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According to FDA DSCSA guidance, what information is part of a drug-package product identifier?

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  1. According to FDA DSCSA guidance, what information is part of a drug-package product identifier?
    • A standardized numeric identifier, serial number, lot number, and expiration date
    • Tablet color and shape only
    • A patient’s diagnosis and allergies
    • The prescribing pharmacist’s name only
  2. What did the cited MedGuard study evaluate in outpatient medication decision support?
    • A guarantee that no prescription could be wrong
    • Alert acceptance, wrong-drug errors, and look-alike/sound-alike alerts
    • The color recognition accuracy of tablet photos
    • A model’s ability to set pharmacy law
  3. What medication-related issues can computer-triggered decision support flag at prescribing?
    • Whether a pharmacy is open
    • Whether a tablet photo is attractive
    • Potential drug-drug interactions, drug-allergy problems, and dosing issues
    • Whether a patient prefers a brand name
  4. What did the cited prescription-extraction study process?
    • Scanned receipts from retail stores
    • X-ray images of pill bottles
    • Barcode scans from a warehouse
    • Unstructured medication information in clinical discharge summaries
  5. What does ASHP safe-use guidance address for automated dispensing cabinets?
    • Policies, procedures, and quality-assurance processes for safe use
    • A rule that all clinical review is automated
    • A guarantee that every cabinet override is safe
    • A single rule for every jurisdiction
  6. What is one mechanism that can contribute to alert fatigue?
    • A unique warning that appears only once
    • Repeated or low-value alerts can reduce attention to later warnings
    • A barcode that correctly matches the drug package
    • A missing user interface
  7. What did the cited barcode eMAR study find about medication-administration errors?
    • Every medication error was eliminated
    • Barcode use replaced clinical checks
    • Barcode use reduced errors in the studied setting but did not eliminate them
    • A barcode confirmed the prescribed dose was clinically appropriate
  8. What is one purpose of a serialized product identifier under DSCSA?
    • Diagnose a drug allergy
    • Determine whether a dose fits a patient
    • Confirm a drug interaction is harmless
    • Support tracing a covered drug package through the supply chain