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The study tested for 95 OWCs, including pharmaceuticals. Most (82) of the OWCs were found in at least one stream sample, and 13% of the streams contained more than 20 OWCs. Many of the OWCs were pharmaceuticals from common prescription and nonprescription products. Similarly, in a U.S. Geological Survey study of Minnesota wastewater, surface, ground, and drinking waters, OWCs were found in 90% of the samples.4 The highest levels detected were from nonprescription drugs, antibiotics, and prescription drugs, respectively.3,4 Although pharmaceutical contaminants have not been found at therapeutic levels, they have potential adverse consequences, including water quality degradation, endocrine disruption (which translates into problems with physical, mental, and sexual development), antibiotic resistance, and negative public perception regarding water cleanliness. The environmental and physical consequences of improper pharmaceutical waste management are serious. Human male sperm counts have dropped 50% on average since 1939, and there have been increases in infertility, genital defects, cancers caused by hormones (breast and prostate), and neurological disorders in children.5 Endocrine disrupters found in U.S. waterways could have effects on future generations; they interfere with normal functioning of the endocrine system (thyroid, adrenals, ovaries, and testicles), mimic hormones, and affect reproduction, development, and behavior.6 In addition, antibiotic resistance is on the rise; ampicillin-resistant bacteria were found in every U.S. river tested in 1999.6 In a 2000 study, all samples taken from the Ohio River contained Escherichia coli with some resistance to penicillin, tetracycline, and vancomycin.7 Samples containing the highest levels of antibiotics also contained bacteria with the greatest resistance. The assistance of William W. Churchill, M.S., R.Ph., Executive Director of Pharmacy Services, Brigham and Women’s Hospital in Boston, Massachusetts, and Firouzan ‘Fred’ Massoomi, Pharm.D., FASHP, Pharmacy Operations Coordinator, Department of Pharmacy Services, Nebraska Methodist Hospital, Omaha, Nebraska, who served as content experts and reviewers of this document, is gratefully acknowledged. 3 ■ M A N A G I N G P H A R M A C E U T I C A L WA S T E What can we do to prevent these products from entering our waterways and environment? Pharmaceutical waste from clinics, hospitals, and health systems usually is thrown into the trash or dumped into a sink or toilet and thereby placed in the sewer waste stream.8,9 If these drugs are not biodegraded or eliminated during sewage treatment, they eventually reach drinking water. In fact, most sewage and water treatment facilities do not take pharmaceutical contaminants into consideration, so these wastes are left untreated to enter our surface, ground, and drinking water.10 Pharmaceutical waste can also contaminate the environment through improper incineration or landfill placement. By educating ourselves about this issue and the relevant regulations, pharmacists can help reduce the amount of pharmaceutical waste and potential OWCs entering the environment from hospitals and other health care organizations. Attempts to regulate the disposal of health care waste are not new. The federal Resource Conservation and Recovery Act11 (RCRA) has been in place since 1976. Enforced by EPA, it regulates and tracks the disposal of solid waste, setting forth strict rules for facilities that generate, transport, store, and dispose of hazardous waste. RCRA defines hazardous waste as chemicals or formulations so detrimental to the environment that they must be separated for special disposal and cannot be introduced into sewers or placed in landfills.6 Approximately 5% of all pharmaceutical agents are considered “RCRA hazardous.”6 However, many more pharmaceutical agents have RCRA-hazardous characteristics. One reason for this is due to the fact that the RCRA hazardous pharmaceutical agent list (Appendix A) has not been updated as more agents have come to market. Recently, EPA and some states have begun stricter enforcement of RCRA and have levied significant corporate and personal fines for noncompliance and negligence. There is no statute of limitations on personal liability, and violations can involve prison sentences.8 Which waste is hazardous? An environmentally sound approach to the complex issue of pharmaceutical waste management has been hampered by the distinction between medical waste (biohazardous, infectious waste 4 ■ placed in the “red bag” waste stream) and hazardous waste (RCRA waste stream).12 Clearly defining pharmaceutical waste streams is the first step toward effective management. Nonhazardous pharmaceutical waste. Some have considered that once the manufacturer’s packaging is opened, any unused or partially used product is nonhazardous pharmaceutical waste.13 Examples include unused or partially used vials, ampuls, or bottles; unused or partially used i.v. bags and tubing containing drugs; discontinued medications that are not suitable for reuse; and tablets and capsules that have been dropped or spit out by a patient. Outdated drugs being discarded may be also be included in this category.6 Discontinued medications that patients have brought from home and left are also considered pharmaceutical waste that should be disposed of in accordance with EPA, state, and Drug Enforcement Administration regulations.6 The impact of these types of pharmaceutical waste on public health and the environment is unclear. When permitted by both state regulations and RCRA, this waste can be solidified and placed in a landfill.14 However, a better management practice is to have nonhazardous pharmaceutical waste processed by a medical waste incinerator or a properly permitted municipal waste incinerator. An exception to this is i.v. solutions without drug additives; these can be placed in sewer systems. Disposal of devices used to administer nonhazardous medications, such as inhalers that use propellants, is another consideration. In addition to RCRA requirements, some states have regulations specific to the device and propellant used to deliver drugs; these must be considered in establishing waste streams. In Nebraska, for example, hospitals are required to either segregate inhaler devices from the normal waste stream or puncture and triple rinse the container before disposal in the nonhazardous waste stream. Hazardous pharmaceutical waste. As a starting point for determining which pharmaceutical waste is hazardous, RCRA definitions must be considered. Drugs deemed hazardous by federal EPA regulations are categorized as “P list,” “U list,” or M A N A G I N G P H A R M A C E U T I C A L WA S T E “chemical (D-list) characteristic.”15 P-listed items are considered acutely toxic (e.g., epinephrine, phentermine, physostigmine, nicotine, nitroglycerin, and warfarin >3%); both the drug and the container that held the drug are considered hazardous and must be disposed of in an RCRA-approved container. U-listed items are considered toxic (e.g., phenol, lindane, choral hydrate, and selected antineoplastic waste). Items on the chemical characteristic list are pharmaceuticals that cause wastes with any of the following characteristics: ignitability, corrosivity, reactivity, and toxicity. Ignitability applies to an aqueous solution that contains 24% alcohol or more by volume and has a flash point less than 140 degrees F (e.g., rubbing alcohol, topical preps, benzoin, paclitaxel). Corrosivity applies to an aqueous solution having a pH of 2 or lower (acidic) or of 12.5 or higher (basic) (e.g., chemicals used for compounding, such as glacial acetic acid and sodium hydroxide). Reactivity applies to waste with properties that are normally unstable and readily undergo violent changes without detonating; that react violently with water; or that when mixed with water generate toxic gases, vapors, or fumes in a quantity sufficient to cause human and environmental harm (e.g., certain nitroglycerin formulations, although some may be considered exempt by individual states). Toxicity applies primarily to heavy metals that may be above maximum concentration or regulatory levels (e.g., barium, cadmium, selenium, thimerosal). It is important to note that the diluent or preservative, rather than the active ingredient, in a commercial or compounded drug may be the culprit in regard to RCRA regulations. Determining the appropriate waste stream. As new drugs are added to formularies, it is the responsibility of each hospital to determine the appropriate waste stream for each new item. Clearly, not all pharmaceutical waste is considered hazardous according to RCRA definitions. However, RCRA does not adequately regulate a number of hazardous drugs. Even if not classified as hazardous, some pharmaceutical wastes are dangerous to the environment. For example, if a chemotherapy i.v. bag has been hung but not completely used, and if it can be separated from the patient-exposed sharp without exposure of the employee, it should 5 ■ be removed and disposed of as RCRA hazardous waste. If chemotherapy residue cannot be removed safely from the i.v. bag, it should be disposed of in a trace chemotherapy container as infectious chemotherapeutic waste.14 Pharmaceutical waste is considered dangerous if it contains any of the following: ■ More than one P- or U-listed drug, ■ Chemotherapy agents, ■ Drugs meeting National Institute for Occupational Safety and Health (NIOSH) or Occupational Safety and Health Administration (OSHA) criteria, ■ Drugs with LD50 (lethal dose in 50% of test animals) less than or equal to 50 mg/kg, ■ Endocrine disrupters, ■ Immunosuppressants, and ■ Vitamins and mineral preparations with potential toxicity due to chromium, selenium, or cadmium. When hazardous drug waste is infectious, a double hazard exists. Some states may require a separate waste stream for infectious hazardous pharmaceutical waste. With the extra time and caution required, this may be one of the most expensive waste streams to manage. This waste must be separated for proper handling by a RCRA-permitted incinerator. Generator status and waste streams Before implementing a formal waste stream program, a facility must determine its “generator status.” RCRA defines a facility’s generator status and the associated regulations according to the amount and type of waste generated over time. A large quantity generator (LQG) generates more than 1000 kg/month of hazardous waste or more than 1 kg/month of P-listed waste.6,16 A small quantity generator (SQG) generates less than 1000 kg/month but more than 100 kg/month of hazardous waste, and no more than 1 kg/month of P-listed waste, and accumulates less than 6000 kg of hazardous waste at any time.16 A conditionally exempt small quantity generator (CESQG) generates no more than 100 kg/month of hazardous M A N A G I N G P H A R M A C E U T I C A L WA S T E waste and no more than 1 kg/month of P-listed waste. Whether or not an organization notifies EPA of its waste generation depends on the amount of hazardous waste it generates. LQGs and SQGs must have an EPA identification number. Knowing the amount and type of waste generated, the facility can determine what improvements can be made and whether new waste streams are warranted. a variety of disposal methods.19 It was apparent that the patients had not been properly educated about pharmaceutical waste disposal. Pharmacies had specific policies for expired or undispensed pharmaceuticals but lacked uniform guidelines on disposal. Only 5% of the 100 pharmacies surveyed had consistent recommendations for their patients on drug disposal. The main waste streams that hospital pharmacists use to dispose of solid pharmaceutical waste are (1) municipal incineration of pharmaceutical packaging, empty/partial vials, empty/partial glass and plastic bottles, ointments, and so forth, and (2) incineration of chemotherapy sharps and chemotherapy soft waste in a medical waste incinerator. Landfills are the ultimate destination of both of these waste streams. Pharmacists’ lack of awareness or understanding of the cumulative effect of improperly disposed pharmaceutical waste on human health and the environment is an important challenge to be overcome.17 Educating health care professionals about the issue, the relevant state and federal regulations, and the consequences of noncompliance will go a long way toward promoting more effective pharmaceutical waste management. Each health care institution will need to make changes in its processes for drug dispensing, administration, wastage, return, and disposal. RCRA regulates how these waste streams should be used, and inappropriate use can have harmful outcomes. Compliance with the regulations is a best management practice for hazardous pharmaceutical waste. For example, the regulations state that RCRA waste must be incinerated by a facility approved by EPA for managing this waste; a company that normally incinerates or autoclaves chemotherapy waste may not be set up to render RCRA waste EPA-safe. Compliance challenges Fully complying with RCRA regulations will present both operational and financial challenges for institutions. Operational challenges. Processes that require manual sorting of pharmaceutical waste are time consuming, potentially dangerous to the sorter, and labor intensive (for data entry and database management as well as the actual sorting), and they may not be in compliance with regulations. Direct care providers’ general lack of knowledge or misunderstanding of state and federal regulations is a potential contributor to noncompliance.17 Pharmacies need uniform guidelines for the safe disposal of expired medications, and pharmacists should include this information in routine patient education.18 A survey of consumers and pharmacies about medication disposal habits revealed 6 ■ Financial challenges. Complying with RCRA regulations may place an additional financial burden on health systems. For example, newer, more toxic pharmaceuticals may require more intensive waste management. Changes in prescribing practices may place additional financial burden on an institution due to additional wastes generated from these changes. Also, institutions may face fines for noncompliance. A facility that is not in compliance with regulations for managing its listed waste could be fined $32,500 per day. In addition, failure to institute guidelines for proper segregation of waste and to educate staff about them can be expensive, because processing costs vary significantly by type of waste. Medical waste (red sharps containers) costs 18 cents to 35 cents per pound; chemotherapy waste (yellow containers), $4 per pound; RCRA hazardous waste, $2 to $4 per pound; and infectious hazardous waste, $4 to $8 per pound. Potential solutions New waste streams. For proper handling of hazardous pharmaceutical waste, health care organizations most likely will need to create additional waste streams.17 All facilities must review their current policies and procedures to ensure compli- M A N A G I N G P H A R M A C E U T I C A L WA S T E ance with state and federal pharmaceutical waste management and environmental regulations.20 Computerization, automation, and bar-code scanning technology may be useful in the development of safe and effective pharmaceutical waste management streams. Smith8 has used diagrams to illustrate current and potential waste streams. New pharmaceutical waste management streams would include P-, U-, and D-listed wastes; bulk and residue chemotherapy; chemotherapy spill clean-up materials; toxic hazardous waste; ignitable hazardous waste; and nonhazardous pharmaceutical waste. In addition, infectious hazardous and compressed gas aerosols should be considered as separate waste streams. Ignitable hazardous waste should be segregated, properly labeled, stored, transported, and disposed of by a specialized broker and a federally permitted RCRA incineration firm. Waste management team. An interdepartmental, multidisciplinary team could be formed to be accountable for maintaining compliance with RCRA and state regulations. By evaluating current practices for compliance and potential harm, the team could identify gaps in pharmaceutical waste stream management and work quickly to resolve them. The team could serve as the facility’s liaison with the regional EPA office and possibly with the state environmental or sanitary office and outside consultants. Online tools. Waste management companies have made resources available on the Internet to assist pharmacies in cost-effective and compliant segregation of waste streams. However, more comprehensive tools must be developed to meet the needs of health care facilities across the nation. Pharmaceuticals requiring special disposal can be identified through online databases that enable searches by NDC number and product or generic name.8 Also available online are recommendations citing federal regulations and recommended waste streams, state regulation alerts where the state regulation is more stringent than the federal, and risk management alerts based on professional knowledge and experience. 7 ■ Inventory management. To help control the amount of hazardous pharmaceutical waste generated, minimum inventory levels should be maintained.16,21 Health care facilities should rotate inventory and use the oldest stock first, minimize amounts of unwanted or expired medications22 (original and repacked containers), use multidose vials, prepare patient-specific oral syringes instead of prepacks, centralize disposal of physicians’ samples, and avoid unnecessary prescriptions (especially antibiotics). Items that do not require special handling can go into the municipal trash or sewer system (e.g., unit dose packaging for non-Plisted items, empty medication vials that contained non-P-listed items, partially used nonhazardous items). Empty containers of nonhazardous items can also go in the trash. Reverse distribution. Pharmacies can also minimize the amount of pharmaceutical waste by using reverse distribution, in which unused but potentially usable pharmaceuticals are returned to the manufacturer for credit.15 To facilitate this process, EPA has determined that health care facilities do not have to consider returned pharmaceuticals as “discarded materials” and therefore do not have to treat them as hazardous waste. The burden for proper disposal thus shifts to the reverse distributor, which must comply with Return Industry Association (RIA) standards.15 Pharmaceutical waste processed through reverse distribution does not count toward a facility’s hazardous waste generator status. State and county activity. Many states and some counties have specific regulations that are much more stringent than the federal RCRA regulations. Facilities should contact their state EPA or regulatory body to learn what requirements apply. EPA initiatives. EPA has at least four current pharmaceutical waste initiatives. Two will specifically address pharmaceuticals that cannot be disposed of in sewers. Implementing a plan Organizations that implement a comprehensive pharmaceutical waste management plan can realize several benefits. For example, the Joint M A N A G I N G P H A R M A C E U T I C A L WA S T E Commission Environment of Care Performance Improvement Initiative23 reduces a facility’s EPA liability and risk exposure to a minimum, protects employees and patients, demonstrates responsible care in dealing with hazardous substances and hazardous wastes, and brings the organization into compliance with several Joint Commission standards.24 Standard EC.3.10 states, “The organization manages its hazardous materials and waste risk” and “organizations must identify materials they use that need special handling and implement processes to minimize the risks of their unsafe use and improper disposal.” Standard EC.9.10 states, “The organization monitors conditions in the environment of care” and “establish and implement processes for reporting hazardous materials and waste spills, exposures, and other related incidents.” Standard EC.9.20 states, “The organization analyzes identified environment of care issues and develops recommendations for resolving them.” Standard EC.9.30 states, “The organization improves the environment of care.” Key points for implementation are as follows: 1. Hazardous waste storage accumulation sites should be in the same locked area that houses mercury, xylene, formaldehyde, and other laboratory chemicals. 2. The maximum storage time should be 90 or 180 days, as determined by the facility’s waste generator status. 3. Institutions should either contract with a hazardous waste broker or develop internal expertise in manifest preparation and land ban preparation (preparing those agents that cannot be disposed of in the landfill). The hazardous waste manifest is a form that has both EPA and Department of Transportation (DOT) components. It is used to document tracking of hazardous waste from the generator through the transporter to the final disposer. This manifest also provides emergency response information for use if a spill occurs in transit. Proper completion of a hazardous waste manifest requires knowledge of the contents of each container of waste, as well as specific DOT training to ensure that proper shipping names are used. There are two approaches to manifesting 8 ■ hazardous waste: profiling and lab packing. In most states, hospitals can provide their vendor with a list of all P, U, and chemical (D-list) waste codes being generated and the vendor can precertify the list and create a waste profile. All possible waste codes will be listed on the manifest for a particular waste stream. This is the simpler, more time-efficient approach. Otherwise, the nursing and pharmacy staffs need to document what is discarded in each container to be able to include all the appropriate waste codes on the manifest; this is lab packing. Hazard classes, such as ignitable and toxic, may be mixed when waste profiling is used, but they cannot be mixed in lab packs. Mixing of hazard classes is dependent on the capabilities of your vendor. A Land Disposal Restrictions form must accompany the manifest. This document indicates what wastes are being disposed of and how they will be treated prior to application to the land; it also ensures compliance with RCRA. The hazardous waste vendor can prepare this. For all of these services, facilities have the option of contracting with a federally permitted RCRA hazardous waste incineration facility or TDSF (treatment, storage, and disposal facility). 4. Nonhazardous drugs should be segregated into non-red and non-yellow containers that are labeled “Nonhazardous Pharmaceutical Waste—Incinerate Only” and are disposed of at a regular medical waste or municipal incinerator that is permitted to accept nonhazardous pharmaceutical waste. Nonhazardous drugs and municipal solid waste that can be disposed of in sewers should not be placed in any container that requires special incineration. 5. For the disposal of controlled substances, the practice of two health care professionals witnessing the waste should continue unchanged. (Needles and empty syringes used to administer controlled substances are discarded in a sharps container.) Monitoring compliance Some hospitals have posted a quick reference guide near disposal areas to help staff comply with pharmaceutical waste disposal practices. Logging each item placed in the hazardous waste container M A N A G I N G P H A R M A C E U T I C A L WA S T E also helps ensure compliance with EPA and other federal or state requirements; the log should include the date, name of the product, estimated amount deposited in the container, and the initials or name of the person disposing of the waste and person hauling it away. To get started and keep compliance on the right path, the facility might choose to use a hazardous waste broker. Key points for monitoring compliance are as follows: 1. Be prepared, in case EPA or the state agency makes an unannounced visit. 2. Promote waste minimization whenever possible. 3. Perform periodic random audits to determine level of compliance. 4. Check and verify staff knowledge of program details. 5. Check waste containers to see if drugs are discarded appropriately. 6. Track quantities of waste generated by type and location. 7. Track costs. 8. Document the entire process, including all policies and procedures, training and competency assessment efforts, and the results of quality assurance audits, for use during state and federal audits. For full compliance with a pharmaceutical waste management program, it is vitally important to ensure that all medications are disposed of in the proper waste stream. Key points include the following: 1. Flush nonhazardous liquid pharmaceuticals into the sewer system, or, as best management, send them to a medical waste incinerator or appropriately permitted municipal waste incinerator. EPA is considering an initiative that will prevent the placement of certain drugs in sewers. 2. Intravenous solutions: Leave the tubing attached to the i.v. bag and clamp the tubing. 3. Free liquids: Avoid squirting free liquids into hazardous waste containers. 4. If P-listed waste or infectious hazardous waste is placed in the wrong container, then the whole container becomes P or dual waste. 9 ■ 5. Compressed-container medications (aerosols) must be separated for safety. 6. Infectious hazardous waste must be separated from all other pharmaceutical waste, since it is the most expensive type of waste to dispose of. 7. Hazardous waste containers must be closed at all times except when waste is being added. Enforcement EPA is in the midst of an initiative to enforce RCRA with regard to pharmaceuticals in the same manner that has always been used for chemical plants. In the past, health care institutions and practitioners were given a “pass” on enforcing rigorous disposal practices. That is no longer the case. In addition, states such as California, Washington, Minnesota, and Florida have become more active, and some states have regulations that are more stringent than those of EPA.25 States are allowed to enact regulations that are more stringent than federal regulations. It is the responsibility of each facility to monitor waste stream management compliance. Facilities should be aware that the Joint Commission, Centers for Medicare and Medicaid Services, state boards of pharmacy, and the Drug Enforcement Administration can alert EPA to violations. As problems are identified, facilities should perform a gap analysis to understand and formally address each issue. Conclusion Regulatory involvement and environmental concerns are causing pharmacists to take a closer look at how their organizations are managing pharmaceutical waste. Each organization should evaluate its current waste management practices in comparison with federal EPA and state regulatory guidelines. Organizations must then develop a comprehensive plan for full compliance through segregation of waste into the appropriate waste streams. New interpretations or changes in existing regulations may arise as government surveyors and health care providers and administrators exchange information. Pharmacists can play a significant role in reducing medication waste and solving the pharmaceutical waste disposal problem. M A N A G I N G P H A R M A C E U T I C A L WA S T E References 1. Daughton CG. Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. II. Drug disposal, waste reduction, and future directions. Environ Health Perspect. 2003;111(5):775–85. 2. Daughton C. Introduction—Environmental stewardship of pharmaceuticals: the green pharmacy. U.S. Environmental Protection Agency, National Exposure Research Laboratory, Environmental Sciences. web.archive.org/web/20030627025308/www.epa.gov/esd/ chemistry/ppcp/greenpharmacy-intro.htm (accessed 2007 July 14). 13. Pai MP, Graci DM, Bertino JS. Waste generation of drug product sample versus prescriptions obtained through pharmacy dispensing. Pharmacotherapy. 2000;20(5):593–5. 14. Pharmaceutical waste management issues and solutions. Vestara. http://www.vestara.com/images/Issues_Solutions.pdf (accessed 2007 July 3). 15. Pharmaceutical waste in health care facilities. Hospitals for a Healthy Environment. h2e-online.org/hazmat/pharma.html (accessed 2007 September 5). 3. Kolpin DW, Furlong ET, Meyer MY et al. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999–2000: a national reconnaissance. Environ Sci Technol. 2002;36(6):1202–11. http://pubs.acs.org/cgi-bin/ jtextd?esthag/36/6/html/es011055j.html. 4. Lee KE, Barber LB, Furlong ET et al. 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