Reading 19 & 20 - Indiana Rules (IAC)

Question 1

Definition of supervision

Answer 1

must be able to ensure quality of care by providing real-time act of oversight (could be virtual)

Question 2

All pharmacy personnel must have what type of certificate or licensure?

Answer 2

HIPAA license
hold a valid license issued by the BoP

Question 3

How many attempts do you get for your NAPLEX and MPJE?

Answer 3

5 total
NAPLEX can only be retaken 3 times within 12 month period

Question 4

In order to get reciprocity in Indiana, what are the requirements?

Answer 4

-pass the MPJE
- fill out an application
- might need to retake the NAPLEX if not active license for 12 months

Question 5

What are some additional requirements when a pharmacy permit is issued within a larger licensed area?

Answer 5

-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

Question 6

Dangerous drug prescription label MUST contain these two additional requirements:

Answer 6

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

Question 7

When does the CE biennium start vs when the licensing biennium start?

Answer 7

January 1st of even numbered years (2024)

Julhy 1st of even numbered years (2024)

Question 8

How long should you file certificates of completion for CE requirements?

Answer 8

at least 4 years from the end of the biennium

Question 9

Reversible condition

Answer 9

requires intervention to resolve within a reasonable amount of time

Question 10

Temporary condition

Answer 10

issue resolves within a reasonable amount of time WITHOUT intervention

Question 11

Quality related event

Answer 11

inappropriateprovision of pharmaceutical service whether or not there was an ADR

Question 12

Sentinel Event

Answer 12

unexpected occurrence involving a serous ADR

Question 13

consulting pharmacists

Answer 13

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

Question 14

Supplying pharmacist

Answer 14

accepts responsibility for all drugs and devices solid in a supplying pharmacy (pharmacy providing drugs to a long term care)

Question 15

Records of all processes involved in pharmacy quality or sentinel events should be kept for how long? Who is in charge of this?

Answer 15

2 years
Pharmacist in Charge

Question 16

How often should the quality committee review events? Who ensures this happens?

Answer 16

every 3 months
Pharmacist in Charge

Question 17

What are some ways hospital staff have access to drugs without pharmacists or pharmacy open?

Answer 17

-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

Question 18

Who is required to be involved in the committee that decides emergy kit drugs?

Answer 18

Consulting pharmacist
licensed nurse
physician
facility administrator

Question 19

What should be on the exterior label of the emergency drug kits?

Answer 19

drug name
drug strength
quanity
expiration date

Question 20

What should all the drugs be labeled with on the inside of a emergency drug kit?

Answer 20

Drug name
drug strength
manufacturer
lot number
expiration date

Question 21

What should nurses record when they use drugs from an emergency drug kit?

Answer 21

Patient name
Drug name
Strength
Quantity removed
Date
Time

Question 22

When a controlled substance is in an emergency drug kit, what other precautions should be taken?

Answer 22

An oral authorization from a physcian is necessary when removing a controlled substance.
These CS should be included in the CS inventory

Question 23

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

Answer 23

directions of use

Question 24

What is required on the labeling of a unit-dose packaging?

Answer 24

Drug name
Drug strength
Control number/expiration date

Question 25

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

Answer 25

-prescriber address (you ONLY need the name)

Question 26

How long should records for controlled substances be stored in an category II permit?

Answer 26

2 years

Question 27

What are the requirements for a patient to use their own prescriptions in a hospital setting?

Answer 27

Nurse witness the administration and record it
patient maintains the med by their beside OR special storage area

Question 28

ISO Class 5 means how many particles per cibic foot?

Answer 28

< 100 particles that are 0.5 microns

Question 29

Definition of sterile compounds

Answer 29

free from LIVING microbes

Question 30

Characteristics for parenteral sterile compounds for quality include:

Answer 30

sterility
potency
preparation activities
checks and tests

Question 31

What additional requirements are needed on a label of sterile compounded products?

Answer 31

-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

Question 32

How often do biological safety cabinets (like laminar hood) need to be certified?

Answer 32

every 6 months
keep DOCUMENTATION for 2 years

Question 33

What is required on a transfer script?

Answer 33

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

Question 34

With every prescription a pharmacist must…

Answer 34

OFFER to counsel

Question 35

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

Answer 35

-pharmacy intern counseling (need to offer to them to speak to a pharmacist)
- asking if the patient has questions

Question 36

What needs to be in a patient’s profile in a pharmacy?

Answer 36

Name
Address
phone #
DOB
Gender
Current Meds
Disease states
Allergies
Drug reactions
Pharmacy comments

Question 37

Temporary Variance

Answer 37

Exception to a rule or regulation
good for 6 months and may be renewed 5 times

Question 38

What is NOT considered a cognitive service?
- Pharmacist undergoing a DUR
- Pharmacy intern counseling a patient
- Medication error review
- Reporting a medication error
- MTM

Answer 38

Reporting a medication error

Others that are NOT — thrid party claims, sale calls, record keeping, being nice to a customer