EPA Inspections of Drug Disposal Practices Can Be a Learning Moment

[March 15, 2008, AJHP News]

Greg Lavine

BETHESDA, MD, 29 February 2008—Fred Massoomi was not quite sure what to make of his requested presence at a meeting between hospital representatives and U.S. Environmental Protection Agency (EPA) officials in September 2004.

The pharmacy operations coordinator for Nebraska Methodist Hospital, in Omaha, thought he might have to answer a few questions, but he soon found himself in the hot seat.

An EPA inspector began talking about a law Massoomi had not heard of-the Resource Conservation and Recovery Act (RCRA).

Passed in 1976, the law dictates how certain hazardous wastes must be handled. RCRA in recent years has become a familiar term around hospital pharmacies.

There were no reported violations for Nebraska Methodist Hospital to prompt the 2004 visit. Instead, EPA inspectors had come to the area based on violations at a nearby U.S. Department of Veterans Affairs medical facility. Massoomi's hospital was one of two local medical centers randomly selected for inspection while the EPA team was in town.

Since Nebraska Methodist Hospital has a cancer center, the inspector began asking for manifests and disposal records for the cytotoxic drug cyclophosphamide. The purchasing records were not a problem, but there was no documentation for disposal of the drug, he said.

Massoomi soon learned that this drug was identified as U058 on RCRA's U list of hazardous substances. Along with the P list, pharmaceutical substances on the U list are discarded commercial chemical products considered to be ignitable, corrosive, reactive, or toxic.

Pharmacies that work with any P- or U-listed substances must have a separate waste stream for disposing of those materials. The drugs should not be mixed with needles or other typical medical waste heading for disposal.

Nebraska Methodist Hospital was careful to put cyclophosphamide in yellow “sharps” containers, but this action was in violation of RCRA.

Hospital officials learned they had 90 days to come into RCRA compliance or face daily fines of up to $32,500. Additionally, Massoomi and the hospital's chief executive officer could be held personally liable for RCRA violations.

Despite the high stakes, Massoomi tried not to look at the inspection process as a crisis. Instead, he tried to make the best of the situation.

“We used her as a resource,” Massoomi said of the inspector, taking the opportunity to ask for recommendations on waste management in the pharmacy. The hospital was not fined for any violations.

“We're responsible for these drugs from cradle to grave,” he said.

Putting plans in place to manage RCRA substances was only part of the challenge facing the Nebraska hospital. Internal compliance was a significant hurdle, as busy nurses frequently tossed RCRA pharmaceuticals into the wrong disposal bins.

Massoomi said the hospital tried education programs with limited success. The pharmacy even began placing RCRA drugs into black plastic bags that were specifically labeled for disposal in corresponding black bins, but results did not improve much.

“I can only get the nurses to do what they can do,” he said of disposing the RCRA drugs in separate containers.

He realized that nurses felt burdened with enough regulations already as they doled out up to 300 medication doses a day, and this was one more drain on their time. Massoomi is hopeful that technology can help solve the nursing compliance issues.

“We're trying to take the . . . thinking out of the process,” he said of the decision-making process for disposing of excess or unneeded portions of RCRA drugs.

A future waste disposal system could involve scanning bar-coded drugs before disposal. An electronic unit would then open the proper bin to accept the waste.

Hospital leaders briefly considered putting all waste in black bins for RCRA disposal, but that would spark higher disposal costs. Furthermore, all that extra material could push the hospital into a higher waste generation category, which would trigger new rules.

Bringing all necessary personnel-from pharmacy staff to nurses-onto the same page is not the end of coming into RCRA compliance, Massoomi explained.

In addition, once the waste is properly collected, it must be sent to a RCRA-certified disposal facility. Not all facilities licensed to handle medical waste are necessarily licensed to handle RCRA-related waste. Massoomi recommends that pharmacies ask to see certification for companies that handle waste.

While many hospitals have the luxury of coming into RCRA compliance on their own terms, Nebraska Methodist Hospital was not alone in having an inspection prompt a change in operations. Medical centers in various EPA regions have come under scrutiny.

“We're fairly active on the enforcement side,” said Lisa Papetti, senior enforcement coordinator for RCRA in EPA Region 1, which covers the six New England states.

Papetti stressed that her region also has an active program to assist hospitals and medical centers wanting to come into compliance with RCRA.

Massoomi added that private companies, such as PharmEcology, a Wisconsin company, can audit a pharmacy's current waste management practices.

While RCRA has been a law since the 1970s, much of the early enforcement focus was on industrial plant pollution, Papetti said. In the 1990s, some EPA regions began to branch out, looking at places such as public works departments and colleges. Eventually, hospitals became a target for RCRA compliance.

EPA realized hospitals have issues similar to other industries, including hazardous waste, container management, and training problems.

Unmarked containers and inadequate hazardous-waste training are among the common problems inspectors come across at pharmacies, Papetti said.

“There was a lack of awareness,” she said, when inspectors first began visiting hospitals. While most facilities are now familiar with potential problems, “there's still noncompliance out there.”

Inspection and enforcement activities seem to vary from region to region inside EPA. Region 2, which covers New York, New Jersey, Puerto Rico, and the U.S. Virgin Islands, leans more toward self-audits as opposed to inspections, said Richard Cahill, a spokesman for that region.

Massoomi said he hopes hospitals and pharmacies are willing to take action before a surprise inspection rolls around. And if you find an EPA inspector wanting to poke around your pharmacy, he advises trying to learn from the experience and being honest about what you don't understand.

“Don't try to snow these folks,” he said.