What USP Means for Safe Oncology Nursing Practice
Nurses in oncology who compound hazardous drugs (HDs) may be familiar with the U.S. Pharmacopeial Convention (USP) because of chapter <795> related to compounding nonsterile medications and chapter <797> addressing compounding sterile medications. But what is USP really, and why does it have an impact on oncology nursing practice?
USP is a nonprofit organization originally founded in 1820. The convention is comprised of representatives from more than 450 organizations across the United States and around the world that develop public standards of quality and safety regarding medications and food. Although USP is not a regulatory or enforcement agency, the U.S. Food and Drug Administration, state departments of public health, state boards of pharmacy (if approved to do so by the state), Joint Commission (TJC), and Centers for Medicare and Medicaid Services all enforce USP’s standards.
USP Chapter <800>
Today, all nurses who compound, administer, or care for patients receiving HDs are quickly becoming familiar with the standards in USP Chapter <800>, “Hazardous Drugs – Handling in Healthcare Settings,” which was released in 2016 with an implementation target of July 1, 2018. However, USP decided in 2017 that it would extend the date of implementation until December 1, 2019, to align with revisions to chapter <797>.
The standards in chapter <800> address all aspects of HD handling, including personnel training and responsibilities, facility and environmental requirements, drug compounding and administration, and institutional policies and oversight. For individuals who have worked in settings that follow HD precautions routinely, chapter <800> may not have prompted significant changes, but many practice locations required major renovations and process overhauls (http://www.uspnf.com/notices/gc-800-hazardous-drugs-handling-in-healthcare-settings).
Compliance From Other Organizations
In 2014, Pew Charitable Trust formed an advisory committee (https://www.pewtrusts.org/~/media/assets/2016/02/national_assessment_of_state_oversight_of_sterile_drug_compounding.pdf) of pharmacy experts and state regulators to study state oversight of compounding with the goal of harmonizing requirements across the country with federal law and regulations. Recommendations included compliance with “all applicable USP standards, including general chapters <795> and <797>, new chapter <800> when complete, and other referenced chapters.” At the time, about half of the states conformed to the requirements in <797>, but a follow-up in 2016 found that 32 state boards of pharmacy required compliance with chapter <797> and 11 additional states reported similar or stronger requirements (https://www.pewtrusts.org/en/research-and-analysis/reports/2018/02/state-oversight-of-drug-compounding). The number of states that have fully endorsed chapter <800> has not yet been determined.
Implementation of the quality standards in USP chapters <795>, <797>, and <800> (when effective) are required within TJC’s medication compounding certification. TJC’s “Self-Assessment of Safe Handling Practices for Hazardous Drugs” is a free tool for organizations to assess their readiness (https://hazmedsafety.com/en) for chapter <800> implementation. According to anectodal ONS member feedback, TJC is reviewing safe handling policies to ensure consistency with chapter <800> and will enforce them in reviews after December 1, 2019.
Nurses working in small private practices should be aware of changing USP standards. Chapter <797> allows for small volumes of compounding for immediate use in physician practices; however, chapter <800> will no longer permit it. Chapter <800>’s broader scope will hold even small private offices to the same standards to expand protection to all providers who work with HDs.
USP safety standards have widespread support. Oncology nurses who compound and administer HDs must be aware of the regulations providing oversight to their practice, providing a safer environment for healthcare workers and the patients they care for.