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* 1. Confidentiality Statement

The purpose of this survey is to understand hazardous drug compounding practices, identify challenges and opportunities in hazardous drug compounding, and identify potential opportunities for 503B outsourcing facilities. Information collected from this survey is confidential and will not be shared with entities outside of Eagle.

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* 2. Participant Information

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* 3. Survey Date

Date

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* 4. Facility Type

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* 5. Select the level of readiness for USP 800 of your facility.

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* 6. Briefly describe the remaining activities for USP 800 readiness specific to your facility.

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* 7. Would you/your facility be interested in a USP 800 consult, specifically to assess and review hazardous drug (HD) cleanroom design, HVAC, and engineering controls?

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* 8. Briefly describe the biggest challenge(s) in preparing HDs at your facility, i.e., facility limitations, training and qualification of personnel, HD storage and transfer, development, and implementation of standard operating procedures, short beyond-use dates, etc.

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* 9. Briefly describe engineering controls where HD compounding occurs, i.e., negative pressure, segregated compounding area (SCA), BSC, isolator, etc.

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* 10. Select the type of hazardous drugs compounded by your facility.

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* 11. Does your facility compound HDs for oncology patients?

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* 12. Approximately how many chemotherapy doses, on average, are prepared per day?

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* 13. Approximately how many patients, on average, are treated per day?

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* 14. How far in advance is an order received and how far in advance is an order prepared?

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* 15. List the most commonly prescribed/dispensed HDs at your facility.

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* 16. Are any HDs associated with more waste ($$ or volume) than others?  If so, please list and include the approximate dollar amount or volume of waste.

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* 17. Does your facility practice dose rounding, i.e., to the nearest vial, typically ± 10% of the calculated dose?

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* 18. Is there any standardization across HD dosing, i.e., one fixed-dose per drug? If so, please list drugs associated with standard dosing.

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* 19. Are any HDs compounded prior to receiving order? If so, please list drugs for which anticipatory compounding is practiced, i.e., high volume/predictable drugs, and how far in advance does anticipatory compounding occur, i.e., 1 hour, 1 day, 1 week, etc.

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* 20. Are any HDs batched, i.e., compounded all at once for multiple patients rather than per order, i.e., same drug with different dosing or same drug with same dosing? If so, please list the drugs that are batched.

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* 21. If HDs are batched, are there any drugs that are associated with high waste costs ($$ or volume) due to patient cancellations? If so, please list drugs and their approximate impact on cost.

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* 22. Are multiple doses (different volumes of a single concentration) pulled from one source container, i.e., bulk pharmacy package vial or bag, to obtain different doses? If so, please list drugs, concentration, type of source container, and source container volume.

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* 23. Are there any HDs that are associated with difficulty compounding, i.e., low solubility, increased reconstitution time, ampules requiring filtration, require special storage conditions after compounding, increased vial pressurization, safety concerns, etc.? If so, please list drugs and challenges in compounding.

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* 24. How long are compounded doses kept before discarding?

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* 25. Are there any compounded HDs with a higher potential for dose errors? If so, list the drugs and reason for potential error, i.e., near misses, etc.

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* 26. An Outsourcing Facility, also known as a 503B facility, is an entity that distributes sterile and nonsterile compounded drug products directly to hospitals, clinics, physician offices, and pharmacies not pursuant to a patient-specific order or prescription.  Outsourcing facilities are FDA-registered and regulated and compounded drug products are produced in accordance with Current Good Manufacturing Practices (CGMP). 
Does your facility currently purchase any compounded drugs from a registered outsourcing facility? If so, please list drugs.

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* 27. If there was a 503B outsourcing facility that could provide compounded HDs to your facility, which drugs would they be and why? Please describe the drug, strength/dose, route of administration (i.e., IV push, continuous infusion, etc.) packaging configuration (i.e., pre-filled syringe, ready-to-use IV bag, etc.), and the specific challenge, if applicable.

Reasons may include but are not limited to any of the following:  Waste (reduction/destruction), Safety (medication errors/personnel), Efficiency (labor constraints/difficulty compounding/ease of dispensing), Facility (USP 800 constraints), Cost (ancillary supplies), Expiration dating (longer BUD), Shortage (drug/diluent), other.

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* 28. Does your facility require all purchasing to go through a Group Purchasing Organization (GPO) when available?

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* 29. Please describe any other concerns specific to hazardous drug compounding not covered in the scope of this survey.

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