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NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012

NIOSH Scientific Information Quality - Peer Review Agenda

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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
7272 Wisconsin Avenue
Bethesda, MD 20814
Tel: (301) 664-8664
Fax: (301) 634-5764

Bruce Naumann, Ph.D., DABT
Global Safety and the Environment Merck
Two Merck Drive, WS2W-17
Whitehouse Station, NJ 08889-0200
Tel: 908-423-7908
Fax: 908-423-2122

Marty Polovich PhD, RN, AOCN
Duke Oncology Network
3100 Tower Blvd. 600
Chapel Hill, NC 27707
Tel: 919-419-5051

Stephen Gomez, PhD
Safety Assessment-Toxicology
Genentech, Inc.
1 DNA Way MS: 59
South San Francisco, CA 94080-4990
Biotechnology Industry Organization
Tel: 650-225-7746

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
10903 New Hampshire Ave.
Bldg. 22 Room 2310
Silver Spring, MD 20993
Tel: 301-796-1477
Fax: 301-796-9845

Vernon Wilkes (10NB)
Veterans Health Administration
1717 H Street, Rm 423
Washington, DC 20420
Tel: 202-266-4617

Caroline Freeman
Office of the Director
Directorate of Standards and Guidance
200 Constitution Ave, NW
Washington, DC 20210
Tel: 202-693-2294
Fax: 202-693-1678

Melissa A. McDiarmid, MD, MPH, DABT
University of Maryland
School of Medicine
Occupational Health Project
11 S. Paca Street, Second Floor
Baltimore, MD 21201
Tel: 410-706-7464
Fax: 410-706-4078

Michael J. Olson, PhD, ATS
Pharmaceutical Sustainability Council
Director, Occupational Toxicology
Health, Safety & Performance Centre of Excellence
5 Moore Drive CS 1147
Research Triangle Park, NC 27709
Tel: 919-483-5239

Vaiyapuri Subramaniam, Pharm.D, M.S.,FCP, FASHP, FASCP
Associate Chief Consultant
Pharmacy Benefits Management Services (119)
Department of Veterans’ Affairs
810 Vermont Ave. NW
Washington, DC 20420
Tel: 202-461-7363

Holly Carpenter
Senior Staff Specialist
Occupational and Environmental Health
American Nurses Association
8515 Georgia Ave.
Suite 400
Silver Spring, MD 20910
Tel: 301-628-51-5

Charge to Peer Reviewers:

RE: Updating the NIOSH list of hazardous drugs

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 at the Mayflower Hotel 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 to Barbara MacKenzie at

A very useful website is 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.

The proposed changes to the list will then be placed on the NIOSH Docket.