Transcript Holding a Medication Take Back Event Regulatory

Jennifer Volkman and Teresa Gilbertson
Minnesota Pollution Control Agency
Household Hazardous Waste Program
WHY DO WE COLLECT PHARMS?
Prevent abuse
Prevent poisoning
Prevent environmental impacts
Pathways to the Environment
Household flushing
Permitted sewering
Waste Water
Treatment
Plants
MFG and Medical industry
Human excretion
Landfill effluent
Land spread
solids
Feedlot runoff
Livestock
manure/fertilizer
Surface water
Uptake by
food crops
Groundwater
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Pharms in the Environment
80% of streams and waterways
have traces of pharmaceuticals
Source: US Geological Survey, 2002
Traces of pharms found in drinking
water of at least 46 million
Americans (none found in MN drinking
water sources included in the study)
Source: Associated Press, 2008
Ampicillin-resistant bacteria found in
every U.S. river tested in a 1999 study.
Ambient exposure (5 ppt) to EE2
causes male flathead minnows to
develop feminine characteristics
Pharms in the Environment
NSAID diclofenac found
in carcasses and eaten
by vultures causes
poisoning, renal failure,
and death. Vulture
population has declined
by 95%-97% ; 2-3
species in South Asia
are near extinction.
Copyright 2009 CMFPS
Community Medical Foundation for Patient Safety
5
Health Effects on Humans?
 No adverse effect or causality has been documented
 Chronic low-dose exposure being monitored
 Suspected possible link to:
 Low sperm count in males
 Outbreaks of neural tube defects (spinal bifida)
 Early menstrual development in girls
 Emergence of extreme drug-resistant microbes
Copyright 2009 CMFPS
Community Medical Foundation for Patient Safety
6
Pharmaceuticals in Homes
Accidental Poisoning and Overdoses
•Almost 40% of accidental poisoning occurs
in grandparents’ homes
•Half of all poisonings involve children
under 6 years of age
Source: Minnesota Poison Control, 2004
•13% percent of all poison exposure calls
received in 2008 were related to analgesics
or painkillers.
•Of the 1,756 deaths reported to poison
centers in 2008, most fatalities involved
exposure to drugs by adults between the
ages of 20 and 59
http://www.aapcc.org/
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Prescription Drug Abuse
 Second only to marijuana use
 ~70% of people who have abused opioids got them from
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friends and relatives
Between 1993 and 2005, there was a 93.3 percent increase in
those abusing prescription stimulants like Ritalin and
Adderall.
Among teens who have abused painkillers, nearly one-fifth
(18%) used them at least weekly in the past year.
32% of teens say they abuse prescription painkillers
because they believe they are safer.
Between 1995 and 2005, treatment admissions for abuse of
prescription pain relievers grew more than 300 percent.
Above stats are from http://www.awarerx.org/
sponsored by MN Pharmacists Association
WASTED PHARMS
 Study from England 2005, wasted:
 20 % of pain meds;
 72% of antibiotics;
 50% of beta-blockers/antidepressants.
 Study from Maine 2008, based on detailed mail-back
returns: 40% of prescription drugs were returned unused
by patients.
 47% of LA County residents report that they do not take
antibiotics until they are gone, as prescribed
Current MPCA Efforts
 Provide guidance for collectors of HH pharms
 Review and approve incineration of household
pharms at Waste To Energy facilities in MN
 Water and sediment Monitoring Studies, including endocrine
disruptors, pharms, pesticides: 2007-2011
 Compliance Guidance tools for Health Care industry; MNTAP
Program:
http://www.mntap.umn.edu/healthcarehw/index.html
 Healthcare Industry MPCA location:
http://www.pca.state.mn.us/index.php/waste/waste-andcleanup/waste-management/industry-specific-waste/healthcare-industry.html?menuid=&redirect=1
Focus:
Household Pharms
 Pharmaceuticals include:
 Over the Counter
 Prescription or “legend”
 Pills, gels, liquids
 Syringes
 90+% of HH Pharms are non-hazardous and non-
controlled substances
REFER ALL BUSINESSES TO MPCA!
[email protected]
651-757-2358
GOAL
1. Establish a sustainable collection system for
ALL household generated pharms that complies
with existing regulations.
Became:
2. Change existing regulations so we can collect HH
pharms and dispose of them at reasonable cost.
3. Collection will be safe for consumers, secure to
prevent diversion and as convenient as possible.
Who Regulates HH Pharm
collection?
DEA
State Board
of Pharmacy
State
Government
Drug Enforcement Administration
•Regulates who can collect controlled substances
•Issues approvals to law enforcement for collection
•Requires “witnessed destruction” of CS
-DEA does not prescribe the destruction method
-Federal EPA and state or local regulations apply
•Hosts intermittent National Take-Back Days
-October 29, 2011; 10 am-2pm
•Developing federal regulations for additional
collection options
State Pharmacy Boards
 Regulate who can possess prescription or
“legend” pharmaceuticals.
-Most regulations allow possession by prescribed
patient only
 Regulate pharmacy operations
-Pharmacies in MN are not allowed to take back
legend pharmaceuticals due to potential for
reuse.
Minnesota Pollution Control Agency
 Regulates collection of HHW
 Regulates disposal of HW
 Regulates waste water treatment plants
 Regulates Solid and Haz waste
incineration
 Studies impacts to the environment
What MN Did to get started:
 Established a work group including MPCA,
DEA, Pharmacy Board and MN Pharmacists
Association (5 people, yay!)
 Learned each other’s rules
 Revised statutes and established policy
 Support each others missions
Legislation in MN 2009
Modification to
Board of
Pharmacy
Statutes to allow
possession of
“legend” pharms
by different
entities for the
purpose of
collection for
proper disposal.
• Law enforcement and
other county programs
• Approved waste
management transporters
and facilities
• People!
Policy change to MPCA HHW
rules
 Reduced the level of regulation for entities
that collect pharms only
 Requires notification and annual reporting, but
no fees
 Allowed incineration of pharms at Waste-ToEnergy Facilities in MN
WHO CAN COLLECT HH PHARMS?
 Law enforcement is the only entity that
can collect all pharms 24/7
 Pharmacies and HHW Programs:
 Events only, with law enforcement staff
 No on-site storage of controlled substances
 Non-controlled pharms must be treated on-site
if stored at HHW facilities to minimize diversion
potential
Collection Options - Mail back
 Maine model requires:
Funding
 Law enforcement entity to collect pharms
 Generated excellent data on the types and quantities
of pharms wasted
 Resulted in waste prevention regulations limiting
prescription quantities for certain drugs
 May be a good match for Product Stewardship
 Some diversion concerns raised

Collection Options: Pharmacies
 Can accept non-CS pharms only
 Need larger funding source
 Best participation rates, in theory, due to
convenience
 Successful programs in Washington State and
elsewhere
 Good match for product stewardship
 NON-CS MAILERS $4
Hospitals, clinics and healthcare
organizations
 Collect targeted drugs, such as chemotherapy
waste
 Collect from patients only
 Collect non-CS pharms only
Collection Options: HHW Programs
 In MN it works well for events only with law
enforcement taking immediate possession of CS
during the event and storing it at a law enforcement
facility
 HHW facilities are well-suited for hosting events
 Ideally non-CS pharms are shipped off-site at the
close of the event; otherwise treatment is required.
SO, who is collecting as of October 1, 2011?
• 30+ Counties with
collection at more
than 50 law
enforcement facilities
• 2 programs do
quarterly events
• 1 pharmacy event
• DEA events
• Mail back programs
• Don’t collect if your
county’s trash goes to a
WTE facility?
How do I get started with
permanent collection?
 Find Partners
 Determine the program
coordinator/primary
responsible person
 Determine collection
address/site
The Champion
 Find a
Karl Schreck!
 Sit back and
watch the
program grow
Planning the Program
 Staff time
 Drop off box location
 Companies that make drop boxes/make your
own
 Containers
 Signage/Advertising/Marketing
 Disposal
Security
 Staff safety
 Facility security for non-law enforcement facilities
 Participant safety
 Location of collection bins
 Inside, outside, evidence or secure room
 Video surveillance
 Controlled substance management
Regulatory Requirements for Collectors
(2010 MPCA PMD)
--Notification- Contact [email protected]
 Review guidance document for collectors—basics
on notification, storage, PPE…
 Complete Notification Form and HW ID form
 No license fee
 Notify Board of Pharmacy
 Notify DEA if collecting controlled substances
What will I get?
 About 2 lbs or a plastic grocery bag
of pharms per person.
 10% of total will likely be CS pharms.
 Sharps with syringes containing medicine, small
percentage
 Mercury thermometers and batteries, a few
 Used sharps, a few
 Biohazard waste, not common
 Chemotherapy waste, not common
Container Management
 Container type for collection box and
storage/disposal: non-leaking, puncture
proof, burnable
 Storage space: determines frequency of
transport to incinerator
 Labeling: to prevent mismanagement
 Full container weight: can you move it
Container management
 Check your collection
container frequently!
 Screen waste frequently to
make it easier and to reduce
accident potential
Personal Safety
Latex or vinyl gloves
Be aware of sharps!
Screen in well ventilated area
Discussion on removal of pharms
from individual containers
Sharps and mercury thermometers
 Screen pharms for these items
 Incidental sharps are ok if they have meds in them
 Separate collection for thermometers and sharps
 Options:
 Signage
 Separate collection containers
 Coordinate with local HHW program to manage these
items
Destruction of Collected Pharms
 Flushing: not allowed
 SW Landfilling: not allowed for any HW or CS
pharms in MN
 SW/WTE incineration: allowed for all HH
generated pharms in MN
 HW incineration: allowed in all states (MN
does not have a commercial HW incinerator)
Regulatory Requirements
--Waste Management-2 Options:
1) Contract with HW hauler for all collected
pharms. (Sorting required)
2)
Self-Transport to an approved Waste-ToEnergy facility in MN. (Screening required)
All controlled substance pharms must be
destroyed via compliant “witnessed burn”
Destruction of Pharms
 Find out per pound disposal cost for HW and
WTE incineration options, run the numbers
 Incineration is the best available technology at this
point in time; facility quality varies
 Disposal option will dictate some of your
design, staff time, containers used
 Storage space; sorting time
WTE collection requirements
for Collectors
 Determines acceptable/non-acceptable
items
 Screening to remove mercury items
 Sharps—incidental ok
 No on-site storage; immediate incineration
WTE collection requirements
for Collectors
 Service area for WTE’s will vary
 Recommend packaging: type and size
 Pre-notification instructions
 Fees
HW Transport
Licensed HW Hauler will:
 Will offer prepared manifests for signature
 Will specify container type and other supplies
 Collector retains shipping papers/manifests 5
years
 Controlled substances can be consolidated for
witnessed transport and incineration
Self Transport
 Law enforcement transports controlled
substances
 All pharms must be transported by
government staff in a government vehicle
 Secure containers
 Get receipt from WTE facility
EVENTS
 Call Teresa Gilbertson if you are planning on
setting up an event
 Work with your local HHW program staff
 Tents/water/PPE/traffic control/containers
 Plan for non-pharm wastes
 Location to secure and store pharms at the
end of the event
Event Security!
LOCATION,
Location,
Location!
Plan for the
unexpected!
(Ether)
Regulatory Requirements
Reporting
 Keep shipping papers, bills of
lading, receipts, etc. from
WTE facilities, HW
transporters.
 Report to MPCA in Feb:
pounds and participants for
the previous year.
 Track participation, please
Confiscated vs. delivered pharms
 Pharms and illicit drugs obtained through
enforcement actions are business waste per
EPA
 Disposal option is witnessed HW incineration
 3M a “free” option in 2 years for confiscated
pharms
 Organic illicit drugs can be burned at WTE’s
Advertising and Marketing
 MPCA is working on a consistent
message, tag line and graphics.
 Ask existing programs for
examples
 Supplementary articles to
emphasize “WHY” we collect
Advertising:
 When
 Where
 What
 How
 Do and Don’t
 Newspaper, flyers, radio
Marketing
 Describe the problems
 Describe how collection will help
 Ask, how can you help?
 Publish your good works, results
Secure and Responsible
Drug Disposal Act of 2010
 Directs AG to establish collection scenarios that are
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“secure, convenient and responsible”
Allows delivery of CS to a collection program by
individuals or by long-term care facilities
Increases penalties for bad guys—look out!
Main purpose is to reduce abuse, “also” to help the
environment.
In Rulemaking stage
Could result in collection by pharmacies
State Product Stewardship
Legislation
 Several states are pursuing product
stewardship legislation:
WA, Maine, CA, VT, passed in San Francisco
 Manufacturers are involved in end of life
management infrastructure and costs
Prevention: How Sick Are We, Really?
 US pop accounts for 5% of
world’s pop
 Global production of
pharmaceutical products
annually is $600 billion (US)
 US consumption of these
products is 50% ($300 billion)
 Are we flushing $150 billion
worth of medicines down the
drain?
Copyright 2009 CMFPS
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Prevention:
MaineCare’s 15-Day Limit on Prescription Meds
 Results of research by MBSG and Center on
Aging
 Emphasis on efficacy and safety of medicines
 15-day limit on initial prescription
 Based on potential side effects,
discontinuation rate, and frequent dose
adjustment
 Effective August 6, 2009
 Include Suboxone, Subutex, Chantix and
Nicotine replacement products
Copyright 2009 CMFPS
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Why surveys and reporting is important!
The National Unused &Expired Meds Registry
Non-Pill
$168,860.64
n=3062: mean=$55.15, SD=$167.43, range 0:$3,217.33
Pill
$388,352.28
n=8622: mean=$45.04, SD=$135.62, range 0:$4,851.54
TOTAL ESTIMATED COST OF WASTE = $557,212.92 (US Dollars)
Precise cost of waste is between $724,376.80 and $891,540.67
Copyright 2009 CMFPS
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PREVENT WASTE!!!
The National Unused &Expired Meds Registry
Est. Total
Packsize
Est. Quantity
Returned
691,656 Pills
352,916 Pills
TOTAL ESTIMATED PROPORTION OF WASTE = 51.02%
Copyright 2009 CMFPS
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“If all medicines in the world were
thrown into the sea, it would be all
the better for mankind and all the
worse for the fishes.“
Oliver Wendell Holmes, Sr., 1842
THANK YOU!
Questions?
[email protected]
[email protected]
651-757-2801
“CMFPS 2009” slide references: Matthew Mireles, PhD, MPH
President and CEO, Community Medical Foundation for Patient Safety
(832)778-7777