11-07-2017 06:45 PM
Thanks for the email and your patience. I understand the challenges you and others are facing with these shortages. I don't like Buretrols since they are not a closed-system, in my opinion. A better solution for batching and storing solutions in alternative containers like you are proposing would be to prefill empty IV bags. I am sure there will a shortage of these products or maybe not but you have a closed-system with bags. If you need to do this, I would simulate this process using tryptic soy broth (don't use QI Medical broth since it doesn't consistently support microbial growth--my opinion and personal experience) and fill 10 devices and let these buretrols sit in the pharmacy for 14 days to see if you get any growth. Use media from Hardy Diagnostics or someone else. If you have no growth, then you have objective data to support the decision to follow ASHP and University of Utah's advice. Hope this helps.
11-08-2017 07:18 PM
You are welcome. I want to be clear that the media fill procedure I described is NOT a sterility test. It will test the technique of your staff and the closure integrity of the Burotrels to make sure these containers can be filled aseptically and they are closed and won't allow ambient air/contamination to get into the device.
11-30-2017 03:10 PM
So once a product is compounded or repackaged and the appropriate BUD is assigned (for sake of arguement, let's say I freeze my product and pull as needed), when I remove the drug from the freezer, do I assign a new BUD for refrigeration or room temperature in agreement with that information published in USP 797 or does the new BUD become 12 or 24 hours or immediate use?
Thank you in advance for your thoughts.
Leza Hassett, RPh, MBA
12-04-2017 01:38 PM
I had this same question as was previously posted regarding the use of a dispensing pin with a SDV. I might have missed it, but I did not see an answer.
"Would using a single-dose vial (with a dispensing pin) and drawing up into multiple syringes (3 or more) still be a medium risk? Some feel that since there is only one entry into the original vial due to dispensing pin it should be a low risk, not a medium risk. Thanks in advance for this clarification."
12-05-2017 10:21 AM
In my opinion, attaching three syringes to a dispensing pin is just as complex of an operation as entering a vial three times with a traditional needle. Also, a general principle is that the greater the surface area, the greater the contamination risk. A dispensing pin is larger diameter than a traditional needle, and the screw attachment to the syringe is much larger than the point of contact between the vial septum and a traditional needle. So, I do not think that use of a dispensing pin makes for a less invasive or less complex manipulation resulting in a lower risk CSP.
12-06-2017 08:37 AM
I do not see information to assist with the preceeding question and perhaps that is because there is not one...
If a pharmacy prepared sterile compounded product is remved from the freezer and placed into the refrigerator, what BUD gets assigned? Is it 24 hours, does it follow the refrigeration guidelines in USP 797 for the risk level...?