NIOSH Update to the Hazardous Drug List (Appendix A)

Document

• NIOSH Update to the Hazardous Drug List (Appendix A)

Related Materials

• Peer Reviewers’ Comments [PDF 32 KB]
• Response to Peer Reviewers’ Comments [PDF 32 KB]

Required Elements for Initial Public Posting

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
Academic and Professional Credentials: R.Ph.
Organizational Affiliation: Director, Clinical Standards and Quality Practice, Standards and Quality Division; American Society of Health-System Pharmacists
Areas of Expertise, Discipline, or Relevant Experience: Pharmacy
Recommended by: Scientific or professional association

Bruce Naumann
Academic and Professional Credentials: Ph.D., DABT
Organizational Affiliation: Occupational and Environmental Health Sciences
Merck & Co., Inc.
Areas of Expertise, Discipline, or Relevant Experience: Pharmacology
Recommended by: NIOSH

Marty Polovich
Academic and Professional Credentials: MN, RN, AOCN
Organizational Affiliation: Duke University
Areas of Expertise, Discipline, or Relevant Experience: Nursing
Recommended by: NIOSH

Katie Slavin
Academic and Professional Credentials: BSN, RN
Organizational Affiliation: American Nurses Association
Areas of Expertise, Discipline, or Relevant Experience: Nursing
Recommended by: Scientific or professional association

Debora Van der Sluis
Academic and Professional Credentials: Ph.D.
Organizational Affiliation: Senior Manager, Product Stewardship Programs
Environment, Health and Safety
Genentech, Inc.
Biotechnology Industry Organization
Areas of Expertise, Discipline, or Relevant Experience: Biotherapy
Recommended by: Scientific or professional association

S. Leigh Verbois
Academic and Professional Credentials: Ph.D.
Organizational Affiliation: Pharmacologist
Division of Drug Oncology Products, FDA
Areas of Expertise, Discipline, or Relevant Experience: Pharmacology
Recommended by: Scientific or professional association

Vernon Wilkes
Academic and Professional Credentials: I.H.
Organizational Affiliation: Veterans Health Administration
Areas of Expertise, Discipline, or Relevant Experience:
Recommended by: Scientific or professional association

Caroline Freeman
Academic and Professional Credentials: MPH
Organizational Affiliation: Office of the Director
Directorate of Standards and Guidance
OSHA/DOL
Areas of Expertise, Discipline, or Relevant Experience: Occupational health
Recommended by: Scientific or professional association

Melissa A. McDiarmid
Academic and Professional Credentials: MD, MPH
Organizational Affiliation: University of Maryland
School of Medicine
Occupational Health Project
Areas of Expertise, Discipline, or Relevant Experience: Occupational Health
Recommended by: NIOSH

Chuck Schwartz
Academic and Professional Credentials: Ph.D., DABT
Organizational Affiliation: Director, Toxicology and Hazard Communication
Pfizer Global Environment, Health, and Safety, PhRMA
Areas of Expertise, Discipline, or Relevant Experience: Toxicology
Recommended by: Scientific or professional association

Charge to Peer Reviewers:

Invitation to Reviewers for the NIOSH Hazardous Drugs List Update

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