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Ensure compliance with EPA rule: Ban all sewering of hazardous waste drugs

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October 1, 2019

by A.J. Plunkett (aplunkett@decisionhealth.com)

Review and update policies on the disposal of pharmaceuticals to prohibit the flushing of any drugs into the sewers. Experts say that may be the best way to ensure compliance with a new EPA regulation banning the sewering of hazardous waste pharmaceuticals that went into effect August 21.

The policy update also may help ease requirements on frontline staffers, who will no longer have to keep track of what they can and can’t flush down the drain. And it may even help you stay on the good side of federal regulators, who are encouraging the no-sewering of any drug as a best practice to protect water resources.

The August 21 ban on the sewering of hazardous waste pharmaceuticals is the first deadline set out in new EPA regulations published in a February final rule. That rule overall sets up a new category, Subpart P, under the federal Resource Conservation and Recovery Act (RCRA).

The ban is the only part of the rule that goes into effect at all healthcare facilities across the United States and its territories without exception. That’s because the EPA is declaring the ban under the authority set out by the federal Hazardous and Solid Waste Amendments (HSWA).

Other parts of the final rule, officially known as the “Management Standards for Hazardous Waste Pharmaceuticals & Amendment to the P075 Listing for Nicotine,” are under RCRA and must be approved in each state or territory that has its own RCRA-authorized program (more on that in a bit).

No-sewering ban more stringent

The sewering ban is one of the more stringent changes outlined in the rule. The EPA only has the authority to ban flushing of those drugs deemed to be hazardous waste, as outlined under RCRA regulation, notes Wade Scheel, director of governmental affairs for Stericycle Environmental Solutions.
However, in the preamble to the final rule, the EPA “clearly makes it known” its position on sewering of all drugs, he says.

That preamble states: “We note that although our RCRA statutory authority limits us to apply the prohibition on sewering narrowly to pharmaceuticals that are RCRA hazardous wastes, EPA strongly recommends as a best management practice to not sewer any waste pharmaceutical (i.e., hazardous or non-hazardous) from any source or location.” The EPA even goes on to ask households to do the same.

The concern is that public sewer and water systems were not designed to filter out the complex chemical and biological elements found in many of today’s drugs, even if those drugs are not technically considered hazardous waste, says Scheel.

Pharmaceuticals can have a significant impact on the environment, according to Michael Ganio, PharmD, MS, BCPS, FASHP, director of pharmacy practice and quality with the American Society of Health-System Pharmacists, more commonly known as the ASHP.

“Studies have shown that non-hazardous-waste drugs that are disposed of down the drain can be found in water supplies and in lakes and streams, so a best practice is not to dispose of any pharmaceuticals down the drain,” says Ganio.

Because of such impacts, many larger health systems and healthcare facilities have already abandoned the practice of sewering, notes Scheel.

Smaller facilities should pay special attention

While the new federal ban may not have a major impact on those larger hospitals and healthcare facilities, smaller organizations, especially in rural areas, will have to ensure policies are in place to adhere to the prohibition.

The main problem will be identifying which pharmaceuticals are considered hazardous waste under RCRA and which are not, and then training staff to know the difference, says Scheel.

Having staff make those decisions while also providing care can be an onerous demand, he notes. To help them out and ensure compliance, create a “make-it-easy button” for them and prohibit the flushing of all pharmaceuticals, recommends Scheel.

Facilities that do not want to follow that recommendation will need to inventory the pharmaceuticals disposed of on-site and update their disposal policies to identify which drugs are considered hazardous waste under RCRA, then prohibit those drugs from being sewered.

“The sewering ban applies to hazardous pharmaceutical waste, commonly referred to as P- and U-listed waste. The lists contain drugs that are considered toxic, reactive, corrosive, or ignitable. The lists are not updated frequently, and institutions should have systems in place to ensure the proper disposal of P- and U-listed waste,” says Ganio.

A variety of commercial services, including Stericycle and Waste Management, maintain databases to identify pharmaceuticals considered hazardous upon disposal, as well as those considered hazardous to staff under the USP <800> standards that go into effect December 1, and the long-standing protections against hazardous substances required by OSHA. Some of those pharmaceuticals fall into all categories, while others are in only one, say experts (ECL 12/31/18).

Training should be at least annual

Anyone potentially handling and disposing of the pharmaceuticals that are included in the EPA rule will need to be trained on the no-sewering ban.

Training should occur now or upon hire, says Scheel. And a best practice would be refresher training at least once a year, he says. Although the EPA regulation does not require documentation of training, having documentation will help show compliance, he adds.

“Hospitals and health systems should train all staff who handle hazardous pharmaceutical waste on proper disposal,” says Ganio. “The new rule is an update to an existing rule regulating hazardous pharmaceutical waste, so hospitals and health systems should already have training, policies, and procedures in place to ensure staff are disposing of hazardous pharmaceutical waste correctly.”

“It’s also important to note that not all sections of the new rule are immediately effective and will depend on state EPA adoption of some provisions. For example, the sewering ban is effective on August 21 nationwide, but other provisions in the new rule have to be adopted by state EPAs. Hospitals and health systems should check with their state EPA to determine if and when those parts of the new rule will be adopted,” says Ganio.

Other deadlines later for most

As noted, the sewering ban is promulgated under the HSWA. The rest of the rule—which the EPA says reduces overlapping regulations from the DEA and FDA; tries to clarify how RCRA applies to reverse distribution and reverse logistics operations; and provides some regulatory relief to healthcare facilities that are regulated as large quantity generators by easing up on packaging of some nicotine replacement therapies—is under RCRA.

So by law, states or territories with their own RCRA-authorized programs have until July 1, 2021 to adopt the elements of the new rule—unless they also need to get legislative approval to do so, in which case those states have until July 1, 2022.

But if you are not in a state or territory with your own RCRA program, you were subject to all parts of the final rule as of August 21. That includes Iowa and Alaska, all the U.S. territories except Guam, and Indian Country.

Healthcare facilities in all other states and territories should keep a close eye on what is adopted, experts have said. Federal law requires RCRA-authorized programs to adopt anything that is more stringent, but those programs do not have to adopt anything less strict—for instance, the exemption on throwing away over-the-counter nicotine-patch wrappers or warfarin blister packs.

Kentucky, New Jersey, and Pennsylvania have already indicated they will adopt the rule in its entirety, noted Charlotte A. Smith, RPh, MS, a senior regulatory advisor and founder of PharmEcology Services, now a part of WM Sustainability Services, during a recent webinar for HCPro.

Like the EPA and the other experts, Smith is a fan of healthcare facilities prohibiting the flushing of all drugs, regardless of whether they are hazardous waste or not.

She also co-authored Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States, developed in 2006 and revised in 2008 for the EPA. In the final rule, the federal agency recommends hospitals and other healthcare providers use the blueprint as a continuing resource for best practices.

The blueprint can be found at https://practicegreenhealth.org/sites/default/files/upload-files/pharmwasteblueprint.pdf. Information on the webinar can be found at https://hcmarketplace.com/breaking-new-ground.
 




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