Documentation and Record Keeping Flashcards
7 cards from real KAPS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation and Record Keeping flashcards as text
Which element is required on a compounded sterile preparation (CSP) label under USP ?
Answer: Beyond-use date and time
USP mandates that CSP labels include the beyond-use date (BUD) and time to ensure preparations are not used after their established stability limit.
A technician makes a math error on a compounding worksheet and corrects it before the pharmacist verifies. What is the proper documentation step?
Answer: Cross out the error with a single line, write the correct value, and initial and date the correction
Any correction to pharmaceutical documents must preserve the original entry and show who corrected it and when, consistent with GMP data integrity principles.
According to DEA regulations, which form must be used to document the return of Schedule II substances to a reverse distributor?
Answer: DEA Form 222 (or CSOS equivalent)
Transfers of Schedule II controlled substances, including returns to a reverse distributor, require completion of DEA Form 222 or its CSOS electronic equivalent.
The term 'data integrity' in pharmaceutical documentation refers to:
Answer: Ensuring records are complete, consistent, accurate, and attributable throughout the data lifecycle
Data integrity encompasses the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, and Enduring.
An investigational drug study requires pharmacy records to document each dose dispensed. Which document best serves this purpose?
Answer: Investigational Drug Dispensing Log
An investigational drug dispensing log tracks patient ID, dose, date/time, lot number, and dispensing personnel to meet FDA investigational drug accountability requirements.
Under HIPAA, a pharmacy's minimum necessary standard for releasing patient prescription records means:
Answer: Disclosing only the specific information needed for the stated purpose
The minimum necessary standard requires pharmacies to limit disclosure of protected health information to the least amount required to accomplish the intended purpose.
A hospital pharmacy's perpetual inventory system shows a discrepancy of 5 units for a Schedule II opioid. What is the required action?
Answer: Conduct an immediate investigation, document findings, and report a theft or significant loss to DEA if applicable
Controlled substance discrepancies require immediate investigation and documentation; significant losses must be reported to the DEA using Form 106 within one business day.