs for children
can have two labeled bottles - put all medication in one bottle and let the parent put however much into the second bottle for school
what are the CII opioid prescribing limits for acute pain
3 days
partial fill requirements for CII
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
CII rx requirements for LTCF/hospice patients
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
when should you notify the DEA if a prescriber does not send immediate use rx to pharmacy for LTCF/hospice patient
after 7 days
who may NOT write multiple CII rx at a time
KY APRNs
CIII-V rx requirements
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
what is the days supply that insurances will cover controls?
90 days - BOP can permit up to 1 year
what schedule are butalbital and barbiturate drugs
CIII
what schedule is gabapentin
CV
what schedule is carisoprodol
CIV
what schedule is nalbuphine
CIV
what schedule is pentazocine
CIII
requirements for prescribing anorexiants
BMI 27 or 25 with comorbidities (qsymia is 30 or 27 with comorbidities)
NO CII for weight loss
control rx blank requirements
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
does KY require legend drug rx to be signed by prescriber
NO
who can fill out a 222 form
PIC or POA
who do you report form 106 to?
DEA, CHFS, BOP
when does the DEA require control inventory
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
what are the requirements for control rx written for animals
list owner’s name and species of animal
what purchase records do you need for controls
222 and invoice for CII
invoice for CIII-V
when do you use KASPER for controls
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
who can make the sale for guaifenesin with codeine or opium-containing anti-diarrheals
anyone can make the sale AFTER the pharmacist okays it
limits for pseudoephedrine - records maintained for 2 years
3.6g per day
7.2g per 30 days
24g per year
requirements to sell dextromethorphan
18+
given affirmative defense
ID with DOB
$25 fine for first offense then $200
requirements for prescribing buprenorphine and naloxone for addiction
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
when can an X DEA practitioner prescribe single entity buprenorphine
pregnant females
breastfeeding females
naloxone hypersensitivity
injectable given in office
can telehealth prescribers prescribe controls
NO
APRN prescribing restrictions - physician does not have to be on premises
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
PA-C prescribing restrictions - physician MUST be on premises
only specialized to what physician is
NO CII
30 days CIII no refills
30 days CIV-V with 5 refills
OD prescribing restrictions
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
physician dispensing requirements
no more than 48 hour supply of controls
MUST be on premises
what happens with the death of a prescriber
controls IMMEDIATELY void
legend can be reasonable for patient to find another prescriber
can prescriber request office supply for drugs
YES - fill out invoice or 222 form for CII
CANNOT use rx blank
what are the requirements for prescribers that partake in DATA prescribing
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
when can a prescriber prescribe methadone without a X DEA
a hospitalist or attending can TEMPORARILY prescribe if the addict is hospitalized - CANNOT take home rx
what is USP 825 for
nuclear
compound rx requirements
name, address
drug name, strength, quantity
date
directions
prescriber name, address, DEA if controlled
refill info
BUD
compounded rx label requirements
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
how long should you keep compounding records
2 years
is flavoring considered compounding
NO - unless >5% of the total volume
what references must be kept on hand for compounding
handbook of injectable drugs
king’s guide
micromedex
lexicomp
USP
BUD for non preserved aqueous compounding
14 days
BUD for preserved aqueous compounding
35 days
BUD for nonaqueous dosage forms compounding
90 days
BUD for solid dosage forms compounding
180 days
BUD for water containing compounded drugs requiring refrigeration
14 days
BUD for NON water containing compounded drugs requiring refrigeration
30 days
BUD for single use vials in compounding
6 hours
BUD for multi dose vials in compounding
2 days
how long to maintain HIPPA records
6 years
requirements for poisonous drugs
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
what was the pure food and drug act
lead to creation of FDA (DID NOT CREATE FDA)
accurately labeled drugs and contents
what was the food, drug and cosmetic act
created FDA
safety for drugs
what was the humphrey-durham act
rx vs otc
what was the kefauver-harris act
manufacturer must prove safety and efficacy
which insulins can be bought otc
beef and beef/pork insulins
