CSP Fulfillment and Dispensing 2 — Questions and Answers
Question 1: A refrigerated biologic must be stored at which temperature range per USP labeling conventions?
- 2-8°C (36-46°F) (Correct answer)
- 8-15°C (46-59°F)
- -25 to -10°C (-13 to 14°F)
- 20-25°C (68-77°F)
Correct answer: 2-8°C (36-46°F)
USP defines 'refrigerator' storage as 2-8°C (36-46°F).
Question 2: A patient reports that a cold-chain package arrived with an indicator showing a temperature excursion. What should the pharmacy do first?
- Tell the patient to use the drug if it looks normal
- Instruct the patient not to use it, quarantine it, and check stability data with the manufacturer (Correct answer)
- Tell the patient to put it in the freezer right away
- Ask the patient to return it by regular mail for a refund
Correct answer: Instruct the patient not to use it, quarantine it, and check stability data with the manufacturer
Excursions require quarantine and a stability check with the manufacturer before anyone decides whether the product can be used.
Question 3: Under the Drug Supply Chain Security Act (DSCSA), what must dispensers be able to do with prescription drug packages?
- Re-label them with pharmacy NDCs
- Verify product identifiers and exchange transaction data electronically (Correct answer)
- Ship only via U.S. Postal Service
- Keep products for 10 years after dispensing
Correct answer: Verify product identifiers and exchange transaction data electronically
DSCSA requires interoperable electronic tracing and verification of product identifiers across the supply chain.
Question 4: Why do manufacturers often use limited distribution networks for specialty drugs?
- To lower the drug's list price
- To control handling and data reporting, and to support REMS or complex patient support (Correct answer)
- To avoid FDA approval requirements
- To let any retail pharmacy dispense the drug
Correct answer: To control handling and data reporting, and to support REMS or complex patient support
Limited distribution lets manufacturers make sure handling, patient support, and data reporting are done properly.
Question 5: What is the main purpose of a refill reminder call ahead of a specialty shipment?
- Upselling extra products
- Confirming the patient still needs therapy and checking adherence, side effects, and delivery details (Correct answer)
- Sending the dispensing fee invoice
- Replacing the pharmacist's clinical assessment
Correct answer: Confirming the patient still needs therapy and checking adherence, side effects, and delivery details
Refill calls check ongoing need, adherence, side effects, and delivery details before the pharmacy ships.
Question 6: Which standard governs the handling of hazardous drugs, such as many oral oncolytics, in pharmacies?
- USP <795>
- USP <797>
- USP <800> (Correct answer)
- USP <71>
Correct answer: USP <800>
USP <800> sets the handling requirements for hazardous drugs to protect workers and the environment.
Question 7: When a specialty pharmacy counts oral chemotherapy tablets, which practice is recommended?
- Use the same counting tray as for all other drugs
- Use a dedicated counting tray that is cleaned after each use, and wear gloves (Correct answer)
- Crush the tablets before counting
- Count with bare hands for accuracy
Correct answer: Use a dedicated counting tray that is cleaned after each use, and wear gloves
Hazardous oral drugs should be counted on dedicated equipment with protective gloves to avoid cross-contamination.