Pharmaceutical Waste Topics
Pharmaceuticals are a unique issue for healthcare facilities and require a complex set of rules for correct management and disposal. Many pharmaceuticals used in healthcare facilities are classified as hazardous waste once they become “inherently waste-like,” meaning expired, partially used, leaking, or cannot be credited via reverse distribution (the process of sending your unused pharmaceuticals back to the manufacturer).
There are three options for managing hazardous pharmaceutical waste. First, you can evaluate your formulary to determine which pharmaceuticals are hazardous. For details on how to perform a pharmaceutical waste evaluation, read the MPCA’s factsheet Evaluating Pharmaceutical Waste. However, evaluating your formulary may be very time and resource intensive, especially for small, independent healthcare providers. Thus, the second options is to perform a partial formulary evaluation and assume that all unevaluated pharmaceuticals are hazardous. Or, third, you can simply assume all waste pharmaceuticals are hazardous.
There are ways to reduce your amount of waste pharmaceuticals. For example, implementing or strengthening an inventory control system is an effective way to minimize waste and cost. MnTAP has completed several intern studies related to minimizing pharmaceutical waste. Please visit Environmental Best Practices for Managing RCRA Waste and Case Studies, Resources, and Links for more information and strategies for waste reduction.
The most common way to collect hazardous pharmaceuticals is by using a “RCRA black box.” A few manufacturers make them, and they normally come in 2-gallon, 8-gallon, 12-gallon, and 18-gallon sizes. It is usually best to use the smallest container possible to minimize the opportunity for trash and unintended items to end up in your hazardous waste stream. Note that black is the universally-recognized color to indicate hazardous pharmaceutical waste, but you can use any closed plastic container, as long as it is properly labeled.
In a smaller facility such as a clinic or nursing home, you should place black boxes in any areas where medications are prepped and/or dispensed (such as a nursing station). You should never keep black boxes in patient rooms, as it is illegal to store them in publicly-accessible places. For larger facilities, you’ll want to place black boxes in your pharmacies, utility rooms, sub-sterile rooms, and any other place medications are used and have the potential to be disposed of. In other words, include black boxes in any location that will facilitate staff compliance.
Remember to label the black boxes with the words “hazardous waste” along with a description of the contents, such as “waste pharmaceuticals.” You should put a date on the container so that you can track how long you’ve been collecting in that location. You may want to place posters near the black boxes to remind staff to use them. The purpose is to collect items that are 1) expired (non-returnable through reverse distribution), and 2) opened and unusable (you still have medication left in the vial). DO NOT pour individual tablets or liquids into the black box; you should place the entire vial, pill bottle, etc. into the black box. If you pour individual tablets or liquids into the box, it can become hazardous slurry or sludge that is unidentifiable and will cause you many headaches during a regulatory inspection.
Finally, once your container is full, move it to a designated hazardous waste storage area. That area must include something that provides secondary containment (e.g. a tote or a room without a floor drain). Close the container and write a date on the container as it enters storage. Now it is subject to your weekly inspections and other regulations with regard to storage and transport.
We know that this is a lot of information to process. Please look to our Waste Training Toolkit for step-by-step instructions on collection and storage.
A topic of special concern when we discuss pharmaceutical waste is the Lethality Characteristic, also known as MN01. This is a Minnesota-specific hazardous designation and carries with it rules that affect the healthcare industry. The data needed to determine whether a certain pharmaceutical is hazardous for the lethality characteristic is not always readily available, so performing a thorough evaluation is often challenging. For this reason, MPCA has approved an Alternate Method to evaluate pharmaceutical waste for the lethality characteristic.
The Lethality Characteristic tells us that these are the attributes of potential lethality:
- A drug regulated by the Minnesota Board of Pharmacy
- A pesticide regulated by the Minnesota Department of Agriculture
- A poisonous material regulated for transport by the U.S. Department of Transportation
- A material bearing any of the descriptive or signal terms: Poison, Poisonous, Toxic, Lethal, Fatal, or Deadly
- A material bearing the “skull and crossbones” graphic
- A material bearing the U.S. Department of Transportation “Hazard Class 6.1”
- A National Fire Rating (NFR), Hazardous Materials Identification System (HMIS), Hazardous Material Identification/Information Guide (HMIG) rating Health Division ≥3, or Special Hazard Division “POI”
- A material bearing LD50 data on a Material Safety Data Sheet (MSDS) stating that the LD50 of any of the ingredients is less than the lethality thresholds on page 1 of this fact sheet
Under Minnesota Rules, a waste is definitely hazardous for the Lethality Characteristic when a representative sample of the waste exhibits any of the following:
- An oral LD50 (rat) less than 500 milligrams per kilogram (mg/kg). For example, if you have data showing that the oral LD50 in a rat is 400 mg/kg, it is hazardous.
- A dermal LD50 (rabbit) less than 1000mg/kg.
- An inhalation LC50 (rat) less than 2000 milligrams per cubic meter (mg/m3) for dusts and mists.
- An inhalation LC50 (rat) less than 1000 parts per million (ppm) for gases and vapors.
The Alternate Method assumes a pharmaceutical is lethal (and a hazardous waste) if it is contained in or described by any number of risk factors:
- It is a carcinogen
- It is a chemotherapy agent
- It is a combination U/P-listed drug
- It is an endocrine disruptor
- It is a NIOSH hazardous drug
- It is an OSHA hazardous drug
As you can see, the MN01 Lethality Characteristic greatly increases the amount of hazardous waste your facility may generate. Oftentimes, even with the guidance above, you may still be unsure about whether a product is hazardous or not. When in doubt, you can use the Alternate Method as discussed previously, you can call an analytical testing laboratory to have it tested for lethality, or, if you do not take these steps, you can assume it is hazardous and dispose of it as such. Often, and especially for smaller facilities, it makes the most sense to treat all pharmaceuticals as hazardous waste.
P-listed wastes are of special concern to healthcare facilities because they are difficult to manage, particularly from a staff education standpoint. When a drug is P-listed, not only is the unused portion hazardous, but also the wrappers and packaging that have touched the substance. For example, in an outpatient pharmacy you may dispense from bulk-dose bottles of Coumadin. Once you have dispensed the last pill, you must dispose of the empty pill bottle as a hazardous waste. This rule would also apply, for example, to the wrappers from nicotine patches. As the law reads, if a nurse applies a nicotine patch to a patient, he or she must dispose of the foil wrappers in the RCRA hazardous waste stream. Do note that used nicotine patches or gum are not considered hazardous (no matter how long they were used), and can be thrown into the regular trash according to the law.
The most common P-listed wastes in healthcare are:
- Warfarin (such as Coumadin, a blood thinner)
- Nicotine patches and gum (used for smoking cessation)
- Physostigmine (used to treat glaucoma and Alzheimer’s)
- Arsenic trioxide (such as Trisenox, an antineoplastic agent)
It is worth noting the topic of epinephrine waste. Several years ago, facilities were managing epinephrine as P-listed waste, and some may continue to do so today. However, rigorous testing in late 2008 found that waste epinephrine with concentrations less than .24 percent would no longer be considered Lethal (MN01) or P-listed waste according to the MPCA. The overwhelming majority of epinephrine used in healthcare is at concentrations less than .24 percent, so it can be disposed of in the regular trash (or, as best management practice, in your hazardous waste stream). Find out at which concentrations you use epinephrine before you treat it as regular trash. Visit the Regulatory Consensus on Health Care Issues for more details.
For more information on P-listed waste in general, please visit the MPCA factsheet P List of Acute Hazardous Waste.
Some unopened pharmaceuticals that are no longer usable by a healthcare provider may be eligible for return to manufacturers or consolidators for beneficial use. This process is termed “reverse distribution” by the EPA. It potentially applies to all pharmaceuticals, both hazardous and non-hazardous. To be eligible for shipping to a reverse distributor, pharmaceuticals must be unopened (meaning you could not send an opened half-vial of medication). You must also have reason to believe that the pharmaceutical can be put to good use, as it is unlawful to use reverse distribution purely as a way to reduce your RCRA hazardous waste costs. Finally, the reverse distributor must be able to supply you with reports showing how they used the pharmaceuticals that were sent back to them. If they were ultimately wasted, they must prove that the hazardous wastes were properly shipped to a Treatment, Storage, and Disposal facility.
The rules around reverse distribution are quite strict and the regulatory agencies will likely apply special scrutiny to your reverse distribution program. If you are currently using, or plan to use, a reverse distributor, it would be a very good idea to read the MPCA factsheet Reverse Distribution of Pharmaceuticals.
Controlled substances are a special class of drugs whose disposal is enforced by the U.S. Drug Enforcement Administration (DEA), which maintains a list of substances on the Department of Justice’s website. Sometimes, controlled substances can be collected via reverse distribution or during a sheriff drug take-back event, though these are not sufficient alternatives in all cases. Some facilities also might sewer this waste, though MnTAP cannot endorse or recommend any particular treatment method. If your facility does not provide guidance to you, it may be helpful to discuss the issue with your county or state hazardous waste regulator and obtain an understanding of what they allow, particularly when a pharmaceutical is both a controlled substance and a hazardous waste. You may also want to speak with the pharmacy who supplies you with medications, as they may be helpful in translating the rules as they pertain to you.
Infectious waste and hazardous waste are not synonymous. This is one of the most common mistakes made concerning healthcare wastes. For example, a facility may believe that it is following the law by placing unusable medications into a red bag or sharps bin, but this is untrue under all circumstances. The infectious waste stream is intended for biohazard burdens, such as blood and body fluids, and the waste is often autoclaved (steam sterilized), compacted, and sent to a special landfill. The chemical properties of RCRA waste are not eliminated by the autoclaving process; autoclaving is an inappropriate and ineffective method for treating RCRA hazardous waste. Regulators will be diligent in the inspection process to ensure that you do not have medication waste leaving through your red bags or sharps bins, so it is critical that you understand the difference and manage your program accordingly. There is, however, one situation in which a waste can be “dual” waste (both infectious and hazardous), and it is discussed in the next section.
Dual waste is a special class of waste because it is both infectious and hazardous. For example, let’s say you administer an influenza vaccine via injection, but the patient becomes squeamish and you must withdraw before completely administering the dose. Now you have a sharp (infectious waste) that contains an unusable portion of influenza vaccine (a RCRA hazardous waste). The law states that you must throw this sharp into a third waste stream, called dual waste. This is a very special situation and some sites generate more dual waste than others.
If you are a facility that does generate dual waste, it is prudent for you to segregate this material from any other waste stream. If you choose to have your staff throw their dual waste into the RCRA waste boxes, it will vastly increase the cost of your RCRA waste stream. It will also put the RCRA waste disposal company employees at risk for needle sticks. Thus, you should make every effort to properly label your bins so that sharps never end up in your regular RCRA waste stream. For more information on dual waste, visit the MPCA factsheet Regulatory Consensus on Health Care Issues.
Antineoplastic agents (cancer chemotherapy drugs and cytotoxic drugs) have adverse impacts on both the environment and the people who administer them (the patient care providers). Antineoplastic agents should never be thrown into a landfill, and much care should be given to ensuring they end up in an incinerated waste stream. In healthcare, there are two waste streams whose final destination is incineration: RCRA hazardous waste and the infectious “yellow bag” waste stream. The RCRA hazardous waste stream is appropriate for bulk chemo waste, and the yellow bag waste stream is appropriate for trace chemo waste.
- Bulk chemo waste:
Bulk waste includes any amount of antineoplastic agent that could drip, pour, or be wrung from its host. For example, if you had a spill of these drugs, everything that was used to clean up the spill would be considered bulk waste. In addition, if you do not back-flush your IV sets after administering chemotherapy, the IV bag and tubing would be bulk waste. Any direct free-flowing amount would be considered bulk as well. Bulk chemo waste should be managed in your RCRA hazardous waste stream, such as in your black box. Take care to ensure that your bulk chemotherapy is contained in a tightly closed container and that as few people as possible are exposed to the contents.
- Trace chemo waste:
Trace waste includes anything that was used in the administration of antineoplastic agents, such as disposable gowns and gloves used by the staff, and back-flushed bags of infused chemotherapy. Trace waste is properly managed by disposing of these items in your “yellow bag” waste stream. Yellow bags indicate that the final disposal method will be incineration, versus a red bag which indicates that the waste will be autoclaved (steam sterilized). A yellow bag waste stream is handled by an infectious waste vendor. More on this topic can be found under pathological and large tissue (yellow bag) waste (located within the healthcare infectious waste section of our website).
Though it is beyond the scope of this document, readers should be aware of the occupational hazards associated with exposure to antineoplastic agents. Personal protective equipment should be worn by all who may come into contact with these products, including not only the personal care provider (such as the nurse administering the product), but also housekeepers, laundry workers, and waste handlers. Healthcare workers’ exposure to antineoplastic agents has been linked to adverse reproductive outcomes, chromosomal damage, and other effects. It is especially important for pregnant workers to be protected from antineoplastic exposure. For more information, visit the CDC/NIOSH website on occupational exposure to antineoplastic agents.
Your facility is not required, nor is it always best practice, to accept old medications back from patients. There are nuanced laws around any “take-back” program, and unless you are prepared to deal with all of the requirements associated with becoming such a program, it may be better for you to incorporate education and patient literature into your activities as opposed to accepting patient medication directly.
The best way for a patient/consumer to protect the environment from the impacts of their pharmaceutical waste is to dispose of it using a county collection site. Many, if not all, counties across the state now offer this type of service, and it would be wise to research what is available in your county and create a small handout for patients.
A helpful starting place would be the MPCA website disposing of unwanted medications. The MPCA also maintains a searchable feature for county household hazardous waste (HHW) collection sites. For medication disposal specifically, the Minnesota program is often referred to as “Take It to the Box” and is usually run from a sheriff’s office or county building. An internet search using the terms “Take It to the Box” plus the name of your county should direct you to the programs available in your county. For assistance, please call the MnTAP office at 612-624-1300 (or toll-free at 800-247-0015). We would be happy to help find medication disposal options for patients and consumers in your area.
Links cited in the document above (for those who may be using a print version of this information)
- Evaluating Pharmaceutical Wastes (MPCA)
- The Lethality Characteristic: A Minnesota-specific Hazardous-Waste Characteristic (MPCA)
- The Alternate Method to Evaluate Pharmaceutical Waste for the Lethality Characteristic (MPCA)
- Hazardous Waste Disposal Companies (maintained by Hennepin County)
- Regulatory Consensus on Health Care Issues (MPCA)
- P-List of Acute Hazardous Wastes and Managing Acute Hazardous wastes (MPCA)
- Hazardous Waste Permitting and Treatment, Storage, and Disposal Facilities (TDSF)
- Reverse Distribution of Pharmaceuticals (MPCA)
- Infectious Waste Management Guide for Generators (MPCA)
- Occupational Exposure to Antineoplastic Agents (CDC/NIOSH)
- Patient/Consumer Disposing of Unwanted Medications (MPCA)
- Find Your Household Hazardous Waste (HHW) Collection Site (MPCA)