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Hazardous Drug Alert
April 2009
NIOSH Docket Number 105-A
Summary: The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (CDC) requested comments on proposed additions and deletions to the list of hazardous drugs (Appendix A). The NIOSH Alert was published in September 2004 (/niosh/docs/2004-165/). Following the publication of the Alert, NIOSH reviewed 70 new FDA-approved drugs and approximately 60 that had received special warnings. NIOSH developed a list of approximately 60 drugs that appeared to fit the NIOSH definition for a hazardous drug. Following a public meeting [72 FR 33507], NIOSH posted the proposed list in the Federal Register in July 2007. NIOSH then convened a panel of 10 external reviewers to review the NIOSH list and the public comments. NIOSH reviewed the comments from the external reviewers and revised the proposed list to 24 additions and one deletion.
Docket Number 105 is a collection of documents related to the development and progress of this Hazardous Drug Alert.
Related Docket
Final Document Information
Notice; 75 FR 57044; Final Document announcement; 9/17/10 [PDF – 2,812 KB]
Final document “NIOSH List of Antineoplastic and other Hazardous Drugs in Healthcare Settings, 2010;” 9/1/10 [PDF – 13,255 KB]
Material under Evaluation
74 FR 19570; Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List; 4/29/09 [PDF – 1.70 MB]
Draft Proposed Additions and Deletions to Appendix A of NIOSH Alert on Hazardous Drugs (April 6, 2009); 4/6/09 [PDF – 696 KB]
NIOSH Response to Peer Review Comments (April 6, 2009); 4/6/09 [PDF – 2.95 MB]
Summary of comments received through NIOSH Docket with NIOSH responses; 4/6/09 [PDF – 2.95 MB]
Submissions in order of Receipt
Submission to NIOSH Docket from Thomas Rogers (MD Anderson Cancer Center, Orlando, FL); 5/5/09 [PDF – 375 KB]
Submission to NIOSH Docket from Katie Slavin and Nancy Hughes (American Nurses Association); 5/8/09 [PDF – 781 KB]
Submission to NIOSH Docket from Kay Howard (Upstate Medical University, NY); 5/14/09 [PDF – 406 KB]
Submission to NIOSH Docket from Mark Crosby (Intermountain Home Care); 5/14/09 [PDF – 193 KB]
Submission to NIOSH Docket from Linda McElhiney (Clarian); 5/15/09 [PDF – 274 KB]
Submission to NIOSH Docket from Holly McKillop (Huron Regional); 5/25/09 [PDF – 312 KB]
Submission to NIOSH Docket from Noreen Kishimoto (Kaiser Permanente of Colorado); 6/10/09 [PDF – 280 KB]
Submission to NIOSH Docket from Marie Dimicco (Westchester Medical Center); 6/16/09 [PDF – 402 KB]
Submission to NIOSH Docket from Bruce Chaffee and James Stevenson (University of Michigan Health System); 6/23/09 [PDF – 3.06 MB]
Submission to NIOSH Docket from Justine Coffey (American Society of Health- System Pharmacists); 6/24/09 [PDF – 1.58 MB]
Submission to NIOSH Docket from Elizabeth Treanor (BioPharma EHS Forum); 6/29/09 [PDF – 1.16 MB]
Submission to NIOSH Docket from Michael Cuozzo (Centocor Ortho Biotech Services, LLC); 6/30/09 [PDF – 1.55 MB]
Submission to NIOSH Docket from Gene Murano (Genentech); 6/30/09 [PDF – 1.85 MB]
Submission to NIOSH Docket from Sara Radcliffe (Biotechnology Industry Organization); 6/30/09 [PDF – 2.66 MB]
Submission to NIOSH Docket from Ellen Faria (Johnson & Johnson); 8/7/09 [PDF – 4,171 KB]
Submission to NIOSH Docket from Mariska Kooijmans-Coutinho (Biogen Idec) w/references; 1/13/10 [PDF – 4,819 KB]
Reference #1 – Avonex US Full Prescribing Information, 2008 [PDF – 657 KB]
Reference #4 – Avonex 23rd periodic safety update report, May 17 to November 16, 2009. [PDF – 4 KB]
Reference #5 – March of Dimes (Accessed at http://www.marchofdimes.com) [PDF – 215 KB]
Reference #6 – American College of Obstetrics and Gynaecology (Accessed at http://www.americanpregnancy.org/) [PDF – 147 KB]
Peer review
Title: NIOSH Update to the Hazardous Drug List (Appendix A)
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
Timing of Review: December 2007
Primary Disciplines or Expertise Needed for Review: Pharmacy, Nursing, Pharmacology,
Toxicology, Occupational Health, Industrial Hygiene
Type of Review: Panel
Number of Reviewers: 4-10
Reviewers Selected by: NIOSH, ASHP, ONS, ANA, VA, OSHA, FDA, PhRMA, and BIO
Public Nominations Requested for Reviewers: 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, Clinical Standards and Quality Practice, Standards and Quality Division
American Society of Health-System Pharmacists
Areas of Expertise: Pharmacy
Recommended by: Scientific or professional association
Bruce Naumann, Ph.D., DABT
Occupational and Environmental Health Sciences
Merck & Co., Inc.
Areas of Expertise: Pharmacology
Recommended by: NIOSH
Marty Polovich, MN, RN, AOCN
Duke University
Areas of Expertise: Nursing
Recommended by: NIOSH
Katie Slavin, BSN, RN
American Nurses Association
Areas of Expertise: Nursing
Recommended by: Scientific or professional association
Debora Van der Sluis, Ph.D.
Senior Manager, Product Stewardship Programs
Environment, Health and Safety
Genentech, Inc.
Biotechnology Industry Organization
Areas of Expertise Biotherapy
Recommended by: Scientific or professional association
S. Leigh Verbois, Ph.D.
Pharmacologist, Division of Drug Oncology Products
Food and Drug Administration
Areas of Expertise: Pharmacology
Recommended by: Scientific or professional association
Vernon Wilkes, I.H.
Veterans Health Administration
Areas of Expertise:
Recommended by: Scientific or professional association
Caroline Freeman, MPH
Office of the Director, Directorate of Standards and Guidance
Occupational Safety and Health Administration
Areas of Expertise Occupational health
Recommended by: Scientific or professional association
Melissa A. McDiarmid, MD, MPH
University of Maryland, School of Medicine
Occupational Health Project
Areas of Expertise: Occupational Health
Recommended by: NIOSH
Chuck Schwartz, Ph.D., DABT
Director, Toxicology and Hazard Communication
Pfizer Global Environment, Health, and Safety, PhRMA
Areas of Expertise: Toxicology
Recommended by: Scientific or professional association
Charge to Peer Reviewers:
The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004. Since that time, approximately 70 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. An additional 18 drugs were included from the updated NIH Hazardous Drug List. From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. NIOSH has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. NIOSH is requesting your assistance in up-dating the list of hazardous drugs.
The reviewers will be requested to take part in the following process:
- Review proposed NIOSH changes to the hazardous drug list.
- Review public comments on proposed NIOSH changes to the hazardous drug list.
- Take part in a one-day public meeting in Washington, DC on August 28, 2007.
- Review comments from the public meeting.
- Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting.
- Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting.
The reviewers will be required to sign a conflict of interest form and to provide their individual reviews to NIOSH. NIOSH is not seeking a consensus opinion from the reviewers as a group.