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NIOSH Seeks Comment on Updated List of Hazardous Drugs in Healthcare

Analysis  |  By A.J. Plunkett  
   May 16, 2020

The list, which is a basic reference document for OSHA, USP and other standard-setting organizations, has not been updated since 2016.

Editor's note: This article was written by A.J. Plunkett, editor of Inside Accreditation & Quality, a Simplify Compliance publication.

The CDC’s National Institute for Occupational Safety and Health (NIOSH) is seeking comment through the end of June on a long-awaited update to its list of drugs used in healthcare that pose potential hazards to those who administer and otherwise handle them.

The proposal includes a name change and reorganization of drug lists so that not all antineoplastic drugs, most often associated with cancer treatments, are grouped together. Formerly the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings,” the list will be called more simply the “NIOSH List of Hazardous Drugs in Healthcare Settings, 2020.”

The list, which is a basic reference document for OSHA, USP and other standard-setting organizations, has not been updated since 2016.

Nurses, pharmacists, and physicians should pay particular attention to a companion document published along with the updated list in the May 1 Federal Register outlining how to manage hazardous drugs in healthcare settings, says Kurt Patton, MS, RPh, pharmacist, founder of Patton Healthcare Consulting, and former director of accreditation services for The Joint Commission (TJC).

The companion document, “Managing Hazardous Drug Exposures: Information for Healthcare Settings,” takes information that in the 2016 list was under “Table 5: Personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings” to create a “new, comprehensive document on risk management strategies,” according to the NIOSH proposal.

Table 5 was taken out of the main list “in order to clarify that the list is a hazard identification tool,” according to NIOSH. The new document is 87 pages, but still includes a revised version of the table on PPE and engineering controls.

The Federal Docket folder of supporting information behind the NIOSH proposal includes not only a draft of the actual 2020 list and the document on managing drug exposures, but also a draft of the procedures NIOSH used to develop the 2020 list.

While overall comments are welcome on all the documents, NIOSH is soliciting answers to specific questions on each document, according to the proposal.

Under the section discussing the new document on handling hazardous drugs, healthcare workers—pharmacists, physicians and nurses particularly—should pay special attention to questions 5, 6, 7, and 8, advises Patton.

Those questions seek thoughts on the usefulness of the table on approaches to handling hazardous drugs, including what format changes could be made to improve the table’s usefulness, what information is redundant, suggestions for more useful risk management information, and recommendations on other studies or scientific information “related to the use of a medical surveillance program as an additional approach to protect workers in healthcare settings. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants,” according to NIOSH.

While the list of drugs continues to grow, the proposal does note that some drugs have been removed and that other drugs proposed for addition two years ago were not actually added.

“One highlight is that botulinum toxin (Botox), which had been added to the proposed hazardous drug list in 2018, has now been removed,” notes Patton. “Hospitals that struggle to be compliant with this medication in many outpatient settings will find that removal not adding to their existing regulatory burdens.”

Patton recommends that all the documents in the docket be downloaded and read by potential stakeholders who may want to comment.

The new document on managing drug exposures may be the most significant for healthcare organizations, especially as they ramp to compliance with USP <800> Hazardous Drugs—Handling in Healthcare Settings, says Patton. That USP general chapter became official December 1, 2019, but remains only informational unless adopted by local authorities having jurisdiction.

The update to the 2016 NIOSH list “has been a long time in coming, and it is not finished yet,” pending the newest round of comments, notes Patton.

To add your comments to the process, you must do so by June 30, online, or by mail to NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226-1998. Comments must be identified by docket numbers CDC-2020-0046 and NIOSH-233-C. Remember that comments will be made public, unless you request anonymity.

A.J. Plunkett is editor of Inside Accreditation & Quality, a Simplify Compliance publication.

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