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 USP chapter provides guidance on documentation standards for pharmaceutical compounding facilities?
Answer: USP
USP (Pharmaceutical Calculations in Prescription Compounding) and USP provide compounding documentation standards; however, key compounding record requirements are detailed under USP and frameworks.
A master formulation record (MFR) for a compounded preparation must include all of the following EXCEPT:
Answer: The patient's medical diagnosis
An MFR documents formulation details for reproducibility and quality control but does not include patient-specific medical diagnoses, which belong in clinical records.
When a pharmacist conducts a biennial controlled substance inventory, the inventory must be:
Answer: Conducted within two years of the previous inventory and kept for at least two years
DEA regulations (21 CFR 1304.11) require a biennial inventory within two years of the prior inventory, and the record must be retained for at least two years.
A pharmacy's SOP (Standard Operating Procedure) document should be reviewed and updated at minimum:
Answer: At least annually or whenever a process change occurs
SOPs must be reviewed at least annually and revised when processes change to ensure they reflect current practice and remain compliant with regulations.
In a hospital pharmacy, which documentation is used to verify that a pharmacist performed a double check before dispensing a high-alert medication?
Answer: Independent double-check verification record or electronic medication administration record (eMAR) annotation
A formal independent double-check requires a written or electronic record attributing the verification to each checking individual to meet accreditation and safety standards.
When documenting adverse drug events (ADEs) in a pharmacy setting, which reporting system is used to submit reports to the FDA?
Answer: MedWatch (FDA Safety Reporting Portal)
MedWatch is the FDA's voluntary adverse event reporting program for drugs, biologics, and medical devices, used by healthcare professionals and patients.
A pharmacy destroys expired non-controlled medications. What documentation is required?
Answer: A destruction log specifying drug name, lot number, quantity, destruction method, date, and signatures of witnesses
Even for non-controlled substances, pharmacies should maintain a destruction log for liability, environmental compliance, and audit purposes, though DEA Form 41 specifically applies to controlled substances.