DEA releases final rule on disposal of controlled substances
Pharmacies can voluntarily participate in take-back programs, but cost and liability remain a concern
DEA announced its final rule on prescription drug disposal on Monday, which grants pharmacies the authority to collect and properly dispose of unwanted prescriptions from patients. The program is voluntary for pharmacies that wish to participate.
The final rule, called the Disposal of Controlled Substances, allows community pharmacies to conduct take-back programs and provides patients the option of mailing their unused, unwanted, or expired prescription medications or placing them in a pharmacy-maintained collection receptacle in addition to the currently authorized receptacles found at various local law enforcement agencies. The rule also grants community pharmacies the authority to maintain receptacles at long term care facilities they service.
The final rule was modified from the proposed rule released December 2012, to include hospitals and clinics with an onsite pharmacy and Narcotic Treatment Programs as authorized collectors.
“Prior to the promulgation of this final rule, there were limited opportunities for the public to discard their unwanted prescription drug controlled substances because pharmacies, doctor’s offices, and hospitals were, with very limited exceptions, barred from accepting them,” said Michael H Ghobrial, PharmD, JD, Associate Director of Health Policy at APhA. “Prior to implementation of this final rule, and between DEA take-back days, the public was to determine what medications were appropriate to be flushed or thrown away, which can require additional steps to render them unusable. It’s no wonder there were stockpiles of pharmaceuticals in our nation’s homes—pharmaceuticals that could end up in the wrong hands.”
While APhA supports the overall effort of secure medication disposal options for the public, it remains concerned about potential cost and liability issues for pharmacies that choose to participate.
Potential unknown liabilities could result from stolen or tampered-with receptacles and the placement of inappropriate substances in a receptacle.
The final rule stated receptacles should not only be accessible to the public, but also in an area where controlled substances are stored and where an employee is present. The regulation further provides that the take-back programs are only to be used to dispose of noncontrolled and controlled prescription drugs from patients, and not illegal substances, such as heroin or ecstasy.
Aside from the program’s aim of decreasing the abuse of prescription drugs, DEA sees potential benefits to pharmacies, including additional revenue from increased traffic.
But Ghobrial said he is concerned that with the risks identified above and the lack of funding to cover the costs of participation, there may not be a strong uptake in the health care community.
Some, including David Brushwood, BSPharm, JD, do not see cost as much of a concern as the public acceptance of such programs.
“It’s not a panacea but it’s a useful tool added to other tools that can help reduce access to prescription drugs that can be abused,” said Brushwood, who is Professor of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy.
DEA said the need for options to safely dispose of unused or unwanted medications is evidenced by the positive participation in national medication take-back events that have been held all over the United States since September 2010. According to the DEA, participation in those events has resulted in the collection of over 2,100 tons of medication at over 6,000 sites.
The final rule has been a long time in the making. The proposed regulations were included as part of Congress’s passage of the Secure and Responsible Drug Disposal Act of 2010. Following written comments to DEA on the proposed rule in 2013, APhA originally made comments to DEA about proper prescription drug disposal in March 2009 and at a January 2011 public meeting.