In November 2022, revisions to the United States Pharmacopeia’s (USP) General Chapter <797>, a standard for sterile pharmaceutical compounding – defined as the process of “combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile medication” – were published. USP <797> plays a major role in guiding regulatory bodies and accrediting organizations on sterile compounding. USP’s 2022 revisions to USP <797> were a significant step forward for patient safety and quality of care. These changes included a clear distinction between the administration of medication and compounding, and effectively ended the “one-hour rule,” a restrictive standard stating that all immediate-use sterile products must be administered within one hour after the start of preparation. This standard was clinically burdensome as it limited the flexibility and timing with which anesthesiologists and other health care professionals could prepare medications before administration and streamline workflows. Within this revised guidance, USP made it clear that administration is officially outside the scope of USP <797>. Altogether, the revisions will resolve confusion and workflow disruptions health care professionals have faced for years.
The USP chapters are published annually by the United States Pharmacopeial Convention, a scientific nonprofit organization that sets standards for the identity, purity, manufacturing, and handling of medications that are recognized worldwide. USP chapters numbered below 1,000 represent mandated standards. To maintain compliance with The Joint Commission (TJC) and the Centers for Medicare & Medicaid Services (CMS), facilities, physicians, pharmacists, and other health care providers are required to meet the standards of those USP chapters. USP has no enforcement role.
Ahead of the USP <797> revisions last year, many health care providers were concerned about how regulatory and accreditation bodies would govern the pre-spiking of intravenous (IV) fluid bags, an important patient safety issue related to clinical workflows and physicians’ and other professionals’ ability to fully prepare for patient care. TJC addressed this issue shortly after the publication of USP’s revised guidance, with a statement clarifying that the pre-spiking of IV bags also falls outside the scope of USP <797>. TJC’s statement, which aligned with USP’s Frequently Asked Questions on USP <797>, made clear that its surveys of health care facilities will evaluate compliance with local policy on this IV spiking issue. In addition, the American Society of Anesthesiologists (ASA) published the Statement on Intravenous Fluid Bag Spiking. The statement asserted that based on existing evidence, “spiking I.V. fluid bags and using them within 24 hours for surgery/procedure appears to be an appropriate and safe practice.” Both the ASA statement and revisions from USP <797> will contribute to easing clinical burdens, reducing waste, and streamlining workflows in the perioperative environment, while maintaining utmost patient safety.
The USP <797> revisions reflect nearly two decades of advocacy from ASA and numerous other medical specialty societies and patient safety organizations. The result of this persistent advocacy was a set of national standards that allows health care professionals more flexibility in the administration of medications. These changes allow health care professionals to more seamlessly prepare for emergency situations by having medications ready ahead of time. The revised standards ultimately enable more efficient preparations and safer care for patients.
Where can health care professionals go from here?
TJC has stated that their surveyors’ approach to USP <797>, the administration of medications, and the spiking of IV bags will solely evaluate compliance with local/institution policy. Health care professionals should advise their department chairs and facility administrators to develop clear policies that support patient safety and clinical workflows. Those facility leaders may consider appointing task forces or advisory committees to advance the development of these policies. Health care professionals should also engage with hospital administrators, pharmacy, infection control, and other stakeholders to review and update their protocols. According to TJC, those relevant protocols should be based on specific manufacturer instructions, evidence-based guidelines, and applicable state laws and regulations.
With the issues of USP <797> now settled, the health care community has an opportunity to implement a renewed focus on continuing education for medication safety and the proper handling, preparation, and administration of medications, emphasizing patient safety and safety quality of care.
Elizabeth Rebello is an anesthesiologist.
