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Hazardous Waste Compliance In Health Care Settings
Prescription medications are an important part of maintaining health and improving quality of life for millions of Americans. However, not all medications dispensed to patients are consumed. Appropriately prescribed medications may go unused for a variety of reasons, including: the patient’s medical condition has been resolved before the medication is completely consumed; the patient’s medication supply is not used completely prior to its expiration date; the medication causes an adverse effect and the patient must stop therapy; the medication is ineffective and the physician switches the patient to a different medication; the patient fails to adhere to the prescribed therapy; or the patient dies and leaves behind a supply of medication.1
The topic of pharmaceutical waste has gained recognition in recent years as an increasingly urgent public health and environmental protection issue. The Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Centers for Medicare and Medicaid Services (CMS), and Food and Drug Administration (FDA) have all taken steps to address the problem of pharmaceutical waste in both the community and institutional settings. However, these efforts have not been coordinated and have sometimes conflicted with one another.1 This article provides an update on key legislation and regulations that have emerged as important issues for health care entities to address.1
RESEARCH LEADS TO CHANGES
The generation of prescription drug waste in hospitals, long-term-care facilities (LTCFs), and retail pharmacy practice has a long history of discussion and research. LTCFs offer an example that led to state, regional, and national changes.
Medication waste in LTCFs can include any medication that has been dispensed and paid for, but not consumed, by a particular patient.2 In 1987, Kidder reviewed 13 studies that addressed the magnitude of drug waste in LTCFs.3 In 1992, Shinavier and Kirk assessed medication waste in selected central Texas LTCFs under the same corporate ownership; of 999 prescriptions analyzed, a quantity of 77 (7.7%) was wasted, accounting for $780 (3.7%) of the total prescription ingredient cost of $20,889.4
Paone et al. conducted a two-year (1992–1994) prospective study that evaluated the scope and costs of medication waste in Massachusetts LTCFs.5 They determined the quantity of medications wasted, expense of medications wasted, and reasons for medication waste for 2,360 residents of 17 LTCFs using a data-collection form that was completed by nurses at each facility and collected by consultant pharmacists at monthly intervals. Collectively, 198 months of data representing 852,300 patient days were obtained. Using ingredient costs, the expense of medication waste was estimated at $0.15 per patient day ($4.50 per patient per month); allowing for an average of 8% inflation in medication expenses, the average cost of medication waste based on Kidder’s review would be $6.74 (in 1993 dollars). Wasted medication at the 17 LTCFs in Paone et al. accounted for an estimated 6.7% of the cost of the medications dispensed (range, 1.77% to 11.39%). More than 90% of medication waste resulted from patient deaths; discontinued medications; medication changes; and patient hospitalizations, transfers, or discharges.
Cumulative LTCF research resulted in administrative and/or regulatory actions by CMS, the American Medical Association, the American Medical Directors Association, and the American Society of Consultant Pharmacists in addition to state and federal drug-control agencies. Such actions included improved drug-disposal options, return-for-reuse policies, credits for returns, and other drug-management options and inter-agency coordination that had previously been prohibited or discouraged by law or regulation.
FEDERAL LAW AND REGULATION
In October 1976, amid growing concern over the volume and impact of waste being generated in the United States, Congress passed the Resource Conservation and Recovery Act (RCRA), which applied to solid waste and hazardous waste.
The first RCRA regulation, Hazardous Waste and Consolidated Permit, published in the Federal Register in May 1980, defined a “cradle to grave” approach to handling hazardous waste.6 Congress amended and strengthened the RCRA with the Hazardous and Solid Waste Amendments of 1984, the Federal Facility Compliance Act of 1992, and the Land Disposal Program Flexibility Act of 1996. Each of these acts further defined the scope of the RCRA and strengthened the EPA’s enforcement penalties.
The EPA soon began to investigate pharmaceutical waste accumulation in U.S. water sources and its impact. In 1999, the agency published its findings in Environmental Health Perspectives and coined the term pharmaceutical and personal care products (PPCP), which “refers, in general, to any product used by individuals for personal health or cosmetic reasons or used by agribusiness to enhance growth or health of livestock. PPCPs comprise a diverse collection of thousands of chemical substances, including prescription and over-the-counter therapeutic drugs, veterinary drugs, fragrances, lotions, and cosmetics.” 7
Other groups have also contributed investigative efforts. Survey results from 1999 and 2000 under the Toxic Substances Hydrology Program of the U.S. Geological Survey (USGS) found that 80% of U.S. streams contained one or more pharmaceuticals.8 And since the early 2000s, the U.S. Fish and Wildlife Service and the USGS have been evaluating environmental activities that are potentially responsible for a type of intersex fish: males with oocytes in their testes and/or vitellogenin in their blood. In 2009, the USGS reported widespread findings of intersex fish (mostly smallmouth and largemouth bass) throughout the United States.9 Although no specific chemical or environmental stressor has been identified as the causative factor, the impact of endocrine-disrupting chemicals tops the list of suspects.
With an estimate of more than 70,000 chemicals used regularly worldwide, the EPA is working with the U.S. Labor Department’s Occupational Safety and Health Administration (OSHA), the DEA, and the National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention, as well as private organizations such as The Joint Commission, to identify, address, and enforce safe handling procedures for wastes. However, interpreting and complying with federal regulations can be complicated by individual states’ regulations. This growing body of regulation is having a significant operational and fiscal impact on health care providers’ handling of pharmaceutical waste in their facilities.
RESOURCE CONSERVATION AND RECOVERY ACT
Health care organizations are being influenced in multiple ways to improve their waste programs. The Joint Commission has specifically included hazardous waste management in two of its standards, Medication Management and Environment of Care. Medical waste vendors have become increasingly vigilant about refusing to accept mixed streams of waste: Hazardous waste cannot be discarded with medical waste in red bags.
Under the RCRA, a solid waste is hazardous waste if it exhibits one of four characteristics—ignitability, corrosivity, toxicity, or reactivity—or if it is specifically named on one of the four EPA lists of hazardous waste, P, U, F, and K, in 40 CFR §261.2, subpart D. Drugs listed under P and U include specific unused chemicals; drugs under U are toxic, while those under P are considered acutely toxic. The most common U-list drugs are chemotherapeutic agents (
In 2012, a report by the EPA Office of Inspector General identified more than 100 drugs that met the RCRA definition for hazardous waste but may not have been reviewed by the EPA. The report highlighted an OSHA list that identified 61 pharmaceuticals as hazardous waste and a 2010 NIOSH list of 157 drugs (
Accurate identification of hazardous waste is essential for a health care facility. Facilities that generate more than 220 pounds of hazardous waste or more than 2.2 pounds of P-listed waste a month are considered large-quantity generators. Large-quantity generators must receive an EPA identification number and notify the EPA of their waste-generation activities.12 Many states include the NIOSH and OSHA lists of drugs in their hazardous waste management requirements. Non-RCRA pharmaceutical waste and items not included on any current lists continue to raise environmental concerns and are managed by some states through their own regulations. In early 2014, the EPA announced that it was developing a new proposal to establish standards for the management and disposal of pharmaceutical waste.
The management of controlled substances as waste falls under the DEA’s jurisdiction. The volume of controlled substance waste collected during national “take-back” campaigns (meant to prevent the diversion of controlled substances) helped prompt the DEA to issue a final rule in accordance with the Secure and Responsible Drug Disposal Act of 2010. DEA’s Disposal of Controlled Substances final rule allows certain DEA registrants to modify their registrations to become authorized collectors.13 Collectors are responsible for ensuring that collected controlled substances are rendered “nonretrievable” and that destruction is recorded as required by 21 CFR, part 1304. A letter from the DEA on October 17, 2014, reminded practitioners that drugs administered to patients remain under the control of the practitioner until those drugs are fully exhausted.14 Any remaining or unused drug must be recorded, stored, and destroyed in accordance with 21 CFR § 1304.22(c) and should never be discarded in an institutional collection receptacle.
COMPLIANCE AND PENALTIES
Health care organizations often seek help from vendors to manage this complex, fluid administrative burden. Vendors such as Stericycle, Waste Management, and Clean Harbor offer an array of services, including online databases, onsite reviews and audits, and blogs to assist their clients in managing their waste streams at economical rates.
The cost of removal depends on the type of waste. It is incumbent on facilities to ensure that their policies and procedures facilitate the correct separation of waste. For example, products such as Rx Destroyer and Cactus Smart Sink are available to help manage controlled substances and nonhazardous waste for health care facilities. These products render the medication nonrecoverable and nonretrievable to meet DEA standards. In some states, the end product of these systems may be discarded as solid waste.
The quagmire of state and federal regulations is difficult for health care organizations to navigate, but the consequences for noncompliance can be severe. Congress empowered the EPA to level significant fines against corporations and those responsible for compliance. Section 3008(a) of the RCRA gives the EPA authority to levy administrative, civil, or criminal penalties. Fines may reach up to $37,500 a day per occurrence.15 Six of the seven potential criminal offenses carry penalties of up to $50,000 a day per occurrence and up to five years in jail.16
The EPA has 10 regional offices responsible for oversight in specific states, tribal areas, and territories. To help users obtain state-specific information, the EPA website offers a table of state-specific links for hazardous waste regulations.17 State regulations may permit additional significant fines. The EPA’s Enforcement and Compliance History Online dashboard allows users to analyze state activities and enforcement pertaining to hazardous waste. A review of the dashboard shows California and Missouri, for instance, are actively enforcing their regulations. In 2013, Walmart pleaded guilty to hazardous waste violations in both of those states and with the EPA. The fines totaled $82 million, with the EPA receiving $7.6 million, California $60 million, and Missouri $14 million.18
LTCFs illustrate how broad practice changes were driven by health care professionals in response to waste issues and interagency contradictions that affected patient care. A similar effort by hospitals, combined with quality-of-care initiatives by The Joint Commission and other accreditation organizations, has also influenced these institutions’ drug waste and disposal practices.
In recent years, the initiative has shifted to the rule of law in addressing waste problems, led by the EPA under legislation passed by Congress. Health care organizations face increased financial risks as a result of steep penalties and other potential sanctions if they do not effectively manage drug waste to protect the environment. This environmentally driven strategy resonated with Congress and other advocacy groups, breaking a legal and regulatory logjam that had existed for decades.
Today, health care entities must heed a variety of federal and state agencies in handling and discarding hazardous waste from prescription drugs or personal care products. The EPA and other agencies make resources available to health care workers as well as consumers to assist in proper drug disposal. Health care professionals, through their organizational leadership and/or P&T committees, and health care organizations, through their risk management committees, must ensure that these entities are using environmentally sound or prescribed methods for disposing of hazardous waste. Failure to do so can result in significant financial and legal actions against those who don’t follow the rules for prescription drug or personal care waste.
Examples and Definitions of Pharmaceutical Waste From Federal Agencies
aFull list available at
bFull list available at
cFull list available at
dNitroglycerin patches, pills, tablets, capsules, creams, and inhalers exempted federally
- American Society of Consultant Pharmacists. Pharmaceutical waste practice resource center. Available at: https://www.ascp.com/articles/pharmaceutical-waste-practice-resource-center. Accessed December 4, 2014.
- Mathieson DR, Rawlings JL. Evaluation of a unit dose system in nursing homes as implemented by a community pharmacy. Am J Hosp Pharm 1971;28;(4):254–259.
- Kidder SW. Review of drug waste in long-term care facilities 1976–1983. J Geriatr Drug Ther 1987;1;(3):35–47.
- Shinavier BD, Kirk KW. Medication waste in selected central Texas long-term care facilities under the same corporate ownership. Consult Pharm 1992;7:415–422.
- Paone RP, Vogenberg FR, Caporello E, et al. Medication destruction and waste measurement and management in long-term care facilities. Consult Pharm 1996;11:32–40.
- Environmental Protection Agency. Consolidated permit regulations: RCRA hazardous waste, SDWA underground injection control; CAA prevention of significant deterioration; CWA national pollutant discharge elimination system; and section 404 dredge or fill programs. Fed Regist 1979;44;(116):34244–34344.Available at: http://www3.epa.gov/epawaste/hazard/tsd/permit/tsd-regs/frns/44fr34244.pdf. Accessed November 13, 2014.
- Environmental Protection Agency. Pharmaceuticals and personal care products (PPCPs). Frequent questions. October 282010;Available at: https://www.epa.gov/research. Accessed November 20, 2014.
- U.S. Geological Survey. Pharmaceuticals, hormones, and other organic waste water contaminants in U.S. streams. June 2002;Available at: https://toxics.usgs.gov/pubs/FS-027-02/. Accessed November 13, 2014.
- U.S. Geological Survey. Widespread occurrence of intersex bass found in U.S. rivers. September 2009;Available at: https://www.usgs.gov/centers/cerc. Accessed November 23, 2014.
- Environmental Protection Agency. RCRA online. October 192012;Available at: https://www.epa.gov/wastes/infore-sources/online/index.htm. Accessed November 13, 2014.
- Environmental Protection Agency, Office of Inspector General. EPA inaction in identifying hazardous waste pharmaceuticals may result in unsafe disposal. May 252012;Available at: https://www.epa.gov/office-inspector-general. Accessed November 20, 2014.
- Environmental Protection Agency. Hazardous waste generators. February 62014;Available at: https://www.epa.gov/hw. Accessed November 20, 2014.
- Drug Enforcement Administration, Department of Justice. Disposal of controlled substances. Final rule. Fed Regist 2014;79;(174):53520–53570.
- Rannazzisi J, Deputy Assistant Administrator, Drug Enforcement Administration. Letter to practitioners. October 172014;Available at: http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf. Accessed December 4, 2014.
- Environmental Protection Agency. RCRA inspections & enforcement. Available at: http://www3.epa.gov/region9/waste/enforcement/. Accessed November 20, 2014.
- Environmental Protection Agency. Enforcement of hazardous waste regulations. Chapter III: managing hazardous waste—RCRA subtitle C. Available at: https://www3.epa.gov/epawaste/inforesources/pubs/orientat/rom310.pdf. Accessed November 23, 2014.
- Environmental Protection Agency. Where you live. State-specific universal waste regulations. November 142014;Available at: https://www.epa.gov/hw. Accessed November 23, 2014.
- Clifford S. Walmart is fined $82 million over mishandling of hazardous waste. The New York Times May 282013;Available at: https://www.nytimes.com/2013/05/29/business/wal-mart-is-fined-82-million-over-mishandling-of-hazardous-wastes.html?_r=0. Accessed November 20, 2014.
- Environmental Protection Agency. Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof. July 12014;Available at: http://www.gpo.gov/fdsys/pkg/CFR-2012-title40-vol27/xml/CFR-2012-title40-vol27-sec261-33.xml. Accessed November 13, 2014.
- National Institute for Occupational Safety and Health. NIOSH list of anti-neoplastic and other hazardous drugs in healthcare settings 2010. September 2010;Available at: https://www.cdc.gov/niosh/docs/2010-167/pdfs/2010-167.pdf. Accessed November 13, 2014.
- Occupational Safety and Health Administration. Hazardous drugs. https://www.osha.gov/SLTC/hazardousdrugs/index.html. Accessed November 13, 2014.
- Environmental Protection Agency. Characteristic wastes. May 82013;Available at: http://www3.epa.gov/epawaste/hazard/wastetypes/characteristic.htm. Accessed November 13, 2014.