ampicillin concentration

I recently discovered that our standard, old-fashioned ampicillin is the focus of a Pharmaceutical Industry review that has already caused a major shift in its use, involving JCAHO requirements as well. Apparently, there are no stability data for the usual 100 mg/mL suspension, so the only formulation that can be used is 30 mg/mL. This change naturally casues the volumes to be 3.3 times larger.  Pharmacy explains it in these terms: when you inject the diluent, you are "compounding" the med.  "Compounding"is only allowed in the Pharmacy.  We have used ampicillin suspended by the RN at the bedside just about forever. I cannot find literature on adverse effects that would have caused this change. It's prepared on the spot and injected immediately.  It makes me think that, being an old and unprofitable medication, it needed something to "stir the pot".  I am still very uncomfortable with such volumes, and so are my peripheral IV accesses, i.e. the infants.  I would hope that Neonatal Units would be  exempt from this mandate. Any suggestions? Are all NICUs in the State already using the 30mg/mL? Thank you for your input!

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At our hospital (Santa Rosa Memorial), we no longer have any meds routinely mixed up by the nurses, as per the JC, though we do keep some on hand for STAT first doses when needed. I expect you'll find this is pretty common now. We discussed the concentration issue a few months ago with our pharmacy. There were stability data for 100 mg/mL (one hour, I think), which would work for a dose prepared at the bedside, but which would be uncomfortably short for a med delivered from the pharmacy. We agreed that the standard for iv administration would be 30 mg/mL, which in an infant getting 200 mg/kg/day comes out to 6.7 mL/kg/day -- more than we were accustomed to, but not entirely unreasonable. Of course, we still rely on being able to use 250 mg/mL for the occasional IM injection.

Given that the dose is still the same, and that it's still purchased in exactly the same form, I can't see any way that the pharmaceutical industry would have an interest in pushing this change.

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