Safety First Blog

Breaking Down NIOSH 2024: Antineoplastic Reclassification and Biologic Handling Updates

Posted by Sherlene Christen on Jan 30, 2025 7:49:30 AM

Is it too late to say Happy New Year? Maybe Happy New NIOSH is more appropriate? 🥳

As you know, by the end of 2024, NIOSH delivered a present we’ve been waiting nearly nine years for. This present comes with a bag of screws and nails and that one tool that never works. In other words, we’re happy to have this guidance but it was not without some serious work to get the benefits.

If you’re a Rpharmy customer, we jumped into action and produced a spreadsheet for each client that had organized their list based on the NIOSH 2016 list, showing their current hazardous drug database and the updates required to fall in line with the NIOSH 2024 list. My hope is that this upfront work helped streamline the hazardous drug database update process, saving our Rhazdrugs users hours of manual updates and time spent reviewing the necessary changes in committee meetings.

Suppose you aren’t a Rhazdrugs customer yet. In that case, we sympathize with how overwhelmed you feel as you face the effort required to manually update your hazardous drug list, reorganize tables, and update (possibly hundreds of) Assessments of Risk and your EHR platforms. We do have a solution and are here to help. We’ve got you! 

Let's take a quick look at what’s new in NIOSH 2024. 

#1 NIOSH added 17 new drugs and removed seven drugs. We’ll get this one out of the way first because it was a nothing burger of a change. The clients who were working off of the NIOSH 2020 draft had already removed or added these drugs. 

#2  NIOSH has decided that moving forward, they will not review any biologics or drugs approved by the FDA's CBER (Center for Biologics Evaluation and Research) division. This significant change requires a more individualized approach.

Many clients we know will keep viral vectors such as BCG and other biologics on their hazardous drugs list because they are made with live viruses or human cells and have the potential to carry infectious diseases and, therefore, require stringent handling protocols. Consider this: Even autologous stem cells can be carcinogenic due to previous chemotherapy treatment. Mom knew best when she said, “Put that down; you don’t know where it’s been.” 

In fact, the handling requirements for biologic and cellular/gene therapy products are often more stringent than those for traditional hazardous drugs. Many require dedicated rooms, terminal clean procedures, and enhanced personal protective equipment, leading many of our clients to add an additional table for these non-classified drugs. 

With this update, Table 3 no longer houses drugs with reproductive risks, as those have been added to Table 2 and a column on the list that indicates their reproductive risk hazard. Some of our clients are noting this in the handling information, requiring additional PPE for staff in the reproductive category (pregnant, breastfeeding, or trying to conceive). Remember, the most important thing is to protect your people. 

#3 Antineoplastics are now included in Tables 1 and 2. They are differentiated based on their carcinogenicity and whether the package insert contains MSHI (manufacturer-suggested handling information). This is the most impactful change, as healthcare systems must evaluate newly FDA-approved drugs. 

This change is meant to address complaints about the broad term “antineoplastic.” However, it is confusing because it requires a deeper investigation into the drug's Manufacturer Special Handling Information (MSHI) and carcinogenicity, which can often take years to publish for new drugs, as many of these drugs are fast-tracked through the drug approval process with not enough information to categorize toxicities.

So, what can you do in the lag between FDA approval and MSHI? 

Most of our clients use a "look-alike" method to classify new drugs based on properties similar to those of existing ones. If there are any questions, it’s safest to place a new drug in Table 1. This is really just a band-aid, but these may be your only options when you need safe handling instructions.  

The overall feeling we’re getting from clients is a combination of “Yeah, we knew this was coming” and “Deep sigh, I have to update a lot of AoRs and other documentation.” Again, the two things we stand by when it comes to your hazardous drugs database are: 1. Whatever you do, protect your people first. 2. We’re here to help because we care about protecting healthcare workers as much as you do. 

If you have questions or input on what changes are most important or challenging to your organization, please email us at info@rpharmy.com

Topics: Rhazdrugs, Policy, USP <800>, Technology, NIOSH

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