Pharmaceuticals are an essential element in healthcare delivery, helping patients effectively recover from illness and better manage chronic conditions. A key component in safe pharmaceutical handling is proper waste management. This critical yet complex activity is governed by strict and sometimes confusing requirements.
The following sections address some most commonly asked questions about pharmaceutical waste management and offer suggestions on how to ensure a complete and compliant effort that preserves staff, patient and environmental safety.
What Is Pharmaceutical Waste?
Pharmaceutical waste is any leftover, unused or expired medication that is no longer needed or can no longer be used. It can be classified as either hazardous or non-hazardous depending on its chemical properties and its risk to humans and the environment. There are different requirements for disposing of hazardous versus non-hazardous pharmaceuticals.
What are the Risks of Improper Pharmaceutical Waste Disposal?
If an organization disposes of drugs incorrectly, dangerous chemicals can leach into the surrounding environment and contaminate groundwater, drinking water, plant life and so on. Eventually, this may cause health problems in the community. Improper disposal methods may include washing drugs down sinks, flushing them down toilets, throwing them away in the regular trash or comingling hazardous drug waste with non-hazardous drug waste.
Which Agencies Regulate Pharmaceutical Waste Disposal?
The Environmental Protection Agency (EPA) regulates hazardous waste pharmaceutical disposal through the Resource Conservation and Recovery Act (RCRA). The law requires companies that use hazardous chemicals, including hazardous waste pharmaceuticals, to classify and dispose of them following prescribed criteria and procedures.
About 5% to 10% of pharmaceutical products can be classified as RCRA hazardous waste. EPA regulations do not require organizations to treat non-RCRA pharmaceutical waste as hazardous waste, though some States may have requirements. It is considered best practice to properly dispose of all pharmaceutical waste, whether RCRA or non-RCRA. Other agencies that regulate medicine waste disposal include the U.S. Department of Transportation (DOT), which covers how drug waste should be transported to waste management facilities, and the U.S. Drug Enforcement Administration (DEA), which oversees controlled substance waste management.
What Are the Different Hazardous Waste Generator Types?
The scope of EPA regulations is tied to the amount of hazardous waste an organization generates. A healthcare facility could be a very small quantity generator (VSQG), a small quantity generator (SQG) or a large quantity generator (LQG). Generator type is determined by the volume of non-acute and acute hazardous waste an organization generates.
What Are the Different Hazardous Waste Pharmaceutical Categories?
RCRA pharmaceutical waste falls into one of three categories: P-list waste, U-list waste, and/or characteristic hazardous waste.
P-listed pharmaceutical waste is acutely hazardous and includes drugs such as warfarin and nicotine patches. Note that P-list drug packaging should be considered waste along with drug remnants. U-list waste includes many chemotherapy drugs.
Characteristic hazardous waste is waste that has not been specifically listed as hazardous on the P- or U-lists but still exhibits one or more of the four hazardous waste characteristics. Drugs that fall into this category must be managed as RCRA hazardous waste.
What Are the Four Types of Characteristic Hazardous Waste?
- Ignitable. This type of waste is flammable, flashpoint is one factor in determining ignitability. Examples include alcohol-based cough syrups, and aerosol cans with flammable propellants.
- Corrosive. This category includes acids, bases and is based on pH. A few examples are glutaraldehyde, and pharmaceuticals that are persevered in corrosive materials such as nitric acid.
- Reactive. This type of waste negatively interacts with other chemicals, causing explosions or generating toxic gases or fumes. Unlike other kinds of waste, there aren’t defined testing procedures that organizations can use to determine the reactivity of a substance. Instead, they should refer to the Safety Data Sheet (SDS) associated with a drug to understand whether it falls into this category.
- Toxic. Although there are many products that could be thought of as toxic, from a waste perspective, the EPA only designates certain chemicals as toxic if they are present in specific concentrations. To determine these concentrations, organizations can use a test known as the Toxicity Characteristic Leaching Procedure (TCLP). Some of the chemicals that can be considered toxic are selenium, silver and mercury.
What Is a Hazardous Waste Manifest?
The hazardous waste manifest is a document that accompanies RCRA waste from a healthcare facility to a designated hazardous waste treatment, storage or disposal facility. The manifest 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.
The EPA requires a hazardous waste manifest for off-site shipments coming from SQG and LGQ facilities. The generator (the healthcare organization) is responsible for the accuracy and completeness of the information entered on the manifest.
What Are the Training Requirements for Hazardous Pharmaceutical Waste Disposal?
All staff should be trained on the importance of proper pharmaceutical waste segregation, handling and disposal. In addition, personnel who prepare hazardous materials for transport must complete DOT hazardous materials training and be re-trained at least every three years, so they know how to:
- Safely prepare hazardous waste for shipment
- Select containers
- Place hazardous materials into containers
- Mark or label containers
- Fill out or sign hazardous waste manifests
- Load hazardous waste onto vehicles
- Specify the placard required on the transport vehicle
There are additional training requirements as part of the new, recently published rule by the EPA on the disposal of hazardous waste pharmaceuticals.
What Is the EPA Final Rule?
In 2019, the EPA introduced a new rule governing the disposal of hazardous waste pharmaceuticals for healthcare organizations. Commonly referred to as Subpart P, the rule is designed to more closely align with how healthcare organizations manage hazardous waste pharmaceuticals while safeguarding human health and preserving the environment. Here are a few important topics covered in Subpart P:
- Although all healthcare facilities must follow the rule, small and large quantity waste generators must notify the EPA that they are following the rule, while very small quantity generators (VSQGs) must let the EPA know if they are choosing to follow it as it is optional for this level of generator.
- Controlled substances that are hazardous waste are conditionally exempted from being managed as such.
- Facilities have less stringent options to dispose of containers with residual hazardous waste and p-listed wastes.
- Not part of the EPA Final Rule, but established around the same time, the EPA no longer considers FDA-approved, over-the-counter nicotine replacement therapies, such as patches, gums and lozenges, as hazardous waste when they are discarded. This amendment does not apply to prescription nicotine therapies or e-cigarette products.
How Do You Dispose of Old and Unused Medications?
How you dispose of leftover medications depends on what type of generator you are. Hazardous waste pharmaceuticals generated from healthcare organizations, such as hospitals, doctor’s offices or pharmacies are regulated. Some medication can be categorized as regulated medical waste and others as non-hazardous.
Prior to the EPA Final Rule, healthcare organizations were able to “sewer”, or flush their hazardous waste pharmaceuticals as a means of disposal if they received approval to do so. Now, in order to better protect communities and the environment, the EPA has banned the sewering of hazardous waste pharmaceuticals.
While there are no regulations around consumer disposal, as stewards of the community, many organizations choose to participate in drug take back programs. Examples of these programs include providing customers with envelopes for secure disposal via mail or kiosks where people can drop off their medications. Solutions like these provide consumers with a safe, easy and anonymous way to dispose of leftover medication and keep it out of the environment and communities.
Looking for a Pharmaceutical Waste Management Program?
Stericycle can help improve the safety and reliability of your pharmaceutical waste management program. From compliance training to medication disposal, you can find a service to fit your unique needs. Learn more at https://www.stericycle.com/services/waste-services/pharmaceutical-waste.