This document discusses current federal and state activities around minimizing pharmaceutical waste. It outlines research being done on occurrence and treatment options for pharmaceuticals in the environment. It also discusses federal legislation like the Safe Drug Disposal Act and various state legislation regarding take-back programs. The document notes that 54% of people throw medicines in the trash and 35% flush them, contributing to pharmaceuticals in waterways. It provides strategies to minimize waste at the prescribing, dispensing, and patient levels, and encourages proper disposal and take-back programs.

1. Minimizing Pharmaceutical Waste In Clinical Care GreenPharmEdu.org

2. Current Federal Activities Research—USEPA, USGS, FDA, CDC, NOAA, FWS, ARS, and others are evaluating environmental occurrence, effects, and treatment & stewardship options; coordination through Interagency PiE working group (under CENR). Policy USEPA – UWR & Health Services Industry Study DEA – CSA & impact on drug “take backs” Disposal guidelines Office of National Drug Control Policy (revised 3/09) US Fish & Wildlife/APhA/PhRMASMARxT program

3. National Guidance ONDCP original guidelines, February 2007 Collaboration with FDA and EPA Updated October 2009; defers to FDA for list of drugs to be disposed via sewers DEA and the Controlled Substance Act Recent ANPRM Encouraged to standardize process for what constitutes an exemption for law enforcement personnel Encouraged to standardize recordkeeping requirements Define what constitutes an appropriate destruction of controlled substances Asked to consider many collection options for take back programs ONDCP: Office of National Drug Control Policy DEA: Drug Enforcement Administration CSA: Controlled Substances Act ANPRM: Advance Notice of Proposed Rulemaking

4. Federal Legislation HR 1191 Safe Drug Disposal Act of 2009 Provide for disposal of controlled substances by ultimate users and care takers through state take-back disposal programs Prohibits pharmaceutical company recommendations on drug labels for disposal by flushing HR 1262 The Water Quality Investment Act Includes provisions requiring federal agencies to study the presence of pharmaceuticals and personal care products in the waters of the US

5. State Legislation Maine, Minnesota, Oregon, and Florida have legislation pending that would require drug manufacturers to operate and pay for statewide systems to collect, transport, and dispose of leftover pharmaceuticals from the public and certain facilities In California, legislation is pending that would require the state’s Board of Pharmacy to work with other state agencies, local governments, drug manufacturers, and pharmacies to develop sustainable, efficient policies and programs to manage pharmaceutical wastes and the disposal of devices Would authorize pharmacy to accept return of home-generated pharmaceutical waste

6. How Can Pharmaceutical Waste Enter The Environment? 54% of people throw medicines into the trash 35% of people flush medicines down the toilet Wastewater treatment do not treat medicinal compounds Up to 95% of antibiotics are excreted unaltered into the environment

7. Sources of Pharmaceuticals in Waterways

8. Characteristics of Pharmaceutical Waste Persistence Drugs are considered “pseudo-persistent” due to continuous presence in the environment Significant concentrations of barbiturate drugs in a tributary near a landfill, even though barbiturates had been replaced 30 years ago. Bioaccumluation Increase in the concentration of a chemical in a biological organism over time, compared to the chemical's concentration in the environment. Ecotoxicity A lethal concentration of chemical 96 hours after exposure.15

9. Pharmaceutical Waste and Medical Practices In 2007, the elderly population will waste more than 1 billion dollars of drugs Reducing a prescription to a 28 day supply could reduce the need for discarding by as much as 30%.

11. Control at source

12. Can implement & reduce loading in near term

14. Limit Quantities Limit quantity of medication dispensed on new orders to a 10-day supply before dispensing a full 30 day quantity. Limit quantities of medications dispensed in patients at risk for a terminal episode, newly ordered medications, and medications that are not usually given long term.

15. Hold and Reduce Hold medications during the acute hospitalization period of up to 10 days. Continue to examine prescribing patterns decrease unexpected changes discontinue medications to help eliminate unused and “wasted” medications

16. Be Considerate Moderate prescribing and dispensing patterns of p.r.n. medications. At discharge or transfer to another facility, give remaining medications to the patient or new facility to use. Single Dose electronic dispensing

17. Best Management Practice Destruction by incineration of all discarded drugs is BMP at this time Eliminate drain disposal Eliminate landfilling

18. Cradle to Cradle Medicine In theory, waste occurs when the prescription isn’t effective. If we get to the point where we have no leftover drugs, will that lead to improved therapeutic outcomes? Learning about what is unused will improve the quality of medical care

19. Coastal Health Alliance Three clinics in West Marin On-going take back program paid for by the county Public education West Marin Environmental Health Coalition Clinical staff require patients to bring in their medications on all visits

20. What everyone can do! Commit to a healthy lifestyle Focus on prevention Dispose unwanted medications at take-back sites Purchase drugs in small amounts Ask for medications with low environmental impact All health providers should know what to do with unused medications Take them back!