EPA Proposal On Pharmaceutical Waste Affects Assisted Living Communiti

EPA Proposal On Pharmaceutical Waste: Know the Proposal and Prepare

 

Since the 1990s water contamination by pharmaceuticals has been an environmental issue of concern. Most pharmaceuticals are deposited in the environment through human consumption and waste, and are often filtered ineffectively by wastewater treatment plants which are not designed to manage them. Once in the water they can have diverse, subtle effects on organisms, although research is limited.

Pharmaceuticals may also be deposited in the environment through improper disposal, runoff from sludge fertilizer and reclaimed wastewater irrigation, and leaky sewage. In response, the Environmental Protection Agency (EPA) has issued a proposed rule establishing management standards for pharmaceutical waste that is classified as “hazardous” under the federal law.

The newly proposed standards include requirements for assisted living communities, continuing care retirement communities and other establishments. The proposed rules address recording keeping, storage, labeling and shipping. It also bans healthcare organizations and others from flushing waste pharmaceuticals down the sink and toilet.

Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the present Subtitle C hazardous waste regulations for a number of reasons:

• First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations, but are often involved in the implementation of the regulations.
• Second, a healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed.
• Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in small amounts. To facilitate compliance and to respond to these concerns, the EPA is proposing to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals.

The EPA said in its proposal: “Given that long-term care facilities are licensed settings for the care of their residents and routinely provide healthcare services, we believe that long-term care facilities more closely resemble hospitals than typical residences.”

Additionally, it posits that the hazardous waste generated by long-term care establishments don’t meet criteria for their waste to be considered household hazardous waste and generate a greater variety of hazardous waste pharmaceuticals and a greater quantity of hazardous waste than a typical household generates.

EPA is providing notice that if this rule is finalized, long-term care establishments would need to manage their hazardous waste pharmaceuticals in accordance with the healthcare facility specific management standard. It seeks comment on whether this proposed changed to consider long-term care communities to be healthcare facilities instead of households is appropriate. It’s also seeking comment on whether long-term care groups would pass the cost of compliance onto customers.

Until a new rule is finalized and adopted by authorized states, healthcare facilities and other business entities that generate pharmaceutical hazardous waste must manage these wastes in accordance with the hazardous waste generator requirements.

 

BLOG Date: Wednesday, September 29, 2015
Writer: Ryan Allen