Statement In Opposition to ZSHB 1165 January 18, 2010 Position: respectfully opposes 2SI-IB 1165, which wouldestablish manufacturer-funded drug take back programs for unused medicines in all cities with a population greater than 10,000 people, because: 1| such programs do not reduce amounts of medicines in the environment and could increase drug abuse; 2| manufacturers are prohibited by federal law from taking controlled medicines from patients; 3) such programs could increase the cost of medicines; 4) consumers already have the environmentally sound option of guickly disposing of unused medicines in the household trash system. In summary, opposes funding drug take-back programs for the following reasonsand its member companies are committed to environmental health and patient safety. believes that educating patients about proper disposal using the current household trash infrastructure is efficient, effective, and preserves patient safety. Drug take-back programs would impose a duplicative, complicated, and potentially dangerous new waste disposal system for unused medicines. If adopted, this legislation could have the unintended consequence of undermining its stated goals of reducing illegitimate access to drugs. If a manufacturer, pharmacy, or practitioner were to receive controlled substances from a patient, it would be a violation of the federal Controlled Substances Act (CSA). Once a patient receives a controlled substance from a legitimate prescription, the CSA prohibits the transfer of the medicine to another party, even for disposal, unless the transfer is permitted by the Drug Enforcement Administration. It is unknown whether accidental poisonings and drug misuse and abuse are taking place because of misuse and abuse of medicines currently being used by family members, or from unused medicines in the household, or from diverted or illegally obtained drugs. There is insufficient evidence that such a program is cost-effective or would reduce drug diversion. Instead, the proposed program could create known sites for or access points to aggregated medicines and could unintentionally increase diversion and abuse. We also know such programs would not address the issue of medicines in the environment (to which human use is the primary contributor). A state-mandated take-back program would be expensive to administer-requiring significant financial resources to secure medicines from diversion, to transport medicines for disposal, and to incinerate aggregated medicines in compliance with EPA and DEA laws and regulations. Although the bill says there can be no charge for disposal at the point of sale, it cannot be denied that significant costs will be incurred which will be added to a manuf`acturer's cost of doing business. Therefore, it is reasonable to assume that for those who buy medicines patients and insurers, including the State of Washington Medicaid program), this legislation (perhaps unintentionally) increases the cost of medicines. These costs can be avoided if patients dispose of medicines in the household trash, which can be done in compliance with federal laws and recommended guidelines and is environmentally responsible. The federal govemment recognizes that water quality is a serious issue and is taking steps to address the issue in more broadly. For example, the EPA recently stated that "[c]lean and safe water is a priority for [the Obama] administration The American public has a right to expect their water will be clean, and EPA has an obligation to use its resources and authorities to the fullest to ensure this result." To make this a reality, EPA is providing easy>>to-understand information on water quality to the public; re-examining and strengthening drinking water standards; and more strictly enforcing Water quality laws. In addition to EPA's existing authority and initiatives, Congress is currently discussing legislative initiatives, like the Pharmaceutical Research and Manufacturers of America m~rrm~#~nn 3140 Maringo Rd. SE, Olympia, WA 360-705-1276 Clean Water Affordability Act and the Water lnfrastructure Financing Act that will improve our water quality on a national scale. In an attempt to bring about national uniformity in safely disposing of unused medicines, PhRl\/lA has been working with the myriad of federal agencies that have responsibilities in this area, including the Food and Drug Administration, the Environmental Protection Agency as well as the U.S. Fish and Wildlife Service. In addition, has worked closely on matters of drug abuse with private-sector programs such as DARE and the renowned Partnership for a Drug Free America. At a public hearing in the House Environmental Health Committee on proposed take~bacl4 legislation from the 2009 session, the program director of one of the leading proponents ofthe bill (Washington Citizens for Resource Conservation) told the committee that there are no definitive studies showing a similar program in British Columbia has reduced the risk of accidental poisonings, reduced access to medicines that can be abused, or reduced the practice of flushing medicines down the drain. In testimony seeking an extension of authority for the current pilot take-back program operated by Bartell Drugs and Group Health Cooperative, representatives of the King County Public Health Department and Group Health told the Washington State Board of Pharmacy in July, 2009: "There is no definitive study" on the impact of drug take-back programs;" "because the voluntary pilot programs cannot accept medications classified as controlled substances, patients are advised to dispose of those medicines in their household garbage with other solid waste in with the guidelines ofthe U.S. Food Drug Administratiom" and "it costs Group Health more than $4500 per site annually to operate its 25 take-back sites." the U.S. Fish and Wildlife Service, and the American Pharmacists Association announced in 2008 a coordinated effort to increase patient awareness of the proper manner for safely disposing of unused medicines and over-the>>counter products pursuant to federal guidelines on safe disposal. This Pfosfeln is Called T316 rin A coalition of organizations and businesses has undertaken an initiative to increase public awareness of the proper way to dispose of unused medications by following federal agency guidelines. Participants in the Safe Drug Disposal Northwest program include Washington State Pharmacy Association, Washington State Medical Association, National Association of Chain Drug Stores, Drug Abuse Resistance Education (DARE), Washington Health Foundation and Washington Council of Police and Sheriffs. Over the year, the progranrs outreach/education activities have included: promotion ofa website on safely disposing of unused medications; distributing informational brochures/posters to patients through pharmacies, senior centers and physicians' offices; earned media on the coalition's efforts; and sponsorship of public service announcements by Washington's Superintendent of Public Instruction and Attorney General, To read more about the Safe Drug Disposal Northwest program, visit 5_1-_tt 5 it S-_ti _ini -it Jas 3 The Washington Attorney General's office has convened anew Prescription Drug Advisory Group which has been charged in the next six months: to assist the office to identify funding sources to implement the state's prescription monitoring program to reduce over-prescribing and inappropriate access to medicines; to propose law changes to address the increase in the frequency of pharmacy robberies and burglaries; and to develop a drug disposal program for unused medicines that is endorsed by law enforcement, physicians and other prescribers, pharmacies, manufacturers and solid waste professionals. The PDAG is made up of 30 persons from the various stakeholder interests. llie I lzamzaceutlcal Research ana' Manufacturers of America (PIIRMA) represents the country's leading pharmaceutical research ancl biotechnology companies, which are clevofecl to inventing meclicines that allow patients lo live longer, healthier, and more proa'uctz've lives. PIQRMA compames are leading the way in the new cures. members alone lnveslecl an $50.3 billion in 2008 in discovering and developing new medlcr'nes. lriclusrry-wide resecu'ch and investment reacliecl a recora' $65.2 billion in 2008. Pharmaceutical Research and Manufacturers ofAme-rica 'W'"mfw I