Drug Topics - March 2009 - (Page H8) HSE I Business Management DRUG DISPOSAL DEA rethinks controlled-substance disposal regulations FRED GEBHART, Contributing Editor 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. “Healthcare facilities in particular have a problem,” Zimmer said. “Sewering is traditionally how DEA has recommended controlled-substance disposal. Those days are coming to an end because of environmental concerns. The DEA has not stepped up to the plate on this issue until now.” 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 W W W.D R U GTO P I C S .C O M Network Health Systems SEE INDEX PAGE 8 For more info on this topic, see www.drugtopics.com H8 DRUG TOPICS March 2009 COURTESY GETTY IMAGES / DORLING KINDERSLEY / GARY OMBLER http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064808293c1 http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064808293c1 http://www.drugtopics.com http://WWW.DRUGTOPICS.COM
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