A new federal rule will go into effect next week prohibiting healthcare organizations from flushing hazardous waste pharmaceuticals into the sewer system, which will cause some providers, distributors and pharmacies to change their protocol and processes.
Starting Aug. 21, drugs like opioids and chemotherapies will need to be disposed of through proper channels rather than down the drain, which will cost healthcare facilities time and money if they need to get up to speed. But the Environmental Protection Agency's final rule will also clear up conflicting regulations and ease some requirements, which health systems are applauding.
"I have talked to a lot of hospitals and other healthcare facilities that are still flushing hazardous waste pharmaceuticals; there has been no effort to minimize that practice," said Elise Paeffgen, an attorney in Alston & Bird's environment, land use and natural resources group. "Now they have a hard stop next week that applies across the country. It's definitely a big change for a lot of facilities."
Under the presiding Resource Conservation and Recovery Act, flushing hazardous drugs down the drain or toilet has been permitted, despite the growing awareness of the damage that could cause to the environment. The final rule will immediately stop that, as well as outline a host of changes such as calculating how much waste a facility generates, among others, that will be implemented over time.
Certain states will adopt the federal rules in their entirety, while others will take a more stringent approach applied over the next two years. What's left will be a patchwork of state laws that health systems will have to navigate if they operate or dispose waste in multiple states.
Across Cleveland Clinic's network of hospitals in Northeast Ohio, it will cost the system about $500,000 a year to set up hazardous waste collection bins in each nursing unit, train employees and pay for a third party to properly dispose of the materials, said Scott Knoer, Cleveland Clinic's chief pharmacy officer.
"The regulations need to catch up—you shouldn't be flushing chemotherapies and narcotics down the drain," he said, adding, "Even though it is a good thing, healthcare costs keep rising and reimbursement isn't going to go up, which makes it tough."
The maximum fine will be more than $70,000 dollars per day per violation, although it will be difficult to police, said Delphine O'Rourke, a partner at Duane Morris.
"The fines are significant," she said. "The burden will be on the facility to train and monitor staff."
Sioux Falls, S.D.-based Sanford Health changed its disposal practices in 2014, which means it is already mostly in compliance, said Mark O'Brien, Sanford's pharmacy operations supervisor. But since the not-for-profit health system operates in multiple states, it has to keep a close eye on the state laws, he said.
As for the new federal rule, O'Brien said he was appreciative that it streamlined conflicting controlled substance regulations from the Food and Drug Administration, the EPA and the Drug Enforcement Agency. Healthcare organizations will also treat all hazardous waste alike, rather than differentiate by product.
Another potential benefit to healthcare facilities involves empty pharmaceutical containers, Paeffgen said. Triple rinsing containers with acute waste is no longer required. Also, duplicative reporting requirements have been eliminated and container storage mandates are less onerous, she said.
"As far as the management of pharmaceuticals that are sent to the reverse distributor, most of the requirements will be easier after the final rule is implemented," Paeffgen said. "But for a lot of healthcare facilities that weren't focused on waste management, it will feel like a lot."