The introduction of the United States Pharmacopeia Chapter <797> regulation in 2008 sent and continues to send shock waves through hospital pharmacy departments and other sterile drug preparation settings.
Compounding practices that had been ingrained in the pharmaceutical industry for decades were simply turned upside down, and many pharmacies today remain challenged in their pursuit to successfully comply.
A far-reaching regulation that impacts nearly every step of compounded sterile preparations, the 60-page document requires everything from documentation of compounding activities and staff competencies to compliance with specific architectural and environmental aspects of the clean room. Staff must undergo intensive and continuous education to accurately interpret the extensive protocols found in the all-encompassing regulation to ensure compliance.
While the positive intent of the regulation is to promote safer practices for patients and professionals involved in compounding activity, the reality is the sheer magnitude of the changes remains a compliance challenge for today's pharmacies operating under lean staffing models. However, it's a challenge that must be successfully navigated, as the federal regulatory activity and scrutiny surrounding compounding has become increasingly heightened in the wake of recent health crises traced back to poor practices.
The pharmacy department at Sentara RMH Medical Center — like many located in small to mid-sized community hospitals — battles the day-to-day challenge of having to allocate limited resources in the most efficient and effective way possible. In response to the introduction of USP 797, the 238-bed hospital located in
Streamlining workflows and compliance through automation
Sentara RMH's primary objective has been to streamline manual processes associated with the USP 797 initiative, build standardized compounding processes and ensure compliance. Recognizing the huge resource draw that would be required to achieve success with the extensive documentation and competency requirements of the regulation, pharmacy management made the strategic decision to leverage technology to automate existing manual workflows and increase staff accountability.
Simplifi 797, a complete compliance solution, was chosen for its ability to address every area of compliance from documentation to workflows to education. The availability of more than 30 expert-based policies and procedures and 25 well-tested forms alongside the flexible design of the solution to address unique workflows and individualized tasks has enabled RMH Sentara to move tracking of all compounding activity, sterile and non-sterile, to a completely digital format.
The time associated with manual tracking and paper-based documentation has been significantly reduced, and automatic notification of overdue tasks, exceptions and out-of-range measurements ensures nothing is overlooked. The end-result is that pharmacists' time is freed up for more top-of-license activity, and safety initiatives for patients and staff are enhanced.
Workflow benefits have also extended to other processes beyond USP 797 compliance. By customizing the technology to specific processes and workflows associated with non-compounding areas, staff has been able to streamline procedures with such areas as controlled substances. The workflow data aggregated within the solution also helps pharmacy managers make smarter decisions about resource allocation.
Solid governance for improved competency and accountability
A purposeful change management strategy proved a critical component to success. As many on the pharmacy department staff had been with Sentara RMH for more than a decade, building the case for why the changes were needed was important to achieving buy-in and ongoing success with the initiative.
While many facilities designate and train one expert to oversee processes and compliance with USP 797, Sentara RMH made the strategic decision to make it everyone's responsibility and establish a goal for internal staff advancement. A culture of competency and accountability with sterile products would create a sense of ownership with all involved and advance staff expertise.
A component within the automated technology solution, the CriticalPoint™ training program provided a foundation for success with this goal. The pharmacy team has access to 30 hours of Accreditation Council for Pharmacy Education–approved continuing education through the availability of a highly-interactive course that supports in-depth learning. The program is automatically updated as existing regulations change or new components are introduced.
Having this component available in-house also frees up time that pharmacy management would have to dedicate to education efforts. It becomes a win-win as staff is able to earn continuing education credits needed for certification, and managers can dedicate more time to higher-level initiatives.
Conclusion
In today's healthcare climate, pharmacy managers face unprecedented pressure to operate as efficiently as possible while also maintaining the highest quality and compliance standards to promote patient safety. USP 797 provides many challenges and opportunities to pharmacy departments as they navigate this unique time in healthcare.
By leveraging the clear advantages of automation and embracing USP 797 as an opportunity to advance competency and accountability within its pharmacy department, Sentara RMH has laid a foundation for the standardization of compounding practices, a focal point for regulatory inspections. This kind of strategic response to the new regulation ensures enhanced accuracy, compliance and patient safety.
Jamin Engel, Pharm.D, MBA is the Lead Staff Pharmacist and Sterile Products Coordinator at Sentara RMH.
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