Preventing Pharmaceutical Pollution and Diversion
Kate Hagemann & Sierra Fletcher
Product Stewardship Institute
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Who is the Product Stewardship Institute?
 Non-profit founded in 2000
 Membership
 47 States
 200+ Local governments
 70+ Corporate,
Organizational, Academic
& Non-U.S. Government
Partners
 Board of Directors: 7 states,
4 local agencies
• Multi-stakeholder product
stewardship network
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The Problem: Waste Pharmaceuticals
1. Environmental Concerns
2. Drug Diversion concerns
3. Public Safety Concerns
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1. Environmental Concerns
• Effects in the environment:
– Endocrine disruptors
– Antibiotic resistance
• Pharmaceuticals enter the
environment via a number of
channels
– Agricultural run-off
– Human excretion
– Improper disposal
• Current waste water treatment
plants cannot remove
pharmaceutical compounds
April 15, 2011
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Evidence of pharmaceuticals In our waterways
• Minnesota Pollution Control Agency (2011)
• USGS (June 2002)
•“a broad range of chemicals found in
residential, industrial, and agricultural
wastewaters commonly occurs in mixtures at
low concentrations downstream from areas of
intense urbanization and animal production.
The chemicals include human and veterinary
drugs (including antibiotics), natural and
synthetic hormones, detergent metabolites,
plasticizers, insecticides, and fire retardants.
One or more of these chemicals were found in
80 percent of the streams sampled”
April 15, 2011
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Environmental Impacts
• Ecological impacts remain unknown
• Observed impacts:
– Abnormalities
– Disrupts reproductive systems/risk of
extinction
• Baylor University researchers found
residues human medications in fish.
Include antihistamines, high blood
pressure medication& anti-depressants
"These results demonstrate the increasing need to consider bioaccumulation of emerging
contaminants in the environment," said Dr. Kevin Chambliss, an assistant professor of
chemistry at Baylor, who is a co-lead investigator on the project. "This research proves fish
are being exposed to multiple compounds in our waterways."
April 15, 2011
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Impacts on Human Health
• Largely unknown
• Effects of chronic exposure
to low-levels of
contamination
underexplored in toxicology
April 15, 2011
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What’s wrong with the trash?
• Drugs disposed of in the
trash still are released into
the environment through
the runoff from landfills
known as “leachate”
April 15, 2011
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Clear & Consistent Message
January 24, 2011
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2. Drug Diversion Concerns
• Prescription Drug Abuse is “the
fastest growing drug problem”
according to the Obama
administration
• 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 prescription drug
abusers obtained their drugs from
friends or relatives
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Drug-Induced Deaths Second Only to Motor Vehicle
Fatalities, 1999–2007
Motor vehicle fatalities
Drug-induced
deaths
Suicides
Gunshot deaths
Homicides
Source: National Center for Health Statistics, Centers for Disease Control and Prevention. National Vital
Statistics Reports Deaths: Final Data for the years 1999 to 2007 (2001 to 2010).
Unintentional Drug Overdose Deaths
United States, 1970-2007
In 2007, there were 9.18 deaths per 100,000 population due to
unintentional drug overdose, based on 27,658 deaths.
Source: Centers for Disease Control and Prevention. Unintentional Drug Poisoning in the United States (July 2010).
Safety Concerns
• Storing leftover/expired
medications in the
home increases the risk
of accidental poisoning
and/or taking the
wrong medication
• Children, the elderly
and pets are
particuarly vulnerable
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Need for safe disposal options
• collection programs operating
around the country:
•Household hazardous waste
facilities
•Pharmacies
•Police stations
•One-day collection events
© Product Stewardship Institute – February 25, 2011
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Drug Take–Back
Legislation in the U.S. 2009 -2011
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EPR for Pharmaceuticals –
Legislation in the U.S. 2009 -2011
• “study bills” in CA,
VT, RI
• other take-back
legislation in a dozen
states
• potential federal bill
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Potential Roles in EPR:
Pharmaceuticals
• Mandated
• Manufacturers (“pharma”) develop and implement take-back
program
– Would choose combination of available mechanisms (i.e., law
enforcement involved as long as that is still required)
– Meet program minimum requirements/goals
• Government oversees program & enforces against noncompliant manufacturers
– Education & outreach
• Retail pharmacies could serve as collection sites
• Consumers get information about what to do with leftover drugs
& dispose accordingly (no, this part isn’t easy!)
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Post Consumer Pharmaceutical
Stewardship Association - Canada
– Mandatory Programs:
• British Columbia
– Established in 2000
– more than 97.5% of all pharmacies are participating in the
program (voluntarily)
– patients have access to over 1080 collection locations
• Manitoba
– Established in February 2010
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Companies Participating in PCPSA
1.
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3.
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5.
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35.
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37.
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40.
Abbott Laboratories Limited
Abraxis BioScience
Actelion Pharmaceuticals Canada Inc.
Advantage CKN
Afexa Life Sciences Inc.
Alcon Canada
Amgen Canada Inc.
Amway Canada
Apotex Inc.
Ashbury Biologicals Inc.
Astellas Pharma
AstraZeneca Canada Inc.
Au Naturel Inc.
Axcan Pharma Inc.
Bayer Inc.
Baxter Canada
Bioforce Canada
Biogen Idec Canada Inc.
Biovail Pharmaceuticals Canada
Boehringer Ingelheim Canada Ltd.
Boiron
Bristol-Myers Squibb Pharmaceutical Group
Canada Safeway Ltd.
Chattem (Canada) Inc.
Church & Dwight Canada
Cobalt Pharmaceuticals Inc.
Combe Incorporated
Costco
Cytex Pharmaceutical Inc.
Eli Lilly Canada Inc.
EMD-Serono Canada Inc
Enzymatic Therapy
Ferring Inc.
Gaia Garden Herbal Inc.
Galderma Ltd
General Nutrition Centres Canada
GlaxoSmithKline Consumer Healthcare
GlaxoSmithKline Inc.
Graceway Pharmaceuticals
Helix BioPharma Corp.
41.
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79.
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Herbalife of Canada
Holista Health Canada
Hospira Healthcare Corporation
Hudson’s Bay Company
Indigene Pharma Inc.
Institut Rosell
Jamieson Laboratories Ltd.
Janssen-Ortho Inc.
Johnson & Johnson Inc.
Katz Group Canada Ltd
King Pharmaceuticals
Kripps Pharmacy
Laboratoire RIVA Inc.
Leo Pharma Inc.
Loblaw Companies Ltd
London Drugs Limited
Lundbeck Canada Inc.
Mead Johnson Nutritionals
Mentholatum Co. of Canada Ltd.
Merck Frosst Canada & Co.
Mylan Canada
Natural Factors Nutritional Products Ltd.
Nature's Sunshine Products
Novartis Consumer Health Canada Inc.
Novartis Pharma Canada Inc.
Novo Nordisk Canada Inc
Novopharm Ltd. / Teva Neuroscience
Nu-Pharm Inc
Nucro-Technics Incorporated
Nycomed Canada Inc.
Odan Laboratories
Omega Alpha Pharmaceuticals
Omega Laboratories
Organika Health Products Inc.
Overwaitea Food Group Ltd Partnership
Paladin Labs Inc.
Patheon Inc.
Peoples Drug Mart
Pfizer Canada Inc
Pharmasave
81. Pharmascience Inc.
82. PharmEng Technology Inc.
83. Platinum Naturals
84. Procter & Gamble Inc.
85. Proctor & Gamble Pharmaceuticals Canada Inc
86. ProMedics Nutraceutical Ltd
87. Purdue Pharma
88. Ranbaxy Pharmaceuticals Canada Inc.
89. Ratiopharm
90. Rivex Pharma Inc.
91. Roche Canada
92. Ropack Inc.
93. Sanofi-Aventis Canada Inc.
94. Sandoz Canada
95. Schering Canada Inc.
96. Seaford Pharmaceuticals
97. Sepracor Pharmaceuticals 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. Stiefel Canada Inc.
105. Swiss Herbal Remedies Ltd.
106. Taro Pharmaceuticals 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 Pharmaceuticals
115. Westcoast Naturals
116. WN Pharmaceuticals Ltd.
117. Wyeth Consumer Healthcare Inc.
118. Wyeth - Canada
Participating Companies –
A Few Examples
• Abbott 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
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Upcoming Webinars
Preventing Pharmaceutical Pollution and
Diversion - Spotlight on Iowa
Again: May 3rd at 2-3 Central
Learning from Canada: Post Consumer
Pharmaceutical Stewardship Association
Thursday May 5th 4-5pm Eastern/ 3-4pm Central
Ginette Vanasse, Post Consumer Pharmaceutical Stewardship Association
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Contact
Sierra Fletcher
PSI Director of Policy & Programs
617-236-4886
sierra@productstewardship.us
www.productstewardship.us
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Iowa’s medication disposal program – Update April 2011
Background
• 2009 & 2010 Iowa state legislation
– Funding $150,000
• Joint venture between:
–
–
–
–
Iowa Board of Pharmacy
Iowa Pharmacy Association (IPA)
400+ community pharmacies
20+ statewide partnering organizations
Iowa’s Solution
• IPA partnered with Sharps Compliance, Inc.
– Located near Houston, TX
– Specialize in medical and pharmaceutical waste
disposal for 15 years
• TakeAway™ Environmental Return System
– Turn-key pharmaceutical waste disposal program
– Utilize Iowa community pharmacies
TakeAway™ Program
• TakeAway systems
– 10 and 20 gallons
– Plastic-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 incineration
– Witnessed by law enforcement
– Systems and envelopes sealed up to and during
incineration
Using the TakeAway™ Program
• Gather all unwanted and expired medications
– Leave medications in vials and packaging
– Do NOT include controlled substances
• Bring to a participating pharmacy
(www.iarx.org/takeaway)
– TakeAway system kept behind the counter*
– Personal information remains confidential
TakeAway™ Program in Iowa
• Every Iowa community pharmacy eligible
– 414 pharmacies in all 99 counties participating
• Participating pharmacies receive:
– TakeAway systems**
– Customizable marketing materials
– Business plan for sustaining the program
Since the launch…
• 309 pharmacies on Nov 1; >100 joined ‘post-launch’
• Successful public education/media campaign(s)
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–
–
–
Pharmacy driven
Outside-In
Earth Week/Spring Cleaning 2010
Public Relations 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 medications incinerated (tared weight)
– 15,840 lbs of returned medications collected by pharmacies**
• Partner with NCPA – national TakeAway initiative
www.disposemymeds.org
• Seeking another year of Legislative funding or
sustainable funding from other source(s)
Iowa’s medication disposal program utilizing community pharmacies
www.iarx.org/takeaway
Kate Gainer, PharmD
Vice President, Professional Affairs
Iowa Pharmacy Association
kgainer@iarx.org
www.iarx.org/takeaway