Pharmacy OneSource Blog

The Bottom Line on USP Compliance

Posted on 09/08/17

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At the end of August, Becker’s Hospital Review published the article, The Bottom Line on USP Compliance: What is Your Risk, written by Eric Kastango, MBA, BS Pharm, FASHP, examining the risks associated with sterile compounding and strategies to mitigate that risk.

The article kicks off by providing a snapshot of the current state of pharmacy compliance with USP 797, the industry benchmark defining quality and practice standards for compounded sterile preparations. According to Kastango, with the recent introduction of USP Chapter <800> addressing hazardous drug exposure, USP <797> is gaining influence as state boards adopt it as requirement. While that’s an important step toward overcoming substandard practices that impact patient safety, Kastango points to the 2017 State of Pharmacy Compounding survey indicating only 38 percent of US hospitals are fully compliant with USP 797 as evidence of more work to be done.

In the article, Kastango points out that USP compliance is the foundation for optimal patient safety, which is one reason 32 state boards now require USP 797 compliance, and asserts that the momentum will continue as both CDC and CMS recognize and move to adopt it as a quality standard. According to Kastango, as scrutiny and compliance requirements intensify, pharmacies need to implement strategies to drive compliance and reduce the risk of adverse patient events and the financial and reputational damage they can cause.

Central to driving compliance and reducing risk, Kastango points out, is arming the pharmacy with the tools to develop standard operating procedures, building pharmacy staff competency and expertise, and adopting workflow technologies that help ensure accuracy in the compounding of CSPs. He concludes with the assertion that tolerance of subpar sterile compounding practice has reached a tipping point, and hospitals need to equip pharmacies with the tools to achieve USP 797 compliance or face ever growing risks.

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Topics: Sterile Compounding

About the Author

Deb Oroszlan is the Marketing Director for Pharmacy OneSource - Wolters Kluwer.