Incoming EPA rule will change the game on hazardous waste pharmaceuticals

This member-only article appears in the February issue of Patient Safety Monitor Journal.

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.

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.

In addition, the EPA scheduled at least two informational webinars for January, notes Steven MacArthur, a former hospital safety officer and now senior consultant with The Greeley Company in Danvers, Mass.

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.

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