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New rules for managing pharmaceutical waste easier, cheaper for hospitals and medical practices

Proposed Environmental Protection Agency rules will prevent hospitals from flushing drugs down the toilet or drain.

Susan Morse, Associate Editor

Proposed Environmental Protection Agency rules for the disposal of hazardous waste pharmaceuticals will prevent hospitals and other healthcare facilities from flushing drugs down the toilet or drain.

Certain drugs are currently allowed to go into the wastewater streams.

While most new regulations tend to be complicated and costly, the new EPA rules appear to simplify the pharmaceutical waste disposal process and may actually save hospitals money, according to William Churchill, chief of the Pharmacy department at Brigham and Women's Hospital in Boston.

Certainly the ban on flushing drugs down the drain does that, he said.

"I think they're simplifying things, making things clear," Churchill said on Friday. "In the past some drugs were discarded down the toilet; now it's not allowed. That's really easy, really clear. From an enforcement point of view, it's a pretty easy to get that message out."

[Also: DaVita Healthcare, facing OIG subpoena, to pay $450 million in fraud settlement over drug waste]

The EPA said in its proposal that the intent is to simplify the regulatory burden of the Resource Conservation and Recovery Act's management of hazardous waste.

The proposed EPA rules were published on September 25, and an open comment period will last until November 24.

In another change, the amount of pharmaceutical hazardous waste would not be counted towards the total quantity generated at the facility for purposes of determining its generator status. Generator status is based on the quantity and type of waste generated, with stricter regulations imposed as more waste is generated.

This new rule would allow some hospitals to move from being a large quantity generator to small quantity generator, Churchill said.

The rules affect hospitals, clinics, retail stores, long-term care facilities and reverse distributors, which take back drugs. Contaminants can take the form of pills, patches, liquids, syringes or paper cups.

Some of the new rules could place an additional burden on health systems. For instance, there's a more intensive waste management system for newer, more toxic pharmaceuticals; and changes in prescribing practice could generate additional waste.

Churchill admits he hasn't as yet read the full 80-plus pages of the new rules and that trying to comply with the rigor of regulations is very difficult for a hospital.

However, he said, "My read of this looks like it's going to make things less complicated and less expensive for us."

Enforcement of the rules is often difficult because of the sheer number of people involved, and the amount of hazardous waste.

Brigham and Women's has 2,800 nurses, hundreds of physicians and 300 pharmacy staff, according to Churchill.

"That's 3,000 to 4,000 people expecting to have the ability to comply 100 percent with those regulations 100 percent of the time," he said. "We have 8,000 line items on our formulary. It's very difficult to communication to a nurse, which bin."

Pharmaceutical waste is placed in different bins, with black being among the most hazardous and expensive at around $4 a pound.

Medical waste such as sharps costs 18 to 35 cents per pound; chemotherapy waste goes into yellow containers at about $4 per pound; and infectious hazardous waste costs $4 to $8 per pound.

Non-compliance can elicit heavy fines with one published estimate placing fines at $32,500 per day.

EPA inspectors are also known to drop in, Churchill said.

"They can and frequently do show up," Churchill said.

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Waste disposal is a small part of his total budget because the line item is spread through the hospital's environmental services budget or another department, he said.

Yet cost savings are always a focus.

If the medication called for is 1.1 of a vial, efforts are made to round that amount to one vial, if there would be no adverse effect to a patient, or to batch it so that the remaining  .9 of a vial goes to another patient, he said.

"We make every effort to minimize waste, that is an initiative every hospital pharmacy in the country can undertake," Churchill said. "Many hospitals have already implemented a system to manage pharmaceutical waste."

Twitter: @SusanJMorse

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