2016 Updates to the NIOSH Hazardous Drug List

July 2017 - Vol.14 No. 7 - Page #36
Categories: Biological Safety Cabinets, CAIs/CACIs (Compounding Aseptic Isolators & Compounding Aseptic Containment Isolators) , Closed System Drug-Transfer Devices (CSTDs), PPE/Garb & Gloves

Preventing health care worker exposure to hazardous drugs (HDs) is a critical goal for all organizations, the importance of which is felt more acutely as the July 1, 2018 implementation date for USP <800> Hazardous Drugs—Handling in Healthcare Settings rapidly approaches.1 USP, as well as the American Society of Health-System Pharmacists,2 The National Institute for Occupational Safety and Health (NIOSH),3 and the Oncology Nursing Society4 provide guidance to assist facilities in protecting those employees who come into contact with HDs.

NIOSH defines an HD as any drug identified by at least one of the following characteristics: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans (< 10 mg/day), genotoxicity, or new drugs that mimic existing HDs in structure or toxicity.3 The NIOSH Alert, Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, published in 2004,5 included a sample list of HDs. This list was compiled from information supplied by organizations with lists of HDs used at their institutions, as well as the Pharmaceutical Research and Manufacturers of America (PhRMA). Since its initial publication, the list has been updated in 2010, 2012, and 2014; the 2016 update was published this past September. This latest update includes a review of the 2004 list and adds 34 drugs to the list, five of which have safe-handling recommendations from their manufacturers (see TABLE 1).3 After the 2016 update was released, one additional drug was added (trabectadin), as its manufacturer recommends that it be handled as an HD, and one drug (telavancin) was removed from the list, as it has been determined not to meet the NIOSH definition of an HD.6

Click here to see TABLE 1.

Starting with the NIOSH list, each organization must create its own list of drugs considered to be hazardous, based on the organization’s formulary. More information about how to compile this list is available in reference 3 (see section entitled How to Generate Your Own List of Hazardous Drugs). The Occupational Safety and Health Administration (OSHA) hazard communication standard [29 CFR 1910.1200] requires a written program including a list of chemicals (in this case, HDs) that meet the hazard communication definitions for hazardous, proper labeling, and adequate staff training.3,7

The actual risk to health care workers depends on a drug’s toxicity, how the drug enters the body (ie, dermal, inhalation, or ingestion), and how the drugs are handled (eg, how they are manipulated, how often they are handled, and the type of engineering controls and PPE in place).3 NIOSH provides useful guidance on engineering controls and PPE for HD handling in a number of common scenarios encountered in health care settings (see TABLE 2).

Click here to see TABLE 2.


Health care organizations that handle HDs should review the 2016 NIOSH list to identify which of the drugs on the list are used in their facilities. Once those have been identified, assess the risk to health care workers and determine what type of engineering controls, PPE, and training are required to protect staff from exposure.


  1. United States Pharmacopeial Convention, Inc. <800> Hazardous Drugs—Handling in Healthcare Settings.
  2. Am J Health-Syst Pharm. 2006;63(12):1192-1193.
  3. NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. DHHA (NIOSH) Publication Number 2016-161 (Supersedes 2014-138).
  4. Polovich M, ed. Safe Handling of Hazardous Drugs. 2nd ed. Pittsburgh, PA: ONS, 2011.
  5. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf.
  6. www.cdc.gov/niosh/docs/2016-161/.
  7. www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099.

Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine. She can be reached at jkarpinski@ridgewoodmedia.com.


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