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Occasional Advisor
Posts: 27
Registered: ‎09-21-2015
0

Shortage Item - BUD?

Since all IV products seem to go on shortage/back order, we are discussing how to deal with this situation.

 

For example, THAM was currently on shortage and we have a patients that need it. We are trying to extend our supply. The product comes in 500mL (single dose; i believe it contains no preservatives) and so we were hoping to aliquot 30mLs out of the 500mL bottle. What BUD would be considered? We're thinking it's medium risk and so 9 day BUD refrigerated would be ok. Thoughts?

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: Shortage Item - BUD?

LTN,

 

You can aliquot the THAM out of the vial and into syringes or vials and assign a 9-day refrigerated BUD. You need to treat each unit-dosed container as a single-dose.   In 2012, both CDC and CMS recognized this practice and published guidance documents to that affect.  You can find those documents in another thread within these forums.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 12
Registered: ‎09-25-2017
0

IV Shortages and Conservation Strategies

We, (along with the rest of the country) are looking at ways to conserve IV fluids and how to be pro-active with the impending lack of available IVPBs.  I read ASHP's "Small-Volume Parenteral Solutions Shortages Suggestions for Management and Conservation (Compiled by ASHP and the University of Utah Drug Information Service, October 18, 2017)"

 

I would like to know if we use 1 L bags of commercially available 5% Dextrose in water or 0.9% Sodium Chloride and repackage into burretrols using a repeater pump to fill to either 50 mL or 100 mL, then place the batch in refrigerator, give a 9 day BUD, then remove from refrig and add antibioitic to burritrol solution and dispense, would be be able to assign a 24 hour BUD without sterility testing and meet USP 797 standards?  The burretrol would be sent in lieu of an IVPB, with a hangar attached for the nurse to administer.

 

Alternatively, would we be able to use repeater pump to fill the burritrols, then next step by another technician (medium risk operation) would be to add the antibiotic to each burritrol , label and store in refrigerator with a 9 day BUD, prior to dispensing to an individual patient?

 

A concern was brought up that filling the burritrol may be considered a one hour BUD.  Not sure why this would be considered that when prepared in an ISO 5 environment.

 

Thank you

 

Sue M