Pharmaceutical waste management
Trends in Pharmaceutical Waste Management - April 2nd, 2009
Protecting the integrity of our water resources is one of the most essential environmental issues of the 21st century. There is growing concern for potential adverse human and ecological health effects resulting from the production, use, and disposal of chemicals that offer improvements in industry, agriculture, medical treatment, and even common household conveniences. Research has shown that many compounds can enter the environment, disperse, and persist for far longer than first anticipated. Surprisingly, little is known about the extent of environmental effects, transport, and ultimate fate of many synthetic organic chemicals after their intended use, particularly pharmaceuticals, hormonally active chemicals, and personal care products that are designed to stimulate a physiological response in humans, plants, and animals. These compounds are often released directly to the environment after passing through wastewater treatment processes (via wastewater treatment plants, or domestic septic systems), which often are not designed to remove them.
The U.S. Geological Survey (USGS), the Federal source for science about the earth, natural hazards, and the environment, has been concerned about the environmental presence of these compounds and the potential risks including reproductive impairment, increased incidences of cancer, the development of antibiotic-resistant bacteria, and the potential increased toxicity of chemical mixtures. For many substances, the potential effects on humans and aquatic ecosystems are not clearly understood. The USGS summarized these concerns and the results of their research analyzing the extent of these contaminants in a recent USGS Report, Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in US Streams.
The increasing awareness of the potential harmful effects of these compounds has prompted development of numerous publications of the risks of chemicals known as endocrine disruptors, consumer guidance from state agencies on proper disposal of unused medications, and guidance from the EPA on use and disposal of pharmaceuticals. Numerous other public and private organizations, outlined in this Web site summary, offer guides and assistance for developing a comprehensive waste management program. These programs includes identifying, segregating, managing, and disposing of hazardous pharmaceutical waste, as well as safe handling practices for worker protection. Governmental oversight is also summarized.
U.S. Geological Survey
- Endocrine disruptors
- U.S. Environmental Protection Agency (EPA)
U.S. Environmental Protection Agency (EPA) – Proposed rule for pharmacy waste (2008)
- Recommendations to consumers
The U.S. Environmental Protection Agency's (EPA) Resource Conservation and Recovery Act (RCRA) regulates the disposal of solid waste and includes numerous definitions of hazardous chemical waste.
- A number of common pharmaceuticals, such as epinephrine and warfarin, are listed as acutely hazardous wastes on the P-list published in 40 CFR 262.33 (e).
- A number of chemotherapy items and other drugs such as lindane are listed on the U-list of chemicals found at 40 CFR 262.33 (f).
- If a P or U listed drug is the sole active ingredient when discarded, the item is designated as a hazardous chemical waste and must be managed in compliance with RCRA, similar to discarded xylene or other laboratory chemicals found in healthcare settings.
In addition, drug formulations which exhibit one of the characteristics of hazardous waste including ignitability, corrosivity, toxicity or reactivity must also be managed as hazardous waste if discarded. These management procedures include proper identification, storage, manifesting, transport and disposal at a RCRA approved incineration facility.
EPA Region 2 (New Jersey, New York, Puerto Rico, US Virgin Islands and 7 Tribal Nations) is aggressive in promoting hospital hazardous waste self-audit programs and has begun to levy substantial fines against hospitals where hazardous waste regulations have not been properly implemented.
States such as California, Washington, Minnesota, and Florida have become increasingly active and may have regulations more stringent than the U.S. EPA.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) surveyors are beginning to focus more scrutiny on the hazardous materials and hazardous waste plans required under the Environment of Care Standards.