Management Practices and Control Technologies for Unused Pharmaceuticals at Health Care Facilities Final, Document Control Number 06570

Transcription

1 MEMORANDUM TO: FROM: Meghan Hessenaeur, U.S. EPA Samantha Lewis, U.S. EPA Jill Lucy, ERG Kathleen Wu, ERG DATE: SUBJECT: Management Practices and Control Technologies for Unused Pharmaceuticals at Health Care Facilities Final, Document Control Number The purpose of this memorandum is to report EPA s findings on the management practices and control technologies for unused pharmaceuticals observed at health care facilities. EPA collected data on unused pharmaceuticals management and disposal practices during site visits conducted from 2007 through 2009, summarized in Table A-1 at the end of this memorandum. Additional practices were identified during outreach meetings with trade associations and industry groups and through literature review. Health care facilities use various management practices to achieve the following: Minimize the generation of unused pharmaceuticals, Manage unused pharmaceuticals, and Dispose of unused pharmaceuticals. This memorandum summarizes management and disposal practices EPA identified which avoid disposal down the drain. 1. UNUSED PHARMACEUTICALS DEFINITION AND SUMMARY OF MANAGEMENT OPTIONS Unused pharmaceuticals include expired medications, unwanted medications (e.g., patient/resident discontinues use), and waste medication (e.g., patient/resident refuses to take or spits out). Pharmaceutical waste is generated at health care facilities before, during, and after treatment, as well as during stocking activities needed to ensure sufficient materials are available for regular care. Pharmaceutical waste includes the following (ERG, 2008):

2 Page 2 Waste from stocking activities needed to ensure sufficient materials are available for regular care (expired pharmaceuticals): Approximately three percent of all purchased medications reach their expiration date before they are used (ERG, 2008); and Some pharmacies work with manufacturers to send expired pharmaceuticals to a reverse distributor for credit from the manufacturer prior to disposal. Waste generated before treatment (during preparation): Partially used vials from IV preparation; Partially used vials from filling syringes; and General compounding 1. Waste generated during patient treatment: Excess medication eliminated from overfilled syringes to adjust dose prior to administering to patient; and Used syringes and IVs. Waste generated after patient treatment, or leftover medications: Discontinued, unused preparations; Unused unit doses; and Patients unused medications after treatment completion. Pharmaceutical wastes can be generated in the facility pharmacy, satellite or off-site pharmacies, patient care units, emergency rooms, intensive care units, oncology/hematology departments, radiology departments, rehabilitation centers, ambulances, outpatient clinics, satellite medical clinics, and long-term care facilities (LTCFs). To manage unused pharmaceuticals, health care facilities may reuse or redistribute unopened medication in its original packaging (either on site or off site), send unused pharmaceuticals to a reverse distributor (receive credit and ultimately dispose), or dispose. Redistribution of unused pharmaceuticals includes returning of unopened medications in their original packaging to the on-site or off-site pharmacy. Hospitals own the medication, and the hospital pharmacy (on-site or off-site) can redistribute unopened medication and credit the cost for the unused amount to the patient. At LTCFs, the patient typically owns the medication, and it cannot be redistributed by the LTCF. Typically, LTCFs contract with off-site pharmacies, and off-site pharmacies can redistribute some unopened medications 2 and credit the cost for the unused amount to the patient. 1 Compounding is the process of mixing drugs by a pharmacist or physician to fit the unique needs of a patient. This may be done to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that causes a patient allergy, or to obtain the exact dose needed. 2 LTCFs cannot return controlled substances to LTC pharmacies or reverse distributors; therefore, unopened controlled substances cannot be credited. Also, if private insurance or Medicare Part D has been used to pay for medication, the current practice is to not process partial credit, and the unopened medication cannot be redistributed by the pharmacy.

3 Page 3 If the unused medication is not redistributed by the pharmacy, in some cases it can be donated to charitable institutions, such as programs that assist lower-income patients. Physician samples can be donated to charitable institutions by licensed practitioners if the samples meet certain criteria in 21 CFR Part These criteria include that the sample medication is in the original packaging (unopened and label intact). See the memorandum, Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA-HQ-OW , DCN 06499) for further details. If the health care facility cannot redistribute, send to a reverse distributor, or donate the medication, the unused pharmaceuticals must be disposed. Prior to disposal, health care facilities may render the pharmaceutical irretrievable (e.g., cutting up patches or crushing tablets). Management options for unused pharmaceuticals depend on the type of pharmaceutical (e.g., controlled 3 or non-controlled substance) and regulatory requirements, which vary by state. The following sections of this memorandum outline the management practices and control technologies and when each may be used by a health care facility. 2. SOURCE REDUCTION AND POLLUTION PREVENTION Source reduction and pollution prevention are the use of materials, processes, and practices that reduce or eliminate the generation of wastes (in this case, unused pharmaceuticals) at the source. Health care facilities can implement practices to minimize the generation of unused pharmaceuticals. 2.1 Summary of Source Reduction Practices A brief summary of all source reduction practices identified from literature sources, outreach meetings, and site visits are provided in this section. The summary includes a discussion of when practices could apply and limitations identified by EPA Inventory Control Practices Health care facilities can adopt the following inventory control practices to minimize unused pharmaceutical waste generation: Modify purchasing of inventory facility staff (or outside companies such as contractors and purchasers) can modify purchasing of inventory to reduce waste and identify pharmaceuticals nearing expiration. Perform stock rotation to reduce expired pharmaceutical wastes, identify any short-dated pharmaceuticals and redistribute them to other areas of the facility where they are needed and used immediately. Decline pharmaceutical samples to minimize generation of waste from expired sample medications, decline samples or replace with vouchers for patients. Sample medications are more commonly used at physician offices and clinics, not at hospitals and LTCFs. 3 Pharmaceuticals and certain other chemicals, both narcotic and non-narcotic, whose possession and use are regulated within schedules under the Controlled Substances Act.

4 Page 4 Health care facilities that maintain a detailed inventory of pharmaceuticals purchased, dispensed, and wasted can identify where waste comes from and how to minimize it. Examples of Inventory Control Practices The Marshfield Clinic in Wisconsin implemented an inventory program for all its chemicals and pharmaceuticals used on site. The inventory identified the types, amounts, and locations of pharmaceuticals and chemicals at the various clinic departments. The clinic identified pharmaceuticals and chemicals most commonly wasted. After identifying wastes, the clinic reviewed purchasing and storage of supplies to reduce the amount of unused pharmaceuticals. For example, the clinic found that portions of lidocaine bottles were going unused and disposed. Therefore, the clinic began purchasing smaller lidocaine bottles, which had the additional benefit of reducing lidocaine purchasing costs. The clinic also found that almost every examination room had a half pint of hydrogen peroxide and a half pint of alcohol. Most of these bottles were old and not needed on a regular basis. The clinic now uses one wound-care tray that moves from room to room as needed, reducing the amount of hydrogen peroxide and alcohol purchased and disposed (U.S. EPA, 2009). As part of its inventory process, the clinic also identified whether there were procedures in place to handle chemical and pharmaceutical waste generation. For each department (e.g., labs, operating rooms, etc.), staff designed checklists and used these to identify any need for waste handling procedures. Both the Marshfield Clinic and the Alexian Brothers Medical Center in Elgin, IL encourage replacing pharmaceutical samples with vouchers, which the patient takes to the pharmacy for a free sample. Health care facilities commonly dispose of unused sample medications in the trash or down the drain. The Marshfield Clinic spent a considerable effort in educating its doctors about the problem of accepting samples. As a result of these education efforts, the clinic has reduced its generation of unused pharmaceuticals from drug samples by 80 to 90 percent (U.S. EPA, 2009). Using the same doses for medications for different departments of a hospital helps to facilitate stock rotation. For example, Hennepin County Medical Center (HCMC) in Minnesota was using 15-gram glutose gel tubes in its crash boxes and dispensing 45-gram tubes for diabetics. The facility s diabetics committee recommends 30-gram doses, therefore a portion of the 45-gram tubes went unused. The facility switched all departments to 15-gram glutose gel tubes and was able to rotate tubes from crash boxes to clinical use for diabetics, reducing the volume of expired glutose tubes (MNTAP, 2007) Limited Dose Dispensing Limited dose dispensing practices include limiting the number of doses dispensed to a patient (e.g., unit dose packaging), using trial prescriptions to determine medication effectiveness before writing a full prescription, using smaller containers of pharmaceuticals at the pharmacy and on nursing floors, and using automated dispensing systems. Examples of each practice are described below.

5 Page 5 Unit Dose Dispensing A unit dose is a particular dose of the pharmaceutical ordered for the patient. Often the unit dose is equal to a single unit which is one discrete pharmaceutical dose (e.g., one tablet, one 2- milliliter volume of liquid, one 2-gram mass of ointment). Health care facilities often purchase prepackaged unit doses (e.g., in blister packs or bingo cards) or prepare unit doses at the pharmacy for dispensing to patients (e.g., individually wrapped or dispensed via an automated dispensing system). Health care facilities provide one unit dose of the medication to the patient or resident as needed. For example, the nurse or medication technician removes a single tablet from a blister pack or medication cart each day for daily medication. If the patient or resident stops using the medication, the unopened medication in the blister pack or remaining in the medication cart can be returned to the pharmacy, restocked, and redistributed. As long as the packaging is not opened, medications returned to a hospital pharmacy can be redistributed to another patient. For long-term care pharmacies (commonly off site from the facility), the pharmacy cannot redistribute a returned pharmaceutical unless the pharmacy can refund the customer for the cost of the medication; this is to avoid double billing of a single drug product (ERG, 2009). Examples of Unit Dose Dispensing At the Alexian Brothers Medical Center, 85 percent of the pharmaceuticals are dispensed as unit doses from an automated dispensing system (ADS). The remaining pharmaceuticals (approximately 15 percent) are from bulk containers, and the pharmacy always dispenses the smallest amount possible (U.S. EPA, 2009a). At the Walter Reed Army Medical Center (WRAMC) in Washington, DC, approximately 99 percent of the pharmaceuticals are dispensed as unit doses. The majority of unit doses are blister packs, prepackaged as unit doses and purchased from the manufacturer. Other unit doses are packaged at the on-site pharmacy. Liquid medications are dispensed in 5, 15, and 30 milliliter (ml) doses. WRAMC purchases cream and ointments in multi-use tubes that can be reused when the tube does not touch the patient s wounds (ERG, 2009b). Trial Prescriptions Trial prescriptions are the dispensing of a small quantity of medications (e.g., 10 to 14 day supply) prior to writing a full prescription. This practice helps reduce wasted medications that have high incidences of side effects (e.g., patient might stop taking medication before dispensed quantity is used) or dose adjustments. Prescriptions are typically written and filled for 30 or 90 day supplies to minimize patient copays per dose (required for each prescription regardless of quantity). In cases of discontinued medications, trial prescriptions would create less than half the waste. Example of Trial Prescriptions MaineCare, a health insurance program managed by the Maine Department of Health and Human Services, instituted a new 15-day limit on initial prescriptions for certain medications that have been identified as having high side effect profiles, high discontinuation rates, or frequent dose adjustments (i.e., those medications that have a high rate of waste quantities). The

6 Page 6 limitation went into effect for Suboxone, Subutex, Chantix, and Nicotine replacement products in August Beginning in September and October 2009, limitations apply to additional medications. Prescriptions at higher dose quantities can be obtained with prior authorization. In addition to reducing wasted medication, the policy aims to control health care costs (Cook, 2009). Smaller Container Sizes For hospitals and other facilities with on-site pharmacies, the pharmacy might purchase bulk containers and then package the medication into doses. Large containers might also be used for non-prescription pharmaceuticals and chemicals (e.g., alcohol). During inventory, facilities might identify whether larger containers are expiring or otherwise going unused. In those cases, changing to smaller container sizes can reduce waste generation. Examples of Smaller Container Sizes The Marshfield Clinic uses lidocaine in small amounts. Rather than purchasing lidocaine in 50 milliliter (ml) bottles that need to be discarded 30 days after opening, the clinic began purchasing 15 ml vials or smaller to minimize wasted medication. Automated Dispensing Systems There are multiple types of automated dispensing systems (ADSs), ranging from those that automate dosing per patient to those that function as unit dispensing systems: Some ADSs contain canisters of commonly prescribed medications, and they dispense the unit dose in an individual package after a nurse or other staff enters prescription information. Other ADSs contain drawers (separate for controlled and non-controlled substances) that open only when that medication or prescription is entered for dispensing. After entering the prescription information, the nurse then removes the proper amount of medication. Some ADSs create individual packages that contain several medications for a single patient. For some health care facilities, the use of an ADS machine is not practical. Smaller facilities especially do not have the resources to spend on purchasing the ADS machine. For example, a $15,000 ADS machine is generally not cost effective for small facilities. There would need to be a minimum of 12 to 15 beds to be cost effective (U.S. EPA, 2009d). Some states require that facilities have a pharmacy license to use ADS machines, and most LTCFs do not. If a state requires a pharmacy license, LTCFs might not be able to use ADS machines (U.S. EPA, 2008). Examples of ADSs During outreach meetings with vendors, pharmacies, and health care facilities, EPA received comments on the use of ADS machines. Feedback mentioned the following advantages:

7 Page 7 Quality control. ADSs may help prevent dispensing errors, which ultimately reduces waste. EPA talked with one vender, Talyst, whose Insite TM product provides unit dose dispensing in individual packages (remote dispensing system). This system maintains data on the medication including expiration date. By reviewing the inventory, the pharmacy can remove medications nearing expiration to be used elsewhere (stock rotation). EPA asked about errors in dispensing. Talyst believes they have improved on older models and do track medication errors (either machine or user error). The data found that the error rate for incorrect dispensing is 0.2 percent. These are caught during the nurses final check of the medication (U.S. EPA, 2009c). Compliance with DEA requirements. The pharmacy loads the ADS, and, when medication is needed, the health care facility staff enters the patient information and retrieves the unit dose medication. Medications that remain inside the ADS are considered within the DEA s closed distribution system for controlled substances and can therefore be counted as pharmacy stock. If patients do not take all of the drugs prescribed, the excess can be dispensed to other patients (see 70 FR 25462; May 13, 2005). Unit Dosing. EPA received positive feedback on drawer systems, such as the Omnicell. WRAMC uses the Omnicell ADS to dispense controlled substances, and they are able to reuse or return medications from drawer systems (ERG, 2009b) The Role of Consultant Pharmacists Under 42 CFR Part , skilled nursing facilities participating in Medicare are required to use certain pharmacy services. Medicare requires that a licensed pharmacist or consultant pharmacist review and manage medication regimens. Medicare does not require the use of consultant pharmacists at assisted living or other health care facilities. A consultant pharmacist focuses on reviewing and managing the medication regimens of patients. Consultant pharmacists ensure their patients medications are appropriate, effective, safe, and used correctly. They also identify, resolve, and prevent medication-related problems that may interfere with the goals of therapy. In addition to clinical review, consultant pharmacists may also work with facilities to help them develop policies that include how to manage unused prescription medication. Some pharmacists provide both consulting and dispensing services to nursing facilities (U.S. EPA, 2009e). In other cases, facilities might contract with a separate dispensing pharmacy Returning Unused Medications to the Pharmacy Health care facilities might return unused/unopened pharmaceuticals that have not yet expired to their pharmacy for redistribution. If the pharmacy is on site, both controlled and non-controlled pharmaceuticals can be returned. Larger facilities, such as hospitals, with an on-site pharmacy, often return unused/unopened medication to the pharmacy every 24 hours (e.g., restocking of medication cart used on nursing floor). For facilities using off-site pharmacies, some unused/unopened medication might be returned to the pharmacy for restocking and crediting:

8 Page 8 Hospitals can return non-controlled substances to off-site pharmacies and can also return controlled substances if both facilities are controlled substance registrants with the Drug Enforcement Administration (DEA). LTCFs primarily use off-site pharmacies for dispensing and delivery of medication; less than 0.5 percent operate on-site pharmacies (U.S. EPA, 2009e). LTCFs do not generally have DEA registrants and can only return non-controlled substances to off-site pharmacies. See the memorandum, Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA-HQ-OW , DCN 06499). Expired medications may also be returned to the pharmacy. The pharmacy can then either send to the reverse distributor for credit or properly dispose of the medications. 2.2 Costs for Source Reduction Practices This section summarizes the costs of source reduction practices identified by literature sources, outreach meetings, and site visits conducted by EPA. These costs primarily fall into two categories: 1) cost of labor and 2) cost of purchasing and maintaining the technologies. While waste reduction is an obvious advantage, implementing source reduction practices is driven by the well being of the patient/resident and cost savings to the facility. Facilities are encouraged to adapt source reduction practices as they generally provide an overall cost savings because less pharmaceuticals are purchased, which in turn minimizes the amount of pharmaceuticals wasted. Table 2-1 summarizes these costs, facility requirements, and applicable facilities. The cost savings from purchasing less medication may offset the labor hours and capital cost for source reduction practices. For example, according to Talyst, a pilot facility using their dispensing system for the first time saved up to $10 per patient per day in wasted pharmaceuticals, which easily covered the cost of the rental fee for the unit. A 1995 study revealed that the cost of ADS units to cover 10 acute care units (330 total beds) and 4 critical care units (48 total beds) in a large referral hospital would be $1.28 million over 5 years. Taking into account costs saved from reduced personnel and decreased drug waste, the units had the potential to save $1 million over 5 years (U.S. EPA, 2009c).

9 Page 9 Table 2-1. Summary of the Costs of Source Reduction Practices Pharmaceutical Management Practice Cost Facility Requirements Type of Facility Reference Inventory/ Stock Rotations Dose Dispensing Systems Consultant Pharmacist Services Labor hours (likely a pharmacist or registered nurse). The initial pharmaceutical inventory and evaluation of the stock may be the most time consuming, but once a system has been established it can be easily maintained. The number of hours is directly correlated with the size of the facility, amount of pharmaceuticals maintained on site, number of different locations pharmaceuticals are stored etc. If there is a single point of entry for pharmaceuticals, cost would be less than if there are multiple inventory locations. At a small facility, stock inventory is integrated into medication room management. Talyst s Insite TM 240 can hold and dose 240 different oral solid medications and costs $150,000 per unit to purchase. Talyst s Insite TM 500 can hold and dose 500 different oral solid medications and costs $300,000 per unit to purchase. The rental fee for one Talyst unit is around $3,500 per month. Included in the rental fee is live service and support that covers both hardware and software issues. Talyst also offers hardware service and support training for facilities that purchase more than one unit. Software support is $500 per month. The unit dose systems can also be used as multi-dose systems that package different pharmaceuticals in each pouch. This is included in the cost of the service and support fees. Consultant pharmacist services are required for skilled nursing facilities by law. These services may also be provided to other health care facilities. The consultant pharmacist might be associated with the dispensing pharmacy or a separate entity. None InsiteTM 240 needs 84 inches by 84 inches of floor space and 80 inches of ceiling height InsiteTM 500 needs 80 inches by 90 inches of floor space and 92 inches of ceiling height The InsiteTM 240 fits through a standard door while the InsiteTM 500 requires more preplanning by the facility. None Applicable to all facilities Large facilities Hospitals Multi-unit LTCFs Skilled nursing facilities Inpatient hospices Facilities that use off-site pharmacy services ERG, 2009c U.S. EPA, 2009 Talyst, 2009 Talyst, 2009a Personal communication, 2009 ERG, 2009c

10 Page 10 Table 2-1. Summary of the Costs of Source Reduction Practices Pharmaceutical Management Practice Cost Facility Requirements Type of Facility Reference Return to Pharmacy Labor costs are associated with storing unused pharmaceuticals and collecting returnable pharmaceuticals in a secure location (e.g. nurse s stations). Returns to off-site pharmacies generally occur at the same time that new stock is being delivered. Therefore, no additional cost for postage or delivery. Returned pharmaceuticals to on-site pharmacies are integrated into stocking of medication carts on a 24-hour rotation. Depending on the volume of pharmaceuticals, facilities may need space for temporary collection prior to return. Applicable to all facilities

11 Page MANAGEMENT PRACTICES FOR UNUSED PHARMACEUTICALS Health care facilities that generate unused pharmaceuticals can implement management practices to minimize the disposal of medications. EPA identified the following management practices based on communication with various government entities, health care industry associations, pharmaceutical waste management companies, and health care facilities. These practices are a combination of recommended and implemented practices with the goal of pharmaceutical waste management and disposal. 3.1 Summary of Waste Management Practices This section summarizes the management practices that EPA identified by literature sources, during outreach meetings, and on site visits. These practices assist health care facilities in properly managing and disposing of unused pharmaceuticals. For all types of pharmaceuticals and facilities, waste management practices are developed using the following basic steps: Step 1: Perform an inventory. Health care facilities perform an initial inventory to identify the types of pharmaceuticals and chemicals used, to assess purchasing of pharmaceuticals; and to identify proper waste disposal. Facilities can then perform periodic inventories to identify expired pharmaceuticals and pharmaceuticals close to expiration. Step 2: Implementation of waste management practices. These include the following: For unopened/unused pharmaceuticals (expired): Processing through a reverse distributor for credit (non-controlled substances for both hospitals and LTCFs, controlled substances for hospitals); and Using waste segregation or waste tracking (LTCFs separate noncontrolled and controlled substances. The non-controlled substances may be processed through a reverse distributor, while the controlled substances must be destroyed). For unopened/unused pharmaceuticals (not yet expired): Return to pharmacy for redistribution and credit or proper disposal (non-controlled substances for both hospitals and LTCFs; controlled substances for hospitals); Processing through a reverse distributor for credit (non-controlled substances for both hospitals and LTCFs; controlled substances for hospitals); and Donation through state repository programs (primarily noncontrolled substances and chemotherapy agents).

12 Page 12 For opened pharmaceuticals: Return to pharmacy for proper disposal such as the methods listed below (non-controlled substances can be returned to on- or off-site pharmacies; controlled substances can be returned to on-site pharmacies). On-site pharmacies are typically at hospitals; Processing through a reverse distributor for destruction (noncontrolled substances for both hospitals and LTCFs, controlled substances for hospitals); Using waste segregation or waste tracking (all types of pharmaceuticals and waste streams); and Collection and placement of radioactive waste in long-term storage until radioactive level is equal to background level. Step 3: Communication to staff and training. Communicate the waste management practices being implemented and train staff on how to follow the practices. Training should be revisited throughout each calendar year, to update and refresh staff on proper waste handling Performing an Inventory Facilities inventory all pharmaceutical waste generated and determine the appropriate disposal method. As part of this process, facilities would identify pharmaceutical wastes that are incompatible with other pharmaceutical wastes and, as a safety consideration, should not be disposed of or stored in the same container. Tools exist to help facilities identify the correct disposal methods for each type of pharmaceutical waste, such as the following: Federal or state compliance assistance tools (for example, materials available on U.S. EPA s hazardous waste web site, Health care industry association publications (for example, PracticeGreenHealth s Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care Facilities in the United States (Practice Greenhealth, 2008)); Proprietary databases (for example, PharmEcology s PharmE Inventory Analysis). Figure 3-1 presents an example flowchart from the Washington State Department of Ecology web site to assist facilities in identifying proper disposal methods.

13 Page 13 Start Designation Process Does the material have any value? Yes Send pharmaceuticals back via Reverse Distributor or return to manufacturer. No Was the pharmaceutical a controlled substance? Yes If it designates under WAC or -090, then both hazardous waste regulations and antidiversion regulations must be followed. If it does not designate under -080 or -090, then use the conditional exclusion WAC (3)(nn). No Does the material designate as a RCRA waste? WAC Or -090? Yes Segregate from all other waste No Was the material chemotherapy waste? Yes RCRA-permitted dangerous waste facility (incinerator, landfill, or TSDR vendor) Disposal Cost Savings No Choose a priority Labor Cost Savings You can save time and effort in designation by assuming that your waste designates as state-only dangerous waste. Does the material designate as state-only dangerous waste? WAC No Yes Contact Local Health Department. Dispose of in: a) Solid waste, b) Santiary sewer, if liquid, or c) In municipal incinerator Dispose of at a facility that meets the conditional exclusion. WAC (3)(nn) Source: Washington State Department of Ecology Figure 3-1. Example Pharmaceutical Waste Management Flow Chart Waste Segregation and Waste Tracking To ensure proper disposal of unused pharmaceuticals a health care facility may implement a program to segregate wastes either at time of delivery or at time of waste generation. For example, after delivery and during stocking, a facility might use color-coded stickers on supplies that match the disposal bin color placed at the facility to collect and segregate various types of waste (e.g., black color indicates hazardous waste). The determination of the type of waste at the point of generation is called a pre-sort system.

14 Page 14 Health care facilities often implement these programs to ensure compliance with hazardous waste regulations and to reduce costs by not handling all waste as hazardous. Further segregation of hazardous waste might also be performed. For example, hazardous waste oxidizers might be collected, stored, and packaged for pick up separately. Examples of Waste Segregation and Waste Tracking Waste contractors have programs in place to help implement and communicate disposal practices, including management of unused pharmaceuticals at health care facilities. For example, Stericycle offers a Rx Program, Specialty Waste Solution. Stericycle provides the facility with containers (color-coded), conducts training, and tours the facility to customize the Rx program. One main aspect of the training includes explaining the difference between RCRA 4 defined hazardous waste and biohazardous waste (medical infectious waste) wastes. The facility tours include helping to place containers for maximum use. After implementation, Stericycle performs follow-up training and audits (U.S. EPA, 2009f). The Rx program requires approximately two to three months to implement, which includes training the trainer, training the staff, and deploying the collection bins. The program requires approximately six months total to bring the hospital into full compliance with the Rx program and achieve the maximum collection of unused pharmaceuticals. Stericycle data show that the total amount of unused pharmaceuticals range from 10 to 20 pounds/bed-month total, with about 10 to 20 percent of that volume being hazardous waste (U.S. EPA, 2009f) Reverse Distribution Reverse distribution is a method for pharmacies, hospitals, wholesalers, and other health care facilities to return unused and/or expired pharmaceutical products for potential credit from the manufacturer and for proper destruction. To receive credit, pharmaceuticals must be in original packaging and unopened. Unit doses packaged by the pharmacy cannot be returned to the manufacturer for credit. Most, if not all, large hospitals use reverse distribution for unused pharmaceuticals that are potentially creditable (U.S. EPA, 2009g). Manufacturers (or wholesalers) issue credit for expired pharmaceuticals to offer incentives for pharmacies to stock their shelves with unexpired pharmaceuticals, termed in-dated products. Pharmacies and manufacturers outsource their returns to reverse distributors to ensure that the returns comply with applicable regulations. The reverse distributor determines which medications can receive credit from the manufacturer and then arranges for disposal of these unused medications. The manufacturer maintains the right to evaluate products for potential donation; however, based on a variety of factors, including the product expiration date, the product is typically disposed (ERG, 2008). Under the Controlled Substances Act regulations, a DEA registrant (e.g., hospital employee) may send controlled substances to a DEA-registrant reverse distributor. Employees of LTCFs typically are not DEA registrants and therefore may not send controlled substances to reverse 4 Resource Conservation and Recovery Act

15 Page 15 distributors. LTCFs or their pharmacies can send non-controlled substances to reverse distributors Donation Programs (State Repository Programs) Some states have programs in place to allow the reuse or redistribution of unused pharmaceuticals through state repository programs. Typically, these programs allow the redistribution of unopened medications that are non-controlled substances. Other common requirements include that the medication is properly maintained and expiration date is beyond 6 months at the time of donation. See the memorandum, Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA-HQ-OW , DCN 06499) Return to Pharmacy for Proper Disposal Rather than sorting or managing waste at the health care facility or on the nursing floor, any unused pharmaceuticals may be collected and sent to the pharmacy (on or off site) for proper waste segregation and disposal. To return waste pharmaceuticals to the pharmacy, health care facilities typically set up collection locations: For hospitals, waste pharmaceuticals might be collected on the nursing floor, in waste drawers on medication carts, or in ADS machines. For LTCFs, waste pharmaceuticals might be collected in waste drawers on medication carts or in ADS machines. Some facilities might also be able to participate in community take back programs where a pharmacy or other entity collects unused pharmaceuticals for disposal. However, take back programs are primarily for unused pharmaceuticals generated at households. See the memorandum, Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA-HQ-OW , DCN 06499) Long-Term Storage of Radioactive Waste To prevent exposure to radioactive waste, health care facilities can store the waste in appropriate containers until the radioactive level of the waste equals the background level. The waste can then be disposed as regular trash Communicate Proper Disposal Practices Once the facility identifies the proper disposal methods for the pharmaceuticals used on site, the next step is to communicate the proper disposal method to staff and ensure that the unused pharmaceuticals are disposed in the proper receptacles. 3.2 Costs for Waste Management Practices This section discusses waste management practice costs and presents example cost estimates from site visits. The costs of these practices generally fall into two categories: 1) the cost of labor

16 Page 16 hours to implement and maintain these practices, and 2) the cost of the ultimate disposal method. The primary practice identified on site visits to large hospitals is waste segregation and waste tracking Example Cost Estimates North Memorial Hospital (Robbinsdale, MN) tracked pharmaceutical waste disposal for two years. The quantity of waste disposed included 200,000 pounds of nonhazardous waste, 20,000 pounds of hazardous waste, and 8,000 pounds dual waste (pharmaceutical waste and chemical waste that is both hazardous and infectious). The cost for their waste segregation system includes the following: $250,000 per year for pharmaceutical waste management (not including labor); $150,000 per year for leadership costs, including education, consulting fees, and training needed to initiate the hazardous waste program; and $150,000 per year for training and operation and maintenance of the hazardous waste program (ERG, 2008c). The Baltimore VA Medical Center anticipated spending about $112,000 each year on all waste disposal and about $6,000 each year just on pharmaceutical disposal through their hazardous waste hauler at $13 per gallon of waste. The use of the steam sterilizer and pulverizer for biohazardous waste and sharps costs $0.19 per pound and includes municipal landfill costs (ERG, 2009e). Table 3-1 shows a more detailed break down of costs and facility descriptions for all of the waste management practices discussed in this section.

17 Page 17 Table 3-1. Summary of the Costs of Waste Management Practices Waste Management Practice Costs Facility Requirements Applicability Reference Waste Segregation and Tracking Reverse Distribution/ Return to Manufacturer At the Marshfield Clinic (large facility 700 physicians): Hazardous pharmaceutical waste disposal by a waste hauler is $7 to $10 per pound. For nonhazardous waste, the cost is $112 per 55-gallon drum. The clinic fills the drum every two months, mostly with unused samples and items from inventory/cupboard clean outs. Upfront labor investment to implement the disposal practice in the form of training, color coding pharmaceuticals by waste type, etc. Marginal labor costs include checking how full waste bins are in satellite collection sites, managing waste pick up, and on-going training. At Capital Hospice (small facility 15 beds): The waste hauler (EXP) performs the waste segregation for the facility after the pharmaceuticals are collected. The facility estimates waste disposal pick up once every 6 months. On their last pick up dated February 20, 2009 the invoice was $ and included hazardous, nonhazardous, and controlled substances. The EXP disposal rate for nonhazardous waste is $1.75 per pound. At Thomas Jefferson University Hospital (large facility 925 beds) Facility estimates that obtaining a sufficient waste collection room will require a $160,000 capital cost and $130,000 in operational costs due to their limited space options (Note that this circumstance is due to their urban location and building situation). Cost for incineration of waste in a medical waste incinerator is $0.25-$0.35 per pound. Cost for incineration of waste in a RCRA hazardous waste incinerator is $2.00-$5.00 per pound. The reverse distribution services provided by Guaranteed Returns costs $2.09 per pound of hazardous pharmaceuticals and $0.29 per pound of nonhazardous pharmaceuticals. These costs do not take into account the amount reimbursed for credited items, but that amount is generally negligible. Secured storage space for segregated pharmaceuticals. Space for color coded containers in satellite collection sites such as nursing stations, IV preparation rooms, on-site pharmacies, etc. Temporary storage space for reverse distribution items. Applicable to all facilities Applicable to all facilities U.S. EPA, 2009 U.S. EPA, 2009c ERG, 2009d ERG, 2009e

18 Page 18 Table 3-1. Summary of the Costs of Waste Management Practices Waste Management Practice Costs Facility Requirements Applicability Reference Donation Programs LTC pharmacies have looked at possible solutions for unused medications returned to them by LTCFs. Overall, it is not cost effective to repackage drugs for reuse unless the drugs are very expensive: cost of drugs vs. labor cost to repackage and restock. Labor costs include time to punch medication from unit dose packaging, making sure important medication data is not lost, ensuring that the medication has not been open prior to donation, and ensuring that the requirements of the Health Insurance Portability and Accountability Act (HIPAA) are met. A significant number of labor hours are spent meeting HIPAA regulations; steps include peeling off labels and blacking out patient information from labels. Temporary storage space for donation items. Applicable to all facilities DEA does not allow donation of controlled substances. U.S. EPA, 2009h

19 Page UNUSED PHARMACEUTICALS WASTE DISPOSAL OPTIONS This section discusses the ultimate destination for unused waste pharmaceuticals. One waste disposal option is disposal to the sewer or publicly owned treatment works (POTW) via the drain or toilet. Other disposal options include disposal in regular trash (for controlled substances, includes rendering irretrievable) or disposal in another medical waste stream. The types of medical waste streams include red sharps containers (e.g., facility disposes of controlled substances administered through patches by cutting up and placing in sharps box), biohazardous waste (i.e., in red bags), hazardous waste, and chemotherapy waste. Some waste pharmaceuticals are defined as RCRA hazardous waste and must be managed accordingly. 4.1 Disposal to Regular Trash Regular (or municipal) trash and sterilized medical/infectious waste are generally disposed in municipal waste landfills. Health care facilities might also dispose of nonhazardous, noncontrolled waste pharmaceuticals in the regular trash (e.g., medication refused by the patient, expired pharmaceutical samples, partially used or empty vials of medication). This disposal method is inexpensive and easy. Facilities can render controlled substances unrecognizable by crushing them and mixing with materials such as kitty litter, then dispose of the waste in the general trash. The ultimate disposal of regular trash includes municipal solid waste landfill or incineration, including waste-to-energy plants. 4.2 Disposal to Sewer/POTW Facilities tend to dispose of partially-used intravenous (IV) medications from the patient floor down the drain. All facilities contacted during outreach meetings and site visits disposed of partially-used IVs down the drain. In some cases, the IVs contain primarily electrolytes and total parenteral nutrition. All facilities also disposed of partially-used IVs containing controlled substances (e.g. a Fentanyl IV stopped midstream) down the drain. Some facilities disposed of any partially-used IVs, regardless of the type, down the drain. Other facilities disposed of chemotherapy IVs as hazardous waste, using a resealable bag system and sorting containers. Some facilities also disposed of all controlled substances in the form of pills down the drain. To avoid drain disposal some facilities rendered the controlled substances unrecognizable by crushing them and mixing them with other materials and disposing in the regular trash. 4.3 Off-Site Disposal and Use of Contract Waste Haulers To manage wastes such as waste sharps, biohazardous waste, hazardous waste, and chemotherapy waste, health care facilities often use contract waste haulers and waste disposal companies to collect and properly dispose. Unused pharmaceuticals might be included with these wastes or collected separately for disposal. The ultimate disposal location might be an incinerator (discussed in Section 5.1) or landfill. Waste disposal companies might also perform sterilization of the waste (see Section 5.2) prior to disposal in the landfill.

20 Page 20 Biohazardous sharps. Facilities place used sharps into plastic containers that are collected for sterilization and disposal. The waste is ultimately disposed off site in a landfill (following sterilization). Medical waste, including sharps and biohazardous waste, may also be incinerated; however, currently less than 15 percent of medical/infectious waste is disposed via incineration (Heller, 2008). Biohazardous waste, or regulated medical waste (red bag). Potentially infectious wastes are collected and sterilized prior to disposal or incinerated. The memorandum Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA-HQ-OW , DCN 06499) discusses waste requirements in more detail. Currently, less than 15 percent of medical/infectious waste (sharps and biohazardous waste) is incinerated (Heller, 2008). Most health care facilities manage their waste using non-incineration techniques, such as autoclaving and heat-related sterilization. Following treatment to render the waste noninfectious, health care facilities may dispose of the waste in the regular trash (see Section 4.1). Certain materials such as pathological and trace chemotherapy wastes are not conducive to be treated in an autoclave (U.S. EPA. 2009f). Nonhazardous pharmaceutical waste. Waste haulers collect unused pharmaceuticals from the facility and provide disposal, either incineration or landfill disposal. The waste haulers include companies that specialize in the management of pharmaceutical waste (i.e., facility segregates this waste stream) and municipal trash collectors (i.e., facility does not segregate pharmaceutical waste from the regular trash). EPA RCRA hazardous waste. Waste that is defined as hazardous under RCRA must be collected by a RCRA-authorized waste hauler and disposed in either a hazardous waste landfill or hazardous waste incinerator. Some unused pharmaceuticals are considered hazardous when wasted. See the memorandum Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA- HQ-OW , DCN 06499) for details. Chemotherapy waste. Nonhazardous waste from chemotherapy drug administration is generally collected in yellow bags/containers and handled according to state policy. Based on EPA site visits, facilities typically dispose of nonhazardous chemotherapy waste by incineration (medical waste incinerator or low-temperature incineration) (ERG, 2008b; ERG 2008c; ERG, 2009d; ERG, 2009e; ERG, 2009f). If the chemotherapeutic agent is a listed RCRA-hazardous waste, health care facilities must dispose of these waste pharmaceuticals as hazardous.

21 Page 21 Trace Chemotherapy Waste and Hazardous Chemotherapy Waste. Trace chemotherapy waste (or yellow bag waste) includes all chemotherapy paraphernalia that has potentially been exposed to chemotherapy contamination (e.g., gloves, gowns, and wipes associated with routine handling, preparation and administration of chemotherapy; empty vials, syringes, IV bags, and tubing). This waste is incinerated at medical waste incinerators (Practice GreenHealth, 2008). As noted above, trace chemotherapy wastes are not conducive to be treated in an autoclave (U.S. EPA. 2009f). Any P-listed or U-listed hazardous chemotherapy waste cannot be disposed as trace chemotherapy waste. Medical waste incinerators have less restrictive emission limits and permit requirements compared to hazardous waste incinerators (Practice GreenHealth, 2008). Therefore, all hazardous chemotherapy wastes should be disposed as hazardous waste. Under 40 CFR Part 261.7, empty containers of hazardous waste are not subject to hazardous waste regulations under RCRA (40 CFR Parts 261 through 265, 267, 268, 270, or the notification requirements of section 3010). Empty containers under RCRA for P-listed waste are those containers that have been triple rinsed to remove the chemical. Empty containers for U-listed waste are those containers where all waste have been removed that can be using common practices and the waste remaining meets certain volume and weight requirements. See the memorandum Federal, State, and Local Regulations and Guidance for the Management of Unused Pharmaceuticals from Hospitals and Long-Term Care Facilities (EPA-HQ-OW , DCN 06499) for more details. The term bulk chemotherapy is not a regulatory term but is used to differentiate chemotherapy containers that are not RCRA empty (Practice GreenHealth, 2008). During site visits, EPA asked about disposal of bulk chemotherapy waste. One hospital (WRAMC) separated bulk chemotherapy waste into bulk RCRA hazardous and bulk non-hazardous. Otherwise, all bulk (non-empty) chemotherapy waste is typically collected from the facility by a waste hauler and ultimately disposed off site as hazardous waste (ERG, 2008b; ERG 2008c). 5. CONTROL TECHNOLOGIES As part of the HCI detailed study, ERG reviewed data on technologies that are used to destroy the pharmaceuticals, to render the pharmaceuticals irretrievable, or to treat pharmaceuticals in wastewater. This section provides an overview of the control technologies, costs to implement, and treatment effectiveness. 5.1 Incineration Biohazardous waste (i.e., potentially infectious waste), chemotherapy waste (trace or bulk), and RCRA hazardous waste are commonly disposed via incineration. Although segregation of wastes is encouraged in the industry, sometimes biohazardous waste includes trace (nonhazardous)