Pharmaceutical waste is one of the most common forms of healthcare waste, and it is generated in a range of settings within a hospital. Moreover, there is a wide variety of waste that falls into the pharmaceutical waste category, and the chemical components of the medicine or drug can determine where and how it is disposed.  

The complexity of differentiating between hazardous vs non-hazardous medications can make the containerization and disposal of pharmaceutical waste tricky to navigate compared to other waste streams. However, with a basic understanding of the types of pharmaceutical wastes, as well as the benefits and drawbacks of various disposal strategies, you can create, develop, or refine the right program for your hospital.  
 

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TOPICS WE WILL COVER: 

1 / A Brief Review of Pharmaceutical Waste 

2 / Pharmaceutical Waste Management Strategies 

3 / The Benefits of a Waste Disposal Partner 

A Brief Review of Pharmaceutical Waste 

Pharmaceutical waste comprises two different waste streams: hazardous pharmaceutical waste and non-hazardous pharmaceutical waste. In the most basic sense, hazardous pharmaceutical wastes are those that are regulated by state or federal agencies, whereas non-hazardous pharmaceutical wastes are not regulated. 

The primary federal statute governing the management of hazardous waste is the Resource Conservation and Recovery Act (RCRA) of 1976, so the relevant wastes are sometimes referred to as are RCRA pharmaceuticals (aka hazardous pharmaceuticals) and non-RCRA pharmaceuticals (aka non-hazardous pharmaceuticals).  

Non-RCRA-hazardous pharmaceutical waste can be generated through IV preparation, compounding, spills, or breakage; partially used vials, syringes, and IVs; and outdated products. Prescriptions or over-the-counter drugs are generally considered non-hazardous as long as they do not include any chemicals regulated through RCRA.  

Non-RCRA pharmaceutical waste accounts for at least 85 percent of pharmacy generated waste and includes:  

• U- and P-listed drugs in which the listed chemicals are not the sole active ingredient. 

• Drugs listed as hazardous by the Occupational Safety and Health Administration (OSHA) but non-hazardous by RCRA regulations.  

• Drugs categorized as carcinogenic by the US Department of Health and Human Services National Toxicology Program. 

• Drugs categorized as LD50 at or below 50 mg/kg and endocrine-disrupting compounds  

• Any minerals or vitamin supplements that contain the minimum levels of chromium, selenium, or cadmium to fail the toxicity test (or for which there lacks sufficient information to make a determination.
   

Conversely, many RCRA pharmaceuticals are specifically listed by the Environmental Protection Agency, and are thus always considered hazardous. Pharmaceuticals may also be categorized as hazardous if they are ignitable, corrosive, toxic, or reactive – the four characteristics of hazardous waste.   

It is important to understand the distinction between hazardous and non-hazardous pharmaceuticals not just to ensure compliance with all regulations but because the different classifications of pharmaceuticals require different levels of treatment, with resulting labor and financial impacts.  

In the average hospital, only around 5 percent of medications in the formulary are hazardous.  

Pharmaceutical Waste Management Strategies
 

When it comes to managing this waste stream, it is important to keep in mind that you can always overclassify but never under classify pharmaceutical waste. This leaves two options for waste management.  

Over Classification 

One option for pharmaceutical waste management is to utilize a single container for clinical staff to dispose of all pharmaceutical waste. In this scenario, all pharmaceutical waste is treated as if it were a RCRA hazardous waste, and the subsequent regulatory requirements around containerization, storage, transport, and treatment would apply. These requirements may vary by state or even local laws.  

There are several benefits to the over classification strategy. It requires fewer waste containers in areas that may already be lacking in space; it removes the risk of under-classifying something; and it requires less time to educate clinical staff on proper waste segregation. In addition, clinical staff may often prefer to have a single container for disposal since it does not require much in-the-moment decision making.  

While there are many benefits to utilizing this method, there are some major drawbacks as well. Because of the strict labeling, storage, and disposal regulations that apply to hazardous waste, a hospital could see an increase in their regulatory burden depending on how much waste is generated. Additionally, there is still some level of separation that needs to occur, even among hazardous pharmaceuticals to ensure no incompatibles are disposed of in the same container.  

There is also an increased cost associated with over classification, since hazardous waste is treated at a higher level and is typically accumulated in single-use plastic containers, bringing premium costs for both container purchase and waste treatment.  

Segregation 

An alternative to the over classification method above is to segregate hazardous pharmaceuticals from the non-hazardous pharmaceuticals. This method seeks to ensure that just the 5% of hospital medications listed as hazardous are treated as hazardous. The remainder of the waste would be placed into a non-hazardous pharmaceutical container and sent off for treatment and disposal as such.  

There are many benefits to this method. Reducing the amount of hazardous waste generated in a facility subsequently lessens the facility’s regulatory burden as well as the costs associated with disposal since hazardous waste is generally the highest-cost waste stream. By diverting non-hazardous medications to a non-hazardous waste stream, waste disposal and treatment costs are reduced by a minimum of 50 percent. Additionally, this dual-segregation model enables the use of security-engineered reusable containers for the collection of 85-plus percent of medications, providing protection for staff and patients from theft or misappropriation of opioids.  

Take for example the experience of Irredell Health. By implementing a segregation strategy, Irredell Health was able to significantly reduce the amount of hazardous waste it produced, achieving a 35 percent reduction in costs while also transitioning from the status of a Large Quantity Generator to a Small Quantity Generator of hazardous waste, reducing the regulatory burden.  

Segregation models do come with some detractors. There is a risk that waste is under classified and not sent for appropriate disposal, leading to unwanted consequences for the facility. As a result, clinical education is important in this model to give staff enough information to properly segregate hazardous from non-hazardous pharmaceuticals.  

The Benefits of a Waste Disposal Partner 

While some hospitals may prefer to over-categorize to avoid many of the potential compliance risks, this pathway can be financially unviable for many institutions (not to mention damaging to the environment). The best bet is to implement a waste segregation policy in partnership with a dedicated waste partner like Daniels Health.  

With decades of experience in auditing facilities, designing bespoke disposal plans, and training healthcare workers, Daniels Health is well positioned to support your facility’s needs. Whether it’s through the implementation of a formulary analysis or the introduction of the Pharmasmart container system, there are many ways to improve your pharmaceutical waste program in order to reduce costs and lower your regulatory burden. Give us a call to get started today.  

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