Pharmaceutical Waste Questions
Pharmaceutical waste is not a single category of waste, but several, and the chemicals that comprise pharmaceutical dosage forms are complex and diverse.
Because healthcare professionals have not traditionally focused attention on pharmaceutical waste management, there are a number of misconceptions regarding the proper methods for segregating and disposing of this waste. The following frequently asked questions are designed to help you better understand the challenges involved.
What is hazardous waste?
The Resource Conservation and Recovery Act (RCRA) defines a hazardous waste as a waste that has the potential to cause or significantly contribute to an increase in mortality or an increase in serious reversible or incapacitating reversible illness; or a waste that poses a substantial hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.
RCRA more specifically defines hazardous waste through four lists, P, U, K and F.
- Only the P and U lists are relevant to hazardous waste pharmaceuticals. These include common drugs such as warfarin, nicotine, cyclophosphamide, and lindane.
- RCRA also defines four characteristics of hazardous waste: ignitability, corrosivity, toxicity and reactivity.
- A number of common drug formulations meet the definitions of ignitability and toxicity and must be managed as a hazardous waste when disposed of.
Some highly toxic pharmaceutical products may not conform to technical RCRA definitions of hazardous waste. However, because these products also have the potential to cause harm, they should be treated as hazardous. We classify these products as PharmE Hazardous® waste according to the following criteria:
- Formulations containing P- or U-listed drugs that are not the sole active ingredient;
- the National Institute of Occupational Safety and Health (NIOSH) Hazardous Drug Alert Appendix A;
- Chemotherapy agents not already listed as RCRA hazardous;
- Bulk powders;
- Vitamin or mineral preparations that may fail the toxicity characteristic due to chromium, selenium or cadmium and for which there is inadequate data at this time.
We also have a “Biohazardous (Infectious)” category to classify live, attenuated vaccines, blood products, globulins and other pharmaceuticals that require disposal as infectious waste. You’ll find these under the “PharmE Hazardous®” banner but with the “Regulated Medical Waste” disposal requirements noted.
Is hazardous chemical waste the same as “red-bag,” infectious, biohazardous, or medical waste?
Not at all. One of the most common misconceptions is that hazardous chemical waste can be “red-bagged.” Red-bag waste is, by definition, biohazardous, infectious waste. Treatments such as autoclaving, microwaving, or incineration at a regulated medical waste facility render the infectious waste harmless but is not proper treatment for hazardous chemical waste as defined by the EPA. Hazardous chemical waste must be properly stored, manifested, transported, and incinerated following specific regulations and using federally permitted transporters and incineration firms.
“Cradle-to-grave” tracking ensures that hazardous chemical waste reaches the appropriate treatment facility. RCRA-permitted incineration facilities, known as TSDFs (Treatment, Storage, and Disposal Facilities) burn these chemicals at temperatures high enough to break down the chemicals into their individual components, such as carbon dioxide and water. All potentially toxic elements and compounds, such as heavy metals and carbon dioxide, released during combustion are removed from the stack so that only water vapor is released into the environment.
Which waste pharmaceuticals are considered hazardous chemical waste under RCRA?
Common pharmaceuticals such as nicotine, warfarin (Coumadin®), and a number of chemotherapeutic agents are federally regulated as hazardous waste and must be managed differently than other solid waste.
If a facility already has a chemotherapy waste handling contract, is it in compliance with RCRA?
Medical waste haulers and incineration firms that specifically handle chemotherapy waste routinely specify in their waste acceptance protocols that only paraphernalia such as tubing, gloves, gowns, and EMPTY vials, syringes, and IVs can be accepted for disposal. These items are considered trace chemotherapy and should be incinerated at a regulated medical waste incinerator to prevent employee exposure during autoclaving, microwaving, or other alternative treatment.
Bulk chemotherapy waste should be managed as hazardous chemical waste, even though EPA regulations have not been updated in this area. As a result, the EPA regulates only nine chemotherapy drugs as hazardous chemical waste. These nine drugs – arsenic trioxide, chlorambucil, cyclophosphamide, daunomycin, diethylstilbestrol, melphalan, mitomycin C, streptozotocin, and uracil mustard – must be segregated from yellow trace chemotherapy waste containers, red sharps containers, or red bags, and placed into RCRA hazardous waste containers when present in bulk amounts.
Since many of the non-regulated chemotherapeutic agents are at least as hazardous as the nine listed chemotherapy drugs, good risk management should involve treating all bulk chemotherapy agents as hazardous waste when discarded.
In addition, chemotherapy spill clean-up materials have traditionally been placed in yellow chemotherapy waste containers. Since these materials are overtly contaminated, they should be placed into hazardous waste containers.
What is the difference between trace and bulk chemotherapy waste?
From an EPA perspective, a container that holds the chemotherapy agent arsenic trioxide, which is a P-listed hazardous waste, is not “RCRA empty” unless all the contents have been removed and it is triple rinsed. Since this is not feasible in a healthcare facility, all containers that have held arsenic trioxide should be discarded as hazardous waste, regardless of contents. The only exception the EPA has granted is for a used syringe, which can be discarded as trace chemotherapy.
The other eight chemotherapy drugs regulated by the EPA as hazardous waste are U-listed. If all the contents have been removed that can be removed through normal means (such as drawing liquid out with a syringe), and there is no more than 3% by weight remaining, the container is considered “RCRA empty” and can be disposed as trace chemotherapy waste in the yellow container. If either criterion is not met, it should be disposed of as hazardous waste and would be considered bulk chemotherapy waste.
What is meant by the term “RCRA empty”?
For a container that has held a P-listed hazardous waste to be “RCRA empty” and therefore not regulated as hazardous waste, all the contents must be removed and it must be triple rinsed. For a container that has held a U-listed waste or a characteristic waste to be “RCRA empty,” all contents must be removed that can be removed through normal means, including drawing out with a syringe, and there is no more than 3% by weight remaining. If both of these conditions are met, the container is not regulated as a hazardous waste. EPA has made an exception for used syringes for P- and U-listed waste which can be disposed in either yellow trace chemotherapy or red biohazardous sharps containers, depending on the drug involved.
How do I know if I am managing pharmaceutical waste correctly?
Waste Management’s PharmEcologists® offer specialized expertise in the proper identification, segregation, and management of pharmaceutical wastes, particularly those considered to be hazardous chemical waste by the EPA.
How do you know if your organization could benefit from Waste Management’s pharmaceutical services? Take the simple self-diagnostic quiz below. If you answer “yes” to one or more of these questions, your organization is at risk of violating state and federal environmental regulations.
- Is pharmaceutical waste ending up in red sharps containers in your patient care units?
- Are any unused IV’s or other compounded fluids being disposed of down the drain?
- Are waste pharmaceuticals like warfarin and nicotine, considered hazardous waste by EPA, being combined with other nonhazardous pharmaceutical wastes?
- Are more than trace amounts of chemotherapy in vials, IVs, and syringes being disposed of in yellow “Chemo Waste” containers?
Waste Management can assess your risks and provide solid recommendations to bring your organization into compliance in this complex area of waste management.
Does RCRA compliance impact Joint Commission accreditation?
Yes, the Joint Commission Environment of Care Standards explicitly describes actions that must be taken to comply with hazardous waste regulations.
How does managing hazardous pharmaceutical waste relate to the Joint Commission accreditation process?
Most pharmacists focus on compliance with the Medication Management Standards required by the Joint Commission, whereas Safety Officers and environmental services managers focus on the Environment of Care Standards. They need to work closely together to make sure they consider pharmaceuticals in their response to the Environment of Care Standard 3.10. Under this standard, pharmaceuticals are potential hazardous materials under the OSHA Hazard Communication Standard and potential hazardous waste under the EPA’s Resource Conservation and Recovery Act (RCRA).
What is the relevance of the tracer methodology to pharmaceutical waste management?
The relevance to the tracer methodology occurs at the end of the medication use process where the question can be asked: How was this medication disposed if not administered? This leads right into a discussion of hazardous waste identification and management for unused medications that must be discarded.
With over 170,000 drugs evaluated, the PharmE® Waste Wizard® and the PharmE® Inventory Analysis are cost-effective tools for developing both an OSHA hazardous materials inventory for pharmaceuticals and an EPA hazardous pharmaceutical waste list.
How can PharmEcology® Services help an organization comply with RCRA?
To bring your organization into compliance quickly, we provide:
- PharmE®Inventory Analysis
- PharmE® Waste Wizard®
- PharmE® On-Site Risk Assessment and Implementation Process
- PharmE® Policies and Procedures
- PharmE®Computer-based Training