Navigating the New Requirements for USP 800 Drugs

Online First - Conference Correspondent

Chicago, IL—A clear set of standard operating procedures is at the heart of US Pharmacopeial Convention Chapter 800 (USP 800) compliance, according to Carol Yarrington, PharmD, BCOP, Oncology and Infusion Pharmacy Coordinator and Clinical Oncology Pharmacist, St. Joseph Mercy Health System, Ann Arbor, MI. At the 2016 Annual Hematology/Oncology Pharmacy Association (HOPA) Oncology Pharmacy Practice Management Program, Dr Yarrington provided some tips on how to address the new rule.

USP 800 applies to the handling of hazardous drugs in healthcare settings, and includes requirements pertaining to activities from receipt to disposal, engineering controls and personal protective equipment, medical surveillance, personnel training, and hazard communication.

“Regardless of the setting, USP 800 is going to cost us money, but it should improve staff safety and awareness of the risks associated with handling hazardous drugs,” she said.

In recent years, the risks associated with exposure to hazardous drugs have garnered more attention, but according to Dr Yarrington, nothing about the drugs themselves has changed.

“What has changed is an awareness that hazardous drugs put our staff, our patients, and their friends and family at risk,” she stated.

Dr Yarrington said the most impor­tant change between USP 797 and USP 800 is that the guidelines now apply to physician practices in addition to pharmacies, hospitals, healthcare institutions, patient treatment clinics, and veterinarian offices.

“This could mean big changes for private practice,” Dr Yarrington added.

The Safety Plan

All institutions under the USP 800 rule are required to have an occupational safety plan for hazardous drugs. This document should incorporate the requirements of the rule, and must include, at a minimum, engineering controls, training of personnel (not limited to pharmacy staff), safe work practices, proper use of appropriate personal protective equipment, and policies for hazardous drug waste segregation and disposal.

To create this plan, Dr Yarrington recommends referring to the Occupational Safety and Health Administration, as well as to state and local level requirements. The implementation of a closed-system transfer device for hazardous drug administration is now required, and this can be one of the most expensive parts of achieving USP 800 compliance if organizations are not already using closed-system transfer devices, she said.

Institutions must create and maintain a list of hazardous drugs at their practice setting. If resources are scarce, she recommends adopting the National Institute for Occupational Safety and Health (NIOSH) list of antineoplastic and other hazardous drugs.

“If your list doesn’t match the NIOSH list, meaning you have less drugs on your list than on theirs, you’d better have good documentation as to why,” Dr Yarrington cautioned. In this instance, a risk assessment should be performed to explain discrepancies.

USP 800 also requires the identification of the various types of exposure to hazardous drugs in a practice setting.

“The good news about this requirement is it’s usually a one-time project that only has to be updated if you start doing new procedures,” she said. To avoid breaches in safety, individuals or teams should be identified to assess ongoing compliance, and all personnel handling hazardous drugs in an organization must learn proper precautions to avoid cross-contamination.

Facilities and Staff Safety

According to Dr Yarrington, achieving a USP 800–compliant facility is the biggest and most expensive challenge.

“In designing your sterile compounding space for hazardous drugs, you need to enlist expertise in the design of the room, in the engineering controls needed to meet negative and positive pressure requirements, and in USP 800 knowledge. That’s at least 3 people, but it will likely involve more,” she explained.

Another novel requirement of USP 800 dictates that hazardous drugs be stored in a negative pressure space with ≥12 air changes hourly (as opposed to clean rooms and International Standards Organization 7 anterooms requiring 30 air changes hourly). In addition, designated areas must be available for receipt and unpacking of antineoplastic hazardous drugs (neutral or negative pressure), nonsterile hazardous drug compounding (negative pressure), and sterile hazardous drug compounding (negative pressure). The guidelines also require a positive pressure anteroom (which can create challenges because hazardous drugs can no longer be stored in the anteroom), and a negative pressure buffer room.

“If you’re the person at your institution responsible for learning USP 800, stick to your guns regarding the guidelines. Because when you get inspected, they’ll use a checklist to make sure you’re compliant with everything on the list,” Dr Yarrington advised attendees.

Environmental wipe sampling for hazardous drug surface contamination should be performed every 6 months, and can be costly, approximately $1500 to $2000 per kit, which allows for the testing of 6 spots for the presence of marker drugs.

“They’re called marker drugs because they stick around for a long time, and you want to keep track of where you test so that when you do repeat testing, you sample the same places,” she explained. There is no current standard for acceptable levels of hazardous drug contamination, so levels must be undetectable.

Appropriate personal protective equipment must be worn during every step of hazardous drug handling, and Dr Yarrington recommends consulting the NIOSH guidelines for appropriate personal protective equipment for various situations. Double gloving is required for compounding, administering, and deactivating and decontaminating, and she suggests the use of 6-mL or thicker gloves to reduce the risk for tearing.

“You should also learn what agents your gloves have been tested with, since certain agents like thiotepa can eat through gloves,” she said.

A hazard communication program should be created and shared in USP 800–compliant institutions. This tool includes language about hazardous materials of any kind (from chemotherapy to cleaning chemicals), and should provide readily available safety data sheets.

“Consider including a right-to-know document so that individuals know their risks,” she suggested.

Medical surveillance of staff should be conducted at baseline and continued until exit assessment, and data elements collected should include a medical—including reproductive—history and work history to assess exposure to hazardous drugs, a physical examination, and laboratory testing, and should also include a follow-up plan for employees demonstrating changes during surveillance.

All institutions to which the USP 800 standard pertains should be fully compliant by July 2018.

“USP 800 compliance does require ongoing oversight, and it will be especially tough for some physician’s offices. But I’m excited about it; it teaches staff how to be safe,” Dr Yarrington added.

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Last modified: November 17, 2016