a product stewardship plan - sfenvironment.org · med-project website ... xii. survey ......

A Product Stewardship PlanFor Unwanted Medicine from Households

City and County of San Francisco, CaliforniaJanuary 31, 2018

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Table of ContentsI. Introduction .........................................................................................................................5II. ContactInformation ............................................................................................................5III. PlanDefinitions ...................................................................................................................6IV. UnwantedMedicine ............................................................................................................8V. CollectionofUnwantedMedicine ......................................................................................9

A. UnwantedMedicineCollectionProgram ................................................................91. Outreach.............................................................................................................92. Implementation ..................................................................................................93. Convenience .......................................................................................................94. Services ............................................................................................................10

B. KioskDrop-OffSites ................................................................................................101. KioskDrop-OffSiteLocations ...........................................................................102. Drop-OffSiteKioskPlacementandMaintenanceProgram ............................113. KioskSpecifications ..........................................................................................114. KioskCollection ................................................................................................125. Frequency of Pick-Up .......................................................................................146. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up ..................................147. Unplanned Event Preparedness .......................................................................14

C. Take-Back Events .....................................................................................................151. Method .............................................................................................................152. Procedures .......................................................................................................153. Fees and Costs ..................................................................................................16

D. DisposalofUnwantedMedicinefromKioskDrop-OffSitesandTake-Back Events ...........................................................................................................................16

E. Mail-Back Services for Unwanted Medicine ...........................................................161. Standard Mail-Back Services ............................................................................172. StandardMail-BackServicesforIodine-ContainingMedications ...................173. InjectorMail-BackServicesforPre-filledInjectorProducts ............................184. Inhaler Mail-Back Services for Inhalers............................................................185. Mail-BackPackageAvailability .........................................................................186. Mail-BackPackageCollectionandDisposal .....................................................19

VI. PlanandCollectionGoals .................................................................................................19VII. PatientPrivacy ...................................................................................................................20VIII. Call Center ..........................................................................................................................21IX. Training ...............................................................................................................................21

A. ServiceTechnicianTraining .....................................................................................22X. Vendor,Transporter,andDisposalFacilityInformation ................................................22

A. VendorforKioskDrop-OffSitesand/orTake-BackEvents .....................................22B. CarrierforKioskDrop-OffSitesand/orTake-BackEvents ......................................23C. ReverseDistributorFacility&TransporterforKiosk Drop-OffSitesand/orTake-BackEvents .................................................................23

1. ReverseDistributorFacility ..............................................................................232. Transporter .......................................................................................................23

D. DisposalFacilityforKioskDrop-OffSitesand/orTake-BackEvents .......................231. Disposal Facility ................................................................................................232. Direct Transport Disposal Facility .....................................................................23

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3. Secondary Disposal Facility ..............................................................................24A. VendorforStandardMail-BackPackages ...............................................................24B. ShipperofStandardMail-BackPackages ...............................................................24C. DestructionandDisposalFacilitiesforStandardMail-BackPackages ...................24

1. DestructionFacility...........................................................................................242. Disposal Facility ................................................................................................24

A. VendorforInjectorMail-BackPackages ................................................................24B. ShipperofInjectorMail-BackPackages..................................................................25C. TreatmentandDisposalFacilitiesforInjectorMail-BackPackages .......................25

1. Autoclave Facility .............................................................................................252. Disposal Facility ...............................................................................................25

A. VendorforInhalerMail-BackPackages ..................................................................25B. ShipperofInhalerMail-BackPackages ..................................................................25C. TransferStationforInhalerMail-BackPackages ....................................................25D. DisposalFacilityforInhalerMail-BackPackages ....................................................26

XI. UnwantedMedicineEducationalandOutreachProgramming .....................................26A. Overview .................................................................................................................26B. Audiences ................................................................................................................26C. Messages .................................................................................................................26D. Tools/CommunicationsChannels ...........................................................................27

1. Phone ...............................................................................................................272. MED-ProjectWebsite .......................................................................................273. Materials ..........................................................................................................284. Media Outreach ...............................................................................................28

E. CollaborationwithCountyOfficialsandCommunityOrganizations ......................28F. Disclaimer ................................................................................................................28

XII. Survey .................................................................................................................................29XIII. Packaging ...........................................................................................................................29XIV. CompliancewithApplicableLaws,Regulations,andOtherLegalRequirements........30

A. DEAControlledSubstancesActandImplementingRegulations............................301. DEARegistrationModification .........................................................................31

B. UnitedStatesDepartmentofTransportation(DOT) ..............................................31C. CaliforniaStateBoardofPharmacy ........................................................................31

XV. AnnualReport ....................................................................................................................32AppendixA .................................................................................................................................33

MED-ProjectParticipants ..............................................................................................33AppendixB .................................................................................................................................34

SampleContactListforOutreachandEducationtotheCommunity ..........................34AppendixC .................................................................................................................................35

InterestedSitesandParticipatingKioskDrop-OffSites ...............................................35AppendixD .................................................................................................................................37

PotentialAdditionalKioskDrop-OffSites ......................................................................37AppendixE �� 40

ProposedKioskSignage .................................................................................................41ProposedKioskSignage .................................................................................................42ProposedKioskSignage .................................................................................................43

AppendixF ..................................................................................................................................44SampleMediaList .........................................................................................................44

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AppendixG .................................................................................................................................46SampleStandardMail-BackPackage ............................................................................46

AppendixH .................................................................................................................................47SampleInjectorMail-BackPackage ..............................................................................47

AppendixI ...................................................................................................................................48SampleInhalerMail-BackPackage................................................................................48

AppendixJ ..................................................................................................................................49RequestforApprovaltoAutoclavePre-filledInjectorProducts ...................................49

AppendixK .................................................................................................................................58RequestforApprovalofInhalerMail-BackPackageDisposalProcess .........................58

AppendixL ..................................................................................................................................61SampleCallCenterScript ..............................................................................................61

AppendixM ................................................................................................................................64MED-ProjectWebsite ....................................................................................................64ProposedWebPage ......................................................................................................65ProposedWebPage ......................................................................................................66ProposedWebPage ......................................................................................................67ProposedWebPage ......................................................................................................68ProposedWebPage ......................................................................................................69ProposedWebPage ......................................................................................................70ProposedWebPage ......................................................................................................71

AppendixN .................................................................................................................................72SampleBrochure ...........................................................................................................72

AppendixO .................................................................................................................................74SampleDigitalandLocalSocialNetworks ....................................................................74

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I. Introduction

MED-ProjectLLC(“MED-Project”),onbehalfoftheparticipatingcompaniesidentifiedinAppendix AsubmitsthisProductStewardshipPlan(“Plan”)forUnwantedMedicineincompliancewiththeSanFranciscoSafeDrugDisposalStewardshipOrdinance,SanFranciscoEnvironmentCode,Chapter22,Division1,Sections2200-2219(“Ordinance”)andtheSanFranciscoDepartmentoftheEnvironmentRegulation#SFE-16-01-SDDSO(“Regulation”).TheOrdinancerequirespharmaceuticalProducers1 to develop a Product Stewardship Programtofinanceandmanagethecollection,transportation,anddisposalofUnwantedMedicinefromSanFrancisco Residents.

II. ContactInformation

TheprimarycontactpersonforMED-Projectis:

Dr.VictoriaTravis,PharmD,MS,MBANationalProgramDirectorMED-ProjectLLC1800MStreetNW,Suite400SWashington,DC20036Phone:(844)677-6532Fax:(510)686-8837sanfrancisco@med-project�org

1 AllcapitalizedtermsusedbutnototherwisedefinedhereinshallhavetheirrespectivemeaningssetforthintheOrdinance.

mailto:sanfrancisco%40med-project.org?subject=

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III. PlanDefinitions

BoardofPharmacyistheCaliforniaStateBoardofPharmacy.

Call Center istheMED-ProjectcallcenterforResidents,whichcanbereachedbycallersatthetollfreenumberof1-844-MED-PROJor1-844-633-7765.

CarrierisUnitedParcelService,Inc.(“UPS”),thecommoncarrierusedbyVendortotransportUnwantedMedicinefromKioskDrop-OffSitesand/orTake-BackEvents.

CountymeansthecityandcountyofSanFrancisco,California.

DEAistheU.S.DrugEnforcementAdministration.

DEARuleistheDEAFinalRule,“DisposalofControlledSubstances,”79Fed.Reg.53520et seq., adopted on September9,2014.

DOTistheU.S.DepartmentofTransportation.

FDAistheU.S.FoodandDrugAdministration.

InhalerMail-BackServicesistheprovisionofpre-paid,pre-addressedpackagesforthecollectionanddisposalofinhalers(“InhalerMail-BackPackages”)byPureWayComplianceInc.(“PureWay”).

InjectorMail-BackServicesistheprovisionofpre-paid,pre-addressed,FDA-clearedsharpscontainersforthecollectionanddisposalofPre-filledInjectorProducts(“InjectorMail-BackPackages”)byPureWay.

KioskDrop-OffSiteisalocationhostingaMED-ProjectkioskforthecollectionofUnwantedMedicine.

KioskDrop-OffSiteHostisthedesignatedcontactpersonorpersonsattheKioskDrop-OffSite.

LawEnforcementAgencyor LEAisafederal,state,tribal,orlocallawenforcementofficeoragency.

Mail-BackDistributionLocationisasitethatisaccessibletothepublic,suchasafirestationorlibrary,whichwillprovideMED-ProjectStandardMail-BackPackagestoResidents.

Mail-BackServicesistheprovisionofpre-paid,pre-addressedcontainers,envelopes,orpackagesforthecollectionanddisposalofUnwantedMedicine.

MaintenanceTechniciansare service personnel who are trained to provide services related to kiosks that are partoftheProgram.Thisincludes,butisnotlimitedto,respondingtodamagedkiosks.

MED-ProjectWebsiteistheInternetwebsitelocatedatwww�med-project�org or www�medproject�org.

Plan or ProductStewardshipPlanistheproductstewardshipplanpresentedinthissubmittalbyMED-Project.

Pre-filledInjectorProductsarepre-filledinjectorproductswitharetractableorotherwisesecurelycoveredneedlewheremedicinecannotberemovedfromthemorwheretheycontainmorethantraceamountsofCoveredDrugs.

Programor ProductStewardshipProgramistheproductstewardshipprogramsetforthinthisPlan.

RequiredLanguagesareEnglish,Spanish,Chinese,Russian,andTagalog(Filipino).

ResidentsmeanshumanbeingsresidingintheCounty.“Residents”doesnotincludebusinessgeneratorsofpharmaceuticalwaste,suchashospitals,clinics,doctor’soffices,veterinaryclinics,pharmacies,orairportsecurityandlawenforcementdrugseizures.

ServiceConvenienceGoalsarethegoalsestablishedinOrdinance§2205(b)(1).

ServiceTechniciansarepersonneltrainedtoserviceProgramkiosks.

http://www.med-project.org

http://www.medproject.org

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ShipperisUnitedStatesPostalService(“USPS”),theshipperusedbyVendorforthetransportofUnwantedMedicinecollectedfromResidentsviaMail-BackServices.

StandardMail-BackServicesistheprovisionofpre-paid,pre-addressedenvelopesforthecollectionanddisposalofUnwantedMedicine(“StandardMail-BackPackages”)byStericycleSpecialtyWasteSolutions,Inc.(‘Stericycle”).

Take-BackEventisaneventconductedbyMED-Projectwithoversightbylawenforcementforthecollectionof Unwanted Medicine at Take-Back Events.

UnwantedMedicineisdefinedinSectionIVofthisPlan.

Vendor isanyvendorretainedbyMED-ProjecttocarryoutitsobligationsundertheProgram.

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IV. UnwantedMedicine2

ForthepurposesofthePlan,“UnwantedMedicine”includesallmaterialsidentifiedas“CoveredDrugs”underOrdinance§2202thatqualifyas“UnwantedCoveredDrugs”underOrdinance§2202.AccordingtotheOrdinance,CoveredDrugsmeans“adrugsoldinanyformandusedbyCityResidents,includingprescription,nonprescription,brandnameandgenericdrugs.”UnwantedMedicinedoesnotincludethefollowing:

i. Expiredundispensedsamplesdirectfromphysicians’offices;

ii. Unusedorexpireddrugsfromhospitalsandinstitutions;

iii. Bulkanimalpharmaceuticalsfromfarms(businessuse);

iv. Vitaminsorsupplements;

v. Herbal-basedremediesandhomeopathicdrugs,products,orremedies;

vi. Compressedcylindersandmercurycontainingthermometers;

vii. Cosmetics,shampoos,sunscreens,toothpaste,lipbalm,antiperspirants,orotherpersonalcareproductsthatareregulatedasbothcosmeticsandnonprescriptiondrugsunderthefederalFood,Drug,andCosmeticAct(Title21U.S.C.Chapter9);

viii. Hardsurfaceandtoiletdisinfectantcleaners;

ix. Drugsadministeredinahealthcaresetting;

x. DrugsforwhichProducersprovideapharmaceuticalproductstewardshiportake-backprogramaspartofaFDAmanagedriskevaluationandmitigationstrategy(Title21U.S.C.Sec.355-1);

xi. Drugsthatarebiologicalproducts,meaninganyvirus,therapeuticserum,toxin,antitoxin,oranalogousproductapplicabletotheprevention,treatmentorcureofdiseasesorinjuriesofman,asthesetermsaredefinedby21C.F.R.600.3(h),iftheProduceralreadyprovidesapharmaceuticalproductstewardshiportake-backprogram;

xii. Medicaldevicesortheircomponentpartsoraccessories;

xiii. Used,emptycontainers,vials,andpouchesthatdonotcontainausablequantityofcovereddrugs;

xiv. ScheduleIorotherillicitdrugs.

See SectionXIV.AforcollectionlimitationsimposedbytheDEARule.

2 UnwantedMedicinecollectedatKioskDrop-OffSitesand/orTake-BackEventsdoesnotincludeinhalers,Pre-FilledInjectorProducts,andiodine-containingmedications.

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V. CollectionofUnwantedMedicine

ThePlanprovidesservicestocollectUnwantedMedicine,includingcontrolledsubstances,inanydosageform.Thecollectionmethodsandapplicablelegalrequirementsaredescribedbelow.

A.UnwantedMedicineCollectionProgram1. OutreachPerOrdinance§2203(e)(2),MED-Projectinitiallynotified167siteswithalicensedpharmacyand10LEAlocationsintheCountyoftheopportunitytoparticipateasaKioskDrop-OffSite.MED-Projectcontinuestoperiodicallyperformoutreachviacalls,emails,andsitevisits,withthegoalofestablishingKioskDrop-OffSitesdistributedthroughouttheCounty.Aspartofthisoutreach,MED-ProjectasksifthesitesareinterestedinparticipatingintheProgram,whetherthesitescurrentlyhostakioskorprovideotherservicesforthedisposalofUnwantedMedicine,whetherpharmaciesareDEAregistrants,andifthesiteswouldlikemoreinformationregardingtheProgram.

LEAsandpharmaciesthathostedkiosksintheCountypriortotheProgrammaytransitiontotheProgramuponenteringintoanagreementwithMED-Project.

2. ImplementationMED-ProjectcontinuestoworktosatisfytheServiceConvenienceGoalsthroughsignedagreementswithKioskDrop-OffSiteHosts.MED-ProjectwillsatisfytheServiceConvenienceGoalsinanysupervisorialdistrictinwhichsignedagreementshavenotbeenattainedfortheminimumnumberofKioskDrop-OffSitesthroughMail-BackDistributionLocations.Take-BackEventsmayalsobeconductedwhenKioskDrop-OffSitesandMail-BackDistributionLocationsarenotsufficienttosatisfytheServiceConvenienceGoals.See SectionVfordetailsonhowMED-ProjectwillsatisfytheServiceConvenienceGoals.

CollectionofUnwantedMedicinebeginsatKioskDrop-OffSitesonceagreementshavebeenexecutedwitheachlocation,kioskshavebeeninstalled,siteshavebeentrained,and,inthecaseofpharmacies,allrequirementsoftheDEAandBoardofPharmacyhavebeenmet.

3. ConveniencePerOrdinance§2205(b)(1),MED-Projectwillstrivetoestablishfive(5)KioskDrop-OffSitesineachofthe11SupervisorialDistrictsgeographicallydistributedtoprovidereasonablyconvenientandequitableaccessforallResidents.InSupervisorialDistrictswhereasufficientnumberofKioskDrop-OffSitescannotbeestablished,Mail-BackDistributionLocationswillbeestablishedand,wherenecessary,Take-BackEventswillbeconductedinordertosupplementthedisposalofUnwantedMedicinebyResidentsinthoseareas.

StandardMail-BackServicesshallbeavailableuponrequestfordisabledandhome-boundResidents,therebyofferingmoreopportunitiestodisposeofUnwantedMedicine.

InadditiontotheKioskDrop-OffSites,Mail-BackDistributionLocations,andTake-BackEventsoutlinedabove,MED-ProjectshalljointlyoperateaKioskDrop-OffSitewithineachCounty-ownedpharmacywithall other approved stewardship plans.

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4. ServicesMED-Projectwillroutinelyassessperformance,gaugefeedback,andreviseitsapproachasappropriate.Asimplementationproceeds,MED-ProjectshallcontinuetoapproachorganizationsthatmaybeavailabletoassistlocatingfutureKioskDrop-OffSitesonaperiodicbasis,suchasthoselistedinAppendix B.

ThePlanwillbeimplementedinaflexiblemanner,offeringcoveragetoResidentsthroughacombinationofKioskDrop-OffSites,Mail-BackDistributionLocations,and/orTake-BackEvents,asneeded.Overthecourseofimplementation,additionalKioskDrop-OffSiteswillbeestablishedtotheextentthat(1)additionaleligibleLEAsand/orDEA-registeredcollectorpharmaciesagreetoparticipate,and(2)contractscanbeexecutedwithsuchentities.MED-ProjectwillestablishMail-BackDistributionLocationsand/orTake-BackEventsforunderservedareas.ForeveryengagementwithLEAsandpharmacies,includingtheestablishmentofKioskDrop-OffSitesand/ortheconductingofTake-BackEvents,contractsoutliningtheresponsibilitiesofallinvolvedpartieswillbedrafted,reviewedbyappropriateentities,andsignedbyallpartiesbeforeMED-Projectinstallskiosksand/orschedulesTake-BackEvents.

Mail-BackDistributionLocationsand/orTake-BackEventsshallsupplementKioskDrop-OffSitesinSupervisorialDistrictswheretheServiceConvenienceGoalsarenotmetthroughsignedagreementswithKioskDrop-OffSiteHosts.AsMED-ProjectobtainsadditionalagreementswithKioskDrop-OffSiteHosts,thesesupplementalserviceswilldecrease.

FormoreinformationregardingTake-BackEventscheduling,coverage,andfrequency,seeSectionV.C.

StandardMail-BackServiceswillbeavailabletodisabledandhome-boundResidentsuponrequestandwillbereviewedroutinelyforavailabilityandeffectiveness.See SectionV.EformoreinformationabouttheavailabilityofMail-BackServices.

AlthoughKioskDrop-OffSiteswillnotprovidekioskcollectionforPre-filledInjectorProducts,inhalers,andiodine-containingmedications,Mail-BackServicesforPre-filledInjectorProducts,inhalers,andiodine-containingmedicationswillbeavailablethroughtheCallCenterandMED-ProjectWebsiteforallResidents.UnderacurrentDEAGeneralPublicFactSheetdatedOctober21,2016(the“GeneralPublicFactSheet”),DEAsuggeststhatResidentsshouldnotdisposeofasthmainhalersoriodine-containingmedicationsincollectionreceptaclesormail-backpackagescontainingcontrolledsubstances.IftheGeneralPublicFactSheetismodifiedtoallowforcomminglingofinhalersand/oriodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptinhalersand/oriodine-containingmedicationsincollectionreceptacles,andwilldiscontinueMail-BackServicesforinhalersand/oriodine-containingmedications(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

B.KioskDrop-OffSitesKioskDrop-OffSiteswillbestrategicallyplacedacrosstheCountyinordertobestmeettheServiceConvenienceGoalsestablishedbytheOrdinance.ThisnetworkwillprovideResidentsanumberofdifferentoutletstoparticipateintheProgram.AllKioskDrop-OffSitesshallprovideResidentswithaccesstoProgramkiosksduringregularbusinesshours.

1. KioskDrop-OffSiteLocationsMED-Projectinitiallycontacted10LEAsand167siteswithalicensedpharmacylocatedintheCountyabouttheopportunityserveasaKioskDrop-OffSite.Ofthelocationscontacted,allLEAsand101

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pharmaciesexpressedinterestinparticipatingintheProgram.KioskDrop-OffSitesandMail-BackDistributionLocationsthatareinterestedinorcurrentlyparticipatingintheProgramareidentifiedinAppendix C.

MED-ProjectwillcontinueoutreachtopotentialKioskDrop-OffSitesthatarenotparticipatingintheProgramaccordingtoOrdinanceSection2203(e)(2),suchassiteslistedinAppendix D.

MED-ProjectwillestablishMail-BackDistributionLocations,and/orscheduleTake-BackEventsinanySupervisorialDistrictwheretherearefewerthanfive(5)KioskDrop-OffSites.SeeSectionV.CformoreinformationonTake-BackEventsand SectionV.EforMail-BackServices.

AsrequiredunderOrdinance§2205(b)(4),thePlanwillincludeasaKioskDrop-OffSiteanyeligibleretailpharmacyorLEAwillingtoservevoluntarilyasaKioskDrop-OffSiteforUnwantedMedicineandabletomeetallapplicablelaws,regulations,andotherlegalrequirementswithinthreemonthsoftheiroffertoparticipate.

2. Drop-OffSiteKioskPlacementandMaintenanceProgramKioskinstallationshalltakeplacewithin90daysofasignedagreementandshallbetheresponsibilityofMED-ProjectatLEAsandpharmacyKioskDrop-OffSiteswhentheKioskDrop-OffSiteHosthasidentifiedacompliantplacementlocation.AllkiosksintheProgrammustbesecurelyplacedandmaintainedinsideacollector’sregisteredlocationorLEA’sphysicallocationinaccordancewithDEARule§§1317.75(d)(1)and1317.35(a).Atpharmacies,kioskswillbeplacedintheimmediateproximityofadesignatedareawherecontrolledsubstancesarestoredandatwhichanemployeeispresent(i.e.,canbeseenfromthecounter),pursuantto§1317.75(d)(2).Atahospitalorclinicwithanon-sitepharmacy,kioskswillbeplacedinanarearegularlymonitoredbyemployeesbutnotnearareasofthefacilitywhereurgentoremergencycareisprovided.§1317.75(d)(2)(i).KioskplacementwillalsocomplywithanyapplicableBoardofPharmacyrequirements.CostsassociatedwithinstallationandmaintenancewillbepaidbyMED-ProjectperthecontractswiththeKioskDrop-OffSiteHosts.

Themaintenanceprogramwilladdressitemssuchas:

• Periodicinspectionofkioskstomonitorgeneralwearandtear;• ServiceTechnicianaccesstothekiosksduringtheregularlyscheduledpick-upsandnotificationof

aMaintenanceTechnicianifnecessary;and• ReportingbytheKioskDrop-OffSiteHostofdamagetoakioskorrequestedmaintenanceservice.

3. KioskSpecificationsAkioskwillbeofferedtoalleligiblehostlocations.Pursuantto§1317.75(e),MED-Projectkiosksatpharmacieswill:

• Besecurelyfastenedtoapermanentstructure;• Besecurelylocked,substantiallyconstructedcontainerswithapermanentoutercontainerand

removableinnerliner;• Includeasmallopeningintheoutercontainerthatallowscontentstobeaddedtotheinnerliner,

butdoesnotallowremovaloftheinnerliner’scontents;• ProminentlydisplayasignindicatingthatonlyScheduleII-Vcontrolledandnon-controlled

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substancesareacceptabletobeplacedinthekiosk;and• Havethesmallopeningintheoutercontainerlockedormadeinaccessibletothepublicwhena

KioskDrop-OffSiteemployeeisnotpresent.

Theproposeddesignofthepharmacykioskandproposedsignage(Appendix E)satisfiestheserequirementsthroughtheuseofheavygaugesteel;multiplelockingmechanisms,includingalockingmechanismonthedrop-slot;atamper-proofslot;andcommercialhinges.3Thedesignwillincreasethelikelihoodofconsumerparticipationbyprovidingeasyaccesstowheelchairusers.Thelockingmechanismonthedrop-slotwillpreventkioskoverflowoncethecontainerhasreacheditsmaximumlevelandislockedbytheKioskDrop-OffSiteHost.MED-Projectpharmacykioskswillcomewithappropriateregulatorysignageandinstructions,includinganinstructiontoremovepersonalinformationfromanyUnwantedMedicineandpackagingbeforedepositingthemandlanguagerequiredundertheDEARule4 andbytheBoardofPharmacy.Kiosksignagewillprovideinformationaboutwhatisandisnotacceptedinthe kiosk.

Additionally,under§1317.60(a),MED-Projectkioskinnerlinerswill:

• Bewaterproof,tamper-evident,andtear-resistant;• Beremovableandsealableimmediatelyuponremovalwithoutemptyingortouchingkiosk

contents;• Whensealed,makethecontentsoftheinnerlinernotviewablefromtheoutside;• Clearlyindicatethesizeoftheinnerliner;and• Bearapermanent,uniqueidentifierfortrackingpurposes.

MED-ProjectkiosksandinnerlinerswillalsocomplywithBoardofPharmacyrequirements.

WhiletheDEARuledoesnotrequireLEAkioskstomeetthesesamerequirements,MED-ProjectwillofferthesekiosksandinnerlinerstoLEAs.See DEA Rule at 53531.

4. KioskCollectionUnder§1317.05(c)(2)(iv),pharmacyKioskDrop-OffSiteHostsmustdisposeofsealedinnerlinersandtheircontentseitheron-site,throughcommonorcontractcarrierdeliveryto,orpick-upby,areversedistributorordistributor,orwithDEAassistance.

Section1317.75(c)prohibitsthecounting,sorting,inventorying,orindividualhandlingofanysubstancesdepositedintoapharmacykiosk.Additionally,§1317.60limitsinnerlineraccesstoemployeesofthecollectorandrequirestwoemployeestoimmediatelysealtheinnerlineruponitsremovalfromthepharmacykiosk’spermanentoutercontainer.See §1317.60(b),(c).Section1317.75(g)providesthatpharmacykioskinnerlinerinstallationorremovalshallbeperformed“byorunderthesupervisionofatleasttwoemployeesoftheauthorizedcollector.”Thepharmacykiosksealedinnerlinermustnotbeopened,x-rayed,analyzed,orotherwisepenetrated.See§1317.60(c).

3 As discussed in SectionXI,ifapplicable,MED-ProjectwillcoordinatewithotherapprovedproductstewardshipplanstodevelopclearstandardizedinstructionsforResidentstousekiosksandaconsistentdesign.Appendix EprovidesthekioskdesignandsignageMED-Projectexpectstoproposewhencoordinatingwithotherapprovedproductstewardshipplans.4 Specifically,asrequiredunder§1317.75(e)(4),allkioskswillprominentlydisplayasignstatingthat:“OnlyScheduleII-Vcontrolledandnon-controlledsubstancesthatarelawfullypossessedbytheultimateuserareacceptabletobeplacedinthekiosk.ScheduleIcontrolledsubstances,illicitordangeroussubstances,andanycontrolledsubstancesnotlawfullypossessedbytheultimateusermaynotbeplacedinthekiosk.”

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AtLEAKioskDrop-OffSites,VendorandtheLEAwillmaintainanyrecordsofremoval,storage,ordestructionofthecollectedUnwantedMedicineinamannerconsistentwiththeLEAs’recordkeepingrequirementsforillicitcontrolledsubstancesevidencepursuantto§1317.35.LEAswillrecordtheuniqueidentifierandsizeofthesealedinnerlinertransferredtoVendor. See§1317.35.Additionally,anyUnwantedMedicinewillbestoredinamannertopreventthediversionofcontrolledsubstancesandconsistentwiththeLEA’sstandardproceduresforstoringillicitcontrolledsubstances.See§1317.35.CollectedUnwantedMedicinewillbetransferredtothedisposalfacilityinamannertopreventthediversionofUnwantedMedicineandconsistentwiththeLEA’sstandardproceduresfortransferringillicitcontrolledsubstances.See §1317.35.

MED-Project’sKioskDrop-OffSitecollectionsystemcomplieswiththeseDEArequirementsforpharmacyandLEAKioskDrop-OffSites.Vendor,pharmacies,andLEAsparticipatingintheProgramwillkeepallrecordsrequiredundertheDEARule,includingthoserequiredunder§§1304and1317.35.PharmaciesparticipatingintheProgramwillalsokeepallrecordsrequiredunderBoardofPharmacyrequirements.PharmacyKioskDrop-OffSitesandVendorwillbeinstructednevertocount,sort,inventory,orindividuallyhandle kiosk contents.

PharmacykioskswillbelocatedwhereanemployeeispresentaffordingemployeestheopportunitytovisuallyinspectUnwantedMedicineResidentsattempttodeposit.SeeSectionV.B.2.LEAkioskswillbelocatedinsidetheLEA’sphysicallocation.SeeSectionV.B.2.MED-Project’sKioskDrop-OffSitecollectionsystemwillalsocomplywithallapplicableBoardofPharmacyrequirements.

Pick-upofUnwantedMedicinecollectedatKioskDrop-OffSiteswillbescheduledforallKioskDrop-OffSites,year-round,basedontheirregularbusinesshoursandvolumecollected.WhenarrivingataKioskDrop-OffSite,thekioskwillbecheckedbytheServiceTechniciansforanydamage.

UnwantedMedicinewillbesecurelyremovedfromthekioskbyServiceTechniciansandKioskDrop-OffSiteemployeesfollowingproceduresmeetingallDEArequirements.Specifically,twoKioskDrop-OffSiteemployeeswillholdthetwokeystounlockthekiosk.Oncethekioskisunlocked,theinnerlinerwillberemovedfromthekioskandimmediatelysealed.Theinnerlinerprovidedinthekioskwillbeopaquetopreventvisualrecognitionofthecontents.Thesealedinnerlinerwillnotbeopened,x-rayed,analyzed,orotherwise penetrated.

UnderthesupervisionoftwoKioskDrop-OffSiteemployees,theServiceTechnicianwillpackagethesealedinnerlinerfortransport.Theuniqueidentifieroftheinnerlinerwillbematchedtothetrackingnumberontheshippinglabel.TheServiceTechnicianwillscheduleapick-upbytheCarriertobecompletedwithinafewbusinessdaysandleavethepackaged,sealedinnerlinerwiththeKioskDrop-OffSiteHostforstorageincompliancewithallapplicablelaws,regulations,andotherlegalrequirementsuntilCarrier pick-up.

Vendorwillpreparethematerialsforshipmentandperformapplicablepre-transportationfunctionstocomplywithDOTHazardousMaterialsRegulations.

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5. FrequencyofPick-UpInitially,allKioskDrop-OffSiteswillbescheduledforamonthlypick-upfromthekiosk.VendorwillcommunicatewithMED-Projectintheeventthatthefrequencyofpick-upneedstobechangedbasedonthevolumescollectedovertime.Vendorwillmonitorthevolumesperservicetoensurethatallsitesarereceivingtheappropriateservicefrequency.Vendorwillmanagepick-upservicesasfrequentlyasnecessarytopreventoverflowofthekioskwithoutprovidingunnecessaryinterruptiontotheparticipatingKioskDrop-OffSite.Moreover,VendorwillmonitortheweightofUnwantedMedicinecollectedateachparticipatingKioskDrop-OffSite.

6. ProceduresifaKioskisFullPriortoScheduledPick-UpTheKioskDrop-OffSiteHostshallbeinstructedtolockthedrop-slotofthekioskandnotifyMED-Projectof the need for service if prior to the scheduled date.

VendorshallprovideanetworkoftrainedServiceTechnicians.VendorwillcommunicateservicerequeststofieldmanagersresponsibleforServiceTechnicians.VendorwilldirectservicetoatrainedServiceTechnicianwhoisinclosestproximitytotheKioskDrop-OffSiterequestingtheservice.ThisprocessprovidesforatimelyresponsetoKioskDrop-OffSitesrequiringservicepriortothescheduleddate.

ServicetimelineswillbeassessedbasedonthespecificcharacteristicsoftheKioskDrop-OffSite’sneed.Ifnecessary,Vendorwillbeabletorespondwithinhoursoftherequest.Iftherequestdoesnotrequireanurgentresponse,Vendorwillplantheresponsewithintwotothreebusinessdaysoftherequest.Vendorwillnotexceedonebusinessweekfromtheinitialrequest.Intheinterim,pharmacyKioskDrop-OffSiteHostsshallbeinstructedtosecurethekioskanditscontentsinaccordancewithDEArequirements.

7. UnplannedEventPreparednessVendormaintainsanetworkofemergencyrespondersthatcanbecalledoninthecaseofanemergencyorspillincident.Vendorensurescomplianceofallserviceprovidersthroughabusinessconfidentialqualificationprocess.Thisprocessreviewsthecompliancehistory,managementstructure,financialstability,andotherkeyindicatorsofareliableemergencyresponseserviceprovider.EmergencyresponderswillbringallnecessaryequipmentinordertomanagethespecificneedsoftheKioskDrop-OffSiterequiringemergencyresponse.

Amajorevent,suchasaflood,earthquakeorfire,mayrequireresponsebyaserviceteam.Thiseventcanjeopardizethesecuritycharacteristicsofthekioskaswellasthestructuralintegrityoftheparticipatinglocation.Theteamwillassessthesafetyoftheareaalongwiththelocationstobeserviced.Onceitisdeterminedtheareaissafeforaccess,theteamwillworktosecurethekioskandremoveitscontents.

Alongwithmajoreventpreparedness,VendorprovidestimelyresponsestoeventsthatmaycauseaninconveniencetotheKioskDrop-OffSite.Anexampleofthiskindofeventwouldbeifthekioskisgivingoffanodorpriortothescheduledservicedate.TheKioskDrop-OffSiteHostwillcontactMED-Projectviathededicatedphonenumberand/oremailaddress.Vendorisabletorespondwithintwotothreehoursinmostcaseswhennotifiedofaneedforemergencyresponse.Iftherequestisnotanemergencythatposesanimmediatethreattotheenvironmentorhealth,Vendorwilltypicallyrespondtoaservicelocationwithintwotothreebusinessdaysoftheevent.

Inaddition,personalitemsthataResidentdepositsintothekiosk(i.e.dentistry,watch,keys,wallet,etc.)willnotberetrieved.

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C. Take-BackEventsMED-Project will conduct quarterly Take-Back Events in any Supervisorial District where the Service ConvenienceGoalsarenotmetthroughsignedKioskDrop-OffSiteagreementsandMail-BackDistributionLocations.

MED-ProjectwillconfirmtotheCountythelocationsanddatestoconductTake-BackEventsoncecontractswithsupervisingLEAshavebeenexecuted.LawEnforcementAgencyemployeesshalloverseeallTake-BackEvents.Asstatedinthegoals(see Section VI),itistheintentionofMED-ProjecttoconductTake-BackEventsinordertosupplementKioskDrop-OffSitesandMail-BackDistributionLocationsastheyareimplementedacrosstheCounty.MED-ProjectwillselectthelocationoftheTake-BackEventsbasedupondemographics,currentKioskDrop-OffSites,Mail-BackDistributionLocationsandotherpopulationdiversitycharacteristicstomaximizeResidentaccesstotheeventsandbestmeettheServiceConvenienceGoals.InsituationswherealocationinthecommunitycannotbesecuredinaSupervisorialDistrict,MED-ProjectwillworkwiththeparticipatingLEAinthatdistricttohosttheeventattheprecinctorotherCountyfacilities.

DuetothechangingscheduleofTake-BackEvents,thelistofdatesandlocationswillbemaintainedontheMED-ProjectWebsiteaseventsarescheduledandconfirmed.

1. MethodTheconductingofTake-BackEventsbyMED-ProjectiscontingentuponparticipationandoversightbyLEAs.MED-ProjectwillworkwithparticipatingLEAstoensureTake-BackEventsarecompliantandsuccessful.Eventswillbepromotedandcommunicatedtothepublicthroughlocalcommunicationchannels as outlined in Appendix F.

MED-ProjectTake-BackEventswillmeetallapplicablelaws,regulations,andotherlegalrequirements.MED-ProjectwillcontractwithLEAstooverseeTake-BackEvents.Thesecontractswillprovideforthecollection,transportation,anddisposalofUnwantedMedicinefromTake-BackEventsandensurethatallrequirementsofparticipatingLEAsaremet.MED-ProjectwillworkwithLEAstoaccommodateanyreasonablerequirements.

2. ProceduresMED-ProjectwillpartnerwithLEAstoensurethatatleastonelawenforcementofficeroverseescollectionatallTake-BackEventspursuanttoDEARule§1317.65(a),(b).ThelawenforcementofficerswillmaintaincontrolandcustodyofallUnwantedMedicinecollectedatTake-BackEventsfromcollectionuntilsecuretransfer,storage,ordestructionoftheUnwantedMedicine,asrequiredby§1317.65(b).Onlyultimateusersandpersonsauthorizedtodisposeofanultimateuserdecedent’spropertyinlawfulpossessionofcontrolledsubstancesinSchedulesII-VmaytransferthesesubstancestotheLEAduringtheevent.NootherpersonwillhandlecontrolledsubstancesatTake-BackEventsunder§1317.65(e);however,VendormayassistLEAsinthecollectionofUnwantedMedicineatTake-BackEvents.See DEA Rule at 53539.

Take-BackEventswilltypicallybestaffedbyatleasttwoVendoremployees.VendorwillworkincoordinationwithMED-Project,theCounty,andLEAstomonitorandensurecollectionofallmaterialatTake-BackEventsiscompliantwithallapplicablelaws,regulations,andotherlegalrequirementsandmeetsthepublishedexpectationsoftheplannedevent.Vendorwillworkinconjunctionwithlawenforcementtoensureallmaterialisplacedinacompliantcollectionreceptacleandsecurelyshippedto

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meetallapplicablelaws,regulations,andotherlegalrequirements.AnymaterialthatisnotUnwantedMedicineordoesnotmeetlegalrequirementswillberejected.

VendorandtheLEAwillmaintainallrecordsofcollection,storage,ordestructionofthecollectedUnwantedMedicineinamannerconsistentwiththeLEA’srecordkeepingrequirementsforillicitcontrolledsubstancesevidencepursuantto§1317.35.AnycollectedUnwantedMedicinewillbestoredtopreventthediversionofcontrolledsubstancesandconsistentwiththeLEA’sstandardproceduresforstoringillicitcontrolledsubstances.AnystorageofUnwantedMedicinebyVendorwillalsocomplywiththeapplicablesecurityrequirementsof§§1301and1317,includingtherequirementthatUnwantedMedicineissecurelystoredinamannerconsistentwiththesecurityrequirementsforScheduleIIcontrolledsubstances.

Followingthecompletionofeachevent,containerswillbeweighed,securelypackaged,labeledandshippedincompliancewithallapplicablelaws,regulations,andotherlegalrequirements.ContainersandinnerlinerswillbetrackedviauniqueidentifierstoafacilityidentifiedinSectionX,wheretheyshallbeincinerated.Vendorwillshipthecontainers(andinnerliners)inaccordancewiththerequirementsoutlinedinSectionXIV.B.

3. FeesandCostsMED-ProjectshallpayalladministrativeandoperationalcostsandfeesassociatedwiththeTake-BackEvents.

D. DisposalofUnwantedMedicinefromKioskDrop-OffSitesandTake-BackEventsVendorandCarriershallmanagetheUnwantedMedicinefromKioskDrop-OffSitesandTake-BackEventsincompliancewithallapplicablelaws,regulations,andotherlegalrequirements.Carrierand/orVendorshalldeliverUnwantedMedicinecollectedfromKioskDrop-OffSitesand/orTake-BackEventstotherespectivefacilitiesidentifiedinSectionX.

Allinnerlinerswillbedestroyedinaccordancewithallapplicablelaws,regulations,andotherlegalrequirementsatthedisposalfacilitiesidentifiedinSectionX.

E. Mail-BackServicesforUnwantedMedicineMED-ProjectwillprovidefourtypesofMail-BackServicesthatwillbeavailablethroughtheCallCenterandMED-ProjectWebsite:

• StandardMail-BackServicesfordisabledandhome-boundResidentsasdescribedinSectionV.E.1;

• StandardMail-BackServicesforthecollectionofiodine-containingmedicationsforallResidentsasdescribedinSectionV.E.2;

• InjectorMail-BackServicesforthecollectionofPre-filledInjectorProductsforallResidentsasdescribedinSectionV.E.3;and

• InhalerMail-BackServicesforthecollectionofinhalersforallResidentsasdescribedinSectionV.E.4.

IftheGeneralPublicFactSheetismodifiedtoallowforcomminglingofinhalersand/oriodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptinhalersand/oriodine-containing

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medicationsincollectionreceptacles,andwilldiscontinueMail-BackServicesforinhalersand/oriodine-containingmedications(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

1. StandardMail-BackServicesMED-ProjectwillprovideStandardMail-BackServicesatnocosttodisabledandhome-boundResidentsviatheCallCenterand/orMED-ProjectWebsite.StandardMail-BackPackageswillalsobeavailableatMail-BackDistributionLocationsforallResidentsuntiltheServiceConvenienceGoalsaremetviaKioskDrop-OffSites.Thepre-paidshippinglabelwilldirecttheStandardMail-BackPackagetothefacilityidentifiedinSectionX.StandardMail-BackPackagesforUnwantedMedicineshallcomplywithallapplicablelaws,regulations,andotherlegalrequirements.

PursuanttoDEARule§1317.70(c),theStandardMail-BackPackagesforthecollectionofUnwantedMedicine,notincludinginhalers,Pre-filledInjectorProducts,oriodine-containingmedications,willbe:

• NondescriptandwithoutanymarkingsorinformationpotentiallyindicatingthattheycontainUnwantedMedicine,includingcontrolledsubstances;

• Waterandspill-proof,tamper-evident,tear-resistant,andsealable;• Pre-addressedwithanddeliveredtotheVendor’sregisteredaddress;• Pre-paid;• Providedwithauniqueidentifierenablingtracking;and• Providedwithinstructionsindicatingtheprocessformailingbackthepackages,accepted

substances,anoticeaboutmailingrestrictions,andanoticethatonlypackagesprovidedbytheVendorwillbeacceptedfordestruction.

Ultimateusersandpersonslawfullyentitledtodisposeofanultimateuserdecedent’spropertywillnotberequiredtoprovideanypersonallyidentifiableinformationwhenusingStandardMail-BackPackagestodispose of Unwanted Medicine. See §1317.70(d).Asrequiredunder§1317.70(e),VendorwillonlyacceptStandardMail-BackPackagesitmadeavailable(orpackageslawfullyforwardedunderDEArequirements).Withinthreebusinessdaysofreceipt,VendorwillnotifytheDEAifitreceivesStandardMail-BackPackageslikelycontainingcontrolledsubstancesthatVendordidnotmakeavailableordidnotagreetoreceivepursuanttoDEArequirements.Inaccordancewith§1317.70(f),whenStandardMail-BackPackagesarereceived,onlyemployeesofVendorwillhandletheStandardMail-BackPackages.StandardMail-BackPackageswillnotbeopened,x-rayed,analyzed,orotherwisepenetrateduponreceiptbyVendor.See §1317.70(f).VendorwillkeepallrecordsrequiredundertheDEARule,includingthoseidentifiedin§1304.22(f).

2. StandardMail-BackServicesforIodine-ContainingMedicationsForiodine-containingmedications,MED-ProjectwillofferallResidentsStandardMail-BackServicesandStandardMail-BackPackages,viatheCallCenterand/orMED-ProjectWebsite.Thepre-paidshippinglabelwilldirecttheStandardMail-BackPackagetothefacilityidentifiedinSectionX.IftheGeneralPublicFactSheetismodifiedtoallowforcomminglingofiodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptiodine-containingmedicationsincollectionreceptacles,andwilldiscontinueMail-BackServicesforiodine-containingmedications(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

See AppendixGforasamplepackageandpackagespecifications.

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3. InjectorMail-BackServicesforPre-filledInjectorProductsForPre-filledInjectorProducts,MED-ProjectwillofferallResidentsInjectorMail-BackServicesandInjectorMail-BackPackages,viatheCallCenterand/orMED-ProjectWebsite.Thepre-paidshippinglabelwilldirecttheInjectorMail-BackPackagetothefacilityidentifiedinSectionX.AninstructionsheetdescribinghowtoproperlydisposeofPre-filledInjectorProductsthatexplainswhatmaterialsmaybeplacedinasharpscontainer,howtousethesharpscontainer,andhowtoreturntheInjectorMail-BackPackagewillbeincludedwiththeInjectorMail-BackPackage.

See Appendix Hforasamplepackageandpackagespecifications.

4. InhalerMail-BackServicesforInhalersForinhalers,MED-ProjectwillofferallResidentsInhalerMail-BackServicesandInhalerMail-BackPackages,viatheCallCenterand/orMED-ProjectWebsite.Thepre-paidshippinglabelwilldirecttheInhalerMail-BackPackagestothefacilityidentifiedinSectionX.AninstructionsheetwillbeincludedwiththeInhalerMail-BackPackagethatdescribeshowtoproperlydisposeofinhalers,explainswhatmaterialsmaybeplacedintheInhalerMail-BackPackage,andhowtoreturntheInhalerMail-BackPackage.IftheGeneralPublicFactSheetismodifiedtoallowforcomminglinginhalerswithcontrolledsubstances,MED-Projectwillacceptinhalersincollectionreceptacles,andwilldiscontinueMail-BackServicesforinhalers(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

See Appendix Iforasamplepackageandpackagespecifications.

5. Mail-BackPackageAvailabilityDisabledandhome-boundResidentsmayrequestStandardMail-BackPackagesbycallingtheCallCenterorthroughalinkontheMED-ProjectWebsite.Homehealthcareprofessionalsprovidingservicestodisabledandhome-boundResidentsmayalsorequestStandardMail-BackPackages,onbehalfofaResident,throughtheCallCenterorthroughalinkontheMED-ProjectWebsite.Uponsuchrequest,ResidentswillbeprovidedStandardMail-BackPackagescomplyingwithDEArequirements.

InSupervisorialDistrictswherefewerthantherequirednumberofsignedagreementshavebeenobtainedfromKioskDrop-OffSiteHosts,MED-ProjectwillsupplementKioskDrop-OffSitesbyestablishingMail-BackDistributionLocationsforthedisseminationofStandardMail-BackPackages.MED-Projectwillworkwithfacilitiessuchasfirestationsand/orlibrariestoensurethatMail-BackDistributionLocationsarecentrally located.

StandardMail-BackServicesforiodine-containingmedications,InjectorMail-BackServicesforPre-filledInjectorProducts,andInhalerMail-BackServicesforinhalers,willbeavailabletoallResidentsthroughtheCallCenterandMED-ProjectWebsite.Asnotedabove,iftheGeneralPublicFactSheetismodifiedtoallowforcomminglingofinhalersand/oriodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptinhalersand/oriodine-containingmedicationsincollectionreceptacles,andwilldiscontinueMail-BackServicesforinhalersand/oriodine-containingmedications(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

AllMail-BackServiceswillsupplypackagesthatcontainaninsertwithinstructionsforuseandinformationaboutotheroptionsfordisposingofUnwantedMedicineintheRequiredLanguages.

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6. Mail-BackPackageCollectionandDisposalResidentswillbedirectedtofollowtheinstructionsprovidedviaMail-BackServices.TheUSPSestimatesuptothreebusinessdaysfordeliveryofFirstClassMail.Mail-BackServicesshalldirectpackagestoanapprovedfacilityinaccordancewiththeircontentsandpackageswillbehandledincompliancewithallapplicablelaws.

ForStandardMail-BackPackages,uponarrivingatthedestructionfacility,theyshallbescannedforreceiptverificationandthenrenderednon-retrievable.5Afterthisdestruction,anyremainingStandardMail-BackPackagematerialsshallbeincineratedatthedisposalfacilitylistedinSectionX.AnystorageofStandardMail-BackPackagesreceivedbyVendorwillcomplywiththeapplicablesecurityrequirementsofDEARuleSection1317,includingtherequirementthatUnwantedMedicineissecurelystoredinamannerconsistentwiththesecurityrequirementsforScheduleIIcontrolledsubstances.AllUnwantedMedicinewillbedestroyedpromptly.

ThisPlanproposestotreatInjectorMail-BackPackagesatanautoclavefacilitythroughtheuseofhigh-heatsterilization,anddisposeofthetreatedmaterialsinalandfill.SeethefacilitiesidentifiedinSectionX.MED-Project’srequestforapprovaltoautoclaveInjectorMail-BackPackagesisincludedinAppendixJ.

InhalerMail-BackPackagescontaininginhalerswillbetrackedusingauniqueidentifiertoadisposalfacilityforincineration.TheincineratorfacilityforthedisposalofinhalersisincludedinSectionX.MED-Project’srequestforapprovaltoincinerateInhalerMail-BackPackagescontaininginhalersatamunicipalsolidwastecombustorisincludedinAppendix K.

VI. PlanandCollectionGoals

Theshort-andlong-termgoalsofthePlanaredescribedgenerallyasfollows.AdditionaldetailonimplementationisprovidedinSectionV.A.2.

MED-Projectanticipatesthat,onceallKioskDrop-OffSitesarefullyoperational,theProgramwillcollectapproximately360poundsperKioskDrop-OffSiteduringthecalendaryear.Assuming55KioskDrop-OffSitesareoperationalforthefullyear,MED-Projectanticipatescollectingapproximately19,800poundsofUnwantedMedicinefromKioskDrop-OffSitesin2019.SeeSectionV.BformoreinformationaboutKioskDrop-OffSitecollection.

MED-Projectanticipatesacontinuedneedin2018tosupplementKioskDrop-OffSitesinafewSupervisorialDistrictsthroughMail-BackDistributionLocationsand/orTake-BackEvents.BasedonTake-BackEventcollectiontotalsin2017,MED-Projectanticipatescollectionofapproximately50poundsofUnwantedMedicine per Take-Back Event.

MED-ProjectStandardMail-BackPackageshaveacapacityof8oz.perpackage.DuetothelackofinformationavailablefromcurrentMED-ProjectPrograms,MED-Project’sestimatedcollectiontotalsin2018couldvarybasedonactualusage.Collectionin2018willbeusedtoadjustsubsequentyears’collectiongoals.

5 TheDirectorapprovedMED-Project’sStandardMail-BackPackagedisposalprocessonJuly25,2016.

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GoalArea Short-Term Long-TermCollection Within90daysofPlanapproval,

implementMail-BackServicesforinhalers,iodine-containingmedications,andPre-filledInjectorProductsviatheMED-ProjectWebsiteandCallCenter.

ContinuetosatisfytheServiceConvenienceGoalsthroughestablishedKioskDrop-OffSites,Mail-BackDistributionLocations,and/orTake-BackEvents.

IncreaseretailchainpharmacyparticipationtosatisfytheServiceConvenienceGoalsthroughestablishedKioskDrop-OffSitesinaminimumofseven(7)SupervisorialDistricts.EliminateTake-BackEventsthroughtheestablishingofKioskDrop-OffSitesandMail-BackDistributionLocations.ReducethenumberofMail-BackDistributionLocations.

IftheGeneralPublicFactSheetismodifiedtoallowforcomminglingofinhalersand/oriodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptinhalersand/oriodine-containingmedicationsincollectionreceptacles,andwilldiscontinueMail-BackServicesforinhalersand/oriodine-containingmedications(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

Education&PublicOutreach

DevelopbaselinenumberofMED-ProjectWebsitepageviewsoruniquevisitors.

EstablishabaselineofLEAs;retailpharmacies;otherpharmacies(healthcare,etc.);communitygroups;andotherthirdpartiescontacted,andreportappropriatestatisticsasoutlinedin the Survey and Annual Report SectionsofthisPlan.

Establishabaselinenumberofmediaoutletsreceivingpressadvisory,withaminimumoffiveoutlets.

Establishabaselinepercentageofcommunitycentersreached.

EstablishabaselinenumberofmessagesreturnedbyMED-Projectwithinpredeterminedtimeframe.

Onanongoingbasis,MED-Projectmayreviseand/oraddcommunicationsmaterialsbasedonchangestothePlan.

MED-ProjectwillevaluatemediaandpublicoutreachaswellascollectfeedbackbysurveyinordertomakeadjustmentsandimprovementstotheProgram.ThereviewwillmeasurepercentawarenessoftheProgram,assesstowhatextentKioskDrop-OffSitesandothercollectionmethodsareconvenientandeasytouse,andassessknowledgeandattitudesaboutrisksofabuse,poisoningsandoverdosesfromprescriptionandnonprescriptionmedicinesusedinthehome.ResultsofthereviewwillbepublishedontheMED-ProjectWebsiteestablishedunderSectionXI.D.2.

Collector Outreach

OutreachtoallpotentialeligibleKioskDrop-OffSiteHostsaccordingtorequirementsasoutlinedinOrdinanceSection2203(e)(2).

OngoingcommunicationwithpharmaciesandLEAs.EvaluationofKioskDrop-OffSitesagainsttheServiceConvenienceGoals.

VII. PatientPrivacy

InstructionsateachKioskDrop-OffSitewillinformpeoplewhodepositUnwantedMedicinethattheyshouldcompletelycrossout,remove,orotherwisemakeunreadableanyandallpersonallyidentifiableinformationonthedrugcontainersandpackagingbeforedepositingtheminthekiosk.Incaseswherepeoplefollowtheinstructions,therewillbenoreadablepersonallyidentifiableinformation.

Inadditiontokiosksignage,MED-Projectinstructional,promotional,andeducationalmaterialsencourageResidentstoprotecttheirinformationbyensuringthatpersonallyidentifiableinformationisnotpresentwhenutilizingMail-BackServicesordepositingUnwantedMedicineintokiosks.

Vendorhasadditionalprotectionsavailableforkeepingpersonallyidentifiableinformationsafeandsecure.

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ServiceTechniciansaretrainedinmanagingitemscontainingsensitivepatientinformation.PrivacytrainingispartofaServiceTechnician’sprerequisiteforfieldservices.Asaddedprotection,containers,packages,andenvelopesusedforMail-BackServiceswillbeopaqueratherthanclear.Inaddition,innerlinersusedatKioskDrop-OffSitesandTake-BackEventswillbeopaqueratherthanclear,incompliancewiththeDEARule.Thiswillpreventanyone,includingtheServiceTechnician,fromseeinganyinformationonthecontainersplacedin the kiosks.

MaterialstohelpResidentscrossoutanypersonallyidentifiableinformationwillalsobeavailableatTake-BackEvents.Thiswillensureanypatientinformationondrugpackagingwillbeunreadable.

VIII. Call Center

Per Ordinance §2206,MED-ProjectwilloperateaCallCenterjointlywithallotherapprovedstewardshipprogramsoperatingintheCounty.QuestionsfromResidentswillbemanagedthroughaninteractivevoiceresponse(“IVR”)systemandwiththesupportofanoperatoravailableduringbusinesshours.Iftheoperatorisunavailable,aResidentwillbeabletoleaveamessagetowhichtheoperatorwillrespondwithinonebusinessday.AlloperatorsaretrainedtorespondbasedontherequirementssetbyMED-Project.

TheIVRwillanswergeneralquestions,includingquestionsonthefollowingtopics:

1. Itemsthatcanbedisposedof;2. Disposaloptions;3. DirectionstotheMED-ProjectWebsiteforadditionalinformation;and4. InformationaboutavailableMail-BackServices.

BecausethelistofKioskDrop-OffSitesandMail-BackDistributionLocationsissubjecttochange,ResidentswillbedirectedtotheMED-ProjectWebsiteortoanoperatorfordetailedinformationaboutlocationsandcontactinformation.

IX. Training

Operationalprocedures,includingtraining,aretheresponsibilityoftheKioskDrop-OffSiteHost.MED-ProjectwillsupporttrainingifagreedtowiththeKioskDrop-OffSiteHost.Additionally,MED-ProjectwillmanageasupporthotlinetoanswerquestionsandmonitorcommentsforparticipatingKioskDrop-OffSitesandMail-BackDistributionLocations.

Thesupporthotlinewillsupporttwogeneralcommunicationfunctions:

1. AnswerquestionsandmonitorcommentsfromparticipatingKioskDrop-OffSitesandMail-BackDistributionLocations;and

2. SupportanddirectservicerequestsfromparticipatingKioskDrop-OffSitesandMail-BackDistributionLocations.

MessagesreceivedfromKioskDrop-OffSitesandMail-BackDistributionLocationswillbereturnedwithinonebusinessday.

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Vendorwillcomplywithallapplicablelaws,regulations,andotherlegalrequirements.Vendor’sinternaltrainingprocesswilladdressthefollowing:

• Onboarding&on-truckobservationofjobfunctions;• DOTTraining;• DEATraining;• UnitedStatesEnvironmentalProtectionAgency(“EPA”)WasteCharacterization;• OccupationalSafetyandHealthAdministration(“OSHA”)Training;• WasteHandlingDemo;• TruckOperation;• DEAHandlingDemo;• HealthInsurancePortabilityandAccountabilityAct(“HIPAA”)requirements;• OSHABloodbornePathogensStandard;• Review&WrittenTest;and• Performworkundersupervisiontodemonstrateproficiencypriortocertificationtoserviceclient

accounts.

A.ServiceTechnicianTrainingTheServiceTechnicianshandling,collecting,andtransportingtheUnwantedMedicinewillcompletecomprehensivetrainingunderthedirectionofaCertifiedHazardousMaterialsManagercertifiedSeniorEnvironmentalHealthandSafetyManager.Thistrainingincludesinstructionon:

• DOThazardousmaterialsrequirements;• EPAwastecharacterizationrequirements;• ResourceConservationandRecoveryAct(“RCRA”)hazardouswasterequirements;• DEAcontrolledsubstancestransferprotocols;• OSHArequirements;and• HIPAArequirements.

ServiceTechniciansmustcompletea24or40-hourHazardousWasteOperationsandEmergencyResponseStandard(“HAZWOPER”)course.Additionally,ServiceTechniciansmustcompleteannualrefreshertrainingthatincludesan8-hourtrainingonDOT,HAZWOPER,HIPAA,OSHA,RCRA,andsafetyandsecuritytraining.Finally,ServiceTechniciansreceiveongoingtrainingintheformofdaily“tips”,weeklymeetings,andonlinerefreshercourses.AllVendoremployeesservicingKioskDrop-OffSites,StandardMail-BackServices,and/orTake-BackEvents,willhaveatrainingbasesimilartothatofServiceTechnicians,withcustomizedtrainingasneeded.

X. Vendor,Transporter,andDisposalFacilityInformation

KioskandTake-BackEventCollectionServices

A.VendorforKioskDrop-OffSitesand/orTake-BackEvents• Name:StericycleSpecialtyWasteSolutions,Inc.willserviceKioskDrop-OffSitesandTake-

BackEvents.StericycleSpecialtyWasteSolutions,Inc.mayalsobeusedtotransportUnwantedMedicinefromTake-BackEventstoCleanHarbors-AragoniteorVeolia-PortArthur.StericycleSpecialtyWasteSolutions,Inc.mayalsobeusedtotransportUnwantedMedicinefromtheStericycle,Inc.,Indianapolis,IndianaFacilitytoVeolia-PortArthur.

• Address:2850100thCourtNEBlaine,MN55449• Phone:612-285-9865• Website:www�stericycleenvironmental�com

http://www.stericycleenvironmental.com

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B.CarrierforKioskDrop-OffSitesand/orTake-BackEvents• Name:UnitedParcelService,Inc.willtransportUnwantedMedicinefromKioskDrop-OffSitesto

theStericycle,Inc.,Indianapolis,IndianaFacility.UnitedParcelService,Inc.mayalsobeusedtotransportUnwantedMedicinefromTake-BackEventstotheStericycle,Inc.,Indianapolis,IndianaFacility.

• Address:55GlenlakeParkwayNE,Atlanta,GA,30328• Phone:800-PICK-UPS• Website:www�UPS�com/

C. ReverseDistributorFacility&TransporterforKioskDrop-OffSitesand/orTake-BackEvents1. ReverseDistributorFacility

• Name:Stericycle,Inc.,Indianapolis,IndianaFacilitywillreceiveUnwantedMedicinefromCarrier.

• Address:2670ExecutiveDrive,SuiteA,Indianapolis,IN46241-9901• Phone:317-275-7530• Website:www�stericycleenvironmental�com• Type:DEARegisteredCollectorandReverseDistributor&PermittedHazardousWaste(RCRA)

Treatment,Storage,and/orDisposalFacility

2. Transporter• Name:HeritageTransportwilltransportUnwantedMedicinefromtheStericycle,Inc.,

Indianapolis,IndianaFacilitytoHeritageThermalServices–Ohio.• Address:1626ResearchWay,Indianapolis,IN46231• Phone:(317)486-2973• Website:http://www.heritage-enviro.com/

D. DisposalFacilityforKioskDrop-OffSitesand/orTake-BackEvents1. DisposalFacility

• Name:HeritageThermalServices–OhiowillincinerateUnwantedMedicinereceivedfromtheStericycle,Inc.,Indianapolis,IndianaFacilitybyHeritageTransport.

• Address:1250SaintGeorgeStreet,EastLiverpool,Ohio,43920• Phone:800-545-7655• Website:http://www.heritage-thermal.com/• Type:PermittedHazardousWasteIncinerator

2. DirectTransportDisposalFacility• Name:CleanHarbors-Aragonite will incinerate Unwanted Medicine collected at Take-Back

EventsthatistransportedbyStericycleSpecialtyWasteSolutions,Inc.• Addresses:3MilesE7MilesNofKnolls,Wendover,UT84083• Phone:435-884-8900• Website:www�cleanharbors�com• Type:PermittedHazardousWasteIncinerator

http://www.UPS.com/


http://www.heritage-enviro.com/

http://www.heritage-thermal.com/

http://www.cleanharbors.com

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3. SecondaryDisposalFacility• Name:Veolia–PortArthurwillincinerateUnwantedMedicinethatcannotbeprocessedby

HeritageThermalServices-Ohioand/orCleanHarbors-Aragonite.• Addresses:7665TexasHighway73,Beaumont,TX77705.• Phone:409-736-2821• Website:www�veiolianorthamerica�com• Type:PermittedHazardousWasteIncinerator

StandardMail-BackServices

A.VendorforStandardMail-BackPackages• Name:StericycleSpecialtyWasteSolutions,Inc.willprovideStandardMail-BackPackages.• Address:2850100thCourtNEBlaine,MN55449• Phone:612-285-9865• Website:www�stericycleenvironmental�com

B.ShipperofStandardMail-BackPackages• Name:UnitedStatesPostalServicewillshipStandardMail-BackPackagestotheStericycle,Inc.,

Indianapolis,IndianaFacility.• Address:475L’EnfantPlaza,S.W.Washington,DC20260• Phone:(202)268-2000• Website:www�USPS�com/

C. DestructionandDisposalFacilitiesforStandardMail-BackPackages1. DestructionFacility

• Stericycle,Inc.,Indianapolis,IndianaFacilitywillrenderStandardMail-BackPackages,andthecontrolledsubstancestherein,non-retrievable.

• Address:2670ExecutiveDrive,SuiteA,Indianapolis,IN46241-9901• Phone:317-275-7530• Website:www�stericycleenvironmental�com• Type:EARegisteredCollectorandReverseDistributor&PermittedHazardousWaste(RCRA)

Treatment,Storage,and/orDisposalFacility

2. DisposalFacility• Name:CovantaIndianapolisInc.,IndianapolisResourceRecoveryFacility will incinerate non-

retrievablematerialsfromtheStericycle,Inc.,Indianapolis,IndianaFacility• Address:2320S.HardingSt.,Indianapolis,IN46221.• PhoneNumber:317-634-7367• Website:http://www.covanta.com/facilities/facility-by-location/indianapolis.aspx• Type:MunicipalWasteCombustor

InjectorMail-BackServices

A.VendorforInjectorMail-BackPackages• Name:PureWayComplianceInc.willprovideInjectorMail-BackPackages.• Address:20501KatyFreeway,Suite206,KatyTX77450• Phone:(877)765-3030• Website:http://pureway.com/


http://www.usps.com/


http://www.covanta.com/facilities/facility-by-location/indianapolis.aspx

http://pureway.com/

25

B.ShipperofInjectorMail-BackPackages• Name:UnitedStatesPostalServicewilltransportInjectorMailBackPackagestoMedsharps.• Address:475L’EnfantPlaza,S.W.Washington,DC20260• Phone:(202)268-2000• Website:www�USPS�com/

C. TreatmentandDisposalFacilitiesforInjectorMail-BackPackages1. AutoclaveFacility

• Name:MedsharpswillreceiveInjectorMail-BackPackagesfromUnitedStatesPostalServiceandrenderthemnon-infectious.

• Addresses:17340BellNDr,Schertz,TX78154• Phone:844.800.6981• Website:www�medsharps�com• Type:MedicalWasteProcessingFacility

2. DisposalFacility• Name:TessmanRoadLandfillwillreceivenon-infectiouswastefromMedsharpsanddisposeof

this waste.• Address:7000EIH10,SanAntonioTX78219• PhoneNumber:(210)661-7558• Website:https://www.republicservices.com/customer-support/facilities • Type:MunicipalSolidWasteLandfill

InhalerMail-BackServices

A.VendorforInhalerMail-BackPackages• Name:PureWayComplianceInc.willprovideInhalerMail-BackPackages.• Address:20501KatyFreeway,Suite206,KatyTX77450• Phone:(877)765-3030• Website:http://pureway.com/

B.ShipperofInhalerMail-BackPackages• Name:UnitedStatesPostalServicewilltransportInhalerMail-BackPackagestoDaniels

SharpsmartInc.• Address:475L’EnfantPlaza,S.W.Washington,DC20260• Phone:(202)268-2000• Website:www�USPS�com/

C. TransferStationforInhalerMail-BackPackages• Name:DanielsSharpsmartInc.willbeutilizedtoreceiveInhalerMail-BackPackagesandprovide

fortransporttoCovantaHuntsville,Inc.• Address:4144EastThereseAvenue,Fresno,CA93725• PhoneNumber:(559)834-6252• Website:http://danielsinternational.com/• Type:MedicalWasteTreatmentFacility


http://www.medsharps.com

https://www.republicservices.com/customer-support/facilities

http://pureway.com/


http://danielsinternational.com/

26

D. DisposalFacilityforInhalerMail-BackPackages• Name:CovantaHuntsville,Inc.willincinerateInhalerMail-BackPackagesreceivedfromDaniels

Sharpsmart,Inc.• Address:5251TrianaBlvdSW,Huntsville,AL35805• PhoneNumber:(256)882-1019• Website:https://www.covanta.com/Our-Facilities/Covanta-Huntsville • Type:MunicipalWasteCombustor

XI. UnwantedMedicineEducationalandOutreachProgramming

A.OverviewPerOrdinanceSection2206(c)andtheRegulation,MED-ProjectwillperformpubliceducationandoutreachtoeducateResidentsaboutthecollectionanddisposalofUnwantedMedicinefromhouseholds.

B.AudiencesToeffectivelyeducatethepublicabouttheProgram,MED-ProjectwilldevelopacomprehensivecommunicationscampaignfeaturingbothbroadcommunicationstacticsaswellastargetedoutreachtoaudiencesdirectlyinvolvedinthedistributionanduseofmedicinestoResidents.Theseaudiencesmayinclude:

• Generalpublic;• Pharmacies,includingeducationfordispensersofCoveredDrugs;• RetailersofCoveredDrugs;• Healthcareprovidersandtheirpatients;• Veterinaryfacilitiesandveterinaryhospitals;• Publichealthfacilities;and/or• LEAs.

TheProgramwillincludeeffortstoreachthevariedcultural,linguistic,geographic,andagedemographics,includingthroughoutreachtoethnic,community,andalternate-languagemedia;outreachtocommunityorganizationsservingabroadrangeofaudiences;availabilityofalternatelanguagephonelines(SectionXI.D.1);andavailabilityofeducationalinformationthroughabroadrangeofmediaplatforms.

Demographicinformation,includingrace,ethnicity,language,age,andgeographicdata,maybeanalyzedinordertoappropriatelydirectoutreachandcreateeducationalmaterialstobestservetheuniqueneedsofidentifieddemographics.

C. MessagesMED-Projectanticipatesthatmessagingwill:

• EducateResidentsabouttheappropriateuse,storage,anddisposalofUnwantedMedicine;• EducateResidentsaboutavailableMail-BackServices;and• ProvideResidentswithinformationaboutavailablelocationsandeventsintheirareathatoffer

disposal of Unwanted Medicine.

https://www.covanta.com/Our-Facilities/Covanta-Huntsville

27

Keypointsofemphasismightinclude:

• Theimportanceoftakingmedicinesasprescribedbyyourhealthcareprovider;• Theimportanceofadheringtoandcompletingyourprovider-prescribedtherapy;• Theimportanceofproperlyandsecurelystoringmedicines;• TheimportanceofpromptlyandproperlydisposingofUnwantedMedicine;• HowtofindanduseKioskDrop-OffSites;• HowtoproperlydisposeofUnwantedMedicine;and• Privacyissues(removingpersonallyidentifiableinformationfromlabeledprescriptioncontainers).

D. Tools/CommunicationsChannelsTheProgramwillincludeanumberofcomponentsdesignedtoreachconsumersandprovideconsistentaccesstotimelyandrelevantinformation.DistributionofmaterialswilllikelyincludeaudiencessuchasLEAs,pharmacies,healthcareprovidersandsystems,healthassociations,localgovernmentagencies,andothercommunityorganizations.MED-Projectexpectsthatthetoolsandcommunicationchannelswillinclude:

1. PhoneTheProgramwillprovideaCallCenterforResidentstoobtaininformationaboutKioskDrop-OffSitesandMail-BackDistributionLocations,educationalmaterials,andotheraspectsoftheProgramforthetake-backofUnwantedMedicinefromhouseholds.TheCallCenterwillprovide:

• IVRsupportintheRequiredLanguages.TheCallCenterwillalsoprovideanoptionforcallerstobetransferredtoanoperator.

• BasicinformationabouttheProgram,suchaswheretoobtainmoreinformation(e.g.,theMED-ProjectWebsite),andanoptiontotalkwithanoperatortofindKioskDrop-OffSites,Mail-BackDistributionLocations,and/orTake-BackEvents,ifapplicable,intheResident’szipcodeorlocalarea.

• Arecordedcallscriptdirectingcallerswithmedicalemergenciestocall911anddirectingResidentswithmedication-relatedquestionstocontacttheirhealthcareprovider(s).

Please see AppendixLforasamplecallscript.

2. MED-ProjectWebsiteMED-Projectwilldevelopamobile-friendlyMED-ProjectWebsitewithtranslationsintheRequiredLanguages.MED-ProjectexpectsinformationavailabletouserswillincludepagestohelpResidentsfindlocationsofKioskDrop-OffSitesandMail-BackDistributionLocations,aswellaseducationalmaterials,frequentlyaskedquestionsandresponses,Take-BackEventdatesandlocations,ifapplicable,andresultsofthemostrecentsurveyofProgramawareness.

• ThePlanincludessamplewebpagesfortheMED-ProjectWebsite.Appendix M provides a proof ofconceptexampleforapossibleMED-ProjectWebsitewithsubpages.

• TheMED-ProjectWebsitemayalsoincludeaccesstoapublicrelationstoolkitinadownloadableformat(seeSectionXI.D.3)andcontactinformationforResidents.Atoolkitcouldincludeitemssuchasaflyer/brochure(See AppendixNforanexample)andafrequentlyaskedquestions(FAQ)document.TranslationsofthebrochureandFAQwillbeavailableintheRequiredLanguages.

• CommunityandgovernmentorganizationsandotherpublicinterestgroupsseekingmaterialstopromotetheProgramwillbeencouragedtoaccesstheseresources.

28

3. MaterialsEducationalmaterialsabouttheProgramandhowtoproperlydisposeofUnwantedMedicine,Pre-filledInjectorProducts,inhalersandiodine-containingmedicationswillbeavailablethroughtheMED-ProjectWebsite,throughpotentialthird-partypartners,communityorganizations,andatKioskDrop-OffSites.

ThePlanincludesasampleoftheinformationandeducationalbrochure(AppendixN).EducationalmaterialswilluseplainlanguageandexplanatoryimagestopromoteconsumereducationandcollectionoptionstoResidentswithlimitedEnglishproficiency.

4. MediaOutreachMED-ProjectexpectsthattheProgramwillconductpublicoutreachthroughmediumssuchastraditionalandsocialmedia,postingofeducationalsignage,andatcommunityevents.Outreacheffortswillencouragemediaoutletsandthirdpartygroupstodownloadandusethetoolkit.ThefollowingwillsupporttheUnwantedMedicineeducationalandoutreachprogramming:

• See AppendixLforasamplecallscriptwiththetoolkitincludingflyersinAppendixN and the sampleMED-ProjectWebsiteinformationincludedinAppendix M.

• See Appendix Fforasamplelistofkeymediaoutlets.• See Appendix Oforasamplelistofsocialmediaoutlets

E. CollaborationwithCountyOfficialsandCommunityOrganizationsMED-ProjectexpectsthattheProgramwillworkincollaborationwiththeCounty,asappropriate,tobuildonexistingcommunityoutreachresources,suchaslocalorganizations,medialists,availablepublicmediaoutlets,etc.

TheProgramwillperformthefollowingactivities:

• Briefing Materials Provided to Support Coordination with County Officials:

◊ TheProgramwillprovideaccesstoeducationalandoutreachmaterials,includingthesamplebrochure(see AppendixN),torelevantdepartmentsandofficials.

• Outreach through Community Organizations:

◊ TheProgramwillengagerelevantstakeholdersandcommunityorganizationsbyprovidingselectedcommunityorganizationsidentifiedinAppendix B with the toolkit included in AppendixN.

F. DisclaimerThewrittenandverbaleducationalmaterialsandpublicoutreachtoolsthatarerequiredbytheOrdinanceanddisseminatedunderthisPlanwillincludeadisclaimersimilartothefollowing:“ThismaterialhasbeenprovidedforthepurposeofcompliancewithlegislationanddoesnotnecessarilyreflecttheviewsoftheMED-ProjectortheProducersparticipatingintheMED-ProjectProductStewardshipPlan.”

29

XII. Survey

MED-Projectwillcoordinatewithotherapprovedstewardshipplans,ifapplicable,toconductabiennialsurveyofResidents,pharmacists,veterinarians,andhealthcareprofessionalswhointeractwithmembersofthecommunity,accordingtorequirementsintheOrdinanceandRegulation.

Surveyquestionswillbedesignedtomeasure,ataminimum,(1)percentawarenessofthePrograms,(2)whetherdrop-offsitesandothercollectionmethodsareconvenientandeasytouse,and(3)knowledgeandattitudesaboutrisksofabuse,poisonings,andoverdosesfromprescriptionandnonprescriptiondrugsusedinthehome.AsrequiredbytheOrdinance§2206(a)(4),draftsurveyquestionswillbesubmittedtotheDirectorforreviewandcommentthirty(30)dayspriortodistribution.ResultsofthesurveywillbereportedtotheDirectorandmadepublicontheMED-ProjectWebsitedescribedunderSectionXI.D.2.Theprivacyofallsurveyrespondentswillbemaintained.

ThebiennialsurveywillbeconductedintheRequiredLanguagesandaccordingtorequirementsoutlinedintheOrdinanceandRegulation.

XIII. Packaging

TheOrdinancerequiresthataPlanconsider“separatingcovereddrugsfrompackagingtotheextentpossibletoreducetransportationanddisposalcosts;andrecyclingofDrugpackagingtotheextentfeasible.”Ordinance§2204(h).

MED-Projecthasconsideredandevaluatedoptionsfortheseparationandrecyclingofdrugpackaging.SeparatingandrecyclingdrugpackagingcollectedunderthePlanwouldrequirethemanagementofseparatewastestreamsatKioskDrop-OffSitesandTake-BackEvents,includingawastestreamfordrugpackagingandawastestreamforthedrugsthemselves.

WhiledrugpackagingisexpectedtoconstituteasignificantamountofthewasteincineratedunderthePlan,MED-Projecthasconcludedthatseparationofinnerand/orouterpackagingformUnwantedMedicineand/orrecyclingwouldraisethreesignificantconcerns:

1. Separatingandrecyclingdrugpackagingcouldresultinthedisclosureofconfidentialpatientinformationappearingonprescriptiondrugpackaging;

2. SeparatingandrecyclingdrugpackagingcouldincreasethepotentialforreleasesandleakageofUnwantedMedicine;and

3. Separatingandrecyclingdrugpackagingcouldincreasediversionriskbyaddingadditionalstepstothecollectionprocessand,becausedrugpackagingisoftenusedindrugcounterfeiting,couldbeadiversiontargetitself.

Forthesereasons,thePlandoesnotprovidefortheseparationandrecyclingofpackagingfromUnwantedMedicine.

MED-ProjecteducationandoutreachmaterialsinstructResidentstoreturnUnwantedMedicineataKioskDrop-OffSite,viaMail-BackServices,orataTake-BackEvent,initsoriginalcontainerorinasealedbag.ThesematerialsencourageResidentswhotransfertheirUnwantedMedicineinasealedbagtorecycleallremainingpackaging.

30

XIV. CompliancewithApplicableLaws,Regulations,andOtherLegalRequirements

TheOrdinancerequiresthataPlandescribehowallentitiesparticipatingintheProgramwill“operateunder”allapplicablelaws,regulations,andotherlegalrequirements.Ordinance§2204(d).Asdescribedinmoredetailbelow,thePlanisdesignedsuchthatallentitiesparticipatingintheProgramshallcomplywithallapplicablelaws,regulations,andotherlegalrequirements.

A.DEAControlledSubstancesActandImplementingRegulationsOnOctober12,2010,theUnitedStatesCongressenactedtheSecureandResponsibleDrugDisposalActof2010(“DisposalAct”)asamendmentstotheControlledSubstancesAct(“CSA”).TheDisposalActamendedtheCSAtoallowfortheexpansionofentitiestowhichuserscandeliverpharmaceuticalcontrolledsubstancesfordisposal,subjecttoregulationstobepromulgated.OnSeptember9,2014,theDEAadoptedaruleentitled“DisposalofControlledSubstances”(referredtohereinasthe“DEARule”)toimplementtheDisposalAct.

UndertheDEARule,collectionofcontrolledsubstancesislimitedtoScheduleII,III,IV,orVcontrolledsubstancesthatarelawfullypossessedbyanultimateuserorpersonentitledtodisposeofanultimateuserdecedent’sproperty.SeeDEARule§§1317.75(b)(KioskDrop-OffSites)6;1317.65(d)(Take-BackEvents);1317.70(b)(StandardMail-BackServices).ScheduleIcontrolledsubstances,controlledsubstancesthatarenotlawfullypossessedasdescribedabove,andotherillicitordangeroussubstanceswillnotbecollected.Additionally,astheseprovisionsoftheDEARulelimitcollectionofcontrolledsubstancestothoselawfullypossessedbyanultimateuserorcertainotherpersons,pharmaciesareprohibitedfromdisposingtheirowninventoryorstockthroughtheMED-ProjectProgram.Seealso§1317.05.

TheDEARuleprovidesthatLEAscancontinuetoacceptcontrolledsubstancesfordisposal.However,theDEARulealsoprovidesthatpharmacies,reversedistributors,hospitals/clinicswithon-sitepharmacies,andcertainotherentities,canregisterwiththeDEAas“collectors”andbecomeauthorizedattheirdiscretiononavoluntarybasistoacceptcontrolledsubstances.TheDEARule:

• ProvidesforthecollectionofcontrolledsubstancesatKioskDrop-OffSitesatLEAs,pharmacies,andhospitalswithon-sitepharmacies;

• ProvidesforcollectionofcontrolledsubstancesatTake-BackEvents;• Providesfortheuseofmail-backprogramstocollectcontrolledsubstances;• Allowsforthecomminglingofcontrolledandnon-controlledsubstances;• Establishesdetailedcollection,recordkeeping,security,andothermeasuresforallapproved

collectionmethods;and• Providesthatallcollectedpharmaceuticalproductsbedestroyedsothattheproductsare

renderednon-retrievable.

ThePlanisdesignedsuchthatallentitiesthatarepartoftheProgram,includingVendor,areindividuallyresponsibletocomplywiththeirrespectivecomplianceobligationsundertheDEARule.Vendorwillensurethatthecollection,transportation,anddisposalofUnwantedMedicinecollectedfromKioskDrop-OffSites,viaStandardMail-BackServices,andfromTake-BackEvents,includingcontrolledsubstances,complieswithallDEArequirements,includingthosein§1317.

6 ForKioskDrop-OffSitecollection,onlycertainsubstances“thatarelawfullypossessedbyanultimateuserorotherauthorizednon-registrantpersonmaybecollected.”§1317.75(b).Thislanguageissimilarto,butslightlydifferentthan,provisionslimitingcollectionatTake-BackEventsandthroughStandardMail-BackServicestoultimateusersorotherpersons(lawfully)entitledtodisposeofanultimateuserdecedent’sproperty.See §§1317.65(d);1317.70(b).

31

ControlledsubstancescollectedpursuanttothePlanmaybecommingledwithnon-controlledsubstancesatKioskDrop-OffSites,Take-BackEvents,andthroughStandardMail-BackServicespertheDEARule.See §§1317.75(b)(KioskDrop-OffSites);1317.65(d)(Take-BackEvents);1317.70(b)(StandardMail-BackServices).

1. DEARegistrationModificationPursuantto21C.F.R.§1301.51(b),pharmaciesmaymodifytheirregistrationstobecomeauthorizedcollectorsbysubmittingawrittenrequesttotheDEAoronlineatwww�DEAdiversion�usdoj�gov. This requestmustcontain:

• Theregistrant’sname,address,andregistrationnumber(asprintedontheregistrationcertificate);

• Thecollectionmethodstheregistrantintendstoconduct;and• Asignatureinaccordancewith§1301.13(j).

See§1301.51(b).MED-Projectwillconsultwithparticipatingpharmacies,asrequested,regardinghowtomodifyDEAregistrationstobecomeauthorizedcollectors.

B.UnitedStatesDepartmentofTransportation(DOT)WhentransportingUnwantedMedicine,VendorwillensurecompliancewiththeDOTHazardousMaterialsRegulations(HMR).

C. CaliforniaStateBoardofPharmacyOnJune8,2017,theBoardofPharmacyadoptedtheBoardofPharmacyRegulations,Article9.1ofDivision17ofTitle16oftheCaliforniaCodeofRegulations.LargelybasedontheDEARule,theBoardofPharmacyRegulationsestablishrequirementsapplicabletopharmacies,hospitals/clinicswithon-sitepharmacies,distributors,andreversedistributorsconductingcertaindrugtake-backservices.Amongotherthings,theBoardofPharmacyRegulationsprovide:

• ThatCalifornia-licensedpharmaciesandhospitals/clinicswithon-sitepharmaciesmustbeingoodstandingwith,andnotify,theBoardofPharmacytohostadrugkiosk.See 16CCR§§1776,1776.1(i).

• Thatpharmaciesmust“knowandadhere”toallapplicable“federal,state,andlocalrequirementsgoverningthecollectionanddestructionofdangerousdrugs”whenoperatingadrugtake-backprogram.See 16CCR§1776.1(b).

• Drugkioskplacementandmonitoringrequirements.See 16CCR§§1776.3(b)-(d).• Drugkioskinnerliner,container,andsignagerequirements.See 16CCR§§1776.3(f),(h),(m).• Innerlinerhandling,storage,anddestructionrequirementsfordrugkiosks. See, e.g., 16CCR§§

1776.3(h)-(j),1776.5(a)-(c).• Pharmacyandreversedistributorrecordkeepingrequirements.See 16CCR§§1776.5(e)-(f),

1776.6.• Pharmacydrugmail-backprogramrequirements.See 16CCR§1776.2.

ThePlanisdesignedsuchthatallentitiesthatarepartoftheProgram,includingVendor,areindividuallyresponsibleforcomplyingwiththeirrespectivecomplianceobligationsundertheBoardofPharmacyRegulations.

32

XV. AnnualReport

AnannualreportwillbeprovidedtotheDirectorwithinsixmonthsaftertheendofthefirsttwelve-monthperiodofoperationandannuallythereafter.Ordinance§2209(a).ThisreportwillbeprovidedintheformatrequiredbytheOrdinance.

Forthereportingperiod,thereportwillinclude:

• AlistofproducersparticipatingintheProgram;• Theamount,byweight,ofUnwantedMedicinecollected,includingtheamountbyweightfrom

eachcollectionmethodused,includingKioskDrop-OffSites,Take-BackEvents,andMail-BackServices(usinganaverageweightperpackage/container/envelope,asprovidedbyVendor);

• AlistofKioskDrop-OffSitesandMail-BackDistributionLocations;• Thenumberofmailersprovided,byzipcode;• ThedatesandlocationsofTake-BackEventsconducted;• Transporters,treatment,anddisposalfacilitiesused;• Whetheranysafetyorsecurityproblemsoccurredduringcollection,transportation,treatment,

ordisposalofUnwantedMedicineand,ifso,whatchangeshaveorwillbemadetopolicies,proceduresortrackingmechanismstoalleviatetheproblemandimprovesafetyandsecurity;

• Adescriptionofpubliceducation,outreach,andevaluationactivitiesimplemented;• Adescriptionofhowcollectedpackagingwasrecycledtotheextentfeasible,includingthe

recyclingfacilityorfacilitiesused;• AsummaryofthePlan’sgoals,thedegreeofsuccessmeetingthesegoalsinthepastyear,and

howthesegoalswillbeachievedinthenextyeariftheywerenotmet;and• ThePlan’stotalexpenditures.

33

AppendixAMED-ProjectParticipants

ThelistofparticipatingProducersinMED-Project’sProgramintheCountyisprovidedtotheCountyonaroutinebasistosatisfyOrdinancerequirements.

34

AppendixBSampleContactListforOutreachandEducationtotheCommunity

ThefollowingareAssociations,Agencies,andOrganizationsthatmaybecontactedforassistancewithoutreachandeducationtothecommunity.

HealthSystems: HealthAssociationsandSocieties: Organizations,Districts,andAgencies:

San Francisco Health NetworkUniversity of San Francisco Medical CenterUCSF Benioff Children’s HospitalZuckerberg San Francisco General Hospital and Trauma CenterKaiser Permanente San Francisco Medical CenterDignity Health (St� Francis, St� Mary’s)Sutter Health (Campuses: California, Davies, Pacific, St. Luke’s)San Francisco Chinese HospitalSan Francisco VA Health SystemLaguna Honda Hospital and Rehabilitation CenterLangley Porter Psychiatric Hospital and ClinicsOne Medical GroupGolden Gate Urgent Care

California State Board of PharmacyCalifornia Pharmacists AssociationThe Medical Board of CaliforniaCalifornia Nurses AssociationNational Association of Social Workers California ChapterCalifornia Board of Registered NursingCalifornia Board of Vocational NursingCalifornia Department of Health Care ServicesCalifornia Health and Human Services AgencyPharmacist’s Society of San FranciscoSan Francisco Medical Society

San Francisco Department of Public HealthSan Francisco Environment DepartmentSan Francisco Unified School DistrictSan Francisco Public Utilities CommissionHuman Services Agency of San FranciscoUniversity Systems and CampusesSan Francisco Fire DepartmentAmerican Medical Response San FranciscoCalRecycleRecologyRecycleWhere�org

35

AppendixCInterestedSitesandParticipatingKioskDrop-OffSites

SITE NAME ADDRESS ZIP CODE STATUS

AIDS HEALTHCARE FOUNDATION DBA AHF PHARMACY 4071 18TH ST 94114 PARTICIPATING

ALTO PHARMACY 1400 TENNESSEE ST UNIT 2 94107 PARTICIPATING

CBHS PHARMACY SERVICES 1380 HOWARD STREET #130 94103 PARTICIPATING

CENTRAL DRUG STORE 4494 MISSION ST 94112 PARTICIPATING

CHARLIES DRUG 1101 FILLMORE STREET 94115 PARTICIPATING

CHINESE HOSPITAL PHARMACY 845 JACKSON ST 94133 PARTICIPATING

CLAY MEDICAL PHARMACY 929 CLAY ST STE 103 94108 PARTICIPATING

CVS PHARMACY #2852 731 MARKET ST 94103 INTERESTED

CVS/PHARMACY # 10188 499 HAIGHT ST 94117 INTERESTED

CVS/PHARMACY # 1983 701 PORTOLA DR 94127 INTERESTED

CVS/PHARMACY # 4770 1101 MARKET ST 94103 INTERESTED

CVS/PHARMACY #10035 581 MARKET ST 94105 INTERESTED

CVS/PHARMACY #10080 1059 HYDE ST 94109 INTERESTED

CVS/PHARMACY #10189 1285 SUTTER ST 94109 INTERESTED

CVS/PHARMACY #4675 377 32ND AVE 94121 INTERESTED

CVS/PHARMACY #7657 351 CALIFORNIA ST 94104 INTERESTED

CVS/PHARMACY #7955 2025 VAN NESS AVENUE 94109 INTERESTED

FRANKLIN PHARMACY 1508 FRANKLIN STREET 94109 PARTICIPATING

KAISER FDN HSP FRENCH OUT PHY 321 4131 GEARY BLVD STE 101 94118 INTERESTED

KAISER FDN HSP INP/OUT HSP PHY 31A 315 2425 GEARY BLVD 94115 INTERESTED

KAISER FOUNDATION HEALTH PLAN PHARMACY 2238 GEARY BLVD 6TH FL 94115 INTERESTED

KAISER FOUNDATION HEALTH PLAN PHARMACY 2238 GEARY BLVD 1ST FLOOR 94115 PARTICIPATING

KAISER FRENCH OUTPATIENT PHY 322 4141 GEARY BLVD FIRST FLOOR 94118 PARTICIPATING

KAISER HEALTH PLAN PHARMACY NO 338 2238 GEARY BLVD 94115 INTERESTED

KAISER PERMANENTE PHARMACY #329 4131 GEARY BLVD FL 1 94118 INTERESTED

KAISER PERMANENTE PHARMACY #941 1600 OWENS ST 1ST FLOOR 94158 PARTICIPATING

MISSION WELLNESS PHARMACY 2424 MISSION ST 94110 PARTICIPATING

NEMS - CLEMENT PHARMACY 1019 CLEMENT ST 94118 PARTICIPATING

NEMS - SAN BRUNO PHARMACY 2574 SAN BRUNO AVE 94134 PARTICIPATING

NEMS-NORIEGA PHARMACY 1400 NORIEGA ST 94122 PARTICIPATING

NORTH EAST MEDICAL SERVICES PHARMACY 1520 STOCKTON ST 94133 PARTICIPATINGPC AND MZ SAN FRANCISCO GEN HOSPITAL AND TRAUMA CTR OUTPTPHARMACY MAIN OUTPATIENT 94110 PARTICIPATING

POST AND DIVISADERO MEDICAL PHARMACY 2299 POST ST NO 109 94115 PARTICIPATING

RELIABLE REXALL SUNSET PHARMACY 801 IRVING ST 94122 PARTICIPATING

STUDENT HEALTH SERV PHCY SF 1600 HOLLOWAY AVENUE 94132 PARTICIPATING

http://www2.dca.ca.gov/pls/wllpub/WLLQRYNA$LCEV2.QueryView?P_LICENSE_NUMBER=53727&P_LTE_ID=774




































36

SITE NAME ADDRESS ZIP CODE STATUS

SUTTER PROFESSIONAL PHARMACY 2300 SUTTER ST STE 101 94115 INTERESTED

VISITACION VALLEY PHARMACY 100 LELAND AVENUE 94134 PARTICIPATINGSF SHERIFF’S DEPARTMENT - WOMEN’S RESOURCE CENTER 930 BRYANT ST 94103 PARTICIPATING

SF SHERIFF’S DEPARTMENT 70 OAK GROVE STREET 94107 PARTICIPATING

SF POLICE DEPARTMENT - CENTRAL STATION 766 VALLEJO STREET 94133 PARTICIPATING

SF POLICE DEPARTMENT - SOUTHERN STATION 1251 THIRD STREET 94158 PARTICIPATING

SF POLICE DEPARTMENT - BAYVIEW STATION 201 WILLIAMS AVE� 94124 PARTICIPATING

SF POLICE DEPARTMENT - MISSION STATION 630 VALENCIA STREET 94110 PARTICIPATING

SF POLICE DEPARTMENT - NORTHERN STATION 1125 FILLMORE STREET 94115 PARTICIPATING

SF POLICE DEPARTMENT - PARK STATION 1899 WALLER STREET 94117 PARTICIPATING

SF POLICE DEPARTMENT - RICHMOND STATION 461 6TH AVENUE 94118 PARTICIPATING

SF POLICE DEPARTMENT - INGLESIDE STATION 1 SERGEANT JOHN V. YOUNG 94112 PARTICIPATING

SF POLICE DEPARTMENT - TARAVAL STATION 2345 24TH AVE 94107 PARTICIPATING

SF POLICE DEPARTMENT - TENDERLOIN STATION 301 EDDY STREET 94102 PARTICIPATING



37

AppendixDPotentialAdditionalKioskDrop-OffSites

SITE NAME ADDRESS ZIP CODE

3175 PHARMACY 3175 17TH STREET 94110B & B PHARMACY 1727 FILLMORE STREET 94115

COMMUNITY, A WALGREENS PHARMACY #15296 2262 MARKET ST 94114

COSTCO PHARMACY 144 450 10TH STREET 94103

FRANKLIN PHARMACY 1508 FRANKLIN STREET 94109GOOD LIFE RX PHARMACY 731 LARKIN ST 94109

JOE’S PHARMACY 5199 GEARY BLVD 94118

KOSHLAND PHARM: CUSTOM COMPOUNDING PHARMACY 301 FOLSOM ST STE B 94105

LC MISSION LLC 2462 MISSION ST 94110

LUCKY PHARMACY #755 1515 SLOAT BLVD 94132

LUCKY PHARMACY #756 1750 FULTON ST 94117

MISSION NEIGHBORHOOD HLTH CTR PHCY 240 SHOTWELL STREET 94110

MISSION WELLNESS PHARMACY 350 PARNASSUS AVE STE 505 94117

NIMBLE PHARMACY 2200 JERROLD AVE UNIT Q 94124

NORTH EAST MEDICAL SERVICES PHARMACY 1520 STOCKTON ST 94133PARNASSUS HEIGHTS PHARMACY 350 PARNASSUS AVE #100 94117

PHARMACA INTEGRATIVE PHARMACY INC 925 COLE ST 94117

SAFEWAY PHARMACY #0785 850 LA PLAYA ST 94121

SAFEWAY PHARMACY #0909 730 TARAVAL ST 94116

SAFEWAY PHARMACY #0964 4950 MISSION ST 94112

SAFEWAY PHARMACY #0985 2350 NORIEGA ST 94122

SAFEWAY PHARMACY #0995 1335 WEBSTER ST 94115

SAFEWAY PHARMACY #1490 2300- 16TH ST 94103

SAFEWAY PHARMACY #1507 2020 MARKET ST 94114

SAFEWAY PHARMACY #1711 15 MARINA BLVD 94123

SAFEWAY PHARMACY #2606 298 KING STREET 94107

SAFEWAY PHARMACY #2646 735 7TH AVE 94118

SCRIPTSITE PHARMACY 870 MARKET ST, STE 1028 94102

ST MARY’S MEDICAL CENTER CLINIC PHY 2235 HAYES ST 94117

SUTTER PROFESSIONAL PHARMACY 2300 SUTTER ST STE 101 94115

THOUSAND CRANES PHARMACY 1832 BUCHANAN ST STE 203 94115

TORGSYN DISCOUNT PHARMACY 5614 GEARY BOULEVARD 94121

UCSF AMBULATORY CARE CTR OUTPATIENT 505 PARNASSUS AVE RM M39 94143

WALGREENS #00887 1524 POLK STREET 94109

WALGREENS #00890 135 POWELL ST 94102





































38


WALGREENS #00893 1344 STOCKTON_ST 94133

WALGREENS #00896 3601 CALIFORNIA ST 94118

WALGREENS #01054 3398 MISSION ST 94110

WALGREENS #01109 5260 DIAMOND HEIGHTS BLVD 94131


WALGREENS #01126 1979 MISSION STREET 94103

WALGREENS #01241 1201 TARAVAL ST 94116

WALGREENS #01283 500 GEARY ST 94102

WALGREENS #01297 670 FOURTH STREET 94107

WALGREENS #01327 498 CASTRO ST 94114

WALGREENS #01393 1630 OCEAN AVE 94112

WALGREENS #01403 3201 DIVISADERO_ST 94123

WALGREENS #01626 2494 SAN BRUNO AVE 94134

WALGREENS #02005 2550 OCEAN AVE 94132

WALGREENS #02088 1333 CASTRO STREET 94114

WALGREENS #02125 320 BAY ST 94133

WALGREENS #02152 1899 FILLMORE ST 94115

WALGREENS #02153 790 VAN NESS AVE 94102

WALGREENS #02244 3801 3RD STREET SUITE 550 94124

WALGREENS #02521 300 MONTGOMERY 94104

WALGREENS #02705 2050 IRVING ST 94122

WALGREENS #02866 1363 DIVISADERO ST 94115

WALGREENS #03185 825 MARKET STREET 94103

WALGREENS #03358 1301 FRANKLIN ST 94109

WALGREENS #03383 141 KEARNY ST 94108

WALGREENS #03475 25 POINT LOBOS AVE 94121

WALGREENS #03624 275 SACRAMENTO ST 94111

WALGREENS #03706 3838 CALIFORNIA ST 94118

WALGREENS #03707 2100 WEBSTER ST SUITE 105 94115

WALGREENS #03711 1189 POTRERO AVE 94110

WALGREENS #03849 745 CLEMENT ST 94118

WALGREENS #03869 1750 NORIEGA ST 94122


WALGREENS #04275 456 MISSION STREET 94105

WALGREENS #04318 4129 18TH STREET 94114

WALGREENS #04492 33 DRUMM ST 94111


WALGREENS #04558 300 GOUGH STREET 94102

WALGREENS #04570 3001 TARAVAL STREET 94116








































39




WALGREENS #05487 5300 3RD STREET 94124

WALGREENS #05599 2120 POLK STREET 94109

WALGREENS #06291 116 NEW MONTGOMERY ST 94105

WALGREENS #06557 199 PARNASSUS AVE 94117

WALGREENS #06625 2141 CHESTNUT STREET 94123

WALGREENS #07043 459 POWELL ST 94102

WALGREENS #07044 88 SPEAR STREET 94105

WALGREENS #07150 965 GENEVA AVE 94112

WALGREENS #09886 3400 CESAR CHAVEZ 94110

WALGREENS #10044 45 CASTRO ST SUITE 124 94114

WALGREENS #11385 1580 VALENCIA ST SUITE 101 94110

WALGREENS #13583 901 HYDE ST 94109

WALGREENS #13666 1300 BUSH ST 94109

WALGREENS #13667 5280 GEARY BLVD 94118

WALGREENS #13668 1496 MARKET ST 94102

WALGREENS #13670 200 WEST PORTAL AVE 94127

WALGREENS #15127 1175 COLUMBUS AVE 94133

WALGREENS #15331 500 PARNASSUS AVE J LEVEL ROOM MU-145 94143

WALGREENS #16373 550 16TH STREET 94158

WELLMAN’S PHARMACY 1053 STOCKTON STREET 94108

WELLMAN’S PHARMACY 728 PACIFIC AVENUE #110 94133
























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AppendixE7

KioskPrototypeandProposedSignage

7 IftheGeneralPublicFactSheetismodifiedtoallowforcomminglingofinhalersand/oriodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptinhalersand/oriodine-containingmedicationsincollectionreceptaclesandmodifysignageaccordingly.

41

ProposedKioskSignage

Front Panel Kiosk Art

42


Side Panel Kiosk Art

43


Drop-Slot Kiosk Art

44

AppendixFSampleMediaList

ThefollowingisarepresentativelistofkeymediaoutletstohelpeducateResidentsaboutproperdisposalofexpiredorUnwantedMedicine.Thelistincludeslocalprint,online,television,andradiooutlets,aswellasoutletsspecificallytargetingthediversedemographiccommunitieswithintheCounty.

PrintOutlets CoverageArea Website

Bay Area Reporter San Francisco http://www.ebar.com

El Tecolote (Spanish/English) San Francisco http://eltecolote.org/content/en/

Golden Gate Xpress (University)

San Francisco http://goldengatexpress.org

Jewish Bulletin San Francisco http://www.jweekly.com

Korea Daily San Francisco http://www.koreadaily.com/index_local_branch.html?branch=SF

Marina Times San Francisco http://www.marinatimes.com

New Fillmore San Francisco http://newfillmore.com

Nichi Bei Times (Japanese/English)

San Francisco http://www.nichibei.org

Nob Hill Gazette San Francisco http://nobhillgazette.com/preview/

San Francisco Bay Guardian San Francisco http://www.sfbg.com

San Francisco Bay View San Francisco http://sfbayview.com

San Francisco Business Times San Francisco http://www.bizjournals.com/sanfrancisco/news/

San Francisco Chronicle San Francisco http://www.sfgate.com

San Francisco Examiner San Francisco http://www.sfexaminer.com

San Francisco Foghorn (University)

San Francisco http://sffoghorn.org

San Francisco Frontlines San Francisco http://www.sf-frontlines.com

SF Weekly San Francisco http://www.sfweekly.com

Sing Tao Daily (Chinese) San Francisco https://www.singtaousa.com/?variant=zh-hk&fs=16

Synapse (University) San Francisco http://synapse.ucsf.edu

The Epoch Times (Chinese/English)

San Francisco http://www.theepochtimes.com

The Guardsman (University) San Francisco http://theguardsman.com

The Independent San Francisco http://www.theindependentsf.com

The Korean Times San Francisco http://sf.koreatimes.com

The Noe Valley Voice San Francisco http://www.noevalleyvoice.com/2016/April/index.html

The Potrero View San Francisco http://www.potreroview.net

World Journal (Chinese) San Francisco http://www.worldjournal.com

http://www.ebar.com

http://eltecolote.org/content/en/

http://goldengatexpress.org

http://www.jweekly.com

http://www.koreadaily.com/index_local_branch.html?branch=SF

http://www.koreadaily.com/index_local_branch.html?branch=SF

http://www.marinatimes.com

http://newfillmore.com

http://www.nichibei.org

http://nobhillgazette.com/preview/

http://www.sfbg.com

http://sfbayview.com

http://www.bizjournals.com/sanfrancisco/news/

http://www.sfgate.com

http://www.sfexaminer.com

http://sffoghorn.org

http://www.sf-frontlines.com

http://www.sfweekly.com

https://www.singtaousa.com/?variant=zh-hk&fs=16

http://synapse.ucsf.edu

http://www.theepochtimes.com

http://theguardsman.com

http://www.theindependentsf.com

http://sf.koreatimes.com

http://www.noevalleyvoice.com/2016/April/index.html

http://www.potreroview.net

http://www.worldjournal.com

45

TelevisionOutlets Network

BAVC Public Access

KDTV Univision

KEMO Azteca America

KGO ABC

KNTV NBC

KPIX CBS

KQED PBS

KRON Media General

KSTS Telemundo

KTVU FOX

RadioOutlets CoverageArea

KALW FM 91�7 San Francisco

KCBS AM 740 San Francisco

KCSF (College app radio) San Francisco

KGO AM 810 San Francisco

KQED FM 88.5 San Francisco

KSFO AM 560 San Francisco

KUSF (College online radio) San Francisco

46

AppendixG8

SampleStandardMail-BackPackage

Description:

Plasticenvelopewithreturnlabelandinstructionalflyer

PackageSize:

Outerdimensions:8.25”x12”;innerdimensions:7.375”x10.375”;2”flapwithtamper-evidenthotmelttape,

Returnlabel:4”x4”

Instructionalsheet:5”x7”

PaperStock:

Package:4milwhite/silverpolymailerwithsequentialidentifier

Returnlabel:60#uncoatedlabelstock

Instructionalsheet:80#glosstext

Color:

Package:5/3print(silver,white,white,+2PMSonclearweb;silver+2PMSonwhiteweb)

Returnlabel:K/0nobleeds(personalizedidentifier)

Instructionalsheet:K/K

MED-ProjectmaychoosetochangeitsVendorforMail-BackServicesatanytime,inaccordancewithOrdinancerequirements.8 IftheGeneralPublicFactSheetismodifiedtoallowforcomminglingiodine-containingmedicationswithcontrolledsubstances,MED-Projectwillacceptiodine-containingmedicationsincollectionreceptacles,andwilldiscontinueMail-BackServicesforiodine-containingmedications(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5))�

47

AppendixHSampleInjectorMail-BackPackage

Description:InjectorMail-BackPackageincludingcontainerwithmail-backpackage,returnlabel,andinstructionalflyer

PackageSizes:1.4quartmail-backsystem

PureWaymail-backsolutionsareanexampleofcomplete,turnkeysystemstoprovideforthesafeandcompliantreturnofPre-filledInjectorProductsthroughtheUnitedStatesPostalService.AllPureWaysolutionsaretestedandpermittedtoUSPSspecificationsasoutlinedinUSPSPublication52.

MED-ProjectmaychoosetochangeitsVendorforMail-BackServicesatanytime,inaccordancewithOrdinancerequirements.

48

AppendixI9

SampleInhalerMail-BackPackage

Description:InhalerMail-BackPackageincludingcontainerwithmail-backpackage,returnlabel,andinstructionalflyer

PackageSizes:1.4quartmail-backsystem

PureWaymail-backsolutionsareanexampleofcomplete,turnkeysystemstoprovideforthesafereturnofinhalerwastethroughtheUnitedStatesPostalService.AllPureWaysolutionsaretestedandpermittedtoUSPSspecificationsasoutlinedinUSPSPublication52.

MED-ProjectmaychoosetochangeitsVendorforMail-BackServicesatanytime,inaccordancewithOrdinancerequirements.

9 IftheGeneralPublicFactSheetismodifiedtoallowforcomminglinginhalerswithcontrolledsubstances,MED-Projectwillacceptinhalersincollectionreceptacles,andwilldiscontinueMail-BackServicesforinhalers(exceptforcertainservicesrequiredpursuanttoOrdinance§2205(b)(5)).

49

AppendixJRequestforApprovaltoAutoclavePre-filledInjectorProducts

MED-PROJECT REQUEST FOR APPROVAL TO AUTOCLAVE PRE-FILLED INJECTOR PRODUCTS COLLECTED UNDER THE SAN FRANCISCO SAFE DRUG

DISPOSAL STEWARDSHIP ORDINANCE

January 31, 2018

50

MED-PROJECT REQUEST FOR APPROVAL TO AUTOCLAVE PRE-FILLED INJEC-TOR PRODUCTS COLLECTED UNDER THE SAN FRANCISCO SAFE DRUG DIS-

POSAL STEWARDSHIP ORDINANCE

Pursuant to Sections 2207(c) and 2211(f) of the San Francisco Safe Drug Disposal Stewardship Ordinance (the “Ordinance”), MED-Project, LLC (“MED-Project”) respectfully requests approval from the Director of the San Francisco Department of the Environment (“Director”) to autoclave and landfill Pre-filled Injector Products (as defined in MED-Project Product Stewardship Plan (“Plan”) § III) that are required to be collected through MED-Project’s Unwanted Medicine Stewardship Program (“MED-Project’s Program”) in the city and county of San Francisco (“San Francisco”).

I� BASIS FOR MED-PROJECT’S REQUEST

“Covered drugs,” as defined in the Ordinance, must be disposed of at a permitted hazardous waste disposal facility, or in the alternative, at a permitted large municipal waste combustor if the use of a permitted hazardous waste disposal facility is infeasible based on costs, logistics, or other considerations. Ordinance § 2207(a)-(b). Both of those disposal options are commonly used for unwanted medicine, but there are other well-accepted treatment options for sharps, including Pre-filled Injector Products covered by the Ordinance. The health care industry has adopted autoclaving followed by landfilling as the preferred treatment and disposal option for sharps.

MED-Project will operate its Program through a vendor that has an established system to autoclave sharps, including Pre-filled Injector Products, to render them noninfectious before final disposal. Requiring MED-Project to dispose of Pre-filled Injector Products by incineration under MED-Project’s Program would be inconsistent with well-established industry practice for sharps, disrupt MED-Project’s established treatment and disposal system for sharps, and significantly increase costs. MED-Project is therefore requesting and petitioning for approval to use autoclaves to treat Pre-filled Injector Products, pursuant to Ordinance Sections 2207(c) and 2211(f).

A� Ordinance Section 2207(c)

Under Ordinance Section 2207(c), the Director has discretion to approve alternative final disposal technologies. Manufacturers of covered drugs participating in a stewardship plan may petition the Director for approval to use alternative final disposal technologies that provide superior environmental and human health protection than provided by disposal at a permitted hazardous waste disposal facility or municipal waste combustor, or equivalent protection to these disposal options at lesser cost. Ordinance § 2207(c).

As set forth in more detail below, autoclaving has clear environmental and human health advantages, particularly as compared to incineration. Autoclaving would allow disposal of Pre-

51

filled Injector Products in a manner that is protective of the environment and human health, and it provides equivalent or superior protection regarding the criteria listed in Section 2207(c) of the Ordinance. In addition, treating Pre-filled Injector Products via autoclave is less expensive than incineration at a permitted hazardous waste disposal facility or municipal waste combustor. For these reasons, the use of autoclaves to treat Pre-filled Injector Products collected under MED-Project’s Program should be approved under the petition process for alternative final disposal technologies under Ordinance Section 2207(c).

B� Ordinance Section 2211(f)

Under Ordinance Section 2211(f), the Director may exercise its discretion to approve a proposed plan and waive strict compliance with the requirements of the Ordinance to achieve the objectives of the Ordinance. The Ordinance is intended to provide a safe and convenient collection system for unwanted medicine, and ensure unwanted medicine is properly handled, transported, and disposed of to protect the environment and human health.

As discussed in more detail below, autoclaving would allow for the proper disposal of any Pre-filled Injector Products collected under MED-Project’s Program in a manner that protects the environment and human health, in furtherance of the Ordinance’s objectives. Accordingly, the Director should exercise the discretion granted in Section 2211(f) of the Ordinance and approve autoclaving as a treatment technology for Pre-filled Injector Products.

II� AUTOCLAVING

Autoclaving is a treatment method for medical waste, including sharps, by which the waste is sterilized using heat, pressure, and steam. Autoclaves typically operate at temperatures between 120°C and 300°C, and pump saturated steam generated at elevated pressures in the chamber through the autoclave to kill microbes and completely sterilize the contents.1 After sharps are sterilized in an autoclave, the autoclaved materials are generally disposed of in solid waste landfills.

Autoclaving is the most common method for treating sharps around the world and in the United States, and represents industry best practice for treating these materials. Internationally, autoclaving is recommended by the United Nations General Assembly Human Rights Council for sharps treatment.2 In the United States, it is estimated that approximately 85% of sharps waste is sterilized, mostly through autoclaving, and only 10% of sharps waste is incinerated.3 In California, in particular, autoclaving is used lawfully by hospitals, pharmacies, and even local governments. In

1 HealtH Care WitHout Harm, NoN-iNCiNeratioN mediCal Waste treatmeNt teCHNologies 23 (Aug. 2001), available at https://noharm.org/sites/default/files/lib/downloads/waste/Non-Incineration_Technologies.pdf. 2 U.N. G.A. Human Rights Council, Report of the Special Rapporteur on the adverse effects of the movement and dumping of toxic and dangerous products and wastes on the enjoyment of human rights, U.N. Doc. A/HRC/18/31 (July 4, 2011), available at https://documents-dds-ny.un.org/doc/UNDOC/GEN/G11/144/22/PDF/G1114422.pdf?OpenElement. 3 Impact on carbon footprint: a life cycle assessment of disposable versus reusable sharps containers in a large US hospital (2012), available at http://journals.sagepub.com/doi/pdf/10.1177/0734242X12450602.

https://noharm.org/sites/default/files/lib/downloads/waste/Non-Incineration_Technologies.pdf

https://documents-dds-ny.un.org/doc/UNDOC/GEN/G11/144/22/PDF/G1114422.pdf?OpenElement

http://journals.sagepub.com/doi/pdf/10.1177/0734242X12450602

52

fact, a California State Auditor found that home-generated sharps waste in California is generally treated through the use of autoclaving before being disposed of in a landfill as solid waste, and 16 of the 17 medical waste facilities that treat sharps waste in California use the autoclaving process.4

MED-Project proposes to use an autoclave facility that is permitted as a medical waste treatment facility and accepts home-generated sharps, in accordance with the California Medical Waste Management Act. Cal. Health & Safety Code § 117600 et seq. The law requires that sharps waste be treated at a permitted medical waste treatment facility. Cal. Health & Safety Code §§ 117903. Autoclaving is expressly identified as a lawful treatment option for sharps under the California Medical Waste Management Act. Cal. Health & Safety Code § 118225(a).5 Sharps that are treated and rendered noninfectious are considered solid waste, and may be disposed of in a solid waste landfill. Cal. Health & Safety Code §§ 118225(b), 117695. Therefore, nothing under California law would prohibit or otherwise limit the disposal of Pre-filled Injector Products in the manner proposed by MED-Project.

III� SAN FRANCISCO SHOULD APPROVE THE USE OF AUTOCLAVING TO TREAT PRE-FILLED INJECTOR PRODUCTS.

Autoclaves are protective of the environment and human health, which supports MED-Project’s petition under Ordinance Section 2207(c) and request under Ordinance Section 2211(f). The Director should approve MED-Project’s proposed disposal technology under each standard because autoclaving is a widely-used means to dispose of sharps, including Pre-filled Injector Products; represents industry best practice; and is protective of the environment and human health, as explained further below.

A� San Francisco Should Approve the Use of Autoclaving to Treat Pre-Filled Injector Prod-ucts Under the Standard for Alternative Final Disposal Technologies at Ordinance Section 2207(c).

San Francisco should approve MED-Project’s petition under Ordinance Section 2207(c) to autoclave Pre-filled Injector Products. Under Ordinance Section 2207(c), MED-Project:

may petition the Director for approval to use final disposal tech-nologies that provide superior environmental and human health protection than provided by the disposal technologies in Subsec-tions (a) and (b) of this Section 2207, or equivalent protection at lesser cost.

Ordinance § 2207(c). Subsections (a) and (b) of Ordinance Section 2207 refer to disposal 4 California State Auditor’s Report on Home-Generated Sharps and Pharmaceutical Waste, pg. 31 (May 2017), available at https://www.auditor.ca.gov/pdfs/reports/2016-127.pdf.5 Cal. Health & Safety Code § 118225(a) requires that sharps waste be treated and rendered noninfectious at a medical waste treatment facility or a hazardous waste incinerator by incineration, steam sterilization (which includes autoclaving), or an alternative disposal method approved by the California Department of Public Health.

https://www.auditor.ca.gov/pdfs/reports/2016-127.pdf

53

at a permitted hazardous waste disposal facility and permitted large municipal waste combustor, respectively.

MED-Project’s proposed technology would provide equivalent or superior protection in each of the following areas:

(1) Overall impact on the environment and human health;

(2) Worker health and safety;

(3) Monitoring of any emissions or waste; and

(4) Reduction or elimination of air, water or land emissions con-tributing to persistent, bio-accumulative, and toxic pollution.

See Ordinance § 2207(c). Additionally, autoclaving is less expensive than incinerating these materials at a hazardous waste disposal facility or large municipal waste combustor.

1� Autoclaving provides superior protection related to the overall impact on the environment and human health.

Autoclaving would provide superior protection related to the overall impact on the environment and human health than provided by disposal at a permitted hazardous waste disposal facility or municipal waste combustor, satisfying this criterion under Ordinance Section 2207(c)(4).

As compared to incinerators, autoclaves generate few air emissions.6,7 In addition, autoclaves use far less energy to treat sharps than incineration,8 and therefore minimize the environmental impacts associated with energy production, including greenhouse gas emissions.

Autoclave facilities must comply with federal and state laws. For instance, the proposed autoclave for use in MED-Project’s Program to treat Pre-filled Injector Products complies with Texas’ regulations regarding the treatment and disposal of medical waste, and operates as a Type V Medical Waste Processing Facility under a medical waste registration permit issued by the Texas Commission on Environmental Quality. The facility is also certified to transport medical waste. The permit and certification serve to ensure that the autoclave is operated in a manner that is environmentally sound and protective of human health. The proposed autoclave facility has an 6 State of California, Department of Health Services, Transforming Medical Waste Disposal Practices to Protect Public Health: Worker Health and Safety and the Implementation of Large-Scale, Off-Site Steam Autoclaves 14 (Feb. 2006) (citing J. Emmanuel, Health Care Without Harm, Non-Incineration Medical Waste Treatment Technologies: A Resource for Hospital Administrators, Facility Managers, Health Care Professionals, Environmental Advocates, and Community Members (Aug. 2001), available at http://www.noharm.org/nonincineration (last accessed Nov. 22, 2005)).7 According to a California Air Resources Board technical assessment, in general, air emissions are not a concern from autoclaving as long as inappropriate medical waste, like chemotherapeutic waste, or hazardous chemicals are removed from the waste stream. California Air Resources Board, Technical Assessment Review of the Dioxins Airborne Toxic Control Measure for Medical Waste Incinerators (July 2003), Attachment B available at https://www.arb.ca.gov/toxics/dioxins/attachmentb.pdf; the main body of the Technical Assessment is available at https://www.arb.ca.gov/toxics/dioxins/medwastereview.pdf.8 Incineration or Autoclave? A Comparative Study in Isfahan Hospitals Waste Management System, 25 materia soCio mediCa 48-51 (2013), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3633376/pdf/MSM-25-48.pdf (reporting that autoclaving costs half as much as incineration with regard to energy consumption on water, gas, and electricity).

https://www.arb.ca.gov/toxics/dioxins/attachmentb.pdf

https://www.arb.ca.gov/toxics/dioxins/medwastereview.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3633376/pdf/MSM-25-48.pdf

54

exemplary compliance record, and has not had a single environmental or safety violation since it began operating in 2009.

2� Autoclaving provides superior worker health and safety protections.

Autoclaving provides superior worker health and safety protections by minimizing worker exposure to any potential air contaminants and sharps. The proposed autoclave facility for treating Pre-filled Injector Products under the Program operates in a manner which ensures compliance with all applicable federal and state laws intended to protect workers, including the U.S. Occupational Safety and Health Administration (“OSHA”) Bloodborne Pathogens Standard, OSHA Hazard Communication Standard, and U.S. Department of Transportation (“DOT”) Hazardous Materials Regulations. For instance, the autoclave facility and its employees that are involved in the handling and treatment of sharps waste operate under the facility’s Bloodborne Pathogen Exposure Control Plan.

Employees at the autoclave facility receive extensive training. For example, all employees at the facility that may be exposed to bloodborne pathogens must receive bloodborne pathogen training prior to their assignment and at least annually thereafter. And, all employees involved in packaging, loading, unloading, and transporting the waste receive DOT hazardous materials training. Employees also receive training in other areas, including: accident and injury reporting, compactor use, hazard communication, proper lifting, spill response, waste acceptance protocols, and access and exposure to medical records under the Health Insurance Portability and Accountability Act.

The autoclave facility has a standard operating procedure regarding personal protective equipment, general handling of waste received by the facility, engineering and work practice controls, spill procedures, and incident response. Autoclave employees are required to wear personal protective equipment, including puncture resistant gloves, steel-toe shoes, full coveralls, and appropriate eye protection. The autoclave facility employs operational controls and automated systems to protect workers from exposure to sharps. These include an automated autoclave and mechanical tippers for dumping the waste into the autoclave bins. The facility utilizes a vacuum autoclave that operates in a closed system and contains any air emissions during the autoclave process, which are ultimately vented outside. The facility also has ridge ventilators that provide for ventilation inside the building. Accordingly, workers should not be exposed to any emissions from the autoclave. These operational controls protect workers and limit potential exposure to the sharps and any emissions generated during the autoclave process. As further evidence of the protection of worker health and safety against any potential emissions, a study by the California Department of Health Services measured air pollutants (including mercury, methanol, and total hydrocarbons) at an autoclave facility and found that none were detectable in autoclave workers’ personal air space.9

9 State of California, Department of Health Services, Transforming Medical Waste Disposal Practices to Protect Public Health: Worker Health and Safety and the Implementation of Large-Scale, Off-Site Steam Autoclaves 14 (Feb. 2006) (citing J. Emmanuel, Health Care Without Harm, Non-Incineration Medical Waste Treatment Technologies: A Resource for Hospital Administrators, Facility Managers, Health Care Professionals, Environmental Advocates, and Community Members (Aug. 2001), available at http://www.noharm.org/nonincineration (last accessed Nov. 22, 2005).

55

In addition, the Pre-filled Injector Products collected by MED-Project will be securely contained throughout the process, limiting the risk of exposure to the waste materials at the autoclave and landfill. The California Medical Waste Management Act requires that sharps waste be transported in a “sharps container,” defined as “a rigid puncture-resistant container used in patient care or research activities meeting the standards of, and receiving approval from, the United States Food and Drug Administration as a medical device used for the collection of discarded medical needles or other sharps.” See Cal. Health & Safety Code §§ 118286(b), 117750. MED-Project will provide sharps containers meeting these requirements as part of its mail-back packages and will only accept Pre-filled Injector Products that are returned in such containers. Once the materials are treated in the autoclave, they are transferred to self-contained compactors that compact the waste in roll-off containers before being transported to the municipal waste landfill, where they are deposited into a designated space and covered. This ensures the waste is contained from collection to ultimate disposal.

Given the training, use of personal protective equipment, operational controls, automated systems to protect workers from exposure to sharps, and containment requirements described above, autoclaving Pre-filled Injector Products provides superior worker health and safety protections.

3� Autoclaves must comply with all applicable emissions and waste monitor-ing laws and regulations.

Autoclaves must comply with all applicable environmental and public health laws and regulations relating to emissions and waste monitoring at the federal, state, and local level. Autoclaving results in lower environmental impacts than treating waste at an incinerator or municipal waste combustor. Therefore, autoclaves need not comply with the more extensive regulatory and permit requirements imposed on incinerators and municipal waste combustors related to air emissions.

Under the California Medical Waste Management Act, sharps waste must be tracked from collection through treatment and final disposal. Cal. Health & Safety Code § 118040. MED-Project and its vendor will track all mail-back packages of Pre-filled Injector Products using a unique identifier to ensure the collected materials are appropriately transported, returned, treated, and disposed of. The autoclave will confirm the materials have been treated and sent to the landfill. No other waste monitoring is required. Thus, autoclaves provide equivalent compliance with all established requirements for emissions and waste monitoring.

1� As opposed to incineration, autoclaving would provide equivalent or superior protection from air, water, or land emissions contributing to persistent, bio-accumulative, and toxic pollution.

56

Autoclaving produces minimal air emissions.10 Furthermore, because autoclaves typically operate at temperatures between 120°C and 300°C, they consume far less energy than incinerators, and therefore produce less greenhouse gas emissions and toxic air pollution from energy production.

All materials that have been rendered noninfectious through autoclave treatment will remain securely contained in a sharps container throughout the process as they are transported, handled, and treated at an autoclave facility. The autoclaved materials are then compacted in a sealed roll-off container, and disposed of in a permitted municipal solid waste landfill. The autoclaved materials are therefore contained after treatment, including when they are placed in the landfill.

Also, according to a California Air Resources Board technical assessment, water effluent from the autoclaving process is negligible provided facilities properly segregate their waste.11 With respect to MED-Project’s Program, the effluent from autoclaving Pre-filled Injector Products should not contain hazardous materials.

2� Autoclaving sharps would provide superior or equivalent protection at lesser cost.

Autoclaving sharps is significantly less expensive than incinerating sharps at a permitted hazardous waste disposal facility or permitted large municipal waste combustor.

B� San Francisco Should Exercise its Discretion to Waive Strict Compliance with the Or-dinance Under Ordinance Section 2211(f) and Approve the Use of Autoclaving to Treat Pre-Filled Injector Products.

The Director should exercise its discretion under Ordinance Section 2211(f) to approve MED-Project’s Plan and waive strict compliance with the disposal provisions of the Ordinance in order to achieve the Ordinance’s goals of ensuring unwanted medicine is properly treated and disposed of in a manner that is protective of the environment and human health.

MED-Project’s proposal to autoclave Pre-filled Injector Products and landfill the autoclaved materials meets the objectives of the Ordinance, as evidenced by the information provided above. MED-Project’s proposal would protect the environment and human health because there are minimal, if any, air and water emissions from the autoclaving process. There are also reduced environmental impacts associated with energy production, as compared to incineration, because 10 According to a California Air Resources Board technical assessment, in general, air emissions are not a concern from autoclaving as long as inappropriate medical waste, like chemotherapeutic waste, or hazardous chemicals are removed from the waste stream. California Air Resources Board, Technical Assessment Review of the Dioxins Airborne Toxic Control Measure for Medical Waste Incinerators (July 2003), Attachment B available at https://www.arb.ca.gov/toxics/dioxins/attachmentb.pdf; the main body of the Technical Assessment is available at https://www.arb.ca.gov/toxics/dioxins/medwastereview.pdf.11 The technical assessment noted that “[s]taff at the Los Angeles County Sanitation District indicated that there were no adverse water discharge issues from autoclaves.” California Air Resources Board, Technical Assessment Review of the Dioxins Airborne Toxic Control Measure for Medical Waste Incinerators (July 2003), Attachment B available at https://www.arb.ca.gov/toxics/dioxins/attachmentb.pdf; the main body of the Technical Assessment is available at https://www.arb.ca.gov/toxics/dioxins/medwastereview.pdf.









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autoclaves use less energy to treat sharps. MED-Project’s use of the autoclave would also protect human health and safety against the improper handling and disposal of Pre-filled Injector Products since the autoclave employs automated systems, operational controls, and robust worker health and safety protocols to protect workers from exposure to sharps and any potential emissions from the autoclave.

MED-Project’s proposed disposal process also adequately protects human health and safety because all Pre-filled Injector Products collected by MED-Project are containerized throughout the collection, transportation, autoclaving, and disposal process, dramatically reducing the chance that the workers or the public could be exposed to Pre-filled Injector Products. Accordingly, the use of an autoclave to treat pre-filled injector products collected by MED-Project furthers the objectives of the Ordinance.

IV� CONCLUSION

Based on the foregoing reasons, MED-Project respectfully requests that the Director exercise its discretion and authorize the use of autoclaves for treating Pre-filled Injector Products collected from San Francisco residents under MED-Project’s Program in accordance with Sections 2207(c) and 2211(f) of the Ordinance.

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AppendixKRequestforApprovalofInhalerMail-BackPackageDisposalProcess

MED-PROJECT REQUEST FOR APPROVAL OF INHALER MAIL-BACK PACKAGE DISPOSAL PROCESS

January 31, 2018

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MED-PROJECT REQUEST FOR APPROVAL OF INHALER MAIL-BACK PACKAGE DISPOSAL PROCESS

Pursuant to San Francisco’s Ordinance 31-15, codified at chapter 22 of the San Francisco Environment Code (the “Ordinance”) § 2207(b), MED-Project LLC (“MED-Project”) requests the Director of the Department of the Environment’s (the “Director’s”) approval to use the Covanta Huntsville, Inc. facility (the “Covanta Huntsville Facility”) for the disposal of Inhaler Mail-Back Packages (as defined in MED-Project Product Stewardship Plan (“Plan”) § III). As described below, cost, logistics, and other considerations make disposal of Inhaler Mail-Back Packages at permitted hazardous waste facilities not feasible at this time.

I� THE COVANTA HUNTSVILLE FACILITY’S PROCESS FOR THE DISPOS-AL OF INHALER MAIL-BACK PACKAGES

MED-Project is proposing that Inhaler Mail-Back Packages will be pre-addressed and pre-paid for delivery to a transfer facility for transport the Covanta Huntsville Facility for disposal.1 The Covanta Huntsville Facility will scan the unique barcode on each Inhaler Mail-Back Package to record its receipt before incinerating it.

The Covanta Huntsville Facility is a permitted large municipal waste combustor. The furnaces at the Covanta Huntsville Facility are operated at temperatures exceeding 1800 degrees Fahrenheit.2 As a “waste-to-energy” facility, the Covanta Huntsville Facility uses municipal solid waste, like Inhaler Mail-Back Packages, to generate steam used for the U.S. Army’s nearby Redstone Arsenal’s heating and air conditioning needs.3 To control air pollution, the Covanta Huntsville Facility employs semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, and a continuous emissions monitoring system. Additionally, the Covanta Huntsville Facility has been designated as a Voluntary Protection Program Star facility by the U.S. Occupational Safety and Health Administration, recognizing the facility’s employer’s and employees’ exemplary achievement in the prevention and control of occupational safety and health hazards.4

II� STANDARD FOR THE DIRECTOR TO APPROVE THE COVANTA HUNTS-VILLE FACILITY FOR THE DISPOSAL OF INHALER MAIL-BACK PACK-AGES

Under Ordinance § 2207(b), “[t]he Director may grant approval for a Stewardship Plan to dispose of some or all collected Covered Drugs [including inhalers] at a permitted large municipal waste combustor . . . if the Director deems the use of a hazardous waste disposal facility . . . to be

1 The Covanta Huntsville Facility’s mailing address is 5251 Triana Blvd SW, Huntsville, AL 35805. 2 See Solid Waste Disposal Authority of the City of Huntsville, Waste to Energy, http://swdahsv.org/waste-to-energy/. 3 See Covanta, Covanta Huntsville, https://www.covanta.com/Our-Facilities/Covanta-Huntsville. 4 Id.; U.S. Occupational Health and Safety Administration, All About VPP, https://www.osha.gov/dcsp/vpp/all_about_vpp.html.

http://swdahsv.org/waste-to-energy/

http://swdahsv.org/waste-to-energy/

https://www.covanta.com/Our-Facilities/Covanta-Huntsville

https://www.osha.gov/dcsp/vpp/all_about_vpp.html

https://www.osha.gov/dcsp/vpp/all_about_vpp.html

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infeasible for the Stewardship Plan based on cost, logistics or other considerations.”

III� THE USE OF THE COVANTA HUNTSVILLE FACILITY TO DISPOSE OF INHALER MAIL-BACK PACKAGES SHOULD BE APPROVED UNDER OR-DINANCE § 2207(b) BECAUSE DISPOSAL AT A PERMITTED HAZARDOUS WASTE FACILITY IS NOT FEASIBLE

MED-Project proposes to use the Covanta Huntsville Facility because disposal of Inhaler Mail-Back Packages at permitted hazardous waste disposal facilities is not feasible at this time due to logistics, cost, and other considerations.

First, MED-Project engaged multiple potential vendors to evaluate whether they could distribute, receive, and dispose of Inhaler Mail-Back Packages, but most vendors do not offer such services. Furthermore, the only Vendor willing and able to offer these services for Inhaler Mail-Back Packages, PureWay Compliance Inc., offers disposal at a municipal waste combustor (the Covanta Huntsville Facility). Accordingly, the use of a hazardous waste disposal facility for Inhaler Mail-Back Packages is not logistically feasible at present, given the information MED-Project has received from its Vendor about its access to disposal facilities.

Second, the cost to dispose of Inhaler Mail-Back Packages at a hazardous waste disposal facility would be much greater than the cost to dispose of such packages at the Covanta Huntsville Facility. In MED-Project’s experience, hazardous waste incinerators typically charge significantly more than municipal waste combustors to dispose of the same quantity of waste. Additionally, identifying a hazardous waste disposal facility willing to accept Inhaler Mail-Back Packages and ensuring that MED-Project’s Vendor is capable of delivering Inhaler Mail-Back Packages to that facility would cause delay and increase MED-Project’s costs, further supporting the conclusion that it is infeasible from both a cost and logistics standpoint for MED-Project to dispose of Inhaler Mail-Back Packages at a hazardous waste incinerator.

Third, there are no other laws or requirements, outside of the Ordinance, that would require MED-Project to dispose of Inhaler Mail-Back Packages at a hazardous waste incinerator or preclude MED-Project from disposing of these materials at a municipal waste combustor. Any inhalers collected by MED-Project under this Plan are not regulated under the state’s hazardous waste regulations, and therefore are not required to be treated as hazardous waste.

IV� CONCLUSION

Accordingly, the Director should approve the disposal of Inhaler Mail-Back Packages at the Covanta Huntsville Facility as proposed by MED-Project under Ordinance § 2207(b).

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AppendixLSampleCallCenterScript

ThankyouforcallingtheinformationlinefortheMedicationEducationandDisposalProject,orMED-Project.

CallScript:

• Ifyouareexperiencingamedicalemergency,pleasehangupanddial9-1-1.• Ifyouareexperiencinganon-emergencybutsuspectthatyouorafamilymemberhasingested

somethingpoisonous,pleasecallCaliforniaPoisonControlat800-222-1222.• Kiosksarelocatedthroughoutthecityandprovideconvenientoptionsforreturningexpiredor

unwantedmedicine.Press 3formoreinformationaboutconvenientkiosks.• Mail-BackServicesareavailabletoResidents.Press 4formoreinformation.• Take-BackEventsarescheduledthroughouttheyearandofferResidentsafreeandconvenient

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way to dispose of expired or Unwanted Medicine. Press 5formoreinformation.• Youmaypress 0atanytimetospeakwithanoperatoraboutdisposaloptions.• MED-Projectisaconsumereducationcampaigndedicatedtopropermedicationuseand

consumerdisposal.• MED-Projectremindsyouthattakingyourmedicineasdirectedbyyourhealthcareprovideris

criticallyimportanttoyourhealth.• Ifyouhavequestionsaboutyourmedication,pleasehangupanddialyourhealthcareprovider.• ForadditionalquestionsabouttheproperdisposalofexpiredorUnwantedMedicinefrom

households,pleasegotoMEDProject�org or press 0 to talk to an operator.• Tohearthismenuagain,pleasepress 1.• Thank you for calling MED-Project.

KioskScriptforwhen3isselected:

• KioskstocollectexpiredandUnwantedMedicinearelocatedthroughoutyourlocalarea.Tolocatethekiosksitenearestyou,orforpreciseinformationaboutkiosksitecontactinformation,press 0 to speak with an operator or visit MEDProject�org tosearchbyyourzipcode.Mail-BackDistributionLocationsmayalsobeavailableinyourarea.

• Kiosksacceptmedicationsinanydosageformintheiroriginalcontainerorsealedbag.Noherbalremedies,vitamins,supplements,cosmeticsorotherpersonalcareproducts;inhalers;medicaldevices;sharps;illicitdrugs;oriodine-containingmedicationswillbeaccepted.

• Ifyoudotransferyourmedicationstoasealedbag,pleasebesuretorecycleallremainingpackaging.

• Toprotectyourprivacy,removeorblackoutallpersonallyidentifiableinformationbeforedisposingofyourmedicationsorrecyclingyourdrugpackaging.

• Torepeatthisinformation,press 3.• Toreturntothemainmenu,pleasepress 1.• Thank you for calling MED-Project.

Mail-BackServices10Scriptforwhen4isselected:

• Mail-BackServicesareavailabletoResidentswhoaredisabledandhome-boundorhomehealthcareprofessionalsprovidingservicestodisabledandhome-boundResidents.Mail-BackServicesarealsoavailabletoallResidentsforPre-filledInjectorProducts,inhalers,andiodine-containingmedications.

• Mail-BackDistributionLocationsmayalsobeavailablenearyou.• Torequestamail-backpackage,pleasepress 0 to talk to the operator or visit MEDProject�org.• Mail-backpackagesacceptmedicationsinanydosageformintheiroriginalcontainerorsealed

bag.Noherbalremedies,vitamins,supplements,cosmeticsorotherpersonalcareproducts;medicaldevices;sharps;orillicitdrugswillbeaccepted.



• Torepeatthisinformation,press 4.• Toreturntothemainmenu,pleasepress 1.

10 Mail-backpackagedimensionsorcapacitywillbeincludedinthefinalcallscriptthatispublishedtotheIVR.




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• Thank you for calling MED-Project.Take-BackEventScriptforwhen5isselected:

• MED-ProjectisworkingwithlocallawenforcementandothercommunityorganizationstoofferTake-BackEventsforthecollectionofUnwantedMedicinefromResidents.ForacompletelistofTake-BackEvents,pleasepress 0 to speak to the operator or visit MEDProject�org.

• MedicationsinanydosageformintheiroriginalcontainerorsealedbagareacceptedatTake-BackEvents.Noherbalremedies,vitamins,supplements,cosmeticsorotherpersonalcareproducts;inhalers;medicaldevices;sharps;illicitdrugs;oriodine-containingmedicationswillbeaccepted.



• Torepeatthisinformation,press 5.• Toreturntothemainmenu,pleasepress 1.• Thank you for calling MED-Project.


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AppendixMMED-ProjectWebsite

65

ProposedWebPage

66

ProposedWebPage

67

ProposedWebPage11

11 Mail-backpackagedimensionsorcapacitywillbeincludedinthefinalwebpagethatispublishedtotheMED-ProjectWebsite.

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ProposedWebPage

69

ProposedWebPage

70

ProposedWebPage

71

ProposedWebPage

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AppendixNSampleBrochure

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AppendixOSampleDigitalandLocalSocialNetworks

ThefollowingisarepresentativelistoflocalorganizationsandtheirsocialmedianetworksintheCounty.MED-ProjectwillreachouttorelevantgroupstohelppromotetheProgram.

OUTLET FACEBOOK TWITTERSan Francisco Department of Public Health https://www.facebook.com/San-Francisco-Health-

Network@SF_DPH

University of San Francisco Medical Center https://www.facebook.com/UCSFMedicalCenter @UCSFHospitalsZuckerberg San Francisco General Hospital https://www.facebook.com/Zuckerberg-San-

Francisco-GeneralKaiser Permanente https://www.facebook.com/kpthrive @KPShareDignity Health https://www.facebook.com/dignitymedicalgroupss @dignitymedgroupChinese Hospital https://www.facebook.com/chinesehospitalsfSutter Health https://www.facebook.com/SutterHealth @SutterHealthSan Francisco VA Health System https://www.facebook.com/VeteransAffairs @DeptVetAffairsUCSF Benioff Children’s Hospital https://www.facebook.com/UCSFBenioffChildrens @UCSFChildrensSF Department of the Environment @SFEnvironmentSan Francisco Unified School District https://www.facebook.com/SFUnified/ @SFUnifiedSan Francisco Public Utilities Commission https://www.facebook.com/SFWater/City and County of San Francisco https://www.facebook.com/SF @SFGOVSan Francisco Police Department https://www.facebook.com/SFPD @SFPDSan Francisco Medical Society https://www.facebook.com/San-Francisco-Medical-

Society@SFMedSociety

California Pharmacist Association https://www.facebook.com/CAPharm @CAPharmCalifornia Nurses Association https://www.facebook.com/nationalnurses @NationalNursesNational Association of Social Workers California https://www.facebook.com/naswca @naswcaSan Francisco Fire Department https://www.facebook.com/yoursffd @sffdpioUniversity of California San Francisco https://www.facebook.com/ucsf @UCSFSan Francisco State University https://www.facebook.com/sanfranciscostate @SFSUUniversity of San Francisco https://www.facebook.com/University.of.San.

Francisco@usfca

City College of San Francisco https://www.facebook.com/City-College-of-San-Francisco

The San Francisco LGBT Center https://www.facebook.com/sflgbtcenter @sflgbtcenterChinese American Community Foundation https://www.facebook.com/Chinese-American-

Community-Foundation-198288093627547/@chinesegiving

Latino Community Foundation https://www.facebook.com/latinocommunityfoundation

@LationCommFdn

San Francisco Chronicle https://www.facebook.com/SFGate/ @SFGateNBC Bay Area https://www.facebook.com/NBCBayArea/ @nbcbayareaKFOG Radio https://www.facebook.com/kfogradio @kfogradioSan Francisco Parent Teacher Association @SanFranciscoPTACalifornia Teachers Association https://www.facebook.com/WeAreCTA @WeAreCTA

a product stewardship plan - sfenvironment.org · med-project website ... xii. survey ......

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