Safety First Blog

5 Lessons Learned in the USP <800> Trenches

Posted by Laura Paxton on May 9, 2024 7:49:30 AM
Laura Paxton
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Welcome to the Rpharmy School of Hard Knocks, where we wholeheartedly believe that embracing the successes and challenges of others enhances our learning! 

At Rpharmy, our solutions are deployed across hundreds of hospitals. Through our collaborative relationships with these institutions, we have gained deep insights into their challenges and wins. These five lessons learned during the USP <800> compliance process have percolated to the top through these relationships. We hope these insights help as you continue the critical work of protecting healthcare workers from the dangerous effects of hazardous drug exposure.

1.    The Hazardous Drug list is not (I repeat, IS NOT) a subset of the formulary. 

I may be going out on a limb here to say you probably don’t have heroin on your formulary, but perhaps it should be on your hazardous drugs (HD) list. Stay with me. For many emergency departments, illicit drugs like heroin and fentanyl should be considered as additions to the HD list to ensure nurses and clinicians can access the safe handling information they need should they need to treat a patient who brings an illicit drug into the hospital. 

While NIOSH is the legal standard stating which HDs must be on your list, many of our clients include additional HDs such as non-formulary drugs, illicit drugs, prescriptions that patients bring into the facility and investigational drugs. Thanks to their due diligence, Rhazdrugs currently includes 570 hazardous drugs, while NIOSH 2016 and NIOSH 2020 list half that number. Healthcare workers are vulnerable when that patient brings in medication not on your hospital’s formulary or HD list or an illicit drug makes its way into the emergency department. 

Screenshot 2024-04-17 at 3.14.40 PM

Rhazdrugs includes 570 hazardous drugs added by the hundreds of hospitals that have implemented Rhazdrugs. 

2.    We’re compliant, but it’s unsustainable. 

Which is a nice way of saying: “We’re drowning trying to keep up.”

We want to share a story with you.  We have a Formweb customer who helped us write our USP <800> compliance software, Rhazdrugs, back in 2018. When it came time to roll it out in 2019, that customer said, "Hey, thanks, we did it in the EHR already, but good luck!" Ouch, that one hurt. Fast forward to fall 2023, we heard from them again, and here's why: 

●    While switching from NIOSH 2016 to NIOSH 2020, their team was tasked with manually updating each drug in their spreadsheet and then a Word document. 
●    In Epic, every change for each drug required an IT support ticket, resulting in delayed updates. 
●    Keeping up with annual approvals manually became a full-time job that no one had time for. 
●    The nurses HATED the massive spreadsheet with 752 rows. 
●    One of the last straws was that their designated person left. Is anyone shocked?

Long story short, they realized their process, while compliant, was tedious, manual, and unsustainable at the end of the day.  We’re happy to say this hospital’s Rhazdrugs site goes live in May 2024. They are looking forward to Rhazdrugs’ automation, built-in resources, and support from the Rpharmy team. No more going it alone!

3.    Myth: This can all be done by the designated person.

As you can see in the above story, it can be devastating when a designated person leaves because they are often the only one with organizational knowledge around USP <800>.  We’ve heard other horror stories of how complex this process is to manage, individually or as a committee.  After all, this client reached back out to us four years later.  If you’re the designated person in charge of the spreadsheet/word doc/homegrown solution, you understand it.  I’d warrant a guess that you are incredibly proud of it, as you absolutely should be!  We’ve spoken to several clients as part of their build process, and when they show this to their informatics pharmacist or nurses, they say, “Brace yourself.”  

Rhazdrugs not only provides healthcare workers with the HD safe handling information they need but also houses organizational knowledge and automates tasks like annual approvals to ensure nothing slips through the cracks. 

4.    USP <800> is bigger than the pharmacy. 

USP <800> casts a wide net over departments within your organization, including environmental services, shipping/receiving, clinicians, and pharmacists. USP <800> is truly cross-departmental, leading to important questions like: Where does the budget come from? Who needs access and where? What role do legal and risk management play? 

Since this affects your entire health system, we urge you to consider including these departments in the conversation, both in developing your plan and budgeting resources.  After all, they are the frontline workers who need access to this information.

Screenshot 2023-08-28 at 1.37.31 PM-1


5.    Everyone has gaps. Yes, even you. 

As we work through the implementation of Rhazdrugs at hospitals, we inevitably discover gaps in their USP <800> compliance structure. A gap or two will be found no matter how large the USP <800> team or their initial budget.  This is a complex issue, and many guidelines can be interpreted differently. 

Here are some common gaps we have seen. 

●    Transport HD Handling Guides
●    AoRs
●    Incomplete list of HDs
●    Investigational Drugs
●    Disposal
●    Designated Person
●    Surgical Masks vs. N95s
●    Signage

Check out this blog, where we discuss five of the top 10 gaps in detail. We are here to help you find your gaps while setting up your database and defend your interpretations since we think inspectors like the Joint Commission might be asking the same questions we are.  

The bottom line is that we’re all in this together, and the more we share our lessons learned, the better we will be at protecting healthcare workers from exposure to hazardous drugs. If you have a lesson to share, we’d love to hear it. Please email us at  

Topics: Rhazdrugs, Policy, USP <800>, Formweb, News

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