Interim guidance for USP compliance won’t last forever. It’s time to adapt and prepare for upcoming standard revisions to USP Chapters 795 and 797. Wolters Kluwer Compliance expert, Annie Lambert, PharmD, BCSCP, recently outlined the three most important steps pharmacy teams must take to prepare.
Like every piece of the healthcare system, pharmacies have made significant sacrifices and adjustments in response to the COVID-19 pandemic. Yet selflessly playing their part in beating back the pandemic has also forced pharmacists to scale back efforts at compounding compliance. They’ve done so in response to interim guidance from federal authorities, but that guidance will ultimately end, even as the pandemic persists.
Dr. Annie Lambert, Clinical Program Manager for Compliance Solutions, Wolters Kluwer, recently authored a Pharmacy Times article outlining important steps pharmacies should take to keep drugs safe and effective and maintain compliance when the interim guidance expires.
Where pharmacy compliance stands
Lambert noted that while most pharmacies assert full compliance with USP <797> guidelines, the pandemic forced adjustments to standards in concert with that interim federal guidance. In addition, when hospitals redirected funds to concerns that included preserving staff, many health systems put off renovations to achieve standards issued prior to the pandemic. At this point, a State of Pharmacy Compounding survey found at least half of compounding pharmacies are operating in facilities that are not fully compliant.
Respond today for a better tomorrow
There are, however, a few things pharmacies can do today to prepare for increased regulatory scrutiny. In her article, Lambert highlighted the three most important steps.
1. Use automation to support and optimize pharmacy workflows
Interim changes to compounding have impacted pharmacy workflows. There are low-cost, low-training intensity systems that can help, including IV workflow systems, which nearly 2/3 of hospitals have not yet taken advantage of and which can help extend both staff and supplies.
2. Review the USP <795>, <797>, and <800> chapters
Pharmacy teams should brush up on minimal compliance requirements, and should also take this opportunity to identify holes in their compliance practices and devise solutions.
