MPJE Indiana Flashcards
How many board members?
7
how many board members are pharmacists?
6
1 must be hospital
who appointments board members
governor
how long do board members serve?
4 years
how many times/year do board members convene
8 x
who can attend board meetings?
anyone
How many CE hours are needed for renewal
30 hours every 2 years (even numbers)
CE requirements
max 1/5th of hours in business, management, computers
4/5th must be practice realated
half of hours must be acpe approved
renewal period - pharm license and tech license
June 30th on even numbered years
required hours for pharmaicst license
1500
how much rxs be stored
for 2 years in one of the following:
3 files: Cii, Ciii-v, legend
2 files: noncontrolled and controlled (must have red C stamp)
2 file: CII, all others with red C on ciii-v
do hard copies have to be stored on site?
no, but must be accessible for BOP
time period to notify board of changes of ownership of pharmacy
10 days
time period to notify board of changes to PIC
immediately
time period to notify board of change of address
no timeline, must file with application
time period to notify board of change of hours
no times - must be submitted in writing
how long of closure requires board notification?
5 or more consecutive days
Required equipment
sink with hot and cold water, power sewage outlet, refrigeration
emergency access to pharmacy
supervisor licensed nurse once per shift may access pharmacy if drugs not available in dispensing cabinets. Must be documented and copy of order left
What is adulteration?
An issue is with the product itself
Must err on the side of caution and assume it’s adulterated if the product has been put in a compromising position
What is misbranding?
There is an issue with the words associated with the product
Ex: prescription label requirements are not met
What is cGMP
Current good manufacturing practices
Set minimum requirements for manufacturing of drugs
Do’s and Donts of Compounding
Must be: for an individual patient, with a prescription, but can compound it before receiving the Rx based on prescribing history
Can not be a commercially available product
Does not including reconstituting, mixing, or other instructions on approved labeling
What must be included on an Rx label for an outsourced compounded product?
“This is a compounded drug” Outsourcing facility info Batch number Expiration date Storage instructions List of active ingredients
A pharmacist forgets to dispense a med guide with sertraline. What is this considered?
Misbranding
What class medical device are contact lenses?
Class III - most complicated class as mistakes can cause vision loss
Which drug recall is the most severe?
One
This can cause death, things like wrong drug in bottle
Can the FDA force a recall?
No, they must be voluntary
What is the PPPA
Poison Prevention Packaging Act
Enacted to prevent accidental poisoning in children under 5
What are some CRC exempt products?
Nitro stat, Medrol dose pack, birth control
Reusing a plastic vial is totally okay according to the PPPA
No! Must replace any plastic parts, glass or metal are okay to reuse though
Which DEA form is used for ordering and transferring C-II?
222
What is required to be dispensed with estrogen and contraceptive products?
Patient package insert
PPIs (patient package inserts) are only required outpatient
False! Required inpatient as well
Medication guides are required outpatient only
True!
What is needed with dispensing of promethazine suppositories in a community pharmacy? PPI or CRC, both, or neither
Neither
CRC only applies to oral medication
What DEA form is used to report theft or loss?
Form 106
How soon must theft/loss be reported?
Within 1 business day, in writing
Form 106 does need to be submitted now, it is submitted after circumstances are clear?
What must be done if C-II theft or loss investigation is taking a long time?
DEA must receive updates every 30 days
What is DEA 41 for?
Destruction of controlled substances
What needs to be on a DEA form 41?
2 employee witnesses
Record of destruction
What Practitioners have a DEA number that starts with M?
Mid level practitioner like PA or NP, sometimes pharmacists
What is the PDMA?
Prescription drug marketing act
- bans selling or trading prescriptions purchased by healthcare facilities
- bans offer to sell coupons or samples
How soon do you have to complete a partial fill of a C-II?
Within 72 hours
What is used for generic approvals?
ANDA
What can the DEA not look at during an inspection without a warrant
Sales or financial information
An OTC drug is not packaged in tamper resistant packaging. What is it?
Both adulterated and misbranded
What practitioners haveDEA numbers that start with ABF or G?
Physician
Vet
Podiatrist
Dentist
Can optometrist prescribe controlled substances?
Only tramadol if DEA registered
Legal THC percentage for CBD
0.3%
How many times can a C-III-V be refilled?
5
Who can prescribe methadone?
Only physicians
Formula for DEA license:
- Add together numbers 1,3, and 5
- Add together numbers 2,4,6 and multiply result by 2
- Add products from step 1 and 2
- Last digit of this result should be equal to number 7 in the license.
Maximum limit for opium containing OTC products
8 oz or 48 dosage units
Max behind the counter sale quanitity of codeine
4 oz or 24 dosage units
How long do sudofed sale records need to be retained?
2 years
365 dispensing limit for pseudophed
61.2g
30 day dispensing limit for pseudophed
3.6g
LTC: when can prn medications be given?
only after authorization by licensed nurse or physicain
Can a patient self-admin drugs in LTC?
only if authorized by physician and patient has received training by pharmacist or self-admin knowledge has been evaluated
what must be on the label of a unit dose package in an LTC?
drug name
strength
control number
expiration date
Which can a tech not complete according to state law?
- admin flu vaccine
- receive verbal refill approval from a provider
- obtain a tech license without high school diploma
- dispense rx drug info to a patient
dispense rx drug info to a patient
how long until. a person can reapply after a revocation of their license?
after 7 years and this is for a brand new license rather than reinstatement
What is a censure?
sanction that consists of a verbal expression of disapproval
what is the min and max a license can be suspended for?
no min or max!
What can a practioner do if a sanction is imposed on their license
appeal! and they can have legal representation at their hearing.
what happens if a practioner surrenders their license?
they can avoid a hearing, but the board must agree to the surrender and may impose conditions to the surrender
whats a category I pharmacy permit
a retail permit that allows dispensing of drugs and devices (community pharmacies)
what’s a category II pharmacy permit?
institutional permit for inpatient dispensing under drug order or to an outpatient of the institution via prescription
whats a category III pharmacy permit
closed door central fill, mail order, or processing operation not open to general public
Who may be dispensed to under a category II permit?
employee, student or volunteer of hospital system
retiree of system
independent contractor with relationship with system
member of the system’s governing board
a member of the systems medical staff
*or dependents of these individuals in addition to inpatients
what pharmacy category is a LTCF?
category 2 - “Inpatient”
Can you substitute a generic for a brand name called in by a veterinarian?
NO! must have verbal approval
When can a brand be dispensed to a medicaid patient if generic is avaliable?
if BRAND MEDICALLY NECESSARY is hand written on the script or sent in electronically
can we substitute equivalent biosimilar products?
yes, but practitioner must be notified no later than 10 days after dispensing *refills do NOT require this
what insulins can be sold without a prescription?
regular
nph
combo of these
What is the expiration rule for glucagon and epinephrine
can not dispesne these products if expiration date is less than 12 from date of dispense unless patient consents
Can we substitute epinephrine products that aren’t AB rated?
Yes, but they must be a therapeutic alternate
what must the pharmacist document before initiating a rph refill aka emergency fill
information required for any refill dispensed
dates and time prescriber contacts were attempted
the fact this was dispensed without prescriber authorization
what is important about 30 - 90 day conversions?
can not be done unless a patient has completed an initial 30 day supply of drug therapy unless its written for 90 days initially
