Fulfillment and Dispensing Flashcards

A refrigerated biologic must be stored at which temperature range per USP labeling conventions?

Answer: 2-8°C (36-46°F)

USP defines 'refrigerator' storage as 2-8°C (36-46°F).

A patient reports that a cold-chain package arrived with an indicator showing a temperature excursion. What should the pharmacy do first?

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.

Under the Drug Supply Chain Security Act (DSCSA), what must dispensers be able to do with prescription drug packages?

Answer: Verify product identifiers and exchange transaction data electronically

DSCSA requires interoperable electronic tracing and verification of product identifiers across the supply chain.

Why do manufacturers often use limited distribution networks for specialty drugs?

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.

What is the main purpose of a refill reminder call ahead of a specialty shipment?

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.

Which standard governs the handling of hazardous drugs, such as many oral oncolytics, in pharmacies?

Answer: USP

USP sets the handling requirements for hazardous drugs to protect workers and the environment.

When a specialty pharmacy counts oral chemotherapy tablets, which practice is recommended?

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.