Why Regulate? The Difficulties in Dealing With Pharmaceutical Waste
Waste pharmaceuticals have always been tricky to manage. One difficulty is they’re near ubiquity in our society; hospitals, pharmacies, residential care facilities, and veterinary clinics would not be able to function without the use of certain lifesaving—yet sometimes highly toxic—medications.
For example, the mechanism of action that allows chemotherapy drugs to be effective in combating cancer is also reason for their extreme toxicity, in that all dividing cells are ultimately destroyed by these antineoplastic drugs.
Yet even seemingly ordinary drugs (like the epinephrine inside EpiPens) are listed under the Resource Conservation and Recovery Act (RCRA) as being hazardous or acutely hazardous.
Schools and everyday households aren’t exempt either—presenting no easy legislative solution to safeguard our communities against the hazardous effects of this type of waste.
To add to the complications of dealing with hazardous pharmaceutical waste, the onus usually falls on individual healthcare workers to safely dispose of these wastes.
This can be a problem, as focus is diverted from the care of patients to first learning which pharmaceuticals are hazardous and which aren’t (these wastes are found either on a special RCRA Listed Wastes group, or they will meet one of the four characteristics of hazardous waste), then the proper way to handle medications that meet the federal criteria of hazardous waste.
Proposed Pharmaceutical Waste Regulatory Revisions: 2008 to Now
The 2008 Proposal
In an effort to deal with the problem of waste pharmaceuticals, on December 2nd, 2008, the Environmental Protection Agency (EPA) set out a proposal in which hazardous pharmaceuticals would be added to the Universal Waste Rule. This proposal, if finalized, would have effectively given generators the choice to treat all hazardous pharmaceutical waste as non-hazardous waste.
The EPA explained that their 2008 proposal, if implemented, would have diverted future pharmaceutic waste from landfills and sewer systems, thereby reducing the amount of toxic substances reaching wastewater treatment plants.
The main reason the EPA chose not to finalize the proposal is due to the public’s concerns over the lack of notification requirements for facilities that generate, handle, or transport the supposed “universal waste” pharmaceuticals, and also the absence of an official shipment tracking system for the waste.
The 2015 Proposal
Unlike the earlier 2008 proposal, the EPA’s 2015 proposal for the regulation of hazardous waste pharmaceuticals focuses on a “healthcare facility-specific” form of management.
The proposed changes would not include pharmaceutical waste in the Universal Waste Program, as was earlier proposed.
Currently, the best way for any healthcare facility to manage their pharmaceutical waste is to make use of take-back programs, reverse distribution, or some other method of sending unused, damaged, or mishandled hazardous medications back to the manufacturer.
The new changes to the current system of pharmaceutical waste management could possibly mean less strict adherence to RCRA for generators and an easing of disposal responsibilities for healthcare workers.
A notice of proposed rulemaking is expected to be published by the EPA in June of this year. But as with the 2008 proposal, public debate over the issue is expected to re-shape the content of this most recent plan.
If the newly proposed rule is finalized—however it may end up looking if additional changes are made in the proposal process—all healthcare facilities will have to pay attention. Until then, pharmaceutical waste will continue to be managed under Subtitle C of the Resource Conservation and Recovery Act (RCRA).
For detailed information solutions on how to handle and dispose of your pharmaceutical waste, give us a call at (800) 936-2311 or click here to email us.