memorandum - pepper hamilton1].pdf · see the memorandum, federal, state, and local ......

MEMORANDUM TO: Meghan Hessenaeur, U.S. EPA Samantha Lewis, U.S. EPA FROM: Jill Lucy, ERG Kathleen Wu, ERG DATE: October 8, 2009 SUBJECT: Management Practices and Control Technologies for Unused

Pharmaceuticals at Health Care Facilities – Final, Document Control Number 06570

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):

Memorandum October 8, 2009

• 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 compounding1.

• 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 medications2 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.

Memorandum October 8, 2009 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 203.39. 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-2008-0517, 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., controlled3 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. 2.1.1 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.

Memorandum October 8, 2009 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). 2.1.2 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.


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

Memorandum October 8, 2009 limitation went into effect for Suboxone, Subutex, Chantix, and Nicotine replacement products in August 2009. 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:


• Quality control. ADSs may help prevent dispensing errors, which ultimately reduces waste. EPA talked with one vender, Talyst, whose InsiteTM 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).

2.1.3 The Role of Consultant Pharmacists

Under 42 CFR Part 483.60, 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. 2.1.4 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:


• 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-2008-0517, 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).


Table 2-1. Summary of the Costs of Source Reduction Practices Pharmaceutical

Management Practice Cost Facility Requirements Type of Facility Reference

Inventory/ Stock Rotations

• 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.

• None • Applicable to all facilities

ERG, 2009c U.S. EPA, 2009

Dose Dispensing Systems

• Talyst’s InsiteTM 240 can hold and dose 240 different oral solid medications and costs $150,000 per unit to purchase.

• Talyst’s InsiteTM 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.

• 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.

• Large facilities • Hospitals • Multi-unit LTCFs

Talyst, 2009 Talyst, 2009a Personal communication, 2009

Consultant Pharmacist Services

• 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 • Skilled nursing facilities

• Inpatient hospices • Facilities that use

off-site pharmacy services

ERG, 2009c


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

Memorandum October 8, 2009 3. 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 non-controlled 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 non-controlled substances and chemotherapy agents).


— 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 (non-controlled 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.

3.1.1 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, http://www.epa.gov/osw/hazard/index.htm);

• 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.


Start DesignationProcess

Does the material have any value?

Was thepharmaceutical a

controlledsubstance?

Does the material designate as a RCRA waste?WAC 173-303-080

Or -090?

Was thematerial

chemotherapywaste?

Choose a priority

No

No

No

No

Send pharmaceuticals back viaReverse Distributor orreturn to manufacturer.

If it designates under WAC 173-303-080 or -090, then both hazardous waste regulations and anti-

diversion regulations must be followed.

If it does not designate under -080 or -090, then use the conditional exclusion WAC 173-303-071 (3)(nn).

Segregate fromall other waste

RCRA-permitted dangerous waste facility (incinerator, landfill, or TSDR vendor)

You can save time and effort in

designation by assuming that your

waste designates as state-only dangerous

waste.

Dispose of at a facility that meets the conditional exclusion.WAC 173-303-071(3)(nn)

Contact Local Health Department.Dispose of in:a) Solid waste,b) Santiary sewer, if liquid, orc) In municipal incinerator

Does the material designate as state-only

dangerous waste?WAC 173-303-100

Yes

Yes

Yes

Yes

Yes

Labor Cost SavingsDisposal Cost Savings

No

Start DesignationProcess

Does the material have any value?

Was thepharmaceutical a

controlledsubstance?

Does the material designate as a RCRA waste?WAC 173-303-080

Or -090?

Was thematerial

chemotherapywaste?

Choose a priority

No

No

No

No

Send pharmaceuticals back viaReverse Distributor orreturn to manufacturer.

If it designates under WAC 173-303-080 or -090, then both hazardous waste regulations and anti-

diversion regulations must be followed.

If it does not designate under -080 or -090, then use the conditional exclusion WAC 173-303-071 (3)(nn).

Segregate fromall other waste

RCRA-permitted dangerous waste facility (incinerator, landfill, or TSDR vendor)

You can save time and effort in

designation by assuming that your

waste designates as state-only dangerous

waste.

Dispose of at a facility that meets the conditional exclusion.WAC 173-303-071(3)(nn)

Contact Local Health Department.Dispose of in:a) Solid waste,b) Santiary sewer, if liquid, orc) In municipal incinerator

Does the material designate as state-only

dangerous waste?WAC 173-303-100

Yes

Yes

Yes

Yes

Yes

Labor Cost SavingsDisposal Cost Savings

No

Source: Washington State Department of Ecology

Figure 3-1. Example Pharmaceutical Waste Management Flow Chart 3.1.2 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.


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 RCRA4 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). 3.1.3 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

Memorandum October 8, 2009 distributors. LTCFs or their pharmacies can send non-controlled substances to reverse distributors. 3.1.4 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-2008-0517, DCN 06499). 3.1.5 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-2008-0517, DCN 06499). 3.1.6 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. 3.1.7 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

Memorandum October 8, 2009 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. 3.2.1 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.


Table 3-1. Summary of the Costs of Waste Management Practices

Waste Management

Practice Costs Facility Requirements Applicability Reference Waste Segregation and Tracking

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.

• 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.


U.S. EPA, 2009

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 $272.51 and included hazardous, nonhazardous, and controlled substances.

• The EXP disposal rate for nonhazardous waste is $1.75 per pound.

U.S. EPA, 2009c

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.

ERG, 2009d

Reverse Distribution/ Return to Manufacturer

• 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.

• Temporary storage space for reverse distribution items.


ERG, 2009e


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.


• DEA does not allow donation of controlled substances.

U.S. EPA, 2009h

Memorandum October 8, 2009 4. 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, non-controlled 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.


• 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-2008-0517, 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-2008-0517, 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.


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-2008-0517, 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)

Memorandum October 8, 2009 chemotherapy waste and nonhazardous pharmaceutical waste (U.S. EPA, 2009f). Health care facilities dispose of their various waste streams to three types of incinerators:

• Hazardous waste incinerators; • Hospital/medical/infectious waste incinerators (HMIWI); and • Municipal waste combustors.

Although hospitals might operate on-site incinerators, the majority of incineration occurs at off-site waste disposal facilities. The memorandum, Pathways for Environmental Releases of Unused Pharmaceuticals (EPA-HQ-OW-2008-0517, DCN 06571), discusses the use of incineration as ultimate disposal in more details including operating methods and applicable regulations. Health care facilities might choose incineration as ultimate disposal for wastes to avoid potential leakage into the watershed from landfills. IVs and vials contain liquids which may be a problem in landfills. In addition, facilities might want to ensure proper disposal under RCRA (cradle-to-grave issue). For example, California requires incineration of some RCRA-nonhazardous waste pharmaceuticals (considered CA-only hazardous) (U.S. EPA, 2009f). Some concerns for the use of incineration as a management practice for unused pharmaceutical disposal include access, cost, and air emissions. For example, North Carolina only has two locations where health care facilities can send unused pharmaceuticals for incineration (U.S. EPA, 2009e). In the United States, there are currently:

• 57 hospital, medical, and infectious waste incinerators – 14 commercially operated, 31 located at hospitals, and 12 at other facilities (e.g., pharmaceutical manufacturer, university, public health facility) (U.S. EPA, 2008b); and

• 15 commercial hazardous waste incinerators, as estimated in 2005 (70 FR 59530). Health care facilities currently using regular trash or drain disposal would incur additional costs if waste pharmaceuticals must be incinerated (U.S. EPA, 2009e). 5.2 Sterilization of Waste

Biohazardous waste from health care facilities is sterilized to render it noninfectious prior to disposal as general municipal waste (i.e., regular trash). Although sterilization is effective to treat biohazardous waste, the process does not provide control or treatment of unused pharmaceuticals included in the waste stream. To render the unused pharmaceuticals irretrievable, the sterilization process would include grinding or shredding. These mechanical destruction steps are used in some sterilization process to increase effectiveness and render the waste unrecognizable (U.S. EPA, 2008b). Sterilization processes include the following:

• Autoclaving (steam treatment): use of saturated steam under pressure; • Thermal inactivation: use of dry heat rather than steam. For solid wastes, thermal

inactivation uses an oven. For liquid wastes, a heat exchanger is used. The process


is not as efficient as steam sterilization and is not practical for large-scale waste treatment.

• Chemical disinfection: use of strong oxidizing agents such as hydrogen peroxide or chlorine bleach to kill or inactivate infectious organisms.

• Ultraviolet radiation: used to disinfect wastewaters. • Microwave sterilization: shredded waste is sprayed with water and heated with

microwaves to 200°F. The memorandum, Pathways for Environmental Releases of Unused Pharmaceuticals (EPA-HQ-OW-2008-0517, DCN 06571), discusses the use of steam treatment, autoclaves, and microwaves in more detail.

Sterilization Costs

Costs for on-site sterilization systems include a capital investment, operation and maintenance, and disposal of sanitized medical waste. In addition, health care facilities need to determine if they have adequate space at their facility for an on-site system. Table 5-1 presents capital costs and waste disposal costs for three on-site sterilization technologies.

Table 5-1. Example Costs for Sterilization Technologies

Technology Equipment Cost (Capital Investment),

dollars Waste Disposal Cost

(shipping), per pound Tempico Rotoclave® (advance autoclave) $400,000 to $1 million $0.06 to $0.12 San-I-Pak Autoclave $60,000 to $1 million $0.07 to $0.09 WR2, Inc. Steam Sterilizer $320,000 to $1 million (capacity: 300-

600 pounds per hour) not listed

Source: Burmahl, 2004 5.3 Pyrolysis

Pyrolysis is high-heat thermal process that operates at temperatures equal to or higher than incineration, but involves a different set of chemical reactions than incineration. Because of the high temperature, a wide range of wastes from health care facilities can be treated/destroyed using this process. Heat can be generated using resistance heating, plasma energy, induction heating, natural gas, or a combination of plasma, resistance heating, and superheated steam (Health Care Without Harm, 2001). The pyrolysis process decomposes the organic compounds in the waste. Pyrolysis treatment is a relatively new technology.

Example of Pyrolysis Process

A Canadian company has used a proprietary non-incineration technology to destroy pharmaceutical waste. The process is a closed-loop, indirectly heated system that decomposes the organic components of the pharmaceutical waste and depolymerises the plastic from the

Memorandum October 8, 2009 pharmaceutical packaging. The depolymerized plastic is then recovered as usable oil. According to a representative of this technology, it:

• Offers the destructive benefits of incineration; • Does not produce any harmful emissions such as dioxin; • Recovers up to 90 percent of the available oil for reuse; and • Reduces waste volume by over 90 percent (Gilliam, 2007).

5.4 Treatment of Wastewater from HCI Facilities

Health care facilities discharge wastewater to POTWs. Although POTWs are not specifically designed to remove pharmaceuticals, some pharmaceuticals removals have been reported, specifically from those POTWs with some form of advanced treatment. The memorandum, Pathways for Environmental Releases of Unused Pharmaceuticals (EPA-HQ-OW-2008-0517, DCN 06571), presents information on pharmaceutical removals at POTWs. This section discusses various water treatment technologies used by drinking water treatment plants and the potential removals of active pharmaceutical ingredients (APIs). A 2007 study by the American Water Works Association (AWWA) Research Foundation analyzed the removal of endocrine disrupting chemicals (EDCs), pharmaceuticals, and personal care products using the following water treatment technologies (AWWARF, 2007):

• Coagulation, flocculation, and chemical softening: removal of suspended solids from the water. Includes addition of chemicals to aid in solids removal.

• Activated carbon (adsorption to solids): adsorbs contaminants into porous

material. Common types of activated carbon include powdered activated carbon (PAC) and granular activated carbon (GAC).

• Chlorine oxidation: chemical added to disinfect the water. Chemicals added as

“free chlorine” include gaseous chlorine and concentration hypochlorite liquid (OCl). Chloramines might also be used to oxidize and remove target compounds from the water.

• Ozone oxidation: chemical added to disinfect the water. Advanced oxidation

process (AOP) includes addition of ozone and hydrogen peroxide (H2O2); AOP increases the oxidation (and removal) of recalcitrant micro pollutants.

• Ultraviolet (UV) irradiation: oxidation of organic compounds. AOP includes UV

irradiation and addition of hydrogen peroxide (H2O2).

• Membranes: separation of contaminants in the water based on molecular size or electrostatic interactions on the membrane surface. Membrane types include low-pressure membranes: microfiltration (MF) and ultrafiltration (UF) and high-pressure membranes: reverse osmosis (RO) and nanofiltration (NF).


• Magnetic ion exchange (IX): ion exchange resins act as a repository of loosely held ions (cation or anion) that are exchanged for like-charged ions that have a greater affinity for the resin than the currently held ions. In this application, the resin is composed of a polymer and inorganic magnetic material such as magnetite (Fe3O4), hematite (Fe2O3), nickel, or cobalt.

• Biological processes: degradation of organic chemicals using non-pathogenic

bacteria.

Results of Pharmaceutical Removals

Table 5-2 presents the percent removals for pharmaceuticals and other compounds by the water treatment processes listed above, excluding biological processes (i.e., those performed at POTWs). Removals from biological processes are included in the memorandum Pathways for Environmental Releases of Unused Pharmaceuticals (EPA-HQ-OW-2008-0517, DCN 06571). In general, the results of the AWWA Research Foundation study found the following:

• Coagulation and chemical softening was ineffective in the removal of APIs (the majority of removals were less than 20 percent).

• Activated carbon was effective for the removal of the targeted compounds

provided there is sufficient dose and contact time. Percent removals for the majority of APIs fell into either the 20 to 50 percent removal range or the 50 to 80 percent removal range. The percent removals presented in Table 5-2 for PAC are for a dose of 5 milligrams per liter (mg/L) and a four to five hour contact time.

• Oxidation of the water to remove APIs had varying results.

— The use of free chlorine resulted in greater than 80 percent removal of some APIs (e.g., acetaminophen); however other removals were less than 20 percent (e.g., carbamazepine). Chlorine removals exceeded the removals using chloramines for oxidation.

— For oxidation with ozone, most of the target compounds included in the study reacted quickly at typical drinking water doses and the majority of APIs were removed by at least 50 percent.

— The percent removals for advanced oxidation process (AOP) with ozone and hydrogen peroxide had similar results to oxidation with ozone only; the addition of hydrogen peroxide improved removals by only 5 to 15 percent. However, the AOP increased reaction time (similar removals at 6 minutes for AOP compared to 24 minutes for ozone only). Use of AOP should be considered if contact time is an issue.

— UV irradiation at doses similar to water disinfection removed a smaller number of target compounds. Increasing the dose of UV resulted in


increased removals; however, the use of the AOP (UV irradiation with the addition of hydrogen peroxide) provided the best removals.

Table 5-2 presents removal results for the following chemical oxidation process conditions:

— Chlorine: dose equals 3 mg/L, contact time 24 hours, and pH between 7.9

and 8.5; — Ozone: summary of minimum percent removal with contact time 24

minutes (study results also list greater than 80 percent removal of hydrocodone);

— AOP with UV irradiation and hydrogen peroxide: UV dose equals 372 millijoules per square centimeter (mJ/cm2) and H2O2 dose equal to 5 mg/L.

During the December 11, 2008 conference call with Dr. Bryan Boulanger, Texas A&M University, Dr. Boulanger noted that part of their university research is looking at technologies to treat pharmaceuticals—specifically ones that use advance oxidation. Current technology results for the advance oxidation processes included high dissolved organic carbon due to the degradation of biomatter (U.S. EPA, 2008d).

• Low-pressure membranes without substantial pretreatment were not effective in

the removal of the target compounds. However, the data did show potential for removal of steroids using MF/UF membranes, especially when it is a membrane bioreactor (MBR). MBRs combine membrane filtration with biological treatment into a single process.

• High-pressure membranes, RO and NF membranes, removed nearly all

compounds to levels less than the method reporting limits. During full-scale testing, using a second pass through the RO system demonstrated additional removals. The study noted that a multi-barrier approach to contaminant removal was most successful, such as the double-pass RO or RO/AOP combination.

• Magnetic ion exchange (IX) was not as effective as other water treatment

processes. Most neutral compounds were poorly removed. However, three pharmaceuticals, diclofenac, naproxen, and triclosan had removals greater than 50 percent.


Table 5-2. Percent Removal of Pharmaceuticals in Drinking and Reuse Water Treatment Processes

Water Treatment Processes (a) by Percent Removal Range Target Compound Type of Compound >80% 50 to 80% 20 to 50% <20% Acetaminophen Analgesic

(pharmaceutical) Oxidation (CL; OZONE; & UV-H2O2); Membrane (UF-MBR; RO)

PAC Membrane (NF) Coagulation/softening Membrane (MF; UF) Magnetic Ion Exchange (IX)

Caffeine Psychoactive compound (pharmaceutical)

Oxidation (OZONE) Membrane (UF-MBR; RO)

PAC; Oxidation (UV-H2O2) Membrane (NF)

Coagulation/softening Oxidation (CL) Membrane (MF; UF) Magnetic IX

Carbamazepine Psychoactive compound (pharmaceutical)

Oxidation (OZONE; UV-H2O2) Membrane (RO)

PAC; Membrane (NF)

Membrane (UF-MBR) Coagulation/softening Oxidation (CL) Membrane (MF; UF) Magnetic IX

Diazepam (c) Psychoactive compound (pharmaceutical)

Membrane (RO) PAC; Oxidation (OZONE; UV-H2O2) Membrane (NF)

Oxidation (CL) Membrane (UF)

Coagulation/softening Membrane (UF-MBR) Magnetic IX

Diclofenac Analgesic (pharmaceutical)

Oxidation (CL; OZONE; UV-H2O2); Magnetic IX Membrane (RO)

Membrane (NF) PAC Coagulation/softening Membrane (MF; UF; UF-MBR)

Dilantin Psychoactive compound (pharmaceutical)

Oxidation (UV-H2O2) Membrane (RO)

Oxidation (OZONE) Membrane (NF)

PAC; Magnetic IX

Coagulation/softening Oxidation (CL); Membrane (MF; UF; UF-MBR)

Erythromycin (e) Antibiotic Oxidation (CL; OZONE) Membrane (NF; RO)

Oxidation (UV-H2O2) PAC; Membrane (UF; UF-MBR)

Coagulation/softening Membrane (MF)

Estradiol Steroid (b) Oxidation (CL; OZONE; UV-H2O2) Membrane (RO)

PAC Membrane (UF-MBR; NF)

Membrane (UF) Magnetic IX


Fluoxetine Psychoactive compound (pharmaceutical)

PAC; Oxidation (OZONE; UV-H2O2) Membrane (UF; NF; RO)

Membrane (MF; UF-MBR)

Coagulation/softening Oxidation (CL) Magnetic IX



Water Treatment Processes (a) by Percent Removal Range Target Compound Type of Compound >80% 50 to 80% 20 to 50% <20% Gemfibrozil Heart medication

(pharmaceutical) Oxidation (OZONE; UV-H2O2); Membrane (RO)

Oxidation (CL) Membrane (NF)

PAC; Membrane (UF-MBR) Magnetic IX

Coagulation/softening Membrane (MF; UF)

Hydrocodone (d) Analgesic (pharmaceutical)

Membrane (RO) Membrane (NF) Membrane (UF-MBR)

Membrane (MF; UF)

Ibuprofen Analgesic (pharmaceutical)

Oxidation (UV-H2O2); Membrane (RO)

Oxidation (OZONE) Membrane (UF-MBR; NF)

Magnetic IX Coagulation/softening PAC; Oxidation (CL) Membrane (MF; UF)

Iopromide Contrast media (x-ray) Membrane (NF; RO) Oxidation (UV-H2O2) Oxidation (OZONE) Coagulation/softening PAC; Magnetic IX Oxidation (CL); Membrane (MF; UF; UF-MBR)

Meprobamate Psychoactive compound (pharmaceutical)

Membrane (RO) Membrane (NF) PAC Oxidation (OZONE; UV-H2O2)

Coagulation/softening Oxidation (CL) Membrane (MF; UF; UF-MBR); Magnetic IX

Naproxen Analgesic (pharmaceutical)

Oxidation (CL; OZONE; UV-H2O2) Membrane (UF-MBR; RO)

Magnetic IX PAC Membrane (NF)

Coagulation/softening Membrane (MF; UF)

Oxybenzone Sunscreen PAC; Oxidation (CL; OZONE; UV-H2O2) Membrane (UF-MBR; NF; RO)

Membrane (UF) Magnetic IX Coagulation/softening Membrane (MF)

Pentoxifylline Heart medication (pharmaceutical)

Oxidation (OZONE) Membrane (UF-MBR; RO)

PAC; Membrane (NF) Oxidation (UV-H2O2)

Oxidation (CL)

Coagulation/softening Membrane (MF; UF) Magnetic IX

Sulfamethoxazole Antibiotic Oxidation (CL; OZONE; UV-H2O2) Membrane (RO)

Membrane (NF) PAC; Magnetic IX Membrane (UF; UF-MBR)




Water Treatment Processes (a) by Percent Removal Range Target Compound Type of Compound >80% 50 to 80% 20 to 50% <20% Triclosan Germicide PAC; Magnetic IX

Oxidation (CL; OZONE; UV-H2O2) Membrane (UF; NF; RO)

Membrane (UF-MBR) Membrane (MF) Coagulation/softening

Trimethoprim Antimicrobial Oxidation (CL; OZONE; UV-H2O2) Membrane (RO)

PAC Membrane (NF)

Membrane (UF-MBR) Coagulation/softening Membrane (MF; UF) Magnetic IX

Source: AWWARF, 2007. a – Water treatment process abbreviations include PAC for powdered activated carbon; CL for chlorine oxidation; OZONE for ozone oxidation; UV-H2O2 for advanced oxidation process of UV irradiation and hydrogen peroxide; MF for microfiltration, UF for ultrafiltration, UF/MBR for biologically active UF membrane, NF for nanofiltration, and RO for reverse osmosis. b – Additional steroids included in study, but not presented here. c – For microfiltration (MF), diazepam was not detected and therefore no percent removal is available. d – Removal data only available for membrane systems. e – Results were not available for the removal of erythromycin for magnetic ion exchange.

Memorandum October 8, 2009 5.5 Emerging Wastewater Treatment Technologies

As part of the industry review, EPA looked into emerging technologies that might be used to assist health care facilities in treating pharmaceutical wastes and meeting disposal regulations. EPA met with Clear River Enviro who are developing a product, Pharma Drain™ (patent-pending), to be used in patient care areas, such as nursing stations and doctor’s office. Clear River Enviro is also working on a system to incorporate pill disposal by turning the pill into a liquid before going through the Pharma Drain™. Clear River Enviro has a university partner that is working with ultraviolet (UV) light and nanophotonics for use in the Pharma Drain™. They are also looking into aquaporins, cell membrane proteins that regulate the flow in and out of cells, for a natural reverse osmosis option (U.S. EPA, 2009i). 5.6 Control of Unused Pharmaceuticals by Rendering Irretrievable

To prevent diversion of pharmaceuticals, especially controlled substances, health care facilities render waste pharmaceuticals irretrievable. Facilities are required to render waste controlled substances irretrievable to meet DEA requirements. One DEA-approved method of disposal for waste controlled substances is disposal down the drain. To avoid disposal of controlled substances down the drain, facilities might mix the unused pharmaceutical with an inert substances, such water (solvent) or an adsorbent material (e.g., kitty litter or coffee grounds). The waste pharmaceutical is then disposed in the regular trash. The 2009 Office of National Drug Control Policy guidance, Proper Disposal of Prescription Drugs, recommends that consumers flush certain medications down the toilet or drain, use community drug take-back programs or household hazardous waste collection events, or perform the following actions:

• Take your prescription drugs out of their original containers. • Mix drugs with an undesirable substance, such as cat litter or used coffee grounds. • Put this mixture into a disposable container with a lid, such as an empty

margarine tub, or into a sealable bag. • Conceal or remove any personal information, including Rx number, on the empty

containers by covering it with black permanent marker or duct tape, or by scratching it off.

• Place the sealed container with the mixture, and the empty drug containers, in the trash.

As discussed in Section 5.2, some facilities grind or shred wastes (prior to sterilization) to render the waste unrecognizable and irretrievable. This might be a potential way that controlled substances are being disposed. 6. REFERENCES

1. AWWARF. 2007. American Water Works Association Research Foundation. Removal of EDCs and Pharmaceuticals in Drinking and Reuse Treatment Processes. Denver, Co. Prepared by Shane A. Snyder, Eric C. West and Hongxia (Dawn) Lei, Southern Water


Authority, Henderson, NV and Paul Westerhoff and Yeomin Yoon, Arizona State University, Tempe, AZ. EPA-HQ-OW-2006-0771-1759.

2. Burmahl. 2004. Beth Burmahl. “Selecting A Winning Waste Disposal Technology.“

Health Facilities Managment Magazine. August 2004. EPA-HQ-OW-2008-0517, DCN 06783.

3. Cook, 2009. Letter from Jennifer Cook, Pharmacy Unit Manager for MaineCare Services

to MaineCare Providers. Initial Prescription Limits (Phase III). September 25, 2009. EPA-HQ-OW-2008-0517, DCN 07075.

4. ERG. 2008. Site Visit Report for Capital Returns, Milwaukee, WI. Prepared for EPA

Office of Water. Chantilly, VA. EPA-HQ-OW-2006-0771-1792. 5. ERG, 2008b. Site Visit Report for Abbott Northwestern Hospital. Prepared for EPA

Office of Water. Chantilly, VA. EPA-HQ-OW-2006-0771-1785. 6. ERG. 2008c. Site Visit Report for North Memorial Hospital. Prepared for EPA Office of

Water. Chantilly, VA. EPA-HQ-OW-2006-0771-1770. 7. ERG. 2009. Meeting Summary for Omnicare Long Term Care Pharmacy (Annapolis

Junction, MD). Prepared for EPA Office of Water. Chantilly, VA. EPA-HQ-OW-2008-0517, DCN 06434.

8. ERG. 2009b. Site Visit Report for Walter Reed Army Medical Center, Washington, DC.

Prepared for EPA Office of Water. Chantilly, VA. EPA-HQ-OW-2008-0517, DCN 06437.

9. ERG. 2009c. Site Visit Report for Capital Hospice. Prepared for EPA Office of Water.

Chantilly, VA. EPA-HQ-OW-2008-0517, DCN 06576. 10. ERG. 2009d. Site Visit Report for Thomas Jefferson University Hospital. Prepared for

EPA Office of Water. Chantilly, VA. EPA-HQ-OW-2008-0517, DCN 06435. 11. ERG. 2009e. Site Visit Report for Baltimore VA Hospital. Prepared for EPA Office of

Water. Chantilly, VA. EPA-HQ-OW-2008-0517, DCN 06433. 12. ERG. 2009f. Site Visit Report for Fairfax-Northern Virginia Hematology-Oncology P.C.

Prepared for EPA Office of Water. Chantilly, VA. EPA-HQ-OW-2008-0517, DCN 06577.

13. Gilliam, A. 2007. Comments on the Preliminary 2008 Effluent Guidelines Program Plan.

EPA-HQ-OW-2006-0771-0824.

Memorandum October 8, 2009 14. H2E. 2006. Hospitals for a Healthy Environment. Managing Pharmaceutical Waste: A

10-Step Blueprint for Health Care Facilities in the United States. April 15. EPA-HQ-OW-2006-0771-0244.

15. Health Care Without Harm. 2001. Non-Incineration Medical Waste Treatment

Technologies. Washington, DC. August 2001. EPA-HQ-OW-2008-0517, DCN 07076. 16. Heller. 2008. Katherine Heller and Vesall Nourani. Economic Impacts of Revised MACT

Standards for Hospital/Medical/Infectious Waste Incinerators. RTI International. Prepared for the U.S. EPA Office of Air and Radiation. Research Triangle Park, NC. EPA-HQ-OW-2008-0517, DCN 06837.

17. MNTAP. 2007. Reducing Pharmaceutical Waste from Patient Care Settings. Minnesota

Technical Assistance Program, University of Minnesota. Available online at http://mntap.umn.edu/health/94-PharmWaste.htm. Date accessed February 2007. EPA-HQ-OW-2006-0771-0048.

18. Personal Communication, 2009. Telephone call between Kathleen Wu, ERG and Dave

Doane, Talyst. August 12, 2009. EPA-HQ-OW-2008-0517, DCN 06727. 19. Practice Greenhealth. 2008. Managing Pharmaceutical Waste: A 10-Step Blueprint for

Health Care Facilities in the United States. Revised August 2008. EPA-HQ-OW-2008-0517, DCN 06822.

20. Stephenson, R., and J. Oppenheimer. 2007. Fate of Pharmaceuticals and Personal Care

Products Through Municipal Wastewater Treatment Processes. Water Environment Research Foundation. 03-CTS-22UR. EPA-HQ-OW-2006-0771-1704.

21. Talyst. 2009. Product Specification: Talyst InsiteTM 240. EPA-HQ-OW-2008-0517, DCN

06786. 22. Talyst. 2009a. Product Specification: Talyst InsiteTM 500. EPA-HQ-OW-2008-0517,

DCN 06787. 23. U.S. EPA. 2008. Memorandum: Health Care Industry Study – Outreach Meeting with the

American Health Care Association (AHCA), November 5, 2008. Office of Water, December 23, 2008. EPA-HQ-OW-2008-0517, DCN 06258.

24. U.S. EPA. 2008b. Economic Impacts of Revised MACT Standards for

Hospital/Medical/Infectious Waste Incinerators: Final Report. Office of Air Quality Planning and Standards. Prepared by RTI International. Research Triangle Park, NC. EPA-HQ-OW-2008-0517, DCN 06837.

Memorandum October 8, 2009 25. U.S. EPA. 2008d. Memorandum: Health Care Industry Study – Meeting with Bryan

Boulanger, Texas A&M University, December 11, 2008. Office of Water. EPA-HQ-OW-2008-0517, DCN 06265.

26. U.S. EPA. 2008e. National Biennial RCRA Hazardous Waste Report: Based on 2007

Data (EPA 530-R-08-012). Office of Solid Waste and Emergency Response. November 2008. EPA-HQ-OW-2008-0517, DCN 07077.

27. U.S. EPA. 2009. Memorandum: Health Care Industry Study – Teleconference with Bruce

Cunha, Marshfield Clinic, May 20, 2009. Office of Water, June 3, 2009. EPA-HQ-OW-2008-0517, DCN 06573.

28. U.S. EPA. 2009b. Memorandum: Health Care Industry Study – Teleconference with

Alexian Brothers Medical Center, April 6, 2009. Office of Water, April 20, 2009. EPA-HQ-OW-2008-0517, DCN 06438.

29. U.S. EPA. 2009c. Memorandum: Health Care Industry Study – Meeting with Talyst,

February 24, 2009. Office of Water, March 10, 2009. EPA-HQ-OW-2008-0517, DCN 06501.

30. U.S. EPA. 2009d. Memorandum: Health Care Industry Study – Meeting with ExcelleRx,

February 9, 2009. Office of Water, February 20, 2009. EPA-HQ-OW-2008-0517, DCN 06296.

31. U.S. EPA. 2009e. Memorandum: Health Care Industry Study – Outreach Meeting with

the American Society of Consultant Pharmacists (ASCP), November 3, 2008. Office of Water, February 16, 2009. EPA-HQ-OW-2008-0517, DCN 06256.

32. U.S. EPA. 2009f. Memorandum: Health Care Industry Study - Meeting with Stericycle,

April 16, 2009. Office of Water, April 30, 2009. EPA-HQ-OW-2008-0517, DCN 06439. 33. U.S. EPA. 2009g. Memorandum: Health Care Industry Study - Meeting with Stericycle,

July 23, 2009. Office of Water, August 4, 2009. EPA-HQ-OW-2008-0517, DCN 06497. 34. U.S. EPA. 2009h. Memorandum: Health Care Industry Study - Meeting with the Long

Term Care Pharmacy Alliance (LTCPA), July 23, 2009. Office of Water, August 4, 2009. EPA-HQ-OW-2008-0517, DCN 06295.

35. U.S. EPA. 2009i. Memorandum: Health Care Industry Study – Meeting with Clear River

Enviro, LLC, April 3, 2009. Office of Water. EPA-HQ-OW-2008-0517, DCN 06575. 36. Washington State Department of Ecology. Pharmaceutical Waste Management

Overview. Retrieved from: http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/pages/wastemanagementFC.pdf. EPA-HQ-OW-2008-0517, DCN 06785.

http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/pages/wastemanagementFC.pdf

http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/pages/wastemanagementFC.pdf

Attachment A

MANAGEMENT AND DISPOSAL PRACTICES FROM SITE VISITS AND OUTREACH MEETINGS

A-1

Table A-1. Summary of Pharmaceutical Management and Disposal Practices from Outreach Meetings and Site Visits

Unused Pharmaceutical Stream Type of Pharmaceutical

Management and Disposal Practices Observed/Reported Types of Facilities

Inventory control/stock rotation. Non-Controlled Substance Processing through a reverse distributor for credit.

Hospitals and LTCFs (through their long-term care pharmacy).

Inventory control/stock rotation. Processing through a reverse distributor for credit.

Hospitals only. Requires on-site staff to be DEA registrants, and LTCFs cannot typically use reverse distributors for controlled substances.

Return to pharmacy for reuse or disposal (a).

LTCF (through their long-term care pharmacy).

Controlled Substance

Flush/Drain disposal. Hospitals and LTCFs. Hazardous Waste Hospitals and LTCFs. Hazardous Chemotherapy Waste

Hospitals and LTCFs.

Radioactive Waste

Using waste segregation or waste tracking services by waste management company.

Hospitals. LTCFs do not typically handle radioactive waste. Inventory control/stock rotation.

Expired Unopened/Unused Pharmaceuticals

Unmixed IVs Processing through a reverse distributor for credit.

Hospitals and LTCFs (for those LTCFs that do mix IVs or who store unmixed IVs on site in case of emergency).

A-2




Inventory control/stock rotation. Hospitals and LTCFs. Limited dose dispensing (e.g., single-dose).

Automatic dispensing system (ADS). Return to pharmacy for redistribution and credit.

Hospitals and LTCFs (if not dispensed to patient).

Processing through a reverse distributor for credit.

Non-Controlled Substance

Donation to free clinics or state donation (repository) programs.

Must meet state regulations.

Inventory control/stock rotation. Hospitals and LTCFs. Dose dispensing. Automatic dispensing system (ADS). Return to pharmacy for redistribution and credit. Processing through a reverse distributor for credit.

Hospitals. LTCFs cannot return controlled substances to an off-site pharmacy (requires sender and recipient to be DEA registrants).

Donation to free clinics or state donation (repository) programs – must meet DEA regulations.

Must meet DEA and regulations. Most states do not allow the donation of controlled substances.

Controlled Substance

Flush/Drain disposal Hospitals and LTCFs.

Unopened/Unused Pharmaceuticals (not yet expired)

Chemotherapy Agents Donation to free clinics or state donation (repository) programs.

Must meet state regulations.

A-3




Inventory control/stock rotation. Processing through a reverse distributor for credit.

Hospitals and LTCFs (through their long-term care pharmacy).

Return to pharmacy for proper disposal. LTCFs (through their long-term care pharmacy). Placement in regular trash. Hospitals and LTCFs. Incineration: waste to energy recovery or low temperature

Hospitals

Non-Controlled Substance: Tablets in pharmacies Non-Controlled Substance: Tablets on patient/resident floor

Flush/Drain disposal. LTCFs Non-Controlled Substance: IVs

Flush/Drain disposal. Hospitals and LTCFs.

Inventory control/stock rotation. Hospitals and LTCFs (through their long-term care pharmacy).

Processed through a reverse distributor for credit.

Hospitals only. Requires on-site staff to be DEA registrants, and LTCFs cannot typically use reverse distributors for controlled substances.

Crushing/destroying tablets and discarding with biohazardous waste (red bag).


Crushing and mixing tablets with kitty litter or solvent such as water and discard in regular trash.

LTCFs. Not commonly performed at hospitals

Controlled Substance: Tablets

Return to pharmacy for proper disposal (a).

LTCFs (through their long-term care pharmacy).

Controlled Substance: IVs Flush/Drain disposal Placement in sharps container (may be cut up prior to placement or just folded).

Controlled Substances: Used patches

Cutting and placement in regular trash.




Hazardous waste incineration. Hospitals and LTCFs.

Opened Pharmaceuticals

Hazardous Waste

Hazardous waste landfill. Hospitals and LTCFs.

A-4




Hazardous Chemotherapy Waste and containers with measurable amounts of RCRA hazardous chemotherapy pharmaceuticals

Using waste segregation or waste tracking services by waste management company. Hazardous waste incineration.


Trace (Nonhazardous) Chemotherapy Waste and containers with nonmeasurable amounts of hazardous chemotherapy pharmaceuticals (defined as RCRA-empty at 40 CFR Part 261.7)

Using waste segregation or waste tracking services by waste management company. Incineration


Sharps Using waste segregation or waste tracking services by waste management company. See Sharps Waste below.



Radioactive Waste

Collection and placement in long-term storage until radioactive level is equal to background and then disposal by contract waste hauler (as regular trash).

Hospitals

Biohazardous Waste (Red Bag)

All types of nonhazardous pharmaceuticals if facility disposes with red bag waste

Sterilized and to landfill. Hospitals and LTCFs.

Sharps Waste (Red Box) Used patches from patient floors.

Sterilized and to landfill. Incineration


a – Practice observed during site visit to LTCF. Although the pharmacy recommended this, DEA regulations do not allow the transfer of controlled substances from the LTCF (not a DEA registrant). There are two exceptions to these requirements: 1) return is to a contracted pharmacy with approval from regional DEA office and State Board of Pharmacy; and 2) return occurs using an automated dispensing system.

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