KAPS Documentation and Record Keeping 3 — Questions and Answers
Question 1: Which element is required on a compounded sterile preparation (CSP) label under USP <797>?
- Beyond-use date and time (Correct answer)
- The prescriber's DEA number
- The compounder's home address
- The patient's insurance information
Correct answer: Beyond-use date and time
USP <797> mandates that CSP labels include the beyond-use date (BUD) and time to ensure preparations are not used after their established stability limit.
Question 2: A technician makes a math error on a compounding worksheet and corrects it before the pharmacist verifies. What is the proper documentation step?
- Cross out the error with a single line, write the correct value, and initial and date the correction (Correct answer)
- Erase the error completely and write the correct value
- Start a new worksheet and discard the old one
- Note the error verbally to the pharmacist without written correction
Correct 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.
Question 3: According to DEA regulations, which form must be used to document the return of Schedule II substances to a reverse distributor?
- DEA Form 222 (or CSOS equivalent) (Correct answer)
- DEA Form 106
- DEA Form 41
- DEA Form 224
Correct 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.
Question 4: The term 'data integrity' in pharmaceutical documentation refers to:
- Ensuring records are complete, consistent, accurate, and attributable throughout the data lifecycle (Correct answer)
- Encrypting all patient data with the highest level of security software
- Backing up records to a cloud server daily
- Restricting documentation access to pharmacists only
Correct 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.
Question 5: An investigational drug study requires pharmacy records to document each dose dispensed. Which document best serves this purpose?
- Investigational Drug Dispensing Log (Correct answer)
- Standard retail prescription receipt
- Pharmacy benefit manager (PBM) claim record
- DEA Schedule III inventory report
Correct 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.
Question 6: Under HIPAA, a pharmacy's minimum necessary standard for releasing patient prescription records means:
- Disclosing only the specific information needed for the stated purpose (Correct answer)
- Sharing all available patient records with any requesting healthcare provider
- Providing full records whenever a patient signs a release
- Excluding records older than two years from any disclosure
Correct 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.
Question 7: A hospital pharmacy's perpetual inventory system shows a discrepancy of 5 units for a Schedule II opioid. What is the required action?
- Conduct an immediate investigation, document findings, and report a theft or significant loss to DEA if applicable (Correct answer)
- Adjust the inventory record to match the count without further action
- Wait one week to see if the discrepancy resolves itself
- Notify the nursing unit and request they return any unused doses
Correct 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.
KAPS Documentation and Record Keeping 3
Which element is required on a compounded sterile preparation (CSP) label under USP ?