The United States Pharmacopeia (USP) Chapter 800 was released in 2016 with an enforcement period projected for December 2019. The intent of this chapter was to protect healthcare workers and patients from residual exposure to hazardous drugs (HDs) by providing standards for engineering controls, environmental quality and controls, personal protective equipment, hazard communication programs, personnel training, spill control, and medical surveillance.
With this new chapter coming into effect, institutions are preparing for enforcement of these standards. A study published in the American Journal of Health-System Pharmacy outlined a pharmacy department–led USP 800 compliance collaborative initiative and the steps taken in order to achieve compliance. The initiative took place at the University of North Carolina Medical Center (UNCMC), the flagship of a statewide academic health system comprised of six hospitals. The medical center has a central inpatient pharmacy (CIP), a cancer hospital infusion and inpatient pharmacy (CHIP), and satellite pharmacies. The CHIP is responsible for the majority of the hazardous sterile drug compounds. However, nonsterile HDs are also compounded in other areas. Due to the volume and inconsistency of HD handling at UNCMC, pharmacy leadership initially sought to ensure 70% hospital compliance with USP 800, with a written plan for achieving 100% compliance prior to December 2019.
To determine baseline compliance, a common assessment tool was created to highlight the required USP 800 criteria. At baseline, the CHIP had 51.35% compliance and the CIP had 51.30% compliance. The three major areas of noncompliance included outdated policies and procedures related to the development and maintenance of an HD list; inconsistent and outdated policies on the preparation, administration, and delivery of HDs; and omission of detailed policy and procedures related to the receipt of HDs. In order to address these areas, a collaborative work group was created that included the environmental health and safety department, the epidemiology department, the operational excellence department, the nursing department, and pharmacy leadership. This workgroup was led by the oncology service clinical pharmacy manager and met monthly to discuss plans and progress.
One of the first steps to improve compliance was a full review of the medical center’s existing HD list, followed by revisions to incorporate updates from the most recent National Institute for Occupational Safety and Health document as well as other published literature. Drug-storage procedures were also modified at UNCMC at this time. Refrigerated drug storage within the contaminant secondary engineering control was separated into HD and non-HD refrigerators. For receiving HDs, infrastructure was updated to arrange for wholesaler delivery to the CHIP, instead of to the centralized receiving pharmacy, in order to allow for unpacking of HDs as per USP 800 standards.
Nursing-practice modifications were also part of this program. Prior to this initiative, nursing staff were not using two pairs of chemotherapy gloves for administering oral hazardous agents. Additionally, closed-system transfer devices were not being used. For this reason, nursing education was performed and HD labeling was updated to provide more information regarding administration of HDs and what personal protective equipment was required.
Overall, achieving USP Chapter 800 compliance invited operational, clinical, and financial challenges at this medical center and required months of provision and execution. The pharmacy-led compliance collaborative allowed departments to implement standards to ensure that both healthcare workers and patients were protected from residual exposure to HDs. With this new chapter coming to the forefront, other institutions are likely to follow in UNCMC’s footsteps in order to achieve USP Chapter 800 compliance and prepare for enforcement of these standards.
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Published February 20, 2020