By Rich Thompson, Managing Partner at TEC, LLC
Healthcare providers and households with unused pharmaceuticals must act to reduce accidental or intentional misuse of the medicine and to keep the drugs from entering the environment.
The opioid overdose crisis in the U.S. highlights the misuse of and addiction to a host of opioid based drugs. According to the National Institute on Drug Abuse, the crisis resulted in the deaths of an average of 115 people every day during March 2018. The American Medical Association (AMA) has drawn a connection between the current opioid epidemic and the control of unused medications. This article addresses steps to improve the management of unused medications in the possession of healthcare providers and their patients.
Pharmaceutical drugs regulated under the Controlled Substances Act (CSA) 21 U.S.C. 821 must be managed in accordance with the U.S. Drug Enforcement Administration (DEA) requirements. The overall goal of the CSA is to control the distribution of controlled substances until they are used or destroyed.
Controlled substances are defined and regulated by the DEA depending on the drug’s acceptable use and dependency potential. Drugs currently allowed for medical treatment are divided into five schedules. Schedule I and II drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. Opioid medications are listed as Schedule II substances.
Controlled substances are considered "inventory" if the containers have not been opened or given to a patient. These same medications are considered "waste" if they have been distributed to patients but are expired or unused. Pharmaceutical drug disposal is not regulated by the DEA; it falls under the purview of the U.S. Environmental Protection Agency (EPA) and authorized state environmental agencies.
Pharmaceuticals: Hazardous Waste vs. Solid Waste
Healthcare facilities must comply with Resource Conservation and Recovery Act (RCRA) 42 U.S.C. 6901 regulations for the management of hazardous wastes. RCRA defines hazardous waste in 40 CFR 261 by 1) the characteristics they exhibit (i.e., ignitability, corrosivity, reactivity, and/or toxicity) or by 2) explicitly listed processes that generate wastes. Once hazardous pharmaceuticals are identified under these standards, these wastes must be managed under strictly regulated guidelines until disposed of properly.
Wastes not classified as hazardous are defined as non-hazardous and are regulated under a different set of guidelines. For non-hazardous pharmaceuticals, EPA recommends healthcare facilities send the unused products to a reverse distributor. These reverse distributors act to acquire unused controlled substances for the purpose of returning the drugs to the manufacturer. In many cases, reverse distribution includes a return process with potential credit for the healthcare facility.
Best Practices for Healthcare Providers
How do healthcare providers handle unused medications? These facilities have a legal responsibility to manage wastes through approved services to transport and dispose of these wastes in accordance with RCRA requirements.
New Rules for Pharmaceutical Disposal – Healthcare facilities should be aware of an EPA proposed rule that would build on existing take back programs and aim to simplify management standards for waste pharmaceutical products (https://www.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals). This rule is long in the making, as it was proposed in 2015 (https://www.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals). Healthcare facilities should track this proposed rule and pay special attention to when it is finalized and when it becomes effective.
Redirecting the Disposal of Hazardous Pharmaceuticals - The new regulations prohibit the disposal of pharmaceutical wastes into sewers. EPA studies found that every year more than 6,400 tons of hazardous drugs are flushed down sinks and toilets from healthcare facilities. Understanding which pharmaceuticals are hazardous or nonhazardous is important in the management of a healthcare facility. Hazardous waste pharmaceuticals are typically processed by hazardous waste incineration, with the resulting incinerator ash disposed of in a permitted hazardous waste landfill (40 CFR 264, Subpart O).
Disposal of Nonhazardous Pharmaceuticals - There is a different set of requirements for unused nonhazardous drugs which dictate the procedures employees must follow. In some situations, reverse distribution is not available and, in that case, nonhazardous drug waste still should not be sewered. The wastes should be disposed of in hospital trash to be transported to a solid waste landfill or incinerated in a solid waste incinerator (40 CFR 258 and 40 CFR 264, Subpart O).
Best Practices for Household Consumers
How do household consumers manage unused medications? Many patients are simply unsure of the appropriate way to dispose of these products. This makes the medications subject to misuse or theft by household members and other individuals. Generally, there are several possible alternatives for the disposal of unused medications:
Take Back Programs - The DEA periodically hosts events where temporary collection sites are set up in communities for the safe disposal of prescription drugs. The National Prescription Drug Take Back Day aims to provide a safe means of disposing of medications, while also educating the general public about the potential for abuse. DEA's next Prescription Drug Take Back Day is October 27, 2018 (https://takebackday.dea.gov/). Local law enforcement agencies may also sponsor medicine take back events in your community. Consumers can contact their local waste management authorities to learn about events in their area.
Fixed Collection Locations - Another option for consumers to dispose of unneeded medicines is to transfer these medicines to registered collectors, who collect and dispose of pharmaceuticals. In your community, authorized collection sites may be in retail pharmacies, hospital or clinic pharmacies, and law enforcement facilities. Some authorized collection sites may also offer collection receptacles, sometimes called “drop-boxes,” to assist consumers in safely disposing of their unused medicines (www.cvs.com/content/safer-communities-locate).
Mail-Back Programs - Authorized collectors may operate mail-back programs to receive and destroy schedule II-IV controlled substances received from ultimate users of the medicine. To operate a mail-back program, they must make packages available to the ultimate user. Collectors operating mail-back programs must also destroy the drugs onsite.
Household Trash Disposal - If no take back collection locations are available in your area, and there are no specific disposal instructions, you can also follow these simple steps to dispose of most medicines in the household trash:
Mix medicines with another substance such as dirt, cat litter, or used coffee grounds, place the mixture in a container such as a sealed plastic bag, and throw the container in your household trash.
The Environmental Impact from Improper Disposal
The main way drug residues enter water systems is by patients taking medicines and then naturally passing them through their bodies. When medications are unused, the standard disposal practice has historically been to flush unused pharmaceuticals down the toilet or drain. EPA now recommends healthcare facilities and patients eliminate the practice of flushing unused medications, as studies have identified detectable levels of pharmaceutical compounds in rivers, lakes, and drinking water supplies. Low levels of pharmaceuticals, including antibiotics, hormones, and other drugs have been found in our drinking water supplies (https://www.epa.gov/sites/production/files/2015-06/documents/how-to-dispose-medicines.pdf).
The other ongoing trend involves Extended Producer Responsibility (EPR) laws requiring pharmaceutical manufacturers to manage their products’ waste at end-of-life. EPR rules have been implemented throughout the world. To comply with such legislation, drug manufacturers fund take back programs to securely collect unwanted medicines from the public and ensure the collected materials are managed and disposed of properly.
Following the lead of Canada, France, and other countries, local governments in the United States are beginning to implement pharmaceutical EPR laws through local ordinances. Ordinances have been implemented by several city and county governments in California to require pharmaceutical take back programs.
Prescription medications have the ability to make our lives better. A 2013 Mayo Clinic study found that 7 out of 10 Americans take prescription drugs on a regular basis. However, without the knowledge of how to safely discard expired and unused medications, these drugs can contaminate the environment and pose a threat to humans. Options for disposal must be communicated and readily available to healthcare providers and household consumers.
Rich Thompson is Managing Partner at TEC, LLC providing expert consulting advice to complex environmental compliance issues. He can be reached at email@example.com. To view Rich's Linked-in profile, click Here.
*Image courtesy of the California Product Stewardship Council (CPSC) (www.calpsc.org)
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