If you’re in the business of compounding medications, you’ve likely been aware for some time that the release of United States Pharmacopeia (USP) General Chapter <800> and revisions to General Chapter <795> and <797> standards demand significant changes to your pharmacy operations.
And perhaps you’ve been waiting until the final revisions were announced to begin the process for compliance; updated versions of <795> and <797> were released in November 2022 and will take effect November 2023, which is when <800> becomes officially enforceable.
If you’re one of those who have waited, there is much to learn from the early adopters. Drawing on two webinars hosted by Wolters Kluwer, as well as published interviews1,2,3 this blog post highlights the transformational work of two thought leaders whose work is nearly complete: University Hospitals Health System in Ohio, and Northwell Health, New York state’s largest healthcare provider.
The planning phase
University Hospitals Health System (UHHS) has 32 sterile compounding facilities, including cleanroom suites and segregated compounding areas. Prior to 2017, entity-level leadership teams were left to interpret USP guidelines independent of a health system-wide mandate.
But when the USP <800> standard adoption timeline became clear, UHHS formed a USP steering committee made up of high-level decision-makers. They conducted a gap analysis, leveraging existing technology (Simplifi 797® and JCR Tracers with AMP® software) to determine the level of adherence to USP standards, identify next steps, and develop action plans.
According to Bridget Gegorski, PharmD, MS, BCSCP, the system medication safety officer and the manager of medication safety and drug information at UHHS, once the gap analysis was completed, the steering committee presented a business plan for construction to the Hospital Board of Directors to attain both support and an implementation budget. They also planned monthly reporting of tracer activities and process improvement actions, while forming two subgroups to develop and approve new practice requirements.
Melanie Galvin, PharmD, BCSCP, a senior advisor for the pharmacy service line at Northwell, which has 23 hospitals and five outpatient infusion centers, says that the team there focused its initial work on the proposed USP revisions released in 2021. They were convinced that while the revisions were not final, they were close enough to begin a proactive process for change. Northwell also kicked off its compliance project with a gap analysis, in its case building the analysis around a Joint Commission compliance checklist.
For both health systems, implementation included a number of elements. While the details will vary from site to site, the UHHS and Northwell implementations offer extremely helpful models.
For example, construction might include upgrading individual entity sites, as well as standardizing critical equipment, such as IV hoods and refrigerators across all sites.
It’s also likely you will need to update many, if not all standard operating procedures (SOPs). Perhaps begin by collecting existing SOPs from local entities and using Simplifi 797, which stores all SOPs in readily accessible formats. Effectively communicating the updated SOPs to all applicable personnel is another critical step in this process.
Of course, the updated SOPs and other aspects of the revisions will demand additional training, especially in preparation for the more frequent and rigorous assessments the revised chapters demand. Using the revised chapters as your guide, begin by identifying which personnel must undergo which training and competency assessments. Then define how you will undertake training your personnel properly and how and when you will administer assessments.
Finally, understand that both UHHS and Northwell use Simplifi 797 to track key areas of USP compliance. This makes it easier to ensure you are complying – or at least moving toward compliance – at all times.
Check and adjust
To ensure the implementations are and remain effective, both UHHS and Northwell conduct periodic reviews.
UHHS, for example, built Joint Commission Resources (JCR) tracers in its Tracers with AMP software to audit compliance. This enables leadership to see when individual sites are struggling, and to require action plans until those sites achieve 100% compliance. UHHS also instituted an annual review of all SOPs to ensure they are adapted as needed.
For its monthly meetings, the UHHS’s System USP Committee routinely:
- Checks for updates on the USP revisions, on FDA guidance and monitors NIOSH 2020 status
- Evaluates individual site-level USP tracer results and action plan presentations
- Uses Simplifi 797 to get a snapshot of all task completion data over time
- Ensures PPE is standardized across sites
- Reviews all contracts
- Seeks ways to standardize master formulations
- Addresses all sterile compounding and hazardous drug concerns
The result is that UHHS compliance across the entire health system has steadily improved from 85% and 65% for <797> and <800> respectively to 96% and 98%.
Using similar processes, Northwell attributes much of their success to the sterile compounding and hazardous drug task force. Through the work of the team, Northwell:
- Has maintained Task Completion above 95% for the last 3 years – even during the pandemic
- Deployed standard training modules to meet the core skills described in USP <797>
- Implemented system standard competencies, moved to the increased every 6-month frequency for compounding staff, and increased completion rates overall.
- Implemented new standards for environmental monitoring and frequency
Top ten lessons learned
A number of lessons and suggestions have emerged from these and other successful efforts to adapt compounding operations to the new standards. Here’s a top ten list.
- Begin by carefully reviewing the new requirements in the published USP chapters, because they will require both labor and resource changes.
- Assess the impact of additional environmental and personnel sampling and evaluate return on investment for insourcing versus outsourcing.
- Adopt best practices from the proposed revisions where possible and practical.
- Establish a USP oversight committee and be aware that the committee structure must evolve as your project matures.
- Design an internal audit program to assess readiness and identify areas for process improvement.
- Standardize equipment where possible but be aware that while it eases parts ordering and availability, it also means that some equipment may need repair at the same time, across all facilities if replaced en masse.
- Switch to system-level contracts because they enable you to leverage site volumes for discounts and incentives.
- Build accountability, by making compliance and action plans a monthly agenda item.
- Have the right technology in place. For example, Simplifi797’s ability to track several key areas of USP compliance, its comprehensive templates library, and its ability to send alerts when tests are due are important factors for maintaining compliance.
- Use in-person visits to enhance accountability and assess compliance beyond the checklists.
Many organizations have had good reasons for waiting to begin adapting their compounding operations, but the time to act is now. For a more in-depth look at how a leading organization effectively changed its operations in ways that comply with the new USP standards while enhancing patient safety, you can watch this webinar.