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Posts: 2
Registered: ‎06-20-2012
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Re: Sterility Tests and BUD Webinar

The very first question posted on this thread is about a NICU pharmacy diluting out medications and drawing doses from this dilution.  In the answer to the question this process is described as medium risk compounding.

 

Three questions:

 

1)  Does the designation of medium risk still apply regardless of whether the drug that is being diluted comes from a single dose vs. a multi-dose vial?

 

2)  Does the medium risk designation still apply if the dilution in question is kept refrigerated but used multiple times to draw up doses over the entire 9 day medium risk BUD period? 

 

3) Does the preparation of these dilutions in a sterile empty vial (as in the posted question) vs. in a sterile syringe with a dispensing connector vs. possibly using a CSTD change the answer to question 2?

 

 

Thanks

 

 

Eddie Hankins, PharmD

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Posts: 1,167
Registered: ‎02-23-2010

Re: Sterility Tests and BUD Webinar

Eddie,

 

I copied your questions in order to answer them.  Here is my responses:

 

1)  Does the designation of medium risk still apply regardless of whether the drug that is being diluted comes from a single dose (SDV) vs. a multi-dose vial (MDV) ? If you are diluting a drug, especially one from a MDV, the concentration of the preservative is no longer at its effective level so all CSPs should be considered medium-risk level.  If you are drawing directly and without diluting the drug (e.g., insulin) into syringes and assuming chemical stability, it could be considered a low-risk level CSP. 

 

2)  Does the medium risk designation still apply if the dilution in question is kept refrigerated but used multiple times to draw up doses over the entire 9 day medium risk BUD period?  If you are making a dilution bag, you are technically making a SDV that should be discarded after 6 hours.  The 9 day BUD applies to a finished CSP that will be stored but not re-entered.  If you need to make a dilution bag, I would make multiple single day use bags that could be stored over the 9 days but once punctured, should be treated as a single-dose vial.

 

3) Does the preparation of these dilutions in a sterile empty vial (as in the posted question) vs. in a sterile syringe with a dispensing connector vs. possibly using a CSTD change the answer to question 2? I am not sure how you properly disinfect a dispensing connector after it leaves the hood.  I understand it is done all the time but I don't like it from an infection perspective.  The two studies re: CSTDs had positive media fills which tells me that they couldn't prove that the CSTD maintained the sterility of the drug. It could be a plating issue or a technique issue but there was growth and I absolutely don't agree with the conclusions in either paper.  As much as I would like to converse drug, I would not use a CSTD to extend the life of a SDV based on the published literature.

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.