5. Record Keeping

what is an acceptable time for records to be "readily retrieveable"

48 hours

for an outpatient prescription, what is recorded at the time of verification and fill

- chronologically numbered, dated, and initialed by pharmacist performing final verification

- RX number, dispensing date, initials at time of first fill

prescription filing systems are divided into ___#___ files. what are they?

3

-schedule 2

-schedule 3-5

-noncontrols

how long must scripts be kept for?

Michigan: 5 years from LAST date filled (MI law is stricter. federally, its 2 years)

- but, after 2 years paper copies can be maintained electronically

Medicaid: 7 years

Medicare: 10 years

upon audit, how long do you have to present prescriptions <2 years old? over 2 years?

<2= readily retrievable (48hrs)

>2= 72 hours

in an inpatient setting, records must be maintained for _____ years after discharge and available within ______ upon request

5yrs, 48hrs

what is a pharmacist dispensing log? how long is it maintained?

-for verifying accuracy of controlled meds

-pharmacist must sign electronic document or logbook (either sign and date print out or a separate bound logbook)

- maintained for 2 years

the originating pharmacy and central fill pharmacy must maintain all prescription records for at least ________

5 years from the date of dispensing

- readily retrievable in 48 hours or immediately if electronic

CPMP records

- pt name and address

- serial number of each drug inside

- date prepared and expiration date

- name/initials of pharmacist who made it

- info to describe the design/characteristics of the final product do identical can be made

the BUD for non-sterile compounds is determined by ____

the BUD for sterile compounds is determined by _______

non-sterile: USP 795 based on formulation

sterile: USP 797 based on Category 1 (shorter BUD) and 2 (longer BUD)

what are the BUDs for the following:

-non-aqueous dosage form

- solid dosage form

- preserved aqueous

- non-preserved aqueous

-non-aqueous dosage form: 90 days

- solid dosage form: 180 days

- preserved aqueous: 35 days

- non-preserved aqueous: 14 days

how long should an exempt schedule 5 logbook be kept? retrievable?

2 years; IMMEDIATELY retrievable

a copy of the customer receipt must be kept by the pharmacy for _______

90 days post transaction

Records and electronic dispensing data kept by automated devices should be maintained by the pharmacy responsible for the device for how long?

5 years

(audit records must be maintained for 2 years)

rules regarding storing records offsite

-shipping, financial, and acquisition records can be maintained offsite as long as DEA is notified (Not form 222s)

- can start storing offsite 14 days after DEA receives written notif

on inventory day, if a controlled substance scheduled 3-5 holds less than ________ dosage units, then the count can be estimated

1000

(schedule 2 must be exact)

when must the annual inventory for controlled substances occur

30 days before May 1 or 60 days after [april, may, or june]

how long should inventory records be maintained?

2 years in printed format

copy must be forwarded to DEA/Department/Board upon request

a distribution record to nursing units shall not exceed ______ doses per container

25

those selling pseudoephedrine must renew their training __________

annually

(sales records kept for 2 years)

how long should CE hour completion records be retained?

implicit bias?

opioids training?

CE= 4 years

implicit bias= 6 years from date of application for license

opioid training= 3 renewal periods plus one additional year