EPA
United States
Environmental Protection
Agency
                          Health Care Industry
   Unused Pharmaceuticals Detailed Study
  2007-2009 Data Collection and Outreach
 Pills collected for disposal at a Veterans Home in Nebraska. Reprinted with
           permission from The Omaha World-Herald.
    Public Docket for the Preliminary 2010 Effluent Guidelines Program Plan
      EPA Docket Number EPA-HQ-OW-2008-0517 (www.regulations.gov)
                                      22 September 2009

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I.      Overview

       To date, scientists have identified numerous pharmaceutical compounds at
discernable concentrations in our nation's rivers, lakes, and streams (EPA-HQ-OW-2006-
0771-1694). To address this issue at the source, EPA is studying how the drugs are
entering waterways and what factors contribute to the current situation. Towards this end,
EPA initiated a study on pharmaceutical disposal practices at health care facilities
including hospitals, hospices, long-term care facilities, health care clinics, doctor's
offices, and veterinary facilities. Unused pharmaceuticals include dispensed prescriptions
that patients do not use as well as materials that are beyond their expiration dates.
Another potential source of unused pharmaceuticals is the residuals remaining in used
and partially used dispensers, containers, and devices. In particular, the medications
contained in the dispensers, containers and devices may be sewered (e.g., intravenous
(IV) bags emptied into  sink).1 For many years, a standard practice at many health care
facilities was to dispose of unused pharmaceuticals by flushing them down the toilet or
drain.

       For the Final 2008 Plan EPA completed an interim technical report for the Health
Care Industry (EPA-HQ-OW-2006-0771-1694). The interim technical report focused on
hospitals and long-term care facilities (LTCFs) because these facilities are likely
responsible for the largest amounts of unused pharmaceuticals being disposed into
sewage collection systems within this industry sector. In 2005, there were about 7,000
hospitals and 35,000 LTCFs in the United States (EPA-HQ-OW-2006-0771-1694). EPA
is continuing its detailed study to investigate the following questions:

             What are the current industry practices for disposing of unused
              pharmaceuticals?
             Which pharmaceuticals are being disposed of and at what quantities?
             What are the options for disposing of unused pharmaceuticals other than
              down the drain or toilet?
             What factors influence disposal decisions?
             Do disposal practices differ within industry sectors?
             What best management practices (BMPs) could facilities implement to
              reduce the generation of unused pharmaceuticals?
             What reductions in the quantities of pharmaceuticals discharged to
              POTWs would be achieved by implementing BMPs or alternative disposal
              methods?
             What are the costs of current disposal practices compared to the costs of
              implementing BMPs or alternative disposal methods?

II.     Description of Information Collection Request and Approval Process

       The Paperwork  Reduction Act stipulates that every federal agency must obtain
approval from the Office of Management and Budget before collecting the same or
1 As a point of clarification, the term "unused pharmaceuticals" does not include excreted pharmaceuticals.

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similar information from 10 or more members of the public. An Information Collection
Request (ICR): (1) describes the information to be collected; (2) gives the reason the
information is needed, and (3) estimates the time and cost for the public to answer the
request. After reviewing the request, the Office of Management and Budget may approve
or disapprove the ICR, or place conditions that must be met for approval. This process
was designed to prevent unnecessary collections and reduce costs.

       EPA's survey approval process requires the publication of two Federal Register
notices on the survey design and instruments. These two notices provide the public with
two opportunities to review and comment on the survey before OMB review.

       EPA published the first Federal Register notice for the health care industry ICR
on August 12, 2008 (73 FRN 46903). The public had 60 days to review and comment on
the survey design and instrument. The ICR was originally developed to collect technical
and economic information on unused pharmaceutical management and to identify
technologies and BMPs that reduce or eliminate the discharge of unused pharmaceuticals
to POTWs. EPA received 31 comments and conducted outreach meetings with industry
to obtain further comments on the survey design and instrument.

       Commenters included hospitals and clinics, health care trade associations,
pharmacists associations, reverse distributors, pharmaceutical manufacturers, individuals,
and municipal wastewater treatment plants and their associations. Following publication
of the first Federal Register notice for the ICR, EPA conducted three hour-long
teleconferences in September 2008 with 259 stakeholders to provide an overview of the
project, scope of the survey instrument, potential recipients, and schedule. These
meetings solicited early feedback from participants to facilitate the development of a
subsequent draft of the survey instrument and population and sample frames. These
teleconferences also identified interested stakeholders for the site visits/additional
outreach meetings. Overall, the comments received were supportive of the survey. Most
commenters had a number of suggestions on how to improve the survey. Improvements
suggested were to expand the scope of sectors receiving the survey, to shorten the  survey,
and to tailor the survey to each health care sector. There were a few health care
organizations who felt a survey was not necessary for a variety of reasons including
burden to the facilities, that they are already practicing BMPs, or that they would favor
the more immediate issuance of EPA guidance.

       EPA's outreach (see following sections) identified that there is near universal
interest from  stakeholders to better manage unused pharmaceuticals at health care
facilities. There is also general interest in more quickly advancing the use of best
practices for managing unused pharmaceuticals at health care facilities. This considerable
outreach and  data collection has led EPA to re-consider the use of an industry survey for
this sector.  The survey would be an effective but potentially time-consuming tool for
gathering facility-specific data on the management of unused pharmaceuticals. EPA
estimates that it has gathered sufficient data from its site visits and outreach to begin the
development of best practices  for unused pharmaceutical management at health  care
facilities.

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III.    Outreach Activities in 2007-2009

       The outreach goals for the Health Care Industry (HCI) Detailed Study and ICR
include: (1) establish points of contact between the EPA HCI Team and industry
associations, facilities, contractors, and vendors; (2) further EPA's understanding of the
HCI, including challenges with pharmaceutical management and disposal; (3) discuss
comments on the draft survey and scope of the survey; (4) identify outreach opportunities
to association members and other interested stakeholders; (5) provide transparency on
EPA's actions and decision-making; and (6) identify and resolve issues as early as
possible.

       In 2007 to 2009, EPA worked with a wide range of stakeholders (e.g., industry
representatives; Federal, State, and Tribal representatives; waste management and
disposal companies; and other interested parties) to obtain the best available information
on the industry and its unused pharmaceutical management practices. In total, EPA met
or spoke with over 700 different people during the outreach and data collection activities
from 2007 through 2009. EPA developed its outreach by contacting interested
stakeholders, holding open outreach meetings for anyone interested in EPA's survey
following the first Federal Register notice, and following up with teleconferences and
meetings with contacts from the industry.

       EPA began contacting HCI stakeholders in 2007 to gather information on the
industry and to understand unused pharmaceutical management practices. EPA
completed a preliminary study and developed a draft industry  survey. Following the
September 2008 open outreach teleconferences, EPA contacted various stakeholders
including industry associations, researchers,  facilities, and contractors to set up additional
meetings. See Appendix A for a listing of the meetings  and their document numbers in
the on-line docket (EPA-HQ-OW-2008-0517).

IV.    Site Visits in 2008 - 2009

       EPA visited five hospitals in four states/districts, four LTCFs in three
states/districts, a veterinary hospital in Virginia, a hospice facility in Virginia, a
hematology/oncology clinic in Virginia, a long-term care pharmacy in Maryland, a
reverse distributor in Wisconsin, and a waste management vendor facility in Maryland to
gather data for the HCI Detailed Study. In total EPA conducted 15 sites visits to different
locations and met with 70 different stakeholders during these visits. EPA visited a range
of HCI facilities and operations that demonstrate unused pharmaceutical management
options for that type of facility.

       During each site visit, EPA collected general site information and specific unused
pharmaceutical management and disposal information. The objectives of these site visits
included:

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             Collect information on the amount of unused pharmaceuticals disposed;
             Observe pharmaceutical waste management practices;
             Identify common industry disposal practices, guidance, and regulatory
             requirements;
             Identify challenges with the generation and disposal of unused, unwanted,
             and expired pharmaceuticals;
             Identify BMPs and their costs;
             Understand potential impacts of pharmaceuticals in water; and
             Gather information about how hospitals, LTCFs, or other facilities
             operate.

       Information collected during each site visit is documented in a report.
Confidential Business Information (CBI) in these site visit reports is redacted from the
public versions of the reports in the on-line docket. See Appendix A for a listing of the
site visit reports and their document numbers in the on-line docket (EPA-HQ-OW-2008-
0507).

V.     Other Data Collection Activities in 2007 - 2009

       EPA also identified and collected a series of information during 2007-2009 to
support the HCI Detailed Study. These documents are listed in the on-line docket for the
preliminary study (EPA-HQ-OW-2006-0771) and on-line docket for the current study
(EPA-HQ-OW-2008-0517).

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Appendix A: Summary of Outreach Activities and Data Collection Supporting the EPA HCI Detailed Study




                  Table A-l. HCI Detailed Study Outreach Meetings and Activities
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Title
Meeting with the Pharmaceutical Research and Manufacturers of
America (PhRMA)
Meeting with the Center of Excellence in Assisted Living (CEAL)
Advisory Council
Health Services Outreach Teleconference with Hospitals for a
Healthy Environment (H2E) Members
Health Services Outreach Meeting with Stakeholders
Fifth Annual Maine Benzodiazepine Study Group
Conference & Fourth Annual Unused Drug Return
Conference
Health Services Meeting with SolmeteX
Region 3 Pharmaceutical Workgroup Meeting Notes
Meeting Minutes from EPA/PhRMA Meeting
Health Services Meeting with the Food and Drug Administration
(FDA)
Health Services Meeting with the Members of the Department of
Health and Human Services (HHS)
Summary of the Meeting with the Drug Enforcement
Administration (DEA)
Stakeholder Outreach Meeting
Stakeholder Outreach Meeting
Stakeholder Outreach Meeting
Location
Teleconference
Arlington, VA
Teleconference
Teleconference
Bangor, ME
Teleconference
Teleconference
Teleconference
Bethesda, MD
Teleconference
Washington, DC
Teleconference
Teleconference
Teleconference
Date
05/01/07
10/18/07
10/19/07
10/26/07
10/31/07
12/19/07
01/09/08
01/16/08
03/04/08
04/01/08
07/01/08
09/11/08
09/16/08
09/18/08
DCNa
5964
5961
5962
5963
(b)
5958
5467
5473
5959
5960
5998
6252
6253
6254
                                              A-l

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Table A-l. HCI Detailed Study Outreach Meetings and Activities
No.
15
16
17
18
19
20
21
22
23
24
25
26
27
28
Title
Summary of Voicemail Message from Maureen Gallagher
Meeting with Vestara Regarding the Health Care Industry
Information Collection Request (ICR)
Outreach Meeting with AHA and ASHES
Summary of Phone Conversation with Charlotte Smith from
PharmEcology
Outreach Meeting with the American Society of Consultant
Pharmacists (ASCP)
Outreach Meeting with the American Veterinary Medical
Association (AVMA)
Outreach Meeting with the American Health Care Association
(AHCA)
Summary of Phone Conversation with Bruce Cuhna
Outreach Meeting with the Hematology Oncology Pharmacy
Association (HOP A)
PSI Pharmaceutical Dialogue Meeting
Meeting with the American Society of Health- System Pharmacists
(ASHP)
Meeting with the American Hospital Association (AHA)
Statisticians
National Association of Boards of Pharmacy: Report of the Task
Force on Medication Collection Programs
Meeting with the Assisted Living Federation of America (ALFA)
Location
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Washington, DC
Washington, DC
Teleconference
Washington, DC
Tucson, AZ
Teleconference
Date
10/01/08
10/08/08
10/21/08
11/18/08
1 1/03/08
1 1/04/08
1 1/05/08
11/19/08
12/01/08
12/2/08 and 12/3/08
12/04/08
12/04/08
12/06/08
12/09/08
DCNa
6452
6245
6255
6454
6256
6257
6258
6453
6259
6260
6261
6262
6848
6263
                             A-2

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Table A-l. HCI Detailed Study Outreach Meetings and Activities
No.
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
Title
Meeting with the American Society for Healthcare Environmental
Services (ASHES)
Summary of Phone Conversation with Quest Diagnostics
Laboratories
Meeting with Dr. Bryan Boulanger, Texas A&M University
Email Correspondence with Danette Cox: Nursing Home Survey
Results Conducted by the Metropolitan Water Reclamation
District of Greater Chicago
Summary of Phone Conversation with Nancy Larson
Summary of Phone Conversation with Diane Darvey
Meeting with the Long Term Care Pharmacy Alliance (LTCPA)
Meeting with ExcelleRx
Summary of Phone Conversation with Jon Keyserling of the
National Hospice and Palliative Care Organization
Meeting with Talyst
Meeting with the American Medical Association (AMA)
Email correspondence with Jennifer Crittenden: Mailback
Program data from the UMaine Center on Aging
Meeting with the American Nurses Association (ANA)
Meeting with the National Association of Home Care and Hospice
Meeting with Clear River Enviro, LLC
Teleconference with Alexian Brothers Medical Center
Meeting with Stericycle
Teleconference with Bruce Cunha, Marshfield Clinic
Location
Teleconference
Teleconference
Teleconference
Email
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Teleconference
Email
Teleconference
Teleconference
Teleconference
Teleconference
Washington, DC
Teleconference
Date
12/10/08
12/10/08
12/11/08
12/22/08
01/06/09
01/15/09
02/03/09
02/09/09
02/12/09
02/24/09
02/24/09
02/24/09
03/03/09
03/12/09
04/03/09
4/6/2009
04/16/09
05/20/09
DCNa
6264
6912
6265
6458
6457
6455
6295
6296
6456
6501
6500
6459
6502
6503
6575
6438
6439
6573
                             A-2

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                          Table A-l. HCI Detailed Study Outreach Meetings and Activities
No.
47
48
49
50
51
Title
Teleconference with Brock Slabach, National Rural Health
Association
Teleconference with National Hospice and Palliative Care
Organization (NHPCO)
Teleconference with Centers for Medicare & Medicaid Services
(CMS)
Teleconference with Gei singer Hospital
Meeting with Stericycle
Location
Teleconference
Teleconference
Teleconference
Teleconference
Washington, DC
Date
05/27/09
06/05/09
06/23/09
07/14/09
07/23/09
DCNa
6412
6574
6498
6850
6497
a-EPA Docket Numbers: EPA-HQ-OW-2006-0771 andEPA-HQ-OW-2008-0517
b - See web site: http://www.mainebenzo.org/2007conference.htm
                                                      A-4

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                                   Table A-2. HCI Detailed Study Site Visits
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Title
Site Visit Report for Capital Returns, Milwaukee, WI
Site Visit Report for North Memorial Hospital, Robbinsdale, MN
Site Visit Report for Abbott Northwestern Hospital, Minneapolis,
MN
Site Visit Report for Hope Center For Advanced Veterinary
Medicine
Site Visit Report for Sunrise on Connecticut Ave Washington DC
Site Visit Report for Baltimore VA Medical Center
Site Visit Report for The Methodist Home Washington, DC
Site Visit Report for Genesis HealthCare Churchman Village
Newark, DE
Site Visit Report for Omnicare Long Term Pharmacy
Site Visit Report for Thomas Jefferson University Hospital
Site Visit Report for Francis E. Parker Home for the Aging
Site Visit Report for Walter Reed Army Medical Center
Site Visit Report for Capital Hospice
Site Visit Report for Fairfax -Northern Virginia Hematology
Oncology
Site Visit Report for Stericycle
Location
Milwaukee, WI
Robbinsdale, MN
Minneapolis, MN
Vienna, VA
Washington, DC
Baltimore, MD
Washington, DC
Newark, DE
Annapolis Junction,
MD
Philadelphia, PA
Piscataway, NJ
Washington, DC
Arlington, VA
Arlington, VA
Baltimore, MD
Date
6/3/08
6/4/08
6/4/08
1/7/09
1/26/09
1/13/09
1/30/09
2/3/09
2/20/09
3/17/09
3/16/09
3/30/09
7/22/2009
8/24/2009
9/9/2009
DCNa
6086
6087
6088
6241
6432
6433
6578
6428
6434
6435
6436
6437
6576
6577
6789
a-EPA Docket Numbers: EPA-HQ-OW-2006-0771 andEPA-HQ-OW-2008-0517
                                                    A-5

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Table A-3. HCI Detailed Study Voluntary Data Request Submissions
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Title
Voluntary Data Request for the Health Services Industry - Lakeview
Hospital
Voluntary Data Request for the Health Services Industry - Heritage
Place
Voluntary Data Request for the Health Services Industry - Great River
Medical Center
Voluntary Data Request for the Health Services Industry - Southwest
Regional Hospital Center
Voluntary Data Request for the Health Services Industry - White
County Medical Center - North
Voluntary Data Request for the Health Services Industry - Arkansas
Heart Hospital
Voluntary Data Request for the Health Services Industry - Rapid City
Regional Hospital
Voluntary Data Request for the Health Services Industry - White
County Medical Center - South
Voluntary Data Request for the Health Services Industry - Golden
Living Center Black Hills
Voluntary Data Request for the Health Services Industry - Boulder Park
Terrace
Voluntary Data Request for the Health Services Industry - Northern
Michigan Regional Hospital
Voluntary Data Request for the Health Services Industry - Northern
Michigan Regional Hospital Mental Health Unit
Voluntary Data Request for the Health Services Industry - Facility #1
Voluntary Data Request for the Health Services Industry - Facility #2
Location
Bountiful, UT
Bountiful, UT
Blytneville, AR
Little Rock, AR
Searcy, AR
Little Rock, AR
Rapid City, SD
Searcy, AR
Rapid City, SD
Charlevoix, MI
Petoskey, MI
Petoskey, MI
VA
VA
Date
4/16/2008
4/18/2008
4/21/2008
4/28/2008
4/30/2008
5/16/2008
5/16/2008
5/19/2008
5/20/2008
7/23/2008
7/23/2008
7/23/2008
7/30/2008
7/30/2008
DCNa
5752
5749
5445
5751
5747
6014
6015
5748
5750
5798
5800
5799
5804
5805
                              A-6

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                        Table A-3. HCI Detailed Study Voluntary Data Request Submissions
No.
15
16
17
18
19
20
Title
Voluntary Data Request for the Health Services Industry - Facility #3
Voluntary Data Request for the Health Services Industry - Facility #4
Voluntary Data Request for the Health Services Industry - Facility #5
Voluntary Data Request for the Health Services Industry - Facility #6
Voluntary Data Request for the Health Services Industry - Saint Anne
Home
Voluntary Data Request for the Health Services Industry - Franklin
County Nursing Home
Location
FL
Unknown
Unknown
Unknown
Fort Wayne, IN
Malone, NY
Date
7/30/2008
7/30/2008
7/30/2008
7/30/2008
10/24/2008
12/17/2008
DCNa
5806
5807
5808
5809
6192
6430
a-EPA Docket Numbers: EPA-HQ-OW-2006-0771 andEPA-HQ-OW-2008-0517
                                                    A-7

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