BCPS Medication Safety & Regulatory Compliance 5 — Questions and Answers
Question 1: A pharmacy receives a recall notice for a lot of heparin vials due to contamination. Under FDA Class I recall criteria, this means:
- There is reasonable probability that use of the product will cause serious adverse health consequences or death (Correct answer)
- The product may cause temporary or reversible adverse consequences
- The product is unlikely to cause adverse health consequences
- The recall is voluntary with no regulatory obligation to notify patients
Correct answer: There is reasonable probability that use of the product will cause serious adverse health consequences or death
FDA Class I recalls involve the most serious situation — reasonable probability of serious health consequences or death — requiring immediate action.
Question 2: A prescriber orders vancomycin 'per pharmacy protocol' for a patient with MRSA bacteremia. Which pharmacist activity BEST demonstrates medication safety within this pharmacist-managed protocol?
- Individualizing vancomycin dosing using AUC/MIC-guided monitoring and adjusting based on renal function and serum levels (Correct answer)
- Dispensing a standard dose of vancomycin 1g IV q12h without serum level monitoring
- Using weight-based dosing only and rechecking in 48 hours
- Contacting the prescriber to clarify the order before any action
Correct answer: Individualizing vancomycin dosing using AUC/MIC-guided monitoring and adjusting based on renal function and serum levels
Current ASHP/IDSA/SIDP guidelines recommend AUC/MIC-guided vancomycin monitoring to optimize efficacy and minimize nephrotoxicity.
Question 3: Which practice is recommended by ASHP and ISMP to reduce wrong-patient errors during the dispensing process in a hospital pharmacy?
- Barcode medication administration (BCMA) and positive patient identification at point of care (Correct answer)
- Verbal confirmation of patient name by the nurse prior to dispensing
- Color-coded labels based on patient room number
- Restricting dispensing to one pharmacist per shift
Correct answer: Barcode medication administration (BCMA) and positive patient identification at point of care
BCMA with positive patient identification (scanning the patient's wristband) is the gold standard for preventing wrong-patient medication administration errors.
Question 4: Which type of medication error occurs when a correct drug is prescribed and dispensed but the patient receives it via the wrong route (e.g., oral methotrexate given intrathecally)?
- Route error (wrong route of administration) (Correct answer)
- Prescribing error
- Transcription error
- Monitoring error
Correct answer: Route error (wrong route of administration)
A wrong-route error occurs during administration when a medication is given by a route other than what was intended, which can be catastrophic (e.g., intrathecal vinca alkaloids).
Question 5: Under USP <800>, which personal protective equipment (PPE) is required at minimum when administering (not compounding) hazardous drugs with a known reproductive risk?
- Chemotherapy-rated gloves and a protective gown (Correct answer)
- N95 respirator only
- Standard nitrile gloves only
- No PPE is required for administration of oral hazardous drugs
Correct answer: Chemotherapy-rated gloves and a protective gown
USP <800> requires at minimum chemotherapy-rated gloves and a protective gown for administering hazardous drugs classified with reproductive risk; additional PPE may be required depending on dosage form.
Question 6: A pharmacist is reviewing a new order for clopidogrel in a patient who is a known CYP2C19 poor metabolizer. Which action is MOST appropriate?
- Recommend an alternative antiplatelet agent (e.g., ticagrelor or prasugrel) as clopidogrel requires CYP2C19 for activation (Correct answer)
- Increase the clopidogrel dose to 150 mg daily to compensate for reduced metabolism
- Dispense clopidogrel as ordered since poor metabolizers still achieve some antiplatelet effect
- Add omeprazole to protect against GI bleeding from clopidogrel
Correct answer: Recommend an alternative antiplatelet agent (e.g., ticagrelor or prasugrel) as clopidogrel requires CYP2C19 for activation
Clopidogrel is a prodrug requiring CYP2C19 activation; poor metabolizers have significantly reduced active metabolite levels and antiplatelet response, making alternative agents preferred.
Question 7: Which organization's sentinel event policy requires accredited hospitals to perform a root cause analysis (RCA) and action plan following a serious patient safety event?
- The Joint Commission (TJC) (Correct answer)
- Centers for Disease Control and Prevention (CDC)
- Agency for Healthcare Research and Quality (AHRQ)
- Institute for Healthcare Improvement (IHI)
Correct answer: The Joint Commission (TJC)
TJC's Sentinel Event Policy requires accredited organizations to conduct an RCA and submit an action plan within 45 days of a sentinel event.
BCPS Medication Safety & Regulatory Compliance 5
A pharmacy receives a recall notice for a lot of heparin vials due to contamination.
Under FDA Class I recall criteria, this means: