The bottom line on USP compliance: What is your risk?

Eric Kastango, MBA, BS Pharm, FASHP - Print  | 

Sterile compounding practices are increasingly under scrutiny. State pharmacy boards, in tandem with national efforts by accreditation organizations, are raising the stakes on this critical component of care delivery.

Current quality improvement trends aim to align sterile compounding practices with United States Pharmacopeia Chapter <797> (USP 797)—the accepted industry benchmark defining minimum practice and quality standards for compounded sterile preparations (CSPs) since 2004. An enforceable federal standard that is complemented by the recent introduction of USP Chapter <800> (USP 800) addressing hazardous drug exposure, USP 797 is growing in influence as state boards increasingly adopt the comprehensive standard as a requirement.

These trends represent an important step forward as the industry addresses subpar compounding practices that have long impacted patient safety. Yet, most U.S. pharmacies still fall short of compliance according to the 2017 edition of the annual “State of Pharmacy Compounding” survey, which revealed that only 38 percent of U.S. hospitals are achieving full USP 797 compliance. In addition, three out of 10 facilities reported a compounding-related patient incident within the past five years.

The mounting regulatory focus has certainly raised the bar on USP 797 and USP 800 compliance, but the risks associated with deficient sterile compounding practices go far beyond penalties and corrective action plans. The reality is compounding processes present a high potential for human error and a low rate of detection, opening the door for preventable patient safety incidents that can result in notable financial and reputational fallout.

More than ever, hospital executives need to recognize the risks and opportunities associated with sterile compounding and take action to achieve USP compliance to optimize patient safety. Today’s busy pharmacy environments face notable challenges in meeting the complex requirements due to lack of a top-down support and competency resources. Manual workflows that often characterize sterile compounding processes exacerbate the situation. Going forward, pharmacists who oversee this critical aspect of care delivery in today’s hospitals need access to expert guidance and the right tools to confidently navigate complex USP compliance standards.

A Bird’s Eye View of Risk
USP compliance lays the foundation for optimal patient safety—the primary mission of any pharmacy. When processes are standardized according to industry best practices, pharmacy directors—and the C-Suite—can be confident that the highest quality pillar is met for CSPs. Alternatively, non-compliance presents notable patient safety risks, regulatory backlash and negative bottom line impacts.

Consider that approximately 32 state pharmacy boards require USP 797 compliance, and many others are considering tying sterile compounding certification to these comprehensive guidelines. Hospitals can expect this momentum to continue as both the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services (CMS) recognize the standard for its ability to protect patients from harm and death associated with improperly prepared CSPs. In fact, USP 797 is a requirement for Medicare and Medicaid reimbursement programs.

State boards of pharmacy regularly inspect and monitor progress with USP compliance, and hospitals that fall short face a range of consequences depending on the state. For example, the Commonwealth of Virginia Board of Pharmacy publishes a monetary penalty schedule with corresponding deficiencies. Some fines can reach hundreds or thousands of dollars. Depending on the gravity of the situation, some states may even restrict activity related to CSPs or suspend a pharmacist’s license. In these cases, the financial and workflow burden becomes substantial as hospitals must look to costly third-party providers to fill in the gaps and ensure continuity of high-quality care delivery.

Improving the Outlook
Busy pharmacy directors need tools that help them successfully and confidently navigate the complexities of complyingwith stringent USP 797 and USP 800 standards. While pharmacy best practices have long supported automation as a priority strategy for improving workflows and patient care, sterile compounding processes and quality management are often overlooked.

Many pharmacists want to verify practice with outside experts who have a demonstrated track record to help them implement practices that ensure compliance with applicable USP chapters. Quality management systems exist that help automate USP compliance and facilitate consistent application of the standard on multiple levels including:
• Development of standard operating procedures that inform the actions of staff
• Documentation that all critical tasks detailed in USP standards are completed
• Ongoing competency assessments and detailed e-learning modules
• IV workflow technologies that verify the right drug in the right amounts were used during the compounding of CSPs.

The reality is that tolerance of subpar sterile compounding practice has reached a tipping point. Industry stakeholders and the public at large are demanding a higher standard of care in the wake of ongoing high-profile incidents that have resulted in patient harm and death. USP 797 and USP 800 set a high bar for high-risk processes to ensure the highest level of safety and optimal care delivery, and hospitals need to equip pharmacies with the tools needed to ensure compliance.

By Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, and president of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company. Eric received a coveted ISMP Cheers Award in 2015 for his work related to sterile compounding safety. He is one of four recipients of the 2013 Outstanding Service Award from the Massachusetts Society of Health-System Pharmacists and the 2014 recipient of the NABP Henry Cade Memorial Award that recognized his efforts and assistance to the states and NABP to address the compounding tragedy that occurred in 2012.

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