BCPS Medication Safety & Regulatory Compliance 4 — Questions and Answers
Question 1: Under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard, which document must be accessible to pharmacy staff handling hazardous drugs and contains information on safe handling and spill cleanup?
- Safety Data Sheet (SDS) (Correct answer)
- Material Transfer Agreement (MTA)
- Drug Package Insert (PI)
- Certificate of Analysis (CoA)
Correct answer: Safety Data Sheet (SDS)
OSHA requires Safety Data Sheets (formerly MSDS) to be accessible for all hazardous chemicals including antineoplastic drugs, detailing PPE, spill response, and health hazards.
Question 2: A hospital pharmacist identifies that a prescriber has written methotrexate 'daily' for rheumatoid arthritis instead of 'weekly.' This is a classic prescribing error because methotrexate for RA is dosed:
- Once weekly (Correct answer)
- Once daily
- Twice weekly
- Once monthly
Correct answer: Once weekly
Methotrexate for RA and other non-oncologic indications is prescribed once weekly; daily dosing causes severe toxicity including myelosuppression and mucositis.
Question 3: Which USP chapter sets environmental monitoring and clean room classification standards for sterile compounding?
- USP <797> (Correct answer)
- USP <795>
- USP <800>
- USP <1116>
Correct answer: USP <797>
USP <797> governs sterile compounding including ISO classification of cleanrooms, air quality monitoring, and garbing requirements.
Question 4: A pharmacist notices that the automated dispensing cabinet (ADC) override feature is being used frequently to access medications before pharmacist verification. What is the PRIMARY concern with this practice?
- Medications may be administered without pharmacist review for appropriateness, interactions, or dosing errors (Correct answer)
- ADC overrides increase pharmacy workload unnecessarily
- Override use violates DEA scheduling regulations for all medications
- Nurses may administer medications from incorrect pockets in the ADC
Correct answer: Medications may be administered without pharmacist review for appropriateness, interactions, or dosing errors
ADC overrides bypass pharmacist order verification, removing the critical safety check for dose, indication, interactions, and allergies before patient administration.
Question 5: Which federal law requires community pharmacies to offer counseling to Medicaid patients on new prescriptions and mandates prospective drug utilization review (Pro-DUR)?
- Omnibus Budget Reconciliation Act (OBRA) of 1990 (Correct answer)
- Health Insurance Portability and Accountability Act (HIPAA) of 1996
- Drug Enforcement Administration registration requirements
- Poison Prevention Packaging Act (PPPA) of 1970
Correct answer: Omnibus Budget Reconciliation Act (OBRA) of 1990
OBRA '90 mandates prospective DUR and pharmacist counseling offers for new and refill prescriptions dispensed to Medicaid beneficiaries.
Question 6: A 6-year-old child is prescribed amoxicillin 500 mg three times daily for otitis media. The weight-based dosing recommendation is 80-90 mg/kg/day, and the child weighs 18 kg. What is the MOST appropriate assessment?
- The dose is too high; maximum dose per administration should not exceed approximately 500 mg, but total daily dose of 1500 mg exceeds 80-90 mg/kg/day for 18 kg (Correct answer)
- The dose is appropriate for this age and weight
- The dose is too low; pediatric otitis media requires higher dosing
- The route should be changed to IV for this dose
Correct answer: The dose is too high; maximum dose per administration should not exceed approximately 500 mg, but total daily dose of 1500 mg exceeds 80-90 mg/kg/day for 18 kg
For an 18 kg child at 80-90 mg/kg/day, the appropriate total daily dose is 1440-1620 mg; 1500 mg/day (500 mg TID) falls within range, but individual doses should be recalculated — this is borderline appropriate and warrants verification.
Question 7: Which Joint Commission National Patient Safety Goal (NPSG) specifically addresses the need to reconcile medications across care transitions?
- NPSG 03.06.01 — Maintain and communicate accurate patient medication information (Correct answer)
- NPSG 01.01.01 — Use at least two patient identifiers
- NPSG 06.01.01 — Improve safety of clinical alarm systems
- NPSG 15.01.01 — Identify patients at risk for suicide
Correct answer: NPSG 03.06.01 — Maintain and communicate accurate patient medication information
NPSG 03.06.01 requires organizations to maintain an accurate medication list and reconcile it at transitions of care to prevent errors of omission, duplication, or incorrect dosing.
BCPS Medication Safety & Regulatory Compliance 4
Under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard, which document must be accessible to pharmacy staff handling hazardous drugs and contains information on safe handling and spill cleanup?