Pharmaceutical waste background

Increased awareness around the presence of pharmaceuticals in drinking water has resulted in closer scrutiny and increased regulatory oversight of pharmaceutical waste.  Evidence of feminization of fish raised a red flag and resulted in more studies, closer scrutiny, and concern for human health and the environment.  The U.S. Geological Survey has done extensive work to characterize the kinds and volumes of pharmaceuticals ending up in waterways. Learn more at U.S. Geological Survey's Emerging Contaminants Project.

While hazardous pharmaceutical waste management is a headline news item at the moment, it is not a new regulation. The EPAs  Resource Conservation and Recovery Act (RCRA) was written in 1976, yet healthcare pharmaceuticals (save eight chemotherapeutic agents) flew under the radar, until about 2004.  A hazardous waste compliance assistance effort in EPA Region 2 (NY, NJ, Puerto Rico and the US VI) detected serious inadequacies in the characterization and management of hazardous wastes at healthcare facilities. Enforcement efforts accelerated as a result, Joint Commission began training its surveyors to begin asking questions about proper pharmaceutical management, and today, healthcare facilities are either actively addressing this complex and expensive waste stream (estimated at up to $500 per bed per year) or their programs are in the early stages of implementation.  Hospitals are looking to each other for best management practices before tackling this tough program, in an effort to learn from others and avoid costly missteps.  Where possible, prevention of pharmaceutical waste is the best strategy, and efforts to generate less pharmaceutical waste can result in significant savings.

Pharmaceutical management basics

How should pharmaceuticals be managed when they can no longer be used by humans? As evidence mounts that pharmaceuticals are entering the groundwater, and drinking water reserves, the once-common practice of flushing pharmaceuticals is no longer considered best practice. The challenge to healthcare facilities is to reduce occupational and environmental risks by safely managing and disposing of the pharmaceuticals the organization uses, while developing a set of practices to produce less waste to begin with, and reduce toxicity where alternatives exist.

Pharmaceutical management team

When thinking about who should be involved in conversations about how to properly and effectively manage pharmaceutical waste to meet environmental compliance obligations and protect human health, several key departments come to mind. In addition to the sustainability leader, Pharmacy, Environmental Health and Safety, Environmental Services, Safety, Hazardous Materials (if a separate role), Nursing, Nurse Education, Risk Management and Legal should be engaged in pharmaceutical waste management efforts. This activity could also be addressed within the Joint Commission structure (through both the Medication Management Standard and the Environment of Care under hazardous materials and waste management).

Formulary review

A hospital pharmacy can easily have thousands of distinct pharmaceutical chemicals in its available inventory --often called a formulary. Many organizations begin by identifying which of these pharmaceuticals have a sole active ingredient that is a "listed" hazardous waste under RCRA (typically P- or U-listed), and which qualify as "characteristic" wastes under RCRA (either ignitable, reactive, corrosive or toxic). Some may also qualify as a dual waste (both RCRA hazardous and meet the state definition of regulated medical waste, i.e. a syringe containing a hazardous drug.)  While the prospect of evaluating this number of substances may be overwhelming, only about 4 to 5 percent of the formulary are usually hazardous, which may be equivalent to approximately 100 to 200 of the medications in the formulary.

There are several ways to go about a formulary review process--ranging from partnering with a service provider who may offer the formulary review in exchange for later providing service via a "turn-key" program, to hiring a consultant, to tackling this project with internal resources. All paths are feasible but it is important to understand that RCRA definitions can be confusing and overwhelming to the layperson. Many hospitals turn to outside assistance during the formulary review process.

Learn more about how to conduct a hazardous waste characterization internally.

Management approaches

Practice Greenhealth's guide "Managing pharmaceutical waste: A 10-step blueprint" was written in 2006 and updated in 2009, and for many organizations it continues to be the best place to start for a very comprehensive overview and recommendations for best practices. The blueprint is a must-read for background information on pharmaceuticals in drinking water and an outline of different step-by-step approaches to program implementation. Pharmaceutical waste management is a moving target, however, as EPA is actively considering changes like making pharmaceutical waste management "universal waste." See updates on the proposed EPA changes. Likewise, the regulatory landscape for narcotics and Controlled Substances (as regulated per the US Drug Enforcement Agency) is also under review.

Hazardous pharmaceuticals

Practice Greenhealth has compiled tables listing materials in each of the RCRA P, U, and D lists which may typically be found in healthcare facility waste streams together with their typical uses. For convenience, a selection from the list covering pharmaceuticals specifically is reproduced below. The article contains much useful background information besides, and is recommended reading.)

Please note that these lists are not intended to be complete. The full lists of all P- and U-listed wastes appear in the Code of Federal Regulations, 40 CFR 261.33. (This link will take you to the most recent available version of 40 CFR 261.33.)

Common P-Listed pharmaceuticals:

Common U-Listed pharmaceuticals:

Selected chemotherapy agents by brand name

Many of the chemicals used to treat cancer patients during chemotherapy fall on either the U or P lists. Many of the cytotoxic or chemotherapeutic drugs did not exist when RCRA was released in 1976, but all of these agents should be handled (from a safety perspective) as hazardous waste. These agents are often referred to by their brand names rather than the chemical designations appearing on the lists. For convenience,  listed below are some common brand names, together with their chemical names and RCRA waste codes.

Since new products may be introduced at any time, this list may not include all brand names composed of RCRA listed chemicals.

* Note: While most chemotherapy agents are U-listed, arsenic trioxide is P-listed.

In addition to these brand names, the facility may utilize various other listed drugs that are used in cancer research or treatment, though they have not been FDA-approved for general use. Examples include:

• Azaserine U015
• Chlornaphazin U026
• Ethyl Carbamate U238
• 3-Methylchloranthrene U157

Other chemicals may be added to the RCRA lists at some point in the future. In any case, even if some of the chemotherapy agents in the facility are not currently included among the listed hazardous wastes, they are of necessity extremely toxic, since their primary function is to kill dividing cells. The organization may want to consider handling all chemotherapy agents with the same level of care that is required for the listed hazardous wastes.

Narcotics Disposal

On September 9, 2014, the Disposal of Controlled Substances final rule was published in the Federal Register. The final rule became effective on October 9, 2014.

Resources

NIOSH Updates Hazardous Drug List 2014