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USP <800> Crash Course

USP General Chapter <800> is a set of guidelines for manipulation and handling of Hazardous Drugs (Hazardous Drugs = harmful to people). CMS and other regulatory bodies adopt the guidelines developed by USP into their regulations, (Just like USP <797> gave us regulations about syringe labeling and the "one hour rule"). This chapter goes live December 1, 2019. That means we have roughly 6 months to become compliant. USP <800> tells us how we have to handle hazardous drugs from the moment they enter your facility. Pretend you've just received a shipment of Mitomycin at your loading dock and mentally walk that drug through every area and person who would come into contact with it from unpacking, to storage, to preparation, to administration, to disposal, all the way to when the waste is removed from the center. USP <800> tells us how we have to handle the hazardous drug during every single step.

So how do I know what to do? I recommend scanning USP <800> for a general understanding of what is expected. There are a lot of parts of USP <800> that will not apply to outpatient surgical facilities. HOWEVER, that is because you're going to limit use to hazardous drugs in final dose form (repeat that with me... final dose form!) Final dose form means that the hazardous drugs will NOT be mixed or manipulated by your staff. It means that you will receive your hazardous drugs in a ready-to-administer form and will risk minimal exposure to staff. This is very important. Most outpatient surgical facilities do not have the means to comply with the full USP <800> chapter, (like having a full time pharmacist on staff to mix HD under a laminar flow hood in a controlled environment). However, the chapter explains how facilities restricting use to final dose form can be compliant.

Getting ready for USP <800> Over the next several months, I will continue to revisit USP <800> in a series of my Tuesday Talks with John. Over the coming months I will go through the different areas of preparedness. Here's a rough outline of everything you will have to do for USP <800> compliance:

  1. Evaluate your formulary to determine whether there are any hazardous drugs used at your facility

  2. Perform a risk assessment for every hazardous drug at your center.

  3. Purchase personal protective equipment for hazardous drugs, depending on the type of exposure risks identified.

  4. Ensure proper disposal bins are available

  5. Install signage, if applicable

  6. Provide training to all staff who have contact with hazardous drugs (including materials management)

  7. Perform competencies on trained staff

  8. Approve special policies called Standard Operating Procedures (SOPs) for use of hazardous drugs

  9. Provide all staff with a disclaimer stating that if they come into contact with hazardous drugs, they risk exposure (we will discuss more on this topic later)

I recommend you get started with step ONE. Highlight all the drugs on your formulary that are hazardous. If you're unsure, consult the NIOSH list of Hazardous Drugs for Healthcare. Simply hit the "ctrl+f" keys on your keyboard to use the "find" feature, type in a drug, and see if it's on the NIOSH list.

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