Exam 3 - Indiana Administrative Code Flashcards
IAC defines pharmacist presence in a pharmacy as…
being physically present in the area specified as the dimensions of the pharmacy in the relevant pharmacy permit application
reasonable visual and vocal distance
a pharmacist being physically present within the licensed permitted area or by a means that provides for adequate supervision of techs as individually approved by the board
pharmaceutical care
dispensing legend drug product and delivery of cognitive services
cognitive serices
MTM
prospective drug review
DUR
drug interaction review
collaborative practice
pharmacist prescribing
patient counseling
patient education
patient adherence
preventative health
medication error reduction
continuous quality improvement
real-time online database
continuously updated in real time and allows users to share and store patient information and interface w/ each other in a secure environment over the internet
unlicensed person
not HIPPA trained and
does not hold a valid license/cert/permit/registration
can unlicensed person perform any pharmacy dispensing functions related to legend drugs
no
IAC exam requirements
-completion of pharmacy school and 1500 hours of experience
-application to the board
-take and pass NAPLEX and MPJE in English
if applicant fails naplex and mpje and wishes to retake, they must…
complete a new application
after failure of 2 sittings, applicant must…
appear before the board for consultation and receive written permission from the board
max attempts for NAPLEX and MPJE
5
IAC reciprocity
complete application for license transfer
pass Indiana MPJE
pass NAPLEX if not actively practice in the 12 months prior to application
who decides additional fixtures/equipment for pharmacy
qualifying pharmacist
if the board determines pharmacy has not met requirements, they will notify…
qualifying pharmacist and must be corrected in 30 DAYS of notification
if a pharmacy needs to change their hours, what must they do with their permit?
get a new permit
prescription department may be locked or secured while remainder of pharmacy remains open to public if…
-reasonable barriers
-not enclosed floor to ceiling –> secured and monitored by an electronic monitoring device
-violations recorded and reported to board within 72 hours
-back up power for no less than 36 hours
-electron monitoring system activated or inactivated only by key or combination
pharmacist shall maintain record stating any hours that…
pharmacy was open for business without a pharmacist on duty if those hours vary from the hours listed on the application
record of pharmacist off duty must be maintained for how long
no less than 2 years from date of last entry in the record
for a medication to have properly stored and securely maintained to qualify for a return, it must…
been under the control of licensed nursing personnel the entire time
IAC prescription labeling requirements
-name, address, and phone number of establishment
-date of fill
-rx number
-name of prescriber
-name of patient (if animal do species and owner’s name)
-direction for use as stated in prescription
-name of drug in compliance with IC
what are techs prohibited from
-any duty required to be done by pharmacist
-provision of advice to prescriber or provider
-provision of advice to patient
-dispensing drug info to patient
-receipt of verbal rx from prescriber
-final check on all aspects of a completed RX
how must techs identify themselves
wear identification and identify themselves verbally
for remote practice you must…
have a dedicated office space not used for another purpose, and open to inspection by the board
all pharmacists who are renewing license must complete…
30 hours of CE each biennium
CE biennia run from…
jan 1 of even year to dec 31 of odd year
if pharmacist fails to complete 30 hours during a CE biennium…
they may used hours completed during a succeeding biennium and apply them to previous biennium (can’t double dip)
how long is the biennium offset and why
6 months from jan 1 even to june 30 even to make up any deficit
CE stipulations
-no more than 1/5 business, management, or computer course
-at least 4/5 must be pharmacy practice related
-at least 1/2 of total hours must be ACPE approved
if initial licensure occurs within a biennium, you should accrue…
1.25 hours of CE for each month you are licensed from the date of licensure to the end of the biennium
if licensed in the last 6 months of the biennium…
no CE required for the biennium
define cabinet
mechanical storage device for dispensing
consultant pharmacist
pharmacist who practices pharmacy at LTCF or other residence other than a supplying pharmacist
consulting
provision of non supply related cognitive services
emergency drugs
drugs required to meet immediate therapeutic needs and are not available from another source in sufficient time to prevent harm
pharmacist in charge
pharmacist who directs activities of the institutional pharmacy
quality-related event
inappropriate provision of pharmaceutical services which may result in adverse health incident
reversible condition
condition that required intervention to resolve in a reasonable time
sentinel event
unexpected occurrence involving a serious adverse effect
temporary condition
condition that resolves in a reasonable time without invervention
pharmacist in charge must
establish and carry out performance improvement
develop policies and procedure manual
committee review of quality related events must happen how often
at least every 3 months
cabinets as a source for drugs
-must be properly labeled and prepackaged sufficient for a max of 24 hours
-must be tied to a physicians order or record
-must be reviewed by pharmacist not more than 24 hours later
-policies and procedures must be established to implement this section
one supervisory licensed nurse in any shift may have access to pharmacy and remove drugs and record…
name and strength of drug
amount
date and time
signature of the nurse
copy of the order
for any emergency drugs, pharmacy policy and procedures must assure the following…
availability
control
security
procedures for emergency drugs at minimum must include…
determination of drugs and quantities to be included
labeling for expiration date
process for restocking
security measures
additional rules for drug kits at LTCF
drug name
drug strength or size
quantity included
expiration date of the kit (earliest date in the kit)
drugs in kit for LTCF must be labeled with…
drug name
drug strength or size
name of manufacturer, packer, distributor
lot number
expiration date
nurse in LTCF removing drugs from emergency kit must document…
name of patient
name of drug
strength of drug
quantity removed
date and time of removal
records of anything relating to quality related events must be maintained for at least…
2 years
documentation requirements of quality related events must include…
-each event document by pharmacist to whom its first reported to on the same day as described
-description of event
-pharmacist in charge shall summarize efforts to improve processes
-no patient or employee names should be included in reporting
-member of board can review documentation
all drugs other than unit of use packaged dispensed by an institutional pharmacy must be labeled with:
patient Identification
drug name
strength if applicable
route of admin
quantity
pharmacists initial
location of patient within the institution
unit of use packages in institutional setting must have on their label:
drug name
strength, if applicable
control number and/or expiration date
a patient may only self admin in institution if…
authorized by physician
patient’s knowledge has been evaluated
patient has received training in the proper manner of self-admin by pharmacist or policy
AN NO RISK OF HARM TO PATIENT
can an institutional pharmacy touch drugs that are brought in by patient
no
when can a patient’s brought in meds be used
patient can maintain own meds at bedside or under control of nurse AND nurse in charge witness the admin and maintains records
requirements for sterile compounding
environment control capable of at least ISO class 5
sink w/ hot and cold water outside buffer area
disposal containers
biohazard containers
fridge w thermometer
infusion devices
documentation of cleaning
ISO Class 8 conditions in buffer area
sterile compounding supply requirements
-needles, syringes, and supplies for admixture
-disinfectant cleaning tools and solutions
-antibacterial hand washing
-disposable towels or wipes
-filters
-spill kit
-gowns and gloves
sterile produce reference requirements
at a minimum:
handbook on injectables
king’s guide to parenteral admix
board approved database
if prepping hazardous drugs, what must be kept
OSHA requirements for handling hazards
sterile product patient profile requirements
-patient name, DOB/Age, weight, sex
-product dispensed
-drug content and quantity
-directions for patient
-identification of dispensing pharmacist and personnel responsible for prep
-drug therapy info
-drug allergies
-primary diagnosis
sterile product labeling for inpatient
-date of prep
-patient name and bed number
-name of each drug in preparation, strength, and amount
-expiration date of preparation (and time)
-dispensing pharmacist and whoever prepped
-storage requirements or special warnings
what are the additional labeling requirements for sterile products if patient is at home
prescription number
prescriber’s full name
name, address, and telephone number of the pharmacy
directions for use (rate and date and time of admin)
where must fax machines be located
nonpublic area of licensed pharmacy
pharmacist may not refuse to transfer unless…
transfer would go against professional judgement
what does indiana uniquely require for all types of transfers
DEA numbers
what is an appropriate offer to counsel
-pharmacist counsels
-intern counsels then offers to talk to pharmacist
-written notice of offer recorded
-any person in the pharmacy makes an offer for the pharmacist to counsel
security features for CS blanks
-practice logo in corner
-practitioner name and state issued license number
-fill area
-rx void if more than one rx written per blank
rx log (3/4 x 1/8 x 5/16)
-4 1/4 inch tall x 5 1/2 inch wide
-void watermark