January 27, 2015 — 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 Health
Wolters Kluwer Health is a leading global provider of information, business intelligence and point-of-care solutions for the healthcare industry. Serving more than 150 countries worldwide, clinicians rely on Wolters Kluwer Health's market leading information-enabled tools and software solutions throughout their professional careers from training to research to practice. Major brands include Health Language®, Lexicomp®, Lippincott Williams & Wilkins, Medicom®, Medi-Span®, Medknow, Ovid®, Pharmacy OneSource®, ProVation® Medical and UpToDate®.
Wolters Kluwer Health is part of Wolters Kluwer, a market-leading global information services company. Wolters Kluwer had 2013 annual revenues of €3.6 billion ($4.7 billion), employs approximately 19,000 people worldwide, and maintains operations in over 40 countries across Europe, North America, Asia Pacific, and Latin America. Wolters Kluwer is headquartered in Alphen aan den Rijn, the Netherlands. Its shares are quoted on Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices. Wolters Kluwer has a sponsored Level 1 American Depositary Receipt program. The ADRs are traded on the over-the-counter market in the U.S. (WTKWY).
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