Preven Ng Pharmaceu Cal Pollu on and Diversion
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Preven&ng Pharmaceu&cal Pollu&on and Diversion Kate Hagemann & Sierra Fletcher Product Stewardship Ins&tute How to Participate Today • Open and close your Panel • View, Select, and Test your audio • Submit text questions • Raise your hand • Q&A addressed at the end of today’s session • Everyone will receive an email within 24 hours with a link to view a recorded version of today’s session Who is the Product Stewardship Instute? § Non-profit founded in 2000 § Membership ü 47 States ü 200+ Local governments ü 70+ Corporate, Organizaonal, Academic & Non-U.S. Government Partners § Board of Directors: 7 states, 4 local agencies • Mul4-stakeholder product stewardship network 3 The Problem: Waste Pharmaceucals 1. Environmental Concerns 2. Drug Diversion concerns 3. Public Safety Concerns 4 1. Environmental Concerns • Effects in the environment: – Endocrine disruptors – An&bio&c resistance • Pharmaceu&cals enter the environment via a number of channels – Agricultural run-off – Human excre&on – Improper disposal • Current waste water treatment plants cannot remove pharmaceu&cal compounds April 15, 2011 5 Evidence of pharmaceucals In our waterways • Minnesota Pollu&on Control Agency (2011) • USGS (June 2002) •“a broad range of chemicals found in residen3al, industrial, and agricultural wastewaters commonly occurs in mixtures at low concentra3ons downstream from areas of intense urbaniza3on and animal producon. The chemicals include human and veterinary drugs (including an3bio3cs), natural and synthe3c hormones, detergent metabolites, plas3cizers, inseccides, and fire retardants. One or more of these chemicals were found in 80 percent of the streams sampled” April 15, 2011 6 Environmental Impacts • Ecological impacts remain unknown • Observed impacts: – Abnormali&es – Disrupts reproduc&ve systems/risk of ex&ncon • Baylor University researchers found residues human medicaons in fish. Include an&histamines, high blood pressure medicaon& an&-depressants "These results demonstrate the increasing need to consider bioaccumula3on of emerging contaminants in the environment," said Dr. Kevin Chambliss, an assistant professor of chemistry at Baylor, who is a co-lead inves3gator on the project. "This research proves fish are being exposed to mul3ple compounds in our waterways." April 15, 2011 7 Impacts on Human Health • Largely unknown • Effects of chronic exposure to low-levels of contaminaon underexplored in toxicology April 15, 2011 8 What’s wrong with the trash? • Drugs disposed of in the trash s&ll are released into the environment through the runoff from landfills known as “leachate” April 15, 2011 9 Clear & Consistent Message 10 January 24, 2011 2. Drug Diversion Concerns • Prescrip&on Drug Abuse is “the fastest growing drug problem” according to the Obama administraon • Accidental drug overdoses are now the leading cause of death in 17 states – Average of 7 people die everyday in Florida • 7 out of 10 prescrip&on drug abusers obtained their drugs from friends or relaves 11 Drug-Induced Deaths Second Only to Motor Vehicle Fatali4es, 1999–2007 Motor vehicle fatali4es Drug-induced deaths Suicides Gunshot deaths Homicides Source: Naonal Center for Health Stas&cs, Centers for Disease Control and Preven&on. Naonal Vital Stas&cs Reports Deaths: Final Data for the years 1999 to 2007 (2001 to 2010). Unintenonal Drug Overdose Deaths United States, 1970-2007 In 2007, there were 9.18 deaths per 100,000 popula8on due to uninten8onal drug overdose, based on 27,658 deaths. Source: Centers for Disease Control and Preven&on. Uninten3onal Drug Poisoning in the United States (July 2010). Safety Concerns • Storing leeover/expired medicaons in the home increases the risk of accidental poisoning and/or taking the wrong medicaon • Children, the elderly and pets are par4cuarly vulnerable 14 Need for safe disposal opons • collec&on programs operang around the country: •Household hazardous waste facili&es •Pharmacies •Police staons •One-day collec&on events © Product Stewardship Institute – February 25, 2011 15 Drug Take–Back Legislaon in the U.S. 2009 -2011 16 EPR for Pharmaceu4cals – Legislaon in the U.S. 2009 -2011 • “study bills” in CA, VT, RI • other take-back legislation in a dozen states • potential federal bill 17 Poten4al Roles in EPR: Pharmaceucals • Mandated • Manufacturers (“pharma”) develop and implement take-back program – Would choose combinaon of available mechanisms (i.e., law enforcement involved as long as that is s&ll required) – Meet program minimum requirements/goals • Government oversees program & enforces against non- compliant manufacturers – Educaon & outreach • Retail pharmacies could serve as collec&on sites • Consumers get informaon about what to do with leeover drugs & dispose accordingly (no, this part isn’t easy!) 18 Post Consumer Pharmaceucal Stewardship Associa4on - Canada – Mandatory Programs: • Bri&sh Columbia – Established in 2000 – more than 97.5% of all pharmacies are par&cipang in the program (voluntarily) – paents have access to over 1080 collec&on locaons • Manitoba – Established in February 2010 19 Companies Participating in PCPSA 1. Abbom Laboratories Limited 42. Holista Health Canada 83. Planum Naturals 2. Abraxis BioScience 43. Hospira Healthcare Corporaon 84. Procter & Gamble Inc. 3. Actelion Pharmaceu&cals Canada Inc. 44. Hudson’s Bay Company 85. Proctor & Gamble Pharmaceu&cals Canada Inc 4. Advantage CKN 45. Indigene Pharma Inc. 86. ProMedics Nutraceu&cal Ltd 5. Afexa Life Sciences Inc. 46. Ins&tut Rosell 87. Purdue Pharma 6. Alcon Canada 47. Jamieson Laboratories Ltd. 88. Ranbaxy Pharmaceu&cals Canada Inc. 7. Amgen Canada Inc. 48. Janssen-Ortho Inc. 89. Raopharm 8. Amway Canada 49. Johnson & Johnson Inc. 90. Rivex Pharma Inc. 9. Apotex Inc. 50. Katz Group Canada Ltd 91. Roche Canada 10. Ashbury Biologicals Inc. 51. King Pharmaceu&cals 92. Ropack Inc. 11. Astellas Pharma 52. Kripps Pharmacy 93. Sanofi-Aven&s Canada Inc. 12. AstraZeneca Canada Inc. 53. Laboratoire RIVA Inc. 94. Sandoz Canada 13. Au Naturel Inc. 54. Leo Pharma Inc. 95. Schering Canada Inc. 14. Axcan Pharma Inc. 55. Loblaw Companies Ltd 96. Seaford Pharmaceu&cals 15. Bayer Inc. 56. London Drugs Limited 97. Sepracor Pharmaceu&cals Inc. 16. Baxter Canada 57. Lundbeck Canada Inc. 98. Servier Canada Inc. 17. Bioforce Canada 58. Mead Johnson Nutri&onals 99. Shaklee Canada Inc. 18. Biogen Idec Canada Inc. 59. Mentholatum Co. of Canada Ltd. 100. Shire Canada Inc. 19. Biovail Pharmaceu&cals Canada 60. Merck Frosst Canada & Co. 101. Shoppers Drug Mart, Pharmaprix 20. Boehringer Ingelheim Canada Ltd. 61. Mylan Canada 102. SISU Inc. 21. Boiron 62. Natural Factors Nutri&onal Products Ltd. 103. Solvay Pharma Inc. 22. Bristol-Myers Squibb Pharmaceu&cal Group 63. Nature's Sunshine Products 104. Sefel Canada Inc. 23. Canada Safeway Ltd. 64. Novar&s Consumer Health Canada Inc. 105. Swiss Herbal Remedies Ltd. 24. Chaem (Canada) Inc. 65. Novar&s Pharma Canada Inc. 106. Taro Pharmaceu&cals Inc. 25. Church & Dwight Canada 66. Novo Nordisk Canada Inc 107. Tianshi Health Products 26. Cobalt Pharmaceu&cals Inc. 67. Novopharm Ltd. / Teva Neuroscience 108. Trophic Canada 27. Combe Incorporated 68. Nu-Pharm Inc 109. UniPHARM Wholesale Drugs 28. Costco 69. Nucro-Technics Incorporated 110. USANA Canada Co. 29. Cytex Pharmaceu&cal Inc. 70. Nycomed Canada Inc. 111. Valeant Canada Limited 30. Eli Lilly Canada Inc. 71. Odan Laboratories 112. Vita Health Products Inc. 31. EMD-Serono Canada Inc 72. Omega Alpha Pharmaceu&cals 113. Wal-Mart Pharmacy 32. Enzymac Therapy 73. Omega Laboratories 114. Wellspring Pharmaceu&cals 33. Ferring Inc. 74. Organika Health Products Inc. 115. Westcoast Naturals 34. Gaia Garden Herbal Inc. 75. Overwaitea Food Group Ltd Partnership 116. WN Pharmaceu&cals Ltd. 35. Galderma Ltd 76. Paladin Labs Inc. 117. Wyeth Consumer Healthcare Inc. 36. General Nutri&on Centres Canada 77. Patheon Inc. 118. Wyeth - Canada 37. GlaxoSmithKline Consumer Healthcare 78. Peoples Drug Mart 38. GlaxoSmithKline Inc. 79. Pfizer Canada Inc 39. Graceway Pharmaceu&cals 80. Pharmasave 40. Helix BioPharma Corp. 81. Pharmascience Inc. 41. Herbalife of Canada 82. PharmEng Technology Inc. Par4cipa4ng Companies – A Few Examples • Abbom Laboratories Limited • Bayer Inc. • Bristol-Myers Squibb • Eli Lilly Canada Inc. • GlaxoSmithKline Inc. • Johnson & Johnson Inc. • Pfizer Canada Inc • Procter & Gamble Inc. • Wal-Mart Pharmacy 21 Upcoming Webinars Prevenng Pharmaceucal Polluon and Diversion - Spotlight on Iowa Again: May 3rd at 2-3 Central Learning From Canada: Post Consumer Pharmaceu8cal Stewardship Associa8on Thursday May 5th 4-5pm Eastern/ 3-4pm Central Ginee Vanasse, Post Consumer Pharmaceu3cal Stewardship Associa3on 22 Contact Sierra Fletcher PSI Director of Policy & Programs 617-236-4886 [email protected] www.productstewardship.us 23 Iowa’s medica8on disposal program – Update April 2011 Background • 2009 & 2010 Iowa state legislaon – Funding $150,000 • Joint venture between: – Iowa Board of Pharmacy – Iowa Pharmacy Associaon (IPA) – 400+ community pharmacies – 20+ statewide partnering organizaons Iowa’s Solu&on • IPA partnered with Sharps Compliance, Inc. – Located near Houston, TX – Specialize in medical and pharmaceu&cal waste disposal for 15 years • TakeAway™ Environmental Return System – Turn-key pharmaceu&cal waste disposal program – U&lize Iowa community pharmacies TakeAway™ Program • TakeAway systems – 10 and 20 gallons – Plas&c-lined, heavy-duty cardboard, tamper-resistant, one way entry – 9’’ x 12’’ TakeAway envelopes* • Unacceptable items – Controlled substances – Liquids