PharmEcology Services, WM Sustainability Services
While we wait for the NIOSH 2020 List and related documents to be finalized, let’s take a quick look at what we can expect, based on the Draft versions. As our title indicates, there are significant changes in both the categorization of hazardous drugs in the NIOSH 2020 List and in the processes surrounding these categorizations.
The first major change is the layout itself. The NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, has been greatly expanded and divided into three separate documents: Procedures for Developing the List of Hazardous Drugs in Healthcare Settings; NIOSH List of Hazardous Drugs in Healthcare Settings 2020; and Managing Hazardous Drug Exposures, Information for Healthcare Settings. This last document should be of particular interest to those responsible for USP <800> compliance, once that takes effect, as it provides much more detailed and in-depth guidance.
The second big change is the reduction of the three tables into two: Drugs with manufacturer’s special handling guidance and/or known/suspected carcinogens versus all other hazardous drugs. Jerry Ovesen, Ph.D., the lead author for the NIOSH 2020 guidance process, has made it clear during ASHP and other presentations that the tables are not intended to denote different levels of hazard, although Table One drugs are considered by NIOSH to be “cytotoxic.” USP <800> does note that they recognize “For the purposes of this chapter, the term antineoplastic only refers to antineoplastic drugs included in Table 1 of the most current NIOSH list.”1
The third set of moving parts are the drugs themselves. Thirteen drugs have been proposed for addition and greater than 40% of drugs will change tables.
So, when the music stops, and the Final Version is published, prepare to deal with a lot of moving parts!
For more information on our USP <800> customized NDC-specific Assessment of Risk program, please contact us at firstname.lastname@example.org or 877-247-7430.