CSP CSP - Certified Specialty Pharmacist Specialty Pharmacy Operations and Workflow Questions and Answers 1 — Questions and Answers
Question 1: Which accreditation body specifically developed standards for specialty pharmacy practice in the United States?
- URAC (Correct answer)
- The Joint Commission
- ACHC
- PCAB
Correct answer: URAC
URAC was the first accreditation body to develop specialty pharmacy-specific standards and remains a leading accreditor in the specialty pharmacy space.
Question 2: A specialty pharmacy receives a prior authorization (PA) denial for a biologic agent. What is the most appropriate FIRST step?
- Dispense the medication and bill later
- Initiate a peer-to-peer review request with the prescriber's office (Correct answer)
- Switch to a formulary alternative without consulting the prescriber
- Submit a grievance to the state insurance commissioner
Correct answer: Initiate a peer-to-peer review request with the prescriber's office
A peer-to-peer review allows the prescriber to discuss the clinical necessity directly with the payer's medical reviewer, which is typically the most effective first step in overturning a PA denial.
Question 3: What does the term 'hub services' refer to in specialty pharmacy?
- A centralized distribution warehouse for specialty drugs
- Manufacturer-sponsored programs providing patient support, benefits investigation, and PA assistance (Correct answer)
- A pharmacy software platform for managing high-cost medications
- REMS coordination centers operated by the FDA
Correct answer: Manufacturer-sponsored programs providing patient support, benefits investigation, and PA assistance
Hub services are manufacturer-sponsored patient support programs that assist with benefits verification, prior authorization, copay assistance, and patient education for specific specialty products.
Question 4: Which metric is most commonly used to evaluate specialty pharmacy dispensing efficiency and patient safety?
- Days on hand (DOH)
- Dispense as written (DAW) rate
- Medication error rate per 1,000 prescriptions (Correct answer)
- Net promoter score (NPS)
Correct answer: Medication error rate per 1,000 prescriptions
Medication error rate per 1,000 prescriptions is a key safety metric that specialty pharmacies track to identify process breakdowns and prioritize quality improvement efforts.
Question 5: A specialty pharmacy's limited distribution drug (LDD) contract requires it to report dispensing data to the manufacturer monthly. This is BEST described as a requirement of which program type?
- REMS program
- 340B program
- Limited Distribution Network (LDN) agreement (Correct answer)
- Medicaid rebate agreement
Correct answer: Limited Distribution Network (LDN) agreement
Limited Distribution Network agreements between manufacturers and select specialty pharmacies typically include data reporting obligations as a condition of participation.
Question 6: What is the primary purpose of a cold chain audit in specialty pharmacy operations?
- To verify patient insurance eligibility
- To ensure temperature-sensitive medications were maintained within required ranges during shipping (Correct answer)
- To confirm that pharmacists are licensed in the patient's state
- To validate that copay assistance was correctly applied
Correct answer: To ensure temperature-sensitive medications were maintained within required ranges during shipping
Cold chain audits verify that temperature-sensitive biologics and other specialty products remained within required temperature ranges from manufacturer to patient, protecting drug integrity and patient safety.
