July 19, 2022
Medication plays a critical role in illness recovery and chronic condition management both in formal healthcare settings and in patient homes. A key component in safe medication use is the proper disposal of unneeded pharmaceuticals. When done correctly, pharmaceutical waste management can help protect the environment and help prevent dangerous medications from getting into the wrong hands.
Pharmaceutical waste management is governed by strict and sometimes confusing requirements. To help healthcare providers and patients understand this critical—yet complex—activity, Stericycle has answered some of the most frequently asked questions about medication waste management.
Pharmaceutical waste is any leftover, unused, or expired medication that is being discarded. Patients and healthcare providers produce medication waste in formal settings, as patients recover from surgery or major illness, and in patient homes, as patients manage chronic illness and other conditions.
Between five and 10 percent of all pharmaceutical waste is considered to be “hazardous waste” by the U.S. Environmental Protection Agency (EPA). The EPA classifications depend on each medication’s chemical properties. States may regulate more pharmaceuticals as hazardous waste than the EPA.
If disposed of incorrectly, active pharmaceutical ingredients can be released into the environment. Improper drug disposal methods can include washing drugs down sinks, flushing them down toilets, or throwing them away in the regular trash.
Improper pharmaceutical waste management can also contribute to the opioid epidemic. Leaving unneeded and addictive pain medication in patient homes rather than promptly discarding them can increase the risk that a household member could access and abuse them. Effects of pharmaceutical waste in water can be toxic to our neighborhoods.
Many agencies regulate pharmaceutical waste disposal.
The EPA regulates the disposal of hazardous waste pharmaceuticals through the Resource Conservation and Recovery Act (RCRA).
Other agencies that regulate pharmaceutical waste disposal include the U.S. Drug Enforcement Administration (DEA) and state boards of pharmacy.
In 2019, the EPA finalized a new rule, often referred to as Subpart P, that provides healthcare-specific requirements for managing hazardous waste pharmaceuticals. Some components of Subpart P include:
No. Unfortunately, these terms are used interchangeably but do not mean the same thing. The term “hazardous drug” refers to drugs found on the NIOSH list of Hazardous Drugs. The term “hazardous waste” refers to waste that is listed by the EPA (U, P, F, or K-listed) and/or exhibits a hazardous characteristic (ignitable, corrosive, reactive, and/or toxic); these items are regulated by the EPA through Subpart P. There are cases when a drug is a hazardous waste pharmaceutical and is also on the NIOSH list. There are also cases when a drug is on the NIOSH list but is not a hazardous waste pharmaceutical.
The EPA categorizes facilities based on the volume of hazardous waste they generate. Healthcare facilities can be considered very small quantity generators (VSQG), small quantity generators (SQG), or large quantity generators (LQG). This classification informs how the EPA regulates the waste generator.
Federal law mandates that the first step for any business that generates waste is to “characterize” or identify their waste. Regardless of size or volume, there are tools and organizations like Stericycle that can assist larger generators and smaller healthcare facilities with the identification and characterization of pharmaceutical waste.
A medication is considered “hazardous” if it has one of four key characteristics:
To ensure compliance with the EPA and state government regulations, healthcare organizations should train all staff on proper pharmaceutical waste segregation, handling, and disposal. Additionally, employees who prepare hazardous materials for transport must complete Department of Transportation hazardous materials training and be re-trained at least every three years.
Healthcare organizations should make pharmaceutical waste management training easy to complete and accessible in various forms, including web-based and on-site options, to support staff amid ongoing staff shortages.
Effective pharmaceutical waste disposal procedures begin with a plan. Healthcare administrators should create and train employees on a detailed waste management plan that aligns with applicable EPA, DEA, and state rules.
Subpart P bans all sewer-based disposal of hazardous waste pharmaceuticals, so providers in healthcare settings should at the very least develop a plan to avoid prohibited sewering of hazardous waste pharmaceuticals.
Hazardous pharmaceutical waste is typically collected in black containers clearly labeled “hazardous waste pharmaceuticals,” as required by the EPA. Non-hazardous pharmaceutical waste is typically collected in blue containers.
The EPA requires hazardous pharmaceutical waste to be treated at a permitted treatment facility before disposal. Most pharmaceutical waste is incinerated through a licensed medical incineration site.
A hazardous waste manifest is an EPA-required document that accompanies hazardous waste from a generator site, such as a healthcare facility to a designated hazardous waste facility. It identifies the waste-generating healthcare site, the transporter that carries the waste off-site, and the destination for the hazardous waste treatment, storage, disposal, or recycling.