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Pharmaceutical Waste Stewardship Summit
June 11, 2013 | Milwaukee, WI
1
Thank You to our
Meeting Sponsors!
2
Who is the Product
Stewardship Institute?
3
PSI is a 501 c(3) nonprofit founded in 2000.
Memberships • 47 States • 230 Local gov’ts
Partnerships (95+) • Companies • Organizations • Universities • Non-US gov’ts
Board of Directors • 7 states • 4 local agencies
Advisory Council • Multi-stakeholder (14 members)
Also:
PSI sits on the Global Product Stewardship Council Board of Directors
4 4
Agenda
Great Lakes Pharmaceutical Stewardship Project Update (9:15am – 10:00am)
Regional Roundtable on Drug Take-Back Programs in the Great Lakes (10:00am – 11:00am)
Break (11:00am – 11:15am)
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Agenda
Examining Producer Responsibility Approaches from the Local, State, and Federal Levels (11:15am – 12:30pm)
Lunch (12:30pm – 1:30pm)
Stakeholder Roles in Implementing Take-Back Programs and Impact of the Proposed DEA Rule (1:30pm – 3:15pm)
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Agenda Call to Action and Next Steps for the Great Lakes (3:30pm – 4:30pm)
….Then the fun begins!
River Cruise Reception
8
Great Lakes Pharmaceutical Stewardship
Project Update
9 9
Great Lakes Restoration Initiative: Pharmaceutical Waste
2013 Pharmaceutical Waste Stewardship Summit
June 11, 2013 – Milwaukee, WI
Steve Brachman, Waste Reduction Specialist, Project Leader UW Extension Solid & Hazardous Waste Education Center
Barb Bickford, Medical Waste Coordinator
DNR Waste and Materials Management Program
Milwaukee Journal Sentinel, 9-23-2011 Wisconsin Crime Prevention
Practitioners Association
Public safety concerns
• Documented effects on aquatic life
• Uncertain effects on humans
• Measurable amounts in our surface waters
Environmental concerns
http://ngm.nationalgeographic.com/2010/04/pollution/fish-pharm
Effects on Great Lakes
“Emerging Contaminant Threats and the Great Lakes:
Existing science, estimating relative risk and determining policies”
http://www.greatlakes.org/emerging
Prevent toxic discharges to the Great Lakes and improve water quality and habitat
GLRI Project
• Mail back program
• Working groups
• Regional dialogues
• Model public policies
• Public awareness
• Collaboration
Mail Back Program
Mail back program counties
Pharmaceutical Waste Working Group
Mission: to reduce pharmaceutical waste
and its impacts on Wisconsin’s
environment and communities
SCAODA Recommendations / PWWG Sub-Groups
• Education
• Collection/donation
• Destruction
• Waste reduction
• Funding
• Removal after
death
Regional Dialogues
Model Public Policies
• Protect public health
• Minimize environmental impacts
• Fund collections sustainably
• Reduce waste
Consensus document -- Key Elements:
“Key Elements of Pharmaceutical Collection and Disposal Programs: A Vision for the Great Lakes Region”
http://www.productstewardship.us/displaycommon.cfm?an=1&subarticlenbr=182
Model legislation
Public Awareness
Collaboration
DHS/SCAODA
DATCP
Pharmacies
Sea Grant
Veterinarians
Law enforcement
Community coalitions
Concerned citizens
Local governments
Waste vendors
Educators
Environmentalists
Health care facilities
Legislators
Wastewater treatment plants Etc.
Lessons Learned from GLRI
• DEA regulations are still impeding things
• Destruction is an ongoing challenge
• Public safety trumps the environment
• Broad public support exists
• Legislation will not be easy
Future Directions
• Expand destruction options
• Raise consumer awareness
• Centralize data
• Reduce waste
• Expand coalitions
• Create new funding options
Resources
• Pharma blog (GLRI project website) http://fyi.uwex.edu/pharma/
• Pharmaceutical Waste Reduction http://www.uwm.edu/shwec/pharmaceuticalwaste/
• Product Stewardship Institute http://www.productstewardship.us
• DNR Waste Program pharmaceuticals http://dnr.wi.gov search for “health care waste”
Contacts
• Steve Brachman
Waste Reduction Specialist, UW Extension
[email protected] 414-227-3160
• Barb Bickford
Medical Waste Coordinator, WI Dept. Natural Resources
[email protected] 608-267-3548
Pharmaceuticals Stewardship:
National and Regional Context
30
Support for Drug Take-Back
• Office of National Drug Control Policy (ONDCP) • Part of White House National Drug Control Strategy
• US Drug Enforcement Administration (DEA) • Six National Prescription Drug Take-Back Days since 2010
• US Food and Drug Administration (FDA) • Developed guidelines with ONDCP for drug disposal
• US 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
31
PSI Multi-Stakeholder Dialogue for Pharmaceuticals – 2008
• National dialogue meetings (Sacramento and Wash.
DC) • All stakeholders, some pharmaceutical companies • Agreements (Source reduction, No flushing, Law/Reg
changes)
32
PSI Multi-Stakeholder Dialogue for Pharmaceuticals – 2008
• Sample of items discussed (stakeholder perspectives): – Identified Problem, Goals, Barriers, and Solutions – Data needs (quantities, costs, etc.) – Collection options (pharmacy, law enforcement, mail back,
etc.) – Need for consistent messaging on problem and disposal – US EPA research on aquatic impacts – Regulatory issues related to the collection, transport, and
disposal of pharmaceutical waste from households.
• Formed 4 Workgroups for ongoing involvement
33
Great Lakes Restoration
Initiative Developed pharmaceuticals stewardship
model program Building support for producer
responsibility approach and other policies Enhancing existing voluntary take-back
initiatives Improving messaging & outreach
strategies Drug Take Back Network: website for
locating collection sites, other data
34
PSI and UW-Ext found that only 2% of household pharmaceutical waste is currently collected in the state, despite extensive take-back initiatives
Wisconsin Report for Department of Natural Resources
Source: UW-EXT and PSI
35
Regional Roundtable
on Drug Take-Back Programs in the Great Lakes
36 36
Brief Presentations with State Officials from the Great Lakes
• Solid Waste Agency of Lake County, representing IL (Walter Willis)
• IN Department of the Environment (Lisa Paine Perez)
• MN Pollution Control Agency (Jennifer Volkman)
• OH Environmental Protection Agency (Deb Hoffman)
• WI Department of Natural Resources (Barb Bickford)
• MI Department of Environmental Quality (Chad Rogers) – remote
• NYS Department of Environmental Conservation (Scott Stoner) – remote
37
(3 to 5 minutes each)
State Overview – Key Topics
• The nature of pharmaceutical take-back collections in each state
• Key barriers and challenges
• Opportunities to increase support drug take-back in the state and the Great Lakes region
38
Questions to Consider
• Similarities? • Differences? • Examples to follow? • Other important items?
39
Illinois Collection Data IEPA Program
◦ Approximately 24 collection partners (health depts., local pharmacies, police depts.)
◦ 4 Permanent HHW sites
◦ 10 One day events
◦ Collected 149 drums in 2010, disposal cost $74,000
Save A Star Foundation
◦ 19 Collection boxes at municipal police stations
◦ Most drugs taken by police to DEA collection days, others to Covanta WTE plant in Indianapolis
P2D2 Program (high school student involvement)
◦ 100 locations in 34 IL counties
Last DEA One Day Event in IL
◦ Collected 11.5 tons of material
Key Barriers
IEPA funding is limited, based on LF surcharge fees, not accepting new collection partners since 2009
Local police would engage more if costs could be covered for officer time, and collection containers
Inability to effectively message where collection sites are
◦ Lack of central database, website
◦ Police reluctant to advertise sites beyond municipal boundaries
What More Can be Done
Public Act 97-0545 ◦ Created P2D2 Fund, funding source is $20 fine
for drug related offenses
◦ Money goes into dedicated fund, grants to be provided to local law enforcement to help cover program costs
◦ Fund is not growing as expected, only several thousand dollars, therefore no grant program yet
◦ Amend law to increase fines??
SWALCO and PSI approached drug manufacturers in Lake County, IL in early 2012 with little success
Pharmaceutical Waste Stewardship Summit 2013:
Indiana Unwanted Meds Program Summary
By Lisa Paine Perez
Indiana Department of Environmental Management Office of Pollution Prevention & Technical Assistance
Milwaukee, WI
June 11, 2013
Basic Program Description
– What is it/ How does IN characterize it? How extensive: how many counties, people, programs, pounds of collection, etc.
• Indiana is still in the early stages of developing a state-wide pharmaceutical stewardship program.
• On September 17, 2013 the Attorney General office created a Prescription Drug Abuse Task Force to combat the epidemic of drug abuse and deaths in Indiana.
• Current “Programs”: Sheriff’s offices, Police Departments, Solid Waste Management Districts, various participating pharmacies offer either drop-off boxes or direct drop-off for controlled substances as well as non-controlled. Very few offer mail-in.
• Potential future Program: Proposed Pilot study with IU Health Hospital Pharmacies providing drop boxes for controlled and non-controlled substances to be transported by MedAssure and ultimately disposed of at Covanta Energy, a waste to energy facility.
Key Barriers & How Overcome
– What are the state’s key barriers and how have you overcome them?
• State Pharmacy Board Rules originally not in place, but now are promulgated.
• The lack of DEA regulations are a huge barrier. When the DEA released their proposed rules for public comment in the fall of 2012, the Indiana Rx Drug Abuse Task Force submitted comments and recommendations
• $$$, Transportation, Legislation, Data collection, Mail-in vs Drop Box vs Pharmaceutical Take Back
• Covanta requires law enforcement on site at point of delivery/destruction
Education & Outreach
– What is offered throughout the state?
• AG office online & RxTF, IDEM online and press releases about Marsh Pharmacy annual collection event, Health Dept, Pharmacies – MARSH annual event, IPA
• Once the Task Force launches a take back pilot program with pharmacies in state, it will promote the take back sites through educational messages and material.
Improvements
– What more could be done to improve or advance pharmaceutical stewardship in your state?
• State-wide drop off program
• Potential manufacturer or distributor tax breaks
• Encouraging pharmacies to not advise residents to flush certain medicines due to their high street value (this has potential adverse environmental effects).
• To pass federal legislation that would require pharmaceutical manufacturers to help fund take back programs (i.e. Washington State’s legislative proposal)
Statewide Pharm Collection in MN
0
5000
10000
15000
20000
25000
30000
35000
40000
45000
2007 2008 2009 2010 2011 2012
DEA Events
Perm Sites
Collection Sites as of June 2013
• 128 located at law enforcement
• 15 operated by Health Partners, no CS
• 1 HHW site with quarterly collection (events)
• 17+ Hennepin events; changes annually
• 1 small pharmacy with events
• 5 permitted WTE’s for disposal; potential for 7
• 3M takes confiscated pharms from LE for free
Counties served
Minnesota Program
• Designed to accept controlled substances; law enforcement based.
• MPCA: registers sites; collects data; provides technical assistance (guidance, workshops); permits WTE facilities to accept pharms; conducts sampling of surface waters in MN.
• Introduced PS legislation in 2010; died; JV’d try again in 2014
Ohio The Pharmaceutical Disposal Scene
51
Pharmaceutical collections
• Growing number of sheriff’s office permanent drop-boxes
• 171 locations in 32 (of 88) counties
• One of the first in Ohio : Lake County (near Cleveland). Smallest county, geographically, but 8th in population. They have 7 police departments with 24/7 drop-boxes. They collected 4,000 lbs in 2012.
• Ohio DEA Collection, 4/27/13: 32,369 lbs
52
Key Barriers
• DEA Rules! (not in a good way)
What Ohio is Doing
• Ohio EPA – guidance document
• Ohio Attorney General – drop boxes provided (66 so far)
53
What can we do?
• Funding (Grants)
• Product Stewardship legislation (haven’t even gotten an e-waste bill passed…)
54
2013 recipient of the
Rebecca Wallace Memorial Award
A Special Congratulations to
Barb Bickford, Wisconsin DNR Medical Waste
Coordinator
55
Wisconsin Typical collection programs
• Voluntarily run by law enforcement
• Available in most counties
• Increasingly open year round
• Funded by tax revenues and grants
56
Nature of collections
57
13.1 million lb/yr
4.4 million lb/yr
(1/3 of sold)
93,500 lb/2011
(2% of wasted)
Sold in
Wisconsin
Wasted in
Wisconsin
Collected in
Wisconsin
Amounts collected
58
Challenges
Data collection
Awareness Destruction
Funding
Regulations
59
What do we know? • We don’t know the extent of take-back programs in
Michigan.
• We do know; – Several communities detect pharmaceuticals in their source and waste
water.
– The DEA works with 197 sites to conduct their collection events. • Collected 19,845 lbs. in 2012
– The Yellow Jugs Old Drugs organization works with 252 Pharmacies. • Collected 23,087 lbs. between September 2012 and May 2013
• Collected nearly 33 tons since 2009
– Many counties hold periodical collection days and several have ongoing drop box programs but we don’t have a good handle on who is doing this or the quantities collected.
What Michigan is Doing • We partnered to produce a pharmaceutical waste
best management guidebook for healthcare professionals.
• We are currently administering grants to five different organizations to support collections programs, marketing and outreach.
• We are preparing to award additional grant money to other organizations.
• We are engaging stakeholders to discuss product stewardship approaches to managing unused drugs.
Barriers
• Education
• Access to Collection Resources
• Stakeholder Participation
• DEA regulations
• State Waste Rules
NYS Department of Environmental Conservation
Reducing Flushing of Drugs
in New York State
June 11, 2013
Scott J. Stoner, Chair
Pharmaceuticals Work Group
NYS Dept. of Environmental Conservation
518-402-8193
www.dontflushyourdrugs.net
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NYS Department of Environmental Conservation
NYS - Collection of Drugs • DEC promotes and facilitates collections
• Created procedures (online) on how to conduct
• Promote DEA’s national collection events
• Collections include HHW days, NYC Sanitation, drop boxes in police stations, and collections at Sheriff’s Offices, pharmacies, etc.
• Over 84,000 pounds collected in 2012 in NYS
• Pilot program at LTCF in NY City Watershed – Pickup by Law Enforcement
64
NYS Department of Environmental Conservation
Barriers and Solutions
• Insufficient number of collections
• Need Pharmacy-based collection boxes (DEA new regs)
• Cost of transport to incineration (funding)
• Alternatives to flushing at LTCF (DEA new regs; approval)
Outreach • Don’t Flush Your Drugs campaign
• Website, press releases, posters, flyers, articles, talks,
media interviews
• NYS law requires retailers to post don’t flush notice: Sample
65
NYS Department of Environmental Conservation 66
Facilitated Discussion with State Officials from the Great Lakes
• Solid Waste Agency of Lake County, representing IL (Walter Willis)
• IN Department of the Environment (Lisa Paine Perez)
• MN Pollution Control Agency (Jennifer Volkman)
• OH Environmental Protection Agency (Deb Hoffman)
• WI Department of Natural Resources (Barb Bickford)
• MI Department of Environmental Quality (Chad Rogers) – remote
• NYS Department of Environmental Conservation (Scott Stoner) – remote
67
State Overview – Key Topics
• The nature of pharmaceutical take-back collections in each state
• Key barriers and challenges
• Opportunities to increase support drug take-back in the state and the Great Lakes region
68
Questions to Consider
• Similarities? • Differences? • Examples to follow? • Other important items?
69
Producer responsibility approaches from the local, state, and
federal levels
70 70
Product stewardship vs. EPR Both: Manufacturer responsibility for financing and managing products and packaging
Product Stewardship: • Full Lifecycle • Voluntary or Mandatory
EPR: • Mandatory at End of Life
71
EPR is happening now
in the U.S.
72 72
73 EPR laws in 32 states
(including mattresses, carpet, cell phones, agricultural
pesticide containers, and one “Framework” law)
3 6 8 10 14
24
A look at state EPR laws for multiple products
around the nation
73
…and for pharmaceuticals?
• The only product category with legislatively activity at the local, state, and federal levels
• Unique coalition of key supporters • State and local government officials • Drug abuse prevention advocates • Law enforcement
• Many retail pharmacies • Environmental organizations
• Community groups and other NGOs
74
What does EPR for Pharmaceuticals
really look like?
75
State Level Activity for EPR for Pharmaceuticals
Bills introduced: • California (2013) • Pennsylvania (2012) • Washington (2011) • New York (2011) • Maine (2010) • Maryland (2010) • Minnesota (2010) • Oregon (2009) • Florida (2009)
76
• First federal EPR bill on any product
• Would create National Pharmaceutical Stewardship Organization to implement a national EPR program
• Congresswoman Louise Slaughter (D–NY)
• Plans to reintroduce in 2013 pending final DEA rule
Federal Pharmaceutical
Stewardship Act of 2011
77
New York State introduced two bills in January 2013
• S.642 and A.1584
• Pharmaceutical manufacturers must collect unused and expired drugs from hospitals and residential health care facilities (e.g., nursing homes) for environmentally sound disposal
• Does not cover household pharmaceuticals
78
Pennsylvania’s Pharmaceutical Drug Disposal Act
• HB 1194 introduced April 15, 2013
• Requires drug retailers to establish a system for collecting and disposing of expired and unwanted pharmaceutical drugs at no cost to consumers
• Referred to House Environmental Resources and Energy Committee
79
Alameda County became the first local government in the
U.S. to enact a policy mandating pharmaceutical companies
to design, operate and fund a collection program.
– July 24, 2012
Safe Drug Disposal Ordinance
80
Partial List of Supporters
81 81
Ordinance Needed to Mandate
Producer Responsibility Solution
Mailer (non-controlled only) Pre-paid mailer is provided to consumers
Send meds directly to disposal sites
Works best for elderly, immobile and rural
consumers
82
Disposal Bins Located at convenient designated sites,
including unincorporated areas
Drop off pills only (no containers)
Picked up by integrated waste control and
shipped to disposal site
82
Public Communication Community Organizers
Alameda County Medication Education Disposal Safety Coalition (MEDS)
Alameda County Departments
California Product Stewardship Council (CPSC)
Letters
Petitions
Social Media
Facebook: https://www.facebook.com/AlamedaSafeMeds,
Twitter: http://twitter.com/AlCoSafeMeds
Website: http://www.change.org/petitions/pass-the-safe-medication-disposal-ordinance
Press
Op-Eds
Radio interviews
AP and Reuters wire stories
Clean Water Action Fund
Sierra Club –E-Mail Blasts and Newsletters
Grassroots
Teleosis and Senior Advocacy, Outreach, Education, and Training
83 83
Two Hearings Led to the
Adoption of the Ordinance
84 84
Lawsuit Announced in NYT
Article in the New York Times 12/7/12 quotes complaint:
“The household trash can is a better and safer
alternative, the drug makers say”
Three organizations filed lawsuit:
Pharmaceutical Research and Manufacturers of America
(PhARMA),
General Pharmaceutical Association
Biotechnology Industry Association
Filed in Federal Court claiming violation of the
Commerce Clause of the Constitution
6/20/2013 85 85
2nd Alameda Safe Med Disposal
Conference
Co- Sponsors
86
Statewide Medication Take Back Program
• Modeled after Alameda County’s Ordinance
• Statewide Coverage
•Two year Bill
87
Contact Alameda County
6/20/2013 88
Kamika Dunlap
Policy Assistant
Office of Alameda County Supervisor Nate Miley
(510) 272-3691
Like Alameda County Safe Meds on Facebook
Follow @AlCoSafeMeds on Twitter
88
Producer Responsibility for Meds in California
June 11, 2013
89
CA. Leg/Reg Activity
• CA SB 966 (Simitian) 2007 – Developed “model program” guidelines
– 2010 Report to the legislature encouraged
extended producer responsibility (EPR) legislation
• AB 1442 (Weikowski) 2012 • Amended Med Waste Mgmt Act - Allows common
carrier transport (instead of costly medical waste haulers) of pharma waste
• CA SB 727 (Hannah - Beth Jackson) 2013 – EPR bill for pharmaceuticals
90
SB 966 Report to the Legislature
December 2010 CalRecycle recommends that the Legislature adopt a
combination of two options related to pharmaceutical waste collection programs.
1. Statutory changes to establish clear state roles and responsibilities, provide direction to resolve several implementation challenges, and direct that the Criteria and Procedures for Model Home-Generated Pharmaceutical Waste Collection and Disposal Programs (Model Guidelines) be refined and converted in regulations.
2. Statutory direction to address funding barriers by providing financing through a private sector approach with government oversight, commonly referred to as product stewardship.
http://www.calrecycle.ca.gov/Publications/Documents/General%5C2011008.pdf 91
AB 1442 (Weikowski) 2012:
Removed a Barrier to Collection
1. Amended the Medical Waste Management Act to provide relief from some of the Act’s onerous requirements pertaining to handling waste medications
2. Defines “pharmaceutical waste” which had previously been undefined
1. Exempts from the definition of “pharmaceutical wate” any pharmacetuical that “is being sent” to a properly licensesed “reverse distributor”.
Bill text: http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120AB1442
92
SB 727 – Pharma EPR Bill Senator Hanna-Beth Jackson
• Mirrors Alameda Ordinance
• Statewide coverage
• Two-year bill
• Stakeholder meetings this summer
• Contact Linda Barr at Senator Jackson’s office
916-651-4536
https://www.youtube.com/watch?v=-6eUT8K0akc 93
Don’t Rush to Flush Campaign
• twitter.com/DontRushToFlush
• www.facebook.com/DontRushToFlush
• www.DontRushToFlush.org 94
What is CPSC Doing? Education…
95
Join CPSC
Heidi Sanborn Executive Director [email protected] 916-706-3420
www.CalPSC.org
Connect!
96
Margaret Shield Local Hazardous Waste Management Program in King County
June 11, 2013 – Pharmaceutical Waste Stewardship Summit
Secure Medicine Return
for King County, WA
97
>188,000 pounds
collected since 2006.
98
King County Board of Health
Legislative body that sets county-wide policies and regulations to
protect and promote the health of King County residents.
Subcommittee on Secure Medicine Return
• First meeting July 2013, collected input from stakeholders
during summer through fall of 2012.
• Policy discussions October 2012 through April 2013.
• Public hearing held May 16th on draft legislation.
• Public hearing & potential action scheduled for June 20th.
http://www.kingcounty.gov/healthservices/health/BOH/MedicineTakeback.aspx
Board Chair
Councilmember Joe McDermott
Boardmember
Mayor David Baker
99
Secure Medicine Return Problem Statement
Drug overdose deaths have surpassed car crashes as a
leading cause of preventable death in King County.
Medicines used in the home are the leading cause of
poisonings, especially among children
and seniors.
Medicine take-back programs provide
secure collection and destruction of
unwanted medicines to protect
public health and the environment.
Currently, no sustainable financing for
a medicine take-back system that
meets community needs.
100
Epidemic: Responding to America’s
Prescription Drug Abuse Crisis
2013 National Drug Control Strategy:
1. Education of health providers and the public.
2. Expand prescription monitoring programs.
3. Safe drug disposal – increase return/take-back
and disposal programs.
4. Effective enforcement to address
“pill mills” and “doctor shopping.”
101
Barriers to a Comprehensive Medicine
Take-back System in King County:
• Challenges in collection of controlled
substances – help coming from new DEA draft
regulation! Authorizes take-back by retail pharmacies,
manufacturers, drug distributors, and reverse
distributors.
• Convenience and access – too few drop-off sites;
too much of county unserved.
• Financing – lack of dedicated & adequate funding;
very limited funding for education & promotion.
• Lack of an efficient system – no county-wide
coordination.
102
Product Stewardship Approaches for
Medicine Take-back
Pharmaceutical manufacturers provide
medicine return systems
in B.C., Manitoba, Ontario,
France, Spain & Mexico.
Alameda County, CA has passed a
Safe Drug Disposal Ordinance.
“Product stewardship” is the act of
minimizing health, safety, environmental, and
social impacts, while maximizing economic
benefits of a product and its packaging throughout all
lifecycle stages. 103
Overview of Proposed
Secure Medicine Return Rule & Regulation
Residents bring leftover, expired, and unneeded prescription and
over-the-counter medicines to secure drop boxes in retail
pharmacies or law enforcement offices throughout the county.
If a drop-off site is not available in a specific area then periodic
collection events or prepaid return mailers will be provided.
Collected medicines will be securely handled, transported and
disposed of according to federal & state laws and policies.
Drug producers are required to finance and provide the secure
medicine return system.
Public Health-Seattle & King County provides oversight to ensure
safety and compliance.
104
Overview of Proposed
Secure Medicine Return Rule & Regulation
Drug producers develop a stewardship plan to meet the
requirements and standards of the R&R.
All producers must work together in the “standard” plan, unless
approved to form an “independent” plan.
Drug producers are responsible for costs of:
• Collection supplies, prepaid mailers, collection events
• Transporting collected medicines and final disposal
• Program promotion and evaluation
• Administrative costs
• Fees to Public Health to reimburse costs of oversight
Voluntary collectors will provide in-kind staff time at drop-off sites.
LHWMP will assist with start-up costs of secure drop boxes and
with education/promotion.
105
Overview of Proposed Secure Medicine Return Rule & Regulation
No specific fee to residents allowed at point-of-sale or point-of-
collection.
At least 167 pharmaceutical companies sell medicines for
residential use in Washington State.
Medicine sales in King County alone are > $1.1 billion annually.
Total costs to producers estimated at ~ $1 million per year, which is
less than 0.1% of annual medicines sales.
106
[email protected] 206-263-3059
ONLINE RESOURCES:
http://www.kingcounty.gov/healthservices/health/BOH/
MedicineTakeback.aspx
www.TakeBackYourMeds.org (also Facebook & Twitter) 107
Stakeholder Roles in implementing take-back programs and Impact of the proposed DEA Rule
108 108
DEA’s Proposed Rule: Proper Disposal of Controlled Substances
Overview
109 109
Secure and Responsible Drug Disposal Act
• Amends Controlled Substances Act • Oct. 2010 • More flexibility & less costly • DEA to develop regulations for disposal of
controlled substances • Jan. 2011 – public hearing • Dec. 2012 – DEA issued proposed rule • Feb. 19 – Comment period closed
110
DEA proposed rule expands collection options for the disposal of
controlled substances:
1. Take-back events
2. Permanent collection sites
3. Mail-back programs
111
What’s PSI’s network saying
about the issue?
Support for:
• Co-mingled controlled and non-controlled substances
• Participation from pharmacies & other authorized collectors
• Flushing and garbage disposal discouraged • Law enforcement should handle, store, and transport • Mail-back option limited to collectors with on-site
destruction
112
What else are they saying?
Certain provisions may increase costs and/or result in loss of convenient options • Storing, transporting, and disposing greater quantities • Law enforcement staffing too restrictive • Reverse distributors role limited regarding mail-back
Prevents counting or inventorying • Exemption for research purposes
113
Challenges of the Proposed Rule
Charlotte A. Smith, R. Ph., M.S. Senior Regulatory Advisor
PharmEcology Services WM Healthcare Solutions, Inc.
[email protected] 713-725-6363
114
Legal Disclaimer
This information is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information.
115
Restriction to Ultimate User of Person Acting for Decedent
• Many people using controlled substances are incapacitated
• Provision should be made for family or responsible care-giver to manage the CS for disposal for an “incapacitated ultimate user”
116
Restriction on Take-back Volunteers
• No other person may handle or touch the CS at any time
• Eliminates the ability of Registered Pharmacists to segregate the CS from other drugs
• Will restrict the waste vendor from managing any drugs on-site – In some states, will cause the entire load to
become hazardous waste • Will cause huge amounts of drugs to be managed by
law enforcement
117
No Option for Data Collection
• Well intentioned to reduce opportunity for diversion
• Provision should exist for specific exemption based upon strict protocols for research
• Reverse distributors are required to document receipt and disposal of individual dosage forms of controlled substances and will need an exemption to comply
118
On-Site Destruction Required for Mail-back Programs
• Current proposed regulations requires any entity conducting a mail-back program to have on-site destruction capabilities
• Only a handful of DEA registrants have such capability reducing competition – Incineration facilities who are registered as
reverse distributors
• Consider opening up options for reverse distributors who are managing retail kiosk returns and law enforcement returns
119
The Case for Using Reverse Distributors for Mail Back
• RDs routinely receive controlled substances through the mail and via common carrier such as UPS and FedEx – Including from consumers during a recall event
• RDs have sufficient security in place to managed mail-back packages through final destruction at their contracted incineration facility through a witnessed burn
• Retail pharmacies could provide information on such a mailback process
120
Transfer of Controlled Substances from Law Enforcement to RDs Unclear • DEA recommends law enforcement agencies
keep a record of any transfer of CS to RDs for destruction
• Can this transfer be done by common carrier? • What level of documentation is required?
– At the drug level? – At the package level?
• What records must be kept by the reverse distributor?
121
RDs Required to Destroy the CS Within 14 days of Receipt
• Incinerators are hundreds and sometimes thousands of miles away requiring load consolidation
• Not reasonable for 2 employees to accompany the load
• Need to approve options already in place for hired off-duty police, etc. to witness the burn
122
RDs Required to Store at Schedule II Security Level
• Schedule II security requires a vault that meets specific DEA requirements
• Schedule II controlled substances make up a very small percentage of drugs prescribed to patients
• The requirement to store potentially large shipments of returned pharmaceuticals in current Schedule II vaults may deter RDs from participating
• Storage in the CS cage for Schedules III through V should be considered
123
RDs Required to Use Current Inventory and Reporting Procedures
• Would require use of Form 222 for schedule II drugs and detailed inventories, which is prohibited for collection events
• Recommendation to require an inventory of the containers, not individual drugs
124
Additional Challenges of the Rule
• Lack of specific options for disposal by healthcare facilities
• Requirement of hospitals to use Form 41 – Currently document electronically
• Long term care facilities – Restrictions on servicing by provider pharmacies – Restrictions on access by any LTCF employees – Lack of other alternatives to provider pharmacy
participation
125
Key groups needed to
increase take-backs
126 126
Brief Presentations with Key Stakeholder Groups
• State law enforcement (David Spakowicz, WI Department of Justice)
• Local Law Enforcement (Paul Milbrath, Jefferson County, WI)
• Local Government (Bill Leonard, Hennepin County, MN)
• Pharmacy (Tom Engels, Pharmacy Society of Wisconsin)
• Drug Abuse Prevention Advocate (Russ Jensen, MedDrop, WI)
• Pharmaceutical Destruction (John Waffenschmidt, Covanta)
• Reverse Distributors
127
(5 minutes)
Stakeholder Roles – Key points
• Current role in supporting drug take-back
• Current challenges and opportunities
• How current role may change, if at all, once the DEA rule is finalized
• Potential strategies for enhancing state and regional efforts drug take-back
128
DEA’s National Take Back Initiative
(NTBI)
The State of
WISCONSIN’S
SUPPORT OF
129
Statewide Collaboration
• In early 2010, DEA (WI) asked if WI DOJ if they would like to assist in the NTBI.
• WI AG JB Van Hollen was extremely supportive of the idea.
• WI National Guard (WING) supported the NTBI with transportation and drivers.
• DCI SA accepted Rx from local LEAs at WI State Patrol (WSP) District Posts (FDL, Madison, EC, Wausau and
Spooner)
• WSP supported the NBTI with escorts and secure storage when required. 130
How it Worked?
• Local LEAs would collect the Rx in their communities on Saturday and secure them until the following Monday.
• Local LEAs would transport the Rx to WSP Posts across WI.
• DCI SAs would receive, document and load Rx onto WING trucks.
• WING would transport Rx from WSP Post to DEA-Milwaukee with DCI or WSP escort.
• WING and DEA would combine all Rx and transport them out of state for destruction. 131
Collection Dates and Results
• September of 2010 – Total Sites-86/Total Participants 78/Rx Recd-4,480 lbs.
• April of 2011 – Total Sites-136/Total Participants 120/Rx Recd-18,901 lbs.
• October of 2011 – Total Sites-127/Total Participants 112/Rx Recd-19,820 lbs.
132
Collection Dates and Results (cont.)
• April of 2012 – Total Sites-179/Total Participants 148/Rx Recd-37,642 lbs.
• Ranked 4th in the nation in Rx collected
• September of 2012 – Total Sites-147/Total Participants 123/Rx Recd-22,563 lbs.
• Ranked 5th in the nation in Rx collected
• April of 2013 – Total Sites-179/Total Participants 151/Rx Recd-45,614 lbs.
***WI has always ranked within the top 5 states in the nation in Rx collected.
133
Sheriff Paul Milbrath Jefferson County, WI
134 134
Stakeholder Roles in Implementing
Take-Back Programs and Impact of
the Proposed DEA Rule
Hennepin County’s Perspective
135
Events
136
Collection Receptacles
137
Additional Receptacles Added
138
Senior Housing Facilities
• Definition
• 2012 Pilot Collections
• 2012 Program Expansion
• 2013 Collections
• Senior Fairs
139
Proposed Rule Impact
1.Collector
2.Records
3.Location
4.Label
5.Secure
140
VICE PRESIDENT OF PUBLIC AFFAIRS AT
PHARMACY SOCIETY OF WISCONSIN
TOM ENGELS
Moving WI Pharmacy Quality
Collaborative Forward WPQC has established an accreditation process and
uniform set of pharmacist-provided medication
therapy management services for participating
Wisconsin pharmacy providers.
The program will be made available to both
commercial health insurance plans and publicly-
funded health care programs.
PSW is working with Wisconsin Medicaid to develop
certification requirements for health information
system vendors.
Moving WPQC Forward
• On September 1, 2012, The Wisconsin Department of
Health Services (DHS) launched a medication therapy
management (MTM) program that is closely-aligned with
WPQC criteria.
• DHS has created and will provide a list of Medicaid
members eligible for comprehensive medication review
and assessment services to community pharmacies that
have provider agreements established with DHS.
• DHS is defining a certification procedure for health
information technology.
Moving WPQC Forward
• DHS is defining a certification procedure for
health information technology (HIT) Vendors will
define the information exchange criteria between
DHS and any vendor interested in exchanging
claims data and patient information, facilitating
MTM patient documentation and claims billing.
These data would also become available to
health care providers and DHS claims
processing staff upon completion of MTM
services.
Moving WPQC Forward
• Pharmacy provider adoption of the WPQC
program is paramount to its success.
• Information technology specifications and
certification standards are being developed by
staff at Wisconsin Medicaid and it may become
necessary for additional resources to be
provided to fully design and implement these
WPQC-based program and vendor requirements
with pharmacy software systems.
Moving WPQC Forward
• The WPQC program was selected by the Centers for
Medicaid and Medicare Services (CMS), through the
Health Care Innovation Award grant program, for
statewide expansion.
• WPQC’s responsibility in the CMS project is to positively
impact patient healthcare outcomes and reduce
healthcare costs of the WI Medicaid population.
• It is in the best interest of both WPQC and DHS to
efficiently and accurately identify patients to receive
MTM services as well as collaborate on the evaluation
and analysis of the results of the program.
MEDDROP COLLECTION EVENTS
• Need for partnership for development & implementation: – Local pharmacists, Clean Sweep, Madison Metropolitan Sewerage
District, Health Care organizations, Patient Safety Collaborative
• Importance of volunteers: – Pharmacists, Pharmacy Technicians & Pharmacy students: identify,
sort & separate
– Police: allow ability to accept, handle, sort & store controlled subst.
– Others: direct traffic, runners, surveys, catalog, label, weigh…
• Importance of marketing: – Brand program, website,
– Get word out thru various partner channels
• Importance of being very organized
• Drive through service (to move cars through)
147 147
First MedDrop Event October 2007
• 4 hours
• 40+ volunteers
• Cars - 566
• Controlled substances - 180.5 lbs
• Uncontrolled substances -1,509.5 lbs
• Sharps - 5 lbs
• 18 mercury fever thermometers
– Taken to Clean Sweep
• Total Pounds -1,695.5 (919 gallons)
148
149
150
MedDrop User Survey-2007 • Why are you disposing of the medications? Expired: 72% No longer using: 57% Patient deceased: 15% Not sure what they’re for: 1% Other: 5% • How would you have disposed of the unused Meds
otherwise? Kept them: 60% Thrown them away: 28% Flushed them: 15% Other: 6%
151
Transition from Collection Events to Permanent Drop Boxes
Vision Statement: Let’s put ourselves out of business
• Drop boxes located at local law enforcement (DEA regulations for controlled substances). – Direct supervision, security, storage
• Funds from County government
– Importance of partnership
• Local municipalities share in responsibility & disposal costs.
– $1000 fee
152
MEDDROP PERMANENT BOXES • Safe Communities takes over administration
and hosts website (2011)
• Controlled and non-controlled combined
• Expectations of host law
enforcement:
– Secure location
– Staff to observe, replace full buckets & check contents, move buckets to secure location (on/off site)
– Storage of collected medicines
– Transport secured buckets to collection site 153
Launch of 2 Pilot Drop Box Sites 11/2010
• 8 month collection: 3,250 lbs of drugs (155 buckets) [11/10-7/11]
154
2013 Pharmaceutical Waste Stewardship
Summit
Covanta’s Rx4Safety Program June 11, 2013
Milwaukee, Wisconsin By John G. Waffenschmidt, Vice President
Environmental Science and Community Affairs
Certified Ecologist 155
JGW2994 156
How The Program Works
• E-mail to Covanta Secure Services
• Do the Paperwork
• Run the Program
• Deliver to a Designated Covanta Facility
• Please – No Iodine Containing Products
JGW2994 157
JGW2994 158
Waste Water Disposal and
Beneficial Reuse
Bulk Liquid Products
Industrial Waste Water
Line Purge Water
Petroleum Contaminated
Manufacturing Waste
Paint Overspray
Process Sludge
Adhesives and Sealants
Grinding Residue
Plant Trash
Commodity Waste
Consumer Products
Food Products
Carpet: Broadloom & Tile
Paint and Ink
Bulk Toner & Cartridges
Recalled Products
Personal Care Products
Nutritional Supplements
Liquids and Water
Types of Non-Hazardous Materials
Industrial Waste
Wood and Wood Fiber
TSD Waste Streams
Bulk Paint Powder
Ink and Ink Wastes
Tires & Rubber Waste
Filter Cake and Sludge
Contaminated Soil
Manufacturing Debris
Liquids and Water
Remediation Waste
Coal Tar Soil
Oily Debris and Soil
Treated Wood
Waste Water
JGW2994 159
Program Results to Date
• > Than 600,000 Pounds Destroyed
• Regulatory Shift to Household Hazardous Waste
Exemption
• Thermal Destruction’s Value More Recognized
• Partnerships are Developing in Multiple Communities
• 1,252 Articles with 83 Million Impressions (visits,
readers/papers) JGW2975 160
Opportunities and Challenges
• Opportunities
– We join the chorus seeking to address drug abuse
and water contamination by pharmaceuticals
– A valuable Community Service as part of our
Clean World Initiative
• Challenges
– Need Household Hazardous Waste Exemption
– Need to broaden the overall PS/EPR response
JGW2994 161
DEA Rule Impact
• Overall impact unclear
• DEA should follow the National Research Council Recommendations to the USEPA http://www.nap.edu/catalog.php?record_id=13152
– Address Social, Environmental, Economics
• Should facilitate access to existing thermal destruction
• Should consider a defacto Hazardous Waste Exemption for Pharmaceuticals
JGW2994 162
Potential State-level and Regional
Strategies • DEA regulations enhance the potential for
pharmaceutical EPR with Pharmacy based collection
• Need to understand DEA impact to Non Controlled Substances Take Back Programs
• Effective communication is key
• Pharmaceutical Stewardship should not be forgotten
JGW2994 163
Conclusion
• Energy-from-Waste can fit in a Product
Stewardship framework
• Pharmaceuticals need to be removed from
abusers and never flushed
• Energy-from-Waste performance characteristics
makes it ideal for pharmaceuticals destruction
• All pharmaceuticals should be subject to the
Household Hazardous Waste exclusion
JGW2994 164
Have a nice day….. and a pleasant tomorrow
JGW2994 165
Facilitated Discussion with Key Stakeholder Groups
• State law enforcement (David Spakowicz, WI Department of Justice)
• Local Law Enforcement (Paul Milbrath, Jefferson County, WI)
• Local Government (Bill Leonard, Hennepin County, MN)
• Pharmacy (Tom Engels, Pharmacy Society of Wisconsin)
• Drug Abuse Prevention Advocate (Russ Jensen, MedDrop, WI)
• Pharmaceutical Destruction (John Waffenschmidt, Covanta)
• Reverse Distributors
166
Stakeholder Roles – Key points
• Current role in supporting drug take-back
• Current challenges and opportunities
• How current role may change, if at all, once the DEA rule is finalized
• Potential strategies for enhancing state and regional efforts drug take-back
167
Call to Action and Next Steps for the Great Lakes
• Steps needed to create more and improve
pharmaceutical take-back programs • How best to prepare for the final DEA rule? • Laying the groundwork for EPR legislation • How to best develop consistent messaging on
awareness of the problem and take-back solution
168
Thank you! Scott Cassel, CEO + Founder Product Stewardship Institute
617-236-4822
169
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