Category: Professional Posters
Purpose: The Food & Drug Administration (FDA) recently drafted guidance for insanitary conditions at compounding facilities due to numerous outbreaks of infections and deaths found to be the result of drug products that were contaminated because they were produced under insanitary conditions. Insanitary conditions apply to sterile and non-sterile drugs and could cause a drug to become contaminated with filth or rendered injurious to health. A drug that is contaminated with any filthy, putrid, or decomposed substance is deemed to be adulterated. For this reason, compounding facilities require continuous auditing to avoid insanitary condition to provide safe compounded products.
Methods: Moses H. Cone Memorial Hospital utilized the insanitary conditions FDA guidance document to educate the pharmacy technician staff which helped to identify when conditions were not appropriate to safely complete compounding. The safety gemba walk is a physical walk through of all compounding areas that is done on every shift and is pharmacy technician driven. We utilized the acronym CLEAN to help drive our safety walk and remedy any findings. C-checklist: construct a checklist of items to look for during the safety walk, which was adapted by the FDA insanitary conditions draft. L-look: during each shift cross-over (3 times per day), have staff walk the sterile and non-sterile compounding areas. E-evaluate: staff evaluate what they found and if there were any concerns that need to be addressed. A-address: staff immediately address any insanitary conditions and communicate with the team. N-note: staff notates any findings on the safety walk and uses a web-based application to document and notate remedied actions taken.
Results: With the implementation of the daily safety walks, the pharmacy technician staff were recognizing, documenting, and taking action to resolve the insanitary conditions found in both sterile and non-sterile compounding areas. Opportunities were identified to improve workflow issues of aseptic practices, and the anteroom design, and the difficulty to maintain a “state of control” with an International Organization for Standardization (ISO) class 7 anteroom in which the “dirty” side of the line of demarcation was requiring constant remediation after clean room certifications. This helped to redesign our new clean room space to have two anterooms, based on the newest major revision of United States Pharmacopeia (USP) . We also discovered the further opportunities to advance hands-free functions to reduce contamination of clean room staff’s gloves. This prompted us to take action to provide hands-free door entry into the clean room space, hand-rub dispensers, remote activated intercom system, and a hands-free sink. Moses H. Cone Memorial Hospital developed a technician specialist role to provide support for the constant need for auditing of our compounding areas, environmental monitoring, managing staff competencies, and sterility testing and training.
Conclusion: Through implementation of the gemba walk our compounding environment was always able to maintain a state of control. The gemba walk also helped to determine the design of our new state-of-the-art cleanroom space to avoid common insanitary conditions, provide hands-free devices to ensure glove sterility, and make cleaning easier. Making these changes has helped to become more focused on providing safe, clean compounds for our patients.