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EPA announces final rule to set new standards on hazardous waste pharmaceuticals

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February 1, 2019

Tell your nurses that soon that packaging for a patient’s nicotine patch, gum, or lozenge might go straight into the regular trash — as long as it is FDA-approved as an over-the-counter nicotine replacement therapy.

And your state must sign off on the exemption of the packaging as hazardous waste under the federal Resource Conservation and Recovery Act (RCRA). That’s just one of the benefits you can expect in handling hazardous waste pharmaceuticals at your facility now that the Environmental Protection Agency has finalized its long-awaited “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.”

However, get the word out to everyone in your organization who handles hazardous waste pharmaceuticals that, in the near future, flushing or rinsing those drugs down a drain into the sewers will be specifically prohibited. 

Under the changes first proposed in September 2015, EPA is creating a new subpart P under RCRA that manages hazardous waste pharmaceuticals across a wide array of industries, including hospitals, physician offices, ambulatory care, and other providers who “distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals,” according to the EPA.

USP vs. EPA

While these changes to RCRA were first proposed in September 2015, the work to change requirements to specifically deal with hazardous waste pharmaceuticals has been almost 20 years in the making. 

And this final rule includes a lot of legalese that will be hard to digest and likely will require a lot of refining and explaining in the next several months.

Your facility won’t have don’t have to do it alone. Experts from commercial services such as Waste Management (WM) or Stericycle will be jumping in soon to help customers understand what the new regulations will mean, notes Kurt Patton, MS, RPh, a pharmacist and former executive director of accreditation services for The Joint Commission (TJC). He is founder of Patton Healthcare Consulting, now out of Naperville, Ill.

And one of the first questions that will be asked, says Patton, is how will the new EPA requirements mesh with those in USP <800>, the U.S. Pharmacopeial Convention’s chapter on “Hazardous Drugs„Handling in Healthcare Settings” which is scheduled to take effect on December 1, 2019?

Short answer: They don’t, because they have different purposes, notes Charlotte A. Smith, RPh, MS, a senior regulatory advisor and founder of PharmEcology Services, now a part of WM Sustainability Services. 

The new EPA final rule is protecting the environment from hazardous drug waste, while USP <800> is protecting workers who are handling hazardous drugs, she says.

A drug defined as hazardous in one category may not be included in the category for the other, says Smith. Others overlap. 

Both WM’s PharmEcology Services and Stericycle Environmental Solutions have developed databases and tools to help clients sort out which is which. Other commercial services will also be offering services.

Expect the American Society of Health-System Pharmacists (ASHP) and others to weigh in on implementing the new EPA requirements as well, says Patton.

The rule has benefits

Under the provision, in general, the EPA says hospitals managing their pharmaceutical waste under subpart P will see some benefits. For instance, hospitals will no longer have to count hazardous waste pharmaceuticals in calculating generator status. Those drugs often forced facilities into large-quantity generator, or LQG, status, which is both more expensive and more difficult to manage.

Another big plus for hospitals in the final rule is that hazardous waste drugs regulated as controlled substances will be exempted from hazardous waste regulation, erasing concerns about competing regulations between the EPA and the Drug Enforcement Administration, notes Smith.

A pharmacist by training, Smith is a long-time environmental proponent and one of two primary authors of “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 (see link in Resources).

There are questions remaining

The final rule is a major EPA accomplishment, notes Smith, but there are still many questions to be answered.

Take those nicotine-replacement therapies, for instance. 

Nicotine is considered a long-established acute hazard to the environment, according to the EPA. The disposal of the drug, along with any container that may hold residue of the drug, must be managed under RCRA.

Under RCRA, nurses currently are required to remember to take the packaging for nicotine-replacement therapies and, after providing the drug to the patient, walk the wrapper over to a hazardous waste receptacle, where it is eventually collected, weighed, and added to a facility’s generator totals. 

That requirement alone can force hospitals over the 1 kilogram per month of acute hazardous waste limit that puts the facility into LQG status, which carries disposal requirements that are both more onerous and expensive, say experts.

And its aggravating to the nurses or other staff members who must remember to do it. Not doing it would be a violation of RCRA, which in turn also could be a violation of hazardous waste standards set out by CMS and other accrediting organizations such as The Joint Commission.

While the new final rule exempts any FDA-approved, over-the-counter packaging for nicotine-replacement therapies, the question then follows as to what is considered over-the-counter (OTC), if the replacement therapy is prescribed. 

Generally, patches, gums, and lozenges will be exempted, while nicotine sprays and inhalers will still be regulated. Hospitals should consult with their pharmacists to ensure that the replacement products they use fit the FDA definition of OTC, notes Smith. 

The EPA also notes in a series of frequently asked questions, found on its website (see Resources), that because the exemption is less stringent than current regulation, that change must be adopted by any state with its own rules for hazardous waste management. 

States with their own authorized RCRA programs may adopt laws that are more stringent than federal programs. However, “authorized states are not required to adopt less stringent regulations. The exemption for over-the-counter nicotine replacement therapies will not become effective in states authorized for the RCRA program until states have adopted the exemption,” according to the EPA.

Which leads to another question still to be answered — when will the provisions actually go into effect at your facility or healthcare organization?

When does all this happen?

The rule’s provisions will become effective federally within six months of its publication in the Federal Register. While the rule has been signed and is expected to be published in the Federal Register soon, there is still the question of when states with their own RCRA-authorized programs will adopt the new regulations. 

Each state has its own process for adopting new regulations, and some must include state legislative efforts, notes Darrell J. Oman, program manager for Consulting Services and Client Environmental, Safety & Health Manager, for Stericycle Environmental Solutions.

States and localities may adopt regulations as restrictive as the federal requirements or can be more stringent. They cannot be less stringent than the federal regulations. 

For instance, in Minnesota, where Oman lives, there are state and even some county hazardous waste rules that are more strict than federal rules.

Two states will be under the new final rule within six months of its publication: Iowa and Alaska do not have their own state hazardous waste management program. Meanwhile, hospitals in Florida and Michigan could face major changes — those states manage hazardous waste pharmaceuticals under the Universal Waste Rule, which is no longer allowed, notes Oman.

The one part of the new EPA final rule that will impact any facility or organization who handles hazardous waste pharmaceuticals in any state is the prohibition on flushing the drugs into the sewer system. That will take effect as soon as the rule does, according to the EPA.

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

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