2016 R3 Vivian Futran Fuhrman
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pharmaceuticals stewardship introduction and updates 1 vivian futran fuhrman product stewardship institute march 29, 2016
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Transcript of 2016 R3 Vivian Futran Fuhrman
pharmaceuticals stewardship
introduction and updates
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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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*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
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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
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) [email protected]
www.productstewardship.us
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thank you!
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