HealthJanuary 27, 2015

Wolters Kluwer publishes guide for achieving compliance with USP guidelines for pharmaceutical compounding

A Step-by-Step Guide details the core practice and quality steps needed to optimize patient safety during compounding sterile preparations (CSPs) in healthcare organizations.

Wolters Kluwer, a leading global provider of information for healthcare professionals and students, announced today the release of a complementary guide designed to help healthcare organizations stay compliant with U.S. Pharmacopeia Chapter <797> Pharmaceutical Compounding - Sterile Preparations (USP 797). A Step-by-Step Guide to a USP 797 Compliant Pharmacy details the core practice and quality steps needed to optimize patient safety during compounding sterile preparations (CSPs) in healthcare organizations.

Pharmaceutical compounding practices have come under increased regulatory scrutiny in recent years due to several high-profile instances of patient safety issues associated with CSPs. Industry data reveals ongoing issues with CSPs since 2001, pointing to more than 25 pharmacy compounding errors associated with 1,049 adverse events, including 89 deaths.

Presented in the form of an eBook, the guide educates pharmacy and clinical staff on practices and requirements laid out in USP 797, covering the storage, handling, preparation and transportation of CSPs. Insight is provided into the rationale and oversight of UPS 797 and the three critical first steps healthcare organizations need to take to achieve compliance. Also covered in the guide are three key areas covered by USP 797 requirements and where common compliance failures occur.

In addition to procedural steps, the guide also highlights the use of a web-based compliance management tool — Simplifi 797® — as an industry best practice that better enables all types of pharmacies to achieve and maintain compliance. A UPS 797 quality management system, Simplifi 797 offers everything needed to establish the training, risk management and quality assurance practices necessary for a safe and efficient sterile compounding environment, minimizing the potential for error.

"There is no higher priority for hospitals and healthcare workers than to engage in care delivery that promotes the highest level of safety for patients," said Leo Barbaro, Vice President & General Manager, Clinical Terminologies and Surveillance, Wolters Kluwer Health, Clinical Solutions. "By leveraging the best clinical expertise in the industry, we intend for this guide to serve as a best practice tool for implementing the safest, most accurate pharmaceutical compounding practices."

Click here to download A Step-by-Step Guide to a USP <797> Compliant Pharmacy.

About Wolters Kluwer

Wolters Kluwer (WKL) is a global leader in professional information, software solutions, and services for the health, tax & accounting, governance, risk & compliance, and legal & regulatory sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.