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 Pharmaceutical Waste: A Checklist For Compliance

The improper disposal of drugs isn’t only an environmental threat, it can  put the center at risk of substantial penalties.

 

​Long term and post-acute care (LT/PAC) centers manage a variety of pharmaceuticals as part of everyday patient care, ranging from nonhazardous medications like lidocaine to acutely hazardous drugs such as warfarin. Juggling a variety of responsibilities, centers can be sometimes unprepared to comply with the numerous pharmaceutical waste disposal regulations, which can inadvertently put staff, residents, and the surrounding environment at risk.

Why So Challenging?

There are unique difficulties associated with controlling pharmaceutical waste in the long term and post-acute care space. For example, there are clinicians who come in contact with pharmaceuticals in this context who are not center employees and only come to the center once or twice a week. That said, these clinicians still must be aware of the proper disposal methods and consistently follow them to ensure the center itself does not fall out of compliance.

In addition, many care centers contract with an outside company for pharmacy services. Even though contracted vendors are responsible for managing the pharmacy’s compliance, the care center is still accountable if drugs are improperly disposed of.

The sheer scope of medications can also present problems. Care centers frequently have to dispose of not only hazardous and nonhazardous pharmaceutical waste, subject to regulation by the U.S. Environmental Protection Agency (EPA), but controlled substances as well, which the U.S. Drug Enforcement Administration (DEA) oversees.

Keeping track of the various requirements and what drugs they pertain to can be a big job.

Although LT/PAC centers manage a similar scope of medications as hospitals, they frequently do not have the standardized procedures in place for disposal that their larger-setting counterparts do. One reason is that care centers do not always have the resources to develop and sustain an adequate disposal program. Regardless, it’s still extremely important to maintain compliance.

Consequences Of Noncompliance

By not having a defined pharmaceutical waste management program, a center can put itself at various types of risk. First, substantial penalties for noncompliance can be incurred from EPA and DEA. These penalties can not only cause financial strain, but also impact the overall perception of the care center, which in turn can affect patient and staff retention and loyalty.

Improper disposal can also lead to environmental issues. When LT/PAC centers do not dispose of hazardous pharmaceutical waste correctly, it can leach into the environment, polluting groundwater and freshwater resources.

This presents a significant ethical dilemma, and it can also negatively impact a center’s reputation if discovered.

Follow A Checklist

While attaining reliable compliance with pharmaceutical waste management regulations may seem daunting, there are some straightforward steps that care centers can take to effectively meet the existing requirements.

1. Assess the care center’s inventory. Centers should go through their pharmaceutical inventory and determine what waste they generate and what forms it takes. If the center contracts with an outside pharmacy, make sure to understand the types of waste it has present.
One specific category to look for is P-listed waste, which not only requires centers to be careful when disposing of unused medications but also the empty packaging as well. As mentioned before, controlled substances are another regulatory category of waste of which to be aware.
2. Create a plan. If EPA comes onsite to assess the center’s pharmaceutical waste-disposal program, the first thing they will check is whether the center has a plan in place for proper disposal of the waste stream.
There are several resources online and within vendor centers to help with creating a comprehensive and appropriate plan that can be targeted to the center.
3. Determine how many, and where, waste containers are necessary. The next step is to quantify the waste and determine the right number of containers that are required. Then, centers need to examine where they dispose of pharmaceutical waste and how much waste is generated in each area.
As a rule of thumb, LT/PAC centers typically place at least one pharmaceutical waste container in each medication room.
4. Obtain a scale for P-listed waste. EPA regulations currently require centers to measure this kind of waste before disposal. The amount of P-listed waste generated is taken into account when determining the waste generator status (CESQG, SQG, or LQG).
5. Once equipment is in place, start training staff. Provide as many training options as possible to give staff convenient access to ample education. Depending on the center, this may include online tools, posters, and tips in staff meetings. When providing education, it can be especially helpful to offer specific examples that staff can understand and relate to.
6. Keep manifest records up to date. When EPA staff arrive on site, they will want to review the center’s manifests. Also, should the center have a question about waste disposal, it is helpful to have an accurate record.
7. Perform audits. While developing processes is the first step, centers should verify that they consistently follow those processes.

One method is to periodically observe waste management using a regulation checklist to assess performance. By engaging in a visual audit, it is easy to see what the center is doing well and what areas still need work.

Although creating a pharmaceutical waste compliance program for a long term or post-acute care center can seem overwhelming, it is essential to start this process now to set the center up for compliance success. This also helps to protect against risk for financial penalties and environmental pollution. Making a concerted effort to standardize and manage the process can ensure the center preserves both resident and environmental safety.
 
Kathryn Evans is a national director at Stericycle, a global business services company in Lake Forest, Ill., offering waste management, secure information destruction, sustainability services, and more.
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