NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Additions and Deletions to the NIOSH Hazardous Drug List
August 2013
NIOSH Docket Number 233, CDC-2013-0007
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 available for public comment entitled “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Additions and Deletions to the NIOSH Hazardous Drug List.”
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 and 2012 and covered all new approved drugs and drugs with new warnings up to December 2009. Between January 2010 and December 2011, 48 new drugs received FDA approval and 276 drugs received special warnings (usually black box warnings) based on reported adverse effects in patients. From this list of 324 drugs, 42 drugs were identified by NIOSH as candidate hazardous drugs. Four of these drugs had safe handling recommendations from the manufacturer and NIOSH is following the recommendations of the manufacturers. Therefore, these four drugs will be listed as hazardous without requiring further review. NIOSH has determined that the remaining 38 drugs have one or more characteristics of a hazardous drug. In addition, NIOSH is recommending the addition of one drug requested by several stakeholders and the removal of one drug from the 2012 Hazardous Drug List.
NIOSH requested public comment on the proposed additions and deletions 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-2013-0007 in the search field and click “Search.”
To view related dockets, see Docket 233-A, 233-B, 233-C.
Background Information
Federal Register Notice: Issuance of Final Guidance Publication ; 9/18/14 [PDF- 172 KB]
Peer Review
Title: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2014
Anticipated Date of Dissemination: September 1, 2014
Subject: Hazardous Drug Exposure in Healthcare Settings
Purpose: To provide healthcare workers and healthcare facilities information on hazardous drugs so that proper handling can be performed to reduce worker exposures.
Timing of Review: December 2012
Primary Disciplines or Expertise Needed for Review: toxicology, industrial hygiene, occupational medicine, oncology nursing practices and pharmacy practices
Type of Review: Panel
Number of Reviewers: 4
Reviewers Selected by: NIOSH
Public Nominations Requested for Review Panel: No
Opportunities for the Public to Comment: Publication of a request for public comments
Peer Reviewers Provided with Public Comments Before Their Review: No
Peer Reviewers
Martha Polovich
Academic and Professional Credentials: PhD, RN, AOCN
Organizational Affiliation: Duke University
Areas of Expertise, Discipline, or Relevant Experience: Oncology Nursing
Recommended by: Scientific or professional association
Wendelyn Schmidt
Academic and Professional Credentials: PhD
Organizational Affiliation: FDA
Areas of Expertise, Discipline, or Relevant Experience: Drug Evaluation
Ted Yee
Academic and Professional Credentials: M.D.
Organizational Affiliation: OSHA
Areas of Expertise, Discipline, or Relevant Experience: Occupational Medicine
Melissa McDiarmid
Academic and Professional Credentials: MD, MPH, DABT
Organizational Affiliation: University of Maryland
Areas of Expertise, Discipline, or Relevant Experience: Occupational Health
Recommended by: NIOSH
Charge to Peer Reviewers
The NIOSH Hazardous Drug Committee has reviewed all new FDA drug approvals and new drug warnings for the period January 2010 through December 2011. The committee reviewed 28 new drug approvals and 71 drugs with new warnings and identified 42 drugs as potentially hazardous. Of these 42, 3 already have safe handling guidance in the drug package insert. Therefore, 39 drugs were identified for review by the expert panel.
The meeting will be in Washington DC, September 13, 2012 and will include the members of the expert panel and NIOSH personnel.
The meeting will provide time for discussion about the individual drugs proposed, and other questions you might have.
We are requesting that, as members of the expert panel, you review the list of drugs that NIOSH suggests be added to the list and provide your evaluations and comments on the Word document provided. Please return your reviews by November 1, 2012.
NIOSH will review all comments from the expert panel and post a list of proposed additions to the Federal Register for public comment. NIOSH will then make decisions about updating the list based on all comments.