Occasionally, on an accreditation review, the AORN and ASA position of not using multiple dose vials in the operating room is commented on. At this junction, this is a recommendation — not a regulation.
The assumption/assertion is that use of multiple dose vials in a completely sterile manner is time consuming and prone to non-compliance. Some say that if you use a multiple dose vial, it should be treated as a single dose vial only.
There has been considerable pushback on the AORN position, especially during our nearly two year long experience with unprecedented drug shortages. Some drugs such as insulin and succinylcholine remain primarily as multiple dose vials. While hospital pharmacies with laminar and vertical flow hoods may be capable of preparing single doses from multiple dose vials, ASCs with hoods and sterile technique training are far and few between. Additionally, drugs used in an emergent manner or to titrate a patient would be administered in a more time consuming manner with significant loss of expediency. And what about high cost vaccines?
Common sense prevails: Single patient use vials such as propofol are to be handled appropriately. Any multiple dose vial that has been used in a sterile field, placed on a contaminated surface or used procedural tray or has been used in an emergent procedure should be discarded after use for such purpose.
WHAT NEXT?
The future may well hold for more stringent regulations on the use of multiple dose vials. Manufacturers may have to retool what they bring forth as products, and yet it is difficult to imagine a total prohibition of multiple dose vials, especially with the drug shortage experience we have had. Additionally, the FDA continues to approve multiple dose vials resulting in potential regulatory confusion. Draw out 2 mL of a 20 mL labetalol, which is difficult to find today, and throw out 18 mL? Could be a hard sell. Anesthesia providers should step to the microphone on this one.
Editor's Note: This article originally appeared in Pharm-ASC, a weekly e-mail publication by Sheldon S. Sones, RPh, FASCP, a Newington, Conn.-based consultant pharmacist and safe medication officer.
The assumption/assertion is that use of multiple dose vials in a completely sterile manner is time consuming and prone to non-compliance. Some say that if you use a multiple dose vial, it should be treated as a single dose vial only.
There has been considerable pushback on the AORN position, especially during our nearly two year long experience with unprecedented drug shortages. Some drugs such as insulin and succinylcholine remain primarily as multiple dose vials. While hospital pharmacies with laminar and vertical flow hoods may be capable of preparing single doses from multiple dose vials, ASCs with hoods and sterile technique training are far and few between. Additionally, drugs used in an emergent manner or to titrate a patient would be administered in a more time consuming manner with significant loss of expediency. And what about high cost vaccines?
Common sense prevails: Single patient use vials such as propofol are to be handled appropriately. Any multiple dose vial that has been used in a sterile field, placed on a contaminated surface or used procedural tray or has been used in an emergent procedure should be discarded after use for such purpose.
WHAT NEXT?
The future may well hold for more stringent regulations on the use of multiple dose vials. Manufacturers may have to retool what they bring forth as products, and yet it is difficult to imagine a total prohibition of multiple dose vials, especially with the drug shortage experience we have had. Additionally, the FDA continues to approve multiple dose vials resulting in potential regulatory confusion. Draw out 2 mL of a 20 mL labetalol, which is difficult to find today, and throw out 18 mL? Could be a hard sell. Anesthesia providers should step to the microphone on this one.
Editor's Note: This article originally appeared in Pharm-ASC, a weekly e-mail publication by Sheldon S. Sones, RPh, FASCP, a Newington, Conn.-based consultant pharmacist and safe medication officer.
