by Derek Veilleux
Pharmacies around New England are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800 by July 1, 2018. The mile markers are slipping by, but wherever you are on the road to compliance, it’s not too late to consider your options.
What is USP 800 and does it apply to me?
Aimed at improving employee and patient safety, environmental protection and drug quality, USP 800 was approved by the US Pharmacopeial Convention in 2016 to establish practice and quality requirements for the handling and preparation of hazardous drugs. USP 800 defines handling as any of the following: receiving, storing, dispensing, compounding, and disposing of hazardous drugs. Even if you do not compound hazardous drugs, USP 800 regulates how you receive, store, and dispense them. Compliance will be mandatory July 1, 2018.
These changes to regulations will affect USP 797, for which revisions are now out for review and comment. In addition to moving hazardous drug handling to USP 800, USP 797 will also recategorize and consolidate the current CSP microbial risk categories of low, medium, and high risk into risk categories 1 and 2. Category 1 drugs have a shorter beyond use date (BUD) and may be prepared in a segregating compounding area. Category 2 drugs have a longer BUD and must be prepared in a clean room environment.
How can a gap analysis help me?
A gap analysis provides a clear road map and demystifies the process for responding to recent and upcoming regulatory changes. Its structured approach for reviewing your existing pharmacy and documenting deficiencies as they may apply to USP 797 and USP 800 is the best way to set a baseline against the new regulations.
A thorough gap analysis addresses the physical environment, clinical processes, and hazardous materials management. The team conducting this process should include your facilities director, an architect, engineers, and pharmacy staff. Including a pharmacy consultant may be beneficial, depending on the expertise level of your staff.
Along with reviewing spatial relationships, the gap analysis team documents the mechanical, electrical, and plumbing infrastructure. The team also works with you to understand current state processes and flow. This discussion includes a review of your pharmacy’s compounding and sterile risk levels, including the National Institute for Occupational Safety and Health (NIOSH) documentation and BUD strategies.
A final gap analysis report includes a facility compliance document detailing probable future considerations as well as ratings (poor, fair, or compliant) for existing system components. The report includes recommended solutions for identified deficiencies and order of magnitude costs for addressing them. You may be able to address certain deficiencies through operational changes, an economical way to overcome financial constraints and reduce the level of renovations required.
How do I keep my pharmacy in operation during construction?
You have a number of approaches available to you. The quickest and arguably least expensive approach is to build a new pharmacy in a new location. This turnkey approach requires a new air handler and pharmacy equipment, but it allows your pharmacy team to function without missing a beat. Finding temporary available space in the right location elsewhere in your facility may be your biggest hurdle. You can save some expense by relocating existing equipment, but that will require stoppage of work while you recertify rooms.
Alternatively, you can renovate your existing pharmacy in place, a more complex approach requiring multiple phases and piecemeal construction. Renovation adds a substantial premium to the cost of the project, but in space-poor facilities it may be the only option.
Other options include operating out of a temporary pharmacy, offloading volume to other system pharmacies, subbing out compounding, or parking a mobile pharmacy trailer onsite.
Ultimately, there’s no one-size-fits-all solution to meeting USP 800 compliance. With the destination fast approaching, be sure your approach aligns with your organization’s goals and priorities.
Derek Veilleux
Derek Veilleux, AIA, EDAC, NCARB, is a principal and director of healthcare practice at SMRT Architects and Engineers.
