New standards for handling hazardous drugs in health care facilities are just around the corner. The U.S. Pharmacopeia (USP) Convention’s General Chapter 800 focuses on protecting health care workers through safe handling of hazardous drugs.

Originally scheduled for release in July 2018, USP 800, which includes rules on nonsterile and sterile hazardous drug compounding, was postponed so its release would align with revisions to USP chapters 795 and 797, which concern nonsterile and sterile compounding, respectively. Those new rules are scheduled to be released June 1 and will become mandatory, along with USP 800 on Dec. 1.

With just six months remaining until compliance is required, these new regulations are likely to warrant significant changes. Capital expenditures and organizational process changes affecting a wide array of departments and functions will be required for the handling and administration of hazardous drugs.

Far-reaching requirements

Complying with USP 800 begins with the receipt of a hazardous drug and ends with disposal.

“USP 800 covers nearly everyone working in the organization – materials management, environmental services, nursing, pharmacy, transporters, facility design and more. It also requires clear containment strategies for the handling of these drugs,” says Katrina Harper, PharmD, MBA, BCPS, DPLA, senior clinical manager, center of pharmacy practicing excellence for Vizient.

Upgrades to clean rooms and HVAC systems pose the greatest challenges to USP 800 compliance and can be the costliest changes to make. The new regulations may require special construction to have a separate negative pressure room with a hood vented to the outside environment, which can pose logistical construction challenges for a busy hospital.

Facilities must also factor in additional costs for personal protective equipment, such as gloves and gowns, to ensure they are impermeable for those who do compounding or are handling these drugs. Closed-system transfer devices for administering drugs will be required, further adding to costs.

USP 800 calls for a four-step cleaning process that includes deactivation, decontamination, cleaning and disinfection. That means organizations will likely need to add new cleaning agents to manage spills to ensure all of the hazardous material is properly removed.

“The challenge is that costs for drugs and supplies are escalating at a time when reimbursements are declining. Health systems and especially smaller organizations are struggling to find the resources necessary to comply with this new regulation,” says Joyce Thomas, PharmD, associate principal, pharmacy advisory solutions at Vizient.

Preparing for implementation

While some health care organizations are already working toward compliance with USP 800, others are in the early stages of investigating what to do. Here are some steps to more quickly move your facility toward compliance:

Identify hazardous drugs. A good place to begin is by reviewing the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs for guidance. NIOSH is expected to release an updated list in June 2019.

Determine whether facility changes are needed. Health care organizations may need to construct a space, purchase a new hood or other equipment, or renovate an existing space.

Designate an implementation and compliance person. USP 800 requires each health care organization to have a designated person to oversee implementation and ongoing compliance with the chapter. While there is no requirement about who this person should be, the role requires a deep understanding of the standard and an ability to implement policies and procedures.

Write new policies and procedures. Standard operating procedures (SOPs) are required for safe handling of hazardous drugs through a health care organization. Some of the topics that must be addressed in the SOPs include areas such as an occupational safety program, receipt and transport of hazardous drugs, and the use and maintenance of proper engineering controls. A documented review of these SOPs must be conducted at least every 12 months.

Helping members achieve compliance

It’s important to take steps now to comply with USP 800 and not wait until it is enforceable. In the end, the regulations are designed to make health care facilities safer for everyone.

“USP 800 goes beyond pharmacy. It’s about protecting all health care workers, patients and the environment from accidental exposure to hazardous drugs,” adds Harper.

Vizient offers information, education and expert resources to support members in achieving and maintaining compliance with USP 800. For information, members can request resources such as gap analysis assessments that help pharmacy and hospital leaders quickly evaluate where they stand in terms of compliance and where they should focus efforts.

Members can also request educational slide decks and webinars on USP 800. For a higher level of support, Vizient Pharmacy Advisory Solutions experts are available to conduct an on-site assessment, prepare a customized action plan and assist with implementation.

For more information about complying with USP 800, please contact Joyce Thomas. To request informational or educational resources, please contact Katrina Harper.

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Published: May 21, 2019