USP updates target patient safety concerns within compounding pharmaceuticals

Patient Safety Monitor Insider

January 13, 2016

Revisions outline a more straightforward approach to mitigate patient safety risks

Five years after pharmaceutical experts began reviewing changes to sterile preparation requirements for pharmaceutical compounding, the U.S. Pharmacopeial Convention (USP) has released proposed regulatory updates aimed at preventing patient harm.

The USP announced proposed changes to Chapter <797> Pharmaceutical Compounding?Sterile Preparations in September 2015. Some of the major revisions included reorganizing the previous microbial risk categories from three (low, medium, and high) to two (Category 1 and 2), and introducing new "in-use time" terminology to better define the time frame in which compound sterile preparations (CSP) must be used after it has been opened or punctured.

In an article published on the USP website in late September, Gigi Davidson, RPh, DICVP, director of clinical pharmacy services at North Carolina State College of Veterinary Medicine and chair of the USP Compounding Expert Committee, wrote "<797> was revised having patient safety in mind, by making the standards for compounding sterile preparations as clear as possible to practitioners."

Davidson also made reference to a 2012 meningitis outbreak that put pharmaceutical compounding on high alert. The outbreak, which was ultimately traced back to contaminated epidural solutions prepared at the New England Compounding Center (NECC), led to 64 patient deaths.

Given the high stakes, the Committee was thorough in its review, so much so that at times, experts spent two hours talking about 12 lines of text, according to Rick Schnatz, PharmD, senior manager of healthcare quality standards at USP in Rockville, Maryland.

"The whole premise of the chapter is patient safety, so they wanted to get it right," he says. "Consequently, that takes a lot of time. They wanted to make sure they reflected what stakeholders have asked for, they wanted to input new scientific data that has come out since the last revision in 2008, and they wanted to clarify the chapter to make it easier to read and understand."

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