A Workshop for the Collection of Unwanted Medications in Indiana June 20, 2007

1. Medication Disposal: What’s the Problem?Impacts on Human and Environmental Health Elizabeth Hinchey Malloy, Ph.D. and Susan Boehme, Ph.D. Illinois-Indiana Sea Grant Jessica Winter ORISE Intern, U.S. EPA Great Lakes National Program Office Presented at the Indiana Hazardous Waste Task Force, Inc. workshop*: A Workshop for the Collection of Unwanted Medications in Indiana June 20, 2007 *target audience: solid waste managers, TRIAD programs, waste water treatment plant operators, health departments, household hazardous waste contractors, and interested citizens

2. Presentation Outline Background on the issues: - disposal of unwanted medicine - medicines in the environment Collection programs and initiatives What’s happening in the Great Lakes? Tool kit overview

3. Pharmaceuticals and Personal Care Products (PPCPs) • Includes prescription and over-the-counter (OTC) medications, cleaning agents, cosmetics, nutritional supplements, & skin care products • Produced and used in larger volumes yearly • Released via small quantity generators • Biologically active

4. Source: U.S. Center for Disease Control and Prevention. National Center for Health Statistics. National Health and Nutrition Examination Survey.

5. Disposal of Unwanted Medicines In some cases, medicines are not entirely consumed due to: • Change in prescription • Patient’s health improves before finishing medicine • Patient death • Patient non-compliance • Bulk “economy size” containers of over-the-counter medicines contain more than is needed before expiration date

6. Expired Medication Disposal Survey • Survey of 100 pharmacies and 500 patients* • Pharmacy Policy: • 97% had established policies regarding the disposal of expired UNDISPENSED medication • Pharmacy Advice: • Only 5% had consistent recommendations for patients on PRESCRIBED drug disposal • 25% indicated that the issue of drug disposal was addressed only at the customer’s request * Boehringer, S “What’s the Best Way to Dispose of Medications?” 2004. Pharmacist’s Letter/Prescriber’s Letter 20 (200415)

7. Expired Medication Disposal Habits 500 patients surveyed: • 54% disposed of medications in the trash • 35.4% flushed drugs down the toilet or sink • 7.2% did not dispose of medications • 2% used all medication prior to expiration • 1.4% returned medications to the pharmacy Boehringer, S. “What’s the Best Way to Dispose of Medications?” (2004)

9. Main Risks of Improper Disposal Practices • Environmental impact - Accumulation in waterways  potentially harmful effects on wildlife • Accidental ingestion (children & elderly) - 78,000 children/year under 5 treated for unintentional medication poisoning in U.S. • Illegal use or theft - Appropriation of pharmaceuticals by family and friends, workers in homes, and burglars • Unnecessary accumulation & waste of health care $$$

10. Medicines in theEnvironment • U.S. Geological Survey monitoring study • 139 streams analyzed in 30 states • Contaminants identified in 80% of these streams • 82 contaminants identified (many were pharmaceuticals) • Co-occurrence common; average 7 distinct contaminants identified per stream Kolpin, D.W. et al. 2002. “Pharmaceuticals, hormones, & other organic wastewater contaminants in U.S. streams, 1999-2000: A national reconnaissance.” Environmental Science & Technology. 36(6):1202-1211.

11. Medicines in the Environment • USGS/CDCP study of drinking water facility • Analyzed for 106 contaminants in 24 water samples from locations within a drinking-water- treatment facility and the 2 streams serving the facility • 40 contaminants detected in 1 or more samples of stream water or raw-water supplies in the plant • 34 contaminants detected in >10% of these samples • Some prescription and non-prescription drugs and their metabolites were detected in finished water Stackleberg, P.E. et al. 2004. “Persistence of pharmaceutical compounds and other organic wastewater contaminants in a conventional drinking-water-treatment plant.” Science of the Total Environment. 329:99-113.

12. Effects on Aquatic Organisms: Cause for Concern • Aquatic exposure – chemicals in the aquatic environment can result in continuous, multigeneration exposure. • Feminization of fish - link to estrogen exposure? • Ex: Boulder Creek, CO: female white suckers outnumber males by > 5 to 1; 50% of males have female sex tissue(David Norris, Univ. of Colorado at Boulder) • Effects of antidepressants on fish and frog development? • Ex: Lab studies show low levels of common anti-depressants, including Prozac, Zoloft, Paxil and Celexa, cause development problems in fish, and metamorphosis delays in frogs(Marsha Black, Univ. of Georgia)

13. Entry Pathways of Medicines into the Environment • Outflow from wastewater treatment plants • Surface application of manure and biosolids • Commercial animal feeding operations and aquaculture • Landfill leachate sent to wastewater treatment plants • Septic tanks Source: www.york.ac.uk/.../ gsp/esm/images/pharma1.jpg

14. Medicine Waste Management Issues and Barriers • Communicating the issue to the public • Lack of conclusive research A waste management program for medicines needs to provide: • Safe disposal method (typically hazardous waste incineration) • Identification of controlled substances in order to comply with Drug Enforcement Administration requirements for handling • Convenience to participants • Funding for disposal & publicity • Privacy of medical information

15. What Can Be Done? • Education and awareness • Extended producer responsibility • Pollution prevention • Legislation (regional and national) • Creative thinking on collection • Collections - One-day drop-off events - Long-term take-back programs for consumers’ unneeded medicines (both need collaboration with reverse distributors, pharmacies and/or local police departments)

16. Other Countries’ Initiatives • Australia: • Community pharmacies collect unwanted/expired medications • Paid for by Commonwealth with pharmaceutical industry support • Canada-British Columbia: • Return program established voluntarily by pharmaceutical industry • 75% of all pharmacies in British Columbia accept unused/expired medications • European Union: • 11 nations have take-back programs • Pharmacies accept unwanted pharmaceuticals • More than half operated by pharmaceutical industry/ pharmacies - remainder paid for by municipalities

17. The new (2/21/07) federal prescription drug disposal guidelines advise Americans to: • If alternative methods of disposal are not available, • Take unused, unneeded, or expired prescription drugs out of their original containers • Mix with an undesirable substance • Put in sturdy, opaque, non-descript containers • Throw these containers in the trash • Flush prescription drugs down the toilet only if the label specifically instructs doing so. • Dispose of unused prescription drugs through pharmaceutical take-back programs if available. The White House Office of National Drug Control Policy (ONDCP), Health and Human Services (HHS), U.S. EPA

18. The American Pharmacists Association and the U.S. Fish and Wildlife Service jointly recommend the following (2/14/07): • DO NOT FLUSH unused medications • When tossing unused medications, protect children and pets from the potentially negative effects:  • crush or dissolve solid medications • mix with kitty litter or a solid kitchen substance • place in a sealed plastic bag to reduce the poisoning risk • remove and destroy ALL identifying personal information • check for approved state and local collection programs or with area hazardous waste facilities • Talk To Your Pharmacist

19. Unwanted Medication Collection Initiatives • Local take-back programs & pilots in CA, FL, IN, IL, IA, OH, WI, WA, MI and the Northeast • Legislation in Maine established a mail-in program; IL, MA, WI and CA considering similar legislation • Pharmwaste email listserve – national group of health care professionals, waste management officials, government http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste • Product Stewardship Institute www.pruductstewardship.us • Hospitals for a Healthy Environment organization developing a blueprint for hospital pharmaceutical waste management nationwide

20. What’s Happening in Illinois? • Chicago Collection for Household Unwanted Medicine May 2006 • 3rd annual event, 25 Chicago sites • Spearheaded by Chicago Police, U.S. EPA Region 5, IL-IN Sea Grant • Targeted older citizens • One-day event: 1,330 citizens • turned in 1,600 lbs of • prescription and OTC • medications

21. What’s Happening In Wisconsin? • Collection Events • Outreach – Guidance, FAQs • Law Enforcement Survey • Statewide Working Group • Possible Pilot Program

22. Wisconsin Initiatives: Collection Events 2006 Brown Co. – June 27 & 28 • 175 participanjts • Approx. 3,500 pill containers (109,000 pills) • Est. $230,000 worth of medicine (conservative, based on pharmacists’ estimates of shelf price) • 10% controlled substances Winnebago Co. – Oct. 3 and 4 • 114 participants • 5 x 30-gal. non-controlled (184 lbs.) • 3,426 pills/caps controlled, + assorted liquids • Cost: $1,325.91 Rock Co. – Nov. 11 • Four hours • 132 cars • 261 pounds of prescription/outdated drugs • 37 pounds controlled substances

23. WI DNR Guidance for Collecting Unwanted Household Pharmaceuticals

24. Wisconsin Initiatives: Collection Events

28. Wisconsin Initiatives: Collection Events

30. 125 cars + 3 walk ups = 128

34. Milwaukee collected fourteen 30-gallon drums of non-controlled substances

38. Cool Facts Controlled substances: 10,472 pills Oldest medication: 1925

39. Wisconsin Initiatives: Collection Events

40. Key Issues in WI Right Now • Need disposal options for households where collections have not occurred • Need disposal options for assisted living or long-term care facilities • Need to engage coroners and law enforcement • Need to establish a funding source

41. What’s Happening in Michigan?

42. What’s Happening in Indiana? Indiana DEM has created a brochure to advise residents on medicine disposal (excerpt below). Numerous medicine collections have been organized locally by the TRIAD programs, partnerships between law enforcement and senior citizens’ organizations.

43. IL-IN Sea Grant Resource Kit: Disposal of Unwanted Medications A Resource for Action in Your Community Includes: • Background • What are the substances of concern? • What are the risks of improper disposal? • How do these substances enter the environment? • Take-back program case studies - models of success • Guidance for organizing medicine collections for households • Legislation on disposal and donation of unneeded medication • Materials for public education and outreach • Bibliography of news articles and scientific reports

44. Disposal of Unwanted MedicationsA Resource for Action in Your Community • Reviewed and revised by scientists, doctors, nurses, pharmacists, drug enforcement, waste management professionals, and community organizers • Kit requested by county water treatment/ solid waste officials, environmental groups, other EPA regions and state agencies • Holding workshop/training with solid waste managers in Illinois, Indiana • Now on-line www.iisgcp.org/unwantedmeds

45. Resource Kit Impacts:Short- and Long-Term Short-Term: • Form advisory group for review of resource kit√ • Give presentations on topic widely √ Long-Term: • 1 year  wider distribution of educational materials (clearer, more direct, more accessible); “educate the educator” (e.g. ILCSWMA) • 2 years  public able to “1-stop shop” for info re: mgmt. of household pharmaceutical waste & disposal • 2 years  change disposal habits of public = shift away from flushing, disposing in trash, etc. • 5 years  sustainable collection program established in Great Lakes city • 10 years  measurable decrease of pharmaceuticals in local water supplies/watersheds

46. What is Still Needed? • Research: • Humans, pets, livestock will always be taking medications, so solutions at the WWTP are needed for the long run • Research on designer medications • Determine the relative importance of the different sources: excretion vs. disposal; veterinary vs. human medicine • Curb medicine waste and over- prescribing • Education and outreach

47. To Learn More Elizabeth Hinchey Malloy, IL-IN Sea Grant hinchey.elizabeth@epa.gov Jessica Winter, U.S. EPA GLNPO winter.jessica@epa.gov www.iisgcp.org/unwantedmeds Additional materials and links to ongoing work relevant to this issue are available at the U.S. EPA’s PPCPs web site: www.epa.gov/nerlesd1/chemistry/pharma

48. Acknowledgments • U.S. EPA Great Lakes National Program Office • Scott Morgan, Indiana Household Hazardous Waste Task Force, Inc. • Joanie Burns, Wisconsin Department of Natural Resources • Bart Hagston, Illinois Counties Solid Waste Management Association • Sgt. Jeff Hoffmann, Chicago Police Department • Lara Polansky, UC Santa Barbara & NOAA Hollings Scholar Program