You’ve probably heard about the new USP chapter 800 Hazardous Drugs – Handling in Healthcare Settings, but have you been reluctant to dive in and make changes since the initial official date for compliance has been delayed? (The current expected official date is December 1, 2019.)
Even with the pressure off from the initial deadline, remember: the goal of this new chapter is to protect your staff and patients from harm—and, in turn, protect you from liability. Resolve to get a head start on safety for your staff and patients now, and take the first step by looking at some of the key elements of USP 800 that may drive changes to your facility.
Hazardous and nonhazardous compounding need to occur in separate buffer rooms with few exceptions. These buffer rooms also need to be accessed through an ante-area—they cannot be accessed directly from the corridor. If you have a smaller Pharmacy, you may currently have your drug storage—both hazardous and nonhazardous--as well as your primary engineering control (such as a biosafety cabinet or glove box) all in one room. If this is your current state, you might experience the most heartache with moving into compliance with USP 800—from the need for additional space, equipment, mechanical ventilation, etc.—but you also likely have one of the riskier Pharmacy working environments. Divide (those spaces) and conquer!
Unpacking & Storing
The care of hazardous drug handling in healthcare settings isn’t just limited to compounding activities. The new standards aim to maintain safety from receipt through use and disposal. This includes guidance on activities such as unpacking and storage which have typically occurred within the overall Pharmacy space. Unpacking must occur in a room that has a neutral or negative pressure relationship to adjacent spaces to prevent any particulates from entering adjacent spaces. Pharmacies have typically had a positive pressure relationship with adjacent spaces, so you’ll need to make some modifications to your mechanical systems if you plan to continue unpacking your hazardous drugs within the Pharmacy.
The storage of hazardous drugs must now be separate from nonhazardous drugs, and the storage space must also be negatively pressurized. This applies to both refrigerated and non-refrigerated drugs. Depending on your Pharmacy size and staffing, this typically leads to one of two approaches:
- Provide a separate room for hazardous drug storage that is negatively pressurized, or
- Provide enough space in your hazardous buffer room for the storage of hazardous drugs as this room also requires negative pressurization. This creates more surfaces to clean within the buffer room, but it may be worthwhile at sites with lower staffing if you can create a leaner workflow by minimizing the donning and doffing of PPE to retrieve drugs.
Space for Standard Operating Procedures (SOPs)
Yes, USP 795 and 797 still get their due for providing standards to minimize drug contamination, so the standards you’re already familiar with in terms of ISO class requirements, facility design and cleaning requirements still apply here. USP 800 layers on requirements for facilities to create SOPs specifically regarding the handling of hazardous drugs and offers some recommendations. These processes may require a bit of extra space in the ante and buffer rooms. For example, a line of demarcation (LOD) controls the extent to which a cart can be pushed into the ante-area without requiring additional cleaning. This allows staff to move the cart between the Pharmacy space and the “dirty” side of the ante-area without spending extra time cleaning the cart, but there must be adequate space to maneuver the cart while still allowing for circulation on the “clean” side without crossing the LOD. Providing adequate space for your standard operations will help promote operational compliance and enhance safety for your staff.