1. Product Stewardship for Waste/Unwanted Pharmaceuticals Scott Cassel, Executive Director Product Stewardship Institute, Inc. NAHMMA Conference 2005 Tacoma, WA

2. Why the “sudden” interest? Ubiquitous in our lives. Showing up in environment. USGS study – 2000 Some classes can act as endocrine disruptors linked to abnormalities and impaired reproductive performance in some species. might also be associated with changes in immunity and behavior, and skeletal deformities. Need to know if impact. Collections inhibited by regulations.

3. 3 Classes of Pharmaceuticals Over the Counter (OTC) Prescription Controlled substances (10-15%)

4. What are the sources? Excretion Disposal Long-term care (e.g., nursing homes, group homes, etc.) Hospice Home disposal  Don’t Know: Percentage contributed by each source

5. What are the pathways? Flushing Septic WWTP  biosolids and discharged to streams (after treatment) Garbage Lined landfills  Landfill leachate  WWTP  biosolids and discharged to streams Unlined landfills

6. How are they regulated? Some regulated by RCRA. Some not regulated by RCRA but should be based on characteristics. Some are Controlled Substances regulated by DEA under Controlled Substances Act. There is an HHW exemption for individuals regardless of toxicity. There is an HHW exemption for collection in most states.

7. Key Issues No agreement on whether pharmaceuticals present in environment are linked to human health or environmental problems. No agreeement on the amount of waste/unwanted pharmaceuticals entering environment. Some pharmaceuticals that should be regulated by RCRA are not. Can’t legally collect controlled substances from the public without costly law enforcement and tracking.

8. Current Pilot Projects for Pharmaceuticals Collections at hospitals Collections at pharmacies Collections at central locations (e.g. Senior centers, HHW facility, facilities and clinics)

9. Current Pilot Projects for Pharmaceuticals Alachua County, FL Palo Alto, CA Clark County, WA Marin County, CA BC, Canada L.A. and Orange County, CA

10. Pharmaceutical Take-back Programs Must Address Concerns of anonymity Security of collection method Collection of Controlled Substances Compliance with national/local hazardous waste legislation

11. Who are the Catalysts? Dave Galvin, King County WA Laurie Tenace, FL DEP Other Funders: San Francisco CA Santa Monica CA San Benito County CA Palo Alto, CA Central VT Solid Waste Mgt Agency

12. 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.

13. PSI Dialogue Process 1. Research Pharmaceutical Stewardship Action Plan 2. Dialogue 4 meetings over a year Numerous workgroup conference calls 3. Project Implementation 4. Designing a nationally coordinated pharmaceuticals management system

14. PSI Pharmaceutical Product Stewardship Action Plan Problem Statement Focus Goals Key Issues Potential Solutions Process

15. Focus Unwanted/waste pharmaceuticals Households Long-term care facilities (nursing homes, hospice care) NOT focused on: Personal care products Non-pharmaceutical endocrine disruptors

16. Primary Goals 1.Evaluate need and opportunities for nationally coordinated system for management of unwanted/waste pharmaceuticals that allows for multiple solutions to reflect regional differences.

17. Primary Goals 2.Increase the safe, legal, and env’lly protective collection and disposal of unwanted/waste pharmaceuticals through development of best management practices.

18. Secondary Goals 1. Identify opportunities for reducing unwanted/waste pharmaceuticals 2. Evaluate the amount of unwanted/waste pharmaceuticals available for proper management.

19. PSI Role in Dialogue 1. Facilitate/mediate the dialogue 2. Provide technical research and analysis 3. Design and implement pilot projects 4. Clearinghouse for pharmaceuticals product stewardship policies, programs, and data. www.productstewardship.uswww.productstewardship.us 5. Glue holding the pieces together….

20. Players Pharmaceutical companies/associations Research and Development Generic Government Pharmacies WWTP and Water Treatment Associations Others

21. Next Steps: PSI Dialogue Process Complete Action Plan Dialogue Pending interest Pending funding OR…

22. For More Information Contact… Heidi Sanborn PSI Consultant (916) 485-7753 Hksanborn@comcast.n et Scott Cassel PSI Executive Director 617-236-4855 scott@productstewardship. us www.productstewardship.u s