Prevenng Pharmaceucal Polluon and Diversion

Kate Hagemann & Sierra Fletcher Product Stewardship Instute 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 • Mul-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 – Anbioc resistance • Pharmaceucals enter the environment via a number of channels – Agricultural run-off – Human excreon – Improper disposal • Current waste water treatment plants cannot remove pharmaceucal compounds

April 15, 2011 5 Evidence of pharmaceucals In our waterways

• Minnesota Polluon Control Agency (2011) • USGS (June 2002)

•“a broad range of chemicals found in residenal, industrial, and agricultural wastewaters commonly occurs in mixtures at low concentraons downstream from areas of intense urbanizaon and animal producon. The chemicals include human and veterinary drugs (including anbiocs), natural and synthec hormones, detergent metabolites, plascizers, 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: – Abnormalies – Disrupts reproducve systems/risk of exncon • Baylor University researchers found residues human medicaons in fish. Include anhistamines, high blood pressure medicaon& an-depressants

"These results demonstrate the increasing need to consider bioaccumulaon of emerging contaminants in the environment," said Dr. Kevin Chambliss, an assistant professor of chemistry at Baylor, who is a co-lead invesgator on the project. "This research proves fish are being exposed to mulple 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 sll 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

• Prescripon 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 prescripon drug abusers obtained their drugs from friends or relaves

11

Drug-Induced Deaths Second Only to Motor Vehicle Fatalies, 1999–2007

Motor vehicle fatalies

Drug-induced deaths Suicides

Gunshot deaths

Homicides

Source: Naonal Center for Health Stascs, Centers for Disease Control and Prevenon. Naonal Vital Stascs 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 populaon due to unintenonal drug overdose, based on 27,658 deaths.

Source: Centers for Disease Control and Prevenon. Unintenonal Drug Poisoning in the United States (July 2010). Safety Concerns

• Storing leover/expired medicaons in the home increases the risk of accidental poisoning and/or taking the wrong medicaon

• Children, the elderly and pets are parcuarly vulnerable

14 Need for safe disposal opons

• collecon programs operang around the country: •Household hazardous waste facilies •Pharmacies •Police staons •One-day collecon events

© Product Stewardship Institute – February 25, 2011 15 Drug Take–Back Legislaon in the U.S. 2009 -2011

16 EPR for Pharmaceucals – 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 Potenal 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 sll required) – Meet program minimum requirements/goals • Government oversees program & enforces against non- compliant manufacturers – Educaon & outreach • Retail pharmacies could serve as collecon sites • Consumers get informaon about what to do with leover drugs & dispose accordingly (no, this part isn’t easy!)

18 Post Consumer Pharmaceucal Stewardship Associaon - Canada

– Mandatory Programs: • Brish Columbia – Established in 2000 – more than 97.5% of all pharmacies are parcipang in the program (voluntarily) – paents have access to over 1080 collecon locaons

• Manitoba – Established in February 2010

19 Companies Participating in PCPSA

1. Abbo Laboratories Limited 42. Holista Health Canada 83. Planum Naturals 2. Abraxis BioScience 43. Hospira Healthcare Corporaon 84. Procter & Gamble Inc. 3. Actelion Pharmaceucals Canada Inc. 44. Hudson’s Bay Company 85. Proctor & Gamble Pharmaceucals Canada Inc 4. Advantage CKN 45. Indigene Pharma Inc. 86. ProMedics Nutraceucal Ltd 5. Afexa Life Sciences Inc. 46. Instut Rosell 87. Purdue Pharma 6. Alcon Canada 47. Jamieson Laboratories Ltd. 88. Ranbaxy Pharmaceucals 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 Pharmaceucals 92. Ropack Inc. 11. Astellas Pharma 52. Kripps Pharmacy 93. Sanofi-Avens 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 Pharmaceucals 15. Bayer Inc. 56. London Drugs Limited 97. Sepracor Pharmaceucals Inc. 16. Baxter Canada 57. Lundbeck Canada Inc. 98. Servier Canada Inc. 17. Bioforce Canada 58. Mead Johnson Nutrionals 99. Shaklee Canada Inc. 18. Biogen Idec Canada Inc. 59. Mentholatum Co. of Canada Ltd. 100. Shire Canada Inc. 19. Biovail Pharmaceucals 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 Nutrional Products Ltd. 103. Solvay Pharma Inc. 22. Bristol-Myers Squibb Pharmaceucal Group 63. Nature's Sunshine Products 104. Sefel Canada Inc. 23. Canada Safeway Ltd. 64. Novars Consumer Health Canada Inc. 105. Swiss Herbal Remedies Ltd. 24. Chaem (Canada) Inc. 65. Novars Pharma Canada Inc. 106. Taro Pharmaceucals Inc. 25. Church & Dwight Canada 66. Novo Nordisk Canada Inc 107. Tianshi Health Products 26. Cobalt Pharmaceucals 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 Pharmaceucal 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 Pharmaceucals 113. Wal-Mart Pharmacy 32. Enzymac Therapy 73. Omega Laboratories 114. Wellspring Pharmaceucals 33. Ferring Inc. 74. Organika Health Products Inc. 115. Westcoast Naturals 34. Gaia Garden Herbal Inc. 75. Overwaitea Food Group Ltd Partnership 116. WN Pharmaceucals Ltd. 35. Galderma Ltd 76. Paladin Labs Inc. 117. Wyeth Consumer Healthcare Inc. 36. General Nutrion 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 Pharmaceucals 80. Pharmasave 40. Helix BioPharma Corp. 81. Pharmascience Inc. 41. Herbalife of Canada 82. PharmEng Technology Inc. Parcipang Companies – A Few Examples

• Abbo 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 Pharmaceucal Stewardship Associaon Thursday May 5th 4-5pm Eastern/ 3-4pm Central

Ginee Vanasse, Post Consumer Pharmaceucal Stewardship Associaon

22 Contact

Sierra Fletcher PSI Director of Policy & Programs 617-236-4886 [email protected]

www.productstewardship.us

23 Iowa’s medicaon 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 Soluon • IPA partnered with Sharps Compliance, Inc. – Located near Houston, TX – Specialize in medical and pharmaceucal waste disposal for 15 years

• TakeAway™ Environmental Return System – Turn-key pharmaceucal waste disposal program – Ulize Iowa community pharmacies TakeAway™ Program • TakeAway systems – 10 and 20 gallons – Plasc-lined, heavy-duty cardboard, tamper-resistant, one way entry – 9’’ x 12’’ TakeAway envelopes* • Unacceptable items – Controlled substances – Liquids > 4 oz – Non-drug products TakeAway™ Program • Return shipment for systems and envelopes – Pre-addressed, pre-paid to Sharps in TX – Compliant with DEA, UPS, USPS

• Disposal – Waste-to-energy incineraon – Witnessed by law enforcement – Systems and envelopes sealed up to and during incineraon Using the TakeAway™ Program • Gather all unwanted and expired medicaons – Leave medicaons in vials and packaging – Do NOT include controlled substances

• Bring to a parcipang pharmacy ( www.iarx.org/takeaway) – TakeAway system kept behind the counter* – Personal informaon remains confidenal TakeAway™ Program in Iowa • Every Iowa community pharmacy eligible – 414 pharmacies in all 99 counes parcipang

• Parcipang pharmacies receive: – TakeAway systems** – Customizable markeng materials – Business plan for sustaining the program

Since the launch… • 309 pharmacies on Nov 1; >100 joined ‘post-launch’ • Successful public educaon/media campaign(s) – Pharmacy driven – Outside-In – Earth Week/Spring Cleaning 2010 – Public Relaons Campaign 2011 (ongoing) • Pill Dude • Updated Pharmacy materials • Partner events with law enforcement for CS

2011 • As of April 3, 2011 (~18 months) – 608 returned TakeAway systems (20 gal) – 1,416.1 lbs of returned medicaons incinerated (tared weight) – 15,840 lbs of returned medicaons collected by pharmacies**

• Partner with NCPA – naonal TakeAway iniave www.disposemymeds.org • Seeking another year of Legislave funding or sustainable funding from other source(s)

Iowa’s medicaon disposal program ulizing community pharmacies www.iarx.org/takeaway Kate Gainer, PharmD Vice President, Professional Affairs Iowa Pharmacy Association [email protected]

www.iarx.org/takeaway