This is an update of the article originally published on October 9, 2014. Regulations change frequently. That’s why Sharps Compliance monitors updates and communicates any changes to its customers.
On September 9, 2014, the Drug Enforcement Agency published the Disposal of Controlled Substances Final Rule, which went into effect on October 9, 2014. This new rule allowed registered collectors to place DEA-compliant drug collection receptacles in long-term care facilities (LTCFs) for the collection and disposal of ultimate-user controlled substances (Schedules II-V).
“Best Practices” for Medication Disposal Have Changed
Many people aren’t aware that EPA guidelines and state/local environmental regulations strongly discourage many common medication disposal methods, including:
- Flushing medications: In addition to the EPA’s new rule, the sewering of hazardous waste pharmaceuticals is explicitly forbidden. The DEA also states that the flushing of controlled substances does not meet their non-retrievable standard for disposal. A 2013 EPA study estimated over 46 million Americans could be potentially exposed to up to 4.4 daily doses of an active pharmaceutical ingredient from their wastewater treatment plants. 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 community’s best resource: nurses. Like flushing, this form of disposal likely does not meet the DEA’s non-retrievable standard of disposal. To learn more about how landfilling of medications harms both people and the environment alike, read our article on this topic.
Chemical Solutions May Increase Disposal Costs
Chemical solutions that break down the compounds on-site are relatively new options. These solutions are messy, release a foul odor, require nurses to remove, or “pop,” pills one at a time from blister packs or other packaging. Additionally, these methods of destruction do not meet the DEA’s non-retrievable standard, given the medication does not fully dissolve or takes days to dissolve. Anyone who has ever struggled to remove a single pill from a blister pack knows that this can be a difficult and time-consuming task. In fact, this type of disposal solution can cost a community upwards of $14,000 annually in nursing salary alone.
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.
Nurses must also take time to completely block out Personal Health Information on the packaging to comply with HIPAA before placing that packaging into the trash — overall, consuming even more valuable staff hours and increasing potential facility liability.
Lastly, if chemical solutions are used for the disposal of hazardous waste, controlled, and non-controlled medications, then they must be disposed of by a hazardous waste provider, given the presence of hazardous waste pharmaceuticals and the unknown resulting conglomeration of waste. It causes the customer to “double pay” for disposal: once to purchase the pouch and then a second time to dispose of it by a hazardous waste provider.
Sharps Compliance Offers Safe Medication Disposal Options for LTCFs
Long-term care facilities can now utilize a DEA compliant drug collection receptacle or provide mailback solutions to residents for safe disposal of their medications, including controlled and non-controlled medications. Sharps Compliance has been at the forefront of safe mailback and on-site pharmaceutical collection options. We can help LTCFs safely dispose of unused/unwanted medications and stay compliant with the DEA.
LTCFs have two options for the disposal of comingled controlled and non-controlled substances: collection receptacles or mailback envelopes/boxes. We offer both a collection receptacle program (MedSafe™) and a mailback solution (TakeAway Medication Return System™). As the 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 Substances 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.
LTCFs can utilize a collection receptacle for medication disposal, provided that an authorized collector manages the program. A collector is a DEA registrant that has been approved to administer drug collection programs at an LTCF. The collector for the community is the managing pharmacy that provides medication for the residents (retail, closed-door, or hospital/clinic with an on-site pharmacy). While the collection receptacle is physically located within the community, 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 on-site at the community for up to three business 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 by two people — either two employees from the authorized collector pharmacy or one employee from the authorized collector pharmacy and a second supervisory-level employee from the LTCF.
Mailback Medication Disposal
For LTCFs where residents manage their own medications, specially-designed mailbacks can be used for disposing of controlled substances. The resident places their medication into the mailback, seals it, and gives it to USPS for direct return shipping to the registered collector for destruction. Our 10- and 20-Gallon TakeAway Environmental Return Systems™ are optimal mailback solutions for communities where residents are managing the disposal of their own non-controlled, non-hazardous medications.
To learn more about the 2014 Disposal of Controlled Substances Final Rule and options for a collection receptacle or mailback program for your communities, 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.
For more information on medication disposal in LTCFs, read our other articles:
- This white paper was co-written by Sharps Compliance and Senior Housing News: “Medication Disposal in Senior Living: Understanding New Regulations.”
- Our white paper, “Requirements for Long-Term Care Facilities Under the EPA’s Pharmaceutical Rule,” describes in detail how the new EPA rule affects LTCFs.
- In this video interview, Sharps Compliance’s Director of Regulatory Compliance discusses new EPA regulations and their implications for LTCFs.