Editor’s Note: The following article was compiled by Alice Jacobsohn working with members of the Healthcare Waste Institute. It contains opinions and predictions formulated by that organization and its members.
In the United States, regulations on the transport and disposal of hazardous materials, including infectious substances, regulated medical waste and hazardous waste, are based on international standards and recommendations. The first recommendations were published in 1956 by the United Nations Economic and Social Council’s Committee of Experts on the Transport of Dangerous Goods.
That same council issued a resolution on April 26, 1957, that allowed for subsequent recommendations to consider developments in technology and the changing needs of nations that would decide to adopt an international approach. The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes was adopted in 1989 and became effective in 1992 with significant U.S. influence.
Today, the international community is beginning to focus more on the disposal of pharmaceutical waste because of recent studies suggesting that this waste causes feminization of male fish and sluggish activity, or reduced appetite in fish populations.
Defining the Problem
Pharmaceuticals have been detected in water samples collected from U.S. waterways that are considered susceptible to contamination from various wastewater sources, such as those downstream from intense urbanization or livestock. Abuse of prescription drugs is on the rise with one-third of the abuse by teenagers between the ages of 12 and 17. Crime associated with prescription drug abuse also is on the rise.
Many federal and state agencies are responsible for pharmaceutical materials’ management, but unlike infectious substances and regulated medical waste requirements, pharmaceutical waste does not fit easily within the regulations or is unregulated. The result is the common practice of flushing these wastes down sinks into wastewater treatment systems that are not equipped to manage them, or directly into waterways. In addition, pharmaceutical waste often goes directly to solid waste facilities that are not designed to manage them.
Many states and local law enforcement agencies have created drug collection and disposal (“take-back”) programs for pharmaceutical waste to prevent flushing and abuse, but gaps and a lack of consistency have limited these programs. For example, controlled substances such as morphine and oxycontin cannot be easily collected in take-back programs because of existing management restrictions put in place through the Drug Enforcement Administration (DEA).
A New Approach
In 2010, President Obama signed the Secure and Responsible Drug Disposal Act amending the Controlled Substances Act with the goal of encouraging the DEA to set controlled substance diversion prevention parameters that will allow public and private entities to develop a variety of methods of collection and disposal in a secure and responsible manner. These parameters, when published as final, will address the management of controlled substances by ultimate users and long-term care facilities. Since passage, the DEA has held stakeholder meetings and received preliminary comments on how these regulations should function. A proposed rulemaking is expected before the end of 2012.
The U.S. Environmental Protection Agency (EPA) is deciding what it will do to manage pharmaceutical waste that is hazardous waste under the Resource Conservation and Recovery Act (RCRA). Only five percent of pharmaceuticals are considered hazardous waste by the EPA. Initially, EPA considered a universal waste approach, but many states commented that they would not adopt this method of management. The agency is expected to issue a proposed rulemaking in the spring of 2013 outlining a new approach. At this time it appears EPA is considering the management methods themselves, not whether to include more pharmaceuticals on the RCRA hazardous waste list.
EPA’s water division published a draft guidance document, “Best Management Practices for Unused Pharmaceuticals at Health Care Facilities,” on Sept. 8, 2010, in an attempt to provide recommendations on how to manage drug waste. However, the guidance was fraught with problems surrounding the impacts of suggested practices. This guidance is on hold until after the RCRA-approach is finalized.
Seeking a Cure
The Healthcare Waste Institute (HWI), a policy-making group within the National Solid Wastes Management Association, commented on these agencies’ activities and spent considerable time examining pharmaceutical waste management. HWI’s members own and operate healthcare waste collection and disposal operations and manufacture and distribute equipment and products used for healthcare waste management throughout the United States. Members either manage pharmaceutical materials as part of their business plan or are faced with pharmaceutical management issues because of current disposal practices by customers.
The discussions centered on three key elements:
- Reducing the negative impact that improper disposal of pharmaceutical materials has on the environment and human health;
- Ensuring a fair trade approach that allows for the use of all viable options for proper management of pharmaceutical discards, including waste-to-energy, regulated medical waste (bio-hazardous waste), healthcare waste and hazardous waste disposal; and
- Encouraging the creation of a task force or forum for sharing information on the management of non-hazardous pharmaceutical waste.
In addition, discussions focused on the non-hazardous pharmaceutical waste that comprises 95 percent of drugs for disposal. These drugs fall within an area of waste management that is largely unregulated, are often managed as solid waste and are the greatest source of conflict for the regulated community in terms of defining proper management.
Despite the controversy, most healthcare interests agree that the practice of pouring or flushing pharmaceutical discards down drains must be eliminated. While this does not eliminate the concern of discards through excretion, the changed practice will focus attention on altering the habits of healthcare workers and consumers and reduce the amount of material going to publicly-owned treatment works.
To reduce the risk of exposure, discussions on best management practices (BMPs) should be based on sound scientific reasoning. While mixing pharmaceutical discards with undesirable materials, such as coffee grounds and kitty litter (a recommendation in EPA’s draft BMP guidance) and then disposing of it as municipal solid waste may appear to be a good approach, this option is not practical for commercial healthcare facilities, including hospitals, doctors’ offices and clinics that cannot store these undesirable materials.
The most widely accepted BMP currently available for pharmaceutical waste management is through incinerators regulated by the Clean Air Act, including waste-to-energy facilities, hospital/medical/infectious waste incinerators and hazardous waste incinerators. Because of clean air regulations and other concerns, the number of hazardous waste incinerators remaining in operation today in the United States is limited. Therefore, to ensure that as many communities as possible have access to incinerators for pharmaceutical waste, decision-makers should not limit disposal of pharmaceutical waste to specific RCRA-permitted hazardous waste facilities.
As noted earlier, only five percent of pharmaceuticals on the market are RCRA listed or are considered characteristic hazardous wastes and only six hazardous waste facilities are commercially available. The other 95 percent of pharmaceuticals can be managed effectively through other permitted incinerators, of which there are approximately 100 commercial facilities.
A Practical Prescription
Ultimately, regulations and guidance documents should not require any particular technology or method of disposal. Instead, the requirements should be performance-based, allowing any technology to be proven viable for proper management of pharmaceutical waste.
Commercial markets should not be so open that anyone without experience or knowledge is allowed to manage pharmaceutical discards. Therefore, methods also should include performance-based requirements that prevent diversion and reduce the risk of access to non-prescribed users. This may include the use of tamper-resistant packaging and labeling; handling by trained personnel (e.g., healthcare waste management employees); and improved methods for monitoring, tracking and reporting, such as documenting the number and weight of pharmaceutical waste containers.
While the pharmaceutical discards at issue are the same between commercial and home users, the ability to manage these generation points, enforce regulations and educate participants are different. Therefore, fair and secure practices for consumer take-back programs will likely look different than for commercial facilities. For example, consumer drop-off points should be designed to prevent people from reaching into containers, management of collection events should be by knowledgeable personnel (although not limited to law enforcement officers as currently required by the DEA), mail-back systems should use secure transport through the U.S. Postal Service or other licensed delivery companies, and there should be public awareness campaigns to inform people about the program.
One of the greatest obstacles to properly managing pharmaceutical discards is conflicting information and competing interests among stakeholders. This creates confusion and leads to mismanagement such as the current practice of placing non-hazardous pharmaceutical waste in regulated medical waste or sharps containers that go to autoclaves or other facilities not designed to dispose of pharmaceutical materials.
A single approach to the management of non-hazardous pharmaceuticals is unlikely because there will always be multiple jurisdictions. The importance of communication and cooperation among stakeholders is critical. The development of a federal task force or forum where those with an interest (federal, state, and local governments and industry) can share ideas, discuss regulatory approaches, and determine successful collection programs may help to create an ongoing dialogue as issues evolve. This task force or forum also can be used to assist healthcare waste generators, transporters and disposal facility operators in educating their employees about best management practices and regulations. Regardless of stakeholder decisions, education is the key to implementation.
Regulatory Side Effects May Include…
For solid waste operations, the regulatory activity on pharmaceutical waste management could lead to bans on disposal. For example, if the DEA’s parameters make take-back programs easier to implement, more of these programs may become available and states may encourage their use by forcing compliance. Proposed bills are in play in Colorado, Delaware, Florida, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, Washington and West Virginia on home-generated pharmaceutical waste and take-back programs. California, Massachusetts, New York and Washington are looking for manufacturer responsibility. Illinois, Massachusetts, Michigan, New York, Pennsylvania, Washington and West Virginia also are looking at donation and reuse options. New Jersey is considering “no flush” legislation.
Some states have either added regulations or are making regulatory changes to pharmaceutical waste regulations, including Michigan, New York, North Carolina, Pennsylvania and West Virginia. For example, North Carolina’s regulations state that outdated drugs must be accepted by the manufacturer.
Solid waste facilities should watch for these changes because they may be asked to refuse to accept loads with pharmaceutical waste — especially coming from commercial healthcare facilities. They also may be asked to help by participating in take-back programs. Employers should watch for employee pilfering of pharmaceuticals for personal use or for illegal sale if they decide to accept waste loads from healthcare facilities where landfill disposal is an option.
For solid waste collection companies, when this waste is unregulated, there is no compliance problem with finding non-hazardous pharmaceutical waste in loads. Haulers should work closely with commercial healthcare customers to make sure hazardous drugs and controlled substances are not found in solid waste loads. These discussions also may include options for non-hazardous, unregulated pharmaceutical waste to help customers implement appropriate disposal options.
Alice Jacobsohn serves as director of education, and director of the Healthcare Waste Institute at the National Solid Wastes Management Association. You can email her at [email protected].
Interested in delving deeper into the issues surrounding medical waste management?
Attend the 2012 Healthcare Waste Conference, held May 2–3, collocated with WasteExpo in Las Vegas. For more information, visit www.healthcarewasteconf.com.