Margaret Shield, Policy Liaison Local Hazardous Waste Management Program in King County NW NAHMMA June 24, 2014 Update on King County’s Secure Medicine Return Regulations 1

Why medicine take-back? To protect our kids, families, and environment from leftover medicines in our homes. About one-third of medicines sold go unused each year – roughly 33 million containers of medicines in WA. Public Safety - reduce the amount of drugs available for misuse and Environmental Protection - keep waste medicines out of our waterways and water supplies

Epidemic: Responding to America’s Prescription Drug Abuse Crisis 2013 National Drug Control Strategy: 1. Education of health providers and the public. 2. Expand prescription monitoring programs. 3. Safe drug disposal – increase return/take-back and disposal programs. 4. Effective enforcement to address “pill mills” and “doctor shopping.” 3

Secure AND environmentally sound… Voluntary Medicine Take-Back Programs Some Law Enforcement: can accept all medicines, including controlled substances. Some Pharmacies: cannot accept controlled substances (currently). Secure Tracking & Storage Safe Disposal by High Temperature Incineration 4

National Prescription Drug Take-Back Days DEA-coordinated events in spring & fall Results from Washington Events: April 2014 – 16,677 pounds Oct – 14,508 pounds April 2013 – 14,992 pounds Sept – 13,057 pounds April 2012 – 13,426 pounds Oct – 9,502 pounds April 2011 – 8,535 pounds Sept – 8,931 pounds

Barriers to a Comprehensive Medicine Take- back System in King County 6 Challenges in collection of controlled substances – help coming from new DEA regulation. (hopefully SOON!) Convenience and access – too few drop-off sites; too much of county and state unserved. Financing – lack of dedicated & adequate funding; very limited funding for education & promotion. Lack of an efficient system – no county-wide or state- wide coordination.

New federal regulations for take-back of controlled drugs. Draft rule published in Dec Waiting for final rule….STILL! What we expect in final rule: 3 take-back methods allowed under specific security protocols. (1) Collection receptacles (i.e. drop-off boxes) and (2) mail-back programs may be operated by DEA approved retail pharmacies, drug manufacturers, drug distributors, reverse distributors, and law enforcement. (3) Take-back events may be conducted by law enforcement only. 7 DEA’s Proposed Rule for Secure & Responsible Drug Disposal Act of 2010

Product Stewardship Approaches for Medicine Take-back Pharmaceutical manufacturers provide medicine return systems in B.C., Manitoba, Ontario, France, Spain & Mexico. “Product stewardship” The product producer has the greatest responsibility and ability to minimize adverse impacts of their product throughout lifecycle. Other stakeholders, such as suppliers, retailers, and consumers also share responsibility. 8

Product Stewardship Legislation for Pharmaceuticals in the U.S. Federal: 2011 legislation (HR 2939 – Slaughter). No action taken. States: legislation proposed in 9 states in recent years - CA, FL, ME, MD, MN, NY, OR, PA, WA. None have passed yet. Counties: San Francisco, City & County considered ordinance. Legislation tabled when PhRMA and Genentech agreed to provide grants for city-operated program. July Alameda County, CA passed a Safe Drug Disposal Ordinance. June King County Board of Health, WA passed Secure Medicine Return Regulations. 9

10 Taylor Watson Program Implementation Manager

King County’s Secure Medicine Return Regulation Drug manufacturers whose medicines are sold in or into King County are required to finance and provide a county-wide secure medicine return system. Collection system requirements for secure drop boxes in retail pharmacies or law enforcement offices throughout county. Or periodic collection events or prepaid return mailers. Prescription and over-the counter medicines will be accepted. From residential sources, not clinical or business. Collected medicines must be securely handled, transported and disposed according to federal & state laws and policies. Public Health-Seattle & King County and LHWMP provide oversight to ensure safety and compliance. 11

Timelines: Pharmaceutical Stewardship Laws in Two Counties & Industry’s Commerce Clause Lawsuits Alameda County, CA Safe Drug Disposal Ordinance July 2012 Ordinance passed Dec Federal lawsuit filed by 3 pharmaceutical associations (PhRMA, GPhA, BIO) Aug Northern CA District Federal Judge rules in favor of Alameda County. Nov Pharmaceutical associations appeal verdict to Ninth Circuit Federal Court King County, WA Secure Medicine Return Regulation June 2013 Rule & Regulation passed Nov Federal lawsuit filed by 4 pharmaceutical associations (PhRMA, GPhA, BIO, CHPA) 12

What is the Commerce Clause? Article 1, Section 8 of U.S. Constitution empowers Congress to regulate interstate commerce. “Dormant” Commerce Clause legal doctrine inferred from the Commerce Clause state and local governments may not unduly interfere with interstate commerce. 13

Initial Ruling in Alameda County’s Lawsuit U.S. District Court for the Northern District of California ruled in favor of Alameda County’s Safe Drug Disposal ordinance: Does not discriminate against out-of state entities in the manner prohibited by the dormant Commerce Clause. Does not directly regulate interstate commerce in the manner prohibited by the dormant Commerce Clause. Alameda County has “adequately shown that the Ordinance serves a legitimate public health and safety interest, and that the relatively modest compliance costs producers will incur should they choose to sell their products in the county do not unduly burden interstate commerce.” 14

Pharma Industry Associations Appeal To Ninth Circuit 15

Ag Explaining the Regulations, including official notifications  Developed website & list for interested stakeholders  Contacting obligated entities through certified mail  Consultation & technical assistance Identifying drug producers  Drug Wholesalers required to provide list of producers to county  164 drug producers complied with a Dec. 1, 2013 deadline by providing a “Notice of Intent to Participate in a Stewardship Plan” Agreement with industry to extend Compliance Deadlines. King County’s 2014 compliance deadlines have beeen extended pending decision on Alameda lawsuit in Ninth Circuit. Developing a fee schedule for recovery of agency costs for plan review and oversight. Adopted by Board of Health on May 15, What is King County doing to implement the law?

“This is about saving even just one life…if we can dispose of cans and bottles and oil from our car properly, why can’t we dispose of something the size of a dime that can kill you?” ‒ Bernard Strain, whose teenage son Timothy died last year after accidentally taking prescription methadone pills that had been sitting in a medicine cabinet. New York Times, September 24, 2010

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Where are WA Medicine Take-back Sites? Look it up at 20

WA Secure Medicine Return Bill Requires drug companies selling medicines to pay for and provide a secure statewide take-back program. Supported by Take Back Your Meds Coalition Opposed by pharmaceutical industry 21 Drug companies should step up to disposal problems Feb. 7, 2012 Legislators should approve statewide pharmaceuticals take-back program January 26, 2012

Examples of Producer Stewardship Programs for Take Back of Other Hazardous Products Electronic Waste Mercury lights (CFLs & Fluorescent tubes) Rechargeable Batteries Paint Auto Switches Mercury Thermostats Cell Phones 22