Better science has allowed researchers to detect chemicals in water at tinier and tinier concentrations, and they're finding scores of pharmaceuticals in groundwater, streams and effluent from wastewater treatment plants.
Putting hospitals on notice
Regulators taking more interest in healthcare drug-dumping
Scant evidence indicates these trace amounts of drugs—parts per billion and trillion—pose risks to people or the environment, and much of the stuff is believed to come from the secretions of animals and people who digest them. But federal and state regulators and lawmakers want to prevent unused pharmaceuticals from getting dumped or flushed into sewer systems or sent to landfills, from which chemicals can leach into groundwater.
Hospitals, they're looking at you.
The operative federal law controlling the disposal of dangerous chemicals is the Resource Conservation and Recovery Act, or RCRA (pronounced rick-ra), a 24-year-old statute that primarily targets industrial users. About 5% of pharmaceutical products are regulated under RCRA as hazardous materials. That leaves thousands of products on hospital formularies outside the reach of federal regulation, but the government doesn't want the rest of it going to landfills or down the drain either, even if the national rules haven't caught up yet.
The U.S. Environmental Protection Agency has not been particularly punitive in enforcing RCRA against hospitals. That may be changing as detection improves and public scrutiny increases. In 2008, a Senate subcommittee held a hearing on the presence of pharmaceuticals in drinking water after the Associated Press published a series of stories on the topic.
The subject also caught the interest of New York Attorney General Andrew Cuomo, who launched an investigation into the disposal practices of hospitals and nursing homes. The effort in January yielded settlement agreements with two critical-access hospitals and three nursing homes, whose drugs Cuomo alleged were making their way into the reservoirs and lakes that provide water to 9 million residents of New York City and surrounding communities (Jan. 18, p. 12).
The agreements invoke RCRA, yet prohibit the facilities from using drains and toilets and landfill-bound garbage to dispose of any pharmaceutical product, regardless of whether the feds call it hazardous. All of it must go to an incinerator, and the officially hazardous stuff must go to an incinerator permitted to handle it.
“In New York, it appears they used RCRA to encourage a behavior change that isn't really regulated,” said Charlotte Smith, director of PharmEcology Services. The company, which Smith founded in 2000, offers consulting and services that help healthcare facilities and pharmacies manage pharmaceutical waste. Asked what hospitals most often dump down or flush, Smith said, “Basically any IV that's not chemotherapy—you name it.”
Sensing a growth opportunity, Waste Management subsidiary WM Healthcare Solutions bought PharmEcology last year for an undisclosed sum. PharmEcology and now other companies will check a hospital's inventory against its own databases of what would fall under RCRA and provide assistance segregating and tracking the waste. Smith said she believes inspections by the EPA and its delegated state enforcers are on the rise, based on what she hears from current and prospective clients, some of whom call after unannounced visits from the government. An EPA spokesman declined to say whether the department is focusing increased attention to RCRA enforcement at hospitals.
$37,500 per day
The EPA is authorized to levy penalties up to $37,500 a day for each RCRA violation. A search of the department's enforcement database shows 244 hospitals were found to have violated that statute in the past five years for mishandling hazardous materials, including but not limited to hazardous pharmaceuticals. The department took formal action against 30 of those facilities and imposed penalties on 23, ranging from $700 to $106,267.
Last year the EPA secured an unusual consent agreement with the Veterans Affairs Department hospitals in Leavenworth, Kan., and Topeka, Kan. In addition to paying a $51,500 penalty, the hospitals agreed to spend $482,000 on systems to track and manage pharmaceutical and other chemical waste. The agreement specifically compels the hospitals to spend $42,000 on software that classifies and tracks hazardous pharmaceuticals and to train nursing staff how to use it. The VA declined to be interviewed about the matter.
The federal government is not yet speaking with one voice on the topic. The Food and Drug Administration continues to recommend to the public that they flush certain medications in order to keep them from lingering in households and potentially harming children and pets. The Drug Enforcement Agency requires that unused controlled substances that can't be returned through a reverse distributor must be destroyed under the watch of a witness. The simplest and cheapest way to comply is to flush them.
The EPA, though, is working to make it easier for healthcare facilities to responsibly and legally dispose of hazardous pharmaceutical waste. Under a proposed rule, hazardous pharmaceutical waste would be dealt with under the department's regulations for “universal waste,” a category that includes batteries, light bulbs and pesticides.
The change would mean less stringent restrictions on accumulation of the substances, which still would have to be sent to a RCRA-permitted incinerator. The department expects to finalize the rule in 2011, and states must then be authorized to implement the rule.
“It would simplify the process for facilities,” said Cynthia Reilly, director of practice development for the American Society of Health-System Pharmacists. The organization has requested that the government amend the rule to demand manifests to document the chain of custody until the waste is destroyed, minimizing the risk that the drugs could be reintroduced into the supply chain or the packaging repurposed for counterfeit meds. “If they don't add that, we do not want them to pass it,” Reilly said.
The proposed rule also encourages healthcare facilities to treat all of their unused pharmaceuticals as universal waste, obviating the need for expensive and time-consuming sorting. The shortcut, though, would mean shouldering the higher cost of burning more materials at RCRA-permitted incinerators.
That can cost as much as $5 a pound, generally two to three times the cost of burning it at a medical-waste incinerator and 10 times the cost of sending it to a landfill.
According to the testimony of the U.S. Geological Survey at the Senate hearing, antibiotics in water, not surprisingly, have been shown to kill microorganisms in soil. Some studies indicate that certain drugs in detected concentrations have no effect on aquatic life, while researchers have reached few conclusions about how combinations of chemicals might affect the environment and people, or how aquatic life might respond to long-term exposure to small concentrations of pharmaceuticals. Studies have shown, however, that male fish are feminized by very low levels of endocrine disrupting chemicals, which include pharmaceutical hormones and synthetic hormones but also chemicals in pesticides and detergents, found in treated wastewater.
The EPA does not require wastewater treatment plants to monitor or treat pharmaceuticals as contaminants, though many do so voluntarily. Nonetheless, the EPA's Office of Water is keenly interested in what healthcare facilities are doing with their pharmaceutical waste. “It just seems to make sense, given there's a fairly discrete source at a healthcare facility, actions could be and should be taken to try to minimize those sources,” said Janet Goodwin, chief of the technology and statistics branch in the office's engineering and analysis division.
After surveying the industry, the Office of Water promised to issue a set of best practices, which are expected to be published with the EPA's effluent guidelines by the end of the year. “I think healthcare facilities are concerned about flushing but don't really understand what alternatives are available to them,” Goodwin said. “An important aspect is taking inventory, taking stock of what facilities use and have on a regular basis and figuring out particularly what's being used,” she said. “From that you can start to investigate what's being disposed of, and are there ways you can prevent having to dispose of it by managing your inventories better?”
A few states, notably California, Minnesota and Washington have jumped ahead of the federal government in the scrutiny and outreach dedicated to the disposal habits of healthcare facilities.
Washington state strengthened its regulations to capture a broader array of pharmaceuticals than fall under the RCRA, which specifically lists a number of chemicals found in pharmaceuticals and also deems some chemicals and compounds hazardous because of characteristics, for example, gels that are easily ignitable because of high alcohol content.
In Washington state, the Ecology Department can classify additional pharmaceuticals as “dangerous” based on concentration of chemicals noted as toxic in two other databases, said Tom Cusack, a hazardous waste specialist with the department. Or, Cusack said, a drug can be labeled dangerous by running what's called a bioassay on fish, usually some variety of salmon, a near-holy creature in the Pacific Northwest. That is, scientists put fish in a tank with a certain amount of a drug and then count how many die after a few days.
The variety of the H1N1 vaccine with no thimerosol, for example, isn't regulated by the federal government, but Washington calls it dangerous and requires that it be incinerated.
The state-designated dangerous waste can be stored longer and in greater volumes, but it must go to an incinerator. Anticipating the “universal waste” change at the federal level, Washington recently created an interim enforcement policy aimed at RCRA regulated pharmaceutical waste, which allows facilities to exclude pharmaceutical waste from RCRA reporting requirements and other restrictions while demanding that the waste be shipped with manifests to a RCRA-permitted incinerator.
“We know the hospitals want to do the right thing, and they're trying,” Cusack said.
On the department's website, a list of “frequently asked questions” about the regulations begins with, “Why is Ecology picking on hospitals and the healthcare industry?” (The answer given, in sum, is that the state is catching healthcare up with state and federal rules in place for a couple of decades.)
Mike Smith, environmental services operations and waste compliance manager at Swedish Medical Center in Seattle, described the posture of the state regulators as “collaborative.”
Swedish, Smith said, has laid the groundwork to treat the state-designated dangerous pharmaceutical waste the same way as RCRA waste.
“If we wish to have compliance, the best way to do that is make it simple to put it in the right stream,” Smith said. Otherwise, he said, “We're asking people to make decisions based on expertise they don't have.”
The approach so far has been deployed only in the medical center's pharmacies and chemotherapy units. The disposal cost at the largest campus, First Hill, is about $20,000 and will rise when the procedures hit the patient floors. “We knew it was going to be expensive,” Smith said. “These are the regulations, and we will be in compliance with them, and there's nothing bad about that.” He added, “I liken it to what happened back in the 1970s, when we finally got hip to the fact that you cannot keep polluting the planet. If you do, the planet will burp it right back at you.”
North Memorial Health Care in Robbinsdale, Minn., has been looked to as an early model for aggressively identifying hazardous pharmaceuticals and segregating the waste beginning in 2005.
The changes increased the hospital's annual disposal cost by more than $300,000, though the number is falling as ongoing training has helped the nursing staff deposit waste in the right receptacles, said Michael Burke, director of environmental services at the 416-bed hospital.
North Memorial also segregates its non-hazardous pharmaceutical waste and sends it to an incinerator in Minneapolis that generates electricity by burning garbage. “It's still new to a lot of people,” said Burke, who routinely gives presentations on the topic for peers from other hospitals.
“They're still throwing it down the drain or wherever,” he said. “The model is there. You can no longer say it can't be done.”
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