BETHESDA, MD 28 January 2010—Health care facilities can expect the Environmental Protection Agency (EPA) by October to release a set of best practices for managing excess, expired, and unwanted pharmaceuticals.
The agency recently declared that there was "near universal interest" in better management of unused pharmaceuticals at health care facilities among the hundreds of industry representatives, government representatives, and waste management and disposal companies contacted in 2007–09.
There was also "general interest," the agency said, in "more quickly advancing" health care facilities’ use of best practices for managing unused pharmaceuticals.
EPA’s goal is to get health care facilities, particularly hospitals and long-term-care facilities, to control, reduce, or eliminate their disposal of unused pharmaceuticals down toilets and drains.
Slow the flow. From a study of the health care industry’s management of unused pharmaceuticals, EPA concluded that the standard practice for many years at many facilities had been to flush those products down a toilet or drain.
That practice may no longer be standard, as EPA learned from site visits in 2008.
Nonetheless, the agency has decided to continue studying how the health care industry manages its unused pharmaceuticals.
Part of this endeavor includes gathering information from the public. EPA has asked the public to provide information on a variety of issues related to the management of unused pharmaceuticals. The deadline is February 26. More information on this request is available at http://edocket.access.gpo.gov/2009/pdf/E9-30625.pdf.
New York takes action. Two critical access hospitals in New York are now permanently forbidden from "dumping, discharging, disposing, spilling or placing any pharmaceutical wastes" down toilets, sinks, or drains, according to documents released January 12 by the Office of the Attorney General.
New York is one of the states that have EPA’s approval to administer their own pollutant-discharge elimination systems rather than the national system authorized by the federal Clean Water Act.
During inspections in early 2009, according to documents signed by an assistant attorney general and the hospitals’ chief executive officers, management at O’Connor Hospital and Margaretville Memorial Hospital claimed their facilities did not flush any waste pharmaceuticals down toilets or sinks.
The inspectors interviewed hospital staff members, who contradicted their management’s assertions.
Allegations of violations of state and federal laws and regulations at the hospitals fell into three categories: generation of hazardous wastes, storage of hazardous wastes, and illegal discharge of ignitable hazardous wastes to a publicly owned water-treatment facility.
Attorney General Andrew M. Cuomo’s office said the settlements with the hospitals would end their practice of discarding pharmaceutical waste into the watershed that supplies drinking water to almost half of the state’s residents, including those in New York City.
The office also said that "only trace amounts" of pharmaceuticals have been found to date in the city’s drinking water supply.
As part of the settlement, the hospitals have agreed to implement so-called take-back programs to help households properly dispose of outdated and otherwise unused pharmaceuticals.
Expect best practices by October. EPA said it expects to finish developing best practices for managing unused pharmaceuticals at health care facilities in time for the agency’s final 2010 Effluent Guidelines Program Plan. Publication of that plan, the agency said, is expected in October.
ASHP’s Cynthia Reilly, director of the Practice Development Division, said the Society has discussed the issue of pharmaceutical disposal with EPA and plans to continue doing so.
"We shared with them our existing guidelines, which do address best practices for handling hazardous drugs and their disposal, . . . and will continue to engage with them as they develop best practices in this area," she said.
As for the development of best practices affecting the field of health-system pharmacy, Reilly said "ASHP traditionally views that . . . as an area where we take a leadership role. We certainly have a long history of developing these documents, including the original ‘handling of hazardous drugs’ document."
Look ahead to 2011. EPA’s most recent agenda of regulatory projects states that the agency expects in April 2011 to finalize the rule adding hazardous pharmaceutical wastes to the federal universal waste program.
The universal waste regulations, EPA said, are less stringent than current Resource Conservation and Recovery Act hazardous waste regulations.
Allegations of violations of the act at the Department of Veterans Affairs Eastern Kansas Health Care System led to a settlement in August 2009.
Although the agreed-on civil fine was $51,501, the settlement’s supplemental environmental project was estimated to cost $482,000.
The legal document describing the settlement states that the health system must select and purchase a pharmaceutical tracking software package that will evaluate and identify pharmaceuticals in the hospital formulary by hazard classification. This software was estimated to cost $35,000.
Paul R. Walker, chief of the health system’s pharmacy service, said in a written statement that selection of the vendor to provide the software has been a two-step process.
"Step one was researching what software might be available, have vendors make presentations, and then writing a statement of work to be used by our Contracting Office. Step two is regulatory requirements from the Contracting Office to find a vendor that best meets the statement of work requirements.
"We are now at step two waiting for contracting to tell us who will provide the service," he said in the statement.
