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pharmaceuticals stewardship
introduction and updates
1
vivian futran fuhrmanproduct stewardship institute
march 29, 2016
who is theproduct stewardship
institute?
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product stewardship
manufacturer (“producer”)
responsibility
other government regulatory programs
voluntary programs
mandatory programs
(e.g., EPR)
product stewardship vs. EPR
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92* EPR laws in 33 states
9 11 13 15 24
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43
*not including 10 container deposit laws
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an update on
pharmaceuticals EPR
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PSI’s work on
pharmaceuticals
2008
2010
2014
2015
stakeholder dialogue meetings
secure and responsible
drug disposal
act passes
DEA’s final rule
briefing document
2005
identified the problem & need for a national solution
Source: Cost estimation from King County, WA, 2012
alameda supreme
court case
need for sustainable
funding
accidental poisonings drug abusesafety
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aquatic impactswater quality
environment
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PSI’s work on
pharmaceuticals
2008
2010
2014
2015
stakeholder dialogue meetings
secure and responsible
drug disposal
act passes
DEA’s final rule
briefing document
2005
identified the problem & need for a national solution
alameda supreme
court case
need for sustainable
funding
Source: Cost estimation from King County, WA, 2012
US support for
drug take-back• drug enforcement administration (DEA)
• six national prescription drug take-back days since 2010
• office of national drug control policy (ONDCP)• part of its national drug control strategy
• food and drug administration (FDA)• developed guidelines with ONDCP for drug disposal
• environmental protection agency (EPA)• promotes consumer use of take-back programs
• 43 states• agency websites provide information either on their own state
programs and/or federal DEA take-back days
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PSI’s work on
pharmaceuticals
2008
2010
2014
2015
stakeholder dialogue meetings
secure and responsible
drug disposal
act passes
DEA’s final rule
briefing document
2005
identified the problem & need for a national solution
alameda supreme
court case
need for sustainable
funding
Source: Cost estimation from King County, WA, 2012
what does the DEA rule allow?
• flexibility in collection of controlled substances• mail-back programs by DEA-authorized entities• continues to allow take-back events by law
enforcement agencies
increase in potential collectors will lead to additional permanent collection sites
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february 9, 2016: walgreens announced safe medication disposal program
500 retail store locationsat least 40 states and washington DC
the convenience factor
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PSI’s work on
pharmaceuticals
2008
2010
2014
2015
stakeholder dialogue meetings
secure and responsible
drug disposal
act passes
DEA’s final rule
briefing document
2005
identified the problem & need for a national solution
alameda supreme
court case
need for sustainable
funding
Source: Cost estimation from King County, WA, 2012
14
15
PSI’s work on
pharmaceuticals
2008
2010
2014
2015
stakeholder dialogue meetings
secure and responsible
drug disposal
act passes
DEA’s final rule
briefing document
need for sustainable
funding
2005
identified the problem & need for a national solution
avg program cost $3.50 per capita
alameda supreme
court case
Source: Cost estimation from King County, WA, 2012
key elements of a model epr bill
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• product scope• responsible party• stewardship organization•funding mechanism•convenience standards•preemption
pharmaceuticals EPR programsin canada and europe
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british columbiaestablished in 1996
manitobaestablished in 2011
franceestablished in 1993
hungaryestablished in 2005
portugalestablished in 2001
spainestablished in 2003
canada: 4 programseurope: 15 programs
Source: Health Products Stewardship Association, 2015; Health Care Without Harm Report, 2013
legislative activity at local, state, & federal
levels
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pharmaceuticals EPRin the united states
U.S. EPR laws & legislation forpharmaceuticals
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signed by Governor Baker on march 14
passed unanimouslyin house and senate
massachusetts’substance abuse prevention law
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take-back provision includes:
1. drugs that will be collected
2. responsible parties
3. responsibilities of program
4. agency responsible for oversight
massachusetts’substance abuse prevention law
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massachusetts’substance abuse prevention law
1. collection system for convenient access
2. mandatory stewardship program with no opt-out
3. evaluation before termination
dph regulations will help ensure:
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nationalpharmaceutical stewardship act (PSA)
vivian futran fuhrmanassociate for policy & programs
(617) 236-4771vivian@productstewardship.us
www.productstewardship.us
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thank you!
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