Stay compliant with the updated NIOSH Hazardous Drug List 2024. Explore a six-step action plan to update SOPs, assess risks, and ensure staff safety.
In December 2024, the National Institute for Occupational Safety and Health (NIOSH) published the updated NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, with no lead-in period for compliance. Organizations that handle or compound these drugs must respond by reviewing and updating standard operating procedures (SOPs) and assessments of risk for handling hazardous drugs – and ensure robust training for staff.
With that in mind, the Simplifi+® team at Wolters Kluwer has created a six-step action plan to help organizations respond effectively and efficiently to the NIOSH List changes. Clear, effective communication is essential throughout this plan. The goal, as always, is to keep personnel safe.
Step one: Learn about the updates to the hazardous drug list
Begin by reading the NIOSH List and related documents. In addition, there are several webinars available online, including our own, a joint USP-NIOSH webinar, and an ASHP podcast. Together, these items provide a foundation of knowledge on which to build your action plan.
Step two: Review your current hazardous drug list
To align your facility hazardous drug list with the new NIOSH List format, we suggest the following:
1. Add any new drugs to your list.
2. Remove any drugs that merit removal, but consider the removals carefully.
- Take the case of Bacillus Calmette–Guérin (BCG) vaccine. BCG was removed from the NIOSH List because it is a biologic agent, not because it isn’t hazardous. BCG has MSHI in the package insert, if personnel are handling this agent, you likely want to leave it on your list and provide appropriate training.
3. Consider which drugs are now good candidates for an assessment of risk.
- Drugs that moved from Table 1 to Table 2 should have an assessment of risk if you are not handling these agents with full USP <800> requirements. Make a list of the drugs in your facility that moved from Table 1 to Table 2, including the dosage forms, then perform an assessment of risk .
- Drugs that moved from Tables 2 and 3 to Table 1 probably only need a new assessment of risk template, but you will need a plan to assess for full containment requirements.
4. Identify where hazardous drugs live in your facility, especially if it’s been a while since you’ve examined the hazardous drug life cycle: receiving, storage, compounding, dispensing, administration, and disposal. Are there any new locations? Will you have enough shelf space or refrigerators to store these drugs appropriately?
5. Consider hazardous drugs that have been approved since 2016 and, are not on the 2024 NIOSH List. If you don’t have a process for this now, maybe make these “new” drugs Phase Two, after you’ve worked through the rest of the action plan because you’ll probably learn a lot through this review.
Communication tip: This is a good point to let your personnel know changes are coming and that you’ve got a project plan to keep personnel safe in accordance with the NIOSH List updates.
Step three: Review and update your facility policies and SOPs
The new NIOSH List format and terminology will demand changes to your facility policies and SOPs. At Simplifi, for example, we needed to update six of our 10 SOP templates.
The good news is that you’ve likely already begun this process, as the 2020 USP <800> update requires organizations to review their SOPs annually. As you conduct this new review in response to the NIOSH List release, consider the last time you reviewed your hazardous drug SOPs and how thorough that review was. This may be a good time to go beyond a focus on NIOSH List, to a broader policy content review. Perhaps this review can serve as your new index date for annual policy reviews. Either way, it is essential that you document the review and the approval date.
Communication Tip: In health systems, the pharmacy typically owns any medication-related policies and is, therefore, responsible for communication. For other system policies that impact nursing or the environment of care, you may need to ask other stakeholders to update them.
Step four: Conduct your assessments of risk
For this action plan, it’s likely that assessments of risk will take up the bulk of your organization’s time and energy.
Begin by looking at your assessment of risk documentation template. It will likely need some updates for the terminology changes, and there might be some other things you want to document now. Once you’ve updated the template, go back to the list from Step Two of this plan and start working your way down.
Perhaps start with drugs that are no longer eligible for an assessment of risk because they will need full containment. Document those agents and cross them off your list.
Move on to the new assessment of risk list. For efficiency’s sake, consider if there are similar drugs, drug classes, or dosage forms that you can reference for similar assessments. This can help standardize your approach with consistent containment strategies and work practices. For example, Table 2 drugs that need to be crushed prior to administration could be handled generally in the same way, as long as the other elements of the assessment of risk are valid and consistent.
For health systems in particular, as you review the list, think beyond your inpatient formulary. Hazardous drugs can enter the system or be handled in multiple ways. How will pharmacy or nursing staff handle a patient’s own hazardous drug medication? How will a retail or specialty pharmacy dispense this drug?
Step five: Identify the hazardous drugs for your workforce
Once you’ve worked through the SOPs and assessments of risk, the next step is letting your entire workforce know about any new hazardous drugs and about any changes you’ve made to handling particular drugs.
Consider what systems you need to update to reflect the revisions. Again, strong, clear, thoughtful communication is essential here.
- At a minimum, make your hazardous drug list visible and place it at the point where staff members need to know about hazardous drug precautions.
- Update any printed job instructions. Use technology like QR codes to link to more information.
- Update software tools as needed, such as medication administration and electronic medical record instructions.
- Consider any changes that might help with storage, transport, and labeling. Where drugs are stored and transported, there should be clear signage, much of which is readily available from online vendors.
Step six: Training on the NIOSH hazardous drug list 2024 updates
Last, but certainly not least, any changes to SOPs, assessments of risk, and labeling of hazardous drugs require changes in training personnel.
The first and simplest step is that all staff training must include an overview of the facility's hazardous drug list and related SOPs.
Compounding staff and nursing staff may need additional training based on changes to your assessments of risk and any new drugs in your facility. Depending on the scope of changes at your organization, an interim update via email or staff meeting may be enough, but if you have annual learning modules, don’t forget to update that content as well, which may take a little longer. Importantly, document every change you make.
The 2024 NIOSH List changes require action now for facilities that handle hazardous drugs. Following this six-step action plan will assist you in staying organized and responding effectively and efficiently to the NIOSH List changes. Clear communication of changes is crucial. Keep it simple and answer common questions about drugs that have been removed or have new classifications. In addition, use this opportunity to reiterate that both the NIOSH List and USP <800> are designed to keep personnel safe and that the best way to keep personnel safe is for everyone to do their part.
