07-28-2010 01:34 PM
We have recently asked the physicians (anesthesiologist) to draw up and dilute the ephedrine in surgery on a as needed basis (under the Immediate Use - 1hr BUD). Some of them think this dilution does not fall under <USP> because they are not "preparing according to manufacturer's labeled instructions" therefore do not have to waste it at the end of 1 hour if not used. What is the correct response for them? What is the standard at other facilities?
07-28-2010 02:25 PM
I find it incredulous that because they are "not preparing according to manufacturer's labeled instructions" that somehow beyond use dating somehow does not apply. The purpose of beyond use dating is to ensure the sterility of the product without having to do to sterility testing. A single dose vial drawn up in other than a clean-room in a laminar floor hood would be by definition only for immediate use, and I do not think that whereever the anesthesiologists are drawing this up is going to be better in terms of cleanliness than an IV room.
Beyond use dating would apply only if prepared according to the manufacturer's instructions because that is the dating that the product has been rated for. The vial has not been rated to be prepared in any other way to ensure that the product will still remain sterile. In other words, the beyond use dating of a non-standard prepared vial should be shorter than the <USP> guidelines (not longer) because we have no idea how that non-standard preparation method will affect sterility. I personally do not think a drawing a syringe of ephedrine with my teeth and injecting it into a coke bottle would get to be used beyond one hour, and is certainly not in accordance with the manufacturer's labeled instructions.
08-03-2010 02:52 PM
I am not sure how practical it would be to continually waste and replenish your stock of narcotics and reversal agents during a surgery that lasts longer than one hour. I wish there was more interest in doing some studies to determine whether these widely practiced methods of preparing the medicinal "tools" needed during surgery are really a threat to the patient.
The one hour limit seems a bit arbitrary, unless you have know decompostion problem with the drug after dilution or removal from the manufacturer's packaging.
08-23-2010 12:03 PM
The one-hour limit for CSPs prepared under the immediate-use provisions does not apply to the infusion but all of the activities prior to start of the infusion. Once the preparation is connected to the patient, USP 797 is no longer applicable. The main issue involves the employee practices re: compounding and their understanding of proper hand hygiene and aseptic technique. The overaching focus of the one-hour provision was the sterility of CSPs being prepared in less than ideal environments vs. chemical stability. This is a factor that we have not historically considered. The one-hour limit was the initial timeframe assigned to these formulations because during the revision process, the USP Sterile Compounding Committee received suggested time limits of 30 seconds to 24 hours. We have gotten into some very bad habits re: medication preparation and administration. It is the focus of APIC, CDC and TJC. If you review the attached APIC position paper, you will get additional background on this matter that needs to be considered.