CCP Administrative and Facility Responsibilities 3 — Questions and Answers
Question 1: Which USP chapter governs quality standards for pharmaceutical compounding of sterile preparations, including beyond-use dating and environmental monitoring?
- USP <795>
- USP <797> (Correct answer)
- USP <800>
- USP <1075>
Correct answer: USP <797>
USP <797> is the standard chapter that establishes microbial contamination risk levels, BUD guidelines, and environmental monitoring requirements for sterile compounding.
Question 2: A consultant pharmacist reviews a facility policy requiring PRN (as-needed) medications to be reassessed for continued appropriateness. What is the MOST appropriate reassessment interval in long-term care?
- Every 48 hours
- Every 7 days
- Every 30 days or at each drug regimen review (Correct answer)
- Every 6 months
Correct answer: Every 30 days or at each drug regimen review
PRN medications should be evaluated at least monthly during the drug regimen review to assess continued clinical indication and patient response.
Question 3: Which of the following is TRUE regarding controlled substance disposal in long-term care facilities under DEA regulations?
- Facilities may flush controlled substances down the drain if witnessed by two nurses
- Non-registrant facilities must transfer waste controlled substances to a DEA-registered reverse distributor or authorized collector (Correct answer)
- Controlled substances may be discarded in regular trash if mixed with cat litter
- The state board of pharmacy must witness all controlled substance destructions
Correct answer: Non-registrant facilities must transfer waste controlled substances to a DEA-registered reverse distributor or authorized collector
DEA regulations require that long-term care facilities transfer unwanted controlled substances to a DEA-registered reverse distributor or authorized take-back collector for proper disposal.
Question 4: The 'three-check' system in medication administration refers to verifying the right medication at which three points?
- Before ordering, during dispensing, and at bedside administration
- When removing from storage, before preparation, and before administration (Correct answer)
- At the prescriber's order, at the pharmacy, and at the nursing station
- At shift change, before meals, and at bedtime
Correct answer: When removing from storage, before preparation, and before administration
The three-check system requires nurses to verify the medication when removing it from storage, before preparing the dose, and immediately before administering it to the patient.
Question 5: A nursing facility is cited for having medications stored above 77°F (25°C) in resident rooms. Which regulation does this MOST directly violate?
- HIPAA Privacy Rule
- CMS F-tag F756 (Pharmacy Services) (Correct answer)
- OSHA Bloodborne Pathogen Standard
- DEA Schedule II storage requirements
Correct answer: CMS F-tag F756 (Pharmacy Services)
CMS F-tag F756 requires pharmacy services to ensure medications are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security.
Question 6: What is the purpose of a Medication Therapy Management (MTM) program under Medicare Part D?
- To replace the monthly drug regimen review required under CMS
- To optimize therapeutic outcomes for targeted beneficiaries with multiple chronic conditions and multiple medications (Correct answer)
- To authorize consultant pharmacists to prescribe medications independently
- To reduce costs by substituting all brand-name drugs with generic alternatives
Correct answer: To optimize therapeutic outcomes for targeted beneficiaries with multiple chronic conditions and multiple medications
MTM programs are designed to improve therapeutic outcomes for high-risk Medicare Part D beneficiaries through pharmacist-delivered patient education and medication review.
Question 7: Under the federal Residents' Rights provisions of OBRA '87, a nursing home resident has the right to refuse medication. What should the consultant pharmacist advise facility staff to do?
- Administer the medication covertly in food or liquids
- Obtain a court order to administer the medication involuntarily
- Document the refusal, notify the physician, and explore alternative approaches (Correct answer)
- Discharge the resident for non-compliance
Correct answer: Document the refusal, notify the physician, and explore alternative approaches
Residents have the right to refuse treatment; staff must document refusals, notify the physician, and work collaboratively to understand and address the resident's concerns.
CCP Administrative and Facility Responsibilities 3
Which USP chapter governs quality standards for pharmaceutical compounding of sterile preparations, including beyond-use dating and environmental monitoring?