Hospital pharmacy regulations present new facility challenges

Some refer to United States Pharmacopeia (USP) General Chapter 800, Hazardous Drugs — Handling in Healthcare Settings, as a “heavy lift” for health care  facilities. While a daunting challenge for facilities to implement, the chapter is required, says Jonathan Flannery, CHFM, FASHE, FACHE, American Society for Health Care Engineering senior associate director of advocacy.

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“It’s not just about protecting the patients, but our staffs also,” he says. “You want to make sure whatever drugs you have compounded are safe for your patients. You also want to make sure if the drugs are hazardous, you are not exposing your staff to them.”

The objective of USP 800 is to ensure health care workers and patients are protected from the harm associated with being exposed to hazardous drugs. Eight million health care workers are potentially exposed annually to hazardous drugs, according to the Centers for Disease Control and Prevention (CDC). Workers in departments outside the pharmacy and unaware of their exposure can potentially be harmed by that exposure.

USP 800 was developed to protect health care workers and patients by defining quality standards for handling hazardous drugs and proper environmental controls for compounding drugs. USP 800 covers various aspects of handling hazardous drugs, including receiving, transporting, storing, compounding, dispensing, administering, spills, cleaning and waste disposal.

The chapter is a set of rules and standards written in a context that could be enforced as written, but is not enforceable by USP. The expectation is that by Dec. 1, the majority of states will adopt the chapter as a requirement enforceable by state boards of pharmacy.

The chapter will be instituted in conjunction with USP 797, already in effect. USP 797 was written to protect drugs. While providing a benefit, it did not focus on protection of workers and patients. The first draft copy of USP 800 was introduced in February 2016, followed by years of public comments. The planned original year of adoption was to be 2018, but delays necessitated postponing adoption until late this year.