Disposal of Unwanted Medicines Todd Nettesheim U.S. EPA Great Lakes National Program Office Susan E. Boehme & Elizabeth Hinchey Malloy Illinois-Indiana Sea Grant Specialists & Liaisons to the U.S. EPA GLNPO Our perspective: Oceanographers/Environmental Scientists so Our focus has been keeping the medications out of the environment Unique position to access and help shape the focus of EPA’s funding

Pharmaceuticals and Personal Care Products (PPCPs) Prescription and over-the-counter (OTC) medications, soaps, cleaning agents, cosmetics, nutritional supplements, & skin care products Produced and used in larger volumes yearly 2006: over $274 billion was spent on over 3.7 million prescriptions Consumption increased significantly in last 20 yrs UN projects a 3-fold increase in next 25 years Pharmaceutical products are everywhere in our lives. Scope of the unwanted medication Issue Thousands of distinct chemicals Broad (and increasing) usage Discharged from many small sources Many possess very high biological activity

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 Expiration date reached Bulk “economy size” containers of over-the-counter medicines contain more than is needed There are a number of reasons why pharmaceuticals may not be completely consumed and, therefore, remain (and may eventually reach their expiration date) in the hands of the public or health care facilities. These reasons include: With few exceptions, national, state, and local governments lack clear and consistent guidelines on how the general public can properly dispose of unwanted medicines.

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 From this study, the predominance of disposal of pharmaceutical products in the trash and through the toilet is evident. Boehringer, S. “What’s the Best Way to Dispose of Medications?” (2004)

Main Risks of Improper Disposal Practices Damage to Sewage systems and Septic systems 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 $$$ There are 4 main hazards associated with flushing, sharing, or trashing medications. First, pharmaceutical chemicals in waterways can harm wildlife. Sewage treatment plants are not designed to treat all the substances contained in medications. Therefore, when they are flushed down the toilet or sink, most of these chemicals pass through the wastewater treatment facility and accumulate in rivers, lakes, groundwater, and even in aquatic organisms such as fish and amphibians. Also, both nationally and internationally, medications are the most common poison exposure category, and unsecured storage or disposal to the trash remains a serious problem. Furthermore, as the biggest consumers of prescription medicines, it is a common but risky practice for senior citizens to self-prescribe medicines to treat new, undiagnosed symptoms. Leftover medicines in the home can provide an opportunity for theft and drug misuse or sale. And medicines that are not consumed represent wasted health care dollars. Studies identifying the types and quantities of drugs that go unused could lead to better-informed prescription practice and better advice to patients on how to take prescriptions.

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 systems So how did these chemicals get into the environment? One source is direct outflow to water from wastewater treatment plants. Another possible source is from the sludge from wastewater treatment plants and the manure from medically treated domestic animals. This is typically applied to farmland as a soil amendment and might be a source of contamination of groundwater and runoff. Veterinary treatment on fish farms and direct runoff from livestock farms might be another source- it’s possible that veterinary medicine is an even bigger source to the environment than human medications, but we’ll need more research to determine the relative quantities. And old or poorly designed landfills may leak. Even non-leaking landfills represent a potential source, since the water from them must be pumped out and is usually treated by the municipal wastewater system. Source: www.york.ac.uk/.../ gsp/esm/images/pharma1.jpg

Medicine Waste Management Issues and Barriers Communicating the issue Lack of conclusive research Safe disposal Controlled substances - Drug Enforcement Administration Convenience $ Funding for staff, disposal & publicity Privacy of medical information Misinformation We each work in our own fields but all these issues have to be addressed for a solution to work on a long term basis A consumer awareness campaign has to be established to communicate the procedures that must be followed to safely manage unwanted medicines and to motivate people to participate in the program. While numerous studies have demonstrated the potential harm that pharmaceuticals pose for aquatic organisms, research is still needed to demonstrate the effects of such products on higher organisms and humans. Until more conclusive research, and funding for this research, is available, efforts to promote alternative disposal methods of pharmaceutical products will be hindered, unless a precautionary approach is taken and pharmaceuticals are kept out of the environment. Successful pharmaceutical waste management program must provide: -Safe disposal method. At present, all waste pharmaceuticals that are collected through proper disposal channels are incinerated. There is no legal alternative. -Secure handling and disposal of controlled medications to comply with Drug Enforcement Administration rules and to guard against misuse -Collection programs need to be easy to use if they are to compete with the toilet or the trash. The programs should be free to the public. -A funding source for take-back and disposal programs has to be established and maintained. There is currently no nationally established funding source for residential pharmaceutical waste management. -Privacy of patient medical information should be a priority.

IL-IN Sea Grant Resource Kit: Disposal of Unwanted Medications A Resource for Action in Your Community http://www.iisgcp.org/unwantedmeds/ Purpose: Guide for communities who are looking for a solution for their drug disposal problem Use: Solid waste officials, county and state officials, community groups, environmental and community organizations, pharmacists, researchers Sucesses: Educated 1000’s of individuals on the issue, supported several outreach campaigns for communities holding events, created new networking groups Illinois-Indiana Sea Grant, under a U.S. EPA GLNPO grant, has compiled a resource kit to help communities address this issue. We provide scientific background on the issue, Give examples of programs addressing the issue (we’ve got about 2 dozen case studies from across the US and from Canada, Australia, and Europe,) Step-by-step advice for organizing a collection program Sample outreach materials to publicize the issue, A listing of state laws related to medicine disposal, And a bibliography of news articles and scientific reports on the issue

IL-IN Sea Grant Resource Kit: Disposal of Unwanted Medications A Resource for Action in Your Community http://www.iisgcp.org/unwantedmeds/ Content Introduction to the issue Case Studies of Take-Back Programs How to Hold a Collection Event Materials for Public Outreach and Education Pharmaceutical Donation/Take-Back Legislation International Policy on Medicine Donations Bibliography on Pharmaceuticals, the Environment, and Human Health Information for Nursing Homes and Assisted Living Facilities PowerPoint Presentation Illinois-Indiana Sea Grant, under a U.S. EPA GLNPO grant, has compiled a resource kit to help communities address this issue. We provide scientific background on the issue, Give examples of programs addressing the issue (we’ve got about 2 dozen case studies from across the US and from Canada, Australia, and Europe,) Step-by-step advice for organizing a collection program Sample outreach materials to publicize the issue, A listing of state laws related to medicine disposal, And a bibliography of news articles and scientific reports on the issue

Types of Stewardship Activities One-time consumer collection events Short-term collection campaigns Permanent collection locations On-going one-day events Collection boxes at pharmacies Police stations HHW facilities Mail-back programs

Components of a Successful Collection DEA goal Avoid diversion Comply with State regs Board of Pharmacy Dept. of Health Educate the public, health professionals, & pharmacists Involve pharmacists/Police

Successes of Stewardship Programs Medicines are kept out of the water Public awareness: preventing pollution & making a difference Partnerships develop that can be maintained for other community purposes Innovative approaches to a complex issue will lead to more permanent solutions

Challenges of Stewardship Programs DEA prohibition on accepting narcotics unless law enforcement is present and all controlled substances are documented results in labor-intensive events DEA has not granted any waivers Funding Developing partnerships across many public agencies & private sector law enforcement; pharmacies, water utilities, watershed orgs Local-specific issues lead to “reinventing the wheel” Responsibility is taken off the manufacturer of the medicines

One-Time Collection Events Northeast Recycling Council (NERC) Collection events in small ME, MA, NH, VT, VA communities San Fran Bay Area 39 sites (senior centers, Walgreens); 1,500 citizens; 3,600 lbs Greater Chicago 25 sites (police stations, senior centers, hospitals); 1,300 citizens; 1,600 lbs. Earth Keeper Initiative Regional event; 19 sites (churches); 2,000 citizens, > 1 ton (incl. $500,000 in narcotics) Milwaukee, WI 2 single events: 3,211 lb of non-controlled; 35,000 controlled Others include - Duluth, MN; Allen Cty, IN; Monroe Cty, IN; Sangamon Cty, IL; and Allentown, PA Senior Fest At the Allentown events, they always give an award for the oldest medication on each of the 2 days. Last year, the winners were from 1964 and 1965.

Permanent Collection Locations Los Angeles and Orange County Public education campaign http://www.nodrugsdownthedrain.org/ HHW facilities (non-controlled only) Monroe County, IN TRIAD – police, sheriffs, & senior orgs HHW facilities year-round (non-controlled only) Single events for controlled substances La Crosse, WI HHW facility 4 staff members deputized by county sheriff Flyers distributed at local pharmacies Olmstead Falls, OH (8,600 people) Hospital security office (24/7) (non-controlled only) Other locations include Alachua county, Florida

Mail back programs Maine - Disposal of Unwanted Medications Pilot Designed to meet Maine legislation Unique situation - State DEA accepting unwanted medicines (including controlled substances) Pharmacies to provide for mailer pick up and drop off Phase I – Spring 2008; 4 counties; no marketing Phase II – Fall 2008; statewide; marketing campaign Wisconsin Pilot launching on Earth Day Includes Reverse distribution companyl Need DEA waiver The Maine Prudent Disposal of Unwanted Medications pilot will devise, implement and valuate a mail back plan to remove unused over the counter and prescription medications.  A network of 75 distribution points located at pharmacies will provide for mailer pick up and drop offs to return unused medications. Informational materials for pharmacists, staff and individuals regarding the mailers will be developed and distributed.  In addition, the pilot will test the effectiveness of an educational campaign about the hazards to life, health, and the environment posed by improper storage and disposal of unused mediations.  Environmental Outcomes:  The University of Maine Center on Aging estimate that approximately 1.5 tons of unwanted medications will be collected from households in Maine and disposed of in a prudent fashion.  The project intends to understand the practicality and costs associated with a mail back medication return program. It also expects to provide information on the best methods to educate older adults concerning the hazards of unused medications and improper disposal and a reduction in the amount of medications available for improper disposal and diversion or poisonings and lead to a heightened awareness by the public-at-large and older adults that could lead to accidental deaths, human and animal poisonings, and suicides caused by unused medications.

Solid Waste Agency of Northern Cook County (SWANCC) Illinois Pilot Program Serving about 23 municipalities and 1 million northern Cook County Residents Collecting meds and sharps at City Halls Paid for by revenue from transfer station Disposal costs expected to be about ~$100K for program ($0.10 per person)

Example of what is being returned from a Wisconsin Collection Need to add % numbers to each category Can we rearrange so that “misc” shows up at the end instead of in the middle?? 18

Typically 5-10% of total is controlled substances 19

What is Still Needed? Humans, pets, livestock will always be taking medications, so solutions at the WWTP are needed Research on designer medications Quantify: excretion vs. disposal; farm vs. human Curb medicine waste (over-prescribing) Provide simple solutions for individuals, MDs, Pharmacies, Hospitals (VA), hospices, Rehab centers, schools, etc.

To Learn More www.iisgcp.org/unwantedmeds http://www.epa.gov/ppcp/