In an APhA2019 session titled “USP 800 Deciphering Requirements,” presented on Sunday, March 24th, presenters discussed the purpose of the United States Pharmacopeia Chapter <800>, to whom the chapter applies, and what setting it impacts. The experts also listed resources used to identify hazardous drugs—such as carcinogens, genotoxins, teratogens, and reproductive toxins—and defined the process for establishing a risk assessment. In addition, they identified various types of hazardous drug exposures and explained staff responsibilities for handling hazardous drugs.
According to presenters Patricia Kienle, RPh, MPA, FASHP, director, accreditation and medication safety, Cardinal Health, and L.R. Dillon, RPh, ASQ CMQ/OE, ASQ CQA, ASQ SSGB, ACHC/PCAB CAC, pharmacy consultant, L.R. Dillon Pharmacy Consulting, USP <800> is the first enforceable standard that protects healthcare personnel from risk posed by hazardous drugs. USP (U.S. Pharmacopeia) is a standard-setting organization that seeks to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
Describing the timeline of events that lead to its creation, Dr. Kienle and Dr. Dillon reported that in the 1970s, secondary malignancies were identified in patients following treatment. In the next decade, a positive association between exposure to antineoplastics and adverse reproductive effects emerged, followed by determination of a causal link between cancers in healthcare workers who were exposed to antineoplastics in the 1990s.
To ensure a safe environment for healthcare personnel, the presenters stressed, each facility where hazardous drugs are handled should assign a person to oversee hazardous drug requirements, including formal personnel awareness, training, and monitoring. In addition, training and competency documentation serves as the bedrock of USP 800–compliant facilities, ensuring such aspects as safe receiving and transporting, proper protective equipment, spill awareness, and mixing competency.
Further, the presenters said, employees have both a need and a right to know the hazards and identities of the chemicals they are exposed to when working. Moreover, adhering to OSHA requirements, the presenters stressed, “Personnel of reproductive capability must confirm in writing that they understand the risks of handling hazardous drugs.”
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