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Look to "Blueprint" to understand new EPA requirements on hazardous drug waste

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March 1, 2019

Consider managing all your pharmaceuticals as hazardous waste, especially if you are a smaller facility. And warn your C-suite that you’ll be scrutinized for compliance once new environmental regulations take effect.

The Environmental Protection Agency (EPA) has put a lot of time and effort into revising the federal Resource Conservation and Recovery Act (RCRA). They will want to see facilities implementing the newly finalized “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” says Charlotte A. Smith, RPh, MS, a senior regulatory advisor and founder of PharmEcology Services, now a part of WM Sustainability Services.

The final rule will become effective six months after it is published in the Federal Register. While the pre-published version was signed and posted on the EPA’s website, as of late January it had not been officially posted in the Federal Register. 

States that have their own hazardous waste requirements will be allowed time to adopt the requirements. Only Iowa and Alaska, which do not have state environmental programs, will face implementation within six months of publication.

Work with pharmacy, facilities

Managing all pharmaceuticals as hazardous waste may be more efficient and cost effective for smaller facilities, although larger facilities may not see cost savings. Work with your pharmacy and facilities management department to determine what’s best for your hospital.

Note, however, that the all-pharmaceuticals managing method is among those outlined in a “Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities,” which was touted in the final rule by the EPA as a best management practice (BMP) guide.

The blueprint was last updated in 2008, at the behest of the EPA, when the agency was struggling with the first version of how to handle hazardous waste pharmaceuticals. Then the EPA proposed managing pharmaceuticals under the federal Universal Waste Rule, a proposal that was scrapped after much criticism as not being, in some cases, stringent enough.

In the decade since, EPA officials moved to create a new subpart of RCRA to manage pharmaceutical waste, in acknowledgment of some of the unique aspects of hazardous drugs used in healthcare settings. The rule was proposed in 2015 and finalized late last year.

Among other things, the blueprint explains some of the differences between pharmaceuticals that are hazardous waste, those that are considered hazardous by the CDC’s National Institute for Occupational Safety and Health (NIOSH) and those considered hazardous by the Occupational Safety and Health Administration (OSHA). Those aren’t always the same thing, note experts.

Use ‘Blueprint’ for help

Since “10-Step Blueprint” was noted in the final rule, Inside the Joint Commission went to Smith, one of the blueprint's two principal authors, to ask how hospital compliance officers can best use it as they work to understand the implications of the EPA’s final rule and tell the C-suite leadership what they need to know.

The basic thing to remember, says Smith, is that “although the new rule will change some of the management aspects of hazardous waste pharmaceuticals, the definitions of hazardous waste remain the same,” notes Smith.

“Step Two of the Blueprint provides a concise summary of the definitions and should be reviewed by the directors of EH&S [Environmental Health & Safety] and Pharmacy. EPA notes that these definitions have not changed, but rather the management requirements have been adjusted for the healthcare environment,” says Smith.

The blueprint encourages facilities to consider managing all pharmaceutical waste as hazardous. But it acknowledges there could be reasons not to do so, including cost if a facility qualifies as a large-quantity generator of hazardous waste, which requires a higher — and more expensive — level of management.

“If a healthcare facility is not going to manage all pharmaceutical waste as hazardous, EPA recommends healthcare facilities review and implement the best management practices in Step Three,” notes Smith. “The reason for this is that the new rule only applies to between 5% and 10% of drugs on the market, since the definitions and listings have not been updated since 1980. A vast number of highly toxic drugs have been introduced during that time and are out of scope for EPA regulations at this time. So the BMPs recommend, for instance, that all antineoplastic drugs be managed as hazardous waste, and the industry has responded almost universally in doing so,” says Smith.

“At the time the Blueprint was written, many facilities were still managing waste pharmaceuticals through drain disposal, in red sharps containers, or even the trash. The BMPs therefore, encompassed all hazardous drugs on the NIOSH list and all endocrine disruptors. Now that many healthcare facilities are managing their pharmaceutical waste through incineration, I think it would be safe to say that drugs listed in Table One of the NIOSH Hazardous Drug List of 2016 should be managed as RCRA hazardous waste, but drugs on Tables Two and Three can be managed as non-hazardous pharmaceutical waste through incineration at permitted non-RCRA incinerators,” says Smith.

“It should be noted, however, that EPA’s preference is for all pharmaceutical waste to be managed as hazardous waste. EPA has not done a cost analysis on this process, however, so this is an important area for consideration by healthcare facilities,” she advises.

Cost savings possible

Cost savings can be realized through good management, notes Smith, who began her career as a pharmacist.

“A third area of the Blueprint that deserves serious attention is Step Five: Minimizing Pharmaceutical Waste. This area remains one that has not been adequately addressed but could save the facility cost both in purchasing and waste disposal expenses. Unfortunately, pharmacy departments today are having to spend staff time dealing with drug shortages on an ongoing basis, making it difficult to focus on longer term management issues.”

When presenting all these things to your leadership, make sure they understand that these new requirements will be taken seriously by federal inspectors, or by state regulators once approved.

“In terms of involvement of the C-Suite, I believe the primary message is that EPA has spent considerable time and effort to create a customized subsection for managing pharmaceutical waste in healthcare and will expect the industry to comply with these regulations as they become active federally and in each authorized state,” warns Smith.

But you have time.

“While facilities in Iowa and Alaska will need to come into compliance six months from the publication of the Rule in Federal Register, facilities in other states will have between one and two years as their regulatory agencies and, in some cases, legislatures adopt the new rule ‘as is’ or include stricter rules, as is their right,” says Smith.

“The best method for preparing for this massive change is to come into compliance with the current rules, using the best management practices as noted above.”

Resources
EPA main home page on final rule: https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075




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