CSP CSP - Certified Specialty Pharmacist Specialty Pharmacy Operations and Workflow Questions and Answers 2 — Questions and Answers
Question 1: Under URAC specialty pharmacy accreditation standards, how frequently must a pharmacist-conducted clinical review occur for patients on complex specialty therapies?
- Every 90 days
- At every refill
- Per URAC standards, at least annually with more frequent review based on clinical need (Correct answer)
- Only at initiation of therapy
Correct answer: Per URAC standards, at least annually with more frequent review based on clinical need
URAC requires at minimum an annual clinical pharmacist review, but standards call for more frequent review when patient complexity, adverse effects, or adherence issues warrant it.
Question 2: A specialty pharmacy dispenses a 30-day supply of a high-cost injectable biologic and the patient calls three days later saying it was damaged in transit. What is the BEST course of action?
- Advise the patient to use the damaged product and report the issue later
- Immediately replace the shipment, file a carrier claim, and document the incident (Correct answer)
- Ask the patient to return the product before replacement is considered
- Inform the patient that replacement is the prescriber's responsibility
Correct answer: Immediately replace the shipment, file a carrier claim, and document the incident
Specialty pharmacies must ensure patients have uninterrupted therapy; replacing damaged product immediately, filing a carrier claim, and documenting the incident addresses patient safety, financial recovery, and quality reporting.
Question 3: Which of the following best describes 'white bagging' in specialty pharmacy?
- Dispensing a specialty drug to the patient who self-administers at home
- Shipping a specialty drug directly to the physician office or infusion center for administration (Correct answer)
- Providing drug samples to patients through a specialty pharmacy
- Repackaging bulk specialty drugs into unit-dose containers
Correct answer: Shipping a specialty drug directly to the physician office or infusion center for administration
White bagging refers to specialty pharmacies dispensing medications directly to the provider (physician office or infusion center) rather than to the patient, who then receives administration at the provider site.
Question 4: A CSP is reviewing adherence data and finds that 30% of patients on an oral specialty oncology agent have not refilled within 7 days of their expected refill date. Which intervention is MOST appropriate?
- Automatically dispense the next refill without patient contact
- Implement a proactive outreach program with pharmacist-led adherence counseling (Correct answer)
- Discontinue the patients from the program and notify the prescriber
- Reduce the days supply dispensed to force more frequent contact
Correct answer: Implement a proactive outreach program with pharmacist-led adherence counseling
Proactive outreach with pharmacist-led adherence counseling addresses barriers to refill, such as side effects, cost, or misunderstanding of the regimen, to improve outcomes and adherence rates.
Question 5: Which federal law governs the licensure requirement for a specialty pharmacy dispensing across state lines?
- The Drug Quality and Security Act (DQSA)
- Each state's individual pharmacy practice act requiring non-resident licensure (Correct answer)
- The Omnibus Budget Reconciliation Act (OBRA) of 1990
- The Food, Drug, and Cosmetic Act (FD&C Act)
Correct answer: Each state's individual pharmacy practice act requiring non-resident licensure
Specialty pharmacies shipping medications to patients in other states must obtain non-resident pharmacy licensure in each destination state, as pharmacy practice is regulated at the state level.
Question 6: What is the main advantage of a centralized clinical call center model within a large specialty pharmacy organization?
- It eliminates the need for pharmacist oversight of dispensing
- It provides consistent, standardized patient counseling and clinical monitoring at scale (Correct answer)
- It allows non-pharmacist staff to make clinical decisions independently
- It removes the requirement for REMS certification
Correct answer: It provides consistent, standardized patient counseling and clinical monitoring at scale
A centralized clinical call center enables specialty pharmacies to deliver standardized, high-quality pharmacist counseling and monitoring to large patient populations while maintaining compliance with accreditation standards.
CSP CSP - Certified Specialty Pharmacist Specialty Pharmacy Operations and Workflow Questions and Answers 2
Under URAC specialty pharmacy accreditation standards, how frequently must a pharmacist-conducted clinical review occur for patients on complex specialty therapies?