1. © Product Stewardship Institute, Inc. May 2008 PSI National Dialogue on Medical Sharps Boston, MA May 21-22, 2008

2. © Product Stewardship Institute, Inc. May 2008 What is the Product Stewardship Institute? Non-profit, based in Boston, founded in 2000 Membership 44 State members 51 Local agency members 20 Adjunct Council members Board of Directors: 7 states, 4 local agencies Multi-stakeholder product stewardship network Adjunct Council: business, environmental/organizational 2

3. © Product Stewardship Institute, Inc. May 2008 PSI Full and Affiliate State Members 3

4. © Product Stewardship Institute, Inc. May 2008 Why was the Product Stewardship Institute Created?  Unified voice: State and Local Governments  Fiscal relief for government on waste issues  Objective data for decision-making  Forum for collaboration with industry  Nationally coordinated systems/harmonized regulations 4

5. © Product Stewardship Institute, Inc. May 2008 PSI Projects 5  Medical Sharps  Pharmaceuticals  Fluorescent lamps  Mercury Thermostats  Paint  Electronics  Radioactive Devices  Telephone books  Gas Cylinders  Tires  Beverage containers  Packaging  Batteries  Motor oil

6. © Product Stewardship Institute, Inc. May 2008 What is Product Stewardship? “Product Stewardship" is a principle that directs all those involved in the life cycle of a product to take shared responsibility for reducing the health and environmental impacts that result from the production, use, and end-of-life management of the product. 6

7. © Product Stewardship Institute, Inc. May 2008 PSI Role in Dialogue  Research  Facilitate/mediate dialogue meetings  Implement projects & initiatives  Evaluate projects 7

8. © Product Stewardship Institute, Inc. May 2008 PSI’s “Agenda” Promote product stewardship solutions Reduce product impacts Forge partnerships that share responsibility – Product management – Sustainable financing Get results – not just discussion 8

9. © Product Stewardship Institute, Inc. May 2008 Meeting Objectives General agreement on: – Stakeholder roles/process – Issue statement – Dialogue goals Confirm road map 9

10. © Product Stewardship Institute, Inc. May 2008 Meeting Objectives Learn from presentations and research Explore priority issues and strategies Establish work groups on 2 priority strategies Determine next steps – Meeting date/location – Stakeholder assessment 10

11. © Product Stewardship Institute, Inc. May 2008 Priority Issues and Strategies #1 – Source reduction #2 – Collection, transportation, and disposal infrastructure #3 – Regulation and enforcement #4 – Sustainable financing #5 – Education, outreach, and risk communication 11

12. © Product Stewardship Institute, Inc. May 2008 Stakeholder Roles Authorized to represent company, agency, or organization. Attend 4 meetings (or via phone). Active participation between meetings. Jointly develop agreement. Ensure your interests/others’ interests are met. Participation in dialogue does not preclude legislative activity. Negotiate in good faith. 12

13. © Product Stewardship Institute, Inc. May 2008 Consensus All participants can live with decision and no one will actively block or undermine decision. The greater the stakeholder agreement, the greater the likelihood that the agreement will be sustainable. 13

14. © Product Stewardship Institute, Inc. May 2008 Consensus Consensus is preferable for broad initiatives: – Technical standards – Policies – Legislation Consensus is NOT needed for pilot projects or individual initiatives. 14

15. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting 15 MEETING 2 MEETING 3 MEETING 1 AGREEMENTS START May 2008 August 2008 November 2008 February 2009 2 Workgroups Develop findings Draft work plans Refine draft agreements Refine Workgroups Develop Findings Draft work plans Present Workgroup findings/plans Full financing discussion Discuss additional strategies Present Workgroup findings/plans Discuss additional strategies Start to develop draft agreements MEETING 4 Finalize agreements Develop Implementation Plan Dialogue Meeting Workgroup Activity Road Map

16. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Possible Dialogue Outcomes 16 Pilot projects with measurable results Demonstration project to test comprehensive program Model state policies (e.g., procurement) National standards/requirements

17. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Possible Dialogue Outcomes 17 Business innovations/profitability studies (e.g., reverse logistics potential) Model state or federal legislation Model state or national education campaign National sustainable financing system for the management of medical sharps

18. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Possible Mechanisms for Agreements 18 Letter of agreement between those involved in pilot project Memorandum of agreement between stakeholders stating intent to perform certain activities

19. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting What do we want to avoid? 19 Multiple state solutions Unilateral state or federal regulation

20. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Stakeholder Contributions 20 Manufacturers (sharps and pharmaceuticals) Pharmacy benefit managers/third party payers Insurers Retail pharmacies Government agencies Public health/other associations Waste management companies

21. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Sharps Manufacturers 21  Develop/promote sale of products with safety features  Increase public awareness about importance of safe disposal and collection locations  Produce/sell approved sharps disposal containers for sale with sharps products  Manage and finance safe collection of medical sharps

22. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Pharmaceutical Manufacturers 22  Develop/promote sale of products with safety features  Increase public awareness about importance of safe disposal and collection locations  Require self-injected products to be accompanied by approved sharps disposal container  Manage and finance safe collection of medical sharps

23. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Pharmacy Benefits Managers/Third Party Payers 23  Require self-injected products to be accompanied by approved sharps disposal container  Increase awareness of importance of safe sharps disposal and collection opportunities

24. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Insurers 24  Reimburse costs of sharps disposal containers and collection/disposal of sharps.

25. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Retail/Mail Order Pharmacies 25  Increase public awareness about importance of safe disposal and collection locations  Collect used sharps on site or via mail-back  Provide coupon as incentive to return used medical sharps for disposal  Promote sale of products with safety features

26. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Government 26  Oversee manufacturer collection programs  Increase public awareness about importance of safe disposal and collection locations  Regulation/enforcement to level playing field and maintain fairness

27. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Government, cont. 27  Require that sale of self-injected products includes safe sharps disposal  Provide existing facilities for safe consumer collection convenience  Explore tax credits or other opportunities to encourage private sector participation in sharps disposal programs  Explore public financing options

28. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Potential Contributions: Waste Management Companies 28  Increase awareness of importance of safe sharps disposal and collection opportunities  Provide safe transport and treatment for sharps disposal

29. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Process for Developing Action Plan 29 Draft Problem Statement and Goals Issues/Strategies Interviews/input from over 35 stakeholders Input incorporated into Action Plan Draft Action Plan/comments Input on 2 nd Draft Action Plan – due 2 weeks NOT PSI’s Issue Statement and Goals

30. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Issue Statement 30 Sharps are used for self-injection and blood glucose testing by people with diabetes, patients administering their own medications, and injection drug users. Sharps used in the “community” typically end up in MSW, recycling, or wastewater If not properly disposed of, sharps can pose a hazard to sanitation workers, others

31. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Issue Statement 31 Sharps may also be left in public places Sharps may damage or disable equipment Problem is expected to increase as number of people with diabetes rises and “biologic” drugs expand markets

32. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Dialogue Goal 32 The primary goal of the project is to maximize the safe and environmentally sound collection and disposal of waste sharps by developing a nationally coordinated system that is financially sustainable.

33. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Dialogue Focus 33 This project will focus on sharps generated outside the traditional health care setting, including households, hotels, casinos, restaurants, airports, and other public venues.

34. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Purpose of Presentations 34  Educate attendees on basics  Outline current boundaries of knowledge  Illustrate product stewardship  Show potential for collaboration  Portray possibilities

35. © Product Stewardship Institute, Inc. May 2008 PSI Medical Sharps Dialogue Meeting Issue/Strategy Discussions 35  Background technical information  Clarify issues and strategies  Additional strategies  Prioritize strategies  Workgroups at end of 2 nd day - top 2 strategies