Managing Pharmaceutical Waste

DRAFT

A 10-Step Blueprint for
Health Care Facilities
In the United States

April 15, 2006

Acknowledgements

Table of Contents

Acknowledgements

The Blueprint was written by Eydie Pines, Practice Greenhealth and Charlotte Smith, PharmEcology Associates, LLC.

The U.S. EPA, Office of Solid Waste and Emergency Response, Innovation Initiative, provided funding for the project and Mary Dever and Peggy Bagnoli, U.S. EPA Region I, were responsible for it.

The following people were especially helpful in reviewing the Blueprint:
Fawzi Awad, Saint Paul - Ramsey County Department of Public Health
Laura Brannen, Practice Greenhealth
Michael Burke, North Memorial Medical Center
Gail Cooper, U.S. EPA, Office of Solid Waste
Janet Bowen, U.S. EPA Region I
Jerry Fink, North Memorial Medical Center
John Gorman, U.S. EPA Region II
Kristin Fitzgerald, U.S. EPA, Office of Solid Waste
Sara Johnson, New Hampshire Department of Environmental Services
Lisa Lauer, U.S. EPA, Office of Solid Waste
John Leigh, Dartmouth-Hitchcock Medical Center
Steven Lucio, Novation
Meg McCarthy, U.S. EPA, Office of Solid Waste
Patricia Mercer, U.S. EPA, Office of Solid Waste
James Michael, U.S. EPA, Office of Solid Waste Virginia Thompson, USEPA Region III
David Stitzhal, Pharmaceuticals from Households: A Return Mechanism
Alan Woodard, New York State Department of Environmental Conservation
Catherine Zimmer, Minnesota Technical Assistance Program

Special thanks to staff at Dartmouth-Hitchcock Medical Center for their participation in the project, particularly Lindsey Waterhouse.

back to top

Introduction

The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the country is raising concerns about the potentially adverse environmental consequences of these contaminants. Minute concentrations of chemicals known as endocrine disruptors, some of which are pharmaceuticals, are having detrimental effects on aquatic species and possibly on human health and development. The consistent increase in the use of potent pharmaceuticals, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated.

Pharmaceutical waste is not one single waste stream, but many distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceuticals. Pharmaceutical waste is potentially generated through a wide variety of activities in a health care facility, including but not limited to intravenous (IV) preparation, general compounding, spills/breakage, partially used vials, syringes, and IVs, discontinued, unused preparations, unused unit dose repacks, patients' personal medications and outdated pharmaceuticals.

In hospitals, pharmaceutical waste is generally discarded down the drain or landfilled, except chemotherapy agents, which are often sent to a regulated medical waste incinerator. These practices were developed at a time when knowledge was not available about the potential adverse effects of introducing waste pharmaceuticals into the environment.

Proper pharmaceutical waste management is a highly complex new frontier in environmental management for health care facilities. A hospital pharmacy generally stocks between 2,000 and 4,000 different items, each of which must be evaluated against state and federal hazardous waste regulations. Pharmacists and nurses generally do not receive training on hazardous waste management during their academic studies, and safety and environmental services managers may not be familiar with the active ingredients and formulations of pharmaceutical products.

Frequently used pharmaceuticals, such as epinephrine, warfarin, and nine chemotherapeutic agents, are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA). Failure to comply with hazardous waste regulations by improperly managing and disposing of such waste can result in potentially serious violations and large penalties.

Practice Greenhealth recommends this 10-step approach to help you develop and implement a comprehensive pharmaceutical hazardous waste management program ­ one that combines regulatory compliance and best management practices with waste minimization ­ to safeguard human health and the environment, while minimizing risk in a cost effective manner.

Sumpter, J and Johnson, A. Lessons from Endocrine Disruption and Their Application to Other Issues Concerning Trace Organics in the Aquatic Environment. Vol. 39, No. 12, 2005, Environmental Science and Technology.

back to top of Introduction

back to top

Navigating the Blueprint

The steps in this Blueprint do not necessarily have to be taken consecutively. Some steps will occur in parallel and other steps will probably be referenced throughout the development of your pharmaceutical waste management program. The following summary of the 10-steps describes how each step can be used to develop and implement your pharmaceutical waste management program: Step 1 provides action items that you can begin immediately.
Step 2 is an overview of how the federal Resource Conservation and Recovery (RCRA) regulations apply to pharmaceutical waste management.
Step 3 begins where the regulations leave off providing guidance on how to manage non-regulated hazardous pharmaceutical waste.
Step 4 walks you through the steps necessary to perform a drug inventory review. This step can be very tedious and time consuming.
Step 5 alerts you to waste minimization opportunities.
Step 6 It will be helpful to become familiar with the waste minimization opportunities before assessing your current practices based on the guidance provided in Step 6 and to reference them again after you have performed your department reviews.
Step 7 Taking on the Communication/Labeling Challenge, Step 7 is one of the most critical aspects of implementing a pharmaceutical waste management program and possibly the most challenging. Step 8 How you decide to communicate pharmaceutical disposition information to the people handling the waste will depend and be dependent upon which of the management options presented in Step 8 you select and what you learn in -
Step 9, Getting Ready for Implementation.
Step 10 When all the preparation from Steps 7-9 comes together you will be ready for Step 10, Launching the Program. Next Steps follows Step 10 and provides recommendations for future efforts to facilitate environmentally sound pharmaceutical waste management in health care facilities.

The following icons have been used to assist you in using the Blueprint:
Indicates additional steps where relevant information can be found
Indicates that a recommendation involving this topic can be found in Next Steps
Indicates that additional resources can be found in the Appendices

back to top

back to top of Navigating the Blueprint

Applying the Precautionary Principle

This Blueprint focuses primarily on three aspects of pharmaceutical waste management:

(1) Management of regulated hazardous pharmaceutical waste;
(2) Management of non-regulated hazardous pharmaceutical waste applying best management practices; and,
(3) Minimization of pharmaceutical waste

While your first priority has to be the proper management of hazardous pharmaceutical waste, careful consideration should be given to the management of all pharmaceutical waste. As research data accumulates on the adverse impacts of waste pharmaceuticals on human health and the environment, applying the Precautionary Principle becomes increasingly relevant:

“When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”

When in doubt, apply the Precautionary Principle.

The Wingspread Consensus Statement on the Precautionary Principle can be accessed at http://www.sehn.org/wing.html.

back to top

back to top of Applying the Precautionary Principal

Step One: Getting Started

Designing and implementing a successful pharmaceutical waste management program is a highly interdisciplinary process. It begins by obtaining support from senior management and establishing a committee of stakeholders that will meet regularly to develop and implement the program. This committee may be the current Environmental Health and Safety Committee but must include at minimum the leaders of Pharmacy, Environmental Services, Safety, Nursing, Education, and Infection Control. Additional members for consideration are personnel from Facilities/Engineering, Administration, Laboratory and Purchasing/Materials Management.

Given the complexity of implementation and the potential budgetary impacts (e.g., purchase of pharmaceutical waste containers and potentially increased disposal costs), the newly formed committee may find it valuable to arrange a presentation to senior management explaining the opportunities, challenges and financial implications of proper pharmaceutical waste management without getting into program specific details.

back to top

back to top of Step One

Step Two: Understanding the Regulations

Pharmaceutical waste management is especially challenging given the complexity of the regulations that govern this activity and the multiple regulatory agencies that oversee it. Step 2 focuses primarily on how the federal RCRA regulations apply to hazardous pharmaceutical waste management. It is divided into four major sections to provide a broad overview of the applicable regulations and an awareness of the overlap between RCRA and other statutes.

• Defining Hazardous Waste Categories
• Grappling with Hazardous Waste Combination
• Distinguishing Between Trace and Hazardous Chemotherapy Waste
• Understanding Hazardous Waste Management

USEPA Region 2 has been very aggressive in inspecting and enforcing hazardous waste regulations at the 480 hospitals in New York, New Jersey, Puerto Rico and the U.S. Virgin Islands. Fines have ranged from $40,000 to almost $280,000. USEPA Region 1 has also begun a health care initiative and has notified 250 hospitals in New England of its intention to enforce hazardous waste laws in health care facilities.

State regulations may be more stringent than federal regulations and may vary by state. A number of states, including California, Washington, and Minnesota, have implemented more stringent hazardous waste regulations that impact pharmaceutical waste management. Check your state regulations to make sure that you understand your state-specific requirements.

Next Steps contains a recommendation for clarifying, reconsidering and expanding the RCRA hazardous waste regulations.

There are additional resources in Appendix A: Tools and Resources that will provide you with a more complete understanding of RCRA and your organization's responsibilities.

1. Defining Hazardous Waste Categories

Hazardous wastes are divided into two categories: (1) listed wastes, and (2) characteristic wastes. Listed wastes appear on one of four lists of hazardous waste (F, K, P and U). Pharmaceuticals are found on two of these lists, the P and U lists which both contain commercial chemical products. Characteristic wastes are regulated because they exhibit certain hazardous properties ­ ignitability, corrosivity, reactivity and toxicity.

a. P- Listed Wastes (40 CFR Part 261.33(e))

Pharmaceuticals are chemicals first and therapeutic agents second. P-listed wastes are commercial chemical products that are categorized as acutely hazardous under RCRA.

One of the primary criteria for including a drug on the P-list as acutely hazardous is an oral lethal dose of 50 mg/kg (LD50) or less. LD50 is the amount of a material, given all at once, which causes the death of 50% of a group of test animals. Eight chemicals on the P-list are used as pharmaceuticals (see Table 1).

Table 1: P-listed Pharmaceuticals(Chemotherapy agents are noted in italics)

In health care settings, waste epinephrine (Waste Code P042) is by far the most common hazardous drug waste generated. It is used most often in cardiac care units and during orthopedic and ophthalmic surgical procedures but may be generated anywhere in the facility to treat cardiac arrest and allergic reactions.

i. Two Necessary Conditions (40 CFR Part 261.33)

When a drug waste containing a P-listed constituent of concern is discarded or intended to be discarded, it must be managed as hazardous waste if two conditions are satisfied: (1) the discarded drug waste contains a sole active ingredient (54 FR 31335) that appears on the P list, and (2) it has not been used for its intended purpose (54 FR 31336). To satisfy the definition of sole active ingredient , the listed chemical in the discarded drug must be the only ingredient that performs the intended function of the formulation. Ingredients that serve ancillary functions such as mobilizing or preserving the active ingredient are not considered when determining the sole active ingredient. The phrase “has not been used for its intended purpose” refers to drugs and their associated containers or dispensing instruments that have not been given to a patient and need to be discarded. The portion of an IV infusion that was not given to a patient and needs to be discarded is an example of an item that has not been used for its intended purpose.

ii. Empty Containers of P-Listed Wastes (40 CFR Part 261.7(b)(3))

A container that has held a P-listed waste is not considered “RCRA empty” unless it has been:

(1) Triple rinsed, and

(2) The rinsate is managed as hazardous waste.

Since triple rinsing is not practical in health care settings, all vials, IVs, and other containers that have held a P-listed drug must be managed as hazardous waste, regardless of whether or not all of the contents have been removed.

iii. Dilute Concentrations of P-Listed Waste

There are no concentration limits or dilution exclusions for P-listed hazardous wastes. If saline or another solvent is added to a P-listed chemical, additional P-listed hazardous waste is generated.

iv. Epinephrine Syringe Interpretation

Excess and residue epinephrine in a syringe after the proper dose has been administered to a patient is the single pharmaceutical exception to the definition of the phrase has not been used for its intended purpose. This exception is based on a December 1994 EPA Hotline interpretation. After the proper dose has been injected, EPA considers residues remaining in a syringe to have been used for their intended purpose. Therefore, the syringe containing residue epinephrine is not a P042 hazardous waste and can be discarded as Regulated Medical Waste in a sharps container.

In the interpretative guidance, a reference is made to the syringe as a dispensing instrument. The question arises regarding the regulatory status of other forms of delivery or dispensing instruments, such as an IV bag containing excess or residue epinephrine. EPA has not expanded the definition of a dispensing instrument to include any form of delivery other than a used syringe. Therefore, only excess or residue epinephrine in a used syringe is excluded from regulation as a P-listed waste. All excess or residue epinephrine in other types of dispensing instruments must be managed as a RCRA hazardous waste.

RCRA Online # 13718

v. Nitroglycerin Exclusion

In 2001, a revision to the mixture and derived-from rules (66 FR 27286) excluded all P- and U-listed wastes listed solely for an ignitability, reactivity and/or corrosivity characteristic (including mixtures, derived-from and as generated wastes) once they no longer exhibit a characteristic.

Nitroglycerin, P081, is listed solely for its reactivity characteristic. This action effectively removed medicinal nitroglycerin as a P-listed waste at the federal level since it is a weak, non-reactive formulation that does not exhibit the reactivity characteristic.

Nitroglycerin formulations must still be evaluated for the other characteristics. Some injectables such as nitroglycerin 5 mg/ml in some formulations fail the ignitability characteristic, which is discussed later in this Step.

b. U-Listed Wastes (40 CFR Part 261.33(f))

i. Two Necessary Conditions

There are 21 drugs on the U-list (see Table 2: U-Listed Pharmaceuticals). These chemicals are listed primarily for their toxicity. Similar to a P-listed waste, when a drug waste containing one of these chemicals is discarded, it must be managed as hazardous waste if two conditions are satisfied:

(1) The discarded drug waste contains a sole active ingredient that appears on the U list, and

(2) It has not been used for its intended purpose.

As with P-listed wastes, there is no concentration limit or dilution exclusion.

Table 2: U-Listed Pharmaceuticals (Chemotherapy agents are noted in italics)

ii. Empty Containers of U-Listed Wastes (40 CFR Part 261.7(b)(1))

A container that has held a U-listed waste is considered “RCRA empty” if two conditions are met:

(1) All the contents have been removed that can be removed using normal means, such as drawing liquid out with a syringe;

AND

(2) No more than 3% by weight remains.

If both of these criteria are not met, the container must be managed as hazardous waste. Any residues removed from the empty container must be managed as hazardous waste.

Normal means are practices commonly employed industry-wide to remove the material from that type of container, such as pouring, pumping, aspirating, and draining (40 CFR Part 261.7(b)(1)(i))

c. Characteristic Hazardous Waste (40 CFR Parts 261.21 ­ 261.24)

In addition to the P- and U- listed wastes, a waste is considered hazardous under RCRA if it possesses at least one of four unique and measurable properties or characteristics:

1. Ignitability
2. Corrosivity
3. Reactivity, and
4. Toxicity

As the generator, you are responsible for determining whether a drug formulation that is intended for discard exhibits one of the four characteristics through testing or through knowledge of the drug formulation. Once a characteristic waste no longer exhibits any of these properties, it is no longer considered a hazardous waste. However, RCRA places certain restrictions on the manner in which a waste can be treated (See What is Treatment? below).

i. Ignitability: D001 (40 CFR 261.21)

The objective of the ignitability characteristic is to identify wastes that either present a fire hazard under routine storage, disposal, and transportation or are capable of exacerbating a fire once it has started. There are several ways that a drug formulation can exhibit the ignitability characteristic.

• Aqueous drug formulations containing 24 percent or more alcohol by volume and having a flashpoint of less than 140 degrees F or 60 degrees C must be managed as ignitable hazardous waste. Aqueous refers to a solution containing at least 50 percent water by weight. Since flashpoint data is somewhat hard to obtain, you should consider managing all waste formulations containing 24% or more alcohol as ignitable hazardous waste. Many drugs are relatively insoluble in water and require alcohol to keep them in solution.
• Liquid drug formulations, other than aqueous solutions containing less than 24 percent alcohol, with a flashpoint of less than 140 degrees F or 60 degrees C must be managed as ignitable hazardous waste. Being a non-aqueous solution, the flashpoint is used to make the hazardous waste determination.
• Oxidizers or materials that readily supply oxygen to a reaction in the absence of air as defined by the DOT must be managed as hazardous waste.
• Flammable aerosol propellants meeting the DOT definition of compressed gas must be managed as hazardous waste.

Reference 40 CFR 264 Appendix V Examples of Potentially Incompatible Waste Group 6-A Oxidizers

Primatene aerosol contains epinephrine. The waste code P042 should also be used when manifesting this waste.

ii. Corrosivity: D002 (40 CFR Part 261.22)

Any waste which has a pH of less than or equal to 2 (highly acidic) or greater than or equal to 12.5 (highly basic) exhibits the characteristic of corrosivity and must be managed as a hazardous waste. Generation of corrosive pharmaceutical wastes is generally limited to compounding chemicals in the pharmacy. Compounding chemicals include strong acids, such as glacial acetic acid and strong bases, such as sodium hydroxide.

Step 9: Locating Your Satellite Accumulation Area includes a discussion on managing corrosive pharmaceutical waste.

iii. Reactivity: D003 (40 CFR Part 261.23)

Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes, gases, or vapors when heated, compressed, or mixed with water. Nitroglycerin is the only drug that is potentially reactive. Refer to the section above, entitled Nitroglycerin Exclusion, for an understanding of the regulatory status of medicinal nitroglycerin.

iv. Toxicity: Multiple D Codes (40 CFR Part 261.24)

Forty chemicals have been included in RCRA as a concern in a solid waste landfill environment above certain concentrations. Table 3 provides a subset of that list and examples of drug formulations containing these chemicals and heavy metals. Wastes that exceed these concentrations must be managed as hazardous waste. The test that determines the ability of these chemicals and heavy metals to leach in a landfill environment is called the Toxicity Characteristic Leaching Procedure, or TCLP. If the concentration determined by the TCLP exceeds the stated limits, the waste must be managed as hazardous waste.

Table 3: D-listed Chemicals Used in Drug Formulations

v. Empty Containers of Characteristic Wastes (40 CFR 261.7)

A container that has held a characteristic waste is defined as empty in the same manner as a U-listed waste if all of the contents have been removed that can be removed through normal means and no more than 3% by weight remains.

Normal means are practices commonly employed industry-wide to remove the material from that type of container, such as pouring, pumping, aspirating, and draining (40 CFR Part 261.7(b)(1)(i))

2. Grappling with Hazardous Waste Combinations

This section provides guidance on how to manage combinations of hazardous waste and:

• Personal Protective Equipment (PPE) and spill materials
• Regulated Medical Waste (RMW)
• Sharps, and
• Controlled substances.

a. Contaminated Personal Protective Equipment and Spill Materials

i. Listed Waste

PPE worn to protect employees from exposure to hazardous chemicals, materials used to perform routine cleaning or decontamination of Biological Safety Cabinets and glove boxes, and spill clean up materials may become contaminated with hazardous waste.

According to EPA's contained-in policy , the resulting waste has the same regulatory status as the original listed component. For example, personal protective equipment such as gloves and gowns that is known to be or suspected of having been contaminated with P- or U-listed hazardous waste must be managed as hazardous waste. If PPE is routinely worn but does not appear to have come into contact with listed waste, it is acceptable for it to be discarded either as trace chemotherapy waste, if its use involved chemotherapy agents, or in the trash as solid waste.

EPA''s contained in policy is explained in the following letters: (1) Marcia Williams to Gary Dietrich (2/9/1987); (2) Sylvia Lowrance to Timothy Fields, Jr. (1/3/1989; RCRA Online #11387; and, (3) Devereaux Barnes to Norm Niedergang (2/17/1995; RCRA Online #13732

Any materials used to clean up a hazardous waste spill, such as the contents of an IV bag of epinephrine, must be managed as hazardous waste and cannot be discarded in a trace chemotherapy or solid waste container.

Refer to the section below, Distinguishing Between Trace and Hazardous Chemotherapy Waste, for further discussion of PPE and spill materials contaminated with chemotherapy agents.

ii. Characteristic Waste

The contained-in policy applies differently to characteristic hazardous wastes. PPE and spill materials contaminated with characteristic wastes are hazardous only if the PPE and spill material exhibit a characteristic. However, it is best to be conservative and manage PPE that has been contaminated with a flammable waste or a highly corrosive waste as hazardous waste.

b. Regulated Medical Waste

There will be situations where a combination waste that is both infectious Regulated Medical Waste and hazardous waste must be managed by a limited number of vendors that are permitted to handle both waste streams. The type of dispensing instrument used and the type of drug being administered both play an important role in determining how the resulting waste must be managed.

If, for example, bloody tubing or sharps are not disconnected from an IV bag that contains a partially used P- or U-listed chemical or from one that no longer contains a P-listed chemical, the waste must be managed as both RMW and hazardous waste. Fortunately, in many cases, luer-lock fittings enable the safe disconnection of the tubing or sharps from the IV bag. Disconnecting the tubing or sharps from the IV bag avoids the generation of a waste that is both RMW and hazardous waste and instead enables the management of the tubing or sharps and IV bag individually as RMW and hazardous waste, respectively.

Arsenic trioxide and physostigmine are drugs that may be prepared or administered by syringe and as a result may need to be managed as both hazardous waste and RMW. Some states, such as New York may allow a waste that is both RMW and hazardous to be handled as hazardous waste on the basis that hazardous waste is the more protective category.

c. Sharps

Often partially used syringes, vials or ampules containing P- or U-listed hazardous chemicals or characteristic hazardous wastes are erroneously discarded in RMW sharps containers. Generally speaking, most vendors that manage sharps are not legally permitted to manage RCRA hazardous waste. These vendors are permitted to treat only infectious waste. As the generator, it is your responsibility to train staff that these distinct types of waste are managed differently and must be segregated (e.g., not to discard hazardous waste or waste that is both RMW and hazardous waste in sharps containers unless the containers are specially marked as both infectious and hazardous waste). If hazardous waste is improperly placed in a sharps container, the container should be relabeled as RMW and hazardous waste and managed by a vendor that is permitted to handle both waste streams.

Similarly, it is also possible that during a cardiac arrest code, a vial or ampule of epinephrine may be used and discarded into the sharps container on the crash cart. In this case, a P-listed drug container, which remains hazardous unless triple rinsed, is placed into an RMW container. Here again, the container must be relabeled as an RMW and hazardous waste container and a vendor that is permitted to handle both waste streams must be utilized.

d. Controlled Substances (21 CFR Parts 1300 to 1399)

Controlled substances are those drugs regulated by the Drug Enforcement Administration. They are divided into five schedules based on their potential for abuse.

Controlled substances must be destroyed so that they are beyond reclamation and two health care professionals must document the destruction. Since most hospitals no longer have ready access to incinerators in which to burn the drugs, the next most efficient way to accomplish this is through drain disposal.

There are three controlled substances that are on Schedule IV due to their moderate abuse potential that are also RCRA listed constituents of concern: (1) Chloral hydrate (U034), (2) Paraldehyde (U182), and (3) Phentermine (P046). Other controlled substances may be state listed hazardous waste, as is the case in Minnesota. Be sure to check with your state regulatory agency.

These hazardous controlled substance wastes can be transferred to a limited number of hazardous waste vendors that are also DEA registrants. They also may possibly be sewered. You need to request written permission from your wastewater treatment plant to sewer small amounts of hazardous controlled substances. Sewering of controlled substances may be prohibited in your state or municipality. The hazardous waste regulations pertaining to sewering are described in more detail below in the section entitled, Drain Disposal.

Step 5: Minimizing Pharmaceutical Waste provides examples of controlled substances that are routinely wasted and alternatives that will minimize generation of this waste stream.

Step 9: Selecting the Right Vendor(s) contains requirements for hazardous waste vendors that are also DEA registrants.

Next Steps contains recommendations for working with DEA to eliminate drain disposal, understanding the environmental impacts of managing waste pharmaceuticals in sharps containers and examining the appropriate management of wastes that are both infectious and hazardous.

Appendix A: Tools and Resources provides additional information on controlled substances and DEA requirements.

3. Distinguishing Between Trace and Hazardous Chemotherapy Waste

a. Terminology

There is a great deal of confusion among the terms chemotherapeutic, antineoplastic, and cytotoxic. Technically, chemotherapy is therapeutic chemical treatment. While most commonly used to describe cancer treatment, it was originally used as an anti-infective term in reference to the use of mercury and arsenic before the advent of antibiotics. Some journals still refer to antimicrobial chemotherapy. The term antineoplastic refers specifically to inhibiting or preventing the growth or development of malignant cells, and is the most specific. The term cytotoxic is a very general term referring to any chemical that is toxic to cells. It again has taken on the common meaning of cancer chemotherapy. To confuse matters more, the pharmaceutical profession tends to equate the term biohazardous with cytotoxic. Some manufacturers put both “Cytotoxic” and “Manage as Biohazardous Waste” on the same label. These labels create confusion as the term “biohazardous” waste should be restricted to the commonly accepted definition of infectious waste in state blood-borne pathogens regulations, which are typically items contaminated with pourable, drippable, flakable or squeezable blood, used or unused sharps, and lancing devices.

b. Trace Chemotherapy Waste

The federal RCRA regulations do not address trace chemotherapy waste. There is no recognized distinction between bulk and trace chemotherapy contamination for P- and U-listed hazardous wastes since there isn't a lower concentration limit under which these wastes can exit the regulatory system.

Most state regulated medical waste regulations are either silent or not specific on the definition of trace chemotherapy waste. The original reference to segregating trace chemotherapy waste is found in an article written in 1984 by pharmacy personnel at the National Institutes of Health who pioneered applying the RCRA regulations to antineoplastic wastes. California's Medical Waste Management Act and Wisconsin's newly revised Medical Waste Rules identify trace chemotherapy waste and require incineration at a regulated medical waste facility or other, approved treatment method.

Vaccari, P; Tonat, K; DeChristoforo, R; GTallelli, J, Simmerman, P. Disposal of antineoplastic wastes at the National Institutes of Health, AJHP Vol 41 Jan 1984, pp. 87 ­ 93.

Refer to Appendix A: Tools and Resources for information on how to access the California Medical Waste Management Act and the Wisconsin Medical Waste Rules.

All chemotherapy paraphernalia should be managed as trace chemotherapy waste if there has been the potential for exposure to chemotherapy contamination. Items that are appropriate for management as trace chemotherapy waste include:

• “RCRA empty” vials, syringes, IV bags, and tubing;
• Gowns, gloves, wipes and other paraphernalia associated with routine handling, preparation, and administration of chemotherapy; and
• Wipes and other materials used during routine cleaning and decontamination of a Biological Safety Cabinet or glove box (unless alcohols, phenols or other hazardous materials are used).

c. Hazardous Chemotherapy Waste

One chemotherapy agent is a P-listed constituent of concern and eight chemotherapy agents are U-listed (See Table 4 below). Trace chemotherapy containers have long been used to discard listed chemotherapy drug waste that should be managed as hazardous waste. This is not only illegal but also inappropriate since trace chemotherapy waste is incinerated at an RMW incinerator, not a hazardous waste incinerator. RMW incinerators have less restrictive emissions limits and permit requirements. Discarding “bulk” P- or U- listed chemotherapy agents as trace chemotherapy waste has been the cause of substantial enforcement actions and fines and should be one of the first changes you implement in your pharmaceutical waste management program.

Table 4: P- and U-Listed Chemotherapy Agents

i. Combination Hazardous Chemotherapy and Regulated Medical Wastes

The Oncology Nursing Society strongly discourages unhooking an IV set unless it has been designed to protect employees from exposure. When a chemotherapy waste that is both RMW and hazardous waste is generated, it must be managed by a limited number of vendors that are permitted to handle both waste streams (See the section above on Regulated Medical Waste for information on combination wastes).

ii. Spill and Decontamination Materials

Any materials used to clean up a hazardous waste spill, such as the contents of a used chemotherapy spill kit, must be managed as hazardous waste. This material cannot be discarded in a trace chemotherapy waste container. If overt contamination of the Biological Safety Cabinet or glove box surfaces is known or suspected, all cleaning materials should be discarded as hazardous waste. It is always permissible to manage a waste up to the next hazard class. When making this decision, you should use good judgment based on how often the Biological Safety Cabinet or glove box is used and decontaminated. Unless a closed transfer system such as PhaSeal is being utilized, it is safe to assume that some chemotherapy contamination occurs with each transfer.