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Occasional Advisor
Posts: 11
Registered: ‎02-03-2017
0

Question on documentation of manufactured IV products

[ Edited ]
Hi Eric: my hospital is currently using the Epic system for documentation and checking of compounded IV's. We are using the dispense prep function to document all lot numbers and expiration dates of the ingredients used to compound Iv's and it serves as our log for all CSP's made in the IV room. A question has been raised at my facility in regards to using this same activity (dispense prep) to scan manufactured products already premixed ( for example Vanco 1 gram premix from Baxter) . In doing so, when we look at the order history records for a premix IV that has been documented in dispense prep , it shows: product prepared by : and the name of the pharmacist or technician who documented that premix Vancomycin. My question is the following: is this something that will be breaking the rules for USP 797 as we are documenting an IV that has been already manufactured as prepared by pharmacy? Are you or anyone aware in this forum of how other hospitals handle dispensing and documentation of premix manufactured products dispensed from the pharmacy? Your feedback will be greatly appreciated.
Advisor
Posts: 22
Registered: ‎04-14-2016
0

Re: Question on documentation of manufactured IV products

[ Edited ]

We used Dispense Prep and Check at my previous institution.  We used it for premix bags, as a safety feature for ensuring the correct premix was pulled.  I don't see anything wrong with this practice, or why it would not be compliant with USP 797.  

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Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: Question on documentation of manufactured IV products

Hi Teamleader 14 (would be nice to have real names! :-) )

I agree with Ashtocco that there is no problem with the documentation strategies you are using with EPIC.  Whether it is premixed or compounded, the key is traceability to a specific batch/bag and patient when possible.  The current USP 797 sadly has no explicit requirement for batch or single-dose preparation document. Download and read the proposed revisions to USP 797 since there are specific and explicit documentation requirements for single-dose and batch prepped CSPs.  Having Master Formulation Records and Compounding Logs will be a requirement in the next revision of USP Chapter <797>.  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.