In September 2004, Nebraska Methodist Hospital (NMH) was challenged by the United States Environmental Protection Agency (USEPA) to revise its practice of managing regulated pharmaceutical waste according to the Resource Conservation Recovery Act (RCRA) of 1976. The hospital was in violation by inappropriately designating RCRA drug wastes as hazardous drug waste. At the time, the hospital did not have a waste stream devoted solely to RCRA drug wastes and was not manifesting the quantity of the wastes as required under RCRA. NMH was challenged to comply with RCRA for pharmaceutical waste management or face a $32,500/day fine for non-compliance within 90 days of discovery. Currently, facilities that improperly dispose of drug waste run the risk of fines of up to $37,500 per violation, per day.

The Methodist Hospital Hazardous Materials team—with representation from administration, pharmacy, nursing, housekeeping, risk management, and safety, came up with a five-step approach to meet RCRA’s requirements.

The Five-Step Approach

The first step was to learn the regulations and specific requirements for compliance. We engaged the USEPA inspector as a resource to help understand the intent of the standards and the corresponding survey points for measuring compliance. In reviewing the standards, we discovered that NMH lacked a RCRA waste stream that used a USEPA approved container. We identified a vendor to supply the approved container, Kendall/Covidien, whose container is black in color (RCRA does not mandate a specific container color for RCRA wastes) and defined this waste stream as “RCRA black.”

The second step was to conduct a detailed formulary review and assign waste streams to each medication. Each medication was assigned to one of the following waste streams: USEPA RCRA hazardous drug waste, hazardous drug waste, controlled substances drug waste, non-hazardous drug waste, reverse distributor waste, and sewerable drug waste. In order to satisfy the specific requirements for USEPA compliance, the initial focus was to establish a system to meet RCRA and then fold in the remaining listed waste streams. In addition, the Hazardous Materials team identified all locations where RCRA medications were administered and designated them for specific education.

The third step addressed RCRA regulation compliance strategies at the point of disposal. After reviewing RCRA and identifying the specifics for compliance, the Hazardous Materials team determined that to achieve compliance, a system that consistently directed the waste generator to the proper waste stream would be required. The clear challenge to such a system was educating every nurse who was practicing at the hospital (approximately 950) and accommodating the total number of doses administered annually (approximately 2.2 million). Combining these obstacles with the fact that we were limited to a 90-day period for compliance, we had to devise a system that would quickly and effectively educate and motivate the nursing and pharmacy staff to practice proper pharmaceutical waste segregation. We developed posters to pictorially describe the concept and placed them at every location where medications were stored and administered. Pharmacy supported the concept by manually placing a label on each medication requiring a specialized waste stream, specifically limited to RCRA waste versus hazardous drug waste to address the USEPA violation. The deployment of the new USEPA RCRA containers occurred simultaneous to displaying the posters and placing labels on the products.

The fourth step was to assess the new system. After the first week of implementation, NMH’s pharmacy operations coordinator and safety officer started “trash rounds” to determine compliance. Rounding allowed us to gather feedback from nurses and pharmacists on the process. After rounding, it became clear that the posters and labeling were not effective at directing staff to the proper critical waste stream. In addition, upon inspection of the USEPA RCRA containers, we found more rubbish in the containers than was required, which would have impacted the hospital’s hazardous waste stream generator status and would also lead to a significant cost increase for transportation and disposal of the waste. We continue to use the trash rounds process today as a means for spot-checking compliance.

The fifth step was to tweak the system to meet compliance. Upon presenting our results from the trash rounds at the Hazardous Material team meeting, it was suggested by the oncology nursing lead to employ a colored bagging system for directing the nurses to the right containers—yellow bags for hazardous drug waste to yellow containers and black bags for USEPA RCRA waste to the black containers. The safety officer was aware of a local zip lock baggie manufacturer in the city of Omaha and contacted them with specifications of the colors, grade of plastic, and zip-lock type we would need. The vendor was able to produce the bags at a reasonable cost and turn the order around within a week. The bag system was added to the existing poster, labeling, and container system. After a week with the bag system in place, trash rounds showed a dramatic improvement in compliance. Our process was in alignment with EPA RCRA regulations and we were reclassified as being in compliance. Despite this achievement, subsequent trash rounds indicated that this is a continuous education process and we are obligated to always maintain and seek to improve our processes.

Conclusion
As we all know, inspections of hospitals by regulatory agencies tend to motivate change. In our case, our survey by the USEPA not only enlightened our hospital to existing regulations for hazardous drug waste management, it also stimulated us to establish an effective system to meet compliance.

Firouzan “Fred” Massoomi, PharmD, FASHP, received his doctorate from the University of Kansas School of Pharmacy and has served as the pharmacy operations coordinator at the Nebraska Methodist Hospital for the past 11 years. He currently serves on the Nebraska Pharmacists Association Board of Trustees, is the Nebraska delegate to the ASHP, a member of the ASHP Practice Managers Section Advisory Group on Manager Development, and a member of the Nebraska Multiple Sclerosis Society Board of Trustees.