1. © Product Stewardship Institute, Inc. May 2008 PSI National Dialogue on Medical Sharps Slides for Discussion of Issues : Day 1 (Key Issues # 1, 2, 4)

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

3. © Product Stewardship Institute, Inc. May 2008 Issue #1: Source Reduction Starting point for lifecycle management of any product. What are the possibilities for medical sharps?  Variations in devices (including with safety features)  Variations in treatment 3

4. © Product Stewardship Institute, Inc. May 2008 Potential Strategies 4 a) Investigate whether devices with safety features that are already required at health facilities would remain intact during typical waste hauling and disposal processes. If they would, promote these alternatives outside of health facilities.

5. © Product Stewardship Institute, Inc. May 2008 Issue #2: Collection, transportation, and disposal infrastructure Maximizing safe disposal requires collection opportunities that are safe, convenient, cost effective, and address cultural/privacy concerns. A range of options is probably necessary to meet the diverse needs within a community. 5

6. © Product Stewardship Institute, Inc. May 2008 Potential Strategies Better data on numbers of sharps used by different consumer groups? Determine whether an FDA/OSHA-approved sharps container is necessary for safe collection at drop-off locations. Determine the target parameters for “convenient” collection locations based on population statistics (including urban/rural, # of people with diabetes, # IDUs, etc.). Develop best practices for collection locations, including parameters/standards for kiosks/bins used at collection sites. 6

7. © Product Stewardship Institute, Inc. May 2008 Issue #4: Sustainable Financing A sustainable financing system is needed to conduct widespread safe collection, transportation, and collection. Current financing by governments and consumers at end-of-life is not sustainable. 7

8. © Product Stewardship Institute, Inc. May 2008 Who pays? Consumer (product user) Taxpayer (all residents) 8

9. © Product Stewardship Institute, Inc. May 2008 Financial Problem Externalities Safety Injuries Environment “No such thing as a free lunch!” 9

10. © Product Stewardship Institute, Inc. May 2008 What needs to be funded? Disposal container Disposal Education Planning/oversight Enforcement 10

11. © Product Stewardship Institute, Inc. May 2008 Who pays now? Government/tax payer (collections) Consumer (mail-back) 11

12. © Product Stewardship Institute, Inc. May 2008 Trends in Waste Management Financing Government programs End-of-life (consumer) Manufacturer (advanced recycling fee) Manufacturer (extended producer responsibility) – ISO – Visible fee to consumers – Invisible fee 12

13. © Product Stewardship Institute, Inc. May 2008 Options Government/taxpayers – Centers for Medicare/Medicaid Svcs. – State/local programs – Tax incentives (collection) Sharps mfrs Pharmaceutical mfrs Consumers 13

14. © Product Stewardship Institute, Inc. May 2008 Stakeholder Input What are the 2 main things about financing that you would like addressed in the dialogue? Additional research/information you need to be prepared to discuss financing in more detail? 14

15. © Product Stewardship Institute, Inc. May 2008 Potential Strategies a)Develop a financing system that covers the collection, transportation, and disposal costs for medical sharps generated out the traditional healthcare setting. b)Develop cost estimates for different options nationally. c)Advocate for Medicare Part D/health insurance plans to cover cost of safe disposal. 15

16. © Product Stewardship Institute, Inc. May 2008 Issue #3: Regulation and enforcement Growing number of efforts to regulate sharps disposal Effective regulation requires effective enforcement, which is challenging 16

17. © Product Stewardship Institute, Inc. May 2008 Potential Strategies a) Develop model state legislation (or menu of options), including financing, convenience, education, and an implementation schedule. b) Identify and overcome regulatory obstacles to the collection, transportation, and disposal of sharps. This may include requirements for staff at collection locations or waste handling requirements. c) Advocate for change in FDA regulations to require sharps disposal costs/methods to be included with all self-injected medications. 17