Update on EPA’s Study of Unused Pharmaceuticals from the Health Care Industry

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  • Good morning! My name is Janet Bowen and I work in the EPA Region I office with the healthcare sector. I was asked to give a brief update on EPA’s Study of Unused Pharmaceuticals for the Health care sector. This is an EPA National effort. I would like to thank the EPA Water Office for providing today’s slides. If you have specific questions, I recommend contacting the National experts at the end of the presentation. The overview of this presentation is as follow:

Transcript

  • 1. Update on EPA’s Study of Unused Pharmaceuticals from the Health Care Industry Janet Bowen, EPA Region 1 617-918-1795 November 20, 2008
  • 2.
    • Objectives
    • Background:
      • Clean Water Act (CWA)
      • Effluent Guidelines
      • Effluent Guidelines Planning
      • Paperwork Reduction Act (PRA)
    • Health Care Industry Survey
      • Scope
    • Health Care Industry (HCI) Study
      • Activities and Schedule
    • EPA Contacts
    • Questions/Comments
    OVERVIEW 2 of 19
  • 3.
    • Introduce the HCI Survey and Clean Water Program
    • Provide Background
    • Encourage Participation, Comments and Suggestions in the Development of the HCI Survey
    OBJECTIVES 3 of 19
  • 4. BACKGROUND – Clean Water Act
    • Is the major environmental law governing surface water discharges.
    • Implemented by EPA, in part, through publication of effluent guidelines regulations and discharge permits for point sources of wastewater pollution.
      • Regulations can impose discharge limits or require the use of best management practices (BMPs)
    4 of 19
  • 5. Pretreatment Treatment Wastewater Treatment Plant Effluent Guidelines (ELGs) regulate indirect and direct dischargers Surface Waters Indirect Discharger Direct Discharger BACKGROUND - Effluent Guidelines 5 of 19 Health Care Facilities
  • 6. BACKGROUND – ELGs Planning
    • EPA Conducts a Planning Process on a Biennial Basis:
      • Review existing regulations
      • Study potential new categories for possible regulation
    • EPA Identified the Health Care Industry
      • Based on comments received as part of the 2006 planning cycle
    • EPA 2008 Planning Cycle
      • Studied the discharge of dental amalgam from dentist offices and the disposal of unused medications from hospitals and long term care facilities
    • EPA Finalized the 2008 Plan
      • Included two reports summarizing our study of the disposal of unused medications
      • EPA has posted a pre-publication copy of the most recent plan on its website at http://epa.gov/guide/304m/
    6 of 19
  • 7. BACKGROUND – Paperwork Reduction Act
    • Requires each Federal Agency to seek and obtain Office of Management Budget (OMB) approval before any information can be collected from 10 or more persons.
    • Goals:
      • Minimize the burden on respondents
      • Ensure data collection meets a specific agency need
      • Not unnecessarily duplicate available information
    • Process:
      • Two opportunities for public comments
        • First Federal Register Notice
          • Published on August 12, 2008
          • 90 Day Comment Period closed on
          • November 10, 2008
    7 of 19
  • 8. BACKGROUND – Paperwork Reduction Act
    • Process (Cont):
      • What happens in between Federal Register Notices?
        • EPA will address public comments
        • Tailor the survey according to the feedback provided
      • Second Federal Register Notice
        • 30 Day Comment Period
        • Publish at the time Information Collection Request (ICR) package is submitted to OMB for approval
    8 of 19
  • 9. HEALTH CARE INDUSTRY SURVEY
    • Purpose
      • How much unused, expired and unwanted pharmaceuticals are being disposed and to where?
        • Interest: Disposed to Municipal Wastewater Treatment Plants from Hospitals, Long-term Care Facilities, Hospices and Veterinary Facilities
      • Identify Current Industry Practices, Guidance and Regulatory Requirements
      • Identify Best Management Practices (BMPs)
      • Determine the amount of unused pharmaceuticals disposed of, not just down the drain
    9 of 19
  • 10. HEALTH CARE INDUSTRY SURVEY
    • Want to work directly with industry associations and health care industry representatives
    • Coordinating with Federal, State and local governments
    • Scope of Study
      • Hospitals, hospices, long-term care facilities, and veterinary hospitals
      • EPA requested comments on whether to include in the Study
        • Veterinary clinics
        • Medical and dental offices
        • University and prison health clinics
    10 of 19
  • 11. HEALTH CARE INDUSTRY SURVEY
    • Method for Collecting a Nationally Representative Data
      • Identify national population
        • Welcome suggestions for listing of companies/organizations
      • Identify characteristics that define key differences
        • Example: Location (urban vs. rural)
      • Draw sample of facilities based on key characteristics
    11 of 19
  • 12. HEALTH CARE INDUSTRY SURVEY
    • Overview of Question Categories
      • What are the options for disposing of unused pharmaceuticals other than down the drain or toilet?
      • What factors influence disposal decisions?
      • What Best Management Practices (BMPs) could facilities implement to reduce the generation of unused pharmaceuticals?
      • How do you dispose of
      • your unused pharmaceuticals?
      • Which pharmaceuticals are
      • being disposed of, in what
      • quantities, and at what cost?
    12 of 19
  • 13. HEALTH CARE INDUSTRY STUDY
    • Identified Data Needs
      • No national data exists to quantify:
        • Amount of unused, expired, unwanted pharmaceuticals disposed of
        • Methods of disposal
    • Developed Draft of ICR
      • Includes a questionnaire for medical facilities and another questionnaire for veterinary facilities
    • Published First Federal Register Notice in Accordance with PRA on August 12, 2008
    • Initiated Site Visits
    • Meeting with Stakeholders and Industry Experts on the Survey
      • Three conference calls were held in September 2008
    Activities – Accomplished 13 of 19
  • 14.
    • Meeting with Health Care Industry Associations/Organizations and Industry Experts
      • American Society of Consultant Pharmacist (ASCP)
      • American Hospital Association (AHA)
      • American Association of Homes and Services for the Aging
      • American Health Care Association (AHCA)
      • American Veterinary Medical Association (AVMA)
      • Identify other avenues for feedback
    • Review Comments and Suggestions Provided for HCI Study
    • Perform Site Visits to Health Care Facilities
    Activities – Current HEALTH CARE INDUSTRY STUDY 14 of 19
  • 15. Activities – Next Steps
    • Address Comments and Suggestions Provided in Response to the First Federal Register Notice
    • Ongoing Communication with Stakeholders and Industry Experts
    • Publish a Second Federal Register Notice for Review and Comments
    • Submit ICR to OMB
    • OMB Approves Survey
    • Conduct Nationwide Survey of HCI Facilities
    HEALTH CARE INDUSTRY STUDY 15 of 19
  • 16. SCHEDULE
    • Calendar Year 2008
      • Stakeholders Teleconference
        • September 2008 (three calls held)
      • November 10, 2008 - Deadline for Public Comments for First Federal Register Notice
      • Health Care Facility Site Visits
    HEALTH CARE INDUSTRY STUDY 16 of 19
  • 17. SCHEDULE – Continued
    • Calendar Year 2009
      • Health Care Facility Site Visits
      • Publish Second Federal Notice for Public Review
      • Obtain approval from OMB
      • Conduct Nationwide Survey of Facilities In Scope
    • Calendar Year 2010
      • Develop national estimates of pharmaceutical disposal from survey responses
      • Identify Possible Best Practices for Pollutant Source Control and Associated Costs
      • October 2010 - Development of Final Report to be Published with the 2010 Plan
    HEALTH CARE INDUSTRY STUDY 17 of 19
  • 18. FOR MORE INFORMATION…. Please contact us if you would like to be included in our study. The EPA HCIS Team Contacts are: Meghan Hessenauer 202-566-1040 [email_address] Samantha Lewis 202-566-1058 [email_address] Jezebele Alicea-Virella 202-566-1755 [email_address] 18 of 19
  • 19. Health Services Industry Detailed Study: Management and Disposal of Unused Pharmaceuticals (Interim Technical Report) EPA-821-R-08-013 August 2008 Unused Pharmaceuticals in the Health Care Industry: Interim Report EPA-821-R-08-010 August 2008 Interim Reports – http://www.epa.gov/guide/304m/index.html#hsi-report
  • 20. DISCUSSION QUESTIONS OR COMMENTS? 19 of 19