Pharmaceutical waste is not one single waste stream, but several distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceutical dosage forms. Because healthcare has not traditionally been focused on waste stream management in this area, a number of misconceptions have arisen around the proper methods for segregating and disposing of pharmaceutical waste. The following frequently asked questions have been designed to assist you in coming to a better understanding of this important waste management challenge.

Is hazardous chemical waste the same as “red-bag”, infectious, biohazardous, or medical waste?

No! Click here to understand the difference between RCRA hazardous chemical waste and red-bag waste.

What waste pharmaceuticals would be 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?

Not necessarily. Click here to find out why.

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 other eight chemotherapy drugs regulated by 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 or white container. If either of these criteria 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 the 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.

How do I know if I have a pharmaceutical waste problem?

Click here to take our 30 second pharmaceutical waste quiz.

Why is pharmaceutical waste management an issue now?

Worldwide, both industry and governments are becoming increasingly concerned about how much pharmaceutical waste is being generated by healthcare institutions and about the affect that waste has on our environment. Click here to read more about the organizations who are beginning to bring attention to this issue. 

Is the EPA enforcing RCRA?

Yes, USEPA Region 2 has been very aggressive in inspecting and enforcing hazardous waste regulations in New York and New Jersey. Fines have ranged from $40,000 to almost $290,000. USEPA Region 1 has also begun a healthcare initiative and has issued fines up to $372,000 for hazardous waste violations.  Region 3 and Region 9 have begun educational initiatives and Region 4 has started hospital site inspections. In addition, a number of states have begun their own initiatives, including education and enforcement.

Does RCRA compliance impact JCAHO accreditation?

Yes, the JCAHO Environment of Care Standards explicitly describe actions that must be taken to comply with hazardous waste regulations.

How does managing hazardous pharmaceutical waste relate to the JCAHO accreditation process?

Most pharmacists focus on compliance with the Medication Management Standards required by JCAHO, whereas Safety Officers 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 materials under the OSHA Hazard Communication Standard and potential hazardous waste under the EPA’s Resource Conservation and Recovery Act (RCRA).

What action items of EOC 3.10 need to be applied to hazardous pharmaceutical materials and hazardous pharmaceutical waste?

The action items for EOC 3.10 related to pharmaceuticals direct the organization to:

• Develop a written plan to manage hazardous materials and hazardous wastes;
  
• Identify materials that need special handling;
  
• Mitigate the risks of their unsafe use and improper disposal;
  
• Create and maintain an inventory of both hazardous materials and hazardous wastes;
  
• Establish and implement procedures for managing hazardous materials and hazardous wastes from selection through use or disposal;
  
• Provide adequate space and equipment for safe handling and storage of these items;
  
• Identify and implement emergency procedures for response during a hazardous material or hazardous waste spill or exposure;
  
• Establish procedures for reporting a spill of a hazardous material or hazardous waste;
  

The Environment of Care standards specifically mention chemicals and chemotherapeutic materials. Chemicals should be interpreted to include all pharmaceuticals which should be evaluated as potential hazardous materials and hazardous waste.

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 130,000 drugs evaluated, the PharmE™ Waste Wizard and the PharmE™ Formulary 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® Associates help an organization comply with RCRA?

To bring your organization into compliance quickly, we provide the PharmE® Inventory Analysis, the patented PharmE® Waste Wizard, the PharmE® On-Site Risk Assessment, PharmE® Implementation Support and Certification, and the PharmE® Policies and Procedures, For associations, group purchasing organizations, and other interested parties, we provide seminars. We also offer customized consulting and research to any organization managing or disposing of pharmaceutical waste.