The National Institute for Occupational Safety and Health (NIOSH) published the United States first comprehensive list of drugs that have the potential to cause harm to individuals working with them (a.k.a Hazardous Drugs). In Appendix A of the 2004 NIOSH document Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings the hazardous drug list was presented by generic name with drugs on the list meeting one or multiple characteristics of carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, and/or, structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by these criteria.
The importance of the hazardous drug list has been highlighted by the Joint Commission where they require under Standard 01.01.03 “The organization safely manages high-alert and hazardous medications” under the Element of Performance. “The organization identifies, in writing, its high-alert and hazardous medications. Note: This element of performance is also applicable to sample medications.” The approval of the United States Pharmacopeia Chapter 800: Hazardous Drugs—Handling in Healthcare Settings requires sites under Section 2 List of Hazardous Drugs that sites “must maintain a list of HDs, which must include any items on the current NIOSH list that the entity handles. The entity’s list must be reviewed at least every 12 months”. The overall importance of developing a site specific list is critically important as deemed by the Joint Commission and USP.
Historically, our understanding of hazardous drugs had been limited to antineoplastics/oncology/chemo drugs. The NIOSH list expanded our understanding to the fact that antibiotics (i.e., chloramphenicol), antivirals (i.e., ganciclovir), and oxytocins (i.e., Pitocin) are hazardous to individuals who handle them. The original list was comprised of 136 drugs and since that time NIOSH has updated the list in 2010; 2012, 2014 and just recently in 2016. In each update, the proposed lists are published in the Federal Register for review and input from the public prior to approval/publication.
From the original 2004 list we have seen NIOSH add new drugs, declassify drugs as hazards as evidence has been made available, list non-US approved drugs that may be used in the US, and list key radioisotopes regulated by the Nuclear Regulatory Commission. In the 2016 list we see a new process for classifying the drugs in three groups:
Group 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance;
Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance;
Group 3: Non-antineoplastic drugs that primarily have adverse reproductive effects.
The new classification should assist sites with a better understanding of the risks and assist with developing a strategy for how these drugs should be handled at their site. Table 5 of the NIOSH 2016 Hazardous Drug list provides sites with recommended personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings. This table is key for understanding the proper process and equipment necessary for safety and will make compliance with USP 800 easier to understand.
What steps should sites take with hazardous drugs?
- Download for free and review the 2004 NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings to review how to integrate hazardous drug safety practices with a formulary. Limit the review of Appendix A and defer to the 2016 NIOSH Hazardous Drug list for the most recently approved list. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf
- Download for free and review with a multidisciplinary team the 2016 NIOSH Hazardous Drug list: http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf
- Do a formulary comparison to see which of the drugs on the institution’s formulary are on the NIOSH list.
- Classify the identified drugs on the formulary based on the NIOSH classification system: Antineoplastics; Non-antineoplastics; Reproductive-risk hazardous drugs;
- Purchase and review with a multidisciplinary team USP 800 Chapter Hazardous Drugs—Handling in Healthcare Settings and make the necessary plans for full compliance by July 1, 2018;
- Heed the warning from the NIOSH 2016 Hazardous Drug List “CAUTION: Drugs purchased and used by a facility may have entered the marketplace after the list was assembled. Therefore, this list may not be all-inclusive.” and continually assess new drugs as they are considered for formulary inclusion with a safety review for hazards.
- Continuously educate staff on the hazardous drugs on the formulary and the systems in place to protect them.
- Formally orientate new employees regarding hazardous drugs on the formulary and the systems in place to protect them.
The publication of the 2004 NIOSH Alert with a continuously updated hazardous drug list meets and exceeds the NIOSH mandate of providing “every man and woman in the Nation safe and healthful working conditions and to preserve our human resources.” We are very fortunate to have NIOSH working for the safety of healthcare providers and we must make it a priority to review and embrace the NIOSH documents which have one purpose, our safety.
 NIOSH . NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed October 18, 2016.
 The Joint Commission. Proposed Revisions for Phase I Medication Management Maintenance: Ambulatory Health Care (AHC), Behavioral Health Care (BHC), Critical Access Hospital (CAH), Hospital (HAP), Nursing Care Center (NCC), Office-Based Surgery (OBS), and Home Care (OME) Accreditation Programs. Report Generated by DSSM. Page 13-15. https://www.jointcommission.org/standards_information/prepublication_standards.aspx , Accessed October 16, 2016.
 First Supplement to USP 39-NF 34 Physical Tests/(800) Hazardous Drugs-Handling in Healthcare Settings. August 1, 2016.
 NIOSH . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf Accessed October 18, 2016.