Guardrails Keep Oncology Waste Management on the Right Track

George Calcanes, MD, chief clinical officer at New York Cancer and Blood Specialists

George Calcanes, MD

A large proportion of medical waste in oncology is considered hazardous and must be disposed of correctly. It is part of a humongous stream of waste that has contributed to a medical trash disposal industry estimated at $3.2 billion in 2019, up 4.8% from last year. In fact, close to 200 medical waste disposal businesses were active in the United States in 2019.¹

Those statistics wouldn’t surprise George Calcanes, MD, chief clinical officer at New York Cancer and Blood Specialists in New York City. “I wish there were more that we could do to not generate as much waste as we do, but I’m not hopeful,” he said. “We use a lot of stuff to take care of the patient— I’m always shocked at how much. I think here we have it at the minimum.”

The business of medical waste disposal took off with the Medical Waste Tracking Act of 1988, which established a pilot program to ensure the legal disposal of the many tons of waste produced at clinics and hospitals annually.² Significant accumulations of medical waste had turned up on beaches on the East Coast.

The Centers for Disease Control and Prevention (CDC) estimates that 8 million US healthcare workers are potentially exposed to hazardous drugs in the workplace, so proper disposal methods are needed even before waste leaves the clinic.³ In oncology, particularly with respect to the handling of chemotherapy drugs, workers over time may suffer exposures that cause chronic health effects such as rashes and adverse reproductive outcomes, as well as potential cancers, according to the CDC.

Safety of patients, practitioners, and staff is crucial during the handling and administration of the hazardous products, and safety protocols are heavily prescribed by multiple regulatory bodies. The United States Pharmacopeial Convention, Occupational Safety and Health Administration, National Institute for Occupational Safety and Health, Environmental Protection Agency (EPA), and Drug Enforcement Administration (DEA) maintain lists of hazardous pharmaceuticals and have established standards to protect individuals from hazardous drug exposure, although the EPA has not had authority over medical waste since the Medical Waste Tracking Act expired in 1991. Primary regulation now originates from state environmental and health departments.²

Waste ranges from unused drug products to drug residue on surfaces, needles, gloves, and safety goggles, as well as in human waste that cannot safely be flushed down a toilet. Similarly, waste disposal regulations come in many forms. Medical waste with trace chemotherapy toxins— eg, gloves, draping, empty containers—may be deemed hazardous by certain state standards and can be handled by medical waste disposal companies as long as these items are marked for incineration.³ Various states, however, require that certain items of medical waste be collected by an EPA-permitted transporter.

Jim Schwartz, RPh, executive director of pharmacy operations at Texas Oncology in Dallas, said that although the language of disposal regulations can be complicated, a good system can simplify and clarify the process to avoid mistakes by clinicians and staff. “Empty chemotherapy vials and used syringes—we put those in yellow bins, and they are put in a separate bin away from everything else in the facility,” Schwartz said. Doctors and staff can check the clinic’s readily accessible list of hazardous drugs and dispose of those products safely. “Anytime we have those drugs, we put them in a separate white bin, and they are kept separate from the others,” he said.

Know Before You Throw: What is Hazardous Waste?

A large proportion of a healthcare practice’s budget goes toward supplies, much of which ends up as waste. Across the industry, this results in 7000 tons of waste every day and $10 billion in disposal costs annually.⁴

Healthcare practices can produce up to 25 pounds of waste per day per patient. Of that, approximately 85% is classified as nonhazardous and can be tossed in the trash. The other 15% is classified as regulated waste or biohazardous material (<5%), and containment, handling, and disposal practices must comply with federal and state regulations.⁵ An effective waste management plan can simultaneously cut down on waste and reduce the expense of getting rid of it.

Similarly, a waste management plan will help prevent mishandling of the 15% of materials that fall within the regulated medical waste category. Part of that job can be done by a waste management company, but coop-eration from oncology and other healthcare practices is essential.

“We rely a lot on these facilities to segregate waste from the get-go,” said Cara Simaga, director of regulatory affairs at Stericycle, a medical waste management facility based in Bannockburn, Illinois. “That is key and is why we offer a lot of training documents and color-coded labels. It can be confusing because there are a lot of different wastes that come out of pharmacies and hospitals and practices, especially oncology-related wastes.”

Stericycle, a multinational company, specializes in regulated medical waste management, hazardous waste management, and sharps [eg, syringes] waste management, as well as drug disposal. The company was founded in 1989 in response to the Medical Waste Tracking Act and the tide of medical waste found on beaches in New York and New Jersey. The company reported $3.49 billion in revenue in 2018.⁶

Teamwork for Disposal

Waste management facilities rely on open communication with practices and environmental health and safety departments to ensure that materials are separated properly for final disposal.

For example, practices should know that not everything marked hazardous can go into the same disposal container. “There are different types of incineration facilities for hazardous waste—they burn at a higher temperature,” Simaga said. “We know it is not everybody’s favorite thing, because they have more important things to focus on, such as their patients, but we try really hard to make it easy and streamline for that customer, because we really need them to do the proper segregation on the front end to be successful.”

At Fred Hutchinson Cancer Research Center in Seattle, Washington, staff and practitioners take separation seriously. “You do not want to second guess what it is and what it is not,” said Donald T. Wang, MPH, RBP, CBSP, director of Environmental Health and Safety at Fred Hutch. “Usually the drug is clearly labeled, identifying the materials you are dealing with, and that guides the flow of where to dispose them once they are done.”

Beyond using colored bins, bar codes, and standardized logs, there are other ways to streamline disposal and ensure safety and compliance. “Consistency is everything,” Wang said. “We’ve been using more symbols that make things a little clearer. Rather than numbers and codes, there are more pictures to identify the hazards.”

New Agents Add Complexity

Therapies being developed to target cancer present additional hurdles to regulating and disposing of waste following therapy. In addition to creating the standard stream of intravenous bags, contaminated syringes, and other therapy-related waste, these agents may contain hazardous properties and must be handled with care. For example, the production of chimeric antigen receptor T cells yields hazardous biologics, including anticoagulants and excess viral vectors.⁷

“Cancer treatments are not being tackled only from a chemical end these days. There [are] a lot of exciting [things] going on especially in immunotherapy, but that waste is more of biologic type,” Wang noted. As treatments evolve, protocols ensuring the safe and proper disposal of materials must be adjusted.

“Regulation and technology are always butting heads with each other. We are looking at immunotherapy and nanoparticles, [and] we have radioactive treatments and good old-fashioned chemical treatments, so we have a lot of potential therapies for patients with cancer, and regulations sometimes do not keep up with that,” Wang said. Until every treatment carries a disposal guideline from a regulatory authority, facilities must use their best professional judgment regarding the potential risks of the products, he added.

USP <800>

The development of United States Pharmacopeia (USP) General Chapter <800> has been of concern to practices because of the costly and disruptive changes needed to comply with its terms. The purpose of the chapter, set to be implemented in December 2019, is to describe practice and quality standards for handling hazardous drugs in healthcare settings and promote patient and worker safety, while also protecting the environment.⁸

USP <800> requires a standard operating procedure for the waste disposal and compliance with applicable state and federal regulations; by itself, it does not affect how healthcare facilities handle disposal, Simaga said. “People have been calling us in a panic, asking, ‘How does this change how I dispose of things?’ Practices should continue to refer to the state and federal regulations for disposal. The good thing is, USP <800> has brought attention to waste disposal and will help to make sure that all workers in a healthcare facility are protected when managing waste from oncology medications.”

Accrediting bodies such as The Joint Commission, as well as pharmacy practice laws and professional licensing boards, reference or include USP standards. Enforcement of USP <800> standards, however, will depend on local, state, and federal regulatory agencies.⁸

Following New Standards

Healthcare facilities do need to focus on the f inal rule for the EPA’s Management Standards for Hazardous Waste Pharmaceuticals, which went into effect in 8 states on August 21, 2019, and will apply to all 50 states by July 1, 2021.⁹ The regulation is designed to end a prevalent practice of disposing of leftover medications by pouring them down the drain or flushing them. It also covers the rinsing of pharmaceutical containers.⁹

Hazardous waste pharmaceuticals should be segregated and disposed of in proper containers. Smaller facilities with waste output that might be increased by compliance with the new regulation can maintain their current operating procedures. The rule is intended to prevent an estimated 1644 to 2300 tons of hazardous pharmaceutical waste annually from entering the environment and waterways.⁹

Reducing Waste In and Out of Practice

Although reducing medical waste generation is difficult to achieve, Calcanes sees hope in drug return programs. “We have a program to prevent patients from flushing pills down the toilet. Instead, they can bring their drugs here and we can dispose of them so they do not go into the water supply.”

In a survey at an outpatient pharmacy, more than half of 301 responding patients reported storing unused and expired medications in their homes, and more than half had flushed them down the toilet. Just 20% had ever been given advice about medication disposal by a healthcare provider, and less than one-fourth (22.9%) reported returning unused medication to a pharmacy for disposal.¹⁰

In another survey determining how much medication goes unused, approximately 2 out of 3 prescription medications were reported as not fully used in the study sample of 238 people. The most common reasons given for not using medication were improvement of the disease or condition (42.4%), forgetfulness (5.8%), and adverse events (6.5%). “Throwing medications in the trash” was found to be the most common method of disposal (63%).¹⁰

The DEA sponsors drug take-back days across the country, offering collection sites for unused or expired medication. Waste disposal companies also give practices and community pharmacies envelopes so patients can send unused drugs back to a medical waste facility or drop off bottles at kiosks for proper disposal.

References

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2. Medical waste. Environmental Protection Agency website. epa.gov/rcra/medical-waste. Accessed October 28, 2019.
3. Managing chemotherapy waste. Wisconsin Department of Natural Resources website. dnr.wi.gov/files/pdf/pubs/wa/wa1258.pdf. Published 2008. Accessed October 30, 2019.
4. Hazardous drug exposures in healthcare. CDC website. cdc.gov/ niosh/topics/hazdrug/default.html. Updated September 27, 2018. Accessed October 27, 2019.
5. Waste. Sustainability Roadmap for Hospitals website. sustainabilityroadmap.org/topics/waste.shtml#.XbhXF0VKiu7. Accessed October 28, 2019.
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8. What is USP <800>. Ready for <800> website. readyfor800.com/ what-is-usp-800/. Accessed October 29, 2019.
9. Final rule: management standards for hazardous waste pharmaceuticals and amendment to the P075 listing for nicotine. Environmental Protection Agency website. epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075. Accessed October 29, 2019.
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