Chemicals that comprise pharmaceutical dosage forms are diverse and complex as pharmaceutical waste is not put into one single category. Healthcare professionals have not always focused on waste management which has created several misconceptions on how to properly segregate and dispose of these wastes. These are some of the challenges involved in adequately managing pharmaceutical and chemo waste disposal.

Definition of a Hazardous Waste

The RCRA (Resource Conservation and Recovery Act) states a hazardous waste is a material that has the capability of causing significant health issues. It is a substance which has the potential to cause these issues or has the potential to create an increase in mortality. These materials also have the ability to generate a severe and irreversible illness. They pose a real threat to human health, or the environment when not properly treated, stored, transported, or disposed of under managed services.

There are four lists the RCRA uses to define hazardous wastes specifically:

• P and U lists are relevant to hazardous pharmaceutical wastes. These wastes include drugs such as lindane and cyclophosphamide
• The F list identifies wastes from industrial and manufacturing processes
• The K list identifies waste from specific sectors within the manufacturing sector

There are also four characteristics of hazardous waste defined by the RCRA which are: reactivity, toxicity, corrosivity, and ignitability. Several drug formulations meet these definitions and should be managed as hazardous waste when you dispose of them.

Knowing which drugs meet these formulations can become confusing and knowing the difference between ‘hazardous drug’ and ‘hazardous waste pharmaceutical’ can be difficult. Some mistake them for the same; however, there is a difference you should know to save your facility potential regulatory citations and money.

National Institute for Occupational Safety and Health (NIOSH) makes recommendations through research they conduct to prevent work-related illness and injury. They have created a list of ‘Hazardous Drugs’ that has been based on their potential to cause occupational exposure. The criteria used to define these drugs consists of:

• Teratogenicity or developmental toxicity
• Organ toxicity at low doses
• Toxicity and structure profiles of new medicines that replicate existing drugs and have already been determined to be hazardous
• Carcinogenicity
• Reproductive toxicity
• Genotoxicity

Chemotherapy or antineoplastic agents are the drug categories that most often fit the hazardous drug criteria. Others that fit are some bioengineered drugs, antiviral drugs, hormones, and a few other miscellaneous drugs. Healthcare professionals need to employ safe handling measures that meet the laws regarding safe ways to avoid potential exposure.

There are a few highly toxic pharmaceutical materials that do not always conform to technical RCRA definitions of hazardous waste. These materials still contain the potential to cause harm and should still be treated as hazardous when handling and disposing of them. These materials are classified as PharmE Hazardous and fall under the following criteria:

• P or U listed drugs used in formulations that are not the sole active ingredient
• Chemotherapy agents not put on the RCRA hazardous list
• Mineral or vitamin preparations that can fail toxicity characteristics because of chromium, cadmium, selenium and for which there is not sufficient data at this time
• Bulk powders

What is Red-Bag Waste?

One misconception that is commonly made is placing hazardous chemical waste into red bags. Red bag waste is infectious, biohazardous waste and should be disposed of by a regulated medical waste facility. Hazardous chemical waste needs separate disposal methods. This material has to be stored, manifested, transported, and incinerated following specific regulations. You need a special facility to handle the disposal of this material which has been federally permitted.

Red medical waste bags are designed to hold biohazardous or medical waste. These bags should be used to dispose of liquid or solid materials which are contaminated with blood or potentially infectious materials classified as:

• Body fluids from humans including, vaginal secretions, semen, synovial fluid, cerebrospinal fluid, peritoneal fluid, pericardial fluid, saliva that contains blood, amniotic fluid, and bodily fluid which contains blood, and any body fluids that are difficult to differentiate between bodily flu
• Human tissue or organs that have become unfixed from the human

This is the “Do” list when it comes to determining what to use the red bags for:

• Place into the red bag and items such as used specimen swabs, vaginal speculums, used glucose test strips, blood-soaked materials including gloves, urine dipsticks and material or article contaminated with OPIM
• Sharps must first be in a closed and locked sharps container before placing in a red bag
• You should only place biohazardous waste into the red bag

Before you place the red bag into the container, you need to check that it has not been compromised meaning it should not have tears or rips. You need to segregate and label human pathological waste before placing it into the bag and make sure it is sealed tightly before removing it from the waste disposal bin. When emptying the container, you need to put on gloves, face mask, eye protection, and an apron and keep these items on while you transport it to the disposal service and replace a new bag.

This is the “Don’t” list when it comes to determining what not to use the red bag for:

• Radioactive waste
• Pharmaceutical waste
• Human remains such as fetal remains, complete torsos, or cadavers
• Chemotherapy waste
• Mercury including dental waste such as amalgam sludge, vacuum pump filters, mercury fillings or empty amalgam capsules, non-contact and contact amalgam products, chairside traps
• Empty intravenous bags and tubing unless there is blood present inside of them
• Chemicals including corrosives, alcohol, solvents, waste oils, and formaldehyde
• Lead materials
• Hazardous waste such as heavy metals, batteries, or light bulbs
• Compressed gas cylinders, aerosol cans, inhalers, even if any of these containers are empty
• Sphygmomanometers, glass thermometers, or any medical device or solution which has mercury in it
• Uncontaminated solid waste such as beverage containers or food wrappers as these should be placed in a regular trash container

The red bags should only be disposed of by a service who has been licensed to deal with these materials. You cannot place these bags in your regular municipal or city waste collection containers.

Difference Between Trace and Bulk Chemotherapy Waste

If a container holds the chemotherapy agent arsenic trioxide, which is on the P-list of hazardous wastes, then according to the EPAs perspective is not “RCRA empty.” You would have to remove all the contents from the container and rinse it three times for it to be considered “RCRA empty.” This cleansing is not a feasible task in a healthcare facility, so it is best for you and your staff to discard of any containers which have held these materials as hazardous waste. The EPA has only made one exception, and that is for a syringe which can be discarded as trace chemotherapy.

There are eight other chemotherapy drugs which are listed on the U-list that the EPA states can be considered “RCRA empty” if the contents can be removed using standard means such as drawing liquid out with a syringe and you can leave no more than 3% by weight remaining in the container. If you can meet these criteria, then the container can be placed in a yellow container as trace chemotherapy and disposed of with the use of licensed disposal service.

What is RCRA Empty?

If a container has held a P-listed hazardous waste, it needs to be emptied, and triple rinsed to be considered RCRA empty in order for you to handle it as hazardous waste. If a container has held a U-listed waste, it has to have all contents removed from it through normal means with no more than 3% remaining in the container by weight for you to handle it as hazardous waste. If you can meet both these requirements, the container is then not regulated as a hazardous waste.

How to Manage Your Pharmaceutical Waste Correctly

If you are not clear whether or not your facility should use a pharmaceutical service to dispose of your waste, there are some simple questions to ask yourself to learn the answer. If you can say your facility meets any of these criteria, you could be at risk of violating state and federal environmental regulations if you are not using a proper disposal service.

• You have pharmaceutical waste ending up in your red sharps container inside your patients care rooms
• Do you have unused IVs  or other compounded fluids disposed of down the drains in your facility
• Do you have more than trace amounts of chemotherapy left in vials, and are throwing syringes in yellow “Chemo Waste” containers

Check with the Environmental Marketing Service to have your risks assessed and find solid recommendations to bring your facility into compliance with waste management.

Managing Hazardous Pharmaceutical Waste

The Joint Commission Environment of Care Standards describes which actions must be taken to comply with regulations set for hazardous waste disposal.

Pharmacists in general comply with the Medication Management Standards that have been established by the Joint Commission and environmental services and safety officers generally follow the Environment of Care Standards. Under this standard, 3.10, pharmaceuticals are considered hazardous materials according to OSHA’s Communication Standard and hazardous waste under EPA’s Resource Conservation and Recovery Act.

There are many different agencies involved in setting standards and requiring you to use proper waste disposal methods. Working with Environmental Marketing Services (EMSLLC) will make this task safer, economically better for your facility, and easier for you to make sure you comply with all legal and environmental regulations.

Use a Waste Management Disposal Service to Dispose of Your Pharmaceutical and Chemo Waste

Disposing of hazardous waste is a carefully government regulated industry. This industry receives a lot of scrutiny, and pressures are making it an increasingly complex process. Your facility needs to find peace of mind knowing you are using a service that provides the best available technology available to handle disposing of your pharmaceutical and chemo waste.