Tip of the week: Check out our free story about the EPA's pharmaceutical waste proposal

Hospital Safety Insider, February 4, 2009

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Late last week the Environmental Protection Agency (EPA) extended until March 4 its comment period for a proposed rule to ease certain pharmaceutical waste regulations for hospitals.
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The EPA proposes relaxed pharmaceutical waste rule

The Resource Conservation and Recovery Act’s (RCRA) regulations concerning hospital pharmaceutical waste disposal are complex—but a new rule proposed by the Environmental Protection Agency (EPA) may simplify things.
Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and U-lists (e.g., warfarin, physostigmine, and chemotherapy drugs) are classified as hazardous waste generators.
But the EPA wants to change these pharmaceutical wastes to universal wastes, which would ensure larger quantities of hazardous pharmaceutical wastes are collected and disposed of properly, according to the agency (see “Explaining P, U, and universal wastes” below for an explanation of terms used in this article).
Safety managers and other healthcare professionals can submit their comments about the proposal to the EPA by March 4 (extended from the original February 2 deadline). Go to for full details. If finalized, the EPA expects the regulation to go into effect sometime in 2010.

Some helpful definitions to start

Let’s first explain waste categories related to this EPA proposal:
  • P-listed—Chemicals on the P-list are acutely toxic. A chemical is acutely toxic if it is fatal to humans in low doses, if scientific studies have shown that it has lethal effects on experimental organisms, or if it causes serious irreversible or incapacitating illness.
  • U-listed—The U-list contains chemicals that may be a toxic threat to humans, and may also include chemicals that display other characteristics, such as ignitability or reactivity.
  • Universal—Universal wastes are subject to special provisions intended to ease the burden of managing them, particularly by allowing more time for accumulation of these wastes to allow appropriate recycling or disposal. There are currently four types of universal waste: batteries, pesticides, mercury-containing equipment, and fluorescent lamps. The EPA is proposing to add hazardous pharmaceutical wastes to the universal waste list.

Questioning full compliance with RCRA

Some managers have established programs to follow the current pharmaceutical regulations in-depth—which can include empty containers and vials—while others are unaware RCRA applies to them and haven’t gotten started, says Charlotte A. Smith, RPh, MS, HEM, president of PharmEcology Associates, LLC, of Wawautosa, WI.
Some hospitals still pour these substances down the drain or into municipal waste streams. In response, states such as Minnesota, Florida, and Michigan have forced hospitals to establish pharmaceutical waste programs. But even in those states, compliance among medical centers isn’t 100%.
“We still have a long way to go before a majority of hospitals are in compliance, or even partway,” says Smith, a pharmaceutical waste consultant.

Moving drugs to universal waste

The proposed rule would classify pharmaceutical hazardous wastes as universal waste for disposal—the same category as items such as batteries, pesticides, mercury-containing equipment, and fluorescent lightbulbs. The rule would apply to many different medical facilities, including pharmacies, hospitals, physician offices, outpatient care centers, and ambulatory healthcare services.
If the proposed rule becomes a regulation, it will make it easier for hospitals struggling with following RCRA to the letter, and will force hospitals that are doing little at present to start a disposal program for pharmaceutical waste.
“It will make it easier than if they had to come into full RCRA compliance,” says Robert Dellinger, director of the EPA’s hazardous waste identification division.
Depending on the chemicals involved, universal waste rules allow pharmacies and hospitals to be classified as handlers as opposed to generators under RCRA, giving them the ability to handle larger quantities of the chemicals for longer periods of time on-site with less regulation. The universal waste rule has fewer training requirements, too.
“It’s important to note that universal wastes are still hazardous wastes,” Dellinger says. “So even though the handling requirements are less stringent, [wastes] still have to be disposed of at a permitted hazardous waste management facility.”

Hoping to cut pharmaceutical pollution

Studies have shown that prescription drugs—hazardous and otherwise—are slowly creeping into the nation’s water supply, Dellinger says. Yet, RCRA often confuses hospital and pharmaceutical workers because the rules were written for chemical and drug manufacturers, not those in the distribution chain.
Classifying hazardous drugs as universal waste will keep more of the substances out of municipal dumps and the water supply, the EPA hopes, and in turn cut down on the danger to human health and that of wildlife.
“We wanted to do something that would contribute to the ability of the nation to do a better job managing pharmaceutical waste,” Dellinger says.

Avoiding resale of disposed meds

Although the rule will not mandate nonhazardous pharmaceutical wastes to be placed into the universal waste stream, it encourages hospitals to do so. Dellinger says it’s a safety issue: When people can pick through your waste after it leaves your building, it can end up on the black market, enabling illegal distribution and resale of medications.
Getting 100% of pharmaceutical wastes into the universal waste stream might be practical for small hospitals, Smith says, saving the hassle of sorting hazardous and nonhazardous medications.
However, for large hospitals, going from about 5% of pharmaceuticals considered hazardous to 100% drug disposal as universal waste could cost six or seven figures more per year.
Smith is concerned that if the proposal becomes final, hazardous waste handlers will be allowed to pass the wastes to each other, making black market resale a concern.
Although controlled substances will still require a transfer between Drug Enforcement Agency registrants, she sees the diversion of common prescription medications (e.g., high blood pressure pills) back into the supply chain as a real possibility.
Smith says she plans to recommend the EPA place controls on drugs in the universal waste stream similar to those on other parties who handle and distribute prescription drugs.

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