1. Product Stewardship for Waste/Unwanted Pharmaceuticals Scott Cassel, Executive Director Product Stewardship Institute, Inc. Dave Galvin, King County Local Hazardous Waste Mgt. Program

2. Product Stewardship Institute, Inc. - May 18, 2006 2 Why the interest? Pharmaceuticals are 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. Collections inhibited by regulations.

3. Product Stewardship Institute, Inc. - May 18, 2006 3 WHY Manage Pharmaceutical Waste Two tapdpoles after 57 days of development in the lab. The one on the right, which has yet to sprout limbs, was exposed to fluoxetine, also known as Prozac at 50 parts per billion. Male Fish Producing Eggs in Potomac River Researchers have discovered male fish that have developed female sexual organs because of estrogen and like chemicals in the water. Jim Todd, Washington Citizens for Resource Conservation Emma Johnson Washington State Department of Ecology

4. Product Stewardship Institute, Inc. - May 18, 2006 4 Research Highlights PPCPs are not truly “emerging,”we are just starting to be able to see them. But even now, the vast majority of PPCPs are NOT being measured nor currently measurable.

5. Product Stewardship Institute, Inc. - May 18, 2006 5 Research Highlights Continual inputs create “pseudo-persistence.” Most drugs’ mode of action is not well understood even in humans, let alone in the environment. Still doing bioassays one chemical/one organism at a time. Biology is decades behind the analytical chemistry.

6. Product Stewardship Institute, Inc. - May 18, 2006 6 Research Highlights Antibiotics, hormones, SSRIs receiving most attention Boulder Creek, CO study: 50:50 female:male ratio upstream, 90:10 downstream; ethynyl- estradiol measurably higher downstream. Bioassays of SSRIs showing some sub- lethal effects at environmentally-relevant levels.

7. Product Stewardship Institute, Inc. - May 18, 2006 7 3 Classes of Pharmaceuticals Over the Counter (OTC) Prescription Controlled substances (10-15%)

8. Product Stewardship Institute, Inc. - May 18, 2006 8 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

9. Product Stewardship Institute, Inc. - May 18, 2006 9 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

10. Product Stewardship Institute, Inc. - May 18, 2006 10 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.

11. Product Stewardship Institute, Inc. - May 18, 2006 11 Key Issues No agreement on whether pharmaceuticals present in environment are linked to human health or environmental problems. No agreement on the amount of waste/unwanted pharmaceuticals entering environment. Concern over disposal in the garbage. 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.

12. Product Stewardship Institute, Inc. - May 18, 2006 12 Current Pilot Projects for Pharmaceuticals Collections at hospitals Collections at pharmacies Collections at central locations (e.g. Senior centers, HHW facilities, and clinics)  short-term events and ongoing  law-enforcement staffed

13. Product Stewardship Institute, Inc. - May 18, 2006 13 Selected Current U.S. Pilot Projects for Pharmaceuticals Palo Alto, CA Marin County, CA San Francisco, CA L.A. and Orange County, CA Alachua County, FL Clark County, WA Indiana Northeast

14. Product Stewardship Institute, Inc. - May 18, 2006 14 Pharmaceutical Take-back Programs Must Address Concerns of anonymity Security of collection method Collection of Controlled Substances Compliance with national/local hazardous waste legislation Sustainable financing

15. Product Stewardship Institute, Inc. - May 18, 2006 15 PSI Dialogue Process 1. Research 25 interviews Pharmaceutical Stewardship Action Plan 2. Dialogue/Negotiations 4 meetings over a year Workgroup conference calls between meetings 3. Project Implementation 4. Designing a nationally coordinated pharmaceuticals management system

16. Product Stewardship Institute, Inc. - May 18, 2006 16 PSI Pharmaceutical Product Stewardship Action Plan Problem Statement Focus Goals Key Issues Potential Solutions Process

17. Product Stewardship Institute, Inc. - May 18, 2006 17 PSI Dialogue Focus Unwanted/waste pharmaceuticals Households Long-term care facilities (nursing homes, hospice care) NOT focused on: Personal care products Non-pharmaceutical endocrine disruptors

18. Product Stewardship Institute, Inc. - May 18, 2006 18 Main Goal Develop a nationally coordinated system for the management of unwanted/waste pharmaceuticals that allows for multiple solutions to reflect regional differences.

19. Product Stewardship Institute, Inc. - May 18, 2006 19 Players Pharmaceutical companies/associations Research and Development Generic Government Pharmacies Reverse Distributors WWTP and Water Treatment Associations Others

20. Product Stewardship Institute, Inc. - May 18, 2006 20 For More Information Contact… Dave Galvin, King County WA (206) 263-3085 Dave.Galvin@metrokc.gov Scott Cassel, PSI 617-236-4855 scott@productstewardship.us