May 7, 2020

NIOSH Updates List of Hazardous Drugs in Healthcare Settings for 2020

NIOSH seeks feedback on three new draft documents that address hazardous drugs in healthcare settings. The agency has updated its List of Hazardous Drugs in Healthcare Settings for 2020 as well as its procedures for developing the list. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings is intended to formalize the methodology that NIOSH uses to add hazardous drugs to its list. The document also describes the process for requesting drugs’ removal from or placement on the list. A third draft document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, is intended to help employers establish workplace-specific management procedures for hazardous drugs.

Sixteen drugs have been added to NIOSH’s 2020 list, including three for which the manufacturers have provided special handling information. Five drugs have been removed. The agency has also retitled and reorganized the document. The new name for the list, the NIOSH List of Hazardous Drugs in Healthcare Settings, updates the previous title, the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

“Many of the drugs currently used to fight cancer function differently than those previously used,” the Federal Register notice reads. “Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals.”

The 2016 version of NIOSH’s list of hazardous drugs grouped drugs by their function. As a result, drugs that required different protective measures were grouped together. The 2020 version of NIOSH’s list groups drugs by hazard. Drugs are further grouped into two tables. According to NIOSH, one table comprises drugs that contain special handling information specified by the manufacturer or meet the NIOSH definition of a hazardous drug and are classified as “known to be a human carcinogen” by the National Toxicology Program or as “carcinogenic” or “probably carcinogenic” by the International Agency for Research on Cancer. The second table lists drugs that meet the agency’s definition of a hazardous drug, but do not have special handling instructions and are not classified as carcinogenic by NTP or IARC.

NIOSH previously proposed an entire class of drug, botulinum toxins, for placement on the list. Based on input from the public and stakeholders, including conflicting evidence about the hazards posed by botulinum toxins to workers, NIOSH is not currently proposing that botulinum toxins be added to the list. The agency intends to review the toxicity and the hazards related to occupational exposure to botulinum toxins, and seeks additional studies, data, and expert opinions to evaluate the class of drug more fully.

The public comment period for the NIOSH List of Hazardous Drugs in Healthcare Settings for 2020, Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and Managing Hazardous Drug Exposures: Information for Healthcare Settings will be open until June 30, 2020. Visit the docket page on Regulations.gov to view the draft documents and instructions on submitting comments.