Drug disposal rule sets up providers for noncompliance, groups say

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Drug disposal rule sets up providers for noncompliance, groups say
Drug disposal rule sets up providers for noncompliance, groups say

The government's apparent lack of understanding about the differing characteristics among senior living settings could put some providers “perpetually in noncompliance” with a proposed federal rule regarding the disposal of unused medications, several industry groups contend.

The rule, published by the Environmental Protection Agency in September, would prohibit healthcare facilities (defined to include assisted living communities, continuing care retirement / life plan communities and other senior living and healthcare settings) from disposing down the toilet or drain those pharmaceuticals considered to be hazardous waste. It also would require providers, when they transport drugs off site that are not eligible for a manufacturer's credit, to ship the drugs as hazardous waste, with a hazardous waste manifest, to a Resource Conservation and Recovery Act interim status or permitted facility.

If disposal is managed on site, the rule reads, facilities could handle “non-creditable” drugs similarly to how they would have been managed under the 2008 “universal waste” rule amendment. Facilities would continue to be allowed to send to pharmaceutical reverse distributors those potentially hazardous waste pharmaceuticals that are eligible to receive a manufacturer's credit.

One issue with the rule, however, say industry groups, is that it does not recognize that assisted living and CCRC environments differ from skilled nursing centers.

“In assisted living, our residents have the right to privacy, and many of them manage their own medications,” Argentum Chief Operating Officer Maribeth Bersani tells McKnight's Senior Living. “We would not have the right or the authority, or it's just not the way we operate, to ask them to surrender their medications to us so that we could properly dispose of them. We could tell them how to do it, but we would have absolutely no way to ensure that they did. So the assisted living communities probably would be perpetually in noncompliance.”

Some education of the federal agency on the differences between assisted living and skilled nursing may be in order, Bersani says. “I think they probably … don't know the differences between skilled nursing facility, where all of the medications are managed by the nursing home, versus assisted living, where people can manage their own,” she says. Argentum is asking that assisted living communities be excluded from the rule.

Bersani, on behalf of Argentum, submitted comments on the rule Dec. 22, two days before the extended commenting deadline of Dec. 24. The EPA received 170 letters from healthcare providers, pharmaceutical firms, drug store companies, environmental groups, waste water management companies and other entities by the deadline.

Argentum's other major concern with the proposed rule, Bersani says, is its assumption that all residents receive their medications from the same pharmacy, thereby enabling communities to work with one pharmacy to ensure proper disposal of drugs covered by the rule.

“While many of the larger providers do contract with a pharmacy, the majority of assisted living communities are smaller, and they do not contract,” she says. “People get their drugs from whatever pharmacy they want.” That reality means that, to comply with the rule, most assisted living communities would need to work with several pharmacies, Bersani says.

Argentum also was one of several groups signing a separate letter, dated Dec. 21, expressing similar concerns. In addition to Argentum, that letter was sent on behalf of the American Health Care Association/National Center for Assisted Living, LeadingAge, the National Association for the Support of Long-Term Care, the Senior Care Pharmacy Coalition, the National Community Pharmacists Association, the American Society of Consultant Pharmacists and pharmacy group purchasing organization GeriMed.

Assisted living communities and CCRCs, the groups wrote, do not have the infrastructure nor the procedures in place to collect hazardous waste pharmaceuticals and would incur “significant expenses” to comply with the rule, without remuneration. Compliance would be complicated further by the fact that assisted living communities are regulated at the state level, and requirements vary from state to state, according to the organizations.

“We support efforts to properly and safely dispose of hazardous waste pharmaceuticals. However, we have great concerns about the EPA's broad use of the term ‘long-term care settings,' ” Cheryl Phillips, M.D., LeadingAge's senior vice president of public policy and health services, tells McKnight's Senior Living. “In particular, assisted living facilities and continuing care retirement communities are the individuals' homes, just as if they were still living in their previous residences. Staff members do not have authority to mandate that individuals turn over or dispose of their medications. It appears that throughout this proposed rule, the EPA does not fully understand the nature of these settings or the current regulations pertaining to nursing homes.”

The EPA expects to finalize the rule in 2016. It will be effective six months after that.

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