USP<797> Compliance without ‘Breaking the Bank’?
Facilities facing compliance with USP<797> are often frustrated; concerned that it will cost too much money to become compliant with the chapter. Busy directors are often overwhelmed of the prospect of having to write policies and facilities with little to no space are finding building a proper clean room next to impossible. There is no doubt that many are finding compliance with USP<797> challenging. The truth is that those familiar with USP<797> can often find creative ways to get compliant with the chapter while improving patient safety and without compromising the bottom line. All that is needed is a little creativity and an exercise in ‘thinking outside of the box’.
Directors who do not have time to devote to policy writing and research may benefit from purchasing a prewritten policy manual designed for USP<797> compliance. These manuals can be found on the web and policies can be ‘tweaked’ for application at the given facility. One can also seek the expert advice of a USP<797> consultant. Consultants can provide insight that a purchased template cannot and may save one a lot of work in the end. A consultant may also be able to aid in the brainstorming process when it comes time to developing cost-effective processes that can lead to compliance.
One example of an alternative to constructing a USP<797> clean room may be to utilize a compounding aseptic isolator (CAI) or compounding aseptic containment isolator (CACI). Depending on the needs of the facility, these devices may negate the need for compliance with more rigorous standards. Items that cannot be prepared in the isolator are outsourced to a sterile compounding pharmacy that is USP<797> compliant. Closed system transfer devices (CSTD) may also be an option for facilities that compound hazardous sterile preparations such as chemotherapy. The use of CSTDs may also negate the need for compliance with more stringent buffer area requirements.
Those willing to invest the time and money in building a proper clean room may find that a return on their investment can be made by offering their services as an outsourced pharmacy to those facilities who do not have USP<797>facilities. This is really a win-win situation. The pharmacy that built the clean room can realize an additional revenue stream while the facility who has chosen to outsource their sterile products to the USP<797> compliant pharmacy gains compliance, increased patient safety, increased employee safety and possible dollar savings. When coming up with creative solutions to compliance, one must really look at the big picture. Many facilities fail to consider future cost savings or additional potential revenue streams when exploring avenues to compliance. This is a prime example of where the expertise of a consultant may be valuable.
About the author: Christi Larson, Pharm. D. is the owner and Chief Consultant of I.V. Insights. Dr. Larson is committed to helping clients improve patient care through the implementation of best sterile compounding practices within the healthcare system.
