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 ------- 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. ------- 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. ------- 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: ------- • 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). ------- 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 ------- 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 ------- 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 ------- 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 ------- 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 ------- 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 ------- 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 ------- |