Photo courtesy of Stericycle Inc.
A great concern for health care facilities of all sizes is pharmaceutical waste compliance. It is clear that the problem is multifaceted and takes broad cooperation on the part of many different groups to find a comprehensive solution.
The Clean Water Act of 1972 provided protection for surface water quality in the United States and empowered the Environmental Protection Agency (EPA) with authority to employ tools to restrict pollutants from entering public water supplies. A U.S. Geological Survey in 2002 confirmed that pharmaceutical compounds were detected in 80 percent of the 139 streams sampled in this country. Then the EPA released a 2008 study on unused pharmaceuticals in the health care industry that discussed the management and disposal of unused pharmaceuticals and the presence of pharmaceuticals in the water supply (http://water.epa.gov/scitech/swguidance/ppcp/upload/2010_1_11_ppcp_hcioutreach.pdf.)
How do the drugs find their way into the water supply? Primary factors cited in the EPA report are direct excretion or improper disposal by patients themselves and improper disposal by health care facilities. All too often, health care facilities improperly flush pharmaceuticals, place them in “red bag” regulated medical waste or just throw them into the trash. All three routes can lead to having drugs enter the water supply.
According to the EPA report, pharmaceutical waste is generated at health care facilities before, during and after patient treatment. Approximately 3 percent of all purchased medications expire before they are ever used. Whether drugs are expired or samples are not used, the EPA’s concern remains the same — proper disposal to prevent any drugs from getting into the water supply by direct disposal or as a result of leaching out of landfill waste.
The 1976 Resource Conservation and Recovery Act (RCRA) gave the EPA authority to control hazardous waste from cradle to grave. However, there are not yet specific RCRA regulations directed toward disposal of pharmaceuticals by health care facilities. Such facilities are subject to the same RCRA requirements as any other industry.
It is estimated that 95 percent of the pharmaceuticals disposed of by small-quantity generators such as physicians’ practices, clinics, ambulatory surgical centers and nursing homes fall into the non-RCRA hazardous category. State rules vary, so both non-RCRA and RCRA waste should be segregated and handled separately from regulated medical waste. While such waste disposal services have existed for large facilities such as hospitals, there have been few options for these smaller facilities. Pharmaceutical disposal services are a viable option to prevent improper disposal and for keeping every type of facility in compliance with regulatory requirements.
Pharmaceutical waste is different from viable pharmaceutical products, which have value when returned to the manufacturer or distributor. Compliant disposal for pharmaceutical waste includes pharmaceutical items that cannot be used for their intended purpose and must be discarded. Small-quantity generators should be trained to identify which medications can be sent back to returns processors or reverse distributors for credit. Items without creditable value should be properly managed as pharmaceutical waste.
A medical office building with independent or individual practitioners, a small nursing home or ambulatory surgical center can properly dispose of pharmaceuticals through simple, best-management practices. State and local regulations, applied by waste stream management companies, help to ensure that segregation and proper disposal of pharmaceutical waste from regulated medical waste is not only compliant, but also environmentally sound.
Waste minimization is the first step to reducing the amount of pharmaceutical waste generated at the source. RCRA hazardous waste generators are encouraged to take measures to reduce amounts generated. For example, they should discourage pharmaceutical reps from being too generous in the number of samples they leave behind.
Waste segregation for small generators of pharmaceutical waste may considerably reduce the problem by carefully segregating regulated medical waste from pharmaceutical waste and RCRA hazardous waste and then properly disposing of each category.
How does a facility leader put his or her arms around the process? A formal waste stream management plan should include these six waste categories:
Solid waste. This is commonly used to describe such things as office trash, pizza boxes and similar items that should never be placed with medical or pharmaceutical waste, just as medical or pharmaceutical waste should never be put into regular trash. Staff should be taught to separate these materials into color-coded bags or bags differentiated by visual aids so they are not commingling different waste streams.
Regulated medical waste. This is red bag or biohazardous, potentially infectious waste that is regulated by the state for proper management, storage and disposal. Federally, Department of Transportation (DOT) regulations apply to proper packaging, marking, shipping and transport. Regulated medical waste haulers are required to have the generator who is shipping the waste sign a shipping paper to certify that only regulated medical waste is included in the red bag. These items include visibly bloody gloves and plastic tubing; visibly contaminated personal protective equipment; saturated gauze and bandages; other items saturated with blood and bodily fluids; and closed sharps disposable containers.
The majority of regulated medical waste in the United States is treated by autoclave, a sterilization process that uses steam, time, temperature and pressure to render any potential pathogens noninfectious. While autoclaving is an environmentally sound and proven process, there is some residual wastewater discharge. If improperly managed, pharmaceuticals that were improperly present in red bags could still end up in the process water after autoclaving.
Pathological waste. This is defined differently by various states, but is usually mass tissue that is segregated from other regulated medical waste and marked to be incinerated.
Trace chemotherapy waste. This is permitted for some chemotherapeutic drugs provided that less than 3 percent by weight of the original contents remains at the time of disposal. Based on various state regulations, this waste, too, should be segregated and marked for incineration. However, there are some chemotherapeutic wastes, no matter how small the quantity of residual material, that always must be managed as RCRA hazardous waste. It is important to identify the drugs to make that determination.
RCRA hazardous waste. This may be pharmaceutical or not, and it can never be disposed of in non-RCRA hazardous waste streams. RCRA hazardous waste must be handled by a permitted RCRA hazardous waste hauler and is generally never commingled with regulated medical waste. The EPA, through the Resource Conservation Recovery Act, has stringent rules for the handling of all RCRA hazardous waste, including pharmaceuticals that are classified as RCRA hazardous waste at the time of disposal.
Beyond federal EPA regulations, some individual states also have added other chemicals, compounds and pharmaceuticals to their own lists of state-regulated substances. It is best to check state requirements.
Additionally, Drug Enforcement Agency-controlled substances also must be disposed of separately from regulated medical waste or RCRA hazardous waste. While pharmaceutical waste that is RCRA-hazardous can never be “underclassified” and disposed of as non-RCRA hazardous, pharmaceutical waste can be “overclassified” as RCRA hazardous pharmaceutical waste by placing it with RCRA hazardous waste for disposal. Such overclassification can make things simpler for staff compliance by eliminating the need to have both a non-RCRA hazardous and a RCRA hazardous pharmaceutical waste stream.
However, exceeding certain quantities of RCRA hazardous waste can change generator status according to state and federal regulations, which could result in additional regulatory oversight. Small generators should undertake careful evaluation and consideration of the amount of RCRA hazardous waste generated.
Universal waste. Some states permit the handling of pharmaceutical waste in the category known as universal waste that has regulations that are less stringent than those associated with RCRA hazardous waste. Small generators should check state regulations on universal waste to identify what may be included. They also should be aware that universal waste typically can be stored in any safe location for up to one year on site.
If and when the EPA lists pharmaceuticals as universal waste, they still will need to be discarded at facilities authorized by the EPA or by a state environmental agency. Although they will be classified as universal waste, they will remain subject to DOT hazardous material transportation regulations and will still have to be packaged, marked, labeled and properly identified on DOT shipping papers.
Closing the gap and benefiting a facility means that administrators and clinical staff make the waste stream management program a reality. Facilities professionals should educate and re-educate staff, cover the external regulations for compliance and the internal processes for safety, sustainability and success.
For example, facility staff should be trained to identify “acutely hazardous” or “P-listed” RCRA hazardous waste and how to handle the packaging. Warfarin and nicotine products are common in long-term care facilities (LTCFs). Because they fall into this special regulatory category they are subject to special regulations. An office must segregate packaging of P-listed waste from other RCRA hazardous waste.
To ensure that the amount of on-site P-listed waste is consistently tracked and documented, many LTCFs require a more customized approach that includes collecting P-listed packaging separately from actual P-listed medications. Waste warfarin tablets or unused nicotine patches are generally produced in low volume and can be collected in small, 1.5-quart hazardous pharmaceutical waste containers. Empty packaging such as wrappers, bottles and bubblecards/blister packs, however, may require larger, 2-gallon containers to accommodate bulk, even though empty packaging generally is very light and contributes little weight to the overall P-listed waste generated. Collecting and segregating P-listed waste in this fashion allows for consistent and accurate volume and weight tracking.
Disposal should be made convenient by placing multiple hazardous pharmaceutical waste containers throughout the facility in secure areas accessible only by staff. If the placement of pharmaceutical waste containers requires staff to make a special trip to a remote area like the basement or boiler room, they will be less likely to manage the waste correctly. If hazardous pharmaceutical containers are on each floor or in each wing at a common area like a medicine room or a nurses' station, seamless integration of a pharmaceutical waste program becomes synonymous with success.
Data also should be collected on employee training, such as whether the right drugs are being put into the right disposal containers and on records for total volumes managed and shipping manifests, among other metrics.
Progress should be measured and communicated so that milestones can be celebrated and used to build upon initial successes. The best programs aim to keep everyone engaged and are built into the facility operations.
A team effort
Ultimately, it is up to each facility owner and each health care worker to ensure the conscientious segregation of pharmaceutical waste into the proper waste stream and to ensure that each of those waste streams is properly managed and carefully discarded.
Large physician network prioritizes medication waste
NEA Baptist Clinic, a 40-location, multispecialty practice group of 110-plus physicians, provides care in more than 35 medical specialties throughout Arkansas. It includes the clinical organization as well as a new hospital and cancer center that generate significantly more waste than the clinics combined, because of a full-service lab, a 22-chair infusion suite, clinical research and both medical and radiation oncology teams.
After reviewing compliance measures, the organization’s lab director updated more than 20 facilities with a vendor service to include a formal, sustainable pharmaceutical waste program. Teams were trained to understand the various categories of waste such as corrosive and combustible items, and the corresponding labels for each type.
Staff then began to understand the complexities of waste regulations, including compliance measures for medical and pharmaceutical waste; the different types of waste segregation into colored containers; and the nuances of a change process that, without proper training, could be difficult. For example, the team was surprised to learn that epinephrine is singled out in some states and regulated differently, but not in Arkansas.
The vendor service updates the clinics on regulatory and legislative changes before they occur. It also helps with building site-specific plans required for each clinic and includes the Occupational Safety and Health Administration’s right-to-know and right-to-understand hazard communication that improves the quality and consistency of hazard information.
These steps combined make it safer for workers to do their jobs and set examples for better environmental practices throughout the industry.
Hospital system embraces waste standards
LifeCare Hospitals, Plano, Texas, operates 24 long-term acute care hospitals in nine states. These hospitals specialize in the treatment of medically complex patients who typically require extended hospitalization.
Organizational leaders anticipated increased enforcement of existing rules and new regulations concerning the proper disposal of all hazardous waste, including hazardous pharmaceutical waste.
LifeCare proactively evaluated and implemented a comprehensive program with a primary goal of maintaining regulatory compliance. It chose a vendor service to help get ahead of the compliance curve.
The company strives for its hospitals “to be strong corporate neighbors in each of the communities we serve,” according to Steven Harris, vice president of ancillary services including pharmacy, lab and radiology for LifeCare Management Services. “Employees live and raise families in these communities, and they care for their friends and neighbors every day. So safety, sustainability and compliance are at the top of LifeCare’s priority list.”
Because LifeCare operates in multiple locations, it often faces varying regulatory requirements. The vendor service was able to help guide the organization through the state-by-state, and sometimes city-by-city, variations it encountered.
The pharmaceutical waste compliance program is implemented at all hospitals. Some teams readily adopted the service while others required more time to shape processes and identify practices that would best work in their specific facilities.
The pharmaceutical waste initiative enhances the sustainability commitment of LifeCare. It is also keeping plastic and cardboard out of landfills by recycling and choosing reusable sharps containers.