EPA-821-R-08-013
wEPA
United States
Environmental Protection
Agency
Health Services Industry Study
Management and Disposal of Unused
Pharmaceuticals
(Interim Technical Report)
August 2008
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DISCLAIMER
The discussion in this document is intended solely as the interim technical report. The statutory
provisions and regulations of the U.S. Environmental Protection Agency (EPA) described in this
document contain legally binding requirements. This document is not a regulation itself, nor does
it change or substitute for those provisions and regulations. Thus, it does not impose legally
binding requirements on EPA, states or the regulated community. This document does not confer
legal rights or impose legal obligations upon any member of the public. While EPA has made
every effort to ensure the accuracy of the discussion in this document, the obligations of the
regulated community are determined by statutes, regulations or other legally binding
requirements. In the event of a conflict between the discussion in this document and any statute
or regulation, this document would not be controlling.
The general descriptions provided here may not apply to particular situations based upon the
circumstances. Interested parties are free to raise questions and objections about the substance of
this document and the appropriateness of the application of this document to a particular
situation. EPA and other decision makers retain the discretion to adopt approaches on a case-by-
case basis that differ from those described in this document where appropriate.
Mention of trade names or commercial products does not constitute an endorsement or
recommendation for their use. This document may be revised periodically without public notice.
EPA welcomes public input on this document at any time.
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CONTENTS
Page
1. INTRODUCTION 1-1
2. INDUSTRY PROFILE 2-1
2.1 Number of Facilities 2-4
2.2 Revenues and Employees 2-7
2.3 Number of Companies 2-8
2.4 Number of Small Businesses 2-8
2.5 Ownership 2-10
2.6 Discharge Information 2-11
2.7 Financial Characteristics 2-13
2.7.1 Operating Statistics 2-13
2.7.2 Major Players 2-16
2.7.3 Current Ratio 2-17
2.7.4 Profit Before Taxes 2-18
3. POLLUTANTS OF CONCERN 3-1
3.1 Sources of Pharmaceutical Waste at Health Services Facilities 3-1
3.2 Potential Fate and Effects of Pharmaceuticals atPOTWs 3-2
3.3 Presence of Pharmaceuticals in Water 3-3
4. FACTORS AFFECTING DISPOSAL PRACTICES 4-1
4.1 Federal Regulations 4-1
4.1.1 Controlled Substances Act 4-1
4.1.2 Resource Conservation and Recovery Act (RCRA) 4-2
4.1.3 Medicare andMedicaid 4-4
4.1.4 Health Insurance Portability and Accountability Act (HIPAA) 4-6
4.2 State Regulations 4-6
4.3 Other Factors That Affect Disposal Practices 4-21
4.3.1 LTCFs 4-21
4.3.2 Hospitals 4-22
5. ALTERNATIVES TO WASTEWATER DISPOSAL INCLUDING MANAGEMENT PRACTICES
AND TREATMENT OPTIONS FOR UNUSED PHARMACEUTICALS 5-1
5.1 Current Guidance on Pharmaceutical Waste Management 5-1
5.1.1 Hospitals for a Healthy Environment (H2E) 5-1
5.1.2 Product Stewardship Institute (PSI) 5-2
5.1.3 The Joint Commission 5-2
5.2 Summary of Pharmaceutical Management Practices 5-3
5.2.1 Waste Minimization Techniques 5-3
5.2.2 Reverse Distribution 5-5
5.2.3 Pharmaceutical Waste Disposal Practices 5-5
5.3 Treatment Options 5-8
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CONTENTS (Continued)
Page
6. PATHWAYS FOR ENVIRONMENTAL RELEASES OF UNUSED PHARMACEUTICALS 6-1
6.1 Disposal to Sewer 6-1
6.1.1 Mechanisms for Removal 6-1
6.1.2 Effect of POTW Operating Conditions 6-1
6.1.3 POTW Removal Efficiencies 6-2
6.2 Incineration 6-3
6.3 Disposal to Landfill 6-5
7. DATA COLLECTION STATUS 7-1
7.1 Site Visits 7-1
7.1.1 Capital Returns, Milwaukee, WI 7-1
7.1.2 North Memorial Hospital, Robbinsdale, MN 7-2
7.1.3 Abbott Northwestern, Minneapolis, MN 7-2
7.2 Pharmaceutical Disposal Information from Technical Literature 7-3
7.2.1 Quantities and Identities of Pharmaceuticals 7-3
7.2.2 Reasons for Pharmaceutical Waste 7-4
7.2.3 Disposal Methods 7-4
7.2.4 Examples of Pharmaceutical Waste Management and Alternate
Disposal Methods 7-5
8. NEXT STEPS 8-1
8.1 Industry Questionnaire 8-1
8.2 Site Visits 8-2
8.3 Additional Review of Technical Literature 8-2
9. REFERENCES 9-1
Appendix A: GLOSSARY
11
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LIST OF TABLES
Page
2-1 Bridge Between NAICS and SIC for In-Scope NAICS 2-3
2-2 Bridge Between SIC and NAICS 2-3
2-3 Number of Hospitals by State (2005) 2-4
2-4 Number of In-Scope Nursing and Residential Care Facilities by State (2005) 2-5
2-5 Number of Establishments in 1998, 2002, and 2005 by NAICS Based on County
Business Patterns 2-7
2-6 Nationwide Summary by NAICS (2002) Based on Census 2002 2-8
2-7 Number of Single-Unit and Multi-Unit Firms (2002) 2-8
2-8 Establishment Small Businesses (2002) 2-9
2-9 Firm Small Businesses (2002) 2-9
2-10 For-Profit and Not-for-Profit Establishments (2002) 2-10
2-11 Legal Form of Organization for Establishments (2002) 2-11
2-12 2004 TRI and PCS Facility Counts 2-12
2-13 Typical Pay or Mix for Hospitals 2-13
2-14 Key Operating Statistics of For-Profit Hospital Systems (Quarter Ended
September 30, 2006, Except as Noted) 2-14
2-15 Comparative Company Analysis — 2005 Data 2-15
2-16 Top 10 Largest Healthcare Systems (Ranked by 2005 Net Patient Revenues) 2-16
2-17 Top 15 Nursing Homes Chains — 2005 (Ranked by Number of Facilities) 2-16
2-18 Top 15 Assisted Living Chains — 2005 (Ranked by Number of Beds) 2-17
2-19 2006 Current Ratio of Assets to Liabilities (Liquidity) 2-17
2-20 2006 Profit Before Taxes (%) 2-18
3-1 Concentrations of Selected Pharmaceuticals in Wastewater, Surface Water, and
Groundwater 3-3
3-2 Concentrations of Pharmaceutical Compounds in Effluent from Two Norwegian
Hospitals 3-6
iii
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LIST OF TABLES (Continued)
Page
4-1 Example of Pharmaceutical Waste Management Practices 4-3
4-2 State Regulations for Pharmacy Services at Nursing Homes 4-7
6-1 POTW Removal Efficiencies for Specific Pharmaceuticals in Selected Studies 6-2
7-1 Average Use of Disposal Practices Reported by Santa Barbara Hospitals, LTCFs,
and Pharmacies 7-5
IV
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LIST OF FIGURES
Page
5-1 Example Pharmaceutical Waste Management Flow Chart 5-6
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1. INTRODUCTION
Under the Clean Water Act (CWA), EPA establishes national regulations (called effluent
limitations guidelines and standards) to reduce discharges of pollutants from industries to surface
waters and publicly owned treatment works (POTWs). Section 304(m) of the CWA requires
EPA to publish a final Effluent Guidelines Program Plan every other year and to give the public
an opportunity to comment on such plan before it is final. EPA selected the health services
industry for further analysis in the 2006 Plan (EPA, 2006a) based in part on public concern about
disposal of unused pharmaceuticals from health services facilities and information from other
studies that investigated the presence and potential effects of pharmaceuticals in U.S. waters.
EPA received 17 comments on the 2006 Plan that raised concerns about discharges from health
services facilities. EPA divided the study of discharges from the health services industry into two
study areas: 1) disposal of unused pharmaceuticals to surface water and 2) discharge of mercury
from dental amalgam to surface water (see EPA-HQ-OW-2006-0771, DCN 05518). This interim
report discusses the disposal of unused pharmaceuticals and addresses the following questions:
• How many health services entities exist in the U.S., and how are they structured?
• What unused pharmaceuticals are discharged to surface water (i.e., what are the
pollutants of concern?) What are the current industry practices for disposing of
unused pharmaceuticals and why? Do publicly owned treatment works (POTWs)
report pass-through or interference problems related to unused pharmaceutical
discharges?
• What are the federal, state, or local requirements or guidance for disposal of
unused pharmaceuticals? How are control authorities currently limiting unused
pharmaceutical discharges?
• What management practices and technologies are used as alternatives to
wastewater disposal and/or to control discharges? How effective are these
practices and technologies?
• What are the pathways for the release of unused pharmaceuticals into the
environment?
• What is the amount of unused pharmaceuticals currently being disposed? What
are the costs of the identified technologies and/or management practices?
• What are EPA's next steps in studying the disposal of unused pharmaceuticals to
surface water?
To date, EPA's analysis has focused on hospitals and Long-Term Care Facilities
(LTCFs). EPA plans to expand the scope of its study to include discharges from hospices and
veterinary facilities. This report describes EPA's analysis of unused pharmaceutical discharges
from hospitals and LTCFs and is organized into the following sections:
• Section 2 provides a preliminary profile of the health services industry that
includes the number of hospitals and LTCFs, the number of small businesses,
discharge information, and financial characteristics;
• Section 3 discusses the sources of pharmaceuticals in the environment, the
potential fate of pharmaceuticals at POTWs, and detected concentrations of
pharmaceuticals in wastewater, surface water, and groundwater;
• Section 4 describes the federal and state requirements and other factors that affect
unused pharmaceutical disposal practices currently used by hospitals and LTCFs;
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Section 5 describes management practices and technologies currently used by
hospitals and LTCFs as alternatives to reduce the amount of unused
Pharmaceuticals disposed of in wastewater;
Section 6 describes the pathways through which pharmaceuticals are released to
water, land, and air;
Section 7 describes case studies of hospitals and LTCFs: the quantities and types
of pharmaceuticals disposed of in wastewater, management practices, alternate
disposal methods, and costs associated with disposal;
Section 8 summarizes EPA's 2008 annual review of hospitals and LTCFs and
describes the next steps planned for the 2009 annual review, which is planned to
also include veterinary facilities and hospices.
1-2
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2. INDUSTRY PROFILE
This section provides a preliminary profile of hospitals and LTCFs. The economic data
include the number of establishments in each sector, the number of small businesses, discharge
information, and financial characteristics. For economic information on other health services
industry sectors, including offices, clinics, and veterinary care services, see EPA's 2007 industry
profile (ERG, 2007). EPA presents industry profile information using the North American
Industry Classification System (NAICS) codes and the Standard Industrial Classification (SIC)
codes. The U.S. Census Bureau classifies information by NAICS codes and EPA classifies
discharge information (Toxic Release Inventory (TRI) and Permit Compliance System (PCS)
database information) by SIC code.
Three NAICS codes apply to hospitals and three NAICS codes apply to LTCFs. These
NAICS codes are listed below along with the Census Bureau's definition of each industry:
The following NAICS codes apply to hospitals:
• 622110 — General and Medical Surgical Hospitals. This industry comprises
establishments known and licensed as general medical and surgical hospitals
primarily engaged in providing diagnostic and medical treatment (both surgical
and nonsurgical) to inpatients with any of a wide variety of medical conditions.
These establishments maintain inpatient beds and provide patients with food
services that meet their nutritional requirements. These hospitals have organized
staffs of physicians and other medical personnel to provide patient care. These
establishments usually provide other services, such as outpatient services,
anatomical pathology services, diagnostic X-ray services, clinical laboratory
services, operating room services for a variety of procedures, and pharmacy
services.
• 622210 — Psychiatric and Substance Abuse Hospitals. This industry comprises
establishments known and licensed as psychiatric and substance abuse hospitals
primarily engaged in providing diagnostic, medical treatment, and monitoring
services for inpatients who suffer from mental illness or substance abuse
disorders. The treatment often requires an extended stay in the hospital. These
establishments maintain inpatient beds and provide patients with food services
that meet their nutritional requirements. They have organized staffs of physicians
and other medical personnel to provide patient care. Psychiatric, psychological,
and social work services are available at the facility. These hospitals usually
provide other services, such as outpatient services, clinical laboratory services,
diagnostic X-ray services, and electroencephalograph services.
• 622310 — Specialty (Except Psychiatric and Substance Abuse) Hospitals. This
industry consists of establishments known and licensed as specialty hospitals,
primarily engaged in diagnosing and treating inpatients with a specific type of
disease or medical condition (except psychiatric or substance abuse). Hospitals
providing long-term care for the chronically ill and hospitals providing
rehabilitation, restorative, and adjustive services to physically challenged or
disabled people are included in this industry. These establishments maintain
inpatient beds and provide patients with food services that meet their nutritional
requirements. They have organized staffs of physicians and other medical
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personnel to provide patient care. These hospitals may provide other services,
such as outpatient services, diagnostic X-ray services, clinical laboratory services,
operating room services, physical therapy services, educational and vocational
services, and psychological and social work services.
The following NAICS codes apply to LTCFs:
• 623110 — Nursing Care Facilities. This industry comprises establishments
primarily engaged in providing inpatient nursing and rehabilitative services. The
care is generally provided for an extended period of time. These establishments
have a permanent core staff of registered or licensed practical nurses who, along
with other staff, provide nursing and continuous personal care services.
• 623210 — Residential Mental Retardation Facilities. This industry comprises
establishments (e.g., group homes, hospitals, intermediate care facilities)
primarily engaged in providing residential care services for persons diagnosed
with mental retardation. These facilities may provide some health care, though the
focus is room, board, protective supervision, and counseling.
• 623310 — Continuing Care Retirement Communities. This industry comprises
establishments primarily engaged in providing a range of residential and personal
care services with onsite nursing care facilities for (1) the elderly and other
persons who are unable to fully care for themselves and/or (2) the elderly and
other persons who do not desire to live independently. Individuals live in a variety
of residential settings with meals, housekeeping, social, leisure, and other services
available to assist residents in daily living. Assisted-living facilities with onsite
nursing care facilities are included in this industry.
EPA also used the U.S. Census Bureau's bridge between NAICS and SIC to associate the
EPA discharge information with the appropriate NAICS code (Census, 1997a and 1997b).
Table 2-1 lists the bridge between the in-scope NAICS and SIC codes. Table 2-2 provides a
bridge from SIC code to NAICS code. For some industries there is not a 100 percent direct
comparison between NAICS and SIC. For example, SIC 8361 (residential care) does not fully
flow into in-scope NAICS codes. NAICS 623210 (residential mental retardation facilities)
includes approximately 18 percent of SIC 8361, with the remainder of the establishments out of
the NAICS 623210 scope (Census, 1997b).
2-2
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Table 2-1. Bridge Between NAICS and SIC for In-Scope NAICS
NAICS Code
6221 10: General Medical and Surgical Hospitals
622210: Psychiatric and Substance Abuse Hospitals
622310: Specialty (Except Psychiatric and Substance
Abuse) Hospitals
623 1 10: Nursing Care Facilities
623210: Residential Mental Retardation Facilities
6233 1 1 : Continuing Care Retirement Communities
SIC Code
8062: General Medical and Surgical Hospitals
8069: Substance Abuse Hospitals
8063 : Psychiatric Hospitals
8069: Specialty Hospitals, Except Psychiatric
8051: Skilled Nursing Care Facilities
8052: Intermediate Care Facilities
8059: Nursing and Personal Care Facilities, Not
Classified
Elsewhere
805 1 : Skilled Nursing Care Facilities
8052: Intermediate Care Facilities
8059: Nursing and Personal Care Facilities, Not
Classified
Elsewhere
8361 Residential Care
Not applicable
Source: Census, 1997aand 1997b.
Table 2-2. Bridge Between SIC and NAICS
SIC Descriptions
Nursing Homes and
Assisted Living
Facilities
Intermediate Care
Facilities
Nursing and Personal
Care Facilities, Not
Elsewhere Classified
Hospitals, General
Medical and Surgical
Hospitals, Mental
(Except Mental
Retardation)
Hospitals, Specialty
(Except Psychiatric)
SIC
8051
8051
8052
8052
8059
8059
8062
8063
8069
8069
8069
Percent of SIC is
split into NAICS
Not available
100%
100%
3%
9%
88%
Not applicable
NAICS
623110
623210
623110
623210
623110
623210
622110
622210
622110
622210
622310
623311
NAICS Description
Nursing Care Facilities
Residential Mental Retardation Facilities
Nursing Care Facilities
Residential Mental Retardation Facilities
Nursing Care Facilities
Residential Mental Retardation Facilities
General Medical and Surgical Hospitals
Psychiatric and Substance Abuse Hospitals
General Medical and Surgical Hospitals
Psychiatric and Substance Abuse Hospitals
Specialty (Except Psychiatric and
Substance Abuse) Hospitals
Continuing Care Retirement Communities
Source: Census, 1997aand 1997b.
2-3
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2.1 Number of Facilities
Table 2-3 provides state totals for hospitals (NAICS 622) and Table 2-4 lists the number
of LTCFs (NAICS 623). Table 2-5 presents the changes in the number of establishments
between 1998 and 2005 and compares data from three Census collection periods. In general, the
health services industry has grown. Specialty hospitals (NAICS 622310), such as those treating
patients with cancer, grew by more than 100 percent in the last seven years. More moderate
increases (40 to 60 percent) were seen in residential mental retardation facilities (NAICS
623210) and continuing care retirement communities (NAICS 623311). The number of
psychiatric and substance abuse hospitals (NAICS 622210) decreased 15 percent.
Table 2-3. Number of Hospitals by State (2005)
State
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of Columbia
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
NAICS 622110, General
Medical and Surgical
108
24
77
81
439
76
35
11
12
234
159
21
46
213
120
121
139
106
149
39
55
84
154
138
99
130
58
91
32
NAICS 622210,
Psychiatric and
Substance Abuse
10
1
9
10
71
7
11
3
o
5
48
21
2
6
22
27
5
4
17
27
6
23
24
19
4
7
18
4
4
10
NAICS 622310, Specialty
(Except Psychiatric and
Substance Abuse)
14
1
26
14
59
13
6
1
o
3
116
22
4
4
13
27
6
13
17
64
2
16
24
24
7
10
10
0
5
8
2-4
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Table 2-3. Number of Hospitals by State (2005)
State
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Total U.S.
NAICS 622110, General
Medical and Surgical
27
98
44
231
125
44
174
120
61
217
15
72
57
143
441
46
15
92
103
59
127
24
5,386
NAICS 622210,
Psychiatric and
Substance Abuse
2
19
6
47
16
o
6
20
20
2
39
2
6
0
14
45
6
2
19
7
7
12
5
722
NAICS 622310, Specialty
(Except Psychiatric and
Substance Abuse)
4
38
13
20
14
4
34
30
4
59
3
5
o
6
21
149
6
0
18
4
5
10
0
973
Source: Census, 2005a.
Table 2-4. Number of In-Scope Nursing and Residential Care Facilities by State (2005)
State
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of Columbia
NAICS 623110, Nursing
Care Facilities
250
6
180
323
1,501
211
276
52
16
NAICS 623210,
Residential Mental
Retardation Facilities
193
73
336
83
1,778
163
366
64
64
NAICS 623311,
Continuing Care
Retirement Communities
86
12
103
26
388
57
41
15
7
2-5
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Table 2-4. Number of In-Scope Nursing and Residential Care Facilities by State (2005)
State
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
NAICS 6231 10, Nursing
Care Facilities
815
490
38
88
775
421
396
297
306
323
111
338
569
493
366
213
554
69
177
52
95
406
90
700
519
72
949
380
183
942
103
185
96
329
1,217
104
53
307
287
NAICS 623210,
Residential Mental
Retardation Facilities
545
207
14
59
802
905
393
341
408
338
277
444
841
1,460
1,589
15
314
83
81
91
35
611
244
2,262
838
73
1,128
435
449
1,558
173
240
40
309
898
138
21
225
200
NAICS 623311,
Continuing Care
Retirement Communities
297
89
9
28
162
71
94
89
30
33
28
101
83
92
106
37
134
29
38
15
29
86
25
76
184
13
231
56
105
291
28
80
32
64
250
23
22
112
162
2-6
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Table 2-4. Number of In-Scope Nursing and Residential Care Facilities by State (2005)
State
West Virginia
Wisconsin
Wyoming
Total U.S.
NAICS 6231 10, Nursing
Care Facilities
145
377
23
17,268
NAICS 623210,
Residential Mental
Retardation Facilities
319
881
16
23,420
NAICS 623311,
Continuing Care
Retirement Communities
31
118
2
4,320
Source: Census, 2005a.
Table 2-5. Number of Establishments in 1998, 2002, and 2005 by NAICS Based on County
Business Patterns
NAICS
6221 10: General Medical and Surgical Hospitals
622210: Psychiatric and Substance Abuse Hospitals
622310: Specialty (Except Psychiatric and Substance
Abuse) Hospitals
623 1 10: Nursing Care Facilities
623210: Residential Mental Retardation Facilities
623311: Continuing Care Retirement Communities
Total
Number of Establishments
1998
5,646
848
466
16,060
14,771
3,055
40,846
2002
5,971
797
801
16,779
19,369
4,163
47,880
2005
5,386
722
973
17,268
23,420
4,320
52,089
% Change from
1998 to 2005
-5%
-15%
109%
8%
59%
41%
Source: Census, 1998, 2002, and2005a.
2.2 Revenues and Employees
Table 2-6 lists, for hospitals and LTCFs, the number of establishments, total revenues,
total number of paid employees, average revenue and average number of employees per
establishment based on the 2002 Economic Census data.1 Average revenue and average number
of paid employees were determined by dividing total revenue and total paid employees by the
total number of establishments, respectively. General and surgical hospitals (NAICS 622110)
showed much higher revenue per establishment than the other two hospital categories. For
LTCFs, nursing and continuing care facilities (NAICS 623110 and 623311) had higher revenue
per establishment than residential mental retardation facilities (NAICS 623210).
1 Note: Minor discrepancies in number of establishments arise when comparing County Business Patterns and
Economic Census data due to the different data collection methods. See U.S. Census Bureau, "Overview of
Economic Statistical Programs," http://www.census.gov/econ/ovemew/rndex.html, May 5, 2007.
2-7
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Table 2-6. Nationwide Summary by NAICS (2002) Based on Census 2002
NAICS
622110: General Medical
and Surgical Hospitals
622210: Psychiatric and
Substance Abuse Hospitals
622310: Specialty (Except
Psychiatric and Substance
Abuse) Hospitals
623 110: Nursing Care
Facilities
623210: Residential Mental
Retardation Facilities
6233 1 1 : Continuing Care
Retirement Communities
Total
Number of
Establishments
5,193
603
615
16,568
22,319
3,916
49,214
Revenues
($1,000)
469,726,928
13,626,730
16,759,183
74,116,741
13,279,613
14,861,905
$602,371,100
Paid
Employees
4,772,422
216,005
185,835
1,606,003
371,429
312,583
7,464,277
Average
Revenue per
Establishment
($1,000)
90,454
22,598
27,251
4,473
595
3,795
Employees per
Establishment
919
358
302
97
17
80
Source: Census, 2005b.
2.3 Number of Companies
Table 2-7 shows the number of establishments, total firms, and single- and multi-unit
firms. The majority of hospitals (NAICS 622) are multi-unit firms and the majority of LTCFs
(NAICS 623) are single-unit firms.
Table 2-7. Number of Single-Unit and Multi-Unit Firms (2002)
NAICS
622110: General Medical and Surgical Hospitals
622210: Psychiatric and Substance Abuse Hospitals
622310: Specialty (Except Psychiatric and
Substance Abuse) Hospitals
623 1 10: Nursing Care Facilities
623210: Residential Mental Retardation Facilities
623311: Continuing Care Retirement Communities
Total:
Number of
Firms
3,242
476
332
8,903
5,262
2,881
21,096
Number of
Establishments
5,193
603
615
16,568
22,319
3,916
49,214
Single Unit
Firms
1,543
87
130
7,301
3,602
2,298
14,961
Multi-Unit
Firms
1,699
389
202
1,602
1,660
583
6,135
Source: Census, 2005b.
2.4 Number of Small Businesses
Tables 2-8 and 2-9 list the Small Business Administration (SB A) size standard for each
NAICS industry and the number of establishments that meet these criteria. Table 2-8 presents the
NAICS industries with size standards below $10 million and uses data from the 2002 Census
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reporting of receipts/revenue size of establishments. Table 2-9 presents the NAICS industries
with size standards above $10 million and uses U.S. Census Company Statistics Data. Nursing
and continuing care facilities (NAICS 623110 and 623311) have a size standard of $12.5 million,
hospitals (NAICS 622) have a size standard of $31.5 million in annual receipts, and residential
mental retardation facilities (NAICS 623210) have a size standard of $9 million.
Table 2-8. Establishment Small Businesses (2002)
NAICS
623210: Residential
Mental Retardation
Facilities
Revenue Size
Standard
(Million)
$9.0
Number of
Establishments
22,319
Definitely
Small
20,726
Possibly
Small
1,428
Best
Estimate
Small
22,154
% Small
99.3%
Source: Census, 2005b.
Table 2-9. Firm Small Businesses (2002)
NAICS
622 110: General Medical
and Surgical Hospitals
622210: Psychiatric and
Substance Abuse Hospitals
622310: Specialty (Except
Psychiatric and Substance
Abuse) Hospitals
623 110: Nursing Care
Facilities
6233 1 1 : Continuing Care
Retirement Communities
Revenue Size
Standard
(Million)
$31.5
$31.5
$31.5
$12.5
$12.5
Number of
Firms
3,581
609
548
8,672
2,792
Definitely
Small
981
193
319
7,043
2,179
Possibly
Small
600
134
49
72
26
Best
Estimate
Small
1,581
327
368
7,115
2,205
% Small
44.1%
53.8%
67.2%
82.0%
79.0%
Source: Census, 2007.
For Table 2-8, EPA classified establishments into two categories: "Definitely Small" and
"Possibly Small." EPA counted an establishment in the "definitely small" category if it operated
for the entire year and had revenue ranging from less than $10,000 to $4.99 million. EPA
counted establishments in the $5 million to $9.9 million revenue group in the "possibly small"
category. The SB A size standard of $9 million occurred within the range of this revenue group
for this industry. As a result, some, but not all, of the establishments in that revenue group were
small. EPA assumed that the establishments were evenly distributed within the revenue group
and prorated the company count accordingly. Specifically, NAICS 623210 has a size standard of
$9 million and there are 250 establishments in the $5,000,000 to $9,999,999 revenue category.
EPA estimated the number of "possibly small" establishments by multiplying 250 establishments
by the ratio of the number of units from $9 million to the lower end of the range to the total
number of units in the range — i.e., (9-5) + (9.99-5) = 0.80 — for a total of 200 establishments
(Census, 2005b). EPA counted the 1,237 establishments that did not operate for the entire year in
the "possibly small" category. EPA assumed that the proportion of establishments that did not
operate for an entire year and also qualified as small was equal to the proportion of
-------
establishments that qualified as small in the overall population, 99.3 percent, or 1,228
establishments. Thus, Table 2-8 lists a total of 1,428 possibly small establishments.
For Table 2-9, similar calculations were made for NAICS industries with size standards
larger than 10 million using U.S. Census Company Statistics Data. These data combine 2002
County Business Pattern and 2002 Economic Census Data at a firm level (i.e., multi-unit
establishments are one firm) (Census, 2007). Nursing and residential care facilities (NAICS
623110 and 623311) have an estimated 80 percent of firms that are potentially small businesses.
The best estimated percent of hospitals that are small is 44 percent of general and surgical
hospitals, 54 percent of psychiatric and substance abuse hospitals, and 67 percent of specialty
hospitals.
In general, only hospitals have a substantial portion of large entities (33 to 56 percent).
However, Section 2.5 indicates that many of these entities are not commercial, for-profit
businesses. The Regulatory Flexibility Act sets different size standards for government and
nonprofit entities. For government entities, the size standard is serving a population of 50,000
residents or fewer. For nonprofit entities, a small organization is one that it independently owned
and not dominant in its field (5 U.S.C. 601(3-5)). Thus, a more detailed investigation would
involve identifying individual facilities, their ownership, and whether they serve a population of
more than 50,000 residents.
2.5 Ownership
Table 2-10 splits each industry sector into those that are subject to federal income taxes
(e.g., commercial or for-profit organizations) and those that are not (Census, 2005b). The non-
commercial establishments include federal, state, religious, and other groups organized on a not-
for-profit basis to provide health services. Nearly 90 percent of the general medical and surgical
hospitals (NAICS 622110) are nonprofit organizations. Between half and two-thirds of
psychiatric and substance abuse hospitals (NAICS 622210) and residential mental retardation
facilities (NAICS 623210) are nonprofit. About 40 percent of the continuing care retirement
communities (NAICS 623311) and 20 percent of the nursing care facilities (NAICS 623110) are
nonprofit organizations.
Table 2-10. For-Profit and Not-for-Profit Establishments (2002)
NAICS
6221 10: General Medical and
Surgical Hospitals
622210: Psychiatric and Substance
Abuse Hospitals
622310: Specialty (Except
Psychiatric and Substance Abuse)
Hospitals
623 1 10: Nursing Care Facilities
Total Number of
Establishments
5,193
603
615
16,568
Number of
Establishments
Subject to Federal
Income Taxes
697
211
349
13,101
Non-Tax, Not-for-
Profit
Establishments
4,496
392
266
3,467
% Not-for-
Profit
87%
65%
43%
21%
2-10
-------
Table 2-10. For-Profit and Not-for-Profit Establishments (2002)
NAICS
623210: Residential Mental
Retardation Facilities
623311: Continuing Care
Retirement Communities
Total Number of
Establishments
22,319
3,916
Number of
Establishments
Subject to Federal
Income Taxes
8,173
2,374
Non-Tax, Not-for-
Profit
Establishments
14,146
1,542
% Not-for-
Profit
63%
39%
Source: Census, 2005b.
Table 2-11 presents the legal organization of the commercial entities. Individual
proprietorships are rare for hospitals but more common for LTCFs.
Table 2-11. Legal Form of Organization for Establishments (2002)
NAICS
622 110: General
Medical and
Surgical Hospitals
622210: Psychiatric
and Substance
Abuse Hospitals
622310: Specialty
(Except Psychiatric
and Substance
Abuse) Hospitals
623 110: Nursing
Care Facilities
623210: Residential
Mental Retardation
Facilities
623 3 1 1 : Continuing
Care Retirement
Communities
Number of
Estabh'shments
That File Federal
Income Taxes
697
211
349
13,101
8,173
2,374
Corporations
555
157
267
9,934
6,876
1,401
Individual
Proprietorships
5
1
3
532
914
213
Partnerships
136
53
79
2,632
376
760
Other Legal
Forms of
Organization
1
0
0
3
7
0
Source: Census, 2005b.
2.6 Discharge Information
Table 2-12 presents the number of facilities included in the 2004 databases
TRIReleases2004 v03 andPCSLoads2004 v03 (see EPA-HQ-OW-2006-0771, DCN 04419 and
DCN 04417). Under the Emergency Planning and Community Right-to-Know Act (EPCRA),
certain facilities are required to report toxic chemical releases to EPA's Toxic Release Inventory
(TRI). Facilities are required to report chemical releases to air, disposal to land, and wastewater
releases to streams and POTWs. For SIC 80 (Health Services), only federal facilities are required
2-11
-------
to report to TRI. Further, only facilities that manufacture or use certain toxic chemicals in
quantities greater than the reporting threshold (e.g., more than 1 pound per year of chlorine) are
required to report. No SIC 80 facilities reported wastewater discharges of toxic chemicals to TRI
for 2004.
Table 2-12. 2004 TRI and PCS Facility Counts
SIC Code
805 1 : Skilled Nursing Care Facilities
8052: Intermediate Care Facilities
8059: Nursing and Personal Care
Facilities, Not Elsewhere Classified
8062: General Medical and Surgical
Hospitals
8063 : Psychiatric Hospitals
8069: Specialty Hospitals, Except
Psychiatric
Total
TRI 2004
Direct
0
0
0
0
0
0
0
Indirect
0
0
0
0
0
0
0
Both
0
0
0
0
0
0
0
No Discharge
Reported
0
0
0
1
2
0
o
6
PCS 2004
Direct
Major
0
0
0
1
1
0
2
Direct
Minor
52
25
20
21
10
6
134
Source: TRIReleases2004_v03 (DCN 04419); PCSLoads2004_v03 (DCN 04417).
PCS is a database that tracks permit, compliance, and enforcement status of facilities
regulated by the National Pollutant Discharge Elimination System (NPDES) Program under the
CWA. EPA developed a major/minor classification system for industrial and municipal
wastewater dischargers. Major dischargers almost always have a greater capability to impact
receiving waters if not controlled and, therefore, have received more regulatory attention than
minor dischargers. The major dischargers must report compliance with permit limits monthly to
their permitting authority, and that authority then enters the reported data into PCS, including
pollutant concentration and quantity. EPA does not require permit limit compliance data to be
entered into PCS for minor dischargers; however, facility information is maintained in PCS for
them.
PCS contains facility information for 136 hospitals and LTCFs. Only two of these
facilities (one general medical and surgical hospital and one psychiatric hospital) are classified as
majors and have pollutant concentration and quantity data in PCS. The two hospitals reported
wastewater flows of 8,000 and 40,000 gallons per day. PCSLoads2004 v03 calculates annual
discharge pounds using the pollutant concentration and quantity data from PCS, then weights the
annual pounds of different pollutants on the basis of their toxic potential by calculating toxic-
weighted pound equivalents (TWPE) using EPA's toxic weighting factors (TWFs). The total
calculated TWPE for the two hospitals in PCSLoads2004 v04 is 13.56 TWPE compared to over
20 billion TWPE for all discharges m PCSLoads2004v04.
Of the 52,089 hospitals and LTCFs potentially discharging spent pharmaceuticals that
were estimated in the 2005 U.S. Census Bureau's County Business Patterns data, PCS has
discharge data for two major dischargers and facility identification information for 134 minor
dischargers. Because PCS does not have data for most of the facilities in this profile, most of the
facilities that discharge wastewater must discharge it indirectly to municipal sewer systems.
-------
2.7 Financial Characteristics
The federal government is by far the largest contributor to hospital revenues through
Medicare and Medicaid payments. Table 2-13 summarizes the difference in typical pay or mix
between nonprofit and for-profit markets (S&P, 2006).
Table 2-13. Typical Payor Mix for Hospitals
Payor
Medicaid
Medicare
Private
Self-pay
Other
For-Profit Hospitals
13%
44%
36%
6%
4%
Not-for-Profit Hospitals
35%
19%
16%
22%
8%
Source: S&P, 2006.
The remainder of Section 2.7 describes the financial condition of commercial, for-profit
enterprises.
2.7.1 Operating Statistics
Table 2-14 presents several operating statistics for seven for-profit hospital systems.
Notice that bad debt makes up anywhere between 7.4 to 11.1 percent of revenues. Hospitals
typically collect only 8 to 10 percent of self-pay bills and 50 to 60 percent of copays and
deductibles (S&P, 2006). The bad debt does not necessarily include charily care. Hospitals have
the option of not recording revenue from patients who they determine are unable or unlikely to
pay their bills. By not recording revenue from such patients, a hospital does not record associated
bad debts. A detailed investigation of hospital finances would therefore include examining the
level of both bad debt and charity care (S&P, 2006).
Table 2-15 summarizes the financial statistics for commercial health care companies.
There is a mix of revenue size, profitability, liquidity, and leverage (as measured by the
debt/capital and debt-as-a-percentage-of-net-working-capital).
2-13
-------
Table 2-14. Key Operating Statistics of For-Profit Hospital Systems
(Quarter Ended September 30, 2006, Except as Noted)
Number of hospitals
Licensed beds
Average length of stay
(days)
Total admissions
(% change from
previous year)
HCA Inc a
172
40,382
4.9
(2.6)
Health
Management
Associates
57
8,331
4.2
5.4
Community Health
Systems
76
8,929
4.0
16.9
Lifepoint
Hospitals
51
5,705
4.2
10.1
Tenet
Healthcare
57
14,941
4.9
(3.3)
Triad
Hospitals
50
9,316
4.7
3.1
Universal
Health
Services
21
5,139
4.4
(3.0)
Average
69
13,249
4.5
3.8
Same-store comparison (% chg. from previous year)
Admissions
Revenues per admission
0.1
6.4
0.6
4.6
2.6
7.8
(0.1)
7.3
(3.3)
2.8
3.7
6.0
1.9
6.0
0.8
5.8
As % of revenues
Salaries and benefits
Supplies
Bad debt
Outpatient services
Consolidated EBITDA
margin (%)
41.8
16.8
10.9
16.7
14.4
40.7
13.4
9.5
17.2
16.7
40.1
11.6
10.7
20.9
14.8
39.4
13.9
10.9
17.4
18.4
45.0
18.2
7.4
24.2
5.1
40.4
17.3
11.1
19.7
10.6
44.0
14.1
9.4
20.3
10.7
41.6
15.0
10.0
19.5
13.0
to
Source: S&P, 2006.
a — Excludes ambulatory surgical centers and seven point-venture facilities.
EBITDA — Earnings before interest, taxes, depreciation, and amortization.
HCA — Hospital Corporation of America
-------
Table 2-15. Comparative Company Analysis — 2005 Data
Company
Operating
Revenues
($ Million)
Net Income
($ Million)
Return on
Revenues
(%)
Return on
Assets
(%)
Current
Ratio
Debt/
Capital
(%)
Long-Term
Debt/Net
Working
Capital d
Health Services Facilities
Amsurg Corp.
Community Health Systems Inc.
Genesis Healthcare Corp.
Hospital Corporation of America (HCA) Inc.
Health Management Assoc.
LCA Vision Inc.
Lifepoint Hospitals Inc.
Manor Care Inc.
Odyssey Healthcare Inc.
Sunrise Senior Living Inc.
Tenet Healthcare Corp.
Triad Hospitals Inc.
United Surgical Partner Intl.
Universal Health Services — CL B
VCA Antech Inc.
391.8a'b
3,738.3 ^
1,683.3 c
24,455.0
3,543.8 ^
192.4
1,855. la
3,417.3
381.6 a
1,738.0 b
9,614.0 b'c
4,747.3 c
474.7
3,935.5 ^
839.7 a
36.4
190.1
42.4
1,424.0
353.7
31.7
79.8
161.0
18.6
79.7
(621.0)
229.4
47.1
109.8
67.8
9.3
5.1
2.5
5.8
10.0
16.5
4.3
4.7
4.9
4.6
NM
4.8
9.9
2.8
8.1
7.6
5.0
3.3
6.5
9.4
21.4
3.9
6.9
8.3
6.6
NM
4.3
4.8
3.7
8.3
3.3
2.1
2.1
1.3
0.9
9.1
1.8
1.2
1.9
1.2
1.5
2.9
1.7
1.2
1.8
22.0
48.9
38.2
60.3
13.0
1.0
51.7
45.5
0.0
15.9
79.5
33.6
30.0
31.2
56.1
1.74
3.46
1.89
7.49
NM
0.01
7.92
9.25
0.0
2.02
3.94
1.77
2.98
7.58
6.91
Other Companies with Significant Health Services Facilities Operations
Kindred Healthcare Inc.
Rehabcare Group Inc.
3,924.0 ^
454.3 a
128.6
(17.0)
3.3
NM
7.7
NM
1.5
1.9
2.9
2.0
0.08
0.07
to
Source: S&P, 2006.
a — Data reflect merger or acquisition.
b — Data reflect an accounting change.
c — Data exclude discontinued operations.
d — Analogous to comparing an outstanding mortgage to what remains in the homeowner's checkbook after the monthly bills are paid.
NM — Not meaningful.
-------
2.7.2 Major Players
Table 2-16 lists the top 10 healthcare systems based on 2005 patient revenues. Table 2-17
lists the top 15 nursing care chains based on the number of facilities in 2005. Table 2-18 lists the
top 15 assisted living chains based on the number of beds in 2005 (S&P, 2006).
Table 2-16. Top 10 Largest Healthcare Systems
(Ranked by 2005 Net Patient Revenues)
Chain
Hospital Corporation of America
U.S. Department of Veterans Affairs
Ascension Health
Tenet Healthcare
New York Presbyterian Healthcare
Catholic Healthcare Initiatives
Catholic Healthcare West
Sutler Health
Catholic Health East
Mayo Clinic
Net Patient Revenues
($ Million)
24,445
23,547
10,280
9,441
8,627
6,502
5,463
5,333
4,929
4,902
Total Hospitals
175
156
64
73
34
69
40
24
27
NA
Source: S&P, 2006.
Table 2-17. Top 15 Nursing Homes Chains — 2005
(Ranked by Number of Facilities)
Chain
Beverly Enterprises
ManorCare
Sava Senior Care
Kindred Healthcare
Life Care Centers of America
Evangelical Lutheran Good Samaritan Society a
Genesis Health Ventures
Extendicare Health Services
Trans Healthcare
Sun Healthcare Group
Daybreak Healthcare
Five Star Quality Care
National Healthcare Corporation
Life Care Services
Senior Health Management
Total
Facilities
335
284
256
247
224
192
171
147
98
92
78
76
73
70
68
Number of
Beds
34,292
37,882
30,617
33,050
29,092
14,886
22,549
15,018
10,895
9,916
8,520
6,332
9,163
5,393
8,365
Average Beds
per Nursing
Home
102.4
133.4
119.6
133.8
129.9
77.5
131.9
102.2
111.2
107.8
109.2
83.3
125.5
77.0
123.0
Number of
States of
Operation
23
30
23
29
28
24
12
11
16
14
1
20
10
26
4
Source: S&P, 2006.
a — Not-for-profit hospital; all others are for-profit.
2-16
-------
Table 2-18. Top 15 Assisted Living Chains — 2005
(Ranked by Number of Beds)
Company
Sunrise Senior Living
Emeritus Assisted Living
Atria Senior Living Group
Sunwest Management
Brookdale Senior Living
Extendicare Health Services
Merrill Gardens
Summerville Senior Living
American Retirement
HCR Manor Care
Leisure Care
Five Star Quality Care
Hearthstone Assisted Living
Benchmark Assisted Living
KISCO Senior Living
Number of Beds
32,244
14,483
14,362
12,921
12,529
8,828
8,741
6,097
5,557
5,080
4,867
4,041
4,000
3,992
3,409
Total Faculties
397
181
128
169
295
216
67
62
70
65
36
80
32
43
20
Occupancy Rate
(%)
90.0
83.2
87.0
NA
88.0
87.0
96.0
90.3
93.0
89.0
93.0
92.0
90.0
93.0
95.0
Number of States
of Operation
38
35
27
26
32
17
11
12
19
13
8
17
10
6
5
Source: S&P, 2006.
NA — Not available.
2.7.3 Current Ratio
Liquidity measures an industry's ability to meet current obligations without having to
convert assets to cash with a loss in value. A current ratio is calculated as total current assets
divided by total current liabilities. Table 2-19 lists the current ratio by industry sector and
revenues (RMA, 2007). As shown in Table 2-19, some LTCFs and hospitals in the lower revenue
brackets have current obligations that exceed their available revenue at the time the balance sheet
was calculated; i.e., the current ratio is less than one. This can be due to a number of factors
including obligations that come due before the insurance payments appear (a timing problem for
their liquidity) or obligations that have a substantial portion of uncollectible revenue (i.e., bad
debt and charity care). S&P (2006) reports that bad debt formed an average of 10 percent of
revenues in its analysis of for-profit hospitals. RMA (2007), however, does not report this level
of detail, so the specific causes are not known.
Table 2-19. 2006 Current Ratio of Assets to Liabilities (Liquidity)
Revenues (SMillions)
NAICS
622110: General Medical
and Surgical Hospitals
622210: Psychiatric and
Substance Abuse Hospitals
All
1.9
1.8
SO-S1
0.7
a
S1-S3
1.9
a
S3-S5
1.7
a
S5-S10
2.2
1.3
S10-S25
2.2
2.1
>$25
1.9
1.9
2-17
-------
Table 2-19. 2006 Current Ratio of Assets to Liabilities (Liquidity)
Revenues (SMillions)
NAICS
622310: Specialty (Except
Psychiatric and Substance
Abuse) Hospitals
623 110: Nursing Care
Facilities
623210: Residential Mental
Retardation Facilities
6233 1 1 : Continuing Care
Retirement Communities
All
1.4
1.1
1.5
1.1
SO-S1
a
0.5
a
0.7
S1-S3
1.7
0.8
a
0.7
S3-S5
1.0
1.2
a
1.3
S5-S10
2.1
1.3
1.4
1.0
S10-S25
2.0
1.2
1.4
1.2
>$25
1.3
1.1
1.5
1.3
Source: RMA, 2007.
a — Ten or fewer observations, data not shown.
2.7.4 Profit Before Taxes
Profit before taxes is calculated from an income statement, which is a one-year summary
of costs and revenues. Table 2-20 lists the current ratio by industry sector and revenues (RMA,
2007).
Table 2-20. 2006 Profit Before Taxes (%)
Revenues (SMillions)
NAICS
6221 10: General Medical and
Surgical Hospitals
622210: Psychiatric and
Substance Abuse Hospitals
622310: Specialty (Except
Psychiatric and Substance
Abuse) Hospitals
623 110: Nursing Care
Facilities
623210: Residential Mental
Retardation Facilities
6233 1 1 : Continuing Care
Retirement Communities
AH
4.5
3.5
6.9
5.2
3.5
2.9
$0-$1
2.6
a
a
14.4
a
4.3
$l-$3
6.6
a
8.7
5.2
a
1.6
$3-$5
11.8
a
9.4
3.9
a
2.9
S5-S10
8.7
0.0
10.1
3.3
3.7
1.2
S10-S25
4.8
3.1
7.0
4.2
2.4
2.1
>$25
3.4
5.5
6.1
3.3
2.9
6.2
Source: RMA, 2007.
a — Ten or fewer observations, data not shown.
2-18
-------
3. POLLUTANTS OF CONCERN
Due to developments in analytical methods, researchers are able to detect lower
concentrations of chemicals in the aquatic environment (AWWARF, 2007). A number of studies
conducted over the past 10 years suggest detection of pharmaceutical compounds in treated
wastewater effluent, streams, lakes, seawater, and groundwater, as well as in sediments and fish
tissue (Bren School, 2007). For example, the United States Geological Survey (USGS)
conducted a study of 139 streams in the United States in 1999 and 2000. USGS detected
pharmaceutical compounds in 80 percent of the streams sampled (Kolpin et al., 2002).
Two major pathways in which pharmaceutical compounds enter wastewater are excretion
of partially metabolized pharmaceutical active ingredients and disposal of unused or expired
medications down the drain (Daughton CG, 2007). Pharmaceutical-containing wastewater is
discharged from households and medical facilities such as hospitals, LTCFs, hospices, and
veterinary facilities. Medications are stored in and disposed from a very broad and diverse array
of locations (H2E, 2006). In terms of both excretion and disposal, hospitals, LTCFs, hospices,
veterinary hospitals, and domestic dischargers are expected to be the largest sources of
pharmaceutical discharges (EC Workgroup2, 2005). This Health Services Industry Detailed
Study focuses on the disposal of unused or expired medications down the drain rather than
excretion because disposal is a practice that can be controlled through implementation of best
management practices (BMPs) including waste minimization.
The following subsections describe sources of pharmaceuticals in wastewater, the
potential fate of pharmaceutical active ingredients in POTWs, and concentrations of
pharmaceutical active ingredients detected in wastewater effluent, surface water, and
groundwater.
3.1 Sources of Pharmaceutical Waste at Health Services Facilities
Pharmaceutical waste is generated at health services facilities before, during, and after
treatment, as well as during stocking materials used for regular care (ERG, 2008a):
• Waste from stocking materials for regular care (expired pharmaceuticals):
— Approximately 3 percent of all purchased medications reach their
expiration date before they are used; and
— Some pharmacies work with manufacturers to send back their expired
pharmaceuticals through a reverse distributor.
• Waste generated before treatment (during preparation):
— Partially used vials from IV preparation;
The Emerging Contaminants Workgroup (EC Workgroup) was chartered at the request of the Santa Clara Basin
Watershed Management Initiative (WMI) in 2001 to provide a forum to discuss issues related to endocrine
disrupting compounds and recycled water. The workgroup has since broadened its scope to include all emerging
contaminants of concern, not just those having endocrine disrupting effects. The current purpose of the group is to
collect and review information based on the best available science on emerging contaminants of concern in and
around the San Francisco Bay.
3-1
-------
— Partially used vials from filling syringes; and
— General compounding3.
• Waste generated during patient treatment:
— Excess medication eliminated from overfilled syringes to adjust dose prior
to administering to patient; and
— Used syringes and TVs, which are biohazardous waste.
• 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 pharmacies,
patient care units, emergency rooms, intensive care units, oncology/hematology, radiology,
ambulances, outpatient clinics, satellite medical clinics, and LTCFs (ERG, 2008a).
3.2 Potential Fate and Effects of Pharmaceuticals at POTWs
The major environmental concerns resulting from the disposal of pharmaceuticals in
wastewater include the potential that POTWs may not effectively remove them through
treatment and the possible effects on aquatic life and human health.
Traditional wastewater treatment operations implemented in the 1970s and 1980s at
POTWs are designed to remove conventional pollutants such as suspended solids and
biodegradable organic compounds; they are not designed to remove pharmaceuticals that are
present in discharges from medical and veterinary facilities. POTWs may have implemented
advanced treatment technologies at their facilities. However, these technologies are also not
designed to remove pharmaceuticals. In addition, synthetic compounds, such as pharmaceuticals,
are often manufactured to be resistant to metabolic transformation. As a result, some
pharmaceutical compounds that are present in the influent to POTWs may pass through
treatment systems at conventional POTWs and discharge to receiving waters. Section 6 of this
report describes POTW removal efficiencies for pharmaceutical active ingredients.
There is much information about the health effects of pharmaceutical products at the
therapeutic doses provided in medication (Collier, 2007). There is uncertainty about their
potential effects on public health and aquatic life at the extremely low levels observed in
drinking water and surface water, and ongoing studies continue to research the effects. Potential
concerns include hormone disruption, antibiotic resistance, and synergistic effects from the
mixtures of various pharmaceutical compounds present in water (Bren School, 2007). While
observed levels of pharmaceutical compounds in streams may not be acutely toxic, the effects of
discharges of pharmaceuticals on aquatic life can include subtle and gradual effects, such as
those listed below:
• Selective serotonin reuptake inhibitors (SSRIs). Exposure to SSRIs found in
antidepressants can alter the behavior and reproductive functions offish and
mollusks (Daughton and Ternes, 1999).
3 "Compounding" is the process of mixing drags 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 the patient is allergic to, or to obtain the exact dose needed.
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• Antibiotics. Gradual long-term exposure to antibiotics can result in the selection
of bacterial pathogens that display resistance to antibiotics (Daughton and Ternes,
1999).
• Hormones. There are several documented cases of hormone disruption in fish and
other wildlife (EC Workgroup, 2005). Typically in toxicology, the toxic effects
increase as dose increases. However, endocrinologists have determined that
hormones do not follow this trend and have different effects at different doses
(Myers and Hessler, 2007). At low doses, hormones can affect an organism's
growth, reproduction, and development (Environment Canada, 2007).
Many other types of potential effects have been reported for a wide array of therapeutic
classes (U.S. EPA, 2008). Deciphering the potential for effects can be greatly complicated by the
occurrence of mixture effects (Pomati, 2007). The potential health implication for humans
exposed to drugs recycled from the environment via drinking water or foods is a topic of recent
and ongoing studies (Collins, 2007).
3.3 Presence of Pharmaceuticals in Water
Many studies have been conducted in Europe, Canada, and the United States to determine
the presence of pharmaceutical compounds in wastewater effluent, surface water, and
groundwater. Although these studies demonstrate the presence of pharmaceuticals, they do not
investigate the potential sources of pharmaceuticals in water. Table 3-1 presents concentrations
of pharmaceuticals documented in selected studies: in surface water, groundwater, POTW
influent, and POTW effluent. The concentrations from the studies were compiled in three
references: a 2007 paper by researchers at the Donald Bren School of Environmental Science
(Bren School, 2007), a Water Environment Research Foundation (WERF) report (Stephenson,
2007), and a report sponsored by the American Water Works Association Research Foundation
(AWWRF). Table 3-1 is an example of representative data and does not represent the many
published studies on this topic.
Table 3-1. Concentrations of Selected Pharmaceuticals in Wastewater, Surface Water,
and Groundwater
Compound
Acetaminophen
Benzafibrate
Caffeine
Carbamazepine
Clofibric acid
Diazepam
Therapeutic
Family
Painkiller/anti-
inflammatory
Lipid regulator
Stimulant
Anti-epileptic
Lipid regulator
Central nervous
system agent
Concentration (ug/L)
POTW
Influent a
No data
0.6
ND-31
No data
ND-0.7
ND-0.34
No data
POTW
Wastewater
Effluent a
No data
0.2
No data
No data
ND-0.7
ND
No data
Surface
Water
ND-
10,000
0.015
No data
0.040 -
0.250
0.0716
ND
ND-
0.00213
Ground-
water
No data
0.027
No data
0.27
No data
Reference b'c
AWWARF, 2007 b
Bren School, 2007 b
Stephenson, 2007 c
AWWARF, 2007 b
Bren School, 2007 b
Bren School, 2007 b
AWWARF, 2007 b
3-3
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Table 3-1. Concentrations of Selected Pharmaceuticals in Wastewater, Surface Water,
and Groundwater
Compound
Diclofenac
Erythromycin
Estradiol
Estriol
Estrone
Ethinyl estradiol
Fluoxetine
Gemfibrozil
Ibuprofen
lopromide
Ketoprofen
Naproxen
Progesterone
Propranolol
Salicylic acid
Salicylic acid,
benzyl ester
Sulfa-
methoxazole
Tamoxifen
Therapeutic
Family
Painkiller/anti-
inflammatory
Antibiotic
Steroid
Steroid
Steroid
Steroid
Antidepressant
Lipid regulator
Heart medication
Painkiller/anti-
inflammatory
X-Ray contrast
media
Painkiller/anti-
inflammatory
Painkiller/anti-
inflammatory
Steroid
Beta-blocker
Painkiller/anti-
inflammatory
Painkiller/anti-
inflammatory
Antibiotic
Hormone
Concentration (ug/L)
POTW
Influent a
ND-1.3
No data
No data
No data
No data
No data
No data
<10
No data
0.7-3.02
No data
2.75-
38.7
ND-32
No data
No data
5.7-28.0
1.8-41.0
No data
No data
70
325
ND-3.2
0.320 -
0.882
0.15
POTW
Wastewater
Effluent a
ND-0.29
No data
No data
No data
No data
No data
No data
13-18
No data
0.733-1.3
No data
0.043-4.1
No data
No data
No data
ND-3.0
0.035-9.5
No data
No data
304
2.8
No data
0.25-0.919
0.20
Surface
Water
0.015
Ground-
water
0.006
ND- 0.568
ND-1.0
0.0015-
0.0036
0.0006 -
>0.040
0.001-
0.0041
ND-
0.0051
0.012
ND-
0.012
0.015-
0.048
ND-
1.55
0.084 -
0.20
No data
ND-
5.04
ND-3.6
0.015
0.044
ND-
0.40
ND-
0.199
No data
0.015-
0.036
No data
0.15
No data
No data
No data
No data
No data
No data
No data
No data
0.003
No data
No data
No data
No data
No data
No data
No data
No data
0.29
No data
No data
ND-1.02
No data
No data
Reference b'c
Bren School, 2007 b
AWWARF, 2007 b
AWWARF, 2007 b
AWWARF, 2007 b
AWWARF, 2007 b
AWWARF, 2007 b
AWWARF, 2007 b
Bren School, 2007 b
AWWARF, 2007 b
Bren School, 2007 b
AWWARF, 2007 b
Bren School, 2007 b
Stephenson, 2007 c
AWWARF, 2007 b
AWWARF, 2007 b
Bren School, 2007 b
Bren School, 2007 b
AWWARF, 2007 b
AWWARF, 2007 b
Bren School, 2007 b
Bren School, 2007 b
Stephenson, 2007 c
Bren School, 2007 b
AWWARF, 2007 b
Bren School, 2007 b
3-4
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Table 3-1. Concentrations of Selected Pharmaceuticals in Wastewater, Surface Water,
and Groundwater
Compound
Testosterone
Triclosan
Trimethoprim
Therapeutic
Family
Steroid
Antibiotic
Antibiotic
Concentration (ug/L)
POTW
Influent a
No data
No data
No data
POTW
Wastewater
Effluent a
No data
No data
No data
Surface
Water
0.4-
5.550
ND-
2.300
Ground-
water
No data
No data
ND - 0.249
Reference b'c
AWWARF,2007b
AWWARF, 2007 b
AWWARF, 2007 b
Sources: AWWARF, 2007; Bren School, 2007; Stephenson, 2007.
ND — Nondetect. Nondetect and the less than sign (<) denotes that the value was below sample-specific method
detection limits (MDL). The MDL can change with instrument, analyst, and matrix, and therefore may vary for each
sample. The MDL is different from the Practical Quantitation Level (PQL). EPA sets the PQL as the lowest
concentration of an analyte that can be reliably measured within specified limits of precision and accuracy during
routine laboratory operating conditions. The PQL is always greater than the MDL.
a — Higher concentrations in effluent than in influent due to design of the sampling program, retention times at the
POTW, unrepresentative effluent samples, polar conjugates reforming into the parent pharmaceutical during the
treatment, and interferences from high levels of organic matter (Thomas et al, 2007).
b — The AWWARF, 2007 and Bren School, 2007 studies compiled their data from existing literature and did not
perform water sampling and analysis.
c — The Stephenson, 2007 study performed water sampling and analysis to obtain primary data on Pharmaceuticals
in the environment.
In addition to the studies compiled in the reports listed above, EPA also reviewed other
studies for further information on the presence of pharmaceuticals in wastewater. For example,
USGS samplers in Virginia's Shenandoah and James River Basins monitored for 30
pharmaceuticals. Only eight of the thirty pharmaceuticals were detected, at the following
concentrations:
1,7-dimethylxanthine (a major metabolite of caffeine): ND (<0.005) to
0.012 |ig/L;
Caffeine: ND (<0.005) to 0.048 |ig/L;
Carbamazepine (an anticonvulsant drug): ND (<0.005) to 0.017 |ig/L;
Codeine (a narcotic analgesic): ND (<0.005) to 0.007 |ig/L;
Cotinine (the metabolite of nicotine): ND (<0.005) to 0.0025 |ig/L;
Sulfamethoxazole: ND (O.005) to 0.0037 |ig/L;
Trimethoprim (an antibiotic commonly prescribed in tandem with
Sulfamethoxazole): ND (<0.005) to 0.1 |ig/L;
Venlafaxine (antidepressant): ND (<0.0009) to 0.046 |ig/L.
All eight pharmaceuticals, except Sulfamethoxazole, were detected at multiple sample
sites. The most commonly detected pharmaceutical (at eight often sites) was trimethoprim
(Alvarez, et. al. 2007).
A Norwegian study conducted in 2006 measured concentrations of pharmaceutical
compounds in wastewater from two large hospitals located in central Oslo. The study tested for
20 compounds. Of the targeted compounds, parcetamol, metroprolol, diclofenac, ibuprofen, and
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estriol were detected in all of the effluent samples collected at both hospitals. Paracetamol was
detected at the highest concentrations ranging from 5.42 to 1,370 |ig/L. Table 3-2 presents the
concentrations of pharmaceutical compounds detected in hospital wastewater (Thomas et al,
2007).
Table 3-2. Concentrations of Pharmaceutical Compounds in Effluent from Two
Norwegian Hospitals
Pharmaceutical (Application)
Acetaminophen, or paracetamol (pain
reliever)
Metoprolol (beta-blocker)
Diclofenac (anti-inflammatory)
Ibuprofen (pain reliever/
anti-inflammatory)
17p-estradiol (steroid)
17a-ethinylestradiol (steroid)
Estriol (steroid)
Estrone (steroid)
Oxytetracycline (antibiotic)
Tetracycline (antibiotic)
Demeclocycline (antibiotic)
Chlorotetracycline (antibiotic)
Doxycycline (antibiotic)
Meclocycline (antibiotic)
Trimethoprim (antibiotic)
Ciprofloxacin (antibiotic)
Sulfamethoxazole (antibiotic)
Cefuroxime (antibiotic)
Cyclophosphamide (antitumor agent)
Ifosfamide (antitumor agent)
Ullevftl Hospital
Median
Concentration
(Hg/L)
47
0.951
0.784
0.417
0.028
a
0.319
0.035
a
a
a
a
a
a
1.81
36
0.326
a
a
0.012
Frequency %
100
100
100
100
100
0
100
100
25
50
0
0
42
0
100
75
83
0
8
100
Rikshospitalet
Median
Concentration
Oig/L)
197
3.41
1.55
1.22
0.041
a
0.452
0.014
a
1.25
a
a
a
a
3.07
16.8
1.33
a
a
a
Frequency %
100
100
100
100
100
0
100
92
33
83
8
8
25
0
92
83
92
0
0
50
Source: Thomas et al., 2007.
a — No mean and median concentrations were calculated for analytes with a frequency less than 50%.
Although pharmaceutical compounds have been detected in treated wastewater, surface
water, and groundwater, neither the EPA nor any other organization has quantified how much
results from the disposal of unused Pharmaceuticals versus human excretion (Ruhoy, 2007).
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4. FACTORS AFFECTING DISPOSAL PRACTICES
This section discusses the regulations related to pharmaceutical waste management and
other factors that limit disposal alternatives at medical facilities. The discussion of disposal
limitations focuses on factors that apply specifically to hospitals and LTCFs, and includes:
• Federal regulations;
• State regulations; and
• Non-regulatory factors such as ease of disposal and costs.
LTCFs may have more restrictions and limitations regarding disposal practices than
hospitals. These restrictions include Drug Enforcement Administration (DEA) regulations for
non-DEA-registrants (see Section 4.1.1) and state Medicaid and Medicare and Health Insurance
Portability and Accountability Act of 1996 (HIPAA) requirements (see Section 4.1.4). In
particular, controlled substances may be more frequently flushed down the drain because they
cannot be returned to pharmacies or manufacturers by LTCFs.
4.1 Federal Regulations
This subsection summarizes available information regarding federal regulations for
disposal of unused pharmaceuticals. The major federal regulations that restrict disposal
alternatives for unused medications include:
• The Controlled Substances Act (CSA);
• The Resource Conservation and Recovery Act (RCRA); and
• The Health Insurance Portability and Accountability Act (HIPAA).
4.1.1 Controlled Substances Act
The Drug Enforcement Agency (DEA) enforces the Controlled Substances Act (CSA).
The goal of the CSA is to provide a closed distribution system for controlled substances.4 As part
of this closed distribution system, DEA prohibits the return of controlled substances from end-
users to any DEA registrant, or transfer to anyone except, in certain cases, a law-enforcement
agent. Disposal of controlled substances by DEA registrants is carefully regulated to ensure that
the substance is destroyed or rendered unrecoverable. One acceptable method of destruction is
flushing controlled substances into the wastewater.
Requirements for Hospitals
DEA registrants include individuals that fall into, or are employed by, one of the
following categories: pharmacy, hospital, clinic, practitioner, teaching institution, mid-level
practitioner, manufacturer, distributor, reverse distributor,5 researcher, analytical laboratory,
4 Controlled substances are drugs or other substances, or immediate precursors, included in schedule I, II, III, IV, or
V listed in Section 1308 of Title 21 Code of Federal Regulations. Examples include narcotics, opiates, and
stimulants.
5 DEA defined "reverse distributor" and established it as a new category of registration for handling controlled
substances on May 2, 2005 (see 83 FR 22591; May 2, 2005).
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importer, exporter, or narcotic treatment program. DBA registrants have the following options
for disposing of controlled substances:
• They can return the controlled substance to the pharmaceutical manufacturer.
• They can transfer the controlled substances to a reverse distributor to return them
to the manufacturer or dispose of them.
• They can dispose of the controlled substances under the procedures outlined in 21
CFR 1307.21, which provides that a DBA Special Agent in Charge can authorize
for the disposal of the controlled substance in one of the following manners:
1. By transfer to person registered under the Act and authorized to possess
the substance;
2. By delivery to an agent of the Administration or to the nearest office of the
Administration;
3. By destruction in the presence of an agent of the Administration or other
authorized person; or
4. By such other means as the Special Agent in Charge may determine to
assure that the substance does not become available to unauthorized
persons.
Requirements for Long-Term Care Facilities (LTCFs)
Employees of LTCFs typically are not DBA registrants and therefore may not return
controlled substances to the LTC pharmacy or transfer them to reverse distributors, or any other
DBA registrant, for disposal. This is because controlled substances that are in the possession of a
LTCF are no longer part of the closed distribution system and, as a result, are no longer subject
to DEA's system of accountability. This means that LTCFs must directly dispose of controlled
substances. Only with special approval from the regional DEA offices may LTCF employees
return controlled substances to their contracted pharmacies. DEA states that "In cases where
LTCFs must dispose of controlled substances, they should follow the guidelines within their state
for disposing of the drugs and maintain appropriate documentation of the disposal" (DEA,
2005b). LTCFs and their contracted/associated pharmacies must submit extensive records to
DEA agents documenting the disposal of controlled substances (Lewin Group, 2004).
In 2005, DEA finalized a rule to address the issue of controlled substances accumulating
at LTCFs by allowing registered pharmacies to operate automated dispensing systems (ADS) at
LTCFs (see 70 FR 25462; May 13, 2005). The advantage of ADSs is the dispensing of single
doses to patients. This could potentially reduce the amount of medications that become waste.
4.1.2 Resource Conservation and Recovery A ct (RCRA)
RCRA's definition of hazardous waste includes both "listed" and "characteristic" wastes.
Thus, a pharmaceutical waste may be considered hazardous because: 1) the pharmaceutical or its
sole active ingredient is specifically listed in 40 CFR Part 261.33(e) or (f) (commonly referred to
as the P or U lists, respectively); and/or 2) the waste exhibits one or more characteristic of
hazardous waste (ignitability, corrosivity, reactivity, or toxicity as defined in 40 CFR Parts
261.21-24, respectively). Common pharmaceuticals that are RCRA hazardous wastes when
4-2
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disposed of include epinephrine6, nitroglycerin, warfarin, nicotine, and some chemotherapy
agents (U.S. EPA Region 2, 2007; H2E, 2006).
EPA regulates the generation, storage, transportation, treatment, and disposal of any
pharmaceutical waste defined as hazardous waste. Federal regulations implementing RCRA can
be found at 40 CFR Chapter I Parts 260 through 265. These regulations include hazardous waste
identification, training, manifesting, and notification/recordkeeping requirements. In addition,
RCRA regulations require the transport of hazardous pharmaceutical waste in Department of
Transportation-approved containers to permitted hazardous waste disposal facilities by a
hazardous waste transporter. Thus, RCRA7 prohibits the disposal of hazardous pharmaceutical
waste as regulated medical waste (red sharps, red bag) or chemotherapy waste (yellow or white
sharps, bags) (Chemical Disposal Services, 2008; PharmEcology, 2005). Table 4-1 presents an
example of pharmaceutical waste management practices at health services facilities.
Table 4-1. Example of Pharmaceutical Waste Management Practices
Type of Waste Container
Red bag
Red sharps/needlebox
Trace chemotherapy waste
Hazardous pharmaceutical
waste
Non-hazardous
pharmaceutical waste
Color Code
Red
Red
Yellow or white
Black
White or blue
Contents
Biohazardous, no
pharmaceutical waste
Biohazardous needles, no
pharmaceutical waste
Biohazardous and trace
chemotherapy waste
RCRA and PharmE
Hazardous® waste a
Non-hazardous
pharmaceutical waste
Treatment Method
Autoclave/landfill
Autoclave/landfill
Medical waste incinerator
RCRA incinerator
Medical waste incinerator
Source: ERG, 2008.
a — PharmE Hazardous® is a list of waste identified by PharmEcology that is recommended to be handled as
hazardous waste, even if it is not a P- or U-listed waste.
6 The Agency clarified its regulation at 40 CFR Part 261.33, explaining that epinephrine salts are not included in the
epinephrine P042 listing (since the listing only specifies epinephrine and not epinephrine salts); the salts, therefore,
would be hazardous only if the waste epinephrine salt exhibited one or more of the hazardous waste characteristics
(See "Scope of Hazardous Waste Listing P042 (Epinephrine)," October 15, 2007, RCRA Online* 14778).
7 RCRA has an exclusion, the Domestic Sewage Exclusion (DSE), for hazardous materials that are sent to POTWs.
The DSE exclusion at 40 CFR Part 261.4 (a)(l)(i) and (ii) has two parts: (a)(l)(i) excludes "[d]omestic sewage" and
(a)(l)(ii) excludes "[a]ny mixture of domestic sewage and other wastes that passes through a sewer system to a
publicly-owned treatment works (POTW) for treatment. 'Domestic sewage' means untreated sanitary wastes that
pass through a sewer system. Under Part 261.4(a)(l)(ii), mixtures of sanitary wastes and other wastes (including
hazardous industrial wastes) that pass through a sewer system to a POTW are excluded from Subtitle C regulation.
The exclusion applies to a waste when it first enters a sewer system provided that it will mix with sanitary wastes
prior to storage or treatment by a POTW. The Agency interprets this exclusion to begin at the point of entry into the
sewage system, not at the point the hazardous waste actually mixes with the sewage (45 FR 33097, May 19, 1980).
A mixed stream of chemical process waste (considered a characteristic or listed hazardous waste under RCRA) and
sanitary waste which subsequently leaks from the sewer line before it reaches the POTW would not qualify for the
DSE (OSW, 1997). The rationale behind this exclusion from RCRA included that, "the Agency's pretreatment
program provides a basis for EPA and local communities to insure that users of sewer and treatment systems do not
dump wastes into the system that will present environmental problems" (45 FR 33097, May 19, 1980). Please note
that states may issue regulations that are more stringent or broader in scope than the federal hazardous waste
regulations.
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4.1.3 Medicare and Medicaid
The Centers for Medicare & Medicaid Services (CMS), a federal Agency within the
Department of Health and Human Services, administers the Medicare and Medicaid programs.
Medicare provides health insurance to elderly and disabled Americans, while Medicaid provides
health insurance for low income Americans, including long-term care coverage (CMS, 2007).
LTCFs that are certified by CMS may be recipients of Medicare/Medicaid payments, and must
meet and maintain compliance with the federal requirements for certification of their provider
type. While there are no accrediting organizations for skilled nursing facilities or nursing
facilities, hospitals may be audited for their compliance with federal Medicare and Medicaid
requirements by The Joint Commission (previously known as the Joint Commission on
Accreditation of Healthcare Organizations) or the American Osteopathic Association. A hospital
that fails an audit (done about once every three years) is at risk for losing their federal
certification, and thus their federal funding. Section 5.1.3 discusses the Joint Commission's
standards.
While Medicare is a federal program, Medicaid is a state-run program that is partly
funded by federal dollars. Therefore, many Medicaid requirements are set at the state level,
including regulations for disposal of unused pharmaceuticals. The focus of many federal and
state Medicare and Medicaid requirements for disposal of unused pharmaceuticals are in place to
prevent fraud. The following discusses the Medicare and some of the Medicaid requirements
specific to LTCFs and LTC pharmacies that must be followed for the return and reuse of unused
pharmaceuticals:
Return of Unused Pharmaceuticals. In a March 22, 2006, letter, CMS provided guidance
to state Medicaid programs encouraging them to require LTCFs to return unused medications to
pharmacies and to ensure that Medicaid is repaid for unused treatments when nursing home
patients die, are discharged, or have their prescriptions changed. In addition, some state
Medicaid programs require LTC pharmacies to accept returned unused pharmaceuticals
(excluding controlled substances) from LTCFs. The LTC pharmacy then credits Medicaid for the
unused doses. However, LTC pharmacies typically receive little payment for these return
services and have not found them to be cost effective. For example, when a pharmacy takes back
a previously dispensed medication for disposal, it must pay to have the medication destroyed, but
is not compensated for this service (APhA, 2006).
In addition, the CMS letter recommends that state Medicaid programs limit the amount of
medications provided to LTCFs from their LTC pharmacies at one time to reduce the amount of
prescription drugs wasted (APhA, 2006). Some state Medicaid requirements may determine
whether LTC pharmacies can receive credit for the returned pharmaceuticals:
• Some states allow crediting to LTC pharmacies;
• Some states (at least 10 according to APhA) prohibit crediting; and
• Other states do not have a clear requirement on crediting.
Reuse- of Pharmaceuticals. State boards of pharmacy determine if unused medications
can be returned and redistributed (reuse) and the policies vary by state. Most states allow reuse
' "Reuse" refers to the redistribution of unused pharmaceuticals.
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of uncontaminated pharmaceuticals (excluding controlled substances) that have been in a
controlled environment, such as an automatic dispensing system (APhA, 2006). At least five
states (Arizona, Kentucky, Mississippi, New Mexico, and Texas) strictly prohibit the reuse of
any pharmaceutical. The following states allow reuse of medications:
• California allows counties to collect unused pharmaceuticals from LTCFs,
wholesalers, and manufacturers and redistribute them to the uninsured.
• Oklahoma, Louisiana, and Ohio have passed legislation allowing unused
pharmaceuticals to be redistributed:
— Ohio has not yet implemented a redistribution program due to a lack of
interest by LTCFs.
— Louisiana has 12 pharmacies that redistribute unused pharmaceuticals
collected from LTCFs. Expired drugs, controlled substances, and those
that are potentially dangerous are not accepted. The LTCFs must have
controlled storage and distribution systems and use blister packaging.
• Nebraska permits consumers to return unused drugs if they are in tamper-resistant
packaging (e.g., blister packages) (APhA, 2006).
Physician samples can be donated to charitable institutions by licensed practitioners if the
samples meet certain criteria set for the in 21 CFR Part 203.39.
In January 2006, Medicare Part D was enacted as part of the Medicare Prescription Drug,
Improvement, and Modernization Act of 20039. Part D is a federal program to subsidize the costs
of prescription drugs for Medicare beneficiaries in the United States. Under this program, it is
illegal to reuse medications (ERG, 2008a).
Groups such as the American Society of Health-Systems Pharmacists (ASHP), American
Society of Consultant Pharmacists (ASCP), the American Medical Association (AMA), and the
American Nurses Association (ANA) encourage the redistribution of pharmaceuticals under
certain conditions. The redistribution conditions include: 1) the returned pharmaceuticals are not
controlled substances, 2) the pharmaceuticals are dispensed in tamper-evident packaging and the
packages are returned intact, and 3) policies and procedures are followed for the appropriate
storage and handling of pharmaceuticals at the LTCF (APhA, 2006). If all of these conditions are
met, the current redistribution practice recommended by the APhA is for donation to uninsured
patients (APhA, 2006).
During a November 18, 2007, meeting with EPA, several members of the Center of
Excellence in Assisted Living (CEAL) stated that the CMS Part D requirements often deter
LTCFs from donating or redistributing their unused medications. Once CMS identifies a LTCF
as a donor or as using a reverse distributor, CMS requires the LTCF to maintain record to prove
that Medicare is not double-billed and that the pharmaceuticals are not being illegally
redistributed. Industry groups are finding that the cost of labor to maintain these records
discourages LTCFs from redistributing their unused pharmaceuticals (Hessenauer, 2007).
9 For more information on the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, see
http://www.cms.hhs.gov/mmaupdate/.
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4.1.4 Health Insurance Portability and Accountability Act (HIPAA)
HIPAA requires LTCFs to meet certain privacy requirements. To conform to HIPP A
requirements, LTCFs often destroy all labels that contain private information (e.g., name, birth
date, address, medication) and relabel the medication prior to donation/redistribution of unused
Pharmaceuticals. The facility must document the relabeling of medications to ensure that the
medication name and dose are being transferred properly. Some facilities that accept donations
find that the labor cost of relabeling, auditing, and assuming the risk of administering mislabeled
redistributed pharmaceuticals exceeds the value of donated medication (Hessenauer, 2007).
4.2 State Regulations
State regulations for the disposal of unused pharmaceuticals and controlled substances at
health services facilities vary widely (APhA, 2006; Lewin Group, 2004). Many states require
unused pharmaceuticals to be destroyed but often do not specify the process of destruction;
however, many states (33 according to the Lewin Group) have requirements for the types of
personnel required to conduct and oversee the destruction (Lewin Group, 2004).
Some states have hazardous waste regulations more stringent than EPA's (Premier,
2007). For example, some wastes that are not regulated as hazardous under RCRA are identified
as hazardous in California. These wastes include substances that are listed under Title 22 of the
California Code of Regulations and exceed specified concentration limits. California also
classifies pharmaceutical waste as hazardous if it is toxic when inhaled or is fatal to certain types
offish in laboratory tests. Pharmaceutical wastes that meet California's definition of hazardous
waste (known as "California-only" pharmaceuticals) are subject to the Medical Waste
Management Act (Division 104, Part 14 California Health and Safety Code) and fall under the
regulatory authority of the Department of Toxic Substances Control and the California
Department of Health Services (Bren School, 2007). The California Medical Waste Management
Act requires that all "California-only" pharmaceutical hazardous waste be incinerated
(California, 2002). In addition, the state of California requires medical facilities to obtain
permission from their POTW before disposing of any pharmaceutical waste to their sewerage
system (McGurk, 2003).
To compare existing regulations governing pharmaceutical disposal, EPA collected
information on state and federal regulations pertaining to LTCFs. NHRegsPlus is an online
compilation of federal and state regulations applicable to LTCFs.10 Table 4-2 summarizes EPA's
review of the state regulations regarding pharmacy services in nursing homes.
1 ° NHRegsPlus was created by the University of Minnesota School of Public Health and is available at
http://www.hpm.umn.edu/nhregsplus/.
4-6
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Alabama
Alaska
Arizona
Arkansas
How to Dispose
of ControDed
Substances?
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain); or
Collected by
environmental
agency providing
disposal service
Not addressed
Not addressed
Delivered in
person or by
registered mail to
the Arkansas
Department of
Health
How to Dispose
of Non-controlled
Substances?
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain); or
Collected by
environmental
agency providing
disposal service
Not addressed
Not addressed
All discontinued
medications
(except controlled
drugs) shall be
destroyed on the
premises of the
facility. All
unused
medications shall
be destroyed
(location not
specified). See end
of table for
recommended
destruction
methods.
Who
Destroys
Unused
Meds?
Pharmacist
Pharmacist
Not addressed
Consultant
pharmacist
Who Must Witness
the Destruction?
Registered Nurse
Controlled
substances: a third
witness (law
enforcement official,
management or
supervisory
personnel.)
Not addressed
Not addressed
Nurse
How Soon Must
Medications be
Destroyed?
30 days.
Medications
ordered to be used
on an "as needed"
basis: 90 days
from purchase.
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Unused legend
drugs may be
donated to a
charitable clinic
pursuant to state
regulations.
Not addressed
Not addressed
Facilities may
donate
designated
medications (in
original
packaging) to
charitable
clinics by
following state
regulations.
Record Keeping
and Labeling
Records must be
completed and
maintained by the
facility that include
facility information,
date of destruction or
collection,
destruction method,
prescription details
(e.g., name and
strength of drug,
pharmacy, resident
name), amount
destroyed, and
reason for
destruction.
Not addressed
Not addressed
Not addressed
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
California
Colorado
Connecticut
Delaware
District of
Columbia
How to Dispose
of ControDed
Substances?
Not addressed
Not addressed
Follow state
regulations.
Return to the
pharmacist for
disposal.
Return to the
pharmacist; or
Destroyed
(location not
specified; method
not specified, but
may include
flushing or down
the drain).
How to Dispose
of Non-controlled
Substances?
Not addressed
Not addressed
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain).
See end of table
for recommended
destruction
methods.
Return to the
pharmacist; or
Destroyed
(location not
specified; method
not specified, but
may include
flushing or down
the drain).
Who
Destroys
Unused
Meds?
Not addressed
Not addressed
Non-
controlled
substances
maybe
destroyed by
a licensed
nurse or
pharmacist .
Not addressed
Not addressed
Who Must Witness
the Destruction?
Not addressed
Not addressed
Another staff person
may witness
destruction of non-
controlled
substances.
Not addressed
Two licensed nurses
must witness
destruction of
controlled
substances.
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Not addressed
Not addressed
Not addressed
Not addressed
Each unopened,
sealed
medication may
be returned to
the issuing
pharmacy.
Record Keeping
and Labeling
Not addressed
Not addressed
Destruction details:
date, strength, form
and
quantity of drugs
destroyed; and the
signatures of the
persons destroying
the drugs and
witnessing the
destruction.
Records for the
destruction of drugs
shall be kept on file
for three (3) years.
Labeling and
disposal
requirements a
Labeling and
disposal
requirements a
oo
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Florida
Georgia
Hawaii
Idaho
Illinois
How to Dispose
of ControDed
Substances?
Follow state
regulations.
Not addressed
Discontinued and
outdated drugs:
return to the
pharmacist for
disposal.
Follow state
regulations.
Expired and
unused
medication: follow
facility-specific
policy and
procedure.
How to Dispose
of Non-controlled
Substances?
Destroyed
(facility-specific
policy and
procedure)
Not addressed
Discontinued and
outdated drugs:
return to the
pharmacist for
disposal.
Not addressed
Expired and
unused
medication: follow
facility-specific
policy and
procedure.
Who
Destroys
Unused
Meds?
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Who Must Witness
the Destruction?
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Non-controlled
substances, in
unit dose
containers, may
be returned to
the dispensing
pharmacy.
Not addressed
Not addressed
Not addressed
All discontinued
medications,
except
controlled
substances, shall
be returned to
the dispensing
pharmacy.
Record Keeping
and Labeling
Records of the
disposition of all
substances shall be
maintained in
sufficient detail to
enable an accurate
reconciliation.
Not addressed
Labeling and
disposal
requirements a
It shall be noted in
the
patient' s/resident' s
medical record when
controlled drugs are
returned.
Labeling and
disposal
requirements a
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Indiana
Iowa
How to Dispose
of ControDed
Substances?
Follow state
regulations.
Follow state
regulations.
How to Dispose
of Non-controlled
Substances?
Follow state
regulations.
Return to the
pharmacist for
destruction
(method not
specified, but may
include flushing or
down the drain).
Who
Destroys
Unused
Meds?
Consultant
pharmacist
orlicensed
nurse with a
witness.
Qualified
responsible
nurse with a
witness.
Who Must Witness
the Destruction?
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
7 days.
Within a
reasonable time.
Under What
Conditions are
Medications
Returned/
Donated?
Unopened and
unexposed
medication may
be returned to
the issuing
pharmacy for
credit.
Unit dose
system: unused
drugs prescribed
for deceased
residents shall
be returned to
the pharmacist.
Discontinued
drugs may be
returned to the
pharmacist for
resident credit.
Record Keeping
and Labeling
Disposition of any
released, returned, or
destroyed
medication shall be
written in the
resident's clinical
record and shall
include the following
information: resident
name, name and
strength of the drug,
prescription number,
reason for disposal.,
amount disposed ,
disposal method of
disposition, and date
of disposal, and
signatures of the
persons conducting
the disposal of the
drug.
Labeling and
disposal
requirements a
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Kansas
Kentucky
How to Dispose
of ControDed
Substances?
Destroyed by
pharmacist
(method not
specified, but may
include flushing or
down the drain).
Destroyed as
outlined in federal
and state
regulations.
How to Dispose
of Non-controlled
Substances?
Destroyed by
pharmacist
(method not
specified, but may
include flushing or
down the drain).
Follow federal and
state regulations.
Who
Destroys
Unused
Meds?
Licensed
pharmacist
Not addressed
Who Must Witness
the Destruction?
Licensed nurse
employed by the
facility.
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
The nursing
facility shall
return to the
dispensing
pharmacy any
drugs and
biologicals
which have
been recalled.
Not addressed
Record Keeping
and Labeling
The nursing facility
shall maintain
records of receipt
and disposition of all
controlled
substances. A record
shall be on file in the
facility which
contains the date,
drug name, quantity
of drugs and
biologicals
destroyed, and
signatures of the
pharmacist and
licensed nurse.
Labeling and
disposal
requirements a
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Louisiana
How to Dispose
of ControDed
Substances?
Destroyed by
pharmacist (after
receipt of DBA
authorization).
How to Dispose
of Non-controlled
Substances?
Destroyed or
disposed as
outlined in state
regulations.
Expired
medications:
destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain).
Who
Destroys
Unused
Meds?
For
noncontrolled
drugs, either
licensed
nurses who
are employees
of the nursing
home, or the
consultant
pharmacist.
Who Must Witness
the Destruction?
Controlled
substance: a licensed
pharmacist after
receiving DEA
authorization, and
witnessed by law
enforcement officer
or other licensed
staff.
Non-controlled
substances: two
witnesses (licensed
nurses or the
consultant
pharmacist).
How Soon Must
Medications be
Destroyed?
Discontinued
medication, or the
resident is
discharged to the
hospital, the
nursing home will
retain the
medication(s) for
up to 60 days.
Expired
medication: 90
days.
Under What
Conditions are
Medications
Returned/
Donated?
Not addressed
Record Keeping
and Labeling
Records of non-
controlled
medication
destruction shall be
maintained in the
resident's clinical
record and shall
include the
following:
prescription details,
method and date of
destruction, and
signatures of those
witnessing the
destruction.
All controlled
substances to be
destroyed shall be
inventoried and
listed on a DEA
Form 41, a copy of
which shall be
maintained on the
premises, and a copy
mailed to the
Louisiana State
Board of Pharmacy.
to
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Maine
Maryland
Massachusetts
Michigan
How to Dispose
of ControDed
Substances?
Destroyed
(location not
specified). See end
of table for
recommended
destruction
methods.
Destroyed
(location not
specified; method
not specified, but
may include
flushing or down
the drain).
Not addressed
Not addressed
How to Dispose
of Non-controlled
Substances?
Destroyed
(location not
specified). See end
of table for
recommended
destruction
methods.
Destroyed
(location not
specified; method
not specified, but
may include
flushing or down
the drain).
Not addressed
Not addressed
Who
Destroys
Unused
Meds?
Director of
Nursing
Service or a
designee.
Two members
of the nursing
home staff
(administrator
or nurse) may
destroy
controlled on
the premises
of the facility.
Not addressed
Not addressed
Who Must Witness
the Destruction?
Non-controlled
substances: a
licensed member of
the nursing staff.
Controlled
substances:
Department
representative, a
Maine licensed
pharmacist, or
Federal DBA agent.
Non-controlled
medications shall be
destroyed in the
presence of an
authorized
representative of the
Department or two
witnesses,
authorized by the
facility.
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Following the
death of the
resident,
medications shall
be removed from
circulation within
seventy-two (72)
hours.
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Individual unit
doses, other
than controlled
substances must
be returned to
the pharmacist
and any credit
or rebate made
to person(s)
who originally
paid for the
medication.
Not addressed
Not addressed
Not addressed
Record Keeping
and Labeling
Prior to the
destruction of these
substances by the
authorized person,
the inventory shall
be verified by that
person. Notation
shall be made of the
destruction, date and
signed by all
authorized
individuals.
Labeling and
disposal
requirements a
A record of the
disposal shall be
maintained in the
facility and a copy
shall be forwarded to
the Division of Drug
Control.
Labeling and
disposal
requirements a
Not addressed
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Minnesota
Mississippi
Missouri
Montana
How to Dispose
of ControDed
Substances?
Destroyed as
recommended by
the Board of
Pharmacy or
consultant
pharmacist.
Follow state
regulations.
Not addressed
Removed from the
facility and
destroyed.
How to Dispose
of Non-controlled
Substances?
Follow state
regulations.
Follow state
regulations.
Not addressed
Removed from the
facility and
destroyed.
Who
Destroys
Unused
Meds?
Not addressed
Not addressed
Not addressed
Not addressed
Who Must Witness
the Destruction?
Not addressed
Not addressed
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Drugs and
prescribed
medications
used in nursing
homes may be
returned to the
dispensing
pharmacy
according to
state
regulations.
Not addressed
Not addressed
Not addressed
Record Keeping
and Labeling
For non-controlled
substances, a
notation of the
destruction listing
the date, quantity,
name of medication,
prescription number,
signature of the
person destroying
the drugs, and
signature of the
witness must be
recorded on the
clinical record.
For controlled
substances, the board
or the pharmacist
must furnish the
necessary
instructions and
forms, a copy of
which must be kept
on file in the nursing
home for two years.
Not addressed
Not addressed
Not addressed
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Nebraska
Nevada
New Hampshire
How to Dispose
of ControDed
Substances?
Disposal at the
facility and follow
state regulations.
Not addressed
Destroyed as
outlined in state
regulations.
How to Dispose
of Non-controlled
Substances?
Disposal at the
facility and follow
state regulations.
Not addressed
Destroyed by
incineration or
disposal by
flushing into
sewage system.
Who
Destroys
Unused
Meds?
Pharmacist
assisted by a
licensed nurse
employed by
the facility.
Not addressed
Not addressed
Who Must Witness
the Destruction?
Not addressed
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
The facility may
return
discontinued
medication or
expired resident
medicines to the
dispensing
pharmacy for
credit in
accordance with
state
regulations.
Not addressed
Medication may
be returned to
pharmacies for
credit only
under provisions
of state
regulations.
Record Keeping
and Labeling
Medication name,
strength and quantity
disposed of must be
recorded in the
resident's medical
record, dated and
signed by the
pharmacist.
Not addressed
Not addressed
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
New Jersey
New Mexico
New York
How to Dispose
of ControDed
Substances?
Follow federal and
state regulations.
Not addressed
Not addressed
How to Dispose
of Non-controlled
Substances?
Not addressed
Not addressed
Not addressed
Who
Destroys
Unused
Meds?
Not addressed
Not addressed
Not addressed
Who Must Witness
the Destruction?
All medication
destruction in the
facility shall be
witnessed by at least
two persons
(pharmacist
consultant, a
registered
professional nurse or
a licensed practical
nurse).
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Discontinued
medications: 30
days.
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Where allowed
by law, the
facility shall
generate a
crediting
mechanism for
medications
dispensed in a
unit-of-use drug
distribution
system, or other
system that
allows for the
re-use of
medications.
A resident's
medication may
be returned to
the pharmacy
for credit.
Facilities using
a vendor
pharmacy can
establish
policies and
procedures to
return unused
medications or
drug products
for credit or
reimbursement,
according to
certain state
provisions.
Record Keeping
and Labeling
A record of each
instance of drug
destruction shall be
maintained.
Labeling and
disposal
requirements a
Records shall be
kept of all
medication returned
for credit and/or
disposal.
Not addressed
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
How to Dispose
of ControDed
Substances?
Not addressed
Not addressed
Follow federal and
state regulations.
Not addressed
Not addressed
How to Dispose
of Non-controlled
Substances?
Not addressed
Not addressed
Not addressed
Destroyed
(location not
specified).
Not addressed
Who
Destroys
Unused
Meds?
Not addressed
Not addressed
Not addressed
Director of
nursing and
the consultant
pharmacist.
Not addressed
Who Must Witness
the Destruction?
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Not addressed
Within a
reasonable time.
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Not addressed
Not addressed
Upon death,
transfer, or
discharge of a
resident all
drugs shall be
returned to the
pharmacy, or
disposed.
The facility may
transfer unused
prescription
drugs to city-
county
health
department
pharmacies or
county
pharmacies in
compliance with
requirements.
Not addressed
Record Keeping
and Labeling
Not addressed
Not addressed
Not addressed
The destruction and
the method used
shall be noted on the
clinical record.
Not addressed
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Pennsylvania
Rhode Island
South Carolina
How to Dispose
of ControDed
Substances?
Follow facility-
specific policy and
procedure.
Not addressed
Follow facility-
specific policy and
procedure.
How to Dispose
of Non-controlled
Substances?
Follow facility-
specific policy and
procedure.
Not addressed
Follow facility-
specific policy and
procedure.
Who
Destroys
Unused
Meds?
Determined
by facility
policy.
Not addressed
Not addressed
Who Must Witness
the Destruction?
Determined by
facility policy.
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
At least quarterly.
Not addressed
Discontinued
medications must
not be held
beyond a 90-day
period.
Under What
Conditions are
Medications
Returned/
Donated?
Outdated,
deteriorated or
recalled
medications
shall be returned
to the
dispensing
pharmacy for
disposal in
accordance with
acceptable
professional
practices.
Not addressed
Not addressed
Record Keeping
and Labeling
The method of
disposition and
quantity of the drugs
shall be documented
on the respective
resident's chart. The
disposition
procedures shall be
done at least
quarterly under
Commonwealth and
Federal statutes.
Not addressed
All medications
destroyed must be
documented.
Labeling and
disposal
requirements a
oo
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
How to Dispose
of ControDed
Substances?
Returned to the
pharmacy for
disposal; or
disposed at the
facility.
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain).
Follow federal and
state regulations.
Follow state's
Pharmacy Practice
Act.
Not addressed
Not addressed
Not addressed
Not addressed
How to Dispose
of Non-controlled
Substances?
Returned to the
pharmacy for
disposal; or
disposed at the
facility.
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain).
Follow federal and
state regulations.
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Who
Destroys
Unused
Meds?
Non-
controlled
substance: a
professional
nurse.
Controlled
substance:
destroyed on
the premises
by a
pharmacist
and a
registered
nurse.
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Who Must Witness
the Destruction?
There must be
another witness for
destruction of legend
drugs not controlled
under state
regulation SDCL 34-
20B.
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
How Soon Must
Medications be
Destroyed?
Not addressed
Not addressed
Quarterly basis.
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
Medications,
excluding
controlled
substances, in
unit dose
packaging may
be returned to
the pharmacy.
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Record Keeping
and Labeling
Labeling and
disposal
requirements a
Destruction to be
recorded by a
pharmacist. Such
record shall be kept
in the nursing home.
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
VO
-------
Table 4-2. State Regulations for Pharmacy Services at Nursing Homes
State
Wisconsin
Wyoming
How to Dispose
of ControDed
Substances?
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain).
Not addressed
How to Dispose
of Non-controlled
Substances?
Destroyed on the
premises (method
not specified, but
may include
flushing or down
the drain).
Not addressed
Who
Destroys
Unused
Meds?
Not addressed
Not addressed
Who Must Witness
the Destruction?
Two or more
personnel licensed or
registered in the
health field.
Not addressed
How Soon Must
Medications be
Destroyed?
Within 72 hours of
a physician's order
discontinuing its
use, the resident's
discharge, the
resident's death or
passage of its
expiration date.
Not addressed
Under What
Conditions are
Medications
Returned/
Donated?
May be returned
for credit.
Not addressed
Record Keeping
and Labeling
Not addressed
Not addressed
Source: NHRegsPlus (http://www.hpm.umn.edu/nhregsPlus/index.htm).
Not addressed: States do not have requirements for pharmaceutical disposition beyond what is required by federal regulations.
a — These states require specific disposal based on labeling. See summary below.
to
o
-------
Only four states listed approved or recommended methods of destruction. The methods
approved include the following:
• Arkansas: Incineration, garbage disposal, or flushing down the commode;
• Delaware: Flushing down to sewage system (in the presence of a witness) or
returning to pharmacy;
• Maine: Incineration or flushing down to sewage system; and
• New Hampshire: Incineration or flushing down to sewage system.
The states with labeling regulations included in the database have similar requirements.
Improperly labeled medication containers (e.g., soiled, damaged, incomplete, illegible, makeshift
labels) must be returned to the pharmacist for relabeling or disposal. This requirement is
included in the regulations for Delaware, District of Columbia, Hawaii, Iowa, Kentucky, Maine,
Massachusetts, and South Carolina. South Dakota requires that all improperly labeled medication
should be destroyed. In addition to improper labeling, Delaware, Illinois, Kentucky,
Massachusetts, and South Carolina require containers with missing labels to be disposed of or
destroyed. New Jersey requires that the pharmacy and therapeutics committee establish and
enforce procedures to remove medication containers with improper labeling.
4.3 Other Factors That Affect Disposal Practices
Besides legal requirements, the other major factors that affect disposal practices are
organization size, ease of disposal, and cost. For example, a facility may use flushing as a
primary means of disposal if it has no onsite pharmacy and/or has no pre-existing contract with a
hazardous waste transporter to dispose of the pharmaceuticals. This section discusses the
differences in pharmaceutical handling at LTCFs and hospitals.
4.3.1 LTCFs
In the past, public health agencies and health-related non-government organizations
guided the public to destroy unused medications by flushing them down the toilet. Many LTCFs
have adopted this method for destruction of unused controlled substances. Many LTCFs have
also extended this practice to include flushing of all unused medications — controlled and non-
controlled substances (Garvin, 2007).
For example, a survey conducted by the Bren School of Environmental Science in Santa
Barbara, C A, during 2006 found that, if a LTCF flushed any unused pharmaceuticals down the
drain or toilet, then flushing was the primary disposal method for all pharmaceuticals at that
facility (Bren School, 2007). The 2006 Bren School survey was conducted to gain an estimate of
local quantities of wasted drugs, current disposal practices, feasibility of a drug recycling
program, and likelihood to support a disposal program for the public. Respondents were selected
groups of institutions in Santa Barbara County boundaries, including pharmacies, nursing homes,
hospitals, and hospices (Bren School, 2007).
Each institution was asked 15 questions, both open-ended and categorical over the phone,
and multiple responses were accepted for some of the questions (Bren School, 2007). Topics
covered in the survey included:
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• Current disposal practices,
• Contact with the public,
• Likelihood to supply/support a recycling program,
• Likelihood to support a disposal program for the public, and
• Awareness of the issue.
At the completion of the survey, 116 facilities were contacted, 87 of which fit the
intended category; 42 responses were obtained, for a total response rate of 48 percent (Bren
School, 2007). The survey found that, of LTCFs who flushed any unused pharmaceuticals down
the drain, flushing was the primary disposal method for all pharmaceuticals at that facility. In
addition, the survey found that, in general, LTCFs do not use reverse distributors because the
facilities do not generate enough pharmaceutical waste to justify hiring a reverse distributor. The
company or organization size may also be a factor determining disposal practices at LTCFs. For
example, small nursing homes that are not a part of a larger network may not be aware of the
benefits of using a reverse distributor (Bren School, 2007).
4.3.2 Hospitals
Logistics for disposing of unused pharmaceuticals at hospitals are different than at
LTCFs. Hospitals typically have onsite pharmacies; therefore, it is a common practice to return
expired pharmaceuticals to the hospital pharmacy and then on to the manufacturer for credit or
disposal. Hospitals typically do not prescribe medications far in advance or in large quantities;
this reduces the potential for pharmaceuticals to be wasted. Finally, hospitals typically have pre-
existing arrangements with hazardous waste disposal firms and therefore do not need to make
special arrangements for disposal of unused pharmaceuticals as hazardous waste (Garvin, 2007).
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5. ALTERNATIVES TO WASTEWATER DISPOSAL INCLUDING MANAGEMENT PRACTICES
AND TREATMENT OPTIONS FOR UNUSED PHARMACEUTICALS
This section describes the management practices and treatment options that hospitals and
LTCFs may use as alternatives to unused pharmaceutical disposal to wastewater. EPA notes that
some of the information presented in this section only applies to managing pharmaceutical
wastes at hospitals. EPA will continue to collect information on management practices for
hospitals, LTCFs, hospices, and veterinary facilities during the 2009 Effluent Guidelines annual
review. The remainder of this section describes current guidance on pharmaceutical waste
management, summarizes the management practices outlined in the guidance, and discusses
treatment options for pharmaceutical waste.
5.1 Current Guidance on Pharmaceutical Waste Management
Three organizations that provide guidance to medical facilities on managing
pharmaceutical waste include Hospitals for a Healthy Environment (H2E), the Product
Stewardship Institute (PSI), and the Joint Commission. The guidelines provided by these
organizations all aim to reduce health and environmental impacts from disposal of
pharmaceutical waste. In addition to these three organizations, EPA collected data on state
guidance for pharmaceutical waste management. Section 5.2 discusses the management practices
recommended by these organizations and three states. This section describes the three
nongovernmental organizations.
5.1.1 Hospitals for a Healthy Environment (H2E)
H2E is an organization founded by the American Hospital Association, EPA, Health Care
Without Harm, and the American Nurses Association. H2E educates health service professionals
on pollution prevention opportunities and provides tools and resources to facilitate the industry's
movement toward environmental sustainability. H2E developed a Pharmaceutical Waste
Blueprint that describes a 10-step approach hospitals can use to develop and manage a
pharmaceutical waste management program. The 10 steps include:
• Step One. Form a committee to meet regularly and implement the program. The
committee should include experts in the areas of pharmacy, environmental
science, safety, nursing, education, and infection control.
• Step Two. Understand how RCRA regulations apply to hazardous waste
management.
• Step Three. Consider best management practices (BMPs) for non-regulated
pharmaceutical waste.
• Step Four. Perform a drug inventory for all drugs administered at the facility and
identify the proper disposal method.
• Step Five. Implement practices to minimize the pharmaceutical waste generated.
• Step Six. Conduct a review of current disposal practices to establish the baseline
quantities of pharmaceuticals disposed and determine how frequently certain
types of pharmaceutical waste are generated in different departments of the
facility.
• Step Seven. Select a method for communicating proper disposal methods to staff.
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• Step Eight. Evaluate pharmaceutical waste management options including
segregating waste at the point of generation, segregating waste at a central
location, and managing all pharmaceutical wastes as hazardous.
• Step Nine. Select areas for waste accumulation and storage, choose hazardous
waste disposal and reverse distribution vendors, and implement a pilot program.
• Step Ten. Implement the pharmaceutical waste management program (H2E,
2006).
5.1.2 Product Stewardship Institute (PSI)
PSI is a national nonprofit organization aimed at reducing health and environmental
impacts of consumer products, including pharmaceuticals. Members include 43 states and 50
local government agencies. Businesses and environmental organizations can join PSI as adjunct
members. PSI is now developing a Product Stewardship Action Plan that will focus on unwanted
or waste pharmaceutical products from households and LTCFs. PSI's goal is to develop a
nationally coordinated system for management of unused pharmaceuticals and will focus on the
unused pharmaceuticals that typically enter the municipal solid waste stream, municipal
wastewater, or residential septic systems (PSI, 2008).
5.1.3 The Joint Commission
The Joint Commission11 (formerly the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)) is an independent not-for-profit organization aimed at improving
healthcare by establishing standards and accrediting hospitals and other health services facilities.
The Joint Commission has established a set of standards known as the Environment of Care (EC)
Standards. These standards fall into four groups:
Planning (EC. 1);
• Implement/teach (EC.2);
• Other environmental considerations (EC.3); and
• Monitor and improve (EC.4).
The Joint Commission uses the EC standards to evaluate hospitals' performance in
several areas including environmental protection. The EC requires the appointment of a qualified
individual and designation of a committee responsible for managing implementation of the
standards. In addition, the EC requires the development of the following seven management
programs to improve and maintain the safety of the health services facility, and describes actions
that health services facilities must take to comply with hazardous waste regulations
(PharmEcology, 2005):
Safety;
• Security;
1: The mission of The Joint Commission is to continuously improve the safety and quality of care provided to the
public through the provision of health care accreditation and related services that support performance improvement
in health services organizations. In 1965 Congress passed the Social Security Amendments of 1965 with a provision
that hospitals accredited by JCAHO are "deemed" to be in compliance with most of the Medicare Conditions of
Participation for Hospitals and, thus, able to participate in the Medicare and Medicaid programs.
(www.jointcommission.org/AboutUs/joint commission history.htm)
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• Hazardous materials and waste;
• Emergency preparedness;
• Life safety;
• Medical equipment; and
• Utility systems.
The EC standards do not specifically address disposal of unused pharmaceuticals.
However, pharmaceuticals that are classified as hazardous waste would be managed according to
the standards.
5.2 Summary of Pharmaceutical Management Practices
Managing pharmaceutical waste properly includes minimizing pharmaceutical waste
generated; complying with applicable Federal, state and local regulations; and using BMPs.
Regulations for pharmaceutical waste disposal are described in Section 4 of this report. This
subsection summarizes good management practices that EPA has identified thus far. These
management practices are based on guidance provided by the aforementioned organizations,
three states (California, Minnesota, and Washington), and the Albany Medical Center.
5.2.1 Waste Minimization Techniques
Waste minimization has the following components:
• Inventory of pharmaceuticals;
• Stock rotation;
• Minimizing receipt of sample products; and
• Limiting the amount of pharmaceuticals dispensed at one time.
Some of these practices may be more applicable to hospitals than LTCFs. Below is a
more detailed discussion of each of these components:
Pharmaceutical Inventory
The facility maintains a detailed inventory of pharmaceuticals purchased, dispensed, and
wasted in order to identify where waste comes from and how to minimize. Many hospitals use
computerized inventory management systems that can track historical use and waste data,
compile reorder lists, determine the amount of each pharmaceutical to be stocked, and can be
used to develop labels for pharmaceuticals. When identifying waste minimization opportunities,
a facility determines not just how much medication is wasted but the reasons for waste. Once a
facility has evaluated its current practices, it can determine the most applicable or feasible
method for minimizing its pharmaceutical waste.
Stock Rotation
Stock rotation is a practice that has effectively reduced expired pharmaceutical wastes in
hospitals. Hospital staff maintain inventories of high-use pharmaceuticals and identify
pharmaceuticals that are close to expiring. These short-dated pharmaceuticals are then
redistributed to other areas of the hospital where they are needed. Two Minnesota hospitals,
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Hennepin County Medical Center (HCMC) and Tri-County Hospital in Wadena, identified crash
boxes, crash carts, and ambulances as locations with the greatest potential for pharmaceuticals to
expire. Tri-County Hospital reduced its stock on ambulances by six vials of epinephrine and 15
vials of lidocaine as a result of stock rotation. Expired epinephrine and lidocaine are two
hazardous pharmaceutical wastes commonly generated by this facility (MNTAP, 2007).
Minimizing Product Sample Waste
Pharmaceutical samples can be a large source of wasted medications at hospital
pharmacies. Many samples that are left by pharmaceutical representatives are short-dated and
often expire before they are used. The pharmaceutical representatives are not permitted to take
back expired medications from hospitals. As a result, the hospital is left with the responsibility of
identifying whether the sample is a RCRA hazardous waste and properly disposing of the sample
(Cunha, 2007). Some hospitals no longer accept pharmaceutical samples from representatives
(ERG, 2008b).
HCMC in Minnesota estimated that it accumulated 35 pounds of sample waste, costing
$520 in disposal and sorting fees, over a two-month period (MNTAP, 2007). HCMC corrected
this problem by moving its sample log from the pharmacy to the purchasing department. The
purchasing department was then made responsible for logging in samples and making sure that
no samples were accepted that had less than one year before expiration (MNTAP, 2007).
Dispensing Techniques
Dispensed pharmaceuticals can go unused if the patient has an allergic or adverse
reaction to the medication, no longer requires treatment, or refuses treatment, or if the
medication expires or is ineffective. Hospitals and LTCFs can reduce the amount of
pharmaceutical waste generated by limiting the amount of pharmaceuticals dispensed to patients
and residents at one time. In particular, new prescriptions can be dispensed in limited amounts
until the doctor or nurse determines that the patient does not show any adverse or allergic
reaction to the drug. Options for dispensing pharmaceuticals include:
• Unit Dose Packaging. Unit dose packages ("blister packs") consist of several
sealed compartments, each containing one dose of the prescribed medication. As a
result, unused doses are maintained in a tamper-free packaging and can be
returned to the manufacturer for credit. As described in Section 4, LTCFs may not
return unused controlled substances.
• Limited-Quantity Dispensing. The Albany Medical Center dispenses only a 24-
hour supply of medications to patients. Medications are provided to patients in a
"cassette." At the end of the 24-hour period, pharmacy personnel change out the
patients' cassettes and fill the cassettes for the next 24-hour period. All unused
pharmaceuticals are returned to the pharmacy (Albany Medical Center, 2007).
• Automatic Dispensing Systems. ADSs dispense single doses of medications to
patients and residents. Medications that remain inside the ADS are considered
within the DEA's closed distribution system for controlled substances and can
therefore be returned to the manufacturer (see 68 FR 62255; November 3, 2003).
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• Standardized Medication Dosages. Using the same doses for medications used in
different departments of a hospital helps to facilitate stock rotation. For example,
HCMC in Minnesota was using 15-gram Glutose gel tubes in its crash boxes and
using 45-gram tubes in the Omnicells for diabetics. The facility switched all
departments to 15-gram Glutose gel tubes and was able to rotate tubes from crash
boxes to the Omnicells as they were needed (MNTAP, 2007).
5.2.2 Reverse Distribution
Hospitals and LTCFs have the option of hiring reverse distributors to manage unused
and/or expired medications (not including controlled substances) the facility believes could be
returned to the manufacturer or wholesaler for credit. The reverse distributor determines which
medications may be returned to the manufacturer or wholesaler for credit and arranges for
disposal of unused medications that are waste. The manufacturer or wholesaler credits the
dispenser for the returned medications and determines whether the medications may be reused,
reclaimed, sold overseas, or disposed. Unused pharmaceuticals may be returned to the
wholesaler under the following circumstances (not an exhaustive list):
• There was an oversupply at the dispenser;
• The product has expired;
• A recall has been initiated by the manufacturer;
• The product was received as a result of a shipping error; or
• The product has been damaged (OSW, 1991).
Although reverse distributors will arrange for proper disposal of unused pharmaceuticals
that cannot be returned for credit, reverse distributors are not waste management services. It is
the facility's responsibility to segregate unused pharmaceutical that should be wasted, including
pharmaceuticals that are RCRA hazardous waste, from pharmaceuticals that may be returned for
credit (MNTAP, 2007). When using reverse distribution, guidance suggests that the facility only
mail unused pharmaceuticals to the reverse distributor that the facility believes could potentially
be returned for credit. Otherwise, unused pharmaceuticals would be identified as waste and the
facility may use a waste hauling service for disposal. See Section 4 of this report for a discussion
on limitations for reverse distribution of controlled substances.
5.2.3 Pharmaceutical Waste Disposal Practices
Pharmaceutical waste disposal consists of the following components:
• Perform an inventory of all wastes, including identification of proper disposal and
incompatible wastes;
• Communicate proper disposal practices to staff;
• Limit disposal down the drain by handling all or some unlisted pharmaceutical
wastes as RCRA-listed hazardous.
A more detailed discussion follows.
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Perform an Inventory
Facilities perform an inventory of all pharmaceutical waste generated at the facility 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. For
example, one facility reported using a proprietary database to identify proper disposal methods
for pharmaceutical products by name (Cunha, 2007). In addition, Figure 5-1 presents a flowchart
from the Washington State Department of Ecology Web site to assist facilities to identify proper
disposal methods.
Send Pharmaceuticals back via
Reverse Distributor or
return to manufacturer.
' If it designates under WAG 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
Vjhe conditional exclusion WAG 173-303-071 (3)(nn).y
Does the material
have any value?
Was the
pharmaceutical a
controlled
substance?
Does the
material designate
as a RCRA waste?
WAG 173-303-080
Or -090?
Segregate from \
all other waste /
Was the
material
chemotherapy
waste?
Disposal Cost Savings
Labor Cost Savings
Does the material
designate as state-only
dangerous waste?
WAG 173-303-100
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 t
waste.
Dispose of at a facility that meets
the conditional exclusion.
WAG 173-303-071 (3)(nn)
Contact Local Health Department.
Dispose of in:
a) Solid waste,
b) Santiary sewer, if liquid, or
^ c) In municipal incinerator
Source: Washington State Department of Ecology.
Figure 5-1. Example Pharmaceutical Waste Management Flow Chart
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Communicate Proper Disposal Practices
Once the facility identifies the proper disposal methods for the pharmaceuticals used
onsite, the next step is to communicate the proper disposal method to staff and ensure that the
unused pharmaceuticals are disposed in the proper receptacles. Tools exist to help facilities
automate this process. Some hospitals currently use a bar code system to track drug utilization
and avoid medication errors. This same system can be used to store information about the proper
disposal. For example, one system uses a bar code scanner to categorize waste medications as
infectious, chemotherapeutic, hazardous, mixed hazardous/infectious or lower risk. Once the
type of waste is identified the appropriate tamper-proof container opens automatically. This
system eliminates human error during pharmaceutical waste sorting and identification (Vestara,
2008).
Consider Disposing of Unlisted Pharmaceutical Wastes as RCRA-Listed Hazardous
Manufacturers continue to develop new drugs that are not currently listed as RCRA
hazardous waste. As a result, many unlisted pharmaceutical products that are equally hazardous
to listed pharmaceutical waste may be disposed of down the drain or disposed into municipal
solid waste landfills. Suggested management practices for pharmaceutical waste generally
encourage handling all pharmaceutical waste as hazardous when discarded. The H2E Blueprint
recommends incinerating the following pharmaceuticals as hazardous waste (H2E, 2006):
• Formulations that use listed ingredients that are not the sole active ingredient. To
meet the scope of a P or U listing under RCRA, the pharmaceutical formulation
must contain only one active ingredient. For example, Fluori-methane is a
formulation composed of 15 percent dichlorodifluoromethane (U075) and 85
percent trichloromonofluoromethane (U121). Although both ingredients are U-
listed RCRA hazardous wastes, the combined formulation is not a listed waste
because neither ingredient is the sole active ingredient.
• Chemotherapeutic agents. Only nine chemotherapy drugs are P or U listed. There
are currently over 100 chemotherapy drugs used by the health services industry.
Examples of common chemotherapy drugs that are not listed include
methotrexate, vinblastine, vincristine, and 5-fluorouracil.
• Drugs meeting NIOSH hazardous drug criteria.12 The NIOSH criteria include
mutagenicity, carcinogenicity, teratogenicity or other developmental toxicity,
reproductive toxicity, organ toxicity at low dose, genotoxicity, and structure and
toxicity of new drugs that mimic existing drugs determined hazardous by previous
criteria.
Drugs listed in Appendix VI of the OSHA Technical Manual.13
Drugs with a lethal dose (LD) less than or equal to 50 mg/kg (e.g., Colchicine).
Carcinogenic drugs.
Vitamin and mineral preparations that use heavy metals.
Potential endocrine disrupting compounds.14
12 Appendix A of NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous
Drugs in Healthcare Settings provides a list of drags that should be handled as hazardous. It is available online at
http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Note: these drags may not be P-listed orU-listed
RCRA hazardous waste, but may be classified as RCRA hazardous by characteristic, once they are a waste.
13 The OSHA Technical Manual is available online at http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
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As part of its guidance to health services facilities, the state of California lists the
following pharmaceutical wastes as acceptable for sewering (in general): solutions in IV bags
containing only saline solution, lactate, nutrients such as glucose, vitamins, and added salts such
as potassium or other electrolytes. The state of California encourages health care facilities to
minimize as much as possible the amount of pharmaceutical waste disposed to the sewer15
(McGurk, 2003).
5.3 Treatment Options
As part of the Health Services Industry Study, EPA is obtaining information on
pharmaceutical destruction devices that LTCFs and hospitals may use as an alternative to
wastewater disposal. For example, a Canadian company has used a proprietary non-incineration
technology to destroy pharmaceutical waste. This technology is a closed-loop, indirectly heated
system that pyrolyzes all the organic components of the pharmaceutical waste and depolymerises
all of the plastic from the pharmaceutical packaging. This depolymerized plastic is then
recoverable 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).
EPA will continue to collect information on pharmaceutical destruction technologies
during the 2009 annual review.
14 Many common endocrine disrupters, such as estrogens, testosterone, progesterone, androgens, contraceptives, and
oxytoxics are listed in the NIOSH Hazardous Drug Alert. Additional endocrine disrupting drugs, such as the anti-
fungal ketoconazole, can be found at www.ourstolenfuture.org.
15 The state of California requires health services facilities to obtain permission from their POTW prior to disposing
of pharmaceutical waste down the drain. The POTW then has the authority to deny a facility's request based on
local conditions.
Similarly the King County Industrial Waste Program in Washington issued industrial wastewater discharge
authorizations to all King County hospitals stating that no Pharmaceuticals may be discharged to the sewer as of
2002. King County hospitals use reverse distributors or dispose all pharmaceutical waste as hazardous waste (True,
2007).
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6. PATHWAYS FOR ENVIRONMENTAL RELEASES OF UNUSED PHARMACEUTICALS
Health service facilities have three disposal options for pharmaceuticals that are
identified as waste (i.e., that cannot be returned to manufacturer for credit):
• Disposal to sewer;
• Incineration (RCRA incineration or low temperature incineration); and
• Disposal to landfill.
Currently, EPA does not have information on the quantities of pharmaceuticals disposed
by each option. Section 7 describes the status of EPA's information collection on disposal
practices at hospitals and LTCFs. The remainder of this section describes each disposal pathway
in more detail.
6.1 Disposal to Sewer
The vast majority of hospitals and LTCFs are indirect dischargers. Therefore, wastewater
discharges from these facilities, including pharmaceuticals that are flushed down the drain, are
treated at POTWs before they are discharged to surface waters. As described in Section 3.2 of
this report, POTWs are not designed to remove pharmaceuticals that are present in discharges
from hospitals and LTCFs. Many recent studies characterize treatment effectiveness of certain
technologies, including secondary biological treatment, reverse osmosis, and several drinking
water treatment technologies (AWWARF, 2007; Carballa, 2004; Drewes, 2006; Stephenson,
2007; and Thomas, 2007). The remainder of this subsection summarizes selected studies
regarding the fate of pharmaceuticals at POTWs and the factors that affect their removal by
POTW treatment operations.
6.1.1 Mechanisms for Removal
Studies show that removal of selected pharmaceuticals at POTWs is achieved through
biodegradation and adsorption to solids (Stephenson, 2007)16. Sorption to solids is a major factor
affecting removal efficiencies of pharmaceuticals by physical/chemical and biological treatment.
As described in Section 6.2, sorption to solids is determined by the solid/liquid partitioning
coefficient (Carballa, 2004). Pharmaceuticals with low solid partitioning coefficients will remain
in the aqueous phase, making them available to POTW treatment processes, such as
biodegradation, hydrolysis, and chemical oxidation with disinfectants such as chlorine and
ozone.
6.1.2 Effect of POTW Operating Conditions
In a 2007 study sponsored by the Water Environmental Research Foundation (WERF),
researchers sampled six conventional POTWs achieving secondary treatment and two pilot-scale
membrane bioreactors. They investigated the fate of pharmaceutical and personal care products
16 Carballa et. al. investigated 12 pharmaceuticals and personal care products, including musks, hormones, and
pharmaceuticals.
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(PPCP)17 and examined the effects of changing operating parameters. The study authors
concluded that:
There was no significant difference in PPCP removals between conventional
POTWs and the pilot-scale membrane bioreactors;
Altering hydraulic retention time did not affect PPCP removals;
Media filtration did not provide addition removals for PPCPs present in effluent
from secondary treatment;
Pure oxygen systems showed better removals than conventional aeration;
Secondary treatment followed by reverse osmosis reduced all the analyzed
PPCP17 concentrations to less than the method detection limit; and
Increasing the sludge retention time generally increased removals; however, some
PPCPs still had no removal with increased sludge retention time (Stephenson,
2007).
6.1.3 POTWRemoval Efficiencies
Table 6-1 presents a summary of the POTW removal efficiencies in selected published
studies that EPA has obtained. These select studies provide an overview of the wider body of
published technical literature related to the treatment of pharmaceuticals in water.
Pharmaceuticals that were detected in POTW influent in these selected studies include 17 alpha-
ethinylestradiol, 17 beta-estradiol, caffeine, estriol, estrone, ibuprofen, and testosterone. As
shown in Table 6-1, most of these compounds have compound removals greater than 50 percent.
However, the published removals for these compounds often range from negative removals to
close to 100 percent removals (i.e., compound not detected in effluent). Several factors can
contribute to the high variability of pharmaceutical removal rates found by various sampling
studies (Thomas et al., 2007):
• Pharmaceutical concentrations can be highly variable in the POTW influent. Due
to the design of the sampling program and retention times at the POTW, effluent
samples may not be representative of influent samples.
• Excreted pharmaceuticals are often in their polar conjugate form (sulphates or
glucuronides) and can reform the parent pharmaceutical during the treatment
process at the POTW.
• High levels of organic matter at the POTW influent can cause interferences during
analysis for pharmaceutical compounds.
Table 6-1. POTW Removal Efficiencies for Specific Pharmaceuticals in Selected Studies
Compound
Acetaminophen
(paracetamol)
Alpha-
ethinylestradiol
Therapeutic Family
Painkiller/anti-
inflammatory
Steroid
POTW Treatment
Secondary treatment
Secondary treatment
Reverse osmosis (lab-scale)
Compound
Removal (%)
0 - 100 a
>92
100% removal
Reference
Thomas, 2007
Drewes, 2006
Drewes, 2006
Stephenson and Oppenheimer investigated POTW removals for 21 PPCPs, two of which were pharmaceuticals
(ibuprofen and caffeine).
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Table 6-1. POTW Removal Efficiencies for Specific Pharmaceuticals in Selected Studies
Compound
Beta-estradiol
Caffeine
Ciprofloxacin
Diclofenac
Estriol
Estrone
Ibuprofen
Metoprolol
Naproxen
Sulfamethoxazole
Testosterone
Trimethoprim
Therapeutic Family
Steroid
Stimulant
Antibiotic
Painkiller/anti-
inflammatory
Steroid
Steroid
Painkiller/anti-
inflammatory
Cardiovascular drug
Painkiller/anti-
inflammatory
Antibiotic
Steroid
Antibiotic
POTW Treatment
Secondary treatment
Reverse osmosis (lab-scale)
Secondary treatment
Secondary treatment
Secondary treatment
Secondary treatment
Secondary treatment
Reverse osmosis (lab-scale)
Secondary treatment
Secondary treatment
Secondary treatment
Secondary treatment
Secondary treatment
Secondary treatment
Compound
Removal (%)
85 - >94
65
57 - 100
100% removal
0->99.9a
0-1003
0-27a
>99
94 - 100
98
Ob
42 - 100
100% removal
0->96a
40-65
0-1003
0-50C
40-65
60
0-1003
96 - >99
0-100C
Reference
Drewes, 2006
Carballa, 2004
Thomas, 2007
Drewes, 2006
Stephenson, 2007
Thomas, 2007
Thomas, 2007
Drewes, 2006
Thomas, 2007
Drewes, 2006
Carballa, 2004
Thomas, 2007
Drewes, 2006
Stephenson, 2007
Carballa, 2004
Thomas, 2007
Thomas, 2007
Carballa, 2004
Carballa, 2004
Thomas, 2007
Drewes, 2006
Thomas, 2007
Sources: Drewes et al., 2006; Stephenson and Oppenheimer, 2007; Carballa et al., 2004; Thomas et al., 2007.
NA — Not applicable.
a - One or more samples showed zero (or negative) removals (effluent concentration was greater than influent
concentration); however, the majority of data indicated removal of the compound.
b - The concentration of estrone increased through the treatment works due to the partial oxidation of 17(beta)-
estradiol.
c - Majority of samples showed zero (or negative) removals (i.e., effluent concentration higher than influent
concentration).
6.2 Incineration
Incineration is the thermal destruction of waste. Modern incinerator systems operate at
high temperatures and use controlled air and mixing to alter the chemical, physical, or biological
characteristics of the waste material. The major benefit of incineration over disposal to landfills
and sewers is that the incineration process destroys the pharmaceutical waste, rather than storing
it or transferring it to another medium. During incineration, the organic components of
pharmaceutical waste are oxidized to carbon dioxide, water vapor, oxygen, nitrogen, and acid
gases. However, the inorganic components of the waste and byproducts of incineration can still
be released to the atmosphere through the incinerator exhaust, discharged to wastewater via wet
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air pollution control technologies (e.g., scrubbers), or disposed to landfill with the incinerator ash
(Santoleri, 2006).
Hazardous waste incinerators and medical waste incinerators are currently available for
destruction of pharmaceutical waste. Differences between these incinerators include permitting,
oversight, operating temperatures, emissions control, and final disposition of the resulting ash
(Chemical Disposal Services, 2008). Hazardous waste incinerators are subject to stringent
regulations promulgated under the authority of the following statutory authorities:
• Resource Recovery Act (1965);
Clean Air Act (1970);
• Resource Conservation and Recovery Act (1976); and
• Hazardous and Solid Wastes Amendments (1984).
These regulations require operators of hazardous waste incinerators to install and
maintain proper combustion and air pollution controls. Air pollution control systems typically
include scrubbers designed to remove particulate, heavy metals, hydrocarbons, dioxins and
furans, and acid gases produced from waste containing chlorine, sulfur, phosphorus, and nitrogen
(Santoleri, 2006). The ash recovered from hazardous waste incinerators must be sent to a lined
hazardous waste landfill (Chemical Disposal Services, 2008).
Medical waste incinerators are not as strictly regulated. For example, ash recovered from
medical waste incinerators may be stored in a municipal landfill (Chemical Disposal Services,
2008). In 1997, EPA found that medical waste incinerators were among the top emitters of
mercury and dioxin, and adopted new source performance standards and emission guidelines for
hospital/medical/infectious waste incinerators (see 65 FR 49739). The regulations required the
implementation of good combustion practices to promote complete waste destruction and limit
formation of air pollutants. The regulations, which are still in effect, also required the use of wet
or dry scrubbers to control emissions of particulate matter, dioxins and furans, hydrochloric acid,
and metals. Many medical waste incinerators have closed because they decided to implement
alternative disposal methods rather than meet the new requirements of the standards.
Different incinerator configurations exist for thermal treatment of gases, liquids, and
solids. The vast majority of pharmaceutical waste is expected to be in liquid or solid form.
Incinerators designed to treat solid and liquid feed include fixed-hearth and rotary kiln
incinerators. Fixed-hearth systems, commonly used for medical and municipal waste, burn solid
and liquid waste in a stationary chamber. The rotary kiln incinerator uses a rotating cylindrical
chamber to mix the solid and liquid waste and ensure even distribution of heat. In both systems,
waste enters the primary combustion chamber (which operates at extremely high temperatures,
i.e., 1,300 to 2,000°F), where the air in the combustion chamber volatilizes and oxidizes the
waste. Carbon monoxide and unburned volatiles exit the primary combustion chamber and enter
the secondary combustion chamber, where additional air or oxygen is added to further oxidize
the vapor and ensure complete combustion (Santoleri, 2006). Hazardous waste incinerators must
achieve 99.99 percent destruction and removal of principal organic hazard constituents.18
18 Principal organic hazard constituents are selected based on their toxicity, prevalence in the waste mix, and
difficulty to burn.
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6.3 Disposal to Landfill
Unused pharmaceuticals that are disposed of as solid waste may be sent to a hazardous
waste landfill or a municipal solid waste (MSW) landfill. Unused pharmaceuticals in landfills
generally include pills, tablets, and trace amounts in spent containers. The main concern about
using landfill disposal is the potential for pharmaceuticals to enter surface water and
groundwater through landfill leachate. RCRA regulations include two types of requirements to
control leachate: treatment prior to disposal on land and landfill construction requirements.
Hazardous waste landfills are regulated under RCRA Subtitle C. The RCRA Land
Disposal Restrictions require hazardous wastes to be treated prior to disposal in the landfill. For
example, liquid wastes containing hazardous pharmaceuticals such as epinephrine, nicotine, or
nitroglycerine, are treated using wet air oxidation, chemical oxidation, carbon adsorption, or
combustion. Solid wastes containing these pharmaceutical ingredients must be treated using
high-temperature combustion. Treatment standards for hazardous waste are described in 40 CFR
Part 268. The treatment standards for pharmaceuticals are expressed as a treatment method rather
than as a concentration. For these standards, the waste must be treated using the technology
described in Table 1 of the regulation. For example, chemical oxidation ("alkaline chlorination")
requires:
• Using the following oxidation reagents (or waste reagents) or combinations of
reagents: hypochlorite (e.g., bleach), chlorine, chlorine dioxide, ozone or UV
(ultraviolet light) assisted ozone, peroxides, persulfates, perchlorates,
permanganates, and/or other oxidizing reagents of equivalent efficiency; and
• Operating the treatment unit to substantially reduce the concentration of the
surrogate compound or indicator parameter (e.g., total organic carbon).
Once waste is disposed of in a hazardous landfill, the landfill's construction (per RCRA
design requirements) isolates wastes from contact with moisture to avoid leachate generation.
The top of the landfill has a low-permeability cover and the sides and bottom are lined with a
double-liner system. The outer lining consists of compacted soil and a geomembrane liner. All
leachate is collected in a sump and treated (Zhao and Richardson, 2003).
MSW landfills are regulated under RCRA Subtitle D, which requires that the landfill
have a liner and a leachate collection and treatment system. Unlike Subtitle C, Subtitle D does
not require waste to be treated prior to disposal. In addition, Subtitle D requires only a single
lining with a geomembrane and compacted clay liner. States have the authority to set more
stringent requirements for Subtitle D landfills. As of 2003, seven states required double-liner
systems at Subtitle D landfills (Zhao and Richardson, 2003).
EPA performed a literature search for studies or reports on pharmaceuticals disposed of
in landfills. EPA found that in 2007, the Pharmaceutical Research and Manufacturers of America
(PhRMA) evaluated the potential for 24 active pharmaceutical ingredients to leach from MSW
landfills and their potential releases to surface water (Tischler, 2007). PhRMA compared the
modeled landfill leachate releases to estimates of surface water releases from disposal of unused
pharmaceuticals down the drain. PhRMA selected the 24 example pharmaceutical ingredients to
represent a range of sales per year in the U.S. (i.e., high quantities and low quantities) and a
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range of physical-chemical properties. These pharmaceutical ingredients were also evaluated in
the 2002 USGS study of pharmaceuticals in surface waters (Kolpin et al., 2002).
The PhRMA study calculated that the landfill disposal pathway to surface water
accounted for an average of 0.03% to 0.10% of the estimated aggregate annual surface water
releases for the 24 active pharmaceutical ingredients. Therefore, the study estimated that over
99.9% of active pharmaceutical ingredient surface water releases would be due to patient
excretion, not landfill disposal of unused medicines, assuming that landfill disposal were used
for all unused medicine disposal. The evaluation was based on the assumption that the efficiency
of the pharmaceuticals partitioning to solids in the landfill is 50% of the efficiency of
partitioning in a biological wastewater treatment unit (Tischler, 2007).
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7. DATA COLLECTION STATUS
As part of this study, EPA is collecting information on disposal practices, quantities of
Pharmaceuticals disposed, alternatives to disposal of pharmaceuticals down the drain, and
pharmaceutical waste minimization and management practices. To accomplish this, EPA will
collect data directly from hospitals, LTCFs, hospices, and veterinary facilities and review data
available in scientific literature. EPA plans to use these data to identify and evaluate potential
BMPs or alternative disposal methods; and determine the need for pretreatment standards for
unused pharmaceuticals. EPA will compare disposal practices across the United States and
estimate the amount and types of drugs discharged to surface water.
7.1 Site Visits
In June 2008, EPA visited a reverse distributor in Milwaukee, WI and two hospitals in
Minneapolis, MN. The objectives of these site visits included:
• Observe the reverse distribution process;
• Observe pharmaceutical waste management practices at two hospitals;
• Collect information about available tools and resources for waste characterization
and disposal recommendations;
• Gather data on pharmaceutical identities and quantities disposed to various waste
streams;
• Collect information on costs of pharmaceutical waste management;
• Discuss factors that limit disposal options for some pharmaceuticals, such as
hazardous pharmaceutical waste and controlled substances; and
• Collect general information to improve EPA's questionnaire for health services
facilities.
7.1.1 Capital Returns, Milwaukee, WI
Capital Returns, a national reverse distributor, processes creditable pharmaceutical
returns for pharmacies and pharmaceutical manufacturers. Its customers include:
Hospital, long-term care, mail order, and retail pharmacies;
Pharmaceutical manufacturers; and
Independent and institutional customers.
The facility ensures the proper disposal of expired medications for two major types of
returns (ERG, 2008a):
• Pharmacy returns. Capital Returns receives expired pharmaceuticals that are
eligible for credit, or "creditable," from its pharmacy clients. Staff identify the
expired pharmaceuticals, determine the amount of creditable pharmaceuticals,
identify the manufacturer of the pharmaceuticals, process the return, and either
ship the pharmaceuticals to the manufacturer (if the manufacturer is not a Capital
Returns customer) or send them to incineration for disposal (if the manufacturer is
a Capital Returns customer).
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• Manufacturer returns. Capital Returns receives the creditable expired
Pharmaceuticals that pharmacies return to their pharmaceutical manufacturer
clients. Staff identifies the expired pharmaceuticals, determines the amount of
creditable pharmaceuticals, identifies the pharmacy that made the return,
processes the return, and sends the expired pharmaceuticals to incineration for
disposal.
7.1.2 North Memorial Hospital, Robbimdale, MN
North Memorial Medical Center is a 518-bed, non-profit hospital. North Memorial
developed its hazardous waste management program in response to a 2003 initiative by the
Minnesota Pollution Control Authority (MPCA) to assist hospitals in Minnesota to improve their
hazardous waste management practices and come into compliance with RCRA.19 Following
implementation of the program, North Memorial tracked pharmaceutical waste disposal for two
years. The data indicated that North Memorial disposed of a total of 100,000 pounds of non-
hazardous waste, 20,000 pounds of hazardous waste, and 8,000 pounds of dual waste20 for the
two-year period. The pounds include the weight of vials, tubes, and containers.
The key goal of North Memorial's program is to properly manage pharmaceutical waste
through incineration and avoid flushing. North Memorial uses a pre-sort system to segregate
pharmaceutical waste. Under a pre-sort system, the determination of type of waste is made at the
point of generation. The facility's onsite pharmacy uses a proprietary program to identify proper
disposal practices for each of its 3,000 to 4,000 formularies. These disposal methods are
integrated with the facility's dispensary system. When nurses log into the system, they enter the
national drug code for the medication that they need. The system then displays a message to
indicate whether the pharmaceutical requires special disposal. The North Memorial nursing staff
is trained to place pharmaceutical waste with special disposal requirements into black hazardous
waste bins. Pharmaceuticals without special disposal requirements are placed in white non-
hazardous waste bins. All waste that is disposed of in black bins is logged in for manifesting
purposes, prior to disposal using a hazardous waste transporter. Waste in white bins is not
tracked because it is not regulated, and it is disposed as municipal solid waste. Controlled
substance waste is flushed down the drain.
Pharmaceutical waste minimization practices at North Memorial include managing
inventory, using unit dose vials, ordering pharmaceuticals in unit doses, and repackaging bulk
pharmaceuticals into unit doses. The onsite pharmacy also does not accept pharmaceutical
samples from sales representatives (ERG, 2008b).
7.1.3 Abbott Northwestern, Minneapolis, MN
Abbott Northwestern Hospital is a 640-bed facility and is the largest not-for-profit
hospital in Minnesota. Abbott Northwestern began to develop its hazardous waste management
program in 2005 in collaboration with the MPCA Hazardous Waste Compliance and
19 MPCA's environmental guidance for the health services industry is available online at
http://proteus.pca.state.mn.us/industry/healthcare.html.
20 MPCA refers to pharmaceutical waste and chemical waste that are hazardous and infectious as "dual waste."
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Enforcement department. Abbott's focus was to develop a waste disposal program compliant
with RCRA hazardous waste and Minnesota Lethal guidelines.
21
Abbott's hazardous waste management program uses a "post-sorting" model. Under this
model, nursing staff disposes of all pharmaceutical waste into black hazardous waste containers.
Once full, the waste bins are transferred to a central storage and sorting area. A waste vendor
contracted by Abbott, sorts the pharmaceutical waste into hazardous and non-hazardous. Abbott
Northwestern, with assistance from an independent contractor, compiled a list of wasted
Pharmaceuticals and categorized each as either hazardous or non-hazardous waste (ERG, 2008c).
Based on pharmaceutical waste data for 2006 and 2007, approximately 75 percent of the
sorted pharmaceutical waste generated at Abbott Northwestern is disposed of as non-hazardous
waste (non-hazardous waste and municipal garbage), and 25 percent is disposed of as RCRA
hazardous (P-listed drugs, dual waste, and Minnesota Lethal drugs. Hazardous waste is disposed
using a hazardous waste transporter, while non-hazardous waste is disposed as municipal solid
waste. Controlled substance waste is flushed down the drain (ERG, 2008c).
7.2 Pharmaceutical Disposal Information from Technical Literature
EPA has reviewed available literature on quantities and identities of pharmaceuticals
disposed to wastewater, reasons why pharmaceutical waste is generated, how often facilities use
different disposal methods, and examples of reductions in pharmaceutical discharges to
wastewater through implementation of pharmaceutical waste minimization or alternate disposal
methods. EPA reviewed the following studies and summarized their information in this
subsection:
• Survey of 17 LTCFs located in the Commonwealth of Massachusetts (Paone et
al., 2007);
• Bren School survey of LTCFs, hospitals, and pharmacies in Santa Barbara, CA
(Bren School, 2007);
Kansas State University survey of 59 LTCFs in Kansas (KSU, 2008);
• City of Newberg, OR, pharmaceutical collection program (Bateman, 2007); and
• Pharmaceutical waste management program at a 274-bed LTCF (Conkle, 2008).
7.2.1 Quantities and Identities of Pharmaceuticals
The Massachusetts Society of Consultant Pharmacists surveyed 17 Massachusetts LTCFs
from 1992 to 1994 to evaluate the scope and costs of medication waste in Massachusetts LTCFs.
The survey collected information on the costs of medications that were wasted and the reasons
why medications became waste. The survey did not specify the method of destruction. Therefore,
the quantity of destroyed medications that are disposed to wastewater is unknown. The survey
found that, combined, the 17 facilities destroyed approximately $0.15 of medications per patient
per day. This amount accounts for 6.7 percent of the total value of prescribed medications. The
highest-cost medications destroyed were central nervous system drugs, gastrointestinal drugs,
cardiovascular drugs, and anti-infective drugs (Paone et al., 2007).
21 More information on Minnesota Lethal Guidelines can be found at
http://www.pca.state.mn.us/publications/w-hw2-04.pdf
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The Bren School of Environmental Science and Management conducted surveys to
determine household and institutional disposal practices in Santa Barbara County and to estimate
the public's willingness to pay for a pharmaceutical disposal program. The survey results
indicated that most facilities dispose of only a small percentage of their pharmaceutical stock,
and that the drain and trash are the most common disposal practices for households. Therefore,
the Bren School researchers recommend implementing an education campaign and disposal
program for the public (Bren School, 2007).
The Bren School survey of institutions included hospitals, pharmacies, and LTCFs
located in Santa Barbara. The survey asked facilities to report the percent of their pharmaceutical
stock that is typically wasted. The vast majority of all three types of facilities reported that
between 0 and 5 percent of their pharmaceutical stock is wasted. No hospital or pharmacy
reported more than 10 percent of their pharmaceutical stock as wasted. LTCFs reported the
highest percentage of waste, with at least one facility reporting more than 30 percent of their
pharmaceutical stock wasted. LTCFs commented that their residents' prescriptions changed as
frequently as every six months. The Bren School researchers stated that the frequency of
prescription changes at LTCFs may explain why this category of facilities produces the highest
percentage of pharmaceutical waste (Bren School, 2007).
7.2.2 Reasons for Pharmaceutical Waste
The survey of 17 Massachusetts LTCFs found that prescribed pharmaceuticals were
unused for the following reasons:
Resident died: 35.5 percent;
Medication was discontinued: 34.2 percent;
Resident was transferred: 7.3 percent;
Resident was hospitalized: 6.8 percent;
Medication was changed: 6.3 percent;
Medication was decreased: 3.4 percent;
Other: 2.6 percent;
Medication was increased: 2.0 percent; and
Medication expired: 1.9 percent.
7.2.3 Disposal Methods
The Bren School survey asked hospitals, LTCFs, and pharmacies in Santa Barbara to
rank, on a scale of 1 to 5, how often their facilities use different pharmaceutical disposal
methods, where 5 is very frequently and 1 is never. Table 7-1 presents the average of responses
for each type of facility. All three facility categories reported infrequent drain disposal of unused
Pharmaceuticals. The disposal methods most frequently used by hospitals in Santa Barbara are
reverse distribution, biohazard waste disposal, and hazardous waste disposal. For LTCFs, the
most frequently used disposal methods are reverse distributors, trash, and "other." Pharmacies
indicated that reverse distribution is their primary disposal method (Bren School, 2007).
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Table 7-1. Average Use of Disposal Practices Reported by Santa Barbara Hospitals,
LTCFs, and Pharmacies
Disposal Method
Reverse distributor
Trash
Drain
Biohazard waste
Return to manufacturer
Onsite incinerator
Hazardous waste
Other
Average Response for
Hospitals
3-4
1-2
1-2
3-4
2-3
1
4
1
Average Response for
LTCFs
3-4
2-3
1-2
1-2
1-2
1
1-2
2-3
Average Response for
Pharmacies
4-5
1
1-2
1-2
1-2
1
1-2
1-2
Source: Bren School, 2007.
1 — never;
5 — very frequently.
Kansas State University researchers asked 59 local LTCFs how they dispose of unused
Pharmaceuticals (KSU, 2008). The survey found the following usage rates for disposal methods:
Drain disposal: 46 percent;
Return processors: 24 percent;
Trash: 20 percent; and
Other: 10 percent.
7.2.4 Examples of Pharmaceutical Waste Management and Alternate Disposal Methods
At this time, EPA has reviewed information on two example programs that were
implemented at LTCFs to reduce pharmaceutical wastewater discharges. These programs include
a disposal program implemented by the City of Newberg, OR, and implementation of
pharmaceutical waste minimization practices at an unnamed 274-bed LTCF. These case studies
are described below.
Alternate Disposal Case Study
In 2007, the City of Newberg, Oregon implemented a program to collect and incinerate
controlled and non-controlled substances (take-back program) from four adult care facilities
(Bateman, 2007). Oregon state law allows the return and redispensing of unused pharmaceuticals
from LTCFs that are:
Non-controlled substances;
In unopened, tamper-evident packaging;
Under supervision of a pharmacist;
In packaging that uses the original labeling; and
Stored under conditions specified by the U.S. pharmacopeia standards.
Medications that cannot be returned are stored for disposal. The facilities used mailbox-
like containers to hold unused pharmaceuticals in medication storage areas. The mailboxes are
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locked and bolted to the floor or wall. Controlled substances are picked up by the Newberg-
Dundee Police Department during their quarterly disposal of evidence at a local incinerator. The
non-controlled substances are collected by the franchised hauler, Newberg Garbage Service.
Information is not available regarding the disposal practices at the LTCFs prior to
implementation of the take-back program. Therefore, EPA cannot estimate reductions to
wastewater discharges that result from this program.
Pharmaceutical Management Case Study
In July 2002, a nurse at a 274-bed LTCF monitored the amount of prescriptions that were
destroyed by flushing.22 The facility flushed unit doses of narcotic pills, individually wrapped
Duragesic patches, and sealed liquid containers. These unused medications were destroyed even
though they were never opened. The total cost of medications disposed to wastewater at this
facility totaled almost $2,000 per week ($99,000 per year). The destruction policy at this facility
required nurses to count and log all unused medications and flush the medications in the
presence of two nurses and a consultant pharmacist.
The facility implemented policies to reduce the generation of pharmaceutical waste. The
facility worked with the pharmacy to reduce the quantity of narcotics dispensed to the facility to
one week's supply. Patches were limited to three doses. The facility also asked the pharmacy to
limit the amounts of fluids dispensed for oral medications. These efforts dramatically reduced the
amount of waste requiring destruction at the facility by 90 percent to $200 per week. In addition,
the amount of time required for the LTCF staff and consultant pharmacist to destroy the unused
Pharmaceuticals decreased, and the frequency of destruction was decreased to once every three
months because of the reduction in waste generation (Conkle, 2008).
22 In providing information to EPA, the nurse did not name the LTCF or give its location.
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8. NEXT STEPS
EPA continues to study the issue of how health services facilities are managing and
disposing of unused pharmaceuticals and POTW treatment effectiveness in an effort to identify
the root cause and potential solutions to address the issue of pharmaceuticals in our waterways.
Over the coming year EPA expects to:
• Submit an ICR to the Office of Management and Budget (OMB) for their review
and approval of an industry survey under the Paperwork Reduction Act (PRA), 33
U.S.C. 3501,etseq.;
• Collect additional data through site visits at hospitals, LTCFs, hospices and/or
veterinary facilities;
• Gather more technical and economic information on unused pharmaceutical
management in the Health Services Industry via the industry survey;
• Work closely with industry representatives and other affected stakeholders; and
• Solicit comment on this interim report and the 2009 ELG annual plan.
8.1 Industry Questionnaire
During EPA review of currently available data for the health services industry study,
EPA did not find a national source of information on the disposal of unused pharmaceuticals.
Therefore, EPA is considering an Information Collection Request (ICR), as discussed in detail in
the federal register notice dated August 12, 2008 (see 73 FR 46903, available at
http://www.epa.gov/guide/304m/index.html).
As described in the supporting statement to the ICR, EPA will use the ICR to collect
technical and economic information on unused pharmaceutical management and identify
technologies and BMPs that reduce or eliminate the discharge of unused pharmaceuticals to
POTWs (EPA-HQ-OW-2008-0517, DCN 06103). EPA is collecting data from medical and
veterinary facilities about unused pharmaceutical disposal practices. To collect this information,
EPA will distribute a questionnaire to a nationally representative sample of medical and
veterinary facilities. EPA plans to use two versions of the questionnaire, one tailored to facilities
that treat people (i.e., hospitals, hospices, and LTCFs) and one tailored to facilities that treat
animals (i.e., veterinary facilities). Overall, the goal of these questionnaires is to gain a thorough
understanding of unused pharmaceuticals disposal practices at medical and veterinary facilities at
a national level including:
• The factors driving current disposal practices;
• Information on the amount of unused pharmaceuticals currently disposed of via
the drain or flushing; and
• The alternatives to drain disposal and flushing. In addition, EPA will request
information on alternative management options for unused pharmaceuticals and
the costs associated with alternative management practices.
In the ICR notice, EPA solicited comments about the scope of the ICR and whether EPA
adequately described the industry sectors that would be subject to the data collection. EPA also
solicited comments on what additional entities, if any, should be included in the scope of the
ICR. EPA plans to include health services establishments including hospitals, hospices, LTCFs,
JM
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and veterinary facilities. EPA may consider including veterinary clinics, medical and dental
offices, as well as university and prison health clinics within the scope of inquiry and encouraged
these groups to comment and meet with EPA to discuss their practices.
8.2 Site Visits
EPA also plans to conduct additional site visits to facilities to obtain more detailed
information on how pharmaceuticals are managed, tracked, and disposed as well as influences on
behavior. EPA will continue to work with industry trade groups to identify the best facilities to
visit to identify BMPs and current practices.
8.3 Additional Review of Technical Literature
In addition to the many articles documenting the presence and removal of
Pharmaceuticals in water, there are even more ongoing studies currently underway. EPA will
continue collecting data on pharmaceuticals in water as the publications from these studies
become available.
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9. REFERENCES
Albany Medical Center. 2007. Policy and Procedure: Medication Distribution —Medication
Delivery and Return. January 23. Docket EPA-HQ-OW-2006-0771, DCN 06078.
Alvarez, et. al. 2007. Reconnaissance of Persistent and Emerging Contaminants in the
Shenandoah and James River Basins, Virginia, During Spring of 2007. U.S. Geological Survey
(USGS). Docket EPA-HQ-OW-2006-0771, DCN 06102.
APhA. 2006. American Pharmacists Association. Re-Distribution of Medications. APhA Policy
Committee Background Information. November. Docket EPA-HQ-OW-2006-0771, DCN 04953.
ASCP. 2003. American Society of Consultant Pharmacists. Policy Statement: Statement on the
Return and Reuse of Medications in Long-term Care Facilities. July 11. http://www.ascp.com/
resources/policy/upload/ASCP%20Policy%20Statement%20on%20Return%20&%20Reuse.pdf.
Accessed September 2007. Docket EPA-HQ-OW-2006-0771, DCN 04873.
AWWARF, 2007. American Water Works Association Research Foundation. Removal ofEDCs
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. Docket EPA-
HQ-OW-2006-0771, DCN 06118.
Bateman. 2007. "Pharmaceutical Take-Back Programs in Adult Care Facilities: A Pilot Project in
Newberg, Oregon." Oregon Take-Back Steering Committee Meeting. February 9. Docket EPA-
HQ-OW-2006-0771, DCN 05477.
Bren School. 2007. Donald Bren School of Environmental Science and Management.
Pharmaceuticals in Wastewater Streams: Disposal Practices and Policy Options in Santa Barbara.
University of California, Santa Barbara. May. Docket EPA-HQ-OW-2006-0771, DCN 06075.
California. 2002. State of California Department of Health Services. Letter to Directors of
Environmental Health and Medical Waste Program Managers. October 15. Docket EPA-HQ-
OW-2006-0771, DCN 06076.
Carballa, M., et al. 2004. "Behavior of Pharmaceuticals, Cosmetics and Hormones in a Sewage
Treatment Plant." Water Research 38. Docket EPA-HQ-OW-2006-0771, DCN 06077.
Census. 1997a. U.S. Census Bureau. 1997 Economic Census: Bridge Between NAICS and SIC
Health care & social assistance (NAICS 622). Docket EPA-HQ-OW-2006-0771, DCN 06125.
Census. 1997b. U.S. Census Bureau. 1997 Economic Census: Bridge Between NAICS and SIC
Health care & social assistance (NAICS 623). Docket EPA-HQ-OW-2006-0771, DCN 06126.
Census. 1998. U.S. Census Bureau. County Business Patterns: 1998. Docket EPA-HQ-OW-
2006-0771, DCN 04532.
Census. 2002. U.S. Census Bureau. County Business Patterns: 2002. Docket EPA-HQ-OW-
2006-0771, DCN 04534.
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Census. 2005a. U.S. Census Bureau. County Business Patterns: 2005. Industry Code
Comparison, http://censtats.census.gov/cgi-bin/cbpnaic/cbpsel.pl. Docket EPA-HQ-OW-2006-
0771,DCN 04531.
Census. 2005b. U.S. Census Bureau. Establishment and Firms Size: 2002 (Including Legal Form
of Organization). "Receipts/Revenue Size of Establishments for the United States: 2002." 2002
Economic Census, Health Care and Social Assistance. Subject Series. EC02-62SS-SZ.
November. Docket EPA-HQ-OW-2004-0032, DCN 02943.
Census. 2007. U.S. Census Bureau. Statistics of U.S. Businesses — 2002. Tabulated by Receipt
Size, http://www.census.gov/csd/susb/susb02.htm. Accessed August 10, 2007. Docket EPA-HQ-
OW-2006-0771, DCN 04577.
Chemical Disposal Services. 2008. A Guide to Pharmaceutical Waste Disposal.
http://www.medicalwastesolutions.com/pharm_update.pdf. Date accessed: April 2008. Docket
EPA-HQ-OW-2006-0771, DCN 06080.
CMS. 2007. Centers for Medicare & Medicaid Services, Web site. Available online at:
http://www.cms.hhs.gov/default.asp. Date accessed: August 2007. Docket EPA-HQ-OW-2006-
0771, DCN 05074.
Collier, 2007. Collier, AC. Pharmaceutical Contaminants in Potable Water: Concerns for
Pregnant Women and Children. Journal of Public Health. 2007. Docket EPA-HQ-OW-2006-
0771, DCN 06119.
Conkle, C. 2008. "Narcotic Waste Report." Email correspondence between Cindy Conkle of
Traditions Management and Meghan Hessenauer of EPA. April 4. Docket EPA-HQ-OW-2006-
0771, DCN 06081.
Cunha, B. 2007. Comments on the Preliminary 2008 Effluent Guidelines Program Plan. EPA-
HQ-OW-2006-0771 -0829.
Daughton, C.G., and T.A. Ternes. 1999. "Pharmaceuticals and Personal Care Products in the
Environment: Agents of Subtle Change?" Environmental Health Perspectives 107(Suppl 6).
Docket EPA-HQ-OW-2006-0771, DCN 06120.
Daughton, 2007. Daughton, C.G. Pharmaceuticals in the environment: sources and their
management. A non-copyrighted chapter of Analysis, Fate and Removal of Pharmaceuticals in
the Water Cycle. Edited by Petrovic, M., D. Barcelo, et al. Elsevier Science. Available at
http://www.epa.gov/nerlesdl/bios/daughton/Chapl_Petrovic&Barcelo.pdf. Docket EPA-HQ-
OW-2006-0771, DCN 06121.
DEA. 1997. Drug Enforcement Administration, Office of Diversion Control. Code of Federal
Regulations: Disposal of Controlled Substances. 62 FR 13967; March 24, 1997.
http://www.deadiversion.usdoj.gov/21cfr/cfr/1307/1307_21.htm. Accessed September 2007.
Docket EPA-HQ-OW-2006-0771, DCN 04929.
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DEA. 2005a. Drug Enforcement Administration, Office of Diversion Control. Rules — 2005.
Definition and Registration of Reverse Distributors. 83 FR 22591; May 2, 2005.
http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0502.htm. Accessed September 2007.
Docket EPA-HQ-OW-2006-0771, DCN 04931.
DEA. 2005b. Drug Enforcement Administration, Office of Diversion Control. Preventing the
Accumulation of Surplus Controlled Substances at Long Term Care Facilities. 92 FR 25462;
May 13, 2005. http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0513.htm. Accessed
December 2007. Docket EPA-HQ-OW-2006-0771, DCN 06082.
DOJ. 2006. U.S. Department of Justice. "Tenet Healthcare Corporation to Pay U.S. More Than
$900 Million to Resolve False Claims Act Allegations." News release. June 29.
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DCN 06083.
DOL. 2007. U. S. Department of Labor. NAICS to SIC Employment Ratios for 4-Digit SIC Series.
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0771, DCN 04552.
Drewes, J.E., et al. 2006. Removal of Endocrine Disrupting Compounds in Water Reclamation
Processes. Water Environment Research Foundation. 01-HHE-20T. Docket EPA-HQ-OW-2006-
0771, DCN 06084.
EC Workgroup. 2005. Emerging Contaminants Workgroup. "Discussion Paper on
Pharmaceutical Disposal to Sewer Systems." Emerging Contaminants Workgroup of the Santa
Clara Basin Watershed Management Initiative. February. Docket EPA-HQ-OW-2004-0032,
DCN 02324.
Environment Canada.2007. Endocrine Disrupting Substances in the Environment.
http://www.ee.gc.ca/eds/fact/eds_e.pdf. Accessed November 28, 2007. Docket EPA-HQ-OW-
2006-0771, DCN 06085.
EPA. 2006a. U.S. Environmental Protection Agency. Notice of Availability of Final 2006
Effluent Guidelines Program Plan. Federal Register 71:76644-76667. December 21.
EPA. 2006b. U.S. Environmental Protection Agency. Final Guidance for EPA Rule Writers:
Regulatory Flexibility Act as amended by the Small Business Regulatory Enforcement Fairness
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ERG. 2007. Eastern Research Group. Memorandum: Industry Profile for Long Term Health
Care Facilities, Hospitals, Clinics, and Veterinary Service. Prepared for EPA Office of Water.
August 20, 2007. Docket EPA-HQ-OW-2006-0771, DCN 04511.
ERG. 2008. Site Visit Report for Capital Returns, Milwaukee, WI. July. Docket EPA-HQ-OW-
2006-0771, DCN 06086.
ERG. 2008a. Site Visit Report for North Memorial Hospital, Robbinsdale, MN. July. Docket
EPA-HQ-OW-2006-0771, DCN 06087.
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ERG. 2008b. Site Visit Report for Abbott Northwestern Hospital, Minneapolis, MN. July.
Docket EPA-HQ-OW-2006-0771, DCN 06088.
Garvin, M.G. 2007. Comments on the Preliminary 2008 Effluent Guidelines Program Plan.
EPA-HQ-OW-2006-0771-0851. December 21.
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HQ-OW-2006-0771 -0824.
H2E. 2006. Hospitals for a Healthy Environment. Managing Pharmaceutical Waste: A 10-Step
Blueprint for Health Care Facilities in the United States. April 15. Docket EPA-HQ-OW-2006-
0771, DCN 04876.
Hessenauer, M. 2007. U.S. Environmental Protection Agency. Memorandum to the Public
Record for the 2008 Effluent Guidelines Program Plan. "Health Services Outreach Meeting with
the Center of Excellence in Assisted Living (CEAL) Advisory Council (18 October 2007) —
Final." 17 December. Docket EPA-HQ-OW-2006-0771, DCN 05961.
Holman, S. 2007a. Telephone conversation with Darrell McKigney of Long Term Care
Pharmacy Alliance and Sarah Holman of Eastern Research Group. "Disposal of Unused
Pharmaceuticals from Long-Term Care Facilities." August 31. Docket EPA-HQ-OW-2006-0771,
DCN 04946.
Holman, S. 2007b. Email to Darrell McKigney, Acting Executive Director, Long Term Care
Pharmacy Alliance. "Pharmaceutical Disposal from Long-Term Care Facilities." September 3.
Docket EPA-HQ-OW-2006-0771, DCN 04947.
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Contaminants in U.S. Streams 1999-2000: A National Reconnaissance." Environmental Science
and Technology 36:1202-1211. Docket EPA-HQ-OW-2006-0771, DCN 04958.
Koltz, BJ. 2007. Compounds of Emerging Concern Source Control Programs: Components and
Results. CEC Symposium. Docket EPA-HQ-OW-2006-0771, DCN 05009.
KSU. 2008. Nancy J. Larson. Pharmaceutical Waste Outreach Project. January 31. Docket
EPA-HQ-OW-2006-0771, DCN 06089.
Lee, G.F. 1998. "Deficiencies in Subtitle D Landfill Liner Failure and Groundwater Pollution
Monitoring." National Water Quality Monitoring Conference.
http://acwi.gov/monitoring/conference/98proceedings/Papers/61-lee.htm. Accessed May 2008.
Docket EPA-HQ-OW-2006-0771, DCN 06090.
Lewin Group. 2004. CMS Review of Current Standards of Practice for Long-Term Care
Pharmacy Services. Prepared for Centers for Medicare and Medicaid Services. December 30.
http://www.cms.hhs.gov/Reports/downloads/LewinGroup.pdf. Accessed September 2007.
Docket EPA-HQ-OW-2006-0771, DCN 04952.
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McGurk, J. 2003. Environmental Management Branch, State of California Department of Health
Services. Letter to Directors of Environmental Health, Medical Waste Program Managers, and
California Health Care Associations: "Sewerage Disposal of Pharmaceutical Waste." September
5. Docket EPA-HQ-OW-2006-0771, DCN 06091.
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. Docket EPA-
HQ-OW-2006-0771, DCN 05046.
Myers, P., and W. Hessler. 2007. "Does 'the Dose Make the Poison'?" Our Stolen Future. May
25. http://www.ourstolenfuture.org Docket EPA-HQ-OW-2006-0771, DCN 06092.
NERC. 2005. Northeast Recycling Council, Inc. Best Practice Recommendations for the
Disposal of Unwanted Medications Not Controlled by the U.S. DEA. September 20.
http://www.nerc.org/documents/bmp_disposal_of_unwanted_medications_final.pdf Accessed
September 2007. Docket EPA-HQ-OW-2006-0771, DCN 04879.
OSW, 1991. Sylvia Lowrance, Office of Solid Waste. Letter to Mark Shultz of Pharmaceutical
Services, Inc. 16 May. Docket EPA-HQ-OW-2006-0771, DCN 06093.
OSW. 1997. David Bussard, Office of Solid Waste, Hazardous Waste Identification Division.
Letter to William Warren, Drinker Biddle and Reath. 10 March. Docket EPA-HQ-OW-2006-
0771, DCN 06171.
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Medication Destruction and Waste Measurement and Management in Long-term Care Facilities.
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Docket EPA-HQ-OW-2006-0771, DCN 06094.
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Docket EPA-HQ-OW-2006-0771, DCN 04943.
Pomati, 2007. Francesco Pomati, Chiara Orlandi, Moira Clerici, Fabio Luciani, and Ettore
Zuccato. Effects and Interactions in an Environmentally Relevant Mixture of Pharmaceuticals.
Toxicological Sciences 2008. Docket EPA-HQ-OW-2006-0771, DCN 06122.
Premier. 2007. Pharmaceutical Waste Management.
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EPA-HQ-OW-2006-0771, DCN 04944.
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Pharmaceutical Wastes. February 13. Docket EPA-HQ-OW-2006-0771, DCN 06095.
RMA. 2007. Risk Management Association. Annual Statement Studies 2006/2007. Docket EPA-
HQ-OW-2006-0771, DCN 04572.
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Ruhoy, 2007. Ruhoy, IS. and C.G. Daughton. Types and Quantities of Leftover Drugs Entering
the Environment via Disposal to Sewage - Revealed by Coroner Records. Science of the Total
Environment. 2007. http://www.epa.gov/nerlesdl/bios/daughton/SOTE2007.pdf. Docket EPA-
HQ-OW-2006-0771, DCN 06123.
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2007. Docket EPA-HQ-OW-2006-0771, DCN 04881.
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Systems. http://www.pollutionissues.com/Ho-Li/Incineration.html. April. Docket EPA-HQ-OW-
2006-0771, DCN 06096.
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Matched to North American Industry Classification Codes. Effective July 31, 2006. Docket
EPA-HQ-OW-2006-0771, DCN 04573.
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Pharmaceuticals Released to the Aquatic Environment." Water Resources 131.230.120.11.
Docket EPA-HQ-OW-2006-0771, DCN 06097.
S&P. 2006. Standard & Poor's. Industry Surveys. Healthcare: Facilities. December 26. Docket
EPA-HQ-OW-2006-0771, DCN 04574.
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Products Through Municipal Wastewater Treatment Processes. Water Environment Research
Foundation. 03-CTS-22UR. Docket EPA-HQ-OW-2006-0771, DCN 06098.
Tenet. 2006. Tenet Healthcare Corporation. "Tenet Reaches Partial Settlement with Internal
Revenue Service." Press Release. November 22. http://www.tenethealth.com/TenetHealth/
PressCenter/PressReleases/
Tenet+Reaches+Partial+Settlement+with+Internal+Revenue+Service.htm. Docket EPA-HQ-
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from Hospitals (UllevM andRikshospitalet) and VEAS Wastewater Treatment Works. Oslo.
March. Docket EPA-HQ-OW-2006-0771, DCN 05475.
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0851.2.
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EPA-HQ-OW-2006-0771, DCN 05403.
Zhao, A., and G.N. Richardson. 2003. "US Regulations on Solid Waste Containment Facilities."
The Second China International Exhibition on Solid Waste Treatment and Technology
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Appendix A
GLOSSARY
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Best Management Practices (BMPs) - BMPs include methods to prevent toxic and hazardous
pollutants from reaching rivers, lakes and other surface water and sewage treatment plants. For
example, BMPs for this industry could include, but are not limited to, practices to reduce the
amount of pharmaceuticals generated that are not used or alternatives to disposal of unused
Pharmaceuticals. Example BMPs include dispensing pharmaceuticals as unit doses and using a
reverse distributor for managing returns of unused pharmaceuticals.
Clean Water Act (CWA) - Federal legislation enacted by Congress to "restore and maintain the
chemical, physical, and biological integrity of the Nation's waters" (Federal Water Pollution
Control Act of 1972, as amended, 33 U.S.C. 1251 et seq.).
Controlled Substances - Pharmaceuticals and certain other chemicals, both narcotic and non-
narcotic, whose possession and use are regulated within "schedules" under the Controlled
Substances Act.23
Discharge - The conveyance of wastewater to: (1) United States surface waters such as rivers,
lakes, and oceans, or (2) a publicly owned, privately owned, federally owned, combined, or other
treatment works (i.e., municipal wastewater treatment plant).
Disposal- Intentional placement of unused pharmaceuticals as waste into drain or toilet or into
municipal, medical, or hazardous waste for permanent treatment or disposition.
EDCs - endocrine disrupting chemicals
Facility - Facilities include hospitals and long-term care facilities.
Hospital - An institution that provides medical, surgical, or psychiatric care and treatment for
the sick or the injured.
Long-Term Care Facility - A facility that provides rehabilitative, restorative, and/or ongoing
skilled nursing care to patients or residents in need of assistance with activities of daily living.
Long-term care facilities include nursing homes, rehabilitation facilities, inpatient behavioral
health facilities, and long-term chronic care hospitals.
Organization — An organization that operates one or more hospitals or long-term care facilities.
Organizations may include government-owned, religiously affiliated, nonprofit, and for-profit
organizations.
Patient - Any person receiving medical, surgical, or psychiatric care or treatment at a hospital.
Pharmaceuticals - Any chemical or biological substance, synthetic or non-synthetic, that when
taken by the facility patient or resident will cure or reduce the symptoms of an illness or ongoing
medical condition. Additionally, this definition refers to substances taken by the facility patient
or resident for preventive medicine. This includes over the counter medication, as well as those
prescribed by a physician. Table 1 of Attachment B includes a list of the pharmaceuticals most
23 See http://www.usdoj.gov/dca/piibs/csa.ht.ml for information on the Controlled Substances Act.
A-l
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frequently prescribed according to http://www.rxlist.com/. The definition of pharmaceutical?,
includes, but is not limited to, thepharmaceuticals listed in Table 1 of Attachment B.
Pharmacy - Any unit or organization dispensing pharmaceuticals, whether located within the
facility or outside of the facility.
Pollution Prevention - The use of materials, processes, or practices that reduce or eliminate the
creation of pollutants or wastes. It includes practices that reduce the use of hazardous and
nonhazardous materials, energy, water, or other resources, as well as those practices that protect
natural resources through conservation or more efficient use. For example, pollution prevention
for this industry could include but is not limited to reducing the amount of unused
pharmaceuticals generated at hospitals or long-term care facilities.
PPCPs - Pharmaceuticals and Personal Care Products
Publicly Owned Treatment Works (POTW) - Any state or municipality-owned sewage
treatment plant that is used to recycle, reclaim, or treat liquid municipal sewage and/or liquid
industrial wastes (e.g., municipal wastewater treatment plant).
Resident - Any person receiving rehabilitative, restorative, and/or ongoing skilled nursing care
at a long-term care facility.
Reverse Distributor - A company engaged primarily in the business of accepting
outdated/expired pharmaceuticals from pharmacies and drug wholesalers for the primary
purpose of returning them to the manufacturer for credit.
Surface Waters - Waters of the United States including, but not limited to, oceans and all
interstate and intrastate lakes, rivers, streams, creeks, mudflats, sand flats, wetlands, sloughs,
prairie potholes, wet meadows, playa lakes, and natural ponds.
Unused Pharmaceuticals - Any pharmaceutical purchased or prescribed for a patient or
resident that is not taken by or administered to the patient or resident. These pharmaceuticals
may be returned to the pharmacy, taken back by a reverse distributor, pharmaceutical
manufacturer, or an organization accepting donations (non-disposal). Alternatively,
pharmaceuticals may be intentionally placed into a drain or toilet at the facility or into the
facility's municipal trash, medical waste, or hazardous waste (disposal). This definition does not
include any pharmaceutical ingredients or metabolites excreted or washed from patient or
residents.
Wastewater - Water that is generated from any source at a hospital or long-term care facility
that includes, but not limited to, restrooms, cafeterias, showers, domestic activities, and any
healthcare activity.
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