Improper Discard of Toxic Drugs Hurts Environment, Leads to Fines
Increasingly, state and federal agencies are targeting health-system pharmacies as violators of environmental protection laws.
The Resource Conservation and Recovery Act (RCRA) was enacted in 1976 to address the issue of how to safely manage and dispose of hazardous waste. The RCRA program is administered and enforced by the Environmental Protection Agency (EPA) Office of Solid Waste and authorized state agencies.
RCRA gave EPA the authority to control the generation, transportation, treatment, storage, and disposal of hazardous waste—from cradle to grave.
EPA considers epinephrine, nicotine, warfarin, nitroglycerin, and certain other drugs to be acutely toxic when discarded. Products containing these drugs cannot be disposed of with medical waste or general trash.
What makes waste hazardous? RCRA defines hazardous waste as a solid waste or combination of solid waste that, because of its quantity, concentration, or physical, chemical, or infectious characteristics, may
- Cause or significantly contribute to an increase in deaths or development of serious irreversible or incapacitating reversible illness, or
- Pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.
EPA has four categories that list hundreds of solid wastes as hazardous. The lists are known as the F, K, P, and U lists and can be found in the Code of Federal Regulations under Title 40, section 261.33, or "Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof."
The F and K lists focus on hazardous wastes from industrial and manufacturing processes.
Drugs appear on the P and U lists, which include pure or commercial-grade formulations of specific unused chemicals. Acutely toxic chemicals are found on the P list.
A particular substance is a P- or U-listed waste only if, before discard, it is the sole active ingredient in a commercial product or manufacturing intermediate, according to EPA.
If a drug product is determined not to be a P- or U-listed waste, then the product should be assessed to see if it possesses one of EPA’s four characteristics of a hazardous waste: ignitability, corrosivity, reactivity, or toxicity.
Wastes not mentioned on one of the four RCRA lists may still fall under hazardous wastes regulations when EPA’s four characteristics are considered.
For instance, drug products containing thimerosal—a preservative made with mercury—are considered toxic when declared to be waste. Aqueous solutions containing at least 24% alcohol or more by volume, such as some topical dermatological products, are ignitable. And some nitroglycerin formulations may be considered reactive.
Enforcement varies. State environmental agencies, excluding those in Alaska and Iowa, are authorized by the federal government to conduct hazardous waste inspections.
Authorized state agencies also have the power to enforce RCRA compliance—in some cases by imposing thousands of dollars in fines.
Fine amounts vary with each state. For instance, per violation per day, Idaho’s maximum fine is $10,000, while Georgia’s fines go as high as $50,000. And Minnesota—one of the most stringent states with RCRA regulations—has a maximum fine of $75,000 per violation.
The federal government’s maximum fine is $27,500 per violation per day, said Mary Andrews, attorney adviser for EPA’s Office of Enforcement and Compliance Assurance.
But, she said, EPA steps in only when asked by a state or in cases where a state has not sought federal authorization, as in the cases of Alaska and Iowa.
If federal or state investigators find criminal negligence, pharmacy and hospital administrators are held responsible and could spend time in jail for gross violations, according to EPA officials.
"We take this very seriously," said Jim Berlow, director of EPA’s Hazardous Waste Minimizing and Management Division.
Berlow said states have the authority to be more stringent in defining hazardous waste. And, he said, EPA urges pharmacists and health care administrators to be familiar with their own state’s rules.
"In most cases, it will be the state agencies that will determine if there has been a violation or not, and the responsible party will answer to the state agency in charge," he said.
Berlow said a pharmaceutical product is not necessarily hazardous until it is discarded.
"It’s a tricky issue when you are dealing with drug waste," he said. "Many outdated products are not hazardous because they can be returned to the manufacturer as long as they are in the original container and not opened. But if it is a product that has been partially used, then it must be discarded as waste and therefore stored, transported, and disposed of in the proper way."
Generators of waste, such as health care facilities, can be held responsible if their contracted hazardous waste management company does not properly manage the waste, Berlow added.
Berlow suggested that pharmacists check with state agencies to make sure transporters and disposal facilities have the necessary licenses and permits.
Beyond identification. Hazardous waste generators are required to have an EPA-issued identification number that stays with the discarded property indefinitely.
Health care facilities and other hazardous waste generators are also required to keep records about hazardous waste for up to three years.
EPA defines three categories of hazardous waste generators on the basis of the quantity of hazardous waste they generate each month.
Conditionally exempt small-quantity generators produce less than 220 lb of hazardous waste per month, while small-quantity generators produce between 220 and 2200 lb per month. Large-quantity generators produce more than 2200 lb per month.
Conditionally exempt small-quantity generators must follow special rules when disposing of acutely toxic wastes, or P-listed wastes. If a conditionally exempt generator produces more than 1 kg, or about 2.2 lb, of acutely toxic waste per month, the facility must follow the full regulations that apply to large-quantity generators.
The weight of containers is not counted when determining the amount of hazardous waste to be disposed, according to EPA. The agency regulates "only the material or residue in the container."
But EPA said health care facilities should record the weight of hazardous waste containers, since most transporters and disposal companies charge on the basis of total weight.
Mike Gregory, a hazardous waste enforcement coordinator for Idaho, said most health care facilities are conditionally exempt or small-quantity generators.
But, he said, "It doesn’t take much discarded epinephrine to change a hospital’s hazardous waste category."
Gregory suggested that if a health care facility’s category varies from month to month, it might want to consider regularly following the more stringent requirements to make sure it always complies with the law.
And, Gregory said, before discarding a drug product, a health care facility should seek advice from its state’s environmental agency to determine whether the product is hazardous.
Minnesota and California broadened their RCRA laws by adding stricter requirements.
In addition, Minnesota identifies hazardous wastes by a chemical’s LD50, or the lethal dose at which 50% of all experimental animals die when exposed. A substance with an oral LD50 of <500 mg per kilogram of animal weight is defined as hazardous when discarded. California’s maximum standard is 10 times greater than Minnesota’s, or 5000 mg/kg.
Catherine Zimmer, health care specialist for Minnesota Technical Assistance Program, a nonprofit program of the University of Minnesota’s Division of Environmental Health, said the state’s additional rule was designed to capture substances not listed by EPA.
Help is available. Zimmer’s organization helps train businesses on how to properly store and dispose of hazardous waste and how to keep records.
"We also help them find ways to move away from some of the more toxic things out there that are being used," she said. "It makes sense to take a good look at what businesses are using or whether it is hazardous waste when they dispose of it."
Zimmer acted as chair for the Chemical Waste Minimization Plan Workgroup for the EPA and the American Hospital Association’s Hospitals for a Healthy Environment program.
The project is designed to help the health care industry eliminate the use of mercury in health care and reduce the amount of hazardous and medical wastes generated.
Zimmer said health care ranks, in many states, as the third or fourth highest contributor of mercery to the environment.
"There are more viable alternatives to most hazardous products," she said.
Dave Yardumian, program manager for Georgia’s Hazardous Waste Management Branch, said most health care facilities do not intentionally violate environmental laws.
"It’s usually just from a lack of knowledge that they slip up," he said. "It’s a difficult and time-consuming process to determine which compounds and chemicals are hazardous and which aren’t. But if a hospital takes the time to deal with it, it will save them time and money down the road."
Yardumian said most complaints about violations come from inside a health care facility, rather than from patients or outsiders.
"Employees are usually the ones that see firsthand if violations are taking place in a facility."
Charlotte A. Smith, a pharmacist and president of PharmEcology Associates LLC, an environmental consulting firm headquartered in Brookfield, Wisconsin, said health care facilities often confuse hazardous waste with medical waste.
"So often, the tendency is just to want to red-bag everything," she said. "If it’s red-bagged, it more than likely gets shredded and dumped in a landfill or burned at a temperature that doesn’t do anything to the molecule. If it is hazardous, it needs to be burned at a high enough temperature to reduce it back to water, carbon, and nitrogen."
Smith said the federal government needs to develop standards strictly for pharmaceutical hazardous waste to simplify the process for the health care industry.
And, Smith said, pharmacists would be better prepared to deal with hazardous waste if more pharmacy schools taught RCRA as part of their curriculum.
Education. Vaughn L. Culbertson, chair of Idaho State University’s Department of Pharmacy Practice and Administrative Sciences in Pocatello, said he is making plans to include RCRA in his pharmacy school’s curriculum next year.
"It’s the law, and we should be teaching it," Culbertson said.
But David B. Brushwood, a lawyer and pharmacy health care administration professor at the University of Florida’s College of Pharmacy in Gainesville, said hazardous waste disposal is not an issue for pharmacists.
"It is not a patient care issue but a management issue," he said. "People other than pharmacists should be making those decisions. Pharmacists are trained to provide patient care. A small percentage of the pharmacists we train go on to be pharmacy managers. And then, pharmacists have the right to have somebody else making those decisions."
Karl Williams, adjunct pharmacy law professor for the University of Wyoming’s School of Pharmacy in Laramie, said he plans to "find a way" to include RCRA in his classes in the future.
"It is certainly a useful thing for pharmacists to know, especially if it has some impact on the way they practice," Williams said. "My philosophy is that we should be regulatory in nature and not have to respond to regulations."
PharmEcology’s Smith agreed.
"We need to be proactive so that we are clear about the regulations," Smith said. "Pharmacists need to take the initiative and know what the regulations are so they are not overregulated by the regulators. Pharmacists also need to find ways to reduce waste. And we need to also remember the old axiom, ‘First do no harm.’ We need to make sure what we are using to treat cancer with is not causing cancer in someone else."
For more information about the Resource Conservation and Recovery Act (RCRA) and how to properly dispose of hazardous waste, call the Environmental Protection Agency’s (EPA’s) RCRA hot line at 800-424-9346 or go to the following Web sites: