Consumer Rx Take-Back Programs: Challenges & Solutions. Charlotte Smith, R. Ph., M.S. Director, PharmEcology Services WM Healthcare Solutions, Inc.

Transcription

1 Consumer Rx Take-Back Programs: Challenges & Solutions Charlotte Smith, R. Ph., M.S. Director, PharmEcology Services WM Healthcare Solutions, Inc.

2 Legal Disclaimer This presentation is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information.

3 Pharmaceutical Life Cycle Management: The Perfect Storm Growing environmental awareness Increasing focus on environmental regulations Efforts to green the manufacturing and supply processes Calls for Green Chemistry Public health issues: ODs and poisonings Cost containment through waste reduction

4 March 9, 2008 Drugs in Drinking Water & Healthcare Pharmaceutical Waste 5-month inquiry discovered that drugs were detected in the drinking water supplies of 24 major metropolitan areas September 14, 2008 Majority of 5,700 hospitals and 45,000 long-term care facilities flush unwanted drugs down the drain and do not document amounts according to EPA survey Extrapolation of data from 14 representative facilities in Minnesota yielded an estimated total volume of 250 million pounds of drug waste annually, including packaging April 19, 2009 U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water

5 The Faroes Statement 200 environmental scientists from five continents met at the Faroes Islands in the North Atlantic May 24, 2007 Warned of fetal exposure to toxic substances resulting in fetal programming to the 2 nd and 3 rd generation Lifelong effects: obesity, diabetes, cancers, ADHD, Parkinson s, Alzheimer s, reduced immune system The dose makes the poison replaced by The timing makes the poison New approach to testing of chemicals strongly advocated; 80% of major chemicals never tested for damage to early development

6 Species at Risk

7 Effects of Chronic Exposure to Prozac Developmental delays, forelimb formation, tail resorption Increased time to metamorphosis Increased mortality Black, MC; Rogers, ED; Henry, RB. Endocrine Effects Of Selective Serotonin Reuptake Inhibitors (SSRIs) on Aquatic Organisms Control 38 ppb Prozac

8 EPA May Regulate Pharms in Drinking Water 104 chemicals being considered for possible regulation under the Safe Drinking Water Act Pharmaceuticals considered for the first time Several estrogens included: estradiol, estrone, ethinyl estradiol, mestranol Also erythromycin (antibiotic) & nitroglycerin (cardiac) Collection and evaluation will take years (2013) but could result in drinking water standards for drugs Copyright 2010 Waste Management, Inc.

9 EPA Soliciting Comments: Preliminary 2010 Effluent Guidelines Program Plan Presents summary of current efforts since 2008 to solicit information regarding drug disposal, primarily within the healthcare sector Offers opportunity to provide a variety of input comments on page 68614, section B. Comment period open until February 26, 2010 Access at Submit comments as required on page 68600

10 EPA Proposal to Add Pharmaceuticals to Universal Waste Rule Federal Register publication Dec 2, 2008 Comments were due March 4, /f28161.htm Information: m.htm Proposed UWR only applies to drug waste that meets the definition of RCRA hazardous waste Only intended for healthcare-type generators, not manufacturers Intent to streamline pharmaceutical waste management and encourage consumer take-back programs Estimated April, 2011for federal enactment; states may or may not adopt

11 RCRA and Universal Waste Universal Waste is a subset of RCRA hazardous waste. Federal EPA: Batteries, Pesticides, Mercurycontaining devices, Lamps (bulbs) Federal RCRA Hazardous Waste (includes some pharmaceuticals) Universal Waste FL, MI: RCRA Pharmaceuticals

12 The Challenge: There currently is no global solution for consumer drug disposal Most common to dispose of unused medicines in toilet or trash. Barriers to more appropriate collection and disposal have hindered program development in the past. Momentum building to develop innovative solutions. Community Take-Back Programs are developing at grass roots level

13 Public Perception Not comfortable with drain and landfill options Becoming aware of product stewardship efforts in other industries, including collection, treatment and disposal of: Electronics Batteries Medical sharps Light bulbs Tires Paint Consumers are informed and sophisticated on impacts of chemicals on humans and other species

14 To public health Today s Risks Alarming increase in diversion and prescription drug abuse, particularly by teenagers 15% of 12 th graders report using a prescription drug over the past year Accidental poisoning and death has increased by 10% over the past decade No. 1 cause of overdose deaths Increased risk of inadvertent misuse by the elderly To the environment Disposal down the drain is contributing to surface water and ground water contamination Drugs in the water have been linked to abnormalities and impaired reproductive performance in fish and amphibians

15 Issues to be Resolved Legal: Drug Enforcement Administration Environmental Protection Agency Dept. of Transportation State Boards of Pharmacy, other state regulatory agencies Sustainable (funding): State, county, municipal (e.g. Wisconsin allocates $100,000/year for Rx collection events) Manufacturer Product Stewardship Initiatives gaining momentum

16 Drug Enforcement Administration The original Controlled Substances Act did not address consumer disposal or return Law enforcement entity must be present during collection of controlled substances, thereby limiting community collection efforts Historically, the DEA has been very reluctant to ease these restrictions

17 Pending Legislation to Amend the Controlled Substances Act Safe Drug Disposal Act of 2009 Introduced into the House on February 25, 2009: HR 1191 Introduced into the Senate on June 24, 2009: S 1336 To amend the Controlled Substances Act to provide for the disposal of controlled substances by ultimate users and care takers through State take-back disposal programs To amend the Federal Food, Drug and Cosmetic Act to prohibit recommendations on drug labels for the disposal by flushing Secure & Responsible Drug Disposal Act of 2009 Introduced into the House on March 5, 2009: HR 1359 Introduced into the Senate on June 18, 2009: S To amend the Controlled Substances Act to direct DEA to issue federal rules governing consumer take-back programs

18 Other Federal Regulatory Issues Environmental Protection Agency Household hazardous waste is exempt from the EPA s Resource Conservation and Recovery Act (RCRA) Department of Transportation Pharmaceuticals are routinely shipped to pharmacies labeled as ORM-Consumer Commodity Dispensed prescriptions are routinely sent through the USPS with no DOT labeling United States Postal Service Has agreed on appropriate packaging for consumer mailback program

19 Drug Take-back Pioneers: Charting Unknown Territory How much consumer-generated drug waste occurs annually? What percentage of drugs dispensed is wasted? How much residual, historical waste is in the system that needs to be flushed out What is the most efficient method for collecting/processing drug waste How does efficiency correlate with convenience? What will the costs of each system be? Who should incur the costs?

20 Sustainable Product Stewardship

21 What is Product Stewardship? Shared responsibility for the end-of-life management for products which are deemed hazardous to human health or the environment Includes changes in product design and production, changes in consumer behavior, and decisions regarding cost of proper disposal Often involves competing agendas and differences of opinion as to what entity bears which costs and responsibilities Primary historical reference: Scott Cassel, Ex Dir, Product Stewardship Institute

22 What Makes Drug Collection So Problematic from a Product Stewardship Perspective? Hundreds of manufacturers/repackagers Consumer does not often have choice of products/brands Difficult to separate by origin Bring only those drugs manufactured by ABC drug manufacturer Controlled substance and other regulatory issues Concerns regarding diversion/safety Multiple distribution systems: retail pharmacy, mail-order, internet pharmacy, multi-national sources

23 Historical Process Government agencies/non-profits engage in discussions with manufacturers/retailers Initial resistance of manufacturers to internalizing end-of-life costs into product price Promotion of end-of-life fees Slow movement towards the middle by both sides, resulting in greater responsibility taken by manufacturers and more flexibility by government

24 Learning from the Past State legislative efforts are an important mechanism for moving issues forward nationally Gaining the acceptance and participation of the industry involved is a win-win for industry and the public Corporate leadership is vital for a successful program

25 Extended Producer Responsibility Laws Courtesy Product Stewardship Institute February 2010

26 What Has Worked(Relatively) Well: Battery Recycling Portable Rechargeable Battery Association Established Rechargeable Battery Recycling Corporation (RBRC) in 1995 Management of recovery and recycling of nickelcadmium (NiCd) batteries First national, industry-wide producer responsibility program in US Ni-Cd batteries comprised less than 0.1% of MSW but accounted for 75% of cadmium content

27 Why Batteries? RBRC prompted by 8 state laws with take-back requirements for rechargeable batteries Growing interest in Europe to ban Cd Passage of comprehensive legislation in MN and NJ Battery industry sought federal legislation to facilitate its national roll-out Mercury-Containing and Rechargeable Battery Management Act ( The Battery Act ) Made the Universal Waste Rule immediately effective in all states

28 What Could Be Done Better? In spite of public education, many consumers unaware of program Inherent in voluntary program are free riders, companies that do not support the program but benefit from the take-back efforts Consider mandatory federal program with increasing performance goals to enable manufacturers to factor in costs as data is generated

29 Reasons for Retailers & Manufacturers to Participate Competitive Advantage: perceived as being green and leaders in sustainability efforts Reduction of Business Risk: getting out in front of multiple state legislative efforts to support a mutually agreed upon federal effort Company Leadership: Bold decision to lead Wal-Mart s packaging scorecard initiative Home Depot s Eco Options label program Whole Foods Whole Trade Guarantee

30 Impact on Manufacturers Have a stake in reducing drug waste if costs of disposal must be built into cost structure Potential reduction in sampling/move to vouchers Encouragement of lower introductory prescription limits/options Application of business process to increase efficiencies in take-back efforts Economies of scale emerge

31 Reverse Distribution: Wholesale/Retail Success Story Drug manufacturers have been buying back expired drugs for many years Development of reverse distribution industry in late 1980 s, early 1990 s accelerated and streamlined the process Reverse distributors initially reviled and mistrusted by some manufacturers Many manufacturers now embrace and out-source, resulting in cost reductions and economies of scale Greater visibility and ability to reduce outdate generation by pharmacies/wholesalers

32 Proposed Product Stewardship Bills Florida: HR 1357, SB 2650 (previous session) Maine: HP0557, LD 821 Maryland: HB 648 Minnesota: HF 1217, SF 1568 Oregon: SB 598 (previous session) Washington State: SHB 1165, SB 5279 (duplicate) None have passed to date only a matter of time

33 Common Elements: General Consensus Must accept all OTC, RX drugs; some include veterinary Manufacturer or Importer; retailer not included Target audience: consumers, including long term care facilities, other residential treatment centers, hospice Plan Required of Manufacturer(s): Renewal times differ Flexibility: Urban and rural/mail-back required in some; collection in cities of 10,000+ in others

34 Common Elements: General Consensus Manufacturer(s) must cover all costs; administrative fee may also be levied by state; No fee allowed at time of collection Must include either recovery goals first 3 years (lbs/capita) or other evaluation program Must accept all unwanted covered products regardless of who produced them Annual report (3 of 5 require) Educational outreach required; toll-free number & website (3 of 5)

35 Common Elements: General Consensus State Oversight: Varying degrees, with WA State the most highly defined Pharmacy Responsibilities: Must publicize (3 of 5) Performance Standards: Required (4 of 5) Policies & Procedures/Track/Trace/Security: (3 of 5) Stewardship Organization: To administer and track participation (2 of 5)

36 Common Elements: Lack of Consensus Required Destruction Technologies: Maine, Minnesota, Washington: Require Hazardous waste or superior technology Florida, Oregon: Hazardous waste or other incineration

37 Finding a Way Forward Determine cost efficiency for 3 scenarios: Community take-back Pharmacy kiosk Individual mailback Define cost efficiency By individual? by family unit? By prescription? By pound? Seek federal legislation which allocates funding based on agreed upon parameter Sales into the market? Volume into the market?

38 What s Needed: Product Stewardship Model Language States are clearly adopting language from each other Washington State, Maine, Minnesota very influential Suggested Action Item: Draft model language that retains much of the acceptable common elements Involve industry in dialog Move the discussion to federal legislation with some state flexibility Use federal act to move hazardous pharmaceuticals into Universal Waste Rule (UWR) in tandem with EPA

39 The Maine Declaration First mandatory 15-day introductory prescription for selected drugs as compared to 90 day automatic fill by mail-order pharmacies The Maine Declaration Support for limited first-time prescriptions on selected drugs based on returns data No co-pay so consumer is not penalized Track data system may pay for itself

40 Questions? Contact information: Charlotte A. Smith, R. Ph., M.S., HEM Director, PharmEcology Services 1021 Main Street 1 City Center, Suite 1000 Houston, TX (cell) csmith@pharmecology.com csmith32@wm.com