Over the past 25 years, more than 100 studies have documented hazardous drug (HD) contamination in health care facilities (HCFs). The National Institute for Occupational Safety and Health (NIOSH) estimates, based on occupation, that about 9 million American health care workers (HCWs) are currently exposed to HDs in the workplace. CAREX Canada recently estimated that approximately 75,000 Canadians are exposed to antineoplastic drugs in the workplace, of which at least 75% are women. As the population ages over the next few decades, the number of patients who require chemotherapy to treat cancer is expected to increase. Cancer cases in the United States are forecasted to increase by 56% between 2010 and 2035. The World Health Organization estimates the annual number of new cancer cases worldwide will increase by more than 60% between 2018 and 2040. The number of HCWs exposed to HDs is expected to increase in tandem with this trend. With these projected increases in the need for cancer care, reducing occupational exposure to antineoplastic drugs is a crucial issue.
Since guidance on cytotoxic drug safe handling from the American Society of Health-System Pharmacists (ASHP; formerly American Society of Hospital Pharmacists) was published in 1983, at least 20 US guidelines have made recommendations about aspects of HD safe handling. Faced with persistent reports of HD contamination in HCFs, the United States Pharmacopoeia (USP) saw the need for an enforceable standard for safe HD handling across all health care settings. Building on previous guidance from the ASHP, NIOSH, Oncology Nursing Society (ONS), and Occupational Safety and Health Administration (OSHA), the organization created USP <800> Hazardous Drugs—Handling in Healthcare Settings.8 The goal of USP <800> is to provide a standard for HD handling that promotes patient safety by protecting HDs from contamination, promotes worker safety by protecting HCWs from HD exposure, and protects the environment from HD contamination.
Evolution of USP <800>
The USP is a non-governmental organization that develops standards to improve the quality of pharmaceuticals. Although the organization has no regulatory authority, USP standards are generally adopted and enforced by federal and state government agencies. The USP first addressed safe HD handling in a substantial way when a 2008 revision of USP <797> Pharmaceutical Compounding—Sterile Preparations was revised to align with recommendations from the NIOSH 2004 Safety Alert on HD handling. Recognizing that a document was needed to address sterile and nonsterile HDs across all health care settings, the organization started work on USP <800> in 2010. Under the supervision of the USP Compounding Expert Committee, this work culminated with publication of the final draft in 2016. In the meantime, USP <795> and <797> were undergoing revisions. In September 2017, USP announced that a July 2018 implementation date for USP <800> would be delayed to synchronize implementation of the USP <797> update in December 2019.
Members of the oncology community face a myriad of complex challenges as they strive to achieve compliance with the “should” and “must” recommendations laid out in USP <800>. Council discussions identified key unmet needs related to this goal.
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