01-26-2011 05:11 PM
USP 797 specifies the BUD for CSPs that are compounded under low-med-high risk conditions, but nothing about when repackaging a drug from a vial into single unit dose such syringes. So what would the BUD be when repackaging straight drug into single unit dose syringes that have the same concentration from single dose vials and multiple dose vials?
03-14-2011 05:34 PM
Any aseptic handling of single-dose vials (SDVs) or multiple dose vials (MDVs) should be considered anticipatory compounding. If you are pulling multiple doses from a single-dose vials, I would consider that final dosage form (prefilled syringe) to be a medium-risk level CSP-multiple sticks into a single container. If you are pulling from a multiple-dose vial, I would consider it low-risk level compounding since you are not diluting the preservative. Since it is being put into a new container that has not been tested, giving it 14 day refrigerated BUD seems reasonable. It is critical to use good aseptic technique at all times when performing this type of compounding.
Repackaging is a term that has significant meaning for the FDA. If you are hospital, chances are better than not that you won't have issues with the FDA visiting you but if your pharmacy is not a hospital, the FDA could take great exception and hold you accountable to the requirements of repackaging (e.g. complying with appliable manufacturing regulations). The FDA is currently taking action against non-hospital pharmacies drawing doses up from SDVs and MDVs. Hope this helps.
05-11-2011 12:07 PM
In the example of multiple doses being drawn from a SDV, would the appropriate BUD be 30 hours (at room temp) or 9 days (if refrigerated) or 45 days in a frozen state (-25 to -10 degrees)? Would that same time frame apply to a chemotherapy drug if it was drawn up from a SDV into a syringe without any reconstitution or dilution?
06-15-2011 11:59 AM
If you are drawing up doses directly from a MDV in an uncontrolled setting, I am assuming that the contents of the syringe will be injected immediately. The key when accessing any type of vial is robust aseptic technique. I am attaching the APIC position paper on Safe injection safety for your consideration.
06-21-2011 04:51 PM
What would be the recommendations for a SDV of immunoglobulin? Here is the scenario we are considering. We would use a separate, dedicated counter top (in a separate room from the patients). The counter is frequently cleaned with alcohol and draped as area dedicated for withdrawals from a sterile vial of medication for IM injection. Hands are washed and hand disinfectants utiilzed. Then the vial is swabbed appropriately and entered the first time with a new sterile needle and syringe. That dose is administered immediately thereafter. Minutes later, the next paitent is seen in the other room Again, hands are washed etc. A new sterile needle/syringe would be used to withdraw the remaining solution from the vial and would be given to the second patient. The maximum withdrawals from a single vial would be two. The BUD would be 1 hour for that orignal vial from the first entry time and any doses withdrawn would be given within that time (immediately).
Would this constitute a sound practice? Ideally, we would disgard the vial after one entry and waste the remainder but reimbursement would not even cover the costs of the medication in many cases.
06-22-2011 01:24 PM - edited 06-22-2011 01:26 PM
Hi brm, I believe Darryl Rich of the Joint Commission addressed this in the Safe Injection Webinar thread on this forum:
"SDV's may NEVER be used for multiple patients. This is a significant patient safety issue, and cost is irrelevant. You will be cited for this practice."
"The pharmacy can break down a single dose vial into multiple smaller vials or syringes in a hood "
07-14-2011 09:47 AM
A single dose vial once penetrated has a BUD of 6 hours so----how can, (assuming all low risk preparation parameters are met ) one prepare a CSP with a single dose vial that contains no preservatives (hence single dose) and per the chapter how can this prepared CSP now suddenly have a a limit of 48 hours room temperature or 14 days at a cold temperature?
07-15-2011 11:15 AM
Thanks for your question. For clarification, USP <797> 2008 revision extended the use of a single dose vial (SDV) from immediate discard per USP General Notices and USP <51>, the regulatory standards that FDA must comply with, to a 6 hour extended beyond use dating in an ISO 5 environment. Single-dose containers (vials, etc) are intended for a single puncture. The USP committee received a lot of flack from the FDA over the extension of the vial BUD. We were trying to be sensitive to the waste/cost issues associated with SDVs. Assuming you are working in an ISO Class 5 environment and using aseptic technique and following all of the provisions of the chapter, you have been given the benefit of the doubt that you can maintain the steriltiy of that single-dose vial, hence it will be sterile for up to 6 hours. Technically speaking, using a single-dose more than 3 times within the 6 hours should make all subsequent CSPs masde with that vial medium-risk level with a shorter BUD.
Since the 2004, the risk levels have remained consistent. The issue at hand is that a low-risk level CSP is made using techniques and components that are inherently at low-risk of microbial contamination. The greater the number of aseptic breaches into containers, vials, and bags, the greater the risk of microbial contamination. Media fill studies have demonstrated this fact. Once you prepare a 1gm dose of cefazolin from a 1gm vial, you have a finished dosage form in a closed system that will not be aseptically manipulated until it is spiked for administration, hence the BUD at various storage temperatures.