On September 9, 2014, the Department of Justice published the final rules for the Secure and Responsible Drug Disposal Act of 2010 allowing proper controlled substance disposal. The regulations go into effect October 9, 2014. The amended rules (found here) allow registered collectors, such as closed-door and retail pharmacies to place receptacles in long-term care facilities to collect and dispose of controlled substances (Schedules II-V). Before the rule update, solutions for disposal in long-term care facilities were minimal and often messy and environmentally unsustainable.
Flushing controlled substances, while acceptable in some states, should be avoided as the long-term effects of pharmaceuticals in rivers and streams are unknown. In 2008, the Associated Press found pharmaceuticals in the drinking water of 24 major metropolitan water supplies. Other studies have shown changes in aquatic life such as gender changes in fish, due to pharmaceuticals in the water.
Mixing Medications with Kitty Litter or Coffee Grounds
The purpose of mixing medications with kitty litter or coffee grounds is to mask the medications, but eventually, the mixture ends up in a landfill where the pharmaceuticals can cycle back into the water. Additionally, the process is time consuming and often messy — not the best use of a long-term care facility’s best resource: nurses.
Chemical solutions that break down the compounds onsite are relatively new options. These solutions are messy, release a foul odor, and require nurses to remove, or “pop,” pills one at a time from blister packs or other packaging. In addition, nurses must take time to completely block out Personal Health Information on packaging in order to comply with HIPAA before placing that packing into the trash — overall, consuming valuable staff hours and increasing potential facility liability.
Figure 1: After seven days, medications treated with a chemical solution were emptied into a plastic bag.
The pills were removed from the plastic bag and rinsed off, but the pills were still not liquefied.
Long-term care facilities can now utilize a collection receptacle or provide mailback solutions to residents for safe disposal of their medications, including controlled substances. Sharps Compliance has provided similar solutions, such as the TakeAway Environmental Return System™ for non-controlled/non-hazardous drugs to long-term care since 2009. While a very successful program used in thousands of facilities throughout the United Sates today, the TakeAway Environmental Return System is only designed for non-controlled medication disposal. Long-term care facilities using the TakeAway Environmental Return System for non-controlled substances often use secondary and less manageable solutions (mentioned above) for controlled substance treatment and disposal. With the rule amendment, long-term care facilities can comingle controlled and non-controlled substances both in one of two solutions: collection receptacle or mailback. Sharps Compliance provides a collection receptacle program (MedSafe™) and a mailback solution (TakeAway Medication Return System™). As DEA has stated, “the DEA has considered the diversion risks and determined that the installation and maintenance of collection receptacles by authorized hospitals/clinics and retail pharmacies is the most secure and responsible means by which registrants may collect and dispose of LTCF residents’ pharmaceutical controlled substances.”
Collection Receptacles for Medication Disposal
As outlined in § 1317.60 of the Disposal of Controlled Substance Regulations, a collection receptacle is a substantially constructed container with a permanent outer container and a removable inner liner. Collection receptacles must be securely fastened to a permanent structure and the outer container shall include a small opening that allows contents to be added to the inner liner but does not allow removal of the inner liner’s contents.
Long-term care facilities (LTCF) can utilize a collection receptacle for medication disposal providing an authorized collector manages the program. A collector is a DEA registrant that has been approved to administer collection programs on behalf of a LTCF. The collector for long-term care facilities will usually be the pharmacy that provides medication for the residents (retail, closed-door or hospital/clinic with an onsite pharmacy). While the collection receptacle is maintained at the long-term care facility, the authorized collector will manage the program. Program management includes inserting inner liners into the collection receptacle, removing and sealing inner liners for disposal, and documenting a step log of the procedures.
Note: No LTCF can operate a collection receptacle program without an authorized collector managing the program.
The removable inner liners, once sealed by the authorized collector, can be stored onsite at the long-term care facility for up to three days per the DEA regulations. The inner liners are returned via common carrier to a registered treatment facility for proper destruction. With the goal of diversion as a main concern of the DEA, all steps outlined above are conducted with two people — either two employees from the authorized collector pharmacy or one employee from the authorized collector pharmacy and a second supervisor-level employee from the long-term care facility.
Mailback Medication Disposal
For long-term care facilities in which the residents manage their own medications, specially-designed mailbacks can be used for disposing of controlled substances. The mailback is sealed and provided to USPS for return to a registered collector for destruction. The current 10- & 20-Gallon TakeAway Environmental Return System™ solutions are still optimal for non-controlled medication disposal at long-term care facilities where residents are managing their own controlled substances disposal with a mailback solution.
To learn more about the Secure and Responsible Drug Disposal Act of 2010 and options for a collection receptacle or mailback program for your long-term care facilities, please contact Sharps Compliance at 800.772.5657 or visit our MedSafe website. Additionally, Sharps Compliance continues to offer both medical and hazardous waste management services.