NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced the availability of the following draft document for public comment entitled “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016.”

The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004. This Alert contained Appendix A which was a list of drugs that were deemed to be hazardous and may require special handling. This list of hazardous drugs was updated in 2010, 2012, and 2014 and covered all new approved drugs and drugs with new warnings up to December 2011. Between January 2012 and December 2013, 60 new drugs received FDA approval and 270 drugs received special warnings (including black box warnings) based on reported adverse effects in patients. From this list of 330 drugs, 44 drugs were identified by NIOSH as potential hazardous drugs. In addition to these 44 drugs, the panel members were asked to comment on the addition of one drug requested by several stakeholders. Three drugs had safe handling recommendations from the manufacturer and NIOSH is following these recommendations. Therefore, these 3 drugs will be listed as hazardous without requiring further review. A panel consisting of peer reviewers and stakeholders was asked to review and comment on the 45 potentially hazardous drugs. Reviewers were not asked to provide a consensus opinion and NIOSH made the final determination regarding proposed additions to the 2016 hazardous drug List. NIOSH has determined that the remaining 34 drugs have one or more characteristics of a hazardous drug. Five of the 34 drugs have safe handling recommendations from the manufacturers.

NIOSH requested public comment on the proposed additions to the list of antineoplastic and other hazardous drugs as to the appropriateness of listing these drugs. To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2015-0034 in the search field and click “Search.”

To view related dockets, see Docket 233, 233-B, 233-C.

Peer Review

Title: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016

Subject: NIOSH Hazardous Drug List

Anticipated Date of Dissemination: April 2016

Purpose: Aid healthcare organizations to determine their handling requirements for hazardous drugs

Timing of Review: October 2014

Primary Disciplines or Expertise Needed for Review: Pharmacy, Nursing, Pharmacology, Occupational Health

Type of Review: Panel

Number of Reviewers: 4

Reviewers Selected by: NIOSH

Public Nominations Requested for Reviewers: No

Opportunities for the Public to Comment: Yes

Peer Reviewers Provided with Public Comments Before Their Review: No

Peer Reviewers:

Martha Polovich, PhD, RN, AOCN
Georgia State University
Areas of Expertise: Oncology, Clinical practice, Nursing, Safe handling of hazardous drugs
Recommended by: NIOSH

Melissa A. McDiarmid, MD, MPH
University of Maryland
Areas of Expertise: Occupational health, Oncology
Recommended by: NIOSH

Wendelyn Schmidt, PhD
Food and Drug Administration
Areas of Expertise: Pharmacology
Recommended by: NIOSH

Michael Hodgson, MD, MPH
Occupational Safety and Health Administration
Areas of Expertise: Occupational health
Recommended by: NIOSH

Charge to Peer Reviewers

The NIOSH Alert: “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings” was published in September 2004. This Alert contained Appendix A which was a list of drugs that were deemed to be hazardous and may require special handling. This list of hazardous drugs was updated in 2010, 2012 and 2014 and covered all new approved drugs and drugs with new warnings up to December 2011.

Between January 2012 and December 2013, 60 new drugs received FDA approval and 270 drugs received new warnings based on reported adverse effects in patients. From this list of 330 drugs, 44 drugs were identified by NIOSH as potentially hazardous drugs.

We are requesting that, as members of the expert panel, you review and comment on this list of 44 drugs. In addition, please review and comment on one additional drug requested by several stakeholders. Please submit your evaluations and comments on the complete list of 45 potentially hazardous drugs on the provided spreadsheet.

NIOSH will review all comments from the expert panel and post a list of proposed additions and deletions to the Federal Register for public comment. After the public comment period, NIOSH will make decisions about updating the list of hazardous drugs taking into account all peer, stakeholder, and public comments.

The NIOSH definition of hazardous drug can be found in the 2004 NIOSH Alert Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings in Appendix A.

You can find Package Inserts and FDA approval information, including reviews for individual drugs at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.