Thank you to our sponsors Platinum Gold National

Discussion and “Next Step” Slides: June 20 Sacramento, CA June 19 -20, 2008 ©

Regulatory Challenges: Issues for Discussion a) Change DEA regulations to facilitate collection of waste/unwanted

Fundamental Questions q Why go through the trouble of educating consumers not to flush

Potential Area of Collaboration: Joint research q Research/Study Categories – General q Quantity, type,

Potential Area of Collaboration: Joint research q Research/Study Categories – Safety q Extent of

Potential Area of Collaboration: Joint research q Research/Study Categories – Environment q Percentage of

Potential Area of Collaboration: Joint research q Research/Study Categories – Behavior and Education q

Source Reduction: Strategies for Discussion a) Modify prescribing practices to avoid the excess purchase

Options for Disposal: Strategies for Discussion Develop consensus on best management practices for safe

Options for Disposal: Strategies for Discussion d) e) f) Develop unified and consistent messaging

Options for Disposal: Strategies for Discussion g) Develop strategies for engaging retail pharmacies in

Next Steps n n n Designate and volunteer for workgroups Meeting Summary, Action Planning

Workgroup Process § Present findings/recommendations at 2 nd meeting § Develop work plan including:

Other Follow-up to Meeting #1 n n Meeting summary will be distributed in draft

Meeting #2: Additional Stakeholders n n Pharmaceutical companies Over-the-Counter trade association National pharmacy associations

Meeting #2: Suggested Agenda Items n n n Report back from work groups Federal

Meeting #2: Logistics n Location • n Washington, DC Dates • • • Sept.

Slides: 20

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Thank you to our sponsors! Platinum Gold National Association of Clean Water Agencies Waste Treatment Division, King County, WA San Francisco, CA – Department of the Environment San Benito County Integrated Waste Management Hazardous Waste Management Programs, King County, WA Idaho Department of Environmental Quality King County Solid Waste, WA Los Angeles County Sanitation Districts, CA Minnesota Pollution Control California Integrated Waste Management Board Silver Santa Monica, CA Snohomish County Solid Waste District, WA City of Palo Alto, CA Environmental Compliance City of Palo Alto, CA Central Vermont Solid Waste Management City of Santa Rosa, CA Central Contra Costa Sanitary District, CA Veolia ES Med. Serve

Discussion and “Next Step” Slides: June 20 Sacramento, CA June 19 -20, 2008 © Product Stewardship Institute, Inc. June 2008

Regulatory Challenges: Issues for Discussion a) Change DEA regulations to facilitate collection of waste/unwanted pharmaceuticals from consumers b) Change the Controlled Substances Act to allow for the return of controlled substances © Product Stewardship Institute, Inc. June 2008 3

Fundamental Questions q Why go through the trouble of educating consumers not to flush if there are no aquatic or human health impacts? q Is there a societal benefit to reduce the amount of waste/unwanted medications? q Is there a societal benefit to collect waste/unwanted medications once generated? q Can waste pharmaceuticals be safely disposed of in the home? © Product Stewardship Institute, Inc. June 2008 5

Potential Area of Collaboration: Joint research q Research/Study Categories – General q Quantity, type, and dollar value of waste/unwanted medications. q What are the benefits of take back programs? q What is the best available technology for destruction of waste pharmaceuticals? q What sites in the country accept waste pharmaceuticals and what are the GHG implications of transportation to these facilities? q What actions are necessary to allow hazardous © Product Stewardship Institute, Inc. waste incinerators to accept controlled substances 6 June 2008

Potential Area of Collaboration: Joint research q Research/Study Categories – Safety q Extent of abuse/diversions and accidental poisonings attributable to waste/unwanted medications in the home. q Percentage of pharmaceuticals in home storage attributable to normal use vs. waste/unwanted medications. q What is the cost to society of accidental poisonings from waste pharmaceuticals? © Product Stewardship Institute, Inc. June 2008 7

Potential Area of Collaboration: Joint research q Research/Study Categories – Environment q Percentage of pharmaceuticals entering waterways attributable to excretion vs. other pathways. q Impact on aquatic species and potential impact on human health. q To what degree are pharmaceuticals present in leachate and what risks do they represent? q Are pharmaceutical residuals found in landfill © Product Stewardship Institute, Inc. leachate, and are they expected to increase or 8 June 2008

Potential Area of Collaboration: Joint research q Research/Study Categories – Behavior and Education q What are the reasons and attitudes behind household storage and disposal practices and preferences? © Product Stewardship Institute, Inc. June 2008 9

Source Reduction: Strategies for Discussion a) Modify prescribing practices to avoid the excess purchase of medications (e. g. , samples to try, small initial doses, ID potential allergies/drug interactions up front) b) Educate consumers about taking all medications as prescribed c) Modify insurance reimbursement policies to encourage physicians to prescribe smaller doses to reach thresholds for coverage © Product Stewardship Institute, Inc. June 2008 10

Options for Disposal: Strategies for Discussion Develop consensus on best management practices for safe disposal from the home (either long-term or interim). b) Develop protocols for collecting waste medications under different scenarios, including ultimate disposal. c) Identify existing or develop demonstration programs to collect data on the relative costs, logistics, and performance of mail-back and/or collection through various location. © Product Stewardship Institute, Inc. a) June 2008 11

Options for Disposal: Strategies for Discussion d) e) f) Develop unified and consistent messaging regarding the safe and environmentally sound disposal of waste pharmaceuticals. Evaluate performance of existing and potential future collection programs. Options to reduce the cost of mail-back programs (e. g. , packaging, return distance, etc. ) © Product Stewardship Institute, Inc. June 2008 12

Options for Disposal: Strategies for Discussion g) Develop strategies for engaging retail pharmacies in collecting waste medications (e. g. , share lessons learned from retail pharmacies successfully collecting; increased consumer sales among pharmacies collecting, etc. ). © Product Stewardship Institute, Inc. June 2008 13

Next Steps n n n Designate and volunteer for workgroups Meeting Summary, Action Planning for Meeting #2 © Product Stewardship Institute, Inc. June 2008 14

Workgroup Process § Present findings/recommendations at 2 nd meeting § Develop work plan including: • Major tasks and timelines • Potential pilot opportunities • Staffing and funding requirements • Challenges, barriers © Product Stewardship Institute, Inc. June 2008 15

Other Follow-up to Meeting #1 n n Meeting summary will be distributed in draft form (comments due July 31) Action plan will be distributed in draft form (comments due July 31) Final participant list, agenda, presentations and other resources posted on PSI website Workgroup calls scheduled 16 © Product Stewardship Institute, Inc. June 2008

Thank you to for sponsoring Meeting #2

Meeting #2: Additional Stakeholders n n Pharmaceutical companies Over-the-Counter trade association National pharmacy associations Health care providers © Product Stewardship Institute, Inc. June 2008 18

Meeting #2: Suggested Agenda Items n n n Report back from work groups Federal regulatory issues Location, date, and funder of Meeting #3 © Product Stewardship Institute, Inc. June 2008 19

Meeting #2: Logistics n Location • n Washington, DC Dates • • • Sept. 8 -11 (M-Th) Oct. 6 -7 (M-T) Oct. 27 -30 (M-Th) Nov. 5 -6 (W-Th) Nov. 11 -13 (T-Th) © Product Stewardship Institute, Inc. June 2008 20