Recent weeks have brought a flurry of activity that will change the rules for handling unused pharmaceuticals. Both Congress and the U.S. Environmental Protection Agency (EPA) have moved to regularize practices for disposing of unwanted drugs and medications, with one bill now ready for the President’s signature, a second passed by the House and awaiting Senate consideration, and an EPA guidance document out for public comment.
These developments are happening against a backdrop of longstanding confusion: one federal Web site advises pouring a long list of drugs down the drain, another instructs against flushing and toward trash disposal after mixing unwanted medications with kitty litter, a third requires knowledge of complicated environmental law classifications for hazardous materials, and meanwhile the New York Attorney General’s Office has been prosecuting critical-access hospitals and nursing homes for getting things wrong. New capabilities for detecting low levels in the water system of substances such as birth-control pill estrogens, chemotherapy drugs, mercury-based preservatives, and other worrisome chemicals have raised the profile of this issue, even though no evidence to date links these releases to effects on human health or the ecosystem.
Key recent developments are as follows:
- The Secure and Responsible Drug Disposal Act of 2010, S. 3397. Passed by the Senate and House on September 29, 2010, this legislation is expected to be signed by President Obama shortly. The bill amends the Controlled Substances Act to allow a lawful user of a pharmaceutical that is a controlled substance to deliver it for disposal to a person who is authorized to handle it, if the disposal is consistent with regulations to be promulgated by the U.S. Attorney General. This new law will include provisions for long-term health care facilities and individuals responsible for a deceased individual’s property.
- The Safe Disposal Act of 2010, H.R. 5809, passed by the House on September 22; companion bill S. 1292 is pending before the Senate. This bill would require EPA to study (within 18 months) the environmental impacts of disposal of controlled substances and to formulate recommendations on destruction or ultimate disposal. The bill would also authorize local agencies and organizations to administer drug-disposal drop-off programs, with exemptions from environmental law regimes under the Resource Conservation and Recovery Act (RCRA).
- EPA’s draft guidance on Best Management Practices for Unused Pharmaceuticals at Health Care Facilities, 75 Fed. Reg. 54,627 (Sept. 8, 2010). EPA is requesting comments by November 8, 2010. The guidance proposes a five-step approach, including: (1) conducting an audit to determine the facility’s pharmaceutical disposal baseline; (2) reducing pharmaceutical inventory by purchasing limited-dose packages, replacing samples with vouchers, and better managing of stock on hand; (3) instituting new practices, such as use of reverse distributors, donation programs, and EPA-approved disposal methods; (4) segregating waste by type of treatment and handling system; and (5) establishing training programs for staff. This guidance will apply to hospitals, medical clinics, doctors’ offices, long-term care facilities, and veterinary treatment operations. EPA expects to finalize the guidance by the end of 2010.
Health care facilities of all types should pay close attention to the changing landscape in this area. Affected entities should review and consider commenting on the EPA proposed guidance document, and should be taking steps now to evaluate options for implementing best practices.