Reading 19 & 20 - Indiana Rules (IAC) Flashcards
Definition of supervision
must be able to ensure quality of care by providing real-time act of oversight (could be virtual)
All pharmacy personnel must have what type of certificate or licensure?
HIPAA license
hold a valid license issued by the BoP
How many attempts do you get for your NAPLEX and MPJE?
5 total
NAPLEX can only be retaken 3 times within 12 month period
In order to get reciprocity in Indiana, what are the requirements?
-pass the MPJE
- fill out an application
- might need to retake the NAPLEX if not active license for 12 months
What are some additional requirements when a pharmacy permit is issued within a larger licensed area?
-must be closed off from floor to ceiling
-security: on site sound alarm and off site audible or visual alarms with continuous monitoring
-violations are recorded and reported to the board within 72 hours
-system for back power for at least 36 hours
-electronica monitoring can only be accessed by a pharmacist
Dangerous drug prescription label MUST contain these two additional requirements:
Owner’s name and species if an animal
name of drug in compliance with the generic drug law
*** drug name was NOT a requirement on previous labels
When does the CE biennium start vs when the licensing biennium start?
January 1st of even numbered years (2024)
Julhy 1st of even numbered years (2024)
How long should you file certificates of completion for CE requirements?
at least 4 years from the end of the biennium
Reversible condition
requires intervention to resolve within a reasonable amount of time
Temporary condition
issue resolves within a reasonable amount of time WITHOUT intervention
Quality related event
inappropriateprovision of pharmaceutical service whether or not there was an ADR
Sentinel Event
unexpected occurrence involving a serous ADR
consulting pharmacists
meet all requirement for long term care institutions
like:
-Drug reviews
-offer advice
-develop policies for hangling and storing drugs
- responsible for emergency drug kits
Supplying pharmacist
accepts responsibility for all drugs and devices solid in a supplying pharmacy (pharmacy providing drugs to a long term care)
Records of all processes involved in pharmacy quality or sentinel events should be kept for how long? Who is in charge of this?
2 years
Pharmacist in Charge
How often should the quality committee review events? Who ensures this happens?
every 3 months
Pharmacist in Charge
What are some ways hospital staff have access to drugs without pharmacists or pharmacy open?
-cabinets if record is kept
-1 supervisory nurse per shift has access to remove if recorded (name, drug name strength and amount, date, time)
-emergency kits
Who is required to be involved in the committee that decides emergy kit drugs?
Consulting pharmacist
licensed nurse
physician
facility administrator
What should be on the exterior label of the emergency drug kits?
drug name
drug strength
quanity
expiration date
What should all the drugs be labeled with on the inside of a emergency drug kit?
Drug name
drug strength
manufacturer
lot number
expiration date
What should nurses record when they use drugs from an emergency drug kit?
Patient name
Drug name
Strength
Quantity removed
Date
Time
When a controlled substance is in an emergency drug kit, what other precautions should be taken?
An oral authorization from a physcian is necessary when removing a controlled substance.
These CS should be included in the CS inventory
Which requirements are NOT needed for labeling of drug orders:
- patient room number
- patient ID number
-drug name
-drug strength
-drug quantity
- directions of use
directions of use
What is required on the labeling of a unit-dose packaging?
Drug name
Drug strength
Control number/expiration date
Which requirements are NOT needed for labeling of discharged drugs in an outpatient pharmacy?
- pharmacy phone number
- prescriber address
- Rx number
- Drug name
- Precautionary info, if any
-prescriber address (you ONLY need the name)
How long should records for controlled substances be stored in an category II permit?
2 years
What are the requirements for a patient to use their own prescriptions in a hospital setting?
Nurse witness the administration and record it
patient maintains the med by their beside OR special storage area
ISO Class 5 means how many particles per cibic foot?
< 100 particles that are 0.5 microns
Definition of sterile compounds
free from LIVING microbes
Characteristics for parenteral sterile compounds for quality include:
sterility
potency
preparation activities
checks and tests
What additional requirements are needed on a label of sterile compounded products?
-date of preparation
-name of EACH drug in preparation
-identity of pharmacist compounded
-identity of pharmacist checking
-TIME of expiration
-special warnings and storage requirements
How often do biological safety cabinets (like laminar hood) need to be certified?
every 6 months
keep DOCUMENTATION for 2 years
What is required on a transfer script?
Date of issue
original refills
remaining refills
date of original dispensing
pharmacy name, address, DEA number
original script number
name of pharmacist and intern (if necessary)
+ prescription requirements
With every prescription a pharmacist must…
OFFER to counsel
Which are NOT considered an offer to counsel:
-pharmacy intern counseling
-pharmacist counseling
-asking if the patient has questions
-using a written notice with pharmacy’s number if patient not present
-pharmacy intern counseling (need to offer to them to speak to a pharmacist)
- asking if the patient has questions
What needs to be in a patient’s profile in a pharmacy?
Name
Address
phone #
DOB
Gender
Current Meds
Disease states
Allergies
Drug reactions
Pharmacy comments
Temporary Variance
Exception to a rule or regulation
good for 6 months and may be renewed 5 times
What is NOT considered a cognitive service?
- Pharmacist undergoing a DUR
- Pharmacy intern counseling a patient
- Medication error review
- Reporting a medication error
- MTM
Reporting a medication error
Others that are NOT — thrid party claims, sale calls, record keeping, being nice to a customer
