DEA wants to make it easier for hospitals, long-term-care facilities, patients, and others to dispose of controlled substances. FDA, EPA, and state agencies are also dealing with this issue.
» The Drug Enforcement Administration (DEA) wants to ease the rules and regulations governing the disposal of controlled substances. The agency announced its decision with an "Advance Notice of Proposed Rulemaking" published in the Federal Register on January 21. The notice included more than 100 questions covering current controlled-substance disposal practices, problems, and potential solutions.
"DEA has realized for some time now that [disposal of controlled substances] has become a problem," said Gary Boggs, executive assistant, DEA Office of Diversion Control. "One way to find a solution is to seek input from those who will be affected by the outcome."
The agency has come under criticism for regulations that make it difficult for hospitals, long-term-care facilities, patients, and others to dispose of controlled substances safely and affordably. In most cases, unused controlled substances are flushed or washed into the waste-water system for lack of any better method, said Catherine Zimmer, PhD, consultant with the University of Michigan Technical Assistance Program.
DEA is just one of several agencies rethinking medication disposal needs and practices. The Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and state agencies are also wrestling with the issue, said Cynthia Reilly, director of practice development, American Society of Health-System Pharmacists (ASHP).
ASHP is still preparing its response to DEA's information request. Written comments must be postmarked by March 23; electronic comments must be received by midnight in Washington, DC, on the same day. The requirements for comment can be found at http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064808293c1.
"It's good that DEA is asking these questions," Reilly said. "We see it as a positive step. Their concern is obviously diversion. That is a concern from ASHP's perspective, too."
The questions are directed to what the Controlled Substance Act (CSA) calls ultimate users, patients or family members of patients who have unneeded controlled substances acquired through legal prescriptions.
Questions also have been posed to community, environmental, industry, and other interest groups; law enforcement; long-term-care facilities; hospice and in-home care organizations; pharmacy and narcotic-treatment programs; reverse distributors; state boards of pharmacy and other regulatory agencies; and other interested groups.
Boggs said DEA wants to use the responses to formulate new proposed rules that would make it easier to dispose of controlled substances while reducing the potential for diversion. But the agency's ability to ease current regulations is limited by the Controlled Substances Act. When passed by Congress in 1970, the CSA was written solely to control diversion. It made no provision for the disposal of unused medications. Once a product is dispensed, the CSA assumes that it will be taken as prescribed, with nothing left over.
That leaves hospitals, long-term-care facilities, physician offices, dental offices, veterinary offices, and individual patients with few alternatives. Unused medications can be flushed, washed down the drain, mixed with some unpalatable substance such as coffee grounds or cat litter and disposed in trash, returned to one of a handful of DEA-authorized disposal facilities, or given to local law enforcement.
Each of these methods raises concerns, Zimmer said. Flushing or washing down the drain puts controlled substances into surface water supplies. Medication put into trash that goes to landfills also leeches into the water supply. Few DEA-approved waste-disposal facilities accept controlled substances from individuals, and almost no law-enforcement agencies have the time, personnel, budget, or facilities to accept unwanted medications.
"The act does not contemplate this disposal issue," Boggs said. "The statute does not allow for the disposal of controlled substances. There will need to be a statutory change. I am not aware of any pending legislation, but Congress is definitely aware of this issue."
At least one group has found a partial solution. In Connecticut, long-term-care facilities have begun shredding unused unit-dose medications, including controlled substances. Two facility employees run unused blister packs through industrial shredders, then dump the chaff in solid waste, which is incinerated.