The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. Since its inception, it has been revised to keep up to date with drug development and evolution, and it is undergoing its most recent update. If your pharmacy or facility is involved with hazardous drugs, here are the top three ways the NIOSH update will likely impact your practice.
New drug tables and classifications to understand and track
The basic definition of a hazardous drug has been updated. It is now classified as a drug that:
- Is approved for use in humans by the FDA-CDER, and
- Is not otherwise regulated by the U.S. Nuclear Regulatory Commission, and
- Is accompanied by prescribing information in the package insert that includes a Manufacturer Special Handling Information (MSHI), or
- Is identified as a carcinogenic, developmental, reproductive, genotoxic, or other health hazard
This means that the NIOSH list no longer includes drugs under investigation—you will need to perform an Assessment of Risk (AoR) on those drugs to ascertain appropriate precautions yourself.
Based on this updated definition of hazardous drugs, there have been some major changes to the NIOSH tables. Historically, tables 1, 2 and 3 listed and classified the drugs based on whether they were antineoplastics (Table 1), non-antineoplastics (Table 2) or reproductive-only hazards (Table 3). In the update, NIOSH decided that antineoplastics is no longer the most clear-cut criteria for establishing a list of hazardous drugs; the updated tables use primarily the presence of MSHI and the classification of carcinogenic as their defining criteria. The NIOSH update includes two tables, which are outlined as follows:
- Table 1 includes drugs that:
- Meet the NIOSH definition of Hazardous Drug, and
- Contain an MSHI, and/or
- Are classified by the NTP as a known human carcinogen, and/or
- Are classified by the IARC as carcinogenic or probably carcinogenic.
- Table 2 includes drugs that:
- Meet the NIOSH definition of Hazardous Drug, but
- Do NOT contain an MSHI, or
- Are NOT classified by the NTP as a known human carcinogen, orAre NOT classified by the IACP as carcinogenic or probably carcinogenic
So how were all the drugs on the existing NIOSH list doled out? Based on these criteria, 33 drugs moved from Table 1 to Table 2, 14 drugs moved from Table 2 to Table 1 and 48 drugs moved from Table 3 (which no longer exists) to Table 2. Those drugs that were originally Table 3, and are reproductive hazards only, are identified on Table 2 by blue designation in the supplemental information.
Different Strategies for Assessment of Risk
Understanding the new NIOSH table structure will help you strategize how to move forward with risk assessment, containment strategies, and work practices. The purpose of an AoR is to keep employees safe, based on the NIOSH Hierarchy of Controls.