Hello All
We are assessing our utilization of Multi-Dose Vials for chemotherapy IV compounding in a USP800 fully-compliant hazardous IV cleanroom. We would like to better understand specific practices around the use of MDVs if using the same vial on more than one patient. What has been your risk assessment.
Questions:
(1) Do you use MDVs for chemotherapy compounding?
(2) If yes, do you treat the MDV as a (A)single-dose, single patient vial and waste any remaining product or (B) do you use the MDV on more than one patient, or (C) Use MDV for more than one dose, but only for one patient?
(3) If using MDVs for chemo on more than one patient, what beyond use date do you assign to these vials? (A)Use manufacturer stability for BUD, (B)Internal review of USP, manufacturer, sterility, and stability information by stakeholders and a standardized date assignment based on cleanroom performance and risk assessment, (C) Other (6 hours, 24 hours, 72 hours,..)?
(4) Where do you keep/store MDVs when not in use? (A)leave in hood until used, (B)Remove from hood and place in lidded container inside hazardous IV room, (C) we treat as single use and waste any remaining drug, (D) Other
Thanks so much for your responses.