Product Stewardship for Waste/Unwanted Pharmaceuticals

Scott Cassel, Executive Director Product Stewardship Institute, Inc.

Dave Galvin, King County Local Hazardous Waste Mgt. Program

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.

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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

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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.

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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.

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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.

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

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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

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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

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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.

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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.

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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

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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

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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

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PSI Dialogue Process1. Research

25 interviews Pharmaceutical Stewardship Action Plan

2. Dialogue/Negotiations 4 meetings over a year Workgroup conference calls between meetings

3. Project Implementation4. Designing a nationally coordinated pharmaceuticals

management system

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PSI Pharmaceutical Product Stewardship Action Plan

Problem Statement Focus Goals Key Issues Potential Solutions Process

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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

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Main Goal

Develop a nationally coordinated system for the management of unwanted/waste pharmaceuticals that allows for multiple solutions to reflect regional differences.

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Players Pharmaceutical companies/associations

Research and Development Generic

Government Pharmacies Reverse Distributors WWTP and Water Treatment Associations Others

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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