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

Required Elements for Initial Public Posting

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

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 (/niosh/docs/2004-165/). 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 (/niosh/docs/2014-138).

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. The link to the Alert is /niosh/docs/2004-165/

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

Peer Reviewers

1. Martha Polovich
   Academic and Professional Credentials: PhD, RN, AOCN
   Organizational Affiliation(s): Georgia State University
   Areas of Expertise, Discipline, Relevant Experiences: Oncology, Clinical practice, Nursing, Safe handling of hazardous drugs
   Recommended by Scientific/Professional Society or General Public: NIOSH
2. Melissa A. McDiarmid
   Academic and Professional Credentials: MD, MPH
   Organizational Affiliation(s): University of Maryland
   Areas of Expertise, Discipline, Relevant Experiences: Occupational health, Oncology
   Recommended by Scientific/Professional Society or General Public: NIOSH
3. Wendelyn Schmidt
   Academic and Professional Credentials: PhD
   Organizational Affiliation(s): Food and Drug Administration
   Areas of Expertise, Discipline, Relevant Experiences: Pharmacology
   Recommended by Scientific/Professional Society or General Public: NIOSH
4. Michael Hodgson
   Academic and Professional Credentials: MD, MPH
   Organizational Affiliation(s): Occupational Safety and Health Administration
   Areas of Expertise, Discipline, Relevant Experiences: Occupational health
   Recommended by Scientific/Professional Society or General Public: NIOSH