BETHESDA, MD 30 January 2009—The Environmental Protection Agency (EPA) proposed an amendment to a rule in December that could change how hospital pharmacies dispose of pharmaceutical waste that is considered hazardous.
While there are a number of decisions that EPA officials must still make regarding details of the amendment to what is known as the Universal Waste Rule, the basic idea is to streamline how pharmacies deal with pharmaceutical waste.
“It sounds like the EPA really wants to make sure that none of these chemicals get into the environment,” said Fred Massoomi, a hospital pharmacist in Nebraska. “They think that . . . streamlining [the disposal process] and making it easier could minimize the potential of that to occur.”
Hospital pharmacies across the nation currently have to follow an EPA regulation known as the Resource Conservation and Recovery Act (RCRA) when disposing of products that include ingredients on a list of hazardous substances.
Implementing the existing RCRA regulation can be challenging and tedious work for pharmacies, said James Hoffman, a pharmacist at St. Jude Children’s ResearchHospital in Memphis, Tennessee.
“In general from everything I’ve looked at so far, it seems like the amendment to the Universal Waste Rule is really a positive thing for hospital pharmacy,” said Hoffman, who is the institution’s medication outcomes and safety officer. “It really seems like it simplifies things.”
Massoomi, who works at NebraskaMethodistHospital in Omaha, said for any waste products containing RCRA-listed chemicals, pharmacists must provide careful documentation and make sure the waste is sent to a properly authorized facility for final disposal. RCRA-listed waste must be dealt with in a waste stream that is separate from other types of pharmaceutical waste.
EPA regulators now want to offer pharmacies the chance to include all pharmaceutical waste in the Universal Waste Rule. The proposed amendment appeared in the Federal Register on December 2, 2008.
This rule covers hazardous waste such as batteries, pesticides, and mercury. Under the proposed amendment, all pharmaceutical waste could be sent to a disposal facility now operating under the Universal Waste Rule.
While much of the proposed rule change looks potentially helpful to pharmacists, there are still blanks left to be filled in, Massoomi said.
“I would caution a lot of hospitals to not get too antsy and excited about it,” he said.
Even if the rule amendment is approved, each state would have to choose whether to accept the new regulation. Some states have stricter rules about pharmaceutical waste handling and may decide against adopting the newly amended rule.
“This in no way replaces RCRA at all,” Massoomi said. “RCRA will still be on the books.”
Charlotte Smith, of PharmEcology Associates, said the proposed rule amendment should make things easier for hospitals to manage pharmaceutical waste, but there are some problems with the current version of the proposal.
Under RCRA, extensive manifests have been required to make sure hazardous waste reaches an authorized disposal facility and is properly handled. This cradle-to-grave chain of ownership has been one way to prevent drug diversion as well as illegal dumping. The current version of the Universal Waste Rule would not require the same level of documentation for transport and disposal, Smith explained.
Massoomi added that hospitals could be held liable for any RCRA-listed chemicals that are improperly disposed of under the proposed Universal Waste Rule amendment.
Smith said she would like to see the Universal Waste Rule ease restrictions in hospitals, as currently proposed, but add language to preserve cradle-to-grave documentation for disposal now required under RCRA.
Regardless of the disposal questions, the proposed rule is intended to make managing waste easier. But EPA also hopes the new rule leads to cost savings by eliminating the need to sort pharmaceutical waste.
Smith said that in some cases, pharmacies would be able to store waste for longer periods of time to allow for fewer disposal pickups each year. Under RCRA, depending on how much waste a facility produces each year, pharmacies can store waste for up to 90 or 180 days once it is moved out of the pharmacy.
The Universal Waste Rule would give pharmacies one year from the date of the first item being discarded to sit in storage before needing to be sent to a disposal facility.
Massoomi said there are still questions as to how EPA will define pharmaceutical waste, such as whether containers, used intravenous bags, and tubing should be included under the new rule. The federal agency has also asked for information from pharmacies about how much pharmaceutical waste is generated per month and what percentage falls under RCRA rules.
Even as the Universal Waste Rule evolves, it is obvious that EPA is trying to make sure pharmaceutical waste is handled in a more responsible manner, Massoomi said.
“They made a very clear statement in this document that they do not want pharmaceuticals going down the drain, unless it is directed in the package insert,” he said.
Massoomi said he only knows of about a dozen products that have FDA-approved labeling that dictate the drug may be disposed of down the drain.
“I think this is the first step in where they want to go,” he said of the EPA, “but it’s not the last step.”
