Presentation Abstract

Environmental Stewardship of Waste Pharmaceuticals From a Hospital Perspective
Charlotte A. Smith
PharmEcology Associates, LLC, Brookfield, WI

Common practices of pharmaceutical waste disposal in hospitals involve the sewering or landfilling of virtually all discarded pharmaceuticals except chemotherapy agents, which are often sent to a regulated medical waste incinerator. These practices are out of sync with both the emerging concerns about pharmaceuticals in the environment and with the requirements of the Resource Conservation and Recovery Act (RCRA) to identify, segregate, and properly manage drugs that are defined as hazardous waste.

U.S. Environmental Protection Agency (EPA) RCRA regulations define a number of common drugs such as epinephrine, warfarin, lindane, and nine chemotherapy agents as hazardous waste when discarded. Approximately 5 percent of the current products on the market are RCRA hazardous waste if discarded. Until recently, EPA and state authorities had not been enforcing RCRA in hospitals. Enforcement efforts by EPA Region 2 and Minnesota, Florida, California, and Washington State have begun to focus the attention of hospitals on pharmaceutical waste management. Despite these enforcement efforts, only a minority of health care facilities is successfully complying with RCRA.

The RCRA regulations have not been significantly updated since 1976 and have not kept up with drug development. More than 100 toxic chemotherapeutic agents can legally be sewered or landfilled under the federal regulations. Fortunately, many health care professionals are aware of the hazardous nature of these drugs and some higher level of treatment is usually provided, although not always the most environmentally sound.

When all RCRA drugs and all chemotherapy agents are destroyed at an RCRA-permitted incinerator, approximately 85 percent of the drug market is still routinely sewered or landfilled, including endocrine disruptors, antihypertensives, antidepressants, anticholesteremics, and antibiotics. Based on an increasing body of research, it is apparent that the continuous introduction of these agents into aquatic environments may have negative consequences on fish and other aquatic species. The impact on human health is not yet known.

In most states, the issue of how pharmaceutical waste is being disposed in hospitals and other health care organizations, such as long-term care facilities and clinics, barely has been considered by either the regulatory community or health care providers. Only the states of California and Washington have required the incineration of all drug waste that cannot meet stringent toxicity limits. Minnesota has extended hazardous waste regulations to include approximately 15 percent of drugs on the market and has encouraged strongly the incineration of the remaining 85 percent.

EPA Region 1 has funded two relevant grants to Hospitals for a Healthy Environment. The first is to develop a national blueprint for pharmaceutical waste disposal and includes Dartmouth-Hitchcock Medical Center and PharmEcology Associates. The second grant involves the training of surveyors for the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) on the importance of compliance with hazardous waste regulations and other pollution prevention practices. As JCAHO accreditation is of vital importance to many hospitals, this attention will stimulate compliance activity.

An additional barrier to preventing the entry of potent pharmaceuticals into aquatic systems is the requirement by the Drug Enforcement Administration that all unused controlled substances (drugs of abuse) be rendered nonrecoverable and that process be double-witnessed by two health care professionals. With the closing of most hospital incinerators, the most efficient and cost-effective way to render these waste drugs nonrecoverable is through sewering. Although the search for alternative methods is ongoing, consideration should be given to possible regulatory changes in this area.

Barriers to compliance, such as the ill fit of an industrial hazardous waste model to a health care setting and the lack of interpretive guidance by EPA headquarters has created a nonrational and extremely confusing regulatory environment. It simply is unrealistic to expect every nurse on the floor of a hospital to know which of the 2,000 to 4,000 drugs administered are RCRA hazardous wastes when discarded. In the short term, given the complexity of waste segregation and management challenges inherent in health care settings, every effort should be made by EPA to uniformly clarify regulatory requirements. In the long term, an adaptation of current regulations for health care organizations should strongly be considered by EPA to bring clarity and rational decisionmaking into this significant source of environmental contamination. By utilizing its convening powers, EPA is in a position to bring together the pharmaceutical supply chain and other relevant stakeholders to explore the use of voluntary, collaborative approaches to pharmaceutical waste identification, management, and minimization.

Hospitals are crisis-oriented organizations with multiple priorities constantly vying for scarce resources. Attention should be given to those leaders that have made the investment in time and money to manage their pharmaceutical waste in an appropriate and compliant manner. Encouragement, both through education and the motivation of possible enforcement of existing hazardous waste regulations, should be employed to encourage other hospitals to develop a more compliant and environmentally sound pharmaceutical waste management system.

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