Pharmacy Quality Assurance Flashcards
7 cards from real PTCE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Pharmacy Quality Assurance flashcards as text
Which federal law requires pharmacies to have systems in place to prevent dispensing of counterfeit or adulterated drugs?
Answer: The Drug Supply Chain Security Act (DSCSA)
The DSCSA establishes electronic tracing requirements for prescription drugs to protect the supply chain from counterfeit, stolen, or adulterated products.
A root cause analysis (RCA) is most appropriately triggered by:
Answer: A sentinel event or serious medication error
RCA is a structured investigation method reserved for serious events (sentinel events, significant errors) to identify underlying system failures.
What does the term 'lot number' refer to on a pharmaceutical product?
Answer: A unique identifier linking units to the same manufacturing batch
A lot number (batch number) uniquely identifies all units produced in a single manufacturing run, enabling targeted recalls and traceability.
Which practice helps prevent medication errors related to look-alike/sound-alike (LASA) drugs?
Answer: Using tall-man lettering and physical separation of LASA drugs
Tall-man lettering (e.g., hydrALAzine vs. hydrOXYzine) and physical separation are proven strategies to reduce LASA medication errors.
Which action should be taken when a medication refrigerator temperature log shows a temperature excursion overnight?
Answer: Quarantine the affected medications and consult the pharmacist or manufacturer
Temperature excursions require quarantine of affected products and evaluation by the pharmacist or manufacturer to determine if stability is compromised.
A pharmacy's policy requires double-checking high-alert medications before dispensing. This type of independent double-check is classified as which QA strategy?
Answer: Human redundancy verification
An independent double-check by a second trained individual is a human redundancy strategy specifically used for high-alert medications to catch errors.
Which document serves as the legal and quality record of all ingredients, quantities, and steps used to prepare a specific compounded preparation?
Answer: The master formulation record and compounding log
The master formulation record (formula) and batch/compounding log together document every aspect of preparation and serve as the official QA and legal record.