jennifer volkman and teresa gilbertson minnesota pollution control agency household hazardous waste...
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Jennifer Volkman and Teresa GilbertsonMinnesota Pollution Control Agency
Household Hazardous Waste Program
WHY DO WE COLLECT PHARMS?Prevent abusePrevent poisoningPrevent environmental impacts
Pathways to the EnvironmentPathways to the Environment
Human excretion
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Waste Water Waste Water Treatment Treatment
PlantsPlants
Land spread Land spread solidssolids
Feedlot runoff SurfaceSurface waterwater
Uptake by Uptake by food cropsfood crops
GroundwaterGroundwaterLivestock manure/fertilizer
Permitted seweringMFG and Medical industry
Household flushing
Landfill effluent
Pharms in the EnvironmentPharms in the Environment
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
80% of streams and waterways have traces of pharmaceuticalsSource: US Geological Survey, 2002
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
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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 SafetyCommunity Medical Foundation for Patient Safety
Health Effects on Humans?No adverse effect or causality has been documentedChronic low-dose exposure being monitoredSuspected possible link to:
Low sperm count in malesOutbreaks of neural tube defects (spinal bifida)Early menstrual development in girlsEmergence of extreme drug-resistant microbes
6Copyright 2009 CMFPS Community Medical Foundation for Patient SafetyCommunity Medical Foundation for Patient Safety
Pharmaceuticals in HomesAccidental Poisoning and Overdoses
•Almost 40% of accidental poisoning occurs in grandparents’ homes•Half of all poisonings involve children under 6 years of ageSource: Minnesota Poison Control, 2004
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•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/
Prescription Drug AbusePrescription Drug Abuse
WASTED PHARMSWASTED PHARMSStudy 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 EffortsCurrent MPCA EffortsProvide guidance for collectors of HH pharmsReview 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-and-cleanup/waste-management/industry-specific-waste/health-care-industry.html?menuid=&redirect=1
Focus:Focus:Household PharmsPharmaceuticals include:
Over the CounterPrescription or “legend”Pills, gels, liquidsSyringes
90+% of HH Pharms are non-hazardous and non-controlled substances
REFER ALL BUSINESSES TO [email protected] 651-757-2358
GOAL1. 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?
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 BoardsRegulate 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 AgencyRegulates collection of HHWRegulates disposal of HWRegulates waste water treatment plantsRegulates Solid and Haz waste
incinerationStudies 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 rulesRevised statutes and established policySupport each others missions
Legislation in MN 2009Legislation in MN 2009
Policy change to MPCA HHW rulesReduced the level of regulation for entities
that collect pharms onlyRequires notification and annual reporting,
but no feesAllowed incineration of pharms at Waste-To-
Energy Facilities in MN
WHO CAN COLLECT HH PHARMS?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 staffNo on-site storage of controlled substancesNon-controlled pharms must be treated on-site
if stored at HHW facilities to minimize diversion potential
Collection Options - Mail backMaine model requires:
FundingLaw 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 StewardshipSome diversion concerns raised
Collection Options: PharmaciesCan accept non-CS pharms onlyNeed larger funding sourceBest participation rates, in theory, due to
convenienceSuccessful programs in Washington State and
elsewhereGood match for product stewardshipNON-CS MAILERS $4
Hospitals, clinics and healthcare organizations
Collect targeted drugs, such as chemotherapy waste
Collect from patients onlyCollect non-CS pharms only
Collection Options: HHW ProgramsIn 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 eventsIdeally non-CS pharms are shipped off-site at the
close of the event; otherwise treatment is required.
• 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?
SO, who is collecting as of October 1, 2011?
How do I get started with permanent collection?Find PartnersDetermine 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 ProgramStaff timeDrop off box locationCompanies that make drop boxes/make your
ownContainersSignage/Advertising/MarketingDisposal
SecurityStaff safetyFacility security for non-law enforcement facilitiesParticipant safetyLocation of collection bins
Inside, outside, evidence or secure roomVideo surveillanceControlled substance management
Regulatory Requirements for Collectors Regulatory Requirements for Collectors (2010 MPCA PMD)(2010 MPCA PMD)
Contact [email protected] Review guidance document for collectors—basics
on notification, storage, PPE…Complete Notification Form and HW ID formNo license fee Notify Board of PharmacyNotify DEA if collecting controlled substances
--Notification----Notification--
What will I get?About 2 lbs or a plastic grocery bagof pharms per person.10% of total will likely be CS pharms.Sharps with syringes containing medicine, small
percentageMercury thermometers and batteries, a fewUsed sharps, a fewBiohazard waste, not commonChemotherapy waste, not common
Container ManagementContainer type for collection box and
storage/disposal: non-leaking, puncture proof, burnable
Storage space: determines frequency of transport to incinerator
Labeling: to prevent mismanagementFull container weight: can you move it
Container managementCheck your collection
container frequently!
Screen waste frequently to make it easier and to reduce accident potential
Personal SafetyPersonal SafetyLatex or vinyl glovesBe aware of sharps!Screen in well ventilated areaDiscussion on removal of pharms
from individual containers
Sharps and mercury thermometersSharps and mercury thermometersScreen pharms for these itemsIncidental sharps are ok if they have meds in themSeparate collection for thermometers and sharpsOptions:
SignageSeparate collection containers
Coordinate with local HHW program to manage these items
Destruction of Collected PharmsFlushing: not allowedSW Landfilling: not allowed for any HW or CS
pharms in MNSW/WTE incineration: allowed for all HH
generated pharms in MNHW incineration: allowed in all states (MN
does not have a commercial HW incinerator)
Regulatory RequirementsRegulatory Requirements--Waste Management--
2 Options:1) Contract with HW hauler for all collected
pharms. (Sorting required)
2) Self-Transport to an approved Waste-To-Energy facility in MN. (Screening required)
All controlled substance pharms must be destroyed via compliant “witnessed burn”
Destruction of PharmsFind out per pound disposal cost for HW and
WTE incineration options, run the numbersIncineration is the best available technology at this
point in time; facility quality variesDisposal option will dictate some of your
design, staff time, containers usedStorage space; sorting time
WTE collection requirements for Collectors
Determines acceptable/non-acceptable items
Screening to remove mercury itemsSharps—incidental okNo on-site storage; immediate incineration
WTE collection requirements for CollectorsService area for WTE’s will varyRecommend packaging: type and sizePre-notification instructionsFees
HW TransportLicensed HW Hauler will:Will offer prepared manifests for signatureWill specify container type and other suppliesCollector retains shipping papers/manifests 5 yearsControlled substances can be consolidated for witnessed transport and incineration
Self TransportLaw enforcement transports controlled
substancesAll pharms must be transported by
government staff in a government vehicleSecure containersGet receipt from WTE facility
EVENTSCall Teresa Gilbertson if you are planning on
setting up an eventWork with your local HHW program staffTents/water/PPE/traffic control/containersPlan for non-pharm wastesLocation to secure and store pharms at the
end of the event
Event Security!
LOCATION, Location, Location!
Plan for the unexpected!
(Ether)
Regulatory RequirementsReportingKeep 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 pharmsPharms and illicit drugs obtained through
enforcement actions are business waste per EPA
Disposal option is witnessed HW incineration3M a “free” option in 2 years for confiscated
pharmsOrganic illicit drugs can be burned at WTE’s
Advertising and MarketingMPCA is working on a consistent
message, tag line and graphics.Ask existing programs for
examplesSupplementary articles to
emphasize “WHY” we collect
Advertising: WhenWhere What HowDo and Don’tNewspaper, flyers, radio
Marketing
Describe the problemsDescribe how collection will helpAsk, how can you help?Publish your good works, results
Secure and Responsible Secure and Responsible Drug Disposal Act of 2010 Drug Disposal Act of 2010
Directs AG to establish collection scenarios that are “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 stageCould result in collection by pharmacies
State Product Stewardship State Product Stewardship LegislationLegislationSeveral 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 US pop accounts for 5% of
world’s popworld’s popGlobal production of Global production of
pharmaceutical products pharmaceutical products annually is $600 billion (US)annually is $600 billion (US)
US consumption of these US consumption of these products is 50% ($300 billion)products is 50% ($300 billion)
Are we flushing $150 billion worth of medicines down the drain?
Copyright 2009 CMFPS 55
Prevention:MaineCare’s 15-Day Limit on Prescription MedsResults of research by MBSG and Results of research by MBSG and
Center on Aging Center on Aging Emphasis on efficacy and safety of Emphasis on efficacy and safety of
medicinesmedicines15-day limit on initial prescription15-day limit on initial prescriptionBased on potential side effects, Based on potential side effects,
discontinuation rate, and frequent dose discontinuation rate, and frequent dose adjustmentadjustment
Effective August 6, 2009Effective August 6, 2009Include Include SuboxoneSuboxone, , SubutexSubutex, , ChantixChantix
and and Nicotine replacement products Nicotine replacement products Copyright 2009 CMFPS 56
Why surveys and reporting is important!The National Unused &Expired Meds Registry
TOTAL ESTIMATED COST OF WASTE =TOTAL ESTIMATED COST OF WASTE = $557,212.92 $557,212.92 ((US Dollars)US Dollars)
Precise cost of waste is between Precise cost of waste is between $724,376.80 $724,376.80 and and $891,540.67$891,540.67
57Copyright 2009 CMFPS
n=8622: mean=$45.04, SD=$135.62, range 0:$4,851.54
n=3062: mean=$55.15, SD=$167.43, range 0:$3,217.33
PREVENT WASTE!!!The National Unused &Expired Meds Registry
TOTAL ESTIMATED PROPORTION OF WASTE = TOTAL ESTIMATED PROPORTION OF WASTE = 51.02%51.02%
58Copyright 2009 CMFPS
“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
