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Preven&ng Pharmaceu&cal Pollu&on and Diversion Kate Hagemann & Sierra Fletcher Product Stewardship Ins&tute
Preven&ng Pharmaceu&cal Pollu&on and Diversion
Kate Hagemann & Sierra Fletcher Product Stewardship Ins&tute
How to Participate Today
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• Q&A addressed at the end of today’s session
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Who is the Product Stewardship Ins4tute?
§ Non-‐profit founded in 2000 § Membership ü 47 States ü 200+ Local governments ü 70+ Corporate, Organiza&onal, Academic & Non-‐U.S. Government Partners
§ Board of Directors: 7 states, 4 local agencies
• Mul4-‐stakeholder product stewardship network
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1. Environmental Concerns
2. Drug Diversion concerns
3. Public Safety Concerns
The Problem: Waste Pharmaceu4cals
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• 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
1. Environmental Concerns
April 15, 2011 5
Evidence of pharmaceu4cals In our waterways
April 15, 2011 6
• 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 produc3on. The chemicals include human and veterinary drugs (including an3bio3cs), natural and synthe3c hormones, detergent metabolites, plas3cizers, insec3cides, and fire retardants. One or more of these chemicals were found in 80 percent of the streams sampled”
• Ecological impacts remain unknown • Observed impacts:
– Abnormali&es – Disrupts reproduc&ve systems/risk of
ex&nc&on • Baylor University researchers found
residues human medica&ons in fish. Include an&histamines, high blood pressure medica&on& an&-‐depressants
Environmental Impacts
April 15, 2011 7
"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."
• Largely unknown • Effects of chronic exposure
to low-‐levels of contamina&on underexplored in toxicology
Impacts on Human Health
April 15, 2011 8
• Drugs disposed of in the trash s&ll are released into the environment through the runoff from landfills known as “leachate”
What’s wrong with the trash?
April 15, 2011 9
Clear & Consistent Message
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January 24, 2011
• Prescrip&on Drug Abuse is “the fastest growing drug problem” according to the Obama administra&on
• 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 rela&ves
2. Drug Diversion Concerns
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Drug-‐Induced Deaths Second Only to Motor Vehicle Fatali4es, 1999–2007
Source: Na&onal Center for Health Sta&s&cs, Centers for Disease Control and Preven&on. Na&onal Vital Sta&s&cs Reports Deaths: Final Data for the years 1999 to 2007 (2001 to 2010).
Drug-‐induced deaths
Motor vehicle fatali4es
Suicides
Homicides
Gunshot deaths
Uninten4onal Drug Overdose Deaths United States, 1970-‐2007
Source: Centers for Disease Control and Preven&on. Uninten3onal Drug Poisoning in the United States (July 2010).
In 2007, there were 9.18 deaths per 100,000 popula8on due to uninten8onal drug overdose, based on 27,658 deaths.
• Storing leeover/expired medica&ons in the home increases the risk of accidental poisoning and/or taking the wrong medica&on
• Children, the elderly
and pets are par4cuarly vulnerable
Safety Concerns
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Need for safe disposal op4ons
© Product Stewardship Institute – February 25, 2011
• collec&on programs opera&ng around the country:
• Household hazardous waste facili&es • Pharmacies • Police sta&ons • One-‐day collec&on events
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Drug Take–Back Legisla4on in the U.S. 2009 -‐2011
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EPR for Pharmaceu4cals – Legisla4on in the U.S. 2009 -‐2011
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• “study bills” in CA, VT, RI
• other take-back legislation in a dozen
states • potential federal bill
Poten4al Roles in EPR: Pharmaceu4cals
• Mandated • Manufacturers (“pharma”) develop and implement take-‐back
program – Would choose combina&on 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 – Educa&on & outreach
• Retail pharmacies could serve as collec&on sites • Consumers get informa&on about what to do with leeover drugs
& dispose accordingly (no, this part isn’t easy!) 18
– Mandatory Programs: • Bri&sh Columbia
– Established in 2000 – more than 97.5% of all pharmacies are par&cipa&ng in the program (voluntarily)
– pa&ents have access to over 1080 collec&on loca&ons
• Manitoba – Established in February 2010
Post Consumer Pharmaceu4cal Stewardship Associa4on -‐ Canada
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1. Abbom Laboratories Limited 2. Abraxis BioScience 3. Actelion Pharmaceu&cals Canada Inc. 4. Advantage CKN 5. Afexa Life Sciences Inc. 6. Alcon Canada 7. Amgen Canada Inc. 8. Amway Canada 9. Apotex Inc. 10. Ashbury Biologicals Inc. 11. Astellas Pharma 12. AstraZeneca Canada Inc. 13. Au Naturel Inc. 14. Axcan Pharma Inc. 15. Bayer Inc. 16. Baxter Canada 17. Bioforce Canada 18. Biogen Idec Canada Inc. 19. Biovail Pharmaceu&cals Canada 20. Boehringer Ingelheim Canada Ltd. 21. Boiron 22. Bristol-‐Myers Squibb Pharmaceu&cal Group 23. Canada Safeway Ltd. 24. Chamem (Canada) Inc. 25. Church & Dwight Canada 26. Cobalt Pharmaceu&cals Inc. 27. Combe Incorporated 28. Costco 29. Cytex Pharmaceu&cal Inc. 30. Eli Lilly Canada Inc. 31. EMD-‐Serono Canada Inc 32. Enzyma&c Therapy 33. Ferring Inc. 34. Gaia Garden Herbal Inc. 35. Galderma Ltd 36. General Nutri&on Centres Canada 37. GlaxoSmithKline Consumer Healthcare 38. GlaxoSmithKline Inc. 39. Graceway Pharmaceu&cals 40. Helix BioPharma Corp. 41. Herbalife of Canada
42. Holista Health Canada 43. Hospira Healthcare Corpora&on 44. Hudson’s Bay Company 45. Indigene Pharma Inc. 46. Ins&tut Rosell 47. Jamieson Laboratories Ltd. 48. Janssen-‐Ortho Inc. 49. Johnson & Johnson Inc. 50. Katz Group Canada Ltd 51. King Pharmaceu&cals 52. Kripps Pharmacy 53. Laboratoire RIVA Inc. 54. Leo Pharma Inc. 55. Loblaw Companies Ltd 56. London Drugs Limited 57. Lundbeck Canada Inc. 58. Mead Johnson Nutri&onals 59. Mentholatum Co. of Canada Ltd. 60. Merck Frosst Canada & Co. 61. Mylan Canada 62. Natural Factors Nutri&onal Products Ltd. 63. Nature's Sunshine Products 64. Novar&s Consumer Health Canada Inc. 65. Novar&s Pharma Canada Inc. 66. Novo Nordisk Canada Inc 67. Novopharm Ltd. / Teva Neuroscience 68. Nu-‐Pharm Inc 69. Nucro-‐Technics Incorporated 70. Nycomed Canada Inc. 71. Odan Laboratories 72. Omega Alpha Pharmaceu&cals 73. Omega Laboratories 74. Organika Health Products Inc. 75. Overwaitea Food Group Ltd Partnership 76. Paladin Labs Inc. 77. Patheon Inc. 78. Peoples Drug Mart 79. Pfizer Canada Inc 80. Pharmasave 81. Pharmascience Inc. 82. PharmEng Technology Inc.
83. Pla&num Naturals 84. Procter & Gamble Inc. 85. Proctor & Gamble Pharmaceu&cals Canada Inc 86. ProMedics Nutraceu&cal Ltd 87. Purdue Pharma 88. Ranbaxy Pharmaceu&cals Canada Inc. 89. Ra&opharm 90. Rivex Pharma Inc. 91. Roche Canada 92. Ropack Inc. 93. Sanofi-‐Aven&s Canada Inc. 94. Sandoz Canada 95. Schering Canada Inc. 96. Seaford Pharmaceu&cals 97. Sepracor Pharmaceu&cals Inc. 98. Servier Canada Inc. 99. Shaklee Canada Inc. 100. Shire Canada Inc. 101. Shoppers Drug Mart, Pharmaprix 102. SISU Inc. 103. Solvay Pharma Inc. 104. S&efel Canada Inc. 105. Swiss Herbal Remedies Ltd. 106. Taro Pharmaceu&cals Inc. 107. Tianshi Health Products 108. Trophic Canada 109. UniPHARM Wholesale Drugs 110. USANA Canada Co. 111. Valeant Canada Limited 112. Vita Health Products Inc. 113. Wal-‐Mart Pharmacy 114. Wellspring Pharmaceu&cals 115. Westcoast Naturals 116. WN Pharmaceu&cals Ltd. 117. Wyeth Consumer Healthcare Inc. 118. Wyeth -‐ Canada
Companies Participating in PCPSA
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• 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
Par4cipa4ng Companies – A Few Examples
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Preven8ng Pharmaceu8cal Pollu8on 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
Ginece Vanasse, Post Consumer Pharmaceu3cal Stewardship Associa3on
Upcoming Webinars
Contact
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Sierra Fletcher PSI Director of Policy & Programs
617-‐236-‐4886 [email protected]
www.productstewardship.us
Iowa’s medica8on disposal program – Update April 2011
Background • 2009 & 2010 Iowa state legisla&on
– Funding $150,000
• Joint venture between: – Iowa Board of Pharmacy – Iowa Pharmacy Associa&on (IPA) – 400+ community pharmacies – 20+ statewide partnering organiza&ons
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 > 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 incinera&on – Witnessed by law enforcement – Systems and envelopes sealed up to and during incinera&on
Using the TakeAway™ Program • Gather all unwanted and expired medica&ons
– Leave medica&ons in vials and packaging – Do NOT include controlled substances
• Bring to a par&cipa&ng pharmacy (www.iarx.org/takeaway) – TakeAway system kept behind the counter* – Personal informa&on remains confiden&al
TakeAway™ Program in Iowa • Every Iowa community pharmacy eligible
– 414 pharmacies in all 99 coun&es par&cipa&ng
• Par&cipa&ng pharmacies receive: – TakeAway systems** – Customizable marke&ng materials – Business plan for sustaining the program
Since the launch… • 309 pharmacies on Nov 1; >100 joined ‘post-‐launch’ • Successful public educa&on/media campaign(s)
– Pharmacy driven – Outside-‐In – Earth Week/Spring Cleaning 2010 – Public Rela&ons 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 medica&ons incinerated (tared weight) – 15,840 lbs of returned medica&ons collected by pharmacies**
• Partner with NCPA – na&onal TakeAway ini&a&ve www.disposemymeds.org
• Seeking another year of Legisla&ve funding or sustainable funding from other source(s)
Iowa’s medica3on disposal program u3lizing community pharmacies www.iarx.org/takeaway
Kate Gainer, PharmD Vice President, Professional Affairs Iowa Pharmacy Association [email protected]
www.iarx.org/takeaway
