In December 2024, the National Institute for Occupational Safety and Health (NIOSH) published its updated NIOSH List of Hazardous Drugs in Healthcare Settings,2024; also known as the NIOSH List. These drugs play a vital role in treating diseases, but healthcare workers who handle or compound these drugs on a daily basis may experience higher and longer-term exposure than many patients. Thus, this publication is essential for keeping workers safe.
As such – and because there is no lead-in period for compliance – now is an important time to review and update standard operating procedures (SOPs) for handling hazardous drugs and to ensure robust training for your staff.
Defining a hazardous drug
NIOSH defines a hazardous drug as one that is:
- Approved for use in humans by the FDA Center for Drug Evaluation and Research (CDER),
- Not otherwise regulated by the US Nuclear Regulatory Commission and
- Either
Includes manufacturer special handling information (MSHI) in the package insert, or
Is identified as containing one or more of the following hazards:
- Carcinogenic,
- Developmental toxicity (including teratogenicity),
- Reproductive toxicity,
- Genotoxicity,
- Organ toxicity at low doses, or
- Mimics the structure or toxicity profile of existing hazardous drugs.
What’s changed in the 2024 NIOSH List of hazardous drugs?
Perhaps the most notable change in the NIOSH List is that there are now only two tables of drugs, instead of three.
Table 1 now includes nonnuclear drugs that are approved through CDER, have MSHI in the package insert and/or meet the NIOSH definition of a hazardous drug, and are either classified by the National Toxicology Program (NTP) as “known to be a human carcinogen” or classified by the International Agency for Research on Cancer (IARC) as Group 1 “carcinogenic to humans” or Group 2A “probably carcinogenic to humans.”
While the AHFS classification of the drug’s therapeutic use still exists in the NIOSH List, it doesn’t determine inclusion in Table 1. If an antineoplastic drug does not have MSHI or is not a carcinogen, it is no longer on Table 1.
Conversely, no longer are all Table 1 drugs are used in the treatment of cancer. For example, Table 1 now includes some immunosuppressive agents, which likely have MSHI, but may not be antineoplastic drugs. In fact, NIOSH moved 15 drugs from Table 2 to Table 1, including estrogens and estrogen combinations, which have been known for years to be carcinogenic.
Table 2 now includes all other hazardous drugs that are nonnuclear, drugs without MSHI in the package insert, and are approved through CDER. These drugs meet one or more of the NIOSH hazardous drug definition criteria but the NTP does not classify them as a “known human carcinogen” and the IARC does not classify them as “carcinogenic to humans” or “probably carcinogenic to humans.”
Many of the drugs from Table 3 in the previous NIOSH List are now in Table 2. And Table 2 is no longer limited to non-antineoplastic drugs. NIOSH does, however, identify drugs in Table 2 that have only met the criteria for a developmental and or reproductive effect.
With these changes in mind, it’s important to know which 35 drugs moved from Table 1 to Table 2. A list of the drugs that changed tables is available in the back of the updated document. Use that information to determine if you want to change how you’ve listed certain drugs and if this necessitates a change in SOPs and previously written assessment of risk documentation.
Other important changes:
- NIOSH added 25 new drugs, but it did not assess drugs the FDA has approved since 2016 – more than 400 new drugs. Until the next update, you can check the NIOSH website for added drugs, as well as the IARC and NTP websites.
- NIOSH removed seven drugs from the prior list, including Bacillus Calmette–Guérin (BCG) vaccine, pertuzumab, and risperidone.
- NIOSH removed Tables 4 and 5. The former Table listed drugs removed between versions; that information is still there, but not in its own table. The latter became the 2023 NIOSH publication: Managing Hazardous Drug Exposures.
- NIOSH added a Biologics License Application (BLA) designation to the list on both tables. These drugs may be proteins, monoclonal antibodies, or conjugated monoclonal antibodies and may require special procedures to protect personnel.
- NIOSH removed the supplemental information column, which provided information about the drug but was not necessarily related to why the drug was listed.
In addition, please note that drugs approved through the Center for Biologic Evaluation and Research (CBER) are not on the NIOSH List. When handling these agents at your organization, personnel will still need to follow special procedures to remain protected. Similarly, NIOSH has not evaluated investigational drugs and drugs with emergency use approvals for inclusion on the NIOSH List.
The impact on USP <800> compliance
Most designated persons and organizational leaders have had time to plan for this release, as the 2020 USP <800> update corresponded to the 2020 NIOSH draft release of the 2024 update. Organizations should now incorporate the new NIOSH List into their own hazardous drug list and review processes accordingly, especially since the changes will likely also affect the existing assessment of risk documentation and, therefore necessitate new handling processes.
Handling any hazardous drug active pharmaceutical ingredients (APIs) and Table 1 antineoplastic drugs that require manipulation, other than counting and repackaging, must follow all handling requirements in USP <800>. This includes negative pressure storage, containment primary and secondary engineering controls, supplemental engineering controls, and personal protective equipment.
All other drugs on the NIOSH List are eligible for an assessment of risk to determine what alternate containment strategies and work practices might be applicable. If you choose not to have an assessment of risk for those eligible drugs, then you have to follow all of the handling requirements found in USP <800>.
For an assessment of risk, USP <800> requires that you include and document:
- Type of hazardous drug: Identify if the drug is on Table 1 or 2, including if the drug is antineoplastic or reproductive risk only
- Dosage form: Tablet, capsule, oral solution, IV, powder for reconstitution, injection not requiring manipulation, or topical
- Risk of exposure to personnel handling the hazardous drug
- Packaging: Unit dose or unit of use may have less risk than bottles, vials, or splitting tablets
- Type of manipulation: Dispensing final dosage form, splitting tablets, opening capsules, pouring liquid, or drawing up oral syringes
These are the five components to consider when assessing the risk of exposure for your workforce and the types of containment strategies or work practices you can implement to minimize or prevent exposure.
Unfortunately, there is no template or formula. Because every organization is different – from the type of facility and tools to the practice settings and patient populations – it’s critical to document the assessments of risk at the facility or system level, where people understand on-the-ground realities.
Finally, remember that personnel must receive training prior to the introduction of a new drug (or new classification of a drug) and remember to consider training based on the job function.
A six-step action plan for responding to the 2024 NIOSH List
Our recent webinar goes into detail about what organizations can do to respond to the NIOSH List release, but below is a high-level overview
- Learn. Read the NIOSH List and related documents and seek out existing webinars on the topic.
- Review your current hazardous drug list. Make changes to align with the new NIOSH List format and add new drugs as appropriate.
- Review your SOPs. At Simplifi, we have 10 SOP templates and we’ve updated six of them to align with the new NIOSH List structure and terminology.
- Conduct your assessments of risk. This begins with looking at your assessment of risk documentation template, as it will likely need some updates, before applying it to your organizational hazardous drug list from Step Two above.
- Identify the hazardous drugs for your workforce. Clearly communicate to personnel which new drugs are hazardous, which drugs need to be handled differently, and what systems need to be updated to reflect the revisions.
- Train. All of these changes will dictate changes to how you train your personnel.
Throughout all six steps of your action plan, clear communication is crucial. The simpler and more straightforward you are in these communications – and the more you take this opportunity to emphasize that everyone has a role in safety – the more likely you’ll garner buy-in and adoption from personnel. That is crucial, not only because there is no lead-in time for compliance, but also because it is the key to keeping personnel safe.
