NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012: Proposed Additions and Deletions to the NIOSH Hazardous Drug List
October 2011
NIOSH Docket Number 190
NIOSH requested comment on proposed additions and deletions to the list of hazardous drugs. NIOSH reviewed the comments from the external reviewers and revised the proposed list to 31 additions, 4 reclassifications and 11 deletions.
Material Under Consideration
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012 [PDF – 672K]
Correction to the Federal Register Notice dated 6/27/12 [PDF – 171K]
Notice of issuance of Final Guidance Publication [PDF – 77K]
Proposed additions and deletions to hazardous drug list and summary of replies to reviewers comments; 1/1/12 [PDF – 220 KB]
Charge to reviewers – 7/19/11 [PDF – 6,008 KB]
Notice of draft document available for public comment; 76 FR 46299; 8/2/11 [PDF – 1,264 KB]
Submissions to the Docket in Order Received
Submission to the docket from de Lemos (British Columbia Cancer Agency/University of British Columbia/Pan-Canadian Oncology Drug Review) – 8/2/11 [PDF – 1,144 KB]
Submission to the docket from Ponto (University of Iowa) – 8/3/11 [PDF – 706 KB]
Submission to the docket from Cole (GE Healthcare) – 8/4/11 [PDF – 423 KB]
Submission to the docket from Brittain (private person) – 8/9/11 [PDF – 542 KB]
Submission to the docket from McElhiney (Indiana University Health) – 8/9/11 [PDF – 544 KB]
Submission to the docket from Beamer (private person) – 8/12/11 [PDF – 6,410 KB]
Submission to the docket from Badry (private person) – 8/15/11 [PDF – 1,557 KB]
Submission to the docket from Folstrom (Eisenhower Medical Center) – 8/15/11 [PDF – 438 KB]
Submission to the docket from private person – 9/27/11 [PDF – 755 KB]
Submission to the docket from McKinney (private person) – 9/27/11 [PDF – 13 KB]
Submission to the docket from Eisenstein (Central Virginia Training Center) – 9/27/11 [PDF – 800 KB]
Submission to the docket from Krause (Central Virginia Training Center) – 9/27/11 [PDF – 776 KB]
Submission to the docket from Burton (Central Virginia Training Center) – 9/28/11 [PDF – 751 KB]
Submission to the docket from Lipscomb (Central Virginia Training Center) – 9/28/11 [PDF – 774 KB]
Submission to the docket from Bower (Eisai, Inc.) – 9/29/11 [PDF – 10,775 KB]
Submission to the docket from McElhiney (Indiana University Health) – 9/30/11 [PDF – 593 KB]
Submission to the docket from Maddox (private person) – 9/30/11 [PDF – 417 KB]
Response to Maddox (private person) from Connor (NIOSH) – 9/30/11 [PDF – 1,294 KB]
Submission to the docket from Rogers (Virginia Department of Behavioral Health and Developmental Services) – 10/1/11 [PDF – 541 KB]
Submission to the docket from McGrath (Bristol-Myers Squibb Co.) – 10/3/11 [PDF – 2,108 KB]
Submission to the docket from Coleman (Theravance, Inc.) – 10/3/11 [PDF – 11,469 KB]
Submission to the docket from Menighan (American Pharmacists Association (APhA)) – 10/3/11 [PDF – 2,068 KB]
Submission to the docket from Topoleski (American Society of Health-System Pharmacists) – 10/3/11 [PDF – 2,601 KB]
Peer review
Title: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012
Subject: NIOSH Hazardous Drug List
Purpose: To provide an update of the list of hazardous drugs in the Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings and NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010.
Timing of Review: December 2009
Primary Disciplines or Expertise Needed for Review: Pharmacy, Nursing, Pharmacology, Toxicology, Occupational Health, Industrial Hygiene
Type of Review: Panel
Number of Reviewers: 10
Reviewers Selected by: NIOSH, ASHP, ONS, ANA, VA, OSHA, FDA, BIO
Public Nominations Requested for Review Panel: No
Opportunities for the Public to Comment: Yes
Peer Reviewers Provided with Public Comments Before Their Review: Yes
Peer Reviewers:
Cynthia Reilly, R.Ph.
Director, Practice Development Division
American Society of Health-System Pharmacists
Bruce Naumann, Ph.D., DABT
Global Safety and the Environment
Merck
Marty Polovich PhD, RN, AOCN
Duke Oncology Network
Stephen Gomez, PhD
Safety Assessment-Toxicology
Genentech, Inc.
S. Leigh Verbois, Ph.D.
Supervisory Pharmacologist
Division of Drug Oncology Products
Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
Vernon Wilkes (10NB)
Veterans Health Administration
Caroline Freeman
Office of the Director
Directorate of Standards and Guidance
OSHA/DOL
Melissa A. McDiarmid, MD, MPH, DABT
University of Maryland
School of Medicine
Occupational Health Project
Michael J. Olson, PhD, ATS
Pharmaceutical Sustainability Council
Director, Occupational Toxicology
Health, Safety & Performance Centre of Excellence
GlaxoSmithKline
Vaiyapuri Subramaniam, Pharm.D, M.S.,FCP, FASHP, FASCP
Associate Chief Consultant
Pharmacy Benefits Management Services (119)
Department of Veterans’ Affairs
Holly Carpenter
Senior Staff Specialist
Occupational and Environmental Health
American Nurses Association
Charge to Peer Reviewers:
The NIOSH Hazardous Drug Committee has reviewed all new FDA drug approvals and new drug warnings for the period since the first update to the list (June 2007) through December 2009. The committee reviewed 69 new drug approvals and 156 drugs with new warnings drugs and identified 49 drugs as potentially hazardous. Of these 49, 7 already have safe handling guidance in the drug package insert. Therefore, 42 drugs were identified for review by the expert panel.
As part of a review of the 2004 list, we are also asking you to reevaluate 5 interferons and one monoclonal antibody.
The meeting will be in Washington DC, September 29, 2010 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 spreadsheet provided. Please return your reviews by November 1, 2010.
A very useful website is http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. You can find PI’s, and FDA approval information including reviews for individual drugs.
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.