PAVINGTHEPOLICYPARKWAYFORTHENATION’SFIRSTSUPERVISEDINJECTION

FACILITY

JKCostello,M.D.8/8/2016

AbstractSupervisedinjectionisacontemporaryharmreductionmeasurethataimstoreducetheadverseeffectsofinjectiondruguse.SuchfacilitieshavesuccessfullyreducedoverdosesandpublicinjectioninEurope,Australia,andCanada.Therecurrentlyexistnosupervisedinjectionfacilities(SIFs)intheUSA,althoughtheyarenowpartoftheconversationonoverdosereductioninthiscountry.Thisprojectisamixed-methodssurveyassessingthepotentialtoestablishaSIFinDenver,Colorado.Denverpossessesseveralattributesmakingitacandidateforsupervisedinjection,includingarobustharmreductionorganization,liberalsocialpolicies,andaprominentpublicdrugusescene.Unfortunately,drugoverdoseisalsoontheriseinDenver.Supervisedinjectioncouldhelpalleviatethelattertwoproblemsinacost-effectivemanner.Thisprojectaimstoinformtheresearchquestion,“CanDenverestablishasupervisedinjectionfacility?”Theresearchinvolvesasemi-structuredinterviewwithquantitativevariablesincludingLikertscaleratingsanddiscretefrequencies.Subjectsincludeabroadsampleofpeoplewhoinjectdrugs(PWID)aswellascommunitystakeholdersfromthebusiness,healthcare,andmunicipalrealms.Analysesincludestatisticalcomparisons,qualitativeanalysisofinterviewdata,mapping,geospacialmapping,cost-effectivenessanalysis,andcost-benefitanalysis.FollowingarerecommendationsonthenextstepsinthepushforaSIFinDenver.

I. IntroductionInjectiondruguseisanuncommonbutuniquelydestructivehealthbehavior.Itiscloselyassociatedwithaddictionanddependency.Itseffectspervadethelivesofusers,causingsignificantproblemsinvirtuallyeveryrealmoffunctioning.Furthermore,theeffectsofinjectiondrugusespillovertofamilymembers,thehealthcaresystem,andevenbystanderswhodonotengageininjecting.Theinjection-relatedburdenofcrime,disease,andpublicdisorderisthussharedbyusersandnonusers.Prohibitionsondrugusehavelargelyfailedtostemdruguseinallitsforms.Evencountrieswithverystrictdruglawshaveratesofinjectiondruguseapproaching1inevery200adults;sometimes,ratesareactuallylowerincountrieswithmoreliberaldruglaws(Mathers2008).Often,strictdruglawshaveacounterintuitiveeffectondruguse.Insteadofceasingdrugusetocomeintocompliancewiththelaw,usersinsteadengageinmoreriskybehaviors(Burris2004).Someschoolsofthoughtaddressdruguseasadangeroushealthbehaviorratherthancriminalactivity.Oneoftheseapproachestodrugpolicyiscalledharmreduction.Harmreductionis“asetofpracticalstrategiesandideasaimedatreducingnegativeconsequencesassociatedwithdruguse.”Othershavedefinedharmreductionas“meetinguserswherethey’reat”andotherdefinitionsemphasizethatharmreductionacceptscontinueduseofdrugs.Thisapproachacknowledgesthatdruguseisarealityandtriestodecreasetheattendantharmstoindividualandcommunitylifeandwell-beinginsteadofencouragingabstinence(HarmReductionCoalition2015).Twocurrenttopicsininjection-relatedharmreductionaresyringeaccessandoverdoseprevention.Syringeaccess,alsoknownasneedleexchange,notonlyprovidessterileneedlestoinjectionusersbutalsohelpsthemdisposeofneedlessafely.Government-fundedstudiesintheUShavefoundsyringeaccesscanreduceneedlesharingandthespreadofbloodbornedisease,primarilyHIVandhepatitisC(SAMSHA2015).Overdosepreventionincludeseducationandprovisionofnaloxone,anopioidantagonistagentwhichcanimmediatelyreverseopiateoverdose.ThesepracticeshavebecomecommonplaceinmanyUScitiesoverthepasttwentyyears;theynowformacornerstoneofthepublichealthapproachtoinjectiondruguse.WhileHIVandhepatitisspreadhavebeenaddressedbyneedleexchange,opioidoverdoseisanemergingpublichealthcrisis.Formanyyears,overdosewasaminorcauseofdeathintheUSandoccurredmainlyinyoungmales.From2001to2014,thenumberofoverdosedeathsfromopioidpainkillersnearlytripled.Overthesameperiod,thenumberofheroinoverdosedeathsincreasedsixfold(NIDA,2015).Overdoseistheleadingcauseofinjurydeathforpeopleages25to64;injuryistheleadingcauseofdeathfrom25to44andthethird-leadingcauseofdeathforpeople35to64.Intermsoflostyearsoflife,overdosethuscomprisesahugemortalityburdenintheUS,accountingfor27%ofthecostsofallfatalinjury(CDC,2016).Inmanyplaces,includingColorado,substanceabuseandoverdosearetheleadingcauseofdeathforhomelessadults(Baggett2013andColoradoCoalition2014).Whilefataloverdosesonprescriptionopioidsstilloutnumberheroinoverdoses,heroinoverdosesareundoubtedlyanepidemicintheirownright.TheColoradoDepartmentofPublicHealthandEnvironmentcitesa700%increaseinheroin

overdosedeathsoverthe12yearsfrom2003to2015asevidenceforthisepidemic;virtuallyalltheseoverdosesoccurredduetoinjection(Wild,2016).Onemethodforpreventingoverdosesiscalledsupervisedinjection.KnowninEuropeasdrugconsumptionfacilities,supervisedinjectionfacilities,orSIFs,havedevelopedoverthelastthirtyyearstojointlyaddresssyringeaccessandoverdoseprevention.TheybeganintheNetherlandsandSwitzerlandasorganicresponsestoopendrugscenesandriskyinjectionpractices.TheyhavesincespreadtomanymajorcitiesinEurope,Australia,andCanada.ThefirstSIFsemergedinthe1970sand1980sinEurope.Manywerefoundedtoprovidegeneralsocialservicestoindigentpersons.Theprevalenceofinjectingdrugsamongthemarginalizedpatronsofthesefacilitiesledmanyofthesitestobecomedefacto“shootinggalleries,”wherepeopleuseddrugsinbathroomswithimpunity.Ratherthanattempttostampoutthepractice,onefacilityinBern—acaféforhomelesspeople—insteadprivatelysanctionedit.Thus,thefirstofficialsupervisedinjectionfacilitiessimplyinvolvedoutsidestakeholders,suchascityofficialsandothernonprofitproviders,tosupportwhatwasalreadyhappeningonthepremises.Thesefacilitiesdidnotsimplyhappenhaphazardly.Theygrewfromprivateeffortsthatwereignoredortoleratedbycitygovernmenttowell-fundedorganizationswiththefullsupportofhealthandlawenforcementofficials.In1996,supervisedinjectionwasacceptedonafederallevelintheNetherlands.Municipalitiesthatwishtostartasupervisedinjectioncentermustconvenea“trianglecommittee”composedofpolice,prosecutors,andthemayor.ManyDutchsupervisedinjectioncentersarerunbyregionalgovernments(Dolan,2000).InGermany,ontheotherhand,supervisedinjectioncentersareusuallyrunbynon-governmentalorganizations(NGOs).ThereisnotaformalapprovalprocessinGermany,butawiderangeofstakeholdersincludingneighbors,lawenforcement,businessowners,andthelocalgovernmentareusuallyconsultedpriortoSIFestablishment.TheseSIFsoftenreferinternallytoaffiliatedtreatmentcentersandothersocialservices.GermanSIFsoperatedundertacitapprovaluntil2000,whenfederallegislatorsestablishedanexemptiontodruglawsallowingSIFstooperate(Kothner,2011).InAustralia,SIFshadactuallybeenapprovedforseveralyearspriortotheestablishmentoffacilities.Illegalshootinggallerieshadlongoperatedinsexshopsinlargecitiesthroughoutthecountry.Whenofficialslearnedofthis,theydecidedtogoforwardwithsupervisedinjection.However,theregulationsforsupervisedinjectionwereonerous,andin1998,alocalchurchopenedanunsanctionedSIF.Itwasclosedandthereverendarrested.In1999,regulationswererelaxed,buttherewereproblemsfindinganorganizationtooperatetheSIF;first,theVaticanorderedaCatholicchurchtowithdrawitssupport,andlaterauniversitywasorderedtodisassociatefromtheeffortunderthethreatofwithdrawaloffunding.Finally,anotherchurchsteppeduptooperatetheSIFforthe18-monthtrialperiodandithascontinuedtooperatetheSydneylocationeversince(Dolan,2000).Severalyearslater,theCanadianHealthMinistryapprovedaSIFinVancouvertomitigatetheunprecedentedpublicinjectionsceneinthecity’sdowntownlowereastside.In2003,HealthCanadaandtheBCMinistryofHealthagreedtofundtheregionalhealthauthority,VancouverCoastalHealth(VCH)Authority,foraSIFonatrialbasis.ThePortlandHotelSocietyco-operatesInsitewithVCH.Thefunding—andthetemporaryapprovalforInsitetooperate—hasbeenquitetenuousinthenearly15yearssinceInsitewasestablished.ChangesintherulingpartyandministerialpostshaveseveraltimesthreatedtheSIF’sexistence.(VancouverCoastalHealth,2015)

ImagecourtesyofDavidHerThemapaboveshowsthedistributionofSIFsasofJuly2016.ThereisstillnosupervisedinjectionfacilityintheUSA.Whileinfectiousconsequencesofdrugusehavestabilizedinmanyplaces,overdoseratesforalldrugs,andopiatesinparticular,haveincreaseddramaticallysince2000(NIDA2015).Supervisedinjectionfacilitieshavethepotentialtodecreaseoverdoses.TheDrugPolicyAlliance,amajorproponentofdecriminalizationandharmreductionefforts,hastargetedSanFranciscoandNewYorkCityforpilotSIFprograms(DPA2015).ThisprojectaddressestheprospectofaSIFinDenver.WhileDenverisnotcurrentlytargetedbynationalharmreductionagenciesforaSIF,theliberalsocialpoliciesofthecurrentmunicipalgovernmentandprogressivesocialclimateofthestatemakeDenverapromisingvenueforfurtheringharmreductioneffortsinourcountry.TheestablishmentofaSIFinDenverwouldpavethewayforotherstatestofollow.

A. LiteratureReviewCurrently,manybarriersexistforsupervisedinjectionfacilitiesintheUSA.However,foreachbarrier,thereisanopportunity.Thesespanseveraldisciplines:medical,legal,financial,andpublichealthandsafety.Thisliteraturereviewwillproceedbysubjectarea,notingopportunitiesaswellasoverlap.Itwillconcludewithasummaryofarecentmeta-analysisoftheliteratureonSIFs,themostcomprehensivestudytodateaboutthemedical,social,andlegalconsequencesofsupervisedinjection.OpportunityOne:MedicalTheliteratureregardingmedicalbenefitsofSIFsislimited.Theselimitationsstemfromtheethicalandlogisticaldifficultiesinstudyingmarginalizedillicitdrugusers,thelimitedgeographicscopeofcountriesinwhichSIFsoperate,fundingchallenges,andtheillegalityofinjectiondruguseinnearlyeverycountry.SIF’spotentialmedicaleffectsextendtofourmajorrealms:1)Acutebenefits,chieflyreductionin

overdoserisk;2)diminishingtheriskofchronicbloodborneillness,primarilyhepatitisCandHIV;3)preventinginjection-associatedillnesses,suchasendocarditisandabscess;and4)linkinguserswithresourcestodecreaseorabstainfromdruguse.TwostudiesindicatethatSIFsdecreasefatalityratesforoverdoseamonginjectiondruguserswhoutilizethem.Vancouver’swell-studiedSIF,Insite,publishedalandmarkstudysuggestingthatfataloverdosesdeclinedby35%intheimmediateneighborhoodofanewSIF,comparedwithsmallbutinsignificantdeclinesinotherareasofthecity(Howell2013).AnextremelythoroughstudyoftheMedicallySupervisedInjectingCenter(MSIC)inSydney,Australiashowednodefinitiveevidenceofreductioninoverdosesintheareaofthefacility(MSIC2003).Alargemeta-analysisandpolicypaperbytheEuropeanMonitoringCentreforDrugandDrugAddictionsuggestedanecdotallythatoverdosesdecreased;however,thisstudyfoundonlyanabsenceofoverdosesinsideSIFsratherthanadeclineinoveralloverdoses(Hedrich2003).SIFshavethepotentialtoreduceoverdosedeathsthroughseveralmechanisms.Mostdramatically,theyareabletodirectlyreverseoverdosesthroughadministrationofnaloxoneviainjectionornasalinsufflation.Naloxoneadministrationishighlyeffectiveevenviainformallytrainedpeers,with83to96percentofoverdosessuccessfullyreversed,mostoftenbyasingleinjectionofnaloxone(Bennett2011andPiper2008).OnthepremisesofaSIF,overdosesareextremelyrareandfataloverdosesnearlyunheardof.One18-monthstudyofover300,000injectionsresultedinnofatalities.Inaddition,althoughSIFsdonotroutinelytestforpurityofinjectables,clientprivacyallowsformorecarefulinjections.Unfortunately,verylittledatasupportthehypothesisthatSIFsimprovemedium-termandlong-termhealthoutcomes,particularlyrelatedtobloodborneandskininfections.Somestudiesstatethattheseoutcomesarenotamenabletostudythroughstandardmethods,andithasbeensuggestedthathepatitisCissoprevalentamongcurrentusersthatsignificantreductionsinprevalenceareimplausible.ThereisampleliteraturesuggestingthatSIFsmightimproveinjection-relatedbehaviorsandaccesstomedicaltreatment.Homelessnessandunstablehousingareassociatedwithahostofunsafeinjectingbehaviors,fromreusingneedlesandotherparaphernaliatoimproperdisposal.Theseusersare,inturn,morelikelytoexperiencebothinfectiousandnon-infectiousconsequencesincludingoverdose,hepatitisC,andHIV(SIFNYC,2015).Onelargequantitativestudyshowedadecreaseinneedlesharing(Fast2008).Therearealsoanecdotalreportsofsuchdecreases(Wood2007)afterSIFimplementation.Perhapsmoreimportantly,peoplewhoinjectedatInsitereportedimprovementsinavarietyofhealthbehaviors,includingsafesex(Milloy2010),sterileinjection,andaccessinghealthcare.ManyusersreportthattheyfeelfarmorecomfortablewithSIFhealthcarestaffthantraditionalinstitutionalhealthcareproviders.Anotheradvantageofsupervisedinjectionfacilitiesisthatmanysuchfacilitiesarelinkedtoacontinuumofcareforsubstanceabuse(Dolan2000).TheonlylargestudyonSIFs’effectontreatment-seekingdemonstratedasignificant30%increaseinpatientsaccessingtreatmentaftertheestablishmentofaSIF;contactwithasubstanceabusecounselorfurtherboostedtreatmentenrollmentby50%overbaseline(DeBeck2011).InoneyearatInsite,488usersenteredtheonsitedetox/treatmentfacility,appropriatelycalledOnsite(VCH2015).However,large-scalestudieshavenotdemonstratedadirectlinkbetweenuseofaSIFandlong-termcessationofdruguse.

Inconclusion,thereisinsufficientevidenceoflarge-scalemedicalbenefittorecommendfororagainstestablishmentofaSIFonmedicalgroundsalone.Whilesupervisedinjectionishighlyunlikelytohavemedicaldrawbacks,thereissimplyanabsenceoflarge-scale,rigoroustrialsofsupervisedinjectiontosuggestacausativerelationshipbetweentheestablishmentofaSIFandimprovementinhealthoutcomesforPWID.OpportunityTwo:Legal

LegalissuesareundoubtedlytheprimarybarrierstoestablishmentofaSIFintheUSA.Byanyinterpretation,aSIFwouldviolatefederallaw.However,municipalandstatelawshavecircumventedfederallawinsomeinstances,mostnotablybylegalizingmarijuana.Abroad,manySIFsoperateunderlocalapprovalandtechnicallyviolatenationallaws.Therefore,theillicitnatureoftheenterprisedoesnotentirelyruleoutthepossibilityofanAmericanSIF.

SIFsnecessarilyviolateatleasttwosectionsoftheControlledSubstancesAct(CSA),thepreeminentlawbanningdruguse.Section844prohibitsdrugpossession,whichmeansthatvirtuallyeverycliententeringaSIFviolatesfederallaw.Section856,the“CrackHouseStatute”,makesitillegalto“knowinglyopenormaintainormanageorcontrolanyplaceforthepurposeofunlawfullyusingacontrolledsubstance”(ControlledSubstancesAct2010).

Itislikelythatcourtswouldagreethatsupervisedinjectionfacilitiesqualifyastheequivalentof“crackhouses”sincedrugconsumptionistheverypurposeofaSIF.Byincludingstaffingandinjection-relatedequipment,SIFsgobeyondmereprovisionofasafeplacetousedrugs(Rayfield2009).However,someappealscourtshaveusedthetestthataplacemustcontributetomanufacturingordistributionofdrugsinordertoqualifyunderthisstatute.Overall,thelegalityofaSIFisuncertain.ThereisverylittlelegaltheoryonSIFsduetotheabsenceofeffortstocreateoneintheUS.

Somelegalcommentatorsspeculatethatstateauthorities“haveclearlegalauthoritytoauthorizeSIFs,justastheycanlegalizethecultivation,distribution,andpossessionofmarijuanaformedicalpurposes”(Beletsky2008).However,justasfederalauthoritiesfrequentlycrackdownonmarijuanausethatviolatesfederaldruglaws,theywouldbeevenmorelikelytoinvestigateflagrantviolationsinvolvingharddrugs.Itisalsolikelythatdifferentjudgeswouldinterpretthisstatuteindifferentways,soinordertoensuresustainabilityofSIFsandthetrustofpotentialclients,ensuringdurableexemptionstofederalcontrolledsubstancelawwouldbeimperative.

OpportunityThree:FinancialTheabsolutecostsformostsupervisedinjectionfacilitiesarelow,especiallywhencomparedtootherpublichealthefforts.Forinstance,Insite—averylargesupervisedinjectionfacilityserving6,500clients—costsonly$2.2millionperyear(VCH2015).Meanwhile,thelifetimediscountedcostfortreatingHIVis$200,000to$300,000perinfection(allcurrencyvaluesin2015Americandollars);forhepatitisC,thecorrespondingcostisnow$56,000duetorecentadvancesindrugtherapy(Chhatwal2015).WhilethecostforHIVtreatmenthasnotchangedsignificantlyinrecentyears,theexpectedcostsforhepatitistreatmenthaverisensteeply.Giventhewell-definedcostsoftreatingHIVandhepatitisC,calculatingthecosteffectivenessofaSIFshouldberelativelystraightforward.However,assessmentofthecost-effectivenessofsuchfacilitiesis

actuallyverydifficulttomeasure,andthereareonlyahandfulofstudiesthatevenattempttomeasurethecost-effectivenessofaSIF.Currentstudiesoncost-effectivenessfocusonmathematicalmodeling,makingassumptionsaboutneedle-sharingratesandbasingmostanalysesonHIVandHCVpreventionalone.Therearefoursuchstudies,threeofwhichstemfromVancouver’sInsite.TheseanalyseshavebeenusedtoprospectivelyevaluatepotentialsitesforSIFsinOttawaandToronto.TheirfindingshaveshownmodestbenefitsthroughHIVandHCVpreventionmeasuredtogether,butnotseparately(AndresenandBoyd2010,BayoumiandStrike2012).Cost-effectivenessstudiesofSIFs,whilelimitedtothetwoaforementionedcountries,havegenerallyshownsignificantcostreductionsduetoapresumeddecreaseinoverdose,HIV,andhepatitisCtransmission.BayoumiandZaric(2008)calculatedthedirectmedicalcostsavingstotheCanadianhealthsystemat$14millionovertenyears.AnotherstudysuggestedthatInsitecreates$5.12foreverydollarspentthroughincreasedlifespansandreductionsinfutureexpenditures(AndresonandBoyd,2010).

Thereareobviousdifficultiesinmeasuringthefinancialbenefitsofavoidingpublicnuisance.Nostudiesmeasurereductioninbloodbornediseasesamongnon-SIFclientssuchaslawenforcementorhealthcareproviders,muchlessthegeneralpublic.Noattemptshavebeenmadetoputadollaramountontheimprovementsinqualityoflifeforpeoplewholiveandworkinurbanareaswheredruguseanddealingarepresent.Overall,thevalidityofsuchcost-effectivenessstudiesisquestionable.EvenHealthCanada’ssummaryreportofthefirstfiveyearsofInsite’soperationcitesthesestudieswiththedisclaimer“theEACwerenotconvincedtheseassumptionswereentirelyvalid”(HealthCanada2008).OpportunityFour:PublicHealthandSafetyImprovementsinpublicorderarecitedasoneoftheprimarybenefitsofSIFs.Paradoxically,increasesinstreetcrimeandpublicdrugusearefearedbymanypotentialSIFneighbors.Thereisasignificantamountofanecdotalandquantitativeresearchonthistopic,nearlyallofitneutraltofavorable(Zobel2004;MSIC2003;Wood2004).MostoftheliteraturereportsontheexperienceofneighborsandbusinessesinthevicinityofaSIF.SeveralstudiesfundedbymunicipalgovernmentssuggestbenefitsofSIFs.Particularly,SIFscanimprovepublicorderby“doingawaywithopendrugscenes,decreasingdruguseinpublicplaces,recoveringusedsyringes,andreducingtheimpactofdrugproblemsonresidentialareas,”accordingtoastudyfundedbytheSwissOfficeofPublicHealth(Zobel2004).AnotherstudyofaSIFinSydneyfoundnoincreaseincrime,nodecreaseinpublicamenity,andgeneralacceptanceoftheinitiativebythecommunity(MSIC2003).AVancouverstudyshowedsignificantdecreasesinpublicinjecting,discardedneedles,andinjection-relatedlitterintheneighborhoodofInsite(Wood2004).Inaddition,drugusersalsoexperienceimprovementsinsafetyandorderduetoSIFs.OneofthemostcommonbenefitscitedbyusersofSIFsisafeelingofsafetynotexperiencedwhileinjectingelsewhere(Fairbairn2008).Intoxicatedinjectorsdisproportionatelyfallvictimtoassault,rape,andpropertycrimes.Whilecrimesagainstdrugusersarebynaturedifficulttomeasure,theremaybesignificantindirectbenefitfromthesafetyofaSIF.Afeelingofsafetyislikelytoresultinsaferinjectingpractices,suchastakingmoretimetosterilizeskinandneedles,cookingandfilteringdrugs,andtestingdrugsbydividingadoseintotwoshots(Jozaghi2013).MostusersatInsiteandanotherVancouverinjectionfacilitybelievedthatSIFssavedlives(Milloy2008).

TheseopportunitiestoimprovethehealthofPWIDandcommunitysafetyhavebeenencapsulatedintosixmainobjectivesofsupervisedinjectionfacilities,ordrugconsumptionroomsintheEuropeanparlance.Theseobjectivesweredistilledfromyearsofexperienceintheseminalreportondrugconsumptionrooms,a2004whitepaperfromtheEuropeanMonitoringCenterforDrugsandDrugAddiction(Hedrich2004).Theobjectivesare:

1) Toreachasmuchofthetargetpopulationaspossible.Thisobjectivesreferstolong-terminjectors,streetinjectors,andothermarginalizedpopulationsnotintreatment.

2) Toprovideasafeenvironmentthatenableslower-risk,morehygienicdrugconsumption.Naloxoneavailabilityisakeyaspectofthisobjective.

3) Toreducemorbidityandmortality.Inadditiontoreducingoverdosedeaths,thisentailslonger-termimprovementsinhealththrougheducationandbehaviorchanges.

4) Tostabilizeandpromotethehealthofserviceusers.Thisisalonger-termgoals,relatingtoincreasingaccesstohealthcare,drugtreatment,andothersocialservices.

5) Toreducepublicdruguseandassociatednuisance.Thisgoaladdressesthedrugscenescommoninlargecitieswheresalesaretransactedanddrugsconsumed.

6) Topreventincreasedcrimeinandaroundconsumptionrooms.Thisobjectivereferstoacquisitivecrimeaswellasdrugsalesinsideandoutsidethefacility.

Themostcomprehensivemeta-analysisofsupervisedinjectionsitessuggeststhatSIFsachievetheseobjectives.Whiletheanalysiswaslimitedbyitsgeographicalscope(moststudieswereconductedineitherVancouverorSydney),itisthebestavailableindicationofSIFefficacytodate.

1) ThemostcommonSIFclientisamalebetween30and35yearsofage.Manyoftheseclientsengagedinsexworkorhadahistoryofoverdose,dailyinjections,andbloodbornediseases.Before-and-aftersurveysofPWIDwhostatedanintentiontouseaSIFshowedthatabout75%ofthemdiduseaSIFregularly.

2) ThestudiesindicatethatSIFusersinjectmorehygienicallyaftertheestablishmentofafacility.StudiesfromVancouversuggestthatSIFusersshareneedleslessfrequentlyandreusetheirownneedleslessfrequently.However,therehasnotbeenaconvincingdemonstrationthatSIFsontheirownreducetransmissionofHIVandHepatitisC.

3) ReductioninoverdoseisperhapsthemostlogicaloutcomeofaSIF.Theavailabilityofhealthcareprofessionalsandamedicationthatcanreverseoverdosesmeantthatnostudyinthismeta-analysisobservedafataloverdoseataSIF.Furthermore,overdosesintheneighborhoodofInsite,Vancouver’sSIF,declinedby35%afterthesitestartedoperating.Sydneyfoundthatambulancecallsforoverdosesdecreasedby68%duringtheSIF’soperatinghours.

4) Onecommonly-soughthealthservice,drugtreatment,maybeassociatedwithattendanceataSIF.DetoxificationservicesandinitiationofmethadonebothincreasedinVancouverforusersofInsiteandmanyclientsutilizedwoundcareservices.

5) SignificantreductionswerenotedinVancouverforthenumberofpublicinjections,syringesdropped,andinjection-relatedlitter.Thesewereconfirmedbothbyself-reportandthird-partycounts.InSydney,acommunitysurveyrevealedthatseveralstakeholdergroupsnoticedlesspublicinjectionandinjection-relatedlitter.

6) NostudieshavedemonstratedchangesindrugdealingafterSIFshaveopened.Mostsuchstudieswereintendedtoshownoninferiority(thatis,alackofanincreaseincrime,asopposedtoadecrease)andseveralusingpolicedepartmentcrimedatahaveindicatedthatacquisitiveandtransactionalcrimedonotincreaseafteraSIFisestablished.

Inadditiontothegoalsoutlinedabove,thismeta-analysisindicatedneutralorpositiveexternalitiesofaSIF.TwostudiesindicatedthataSIFdoesnotincreasethenumberofPWIDinthearea,suggestingthatthe“pulleffect”or“honeypot”oftensuspectedofsocialservicesfordrugusersmightnotapply.Furthermore,surveysofresidentsandworkersintheneighborhoodofSydney’sSIFshowedthatamajorityofresidentssupportedthefacilityandthoughtithadachievedsomeofitsgoals.

However,therearemajorobjectionstotheevidenceintotheefficacyofSIFs.Besidesthelimitedgeographicalscopeofstudies—mostofwhichcomefromInsiteinVancouver—therearealsomethodologicalandpotentialethicalproblemswiththesestudies.First,thereiscriticismthatarticlesonInsitelackscientificrigor.“Thepublishedevaluationsandespeciallyreportsinthepopularmediaoverstatefindings,downplayorignorenegativefindings,reportmeaninglessfindingsandoverall,giveanimpressionthefacilityissuccessful,wheninfacttheresearchclearlyshowsalackofprogramimpactandsuccess,”statesDr.ColinMangham(2007).TherearealsocriticismsofconflictsofinterestregardingthescientistswhoresearchInsite.ManyoftheresearcherswhoevaluateandpublishonInsitealsoadvocatedforitsestablishment.Therefore,theremaybeanincentivetopublicizepositivefindingsthataremorelikelytoresultinInsite’ssurvivalandincreasedfinancialsupport.However,virtuallyalltheprominentobjectionshavebeenraisedbyanti-drugorganizationsandresearchersaffiliatedwiththem(Landolt2011andChristianetal2012).Furthermore,findingsthatsupporttheefficacyofSIFshavebeenpublishedinavarietyofhighlyrespectedpeer-reviewjournalsincludingTheLancet,BMJ,andNewEnglandJournalofMedicine(Christian,2012).WhilesupervisedinjectionwaslongconfinedtoharmreductionliteratureandafewscholarlystudiesfromVancouverandSydney,Australia,ithasinthepastyeararrivedinthemainstreammediaandpolitics.WhiletherearestillnoSIFsoperatingopenlyintheUSA,severalmunicipalitieshavepubliclyexploredtheideaofopeningaSIFtocombatpublicinjectionandoverdose.CommunitiesinCaliforniahaveforseveralmonthsexploredthelegalityofopeningaSIF.CaliforniaAB2495,introducedbyStocktonAssemblywomanSusanEggman,“wouldallowcommunitiestochoosetooffersupervisedconsumptionservicestoaddresslocalhealthandpublicsafetyconcerns.”OnApril5th,thestatelegislatureconvenedacommitteemeetingonthefeasibilityofsupervisedinjection(DrugPolicyAlliance,2016).Bostonrecentlyunveiledplanstoopena“saferoom”whereopioiduserscan“comeifthey'rehighandtheyneedasafeplacetobethat'snotastreetcorner,andnotabathroombythemselves,wherethey'reathighriskofdyingiftheydooverdose.”Althoughthesponsorsofthislocationstatethat“it’snotaplacewherepeoplewouldbeinjecting,”itseemsasmallleapfromaplacelikethistoafull-servicesupervisedinjectionfacility(Bebinger2016).InFebruary,SvanteMyrick,themayorofIthaca,NewYork,unveiledadetailedplantoopenaSIF.“TheIthacaPlan:APublicHealthandSafetyApproachtoDrugsandDrugPolicy”proposesafour-pointplanincludingprevention,treatment,andlawenforcementapproachesinadditiontosupervisedinjection.

Whilethereremainsignificanthurdlesatthestateleveltolegalizingsuchafacility,someprominentstatepoliticianshavevoicedsupportfortheproposal(Foderaro2016).

B. ProblemStatementApersonoverdosesondrugseverytwodaysinDenverCounty(ColoradoCoalitionfortheHomeless2014).Inthecityaswellasthestateatlarge,overdosesareamajorcauseofdeathforColoradoans.Thestatewasrankedasthesecond-worstinthecountryforprescriptionmisuserates.Tocombatthisphenomenon,in2013theColoradoConsortiumforPrescriptionDrugAbusePreventionwascreatedto“establishedacoordinated,statewideresponsetothismajorpublichealthproblem”(ColoradoConsortium2016).AccordingtoDenverCountyMedicalExaminerData,1112peoplediedofadrug-relatedcausebetweenJanuary1,2009andDecember31,2015.Themajorityofthesedeaths,60.3%,involvedatleastoneopioid.Ofthesedeaths,pharmaceuticalopioidswerementionedabouttwiceasoftenasheroin.Therewassomedifficultyidentifyingtheprimarycausativeagentinthesedeaths,sincethemedicalexaminerdatadonotdifferentiatebetweenprimaryandsecondarycauses.However,theratioofpharmaceuticaldeathstoheroindeathscorrespondscloselywithnationallyavailabledataonoverdoses.Nationally,the2014deathrateduetopharmaceuticalopioidswas5.92per100,000people;thecorrespondingrateforheroinwas3.31.InDenver,thoseratesin2014were11.54forpharmaceuticaland6.49forheroin,bothroughlydoublethenationalaverages.Whilecitiesgenerallyhavehigheroverdoseratesthansuburbanandruralareas,itisunlikelythatthisdifferencecompletelyaccountsforthehigherrateinDenver.Itisunknownhowmanyofthepharmaceuticaloverdosesinvolvedinjection,butislikelythattheproportionofheroin-relateddeathsduetoinjectionisnear100%inDenver.

(DenverCountyMedicalExaminer,unpublisheddata)Whileoverdosesonsomedrugsarenotamenabletointervention,opiateoverdosesareeasilyreversedwithaninexpensivemedicationcallednaloxone.Naloxonedistributionhascutdownoverdosedeaths

significantly.(Bennett2011andDPA2015)Supervisedinjectionfacilitiesnotonlyadministerbutalsodistributenaloxonetoparticipants,potentiallyreducingoverdosesintwoways.TheprimarybarrierstoSIFsarecost,participantbuy-in,communityacceptance,andreluctancetopromoteillegalactivities.ThisprojectinvolvesidentifyingtheparticularlocalbarrierstoaSIFanddevelopmentofpolicytoaddressthesebarriers.

II. Methods

TheprimarygoalistoassessthefeasibilityofasupervisedinjectionfacilityinDenver.ThisexploratoryprojectassessestheacceptabilityofaDenverSIFtopotentialclientsaswellascommunitystakeholdersandpowerbrokers.Theprojectmakesrecommendationsbasedonareviewofexistingliteratureandstructuredinterviewswithkeystakeholders.Discussionregardingthepoliticalwill,economicnecessity,clientdemand,andfeasibilityofestablishingaSIFisprovided.

A. PublichealththeoriesSupervisedinjectionrelatescloselytoseveralwell-knownpublichealththeories,includingtheHealthBehaviorModelandSocialCognitiveTheory.TheSocialEcologicalModel,however,mostcloselyresemblesthemultiplefacetsofdrugaddiction.Outsidetheindividual,whosebehaviorsoccupyacentralroleindrugaddiction,lieseveralconcentriccirclesofinteraction.AddictionisaquintessentialexampleoftheprinciplesoftheSocialEcologicalModel,andasupervisedinjectionfacilitycanaddresssomeoftheconflictsthatfaceinjectiondrugusersinthemicrosystem,mesosystem,andexosystem(Bronfenbrenner,1979).Despitetheseperspectives,neverhassupervisedinjectionproceededundertheaegisofpublichealthalone.ThereareseveraltheoriesofpolicychangethatrelatetoapotentialSIF(Miller,1990).Kingdon’s“WindowsofOpportunity”occurswhenaproblemstream,policystream,andpoliticalstreamalign.Thiswouldseemtobethecasewithopioidoverdoseatthispoint(Kingdon2003).Baumgartner’sTheoryofPunctuatedEquilibriumisalsohighlyrelevanttosupervisedinjection.Thistheoryhelpstakeadvantageofsensitivewindowswhenmediaandthepublichavetheirattentiononaparticularissue,whichdefinitelydescribesthecurrentstateoftheopioidcrisisintheUS.Whilesupervisedinjectionitselfmaynotqualifyasseismicchangeindrugpolicy,itcouldheraldashiftawayfrompunitivedrugpoliciesinAmerica(Baumgartner,2009).Supervisedinjectioncanalsobenefitfrombettermessaging.Whereasmanypeoplemightbereluctanttoendorse“legalshootinggalleries,”manymorepeoplesupporttheideaofoverdoseprevention.FramingsupervisedinjectionasapublichealthmeasuretokeeppeoplealiveandkeeppublicareassafeisanexampleofProspectTheory,whichstatesthatreframinganissueintoalargercontext(i.e.,overdoseprevention)andchanginghowoptionsarepresentedcandramaticallyshiftthelikelihoodofsupport(TverskyandKahnemann,1979).

B. SamplingandSurveys

IsampledpotentialSIFclientsthrougharandomsampleofattendeesattheHarmReductionActionCenter,alargesyringeaccessprogramwhereIconductedmyservicelearningproject.IbeganbyaskingthefirstpersontoenterHRACafter9,10,and11AMtointerviewwithme.Surveyswereconductedon

differentdaysoftheweektorandomizethesample.Thismethodalsoavoidedutilizationofanyparticipantdatatoidentifypotentialinterviewsubjects.Thisconstitutesaconveniencesample,sinceHRACusersareself-identifiedneedledrugusers;identificationofrandominjectiondrugusersoutsideHRACwouldbedifficult,invasive,andpotentiallydangerous.SurveyingatHRACallowsclientsasafeenvironmenttocompleteaninterview;interviewingoutsideHRACwouldinvolvemyriadprivacyconcernsanddistractions.Interviewingclientsatanexistingsyringeexchangeisveryefficientaswell,sinceHRACclientswouldbeverylikelytousesupervisedinjectionifitwereavailable.Supervisedinjectionfacilitiesattractmanymarginalized,oftenhomelessPWID.ManyHRACclientsfallintothisdemographicaswell.Ialsointerviewednon-clientstakeholders,includinghealthprofessionals,localgovernmentadministrators,andbusinessowners.Icontactedstakeholdersthroughprofessionalnetworks,mostlyestablishedcontactsofHRAC’sstaff,andusedchainreferralstogainseveraladditionalsubjects.IutilizedamethodologyforidentifyingandcontactingcommunitystakeholdersasoutlinedinStrike’s2015paperonambivalencetowardSIFs.Lawenforcementofficialswereoriginallyincludedinthisgroupofstakeholders,butallthatIcontactedwereunabletogainpermissionfromtheirsuperiorstospeakwithme.Theseinterviewstooktheformofasemi-structuredinterviewcommontoallstakeholderswithanadditionalsectionspecificallyforpeoplewhoinjectdrugs.Questionsweredesignedwithpriorsurveysinmind.Particularly,IexaminedasimilarstudybyBayoumiandStrike(2012)onthefeasibilityofSIFsinTorontoandOttawaforquestions.IalsolookedatNationalHIVBehavioralSurveillancequestionsspecifictoDenver,whichhelpedwithquestionwordingaswellasestablishingintervalsforresponsechoicesasnecessary.Topicsforclientsincludedspecificdrugsandfrequenciesofuse,locationsofdruguse,willingnesstoutilizeaSIF,andperceivedbenefitsandbarriersofSIFuse.Communitystakeholdersweresparedthequestionsregardingdruguse.ThemajorityoftheirquestionnairesfocusedonqualitativereasonsforsupportoroppositionforaSIF(SeeAppendixAforsurveyquestions).Earlyinthestudy,itbecameevidentthatthesamplingtechniqueswereoversamplingmalesandmethamphetamineusers.Therefore,Iutilizedpurposivesamplingtoaccruefemalesandusersofotherdrugs,mostlyheroin.Iaskedstaffmemberstodirectmetofemalesandheroinusersinordertoaccomplishthis.Isetthesamplesizeat40becauseawidelyutilized2010meta-analysisbyMasonsuggestedthatforqualitativeresearch,30subjectsisanadequatesamplesize.Anotherstudyfoundthat,forhomogenoussamples,asfewasfiveinterviewsareadequatetodevelopoverninetypercentofthemes(Guest2006).Theincentive—a$10giftcardtoalocalgrocerystore—provedtobesufficientcompensationandtherewasnotroubleaccumulatingsubjectsinthissetting.Interviewswithotherstakeholders,however,werelimitedbytimeconstraintsandbureaucracy.Iattemptedtointerviewatleastfourindividualsfromeachstakeholdergroupandwassuccessfulatrecruitingfromallgroupsexceptlawenforcement.ThestudyisparamounttobuildingareputablecasefortheestablishmentofalocalSIF.EventhemostlogicalandcompellingcaseforaSIFneedstobejustifiedbydata,andthesurveywillhelptoestablishthenecessityandacceptabilityofaSIFlocally.ThereviewofpaststudieshelpedmetocalibratethefindingsfrommysurveydataandgaugetherelativeutilityofaSIF,giventheexperiencesofpreviouslyestablishedSIFs.

III. Results

Theanalysesofdataconsistoffourmainfacets.First,Iperformstatisticalanalysesofdatafromthesurvey.Next,IanalyzethequalitativeresponsesfromclientsandcommunitystakeholderstoidentifybarrierstoestablishingaSIFaswellasopportunitiestoimprovetheacceptanceofaSIFamongPWIDandthecommunity.Third,thereisamappinganalysisofclientdataleadingtorecommendationsforlikelySIFlocations.Finally,Iprovidecost-effectivenessandcost-benefitanalysesofapotentialSIFinDenver.

A. Quantitative

ThesurveyrespondentscomprisedafairlyrepresentativegroupofpeoplewhoinjectdrugsinDenver.Purposivesamplingwassuccessfulincapturingresponsesfromtheunderrepresentedgroupofwomenandtransindividuals.

(CDC,2015)Allfiguresexceptageareinpercentages.Gendersareself-reported.Ageismedianyears.Bloodborneinfectionsuseself-reportdataformysurveyandcombinedself-report/in-housetestingdataforHRACandNHBS.Drugusefiguresincludeanyuseinthelastsixmonths.

TheprimarycomparisongroupisHRAC’sinternalintakesurvey,whichisgiventoclientswhentheypresentforthefirsttime.TheothercomparisongroupisdrawnfromthequadrennialNationalHIVBehavioralSurveillancesurvey,forwhichIobtainedlocalresults.ThisgivesamuchlargersampleofPWIDwhichisalsolocallyrepresentative.

Allfiguresarewithinstandardmarginsoferrorexceptformethuseandhepatitisprevalence.Itisimportanttonotethatthemediandurationofinjectioninmysurveywasfouryears,whereastheHRACintakesurveysweretakenwhenclientsfirstpresentedtotheagency,whenmanyofthesurvey-takerswerenewertoinjecting.Thehigherratesformethamphetamineusage,HIVandHepatitisCmayalsoreflectmorefrequentandmoredangerousinjectionpracticesofalargelyindigentpopulation,whereasNHBSrecruitedsubjectsmorebroadly.

Fordrugofchoice,figuresarenotcomparabletonationallyavailabledatabecauseIutilizedpurposivesampling,tryingtooversampleheroinusersandwomen.Thepurposeofthisoversamplingisthat,whileaneedleexchangetargetsallinjectiondrugusers,supervisedinjectionfacilitiesspecificallytargetopioidinjectors.IsoughtoutopioidinjectorsduringthesecondhalfofmysurveybecauseInotedthatmanyofthefirsttwentyweremethamphetamineusers.Intheend,ofmy40subjects,21identifiedmethamphetamineastheirdrugofchoice,17identifiedheroin,and2identifiedcocaineastheirdrugofchoice.Onlyinjectabledrugswereacceptedforresponsestothisquestion.

Allfiguresinpercent.Privatereferstohouse/aptandhotel/motel,semi-privatetopublicbathroomandcar.Detox/rehab,shelter,andabandonedbuildingsomittedduetolowpercentages.Datafrommostrecentinjectionomittedduetosimilaritywithmostfrequent.

Publicbathroomsandhouses/apartmentsviedforthemostpopularsettingsforinjectionamongthesurveyrespondents,dependingonhowthequestionwasasked.Virtuallyidenticalnumbersofrespondents(85%vs.82.5%)statedthattheyhadinjectedinthesetwosettingsinthelastsixmonths,whilesimilarlyidenticalproportionsstatedthattheyinjectedinthesesettingsmostfrequently(30%and27.5%)andmostrecently(22.5%and20%).

Campsandstreets/alleyswerethenext-mostpopularsettingsforinjections.Seventy-fivepercentofrespondentsreportedinjectinginthestreetoranalleyinthelastsixmonth,while57.5%haddonesoincamp.Bothcampsandstreets/alleyswerethesiteofthemostrecentinjectionfor17.5%ofrespondents.

Detoxandrehabilitationfacilities,shelters,andabandonedbuildingswereomittedfromthisgraphduetolowfrequenciesofuse.Veryfewparticipantsreportedinjectinginthesesettings,andnoneoftherespondentsreportedfavoringsuchlocations.

Ofthe85%ofrespondentswhoreportedinjectinginpublicbathrooms,fourlocationscomprisedthemajorityofresponses:thepublictransportationsystem,McDonald’s,KingSooper’sgrocerystore,andthelibrary.Relievingtheriskandutilizationburdenfacedbytheselocationsisaprimarygoalofasupervisedinjectionfacility.

Itisclearthat,forsurveyrespondents,injectionoccursmostlyinpublic,oratleastinpublicly-accessiblelocations.ThisisveryimportantdataformakingthecaseforaSIF.Manyoftheselocationsarepatronizedbythegeneralpublic,includingchildren.Thefollowinggraphshowsthatboththemostrecentandmostfrequentinjectionsoccurredinpublicandsemi-publiclocations.Thesefindingsmirrorthoseofasimilarsurveythatfoundpublicandsemi-publicinjectionssitesaremorecommonthanprivatevenuesamongsyringeexchangeclients(SIFNYC,2015).

Therespondentstothesurveyskewtowardfrequentinjection.Infact,thevastmajority(65%)ofrespondentsindicatedthattheyinjectatleastoncedaily,andonequarterofrespondentsstatedtheyshootupthreeormoretimesdaily.

Fortunately,willingnesstoutilizeaSIFishigh.Eighty-fivepercentofrespondentsstatedtheywoulduseaSIFwithoutreservations,while7.5%statedtheymightuseaSIFdependingonthepolicies.Only7.5%saidtheywouldnotuseaSIF.Oneofthe“maybe”respondentssimplywantedthefacilitytobecalled“safeinjection”insteadof“supervisedinjection”,whileanotherstatedthatshewouldattendaSIFonlyifshecouldgetassistancefindingavein.OfthosewhowouldnotuseaSIF,2ofthe3reportedsuspicionsthatthegovernmentwouldmonitororharmthembecauseoftheiruseoftheSIF.

Manyofthefrequentinjectors,particularlythosewithouthomes,reportedthattheywouldusethefacilityforalloftheirinjections,althoughseveralnotedthattheintensityofwithdrawalsymptomsmightleadthemtouseoutsideoftheSIF.

Amajorityofrespondents(62.5%)statedthattheywouldutilizethefacilityatleastonceaday,whileanother25%statedthattheywoulduseitseveraltimesaweek.ItispossiblethattherelativelyhighwillingnesstoutilizeaSIFresultsfromtheproximityofmanyrespondentstopossibleSIFlocationsand,presumably,thelocationwheretheyobtaindrugs.

Thevastmajority(92.5%)ofclientsagreedthatsupervisedinjectioncouldimprovethreeofitsfourmainendpoints:reducingoverdoses,encouragingsaferdruguse,andreducingneighborhoodproblems.Clientswerelessoptimistic(82.5%)thatsupervisedinjectioncouldleadtodecreasesinHIVandhepatitisCtransmission.(comparetoI-track,p.171fromTOSCAsurvey)SeveralofthemmentionedthattheprimaryrouteforHIVandhepatitis—needlesharing—isalreadyobsoleteforthembecauseofsyringeexchange.

ApriorstudyinTorontoandOttawaidentifiedseveralinstrumentalbarrierstopatronizingaSIFsuchasdistance.Distancewasnotconsideredveryimportantbyrespondentsinthissurvey,perhapsbecauseoftherelativelyhighconcentrationofdrugdealingandusingindowntownDenver.Over80%ofrespondentsstatedthattheywouldwalkorbikeoveramile,ortenblocks,toreachaSIF,withsomerespondentsstatingtheywouldwalkmuchfarther.Another82.5%ofrespondentsreportedtheywouldbewillingtotakepublictransportationtoreachaSIF.

Thirty-fivepercentofrespondents,however,statedthattheywouldbehesitanttoutilizeaSIFduetothechancesthattheywouldbespottedenteringorexitingthefacility.Thisproportionwasnotquantifiedinpriorsurveys,butitwasmentionedasapotentialbarrier.Thisisanimportantconsiderationwhenconsideringpotentiallocationsforthefacility.

ThereasonsfornotutilizingaSIFwereverysimilartothoseobtainedinastudyofToronto’sinjectiondrugusers.SimilarproportionscitedeachreasoninDenveraswell.

Idonotinjectanymore

Idonotliketousearoundothers

Iwouldonlyusedrugsathome

IwouldnotfeelsafeataSIF

Denver 42.5 35 30 15Toronto 34 28 19 14PublicHealthAgencyofCanada(2006)

B. Qualitative

WhiletherearepromisingeffectsofaSIFthatmaybereadilyquantified,someresultsarelessamenabletomeasurement.Thesenseofcommunity,trust,andacceptancethatmayaccompanyasupervisedinjectionfacilityareprimarytoreintegrationofPWIDintothecommunity.Infact,eightofthethirty-onerespondentswhogavesubjectiveresponsestothequestion“WhatotherpositiveeffectsdoyouthinkaSIFcouldhave?”mentionedthedecreaseinstigmaorimprovedcommunityacceptanceasaprimarybenefitofsupervisedinjection.Answersincluded:“humanizeusersinasafe,comfortablesetting,”and“bridgethegaponpublicacceptability.”Itseemedthatsomerespondentsfeltlikeasupervisedinjectionfacilitycouldbecomealiminalspacebetweentheirstigmatized,illegalactivitiesandsocietaltoleranceandacceptance.Thisdesiretorejoinorengagewithsocietybuildsonthere-enfranchisementthatstartswithneedleexchangeandcommunitypolicing.

OthercommonresponsesaboutbenefitsofaSIFincludedsafety;thistookseveralforms.Onerespondentreportedthatshebelievedthatusinginacleanenvironmentcouldengendersafershooting

practices.Anothersaidthatlearningaboutsaferpractices,byhelping“instructusersinpropertechniques,”couldleadtobettershootingpracticesbothinsideandoutsidetheSIF.Severalmentionedtestingdrugsforpurity.“Knowingpurityandhavingexperthelpcouldleadtomorecontrolleduse.”Andinaninterestingturn,thesamerespondentsuggestedthatpuritytesting“couldleadtomorepuredopeduetopressureondealers.”

AnotherbenefitofsupervisedinjectionwouldbethecommunityengenderedamongPWIDandtheiradvocatesinthecommunity.OneclientstatedthatDenver’sinjectionscenewas“cleaner”thanothercitiesbecauseelsewherePWIDare“lazy,don’tgiveaf***,”attributingthisdisparitytothepresenceofalargesyringeexchangeprograminDenverthatstressesresponsibilityandsolidarity.

Therewereseveralexamplesofconflictingviewpointsamongclientsregardingsupervisedinjection.Thisisreflectiveoftheinternalizedautophobiadisplayedbymarginalizedgroups.AcommonrefrainfromclientsurveyrespondentswasthatPWID,inordertobecomemoresociallyacceptable,needtofirstimprovetheirbehavior.“Noteveryonewantstowatchyoudothat…forpeoplewhodoinject,bediscreet.”Thisparadoxwasbestdisplayedbyaclientwhosaid,“Asauser,I'mtornbetweenthesetwothings,it'slikebeingbipolarorschizophrenic,”referencingherconflictingdesiresforaplacetousedrugssafelybutnotpromotedruguseinthecommunity.

TherewereclearlyconcernsaboutaSIFevenamongtheclientpopulation.ThemostcommonconcernofclientswasthepotentialforaSIFtoincreasedrugusebyenablingusersandlendingdruguseafurtherauraoflegitimacy.Sevenofthethirty-tworespondentstothequestion“whataresomeotherreasonsthatsupervisedinjectioncouldbeabadidea?”citedthepotentialtoincreaseuse,enableuse,orinitiatenewusers.ManyrespondentscitedtheirdesirenottoinitiatenewinjectorsasareasonwhyaSIFmightbeabadidea.

Therewasalsosignificantconcernthat,ratherthanencouragingacleanerneighborhood,supervisedinjectioncouldleadtoincreasedloitering,littering,anddrugdealing.Aquarterofclientsrespondedwithoneoftheseconcerns,primarilyovercrowdinganddrugdealing,althoughacoupleclientsdidadmitthattheincreaseindrugdealingcouldbenefitthembycreatingaconvenientandcompetitivemarket.Thisistheso-called,theoretical“honeypot”effectofservicesforPWID.Sofar,ithasnotbeenseeninmostareasofSIFsandneedleexchanges(Fast2008andMSIC2003).

Lossofconfidentialitywasalsoaprimaryconcernforclients.Sevenclients,orover20%ofrespondents,statedthatabreachofconfidentialitywoulddissuadethemfromutilizingaSIF.Highlightingtheintimatenatureofinjecting,oneclientstated“disclosingthatpartofyoutootherpeople…couldbedangerous."Arelatedconcern,policesurveillance,wasmentionedbytenindividuals,withonestatingthat“anyinklingofpolice”wouldcausehimtostopusingtheSIFimmediately.

OfgreatestconcernwasthepotentialforusingaSIFtocommitsuicide,eitheronpurposeorthroughcarelessuse.Infact,fivepeoplerespondedthattheywouldnotwanttoreceivenaloxoneintheeventofanoverdose;whilesomesimplysaidthatnaloxonewasnotrelevanttothembecausetheydidnotuseopioids,otherindicatedthattheSIFcouldbeacomfortableplacetooverdoseintentionally:“Ifsomeoneoverdosesinpublicthey'regoingtorushyoutothehospital.Iwanttohaveachoice.”Anotherclientstated“Ilivedmanylivesandmysouliswornout.”Stillanothermentionedthatnaloxoneissuchanunpleasantexperiencethatdeathcouldbepreferable;thisindividualhadnaloxoneonceandstatedthatitwasamiserableexperienceforthreedays.

Obviously,anydeathatasupervisedinjectionfacilitycouldimperilitsexistence.ManyoftheclientsmentionedthatevenasingleoverdosedeathataSIFcoulddissuadethemfromutilizingthefacility.Over20%ofrespondentstothequestion“WhatcoulddissuadeyoufromutilizingaSIF?”includedsafetyoroverdoseintheiranswers,withonespecificallyconcernedaboutintentionaloverdoses.TheyindicatedthatalossofconfidenceinSIFstaffwouldlikelyfollowanyinjuryordeathonthepremises.Twootherrespondentsmentionedthatoverdosescouldconfirmtheirbeliefsthatsupervisedinjectionispartofagovernmentconspiracytoeliminatedrugusers.

Communitystakeholderswerealsoveryconcernedwithreducingoverdosesandaddiction.However,theydiffereddramaticallyonwhetheraSIFcoulddecreasedruguse.Largely,theiranswersreflectedafundamentaldifferenceintheapproachtodrugpolicy,onebasedinabstinenceratherthanharmreduction.OnerespondentworriedthatopeningaSIFwould“keeppeopleinacycleofdestroyingtheirlives,”butanotherthoughtthatengagingSIFuserscouldleadtoincreasedreferralsfortreatment.ManyrespondentsstatedtheywouldnotsupportaSIFifitledtoincreaseddruguse,eveniftherewereother,morevisibleandtangibleimprovements.ThisidealoftreatmentandabstinenceiskeybecauseitsuggestsarouteforappealingtothepublicwhendiscussingaSIF.

Anothermajordifferenceinthecommunitystakeholders’responseswastheytendedtofocusonpublicorderandsafetyissues.SeveralpeoplestatedthattheyhopedaSIFmightmovedruguse“outofthepubliceye”withoutregardforitseffectsontheSIF’sclients.Publicorderwasaconcernforallthreetypesofcommunitystakeholders,whichincludedbusinessowners,healthprofessionals,andcityemployees.Ahealthprofessionalwhoownshisownbusinessstatedthat“reducingneighborhoodproblemsisthepublic’snumberone.We’vetreatedHIVclients,puthandsontodoCPR,”implyingthat,inhishealthprofessionalrole,heunderstandsthebenefitsofharmreductioneffortsbutthathestillwishesforanorderlycityinwhichtorunhisbusiness.

ManyofthecommunitystakeholdersfounditdifficulttoanswerquestionsofthepotentialbenefitsanddrawbacksofaSIFbecauseoftheirlackoffamiliaritywithinjectionpracticesandaddiction.Theirresponsesfocusedoncrime,hazardouslitter,andmoralaspectsofdruguse.Itwasacommonrefrain,particularlyamongsthealthprofessionals,thattheywouldpreferscientificdataontheeffectsofsupervisedinjectionpriortodecidingontheirlevelofsupport.Thissuggestsonewaytotargetthissmallbutimportantstakeholdergroup,butothergroupsdesireddataaswell.OnebusinessownerspecificallywantedtoknowthenumberofPWIDandhowoftentheSIFwasutilizedbeforehemadeadecisiononsupport.Yetanotherwantedtoknowaboutdrugpurity.

Someofthecommunitystakeholders’responseswerecoloredbyasmallnumberofexperienceswithaddiction,especiallythoseofafriendorfamilymember.Forinstance,onebusinessmanagerhadachildwhowasaheroinaddictandhadoverdosednonfatally.Sheagreedthatheroinshouldbelegalized,“butnootherdrugs.”Yetanotherrespondentwasanalcoholichimselfandadvocatedforabstinence-basedrecovery;heopposedaSIFbecauseitwouldbe“enabling.”Appealingtothesepeople,whohaveverytightly-heldanddistinctiveviewsofdruguseandaddiction,couldbeenhancedbytestimonialsandpersonalstoriesfromthoseaffectedbysupervisedinjection.

Anothercommonthemefromtherespondentswasanunwillingnesstoviolatefederaldruglaws.Particularly,citygovernmentofficialsexpressedaneedforpolicychangesatthecity,stateandfederallevelspriortosupportingaSIF.OnecityadministratorreportedthathisopiniononSIFwouldnecessarily

changeifhissuperiorsupportedit;anelectedofficialstatedthatshewouldneedlegalchangesbecause“myprimarybarriertosupportis,‘HowdoIexplainthistoconstituents?’”

OneaspectofthequalitativestudiesthatIhadnotconsideredwasthecontinuumofworkandnon-workrolesofthecommunitystakeholders.Injectioncanintrudeatanypointinthiscontinuum.

Forinstance,thebusinessownerwhosesonisaddictedtoheroinstatedthat,of4000customersatherbusinesseachday,roughly400usetheirbathroomandmanyofthemarehomelessandinjectingdrugsinthebathroom.Thisbusinesshiredasecurityguardtopatroltheparkinglotandinstalledlowlightinginthebathroomtodiscourageinjectinginthebathroom,asveinsarehardertofindinthedark.Still,customersinjectedinthebathroom.Themanagementexploredusingkeyedorcodedbathroomsbutwerediscouragedbytheircorporateofficersfromimplementingthissolution.However,afterthreeoverdosesinseveralmonths,corporaterelentedandtheyhavediminishedtheproblemwithentrycodesonthebathrooms.

Butrecently,acustomeratthisbusinesshadevidentlyinjectedinthebathroomandwaswanderingaroundthestore.Shesatdownatthebloodpressurecuffandputherheaddown;whencontactedbyemployeesshehadlaboredbreathingandabluetingetoherlips.CPRwasadministeredand,againstcompanydirectives,thismanagerdecidedtoadministernaloxone.ThereversalwasasuccessandthecustomerwokeuppriortoEMSarrival.Thisharrowingincidentwasmetwithsilencefromthecorporateoverseers,butthebusinesshascontinuedtousenaloxoneinoverdosesituations,withnodeathson-siteinrecentmemory.

Thisisnottheentirestory,though.Thesamebusinesswastroubledbyneedledisposalintheparkinglot.Themanagerhadtwopermanentdisposalsinstalledintheparkinglotbutstillpeopleleaveneedlesontheground,renderingtheemployeesvulnerabletoneedlesticksevenaftertheyhaveclockedoutandleftthestore.Drivingoutofthelot,shewitnessespeoplesellingandusingdrugsalongthenearbyriver.Whileformanypeoplethespecterofinjectionwouldrelentuponexitingthehighwayinthesuburbs,forhertheworrydoesnotstop,ashersonisconstantlyonhermind.Injectiontrulypervadesherlife.

Anothercityworkerreportedthatdealingwithinjectiondruguseisadailyconcernforhisdepartment,whichischargedwithcleaninguphomelessencampmentsaftertheyareabandonedorbecomeapublichealthhazard.Hestatedthat,byhisestimation,over50%ofencampmentscontainusedneedles.Thedayofourinterviewtherespondenthadhelpedwithcleanupof20needlesinacamp.Hestatedthatonecamphad312needles,allrequiringcarefulcleanup.Hestatedthattheysometimesfindneedlesonplaygroundsorinthegrassneartrails.

OnecityadministratorreportedthathisdepartmenthadtoclosedownbathroomsafterPWIDovertookacitybathroomandcloggedthetoiletswithinjection-relatedlitter.Reopeningthebathroomsrequiredthedepartmenttohireafull-timebathroommonitortoprotecttheirfacilitiesandmonitorforoverdoses,costingthecitytensofthousandsofdollarseachyear.Thisdepartmenthashadfiveemployeessustainneedlesticksinthelastthreeyears.Thisrequirestestingand,potentially,pharmacologicalprophylaxisforsixmonthsinadditiontothepsychologicalangstofdealingwithchronicbloodborneinfection.Fortheseemployees,injectionisnotonlyawork-relatedhazard;itisaconstantperil.Shouldanemployeeacquireabloodbornedisease,itwouldbeanotherexampleofthepervasive

effectsofpublicinjection,havingcarriedoverfromaworkplaceconcerntoapersonalhealthcrisiswiththepotentialtocausefar-reachingeffectsinfinances,intimaterelationships,andactivities.

C. Mapping

SincesupervisedinjectionfacilitiesshouldbelocatedconvenientlynearPWID,Isurveyedrespondentsontheirmostfrequentlocations.Inordertoelicitthemosthonestresponses,Iwordedthisquestiontoconsidertheanonymityandtransienceofmanysurveyrespondents,asking,“nearwhatintersectiondoyouspendthemosttime?”Mostrespondentshadadefiniteanswerforthisquestion.

IusedArcGISgeospatialmappingtoanalyzethesedata(EsriCorporation,Redlands,California).Respondents’locationswereclusteredalongamajoreast-westthoroughfarethroughDenver,ColfaxAvenue.Whilethereisawide,eightmileeast-westdistributionoflocations,peopleliveinanarrowbandoflessthantwomilesfromnorthtosouth.BisectingthisbandisColfaxAvenue.Thegeographicalcenterofthesecoordinates,14thandDelaware,isveryclosetoColfax.Icalculatedthepercentofrespondentslivingwithin½mile,1mile,and1½mileswalkingdistanceoftheproposedcentralfacility,aswellasthosewithintenminutes’drivingtime.

ThefollowingmapshowswherePWIDliveinDenver(orangepins),thecentrallocationforthosepins(greentack),andradiiof½,1,and1½milesfromthatcentrallocation(red,yellow,andbluediscs,respectively).Colfaxisthelongeast-westthoroughfarethatrunsthroughthecenterofthediscs.TheCherryCreek,hometoahigh-intensitydrugdealingarea,arcssoutheast(darkblue)throughthediscs.

Ifwalkingorbikingonlyareconsidered,thecentralfacilitywouldreach45%-55%ofPWID.Only25%ofPWIDidentifiedthemselvesaslivingwithinahalf-mileoftheproposedlocation;thisnumberroseto42.5%and55%forradiiof1mileand1.5miles,respectively.Over80%ofrespondentsreportedthattheywouldbewillingtowalkorbikeoveramiletoreachaSIF,with12.5%morestatingtheywouldwalkbetweenahalf-mileandamile.Anecdotally,severalpeoplereportedwalkingmilesatatimethroughdifficultconditionstoobtaindrugs,statingthattheywouldbewillingtowalkasimilardistancetousedrugsprivately.

Thesearelikelyunderestimatesoftheconvenienceoftheproposedlocation,though.Almostallrespondentsanecdotallyreportedthattheyvisitdowntowntopurchasedrugsortoaccessservices,orsimplyforsocialreasons.Furthermore,Ionlyincludeddistancesuptoonemile(tenblocks)becauseIutilizedpriorsurveyswhendevelopingoptions;IquicklylearnedthatmanypeoplewouldbewillingtowalkmuchfurthertoutilizeaSIF,soitispossiblethat“walkingdistance”includesmorethan55%ofrespondents.

AsinglecentralfacilitywouldbefarmoreaccessibletoPWIDinDenveriftheyarewillingtousepublictransportationandcanaffordit.ThisisduetothecentralizeddrugmarketlocatednearColfax,themainthoroughfare.Severaltransitlines,includingbus,lightrail,andtrain,convergeonColfax.Fortunately,over80%ofrespondentsindicatedthattheywouldbewillingtousepublictransportationtoaccessasupervisedinjectionfacility;inaddition,severalrespondentswithaccesstocarsstatedthattheywouldnotneedtousepublictransportationbecausetheycoulddrivethemselves.

Thismapdisplaystherespondents’livinglocationsaswellasthepurple10-minutedrivingradiusaroundtheproposedfacilityat14thandDelaware.Theproposedlocationishighlyaccessiblebyautomobileorpublictransportation,evenallowingforsomeresidentsofnearbycitiesandsuburbstoreachasupervisedinjectionfacilityquickly.Almost80%ofrespondentslivewithina10-minutedriveoftheproposedfacilityaccordingtostandardtraveltimes.

Lookingatpotentiallocationsofasupervisedinjectionfacility,itisimportantthatapotentialSIFbelocatednotonlyintherightpartoftown,butintherightvenue.Ahigh-trafficarea,particularlyonethatisdistantfromresidences,isideal.Somerespondentsalsonotedthattheywouldpreferarear

entrancesoasnottobeseenenteringtheSIF,althoughrelativelyfew(35%ofrespondents)worriedaboutbeingseenenteringsuchafacility.

ThismapdisplaysthegeographicalcenterofwhererespondentspreferaSIFtobelocated(bluestar);someoftheindividuallocationsarevisible(greydots).Theselocationsclusteronasinglestreet,Colfax;over55%percentofrespondentspreferredthataSIFresideonthisstreet,andnearly50%identifiedalocationonColfaxbetweenSpeerandPearl(roughlythelengthvisualized)astheideallocationforaSIF,demonstratingaveryhighlevelofagreementaboutthelocationofaSIF.TherewasalsoasmallerclusterofresponsesfurthereastonColfax,providingapotentialsatellitelocationforasyringeexchangeprogramorSIF.

Thesemapsshowthatthereisahighlevelofconcordancebetweenwherepeoplespendtheirtimeandwheretheyusedrugs.ThecenterofpreferredSIFlocationsiswithinahalf-mileofthecenteroflivinglocations,stronglysuggestingthattheCapitolHill/CivicCenter/GoldenTriangleareaisanexcellenttargetforDenver’ssupervisedinjectionfacility.

Anideallocationwouldhavecloseproximitytoexistinghealthcareservices.Thiswouldreducecosts,astheestablishmentoftheSIFwouldbelesslikelytoduplicateservicesofnearbyexistingfacilities;improveneighborhoodacceptability,sinceneighborswouldalreadybeusedtothefoottrafficofmedicalclients;andincreaseusage,sinceclientswouldalreadybeintheneighborhoodofaSIF.Forexample,theSt.PeterCenterinVancouverresidesatapreviouslyexistingAIDSCareCenter.ItsclientsgenerallyhavebetterviralloadsuppressionthanotherAIDSpatientsbecauseinjectionbringstheirclientsintocontactwithcareproviders.

D. Cost-EffectivenessandCost-BenefitAnalyses

InorderforaSIFtobeeffective,itneedstobeutilizedfrequently,particularlybyclientswhoareathighestriskforoverdoseorbloodbornediseases.ProjectingtheuseandutilityofaSIFisdifficultbecauseoftheillegalnatureoftheactivitiesconductedtherein;however,aceilingforusecanbeestablishedbysimplyaskingpeoplewhethertheywouldusesuchafacility.AmethodforestimatingpotentialSIFuse,aswellascost-effectivenessmeasurement,wassuggestedbyBayoumiandStrike(2012).

Theoutcomesofinterestinthisanalysisinclude:1)reductioninoverdose2)reductioninHepatitisCand3)reductioninHIV.Theseanalyseswillbeperformedseparatelyduetothedifficultyofcombiningthem.

InordertoestimatethecostsofaSIFandmuchofthedataoninjectiondruguseandfrequency,IassumedthatmanyoftheparameterswouldbeproportionaltothoseinVancouver,thesourceofalmostallthereliablequantitativedataonsupervisedinjection.AfterfindingtheestimatednumberofPWIDinVancouver—13,500(McInnes2009)—andPWIDinDenver--7,500,basedonlocalestimatesandagencydata—IadjustedotherfiguresassumingthatcostsandotherfactorswouldbeproportionaltotheratioofPWID.Therefore,toestimatethecostofaSIF,IusedInsite’scostandsimplyadjustedtoafactorof0.55,theratioofPWIDinDenvertothatofVancouver.Iarrivedatafigureof$1.24millioninAmericandollars.

ToestimatethenumberofpeoplewhoinjectinDenver,Iusedacombinationofnationalstatisticsappliedtothelocalpopulation,withspecificestimatesfromlocalagencies.HRAC,theleadingharmreductionagency,served3100uniqueclientslastyear(Bellamy,personalcommunication,2016).SimplymultiplyingDenver’spopulation(650,000)bythemostrecentnationalprevalenceofpast-yearinjection(0.3%)yields1950,whichisclearlytoolowgiventhenumberofpeopleaccessingservicesatHRAC(USCensus2010,Lansky2014).UsingthepopulationestimateformetroDenver(2.8million)andthesameestimateofpast-yearuseyields8400(USCensus2010,Lansky2014).A2010estimatebytheDenverOfficeofDrugStrategypeggedthepopulationofPWIDinDenverat5000.AreliableestimatebasedonmathematicalmodelingfromVancouver,acitywithasimilarpopulation,is13,500(McInnes,2009).

Ichose7500asanestimateforthenumberofPWIDinDenversinceitisareasonablecompromiseoftheprecedingestimates.Italsoreflectsapatternfromothercitiesinwhichabout40-50%ofPWIDengagewithharmreductionservices.Thisseemsveryreasonablewhenanalyzingotherdatasources.Assumingthatpeopleoverdoseatarateproportionaltothenumberofinjectionusers,about50peoplewouldbeexpectedtodiefromoverdosebyinjectioninDenvereachyeargivenacrudedeathratebyoverdoseof.67per100person-years(Mathers2013).From2014DenverMedicalExaminerdataIanalyzed,about48peoplediedfromfataloverdosesthatmentionedheroin.

Howmanyofthesecouldbepreventedbyasupervisedinjectionfacility?Thisishighlydependentonthedetailsoftheoperationandtheassumptions.Theoperation’shours,location,reputation,andtrustamonguserswoulddeterminetheproportionoftotalsinjectionsthataresupervisedatthefacility.Inordertoconductthecosteffectivenessanalysis,wehavetoassumethatallinjectionsareatequalriskofoverdose.

ThenumberofdeathsandinfectionspreventedisdirectlyproportionaltothepercentoftotalinjectionsinDenverthataresupervisedatafacility.(HealthCanada,2008)IassumedthataSIFinDenverwouldhavethesameuptakeasInsiteinVancouver,andthatPWIDwouldperformthesamenumberofinjectionsperperson.

1.Overdose

Toassessthecostsofoverdose,onemustexaminefatalandnonfataloverdoses.Comparingthesetwoaredifficultbecausethecostsareofverydifferentnatures.Fataloverdosesinvolvesfewerdirectcosts;sometimestransportandcoronercostsaretheonlyassociatedcosts.However,thelossofquality-adjustedlifeishigh,becausemanyofthosewhooverdoseareyoungandotherwisehealthy.Fornonfataloverdose,directmedicalcostspredominate.Whiletherearesomeoverdosesthatresultinpermanentdisabilityduetoanoxicbraininjury,thesearethoughttoberareandincidenceratesforthistypeofoverdosearenotavailable.Therefore,Iwillexaminethedirectmedicalcostsofbothfatalandnonfataloverdoseaswellasthelossoflifeforfataloverdose.

WhiletheDenverMedicalExaminerdoesnotbreakoutoverdosesbyinjection,anaverageof36peoplediedeachyearbetween2009and2015fromheroinoverdoses;themajorityofthesecanbeassumedtobeinjection-relatedbecauseDenver’sheroinisprimarilyblacktar,whichismostofteninjected.Thisisconcordantwithpriorestimatesoftheyearlyopioidoverdosedeathrate,0.67%(Lansky2014)and0.8%(Hall2000).AssumingthatDenverhadbetween5000and7500PWIDduringthisperiodandthat60%ofthosePWIDinjectedheroin,theoverdoserateforpeoplewhoinjectopiatesinDenverwas0.8%to1.2%.Onlyopioidoverdoseswereincludedinthisanalysis,becausefindingsfromotherSIFshaveshownthatmorethan90%ofoverdoseinterventionsinvolvedopioidoverdose.Furthermore,thesavingsfromnon-opioidoverdosesarenegligible,sincethereisnoequivalentantidoteforotherdrugs.

Fornonfataloverdoseincidence,onlyindirectdataareavailable.Twostudieshaveextrapolatednonfataloverdosesfromfataloverdoses.Alargemeta-analysisinAustraliafoundthatthenonfataloverdosecommonlyoutnumbersthefataloverdoserateataratioofroughly25to1.ThisalsocorrespondswellwiththeavailabledataforDenver.Mystudyfoundthatroughly22.5%ofPWIDreportedatleastoneoverdoseinthepastyear.Thisisbetween19and28timesthefataloverdoserate,fallinginlinewiththepriorstudy.However,thisunderestimatestheactualoverdoserate,becausethePWIDarenotlimitedtoasingleoverdoseinayear;onthecontrary,agoodpredictoroffutureoverdoseisprioroverdose.Inmystudy,7.5%hadoverdosedonceinthelastyear,7.5%twice,andanother7.5%threeormoretimes.Therefore,theweightednonfataloverdoserate(totaloverdosesdividedbynumberofpeoplewhoinjectopioids)mightbeashighas45%.

ThecostsfornonfataloverdosearehighwhenEMSissummoned.A2014studyestimatedthat,whenEMSiscalled,hospitaladmissionoccurs55%ofthetime;dischargeafterERtreatmenthappens45%ofthetime.Thecostsforbothoutcomesaresignificant.Admittedpatientsstay,onaverage,3.8daysatacostof$29497.PatientstreatedintheERcost$3640(Bachhuber2014).Theseseemlikehugecosts,consideringthathundredsofoverdosesoccurinDenvereveryyear.However,withthewidespreaddistributionofnaloxonetoopioidusers,veryfewoverdosesactuallyresultinacallforemergencyservices.AccordingtotheHarmReductionActionCenter,only22%ofoverdosesresultinacalltoEMS(Bellamy2016,PersonalCommunication).

Thefinancialcostsforfataloverdosearerelativelylow.Whilesomefataloverdosesresultinintensiveintervention,othersresultsimplyinatransportandanautopsy.Ambulancetransportcostsroughly$1000andanautopsy$1275(Propublica2011).Howmanycasesresultinmoreintensiveinterventionisunknown.

Iperformedcost-effectivenessanalysisandcost-benefitanalysisundertwoseparateassumptionstocalculatetheeconomiceffectsofaSIFinDenver.OneusesyearlyincidencedataonthepopulationofPWIDinDenverandanotherprojectstheutilizationofaSIFinDenverbasedonVancouverstatisticsandimputesthenumberoffatalandnonfataloverdosesfromthat.

Theseseparateanalysesofthefataloverdosespreventedresultedinremarkablysimilarresults.TheresultssuggestedthataSIFcouldprevent2.78to2.85overdosedeathsperyear.Thisassumesthattheoverdoserates,bothyearlyandperinjection,donotchangewhenoneutilizesaSIF.Thedirectcostsavingsfrompreventingthesedeathsweresmall,consistingonlyofambulancetransportandautopsycosts.Whileintensiveinterventionmightoccurpriortodeathinsomeoverdoses,thefrequencyofintensiveinterventionisunknown.Thetotalcostsassociatedwithdeathwere$2275perperson(Coffin2013),althoughthisislikelyasignificantunderestimateduetotheattendanceoflawenforcementandrescuepersonnelatfataloverdoses.

ThesameanalysessuggestedthataSIFcouldpreventmanyhospitaladmissionsthroughearlyintervention.Between67and71nonfataloverdosescouldbeexpectedtooccurattheSIF.WhiletheinterventionintheSIFisthesame—naloxonebyinjectionorinsufflation—SIFstaffwouldbemuchmorelikelytointervenequicklyandpreventthemostexpensivepartofnonfataloverdoses,theambulanceride,ERvisit,andhospitaladmission.Werenaloxonenotwidelyavailable,preventionofnonfataloverdosewouldbenearlycost-saving;however,nowonly20%ofnonfataloverdosesresultinacalltoEMS(Bellamy2016,personalcommunication),cuttingthecostsofoverdosetojustavialofnaloxoneinroughly80%ofcases.

Theanalysessuggestthatsupervisedinjectioncouldbecost-effectivewithregardtooverdosebutisunlikelytocreatesavings.Thecost-effectivenesscalculationishighlysensitivetoaverageageatoverdose,butassumingtheaverageopioidoverdosevictimis39(CDC2015),thesupervisedinjectionfacilitywouldcostbetween$9,400and$12,000perQALYsaved.Thecalculationisalsosensitivetotherateofrepeatedoverdosesbyanindividual;currently,Iassumesthatoverdosedistributionisstochastic.However,studieshaveshownthatoverdosesarehighlypredictableandperhapsevenadditive.Themoreconcentratedoverdosesbecomewithinapopulation,andthemorefrequentlytheyoccurinanindividual,thelesscost-effectivesupervisedinjectionbecomes.

Inthecost-benefitanalysis,supervisedinjection’sdirectbenefitsareoutweighedbyitscostsbyaratioofroughlyfivetoone.ThisresultsprimarilyfromthelowdirectcostsoffataloverdoseaswellastheuncertaintyofhowmanyEMScallsandhospitaladmissionsaSIFmightprevent.Thefollowingisaflowdiagramofthecost-benefitanalysisforfataloverdose.

Somemodifyingvariablesthatmightincreasetheactualcost-effectivenessoftheSIFincludetheutilizationbyyoungerinjectors(oddsratio1.6)andutilizationbyclientswitharecentoverdose(oddsratio2.7).IftheSIFisabletoattractmorehigh-riskinjectorsthenitcouldprovemorecost-effective.

Insite’smathematicalmodelssuggestthat1.08deathsperyearareavertedbyinterveninginoverdoseevents.Ifallnumbersaresimplyscaleddownby45%sinceDenverhasanestimated45%fewerdrugusersthanVancouver,thiswouldindicatethat0.6deathsperyearmightbeavertedbyopeningasupervisedinjectionfacilityinDenver,sotheactualcalculationsforDenversuggestthatitmightpreventslightlymoredeathsthanexpectedbysimpleextrapolationfrompriorstudies.

2.HIV

WhilethereareseveralassumptionsthatwentintotheestimateofreductioninHIVinfection,therearemanyvariablesforwhichreliabledatacanbeascertained.HIVallowsforthemostaccuratecalculationofcost-effectivenessbecausetherearereliablestatisticsforit.ThisislikelyduetotheprolificresearchandfundingsurroundingHIV.ThereisconcordanceaboutHIVprevalenceamongPWIDintheDenverarea(3%)(Bellamy2016personalcommunicationandAl-Tayyib2016personalcommunication)andexcellentdataonthetransmissionprobabilityperact(63/10000)(CDC2015).Iusedthefollowingfunctiontoarriveatestimatesofcasesprevented:

Inthisequation,I**denotesthenumberofcasesprevented, isthenumberofinjectionsattheSIF,ρistheprevalenceofthedisease(eitherHIVorhepatitisC)inPWID,βistheper-acttransmissionratefromaninfectedtononinfectedindividual,and istheneedlesharingrate.

Fromthecasesprevented,Iestimatedquality-adjustedlifeyears(QALYs)lostbyfindinglifeexpectanciesandutilityfunctionsforpeoplelivingwiththerelevantdisease.Ifutilitiesandprevalencedatafordifferentdiseaseseveritieswereavailable,includingasymptomaticHIVversusAIDSandlatenthepatitisversuscirrhosis,Iadjustedforthesedifferences.IthendeterminedthecostperQALY,assumingthattheonlycostsinvolvedwereSIFoperationcosts.

Forcost-benefitanalysis,IfoundthemostrecentestimatesforcostofdiseasetreatmentanddeterminedthenumberofcasesthatwouldneedtobepreventedinorderfortheSIFtobecost-saving.Thisonlytookintoaccountcostsdirectlyassociatedwithdiseasetreatment,suchassofosbuvir/ledipasvirforhepatitis,andnotsecondarycostsfromsyndromicillnessesorcomplicationsofdeferredcare,suchaslivertransplant.

TheprimaryassumptionsthatmustbemadetocompletethisanalysisregardthebehaviorofPWIDwithandwithoutHIVandthefrequencyofsyringesharingamongtheclienteleofapotentialsupervisedinjectionfacility.WhiledatasuggestthatHIV+clientswhoinjectdrugsaremorelikelytoengageinriskybehaviorlikesyringesharing,whethertheysharepreferentiallywithotherHIV-infectedPWIDisunknown.TheirlikelihoodtopatronizeaSIFisalsounknown.Furthermore,dataarescarceontherateofneedlesharing,particularlyinDenver.IntakedatafromHRACshowthataboutone-thirdofnewclientshadsharedsyringesinthepast30days,butitislikelythatthisnumberfallsdramaticallywhenclientsutilizeharmreductionservices,particularlysyringeaccess.Fewerthan20%ofclientsIsurveyedreportedanyreuseofneedlesinthelastsixmonths.(Pinkerton2010)

Eveniftherateofneedlesharingis10%,whichismostlikelyahighestimate,theexpectednumberofHIVinfectionspreventedisroughlyoneeverysixyears.AfteradjustingforHIV-andinjection-relatedlossoflifeexpectancyandqualityoflife,thisresultsinanaverageyearlysavingsof2.85QALY.At$434,558perQALY,thisiswelloutsidetheacceptedboundsforcost-effectiveness.Consideringthatthisfigure

utilizedaveryliberalestimateofsyringesharing,itislikelythateachQALYmightcomeatasignificantlyhighercost.Hence,itisunlikelythatsupervisedinjectioninDenverwouldbecost-effectiveonthebasisofHIVpreventionalone.

Whilethissimplisticanalysismissessomepotentialsecond-degreeeffectsofsupervisedinjection,suchasimprovedsyringedisposalandareductionintheamountofneedlesincirculation,itisunlikelythatanyparameterswouldresultinoutrightcost-effectivenessbasedonHIVprevention.

TheoverwhelmingdifferencebetweenDenverandVancouveristhesignificantlyhigherHIVprevalenceinPWIDinVancouver,17%versus3%,makingthelikelihoodofHIVtransmissionduringsyringesharingfarhigherthere(Pinkerton2010).

Acost-benefitanalysisyieldssimilarresults.Atalifetimeexcessmedicalcostof$229,800perHIVinfection(Schackman2015),aSIFcosting$1.2millionperyearwouldhavetopreventbetweenfiveandsixHIVinfectionsyearlyinordertopayforitself.Asmycalculationsindicate,thisishighlyunlikely.

Puttingthesedataintoalargercontextvalidatesthem.Therewere117documentednewHIVinfectionsinDenverin2013(Dukakis2014);roughly10%ofthesemightberelatedtoinjectiondruguse(drugabuse.gov2012).Ofthesetenoreleveninfections,itisunlikelythatasignificantnumberofthemwouldbepreventedbytheexistenceofasupervisedinjectionfacility,sincelessthanhalfofPWIDinDenverwouldbeexpectedtousetheSIFatall.Evenamongstclients,theproportionofinjectionsdoneataSIFiswellbelow100%.

3.HepatitisC

EventhoughhepatitisCnowhaseffectivetherapieswithhighcurerates,thesetherapiescarrysignificantcostsandaccesstothemislimited.Nationally,treatingalleligiblehepatitisC-infectedpatientsinthenextfiveyearswouldcost$37billionatcurrentprices.Preventionisthusstillsignificantlymorecost-effectivethantreatment(Chhatwal,2015).

ThesameassumptionsandequationsapplyhereasfortheHIVanalysis.Again,theusingbehaviors,injectionfrequencies,andratesofsharingforPWIDwithhepatitisCarelargelyunknown.Therefore,thisanalysisalsoassumessimilarinjectionfrequenciesandsimilarratesofsharingbetweeninfectedanduninfectedindividuals.IalsoassumedthatPWIDdonotassortintogroupsbasedonserotype.Inaddition,IdidnotcalculateQALYdifferencesforthesignificantpopulationofPWIDcoinfectedwithHIVandhepatitisC,giventhecomplexityofaddinganothersubgroupandthelowprevalenceofHIVinDenver.

Evenwithasimplifiedmodel,itisapparentthathepatitisCpreventionalonewouldjustifyaSIF’scost-effectivenessinDenver.Usinghighlyconservativeestimates(includingalow23%prevalenceforhepatitisCandasharingfrequencyof.01)asupervisedinjectionfacilitycouldpreventeightcasesofhepatitisC,preventingdisease-relatedmortalityandmorbidityatacostof$7597perQALY(Bellamy,2016,personalcommunicationandAl-Tayyib,2016,personalcommunication).Thiscomparesfavorablywithmanycurrentinterventionsandfallswellbelowtheacceptedthresholdsof$50,000-$100,000perQALYoftenusedtojudgecost-effectiveness(Neumannetal,2014).

WhetheraSIFcouldbecost-savingwithrespecttohepatitisCislesscertain.Usinganestimatedcostpersustainedvirologicresponse(SVR)of$58,000,aSIFwouldhavetoprevent21.4casesofhepatitisCin

ordertosavemoney,assumingthat100%ofthosetestingpositivereceivedthelatesttreatment.Whilepreventingeightcasesofhepatitiswouldnotbecost-saving,usingamorerealisticfigureforhepatitisCprevalenceamongPWIDof60%wouldleadto26casesofhepatitisCbeingprevented.Therefore,thecost-benefitoutcomeforaSIFwithregardstohepatitisCpreventionisuncertainanddependsontherateofsyringesharingandtrueper-acttransmissionrate.

TheseestimatesarehighlydependentonthewillingnessofpayerstofundhepatitisCtreatmentforpeoplewhocurrentlyinjectdrugs.Thecost-benefitanalysisassumesthat100%ofthoseinfectedwithhepatitisCreceivetreatment,whichisnotcurrentlythecase.AspayersbecomemorewillingtofundhepatitisCtreatment,theSIFactuallybecomesmorecost-effective;inthecurrentstateofaffairs,theSIFwouldactuallyneedtopreventmanymorecasesofhepatitisCinordertobetrulycost-saving.

Interestingly,ifharmreductioneffortsandpaymentforhepatitisCtreatmentweretosignificantlyreducetheprevalenceofhepatitisC,asupervisedinjectionfacilitycouldconceivablybecomeineffectivecost-wiseduetotheloweredprevalenceofhepatitisC.Furthermore,thiscost-effectivenessanalysisishighlysensitivetothecostofhepatitisCdrugs;ifpricescontinuetofallrapidly,preventioneffortswouldbecomelesscost-effectiveastreatmentbecomesmoreaffordable.

HepatitisCpreventionisfarmorecost-effectivethanHIVpreventionbecauseithasasignificantlyhigherprevalencethanHIVinDenver.HepatitisCisalsofarmoreinfectious.Foraccidentalneedlesticks,HIVisestimatedtohaveatransmissionrateof0.6%,whileestimatesforhepatitisCtransmissionrangefrom1.6%to10%perneedlestick.Theper-acttransmissionrateforpurposefulinjectiondruguseislikelysignificantlyhigher.

Theprimaryuncertaintiesinacost-effectivenessanalysisofapotentialsupervisedinjectionfacilityareprevalenceofinjectiondruguseinDenverandthereductioninneedlesharingassociatedwithaSIF.Therearealsodifficultieswithdelineatingtheboundariesofacost-effectivenessstudy,sincePWIDfromoutsideDenvermayutilizebothaSIFaswellashealthcareservicesinthecity,skewingcostshigherthanwouldbeexpectedbypopulation-basedsurveys.Furthermore,therelevanceofcost-effectivenessinamulti-payerhealthcaresystemisuncertain,sincethebenefitsofpreventionfalldisproportionatelytotraditionalpayerswhilethecostsaccruetogovernmentandnonprofits.

Evenso,thecostofaSIFinDenverwouldbesmallcomparedwithcurrenthealthcareoutlays.Evenpublichealthdepartments,whichaccountforasmallfractionofhealthspendinginDenver,couldaffordaSIF;thecostscouldbepartiallycoveredbythesavingsinthecriminaljusticeandhealthcaresystems.InVancouver,theCoastalHealthAuthorityspent$184.8millionlastyearjustonmentalhealthandsubstanceusecommunityservices.Insite,thesupervisedinjectionfacility,cost$2.2million.Thisaccountedforlessthan1.3%oftotalspending(VancouverCoastalHealth,2015).

ThereareotherunknownsthatmayimproveaSIF’sapparentcost-effectiveness.First,onlythereductionsindeathsandqualityoflifeduetooverdose,HIV,andhepatitisCweretakenintoaccountinthisanalysis.ThereisgreatpotentialforaSIFtoengagePWIDintheirhealthcareandprovidealocationforcompassionateproviderstomeetwiththeseclients;thiseffecthasbeendemonstratedinHIV+PWIDinVancouver,whohadimprovementsinmeasuresofhealthinadditiontoreductionsinoverdoseandsharing.OtherSIFshavepreviouslyprovidedinformationandimmunizationsduringoutbreaks(Mathersetal2013).

Also,thisanalysisonlytakesintoaccountfirst-degreeinfections;thatis,thecostsofaninitialnewinfectionwithoutconsideringotherpeoplewhomightbeinfectedbythesentinelinfection.Sincemostinfectedinjectionusersareinfectedbyotherusers,preventingoneinfectioncouldpreventseveralothersinturn.ThecostsavingsmaybeevengreaterinDenver,whichhasafarlowerprevalenceofbothhepatitisCandHIVamongPWIDthanVancouverdoes.Preventioneffortsforinfectiousdiseasearemorecost-effectivewhenthereisanintermediatelevelofprevalence,sinceitisintherangeof50%prevalencewhenanactofsharingismostlikelytoresultinanewinfection.

Thisanalysisalsodoesnotattempttocapturesavingsfromreducingskinandsofttissueinfections(SSTI),whichbysomeestimatesare,financially,thecostliestpartofinjectiondruguse.Itishighlylikelythatsupervisedinjectionfacilitiescouldreducetheseinfectionsbyprovidingsterileconditionsandsuppliesaswellastimetopreparesaferinjections.SIFsalsoprovideon-siteprimarycare,whichcoulddramaticallyreducecostsbyearlysecondarypreventionofSSTI.

IV. Discussion

ThereislittledoubtthattheUSismovingtowarditsfirstsupervisedinjectionfacility.Whereasayearagosupervisedinjectionwasafringetopicforharmreductionagencies,itisnowanagendaitemforcitycouncilsandstatelegislatures.SIFadvocateswoulddowelltolearnfrompreviousharmreductionefforts,particularlysyringeexchange.Intheearly80’s,syringeexchangewasillegal.Manythoughtitaradical,evendangerousidea.However,anepidemic—thistime,HIV/AIDS—promptedradical(albeitbelatedandvariegated)changestolawsandpracticesaroundthecountry.

Theharmreductionfieldhas,inthelasttwentyyears,undertakenseveralsimilaradvocacyeffortsthatmetwithsuccess.Studyingtheestablishmentofsyringeexchangesandnaloxoneaccessprogramsmayenlightenthemovementtowardsupervisedinjection.Bothofthesewereedgyformsofharmreductionintheirinfancies,buttodayhavebecomerelativelywell-acceptedpublichealthmeasures.

Therouteofneedleexchange,orsyringeaccess,to“legitimacy”hasbeenfraughtwithuncertaintyandbacktracking.Eventoday,“legitimacy”isarelativeterm—thereremainnoneedleexchangesinseventeenstates(KaiserFamilyFoundation,2014).

Manygroupsstillopposeneedleexchange.Theyincludelawenforcement,districtattorneys,andcommunityorganizations.In2006,publichealthexpertDr.BarbaraTempalskicharacterizedthelocaldisagreementsoverneedleexchangeasemblematicofanational“struggle…betweenlawenforcementandmedicalprovidersastowhetherdrugusersshouldbedefinedascriminalsormedicalpatients”(Kubi,2012).

InDenver,attemptstosanctionsyringeexchangestatewidestartedin1997butthebillfailed.ThecityofDenver,inanticipationofstatewideapproval,actuallyauthorizedneedleexchange.ColoradoOrganizationsRegardingAIDS(CORA)triedtorevivethebillbutittookuntilthefallof2009,immediatelypriortothesupportivethen-governorRitter’sdeparture,thatsupportersmadeafinalpushtopasstheirbill.Inthespringof2010,CORA’slobbyistworkedwiththeprogressiveMendes-Steadmanlobbyingfirm.Eighty-oneofonehundredsenatorsvotedforit,andthebillwaspassedonMay26th2010.

Meanwhile,atthecitylevel,Denverhadonthebooksthepreviously-mentionedordinanceauthorizingsyringeexchange.Inparallelwithstatewideefforts,theDenverDrugStrategyCommissiondecidedthat

syringeexchangewasapriorityforDenver.Anaideinthen-mayorHickenlooper’soffice,KarlaMaraccini,helpedpushforwardmoreprogressivelocalordinancesaswellasstatewidelegislation.Evenafterthestatebillwaspassed,syringeexchangetook21monthstoimplementbecauseofpoliticalnecessities.Overlyrestrictivepoliciesandzoninglawsmeantthat,whileHRACeventuallyreceivedcitycouncilapproval,theyhadtomovepriortotheonsetofsyringeexchangeactivities.

Thejourneytonaloxoneaccesshasbeenonlyslightlylesstroubled.Naloxonehasanimpressivetherapeuticprofile.Thedrughasfewmedicalsideeffectsanditishighlyeffectiveinreversingoverdoses.Thereisanecdotalevidencethateasynaloxoneaccesscanhelpreduceoverdosedeaths.However,increasingaccesstonaloxonewasnotalwaysrecognizedasabeneficialoverdosereductionstrategy;ittookfifteenyearstorecognizethatcommunity-basednaloxonedistributionwasacost-effective,unobjectionablepractice.

Untilatleast2008,prominentpublichealthofficialsactivelyopposednaloxonedistributiontolaypersons."Idon'tagreewithgivinganopioidantidotetonon-medicalprofessionals.That'sNo.1,"saidDr.BerthaMadras,deputydirectoroftheWhiteHouseOfficeonNationalDrugControlPolicy."Ijustdon'tthinkthat'sgoodpublichealthpolicy."(Knox2008)Otherobjectionswerebasedonconcernsthateasyaccesswouldpreventpeoplefromceasingdruguse."YougivethemtheNarcan,whereistheirmotivationtochange?"saidBaltimoreCounty’slongtimesubstanceabusedirectorMichaelGimbel(Smith2007).PWIDthemselvesalsohadconcernsaboutnaloxoneaccess.Specifically,35%ofheroinusersworriedthatpeoplemightinjectmoreheroinknowingthatanoverdosereversalagentwasnearby,while62%statedthattheywouldbedisinclinedtocall911afteranoverdoseiftheyhadaccesstonaloxone.(Sealetal,2003)Afternaloxoneaccesswasexpanded,boththeseconcernswereshowntobeinvalid(Levineetal2016,Maxwell2005,Seal2005,Wagner2010).

Fortunately,undergroundharmreductioneffortstopromotenaloxonehavenowgivenwaytofederally-endorsedguidelinespromotingnaloxone.Manyefforts,bipartisan,focusonexpandingnaloxoneaccessbeyonditsoriginalscope.Naloxoneaccessforemergencymedicalservices,fire,andpolice(Davis2014)isnowendorsedbytheNationalDrugControlStrategy(WhiteHouse,2013).Inparallel,thetrendofprescribingnaloxonetoPWIDhasexpandedtoprescribingtofriendsandfamilymembers(GoodmanandGilman2001,Wheeleretal2012)and,finally,tostandingordersallowinganyonetoaccessnaloxonethroughapharmacy(Wheeler2015).

InDenver,“naloxonewasaloteasier”thansyringeexchange,saysLisaRaville,executivedirectorofthestate’slargestharmreductionorganization.Formanyyears,theHarmReductionActionCentertriedtofindaphysiciantoprescribenaloxone.In2011,HRACleadersmetaphysicianatafundraiserandshebeganprescribingnaloxoneforHRACclientsinMay2012.However,mostofnaloxonewasusedonthirdparties,sinceitisdifficultforanoverdosingpersontoself-administernaloxone.Dr.Kennedyworriedthatthisopenedhertoliabilityandthefurorofthemedicalboard.

ThisledtoSenateBill14authorizingprescriptionofthird-partynaloxone.Dr.Kennedy’srelationshipwithaphysiciancolleague,statesenatorIreneAguilar,M.D.,enabledDr.Aguilartoco-sponsorthisbill.However,evenwiththisaddedmeasure,manyindividualscouldnotaccessnaloxone.Finally,abillpermittingstandingordersfornaloxonewasratifiedMay2015byanearlyunanimousvote.

Ms.Ravillecitestheimportanceofnetworkingandrealizingawindowofopportunityinthesepolicyefforts.Severaloftheseadvocatesinkeypositions—Dr.KennedyasahealthcareproviderandMs.

Marraciniasacitygovernmentadvocate—happenedfortuitously.Thishighlightstheimportanceofchanceandtheneedtoemphasizeconnectionsinlobbyingandadvocacy.ThelegislatureandelectorateinColoradoandarealsofairlyopen-mindedandamenabletoharmreductionactivities,asevidencedbyHRAC’ssevenlegislativewinsinsevenyears.Finally,dataregardingthesafetyandefficacyoftheseinterventionswerenecessaryandhelpedclinchsupportforthebills(L.Raville,personalcommunication,June2,2016).

Thereislittledoubtthatsanctionedsupervisedinjectionwouldrequirelegalchanges.Asoutlinedabove,supervisedinjectionviolatestwomajorfederalstatutes—theControlledSubstancesActand“crackhouse”statutes.Whiletheseareunlikelytochangeanytimesoon,anysupervisedinjectionfacility(anditsemployees)wouldrequirestateexemptionsfromtheselawsinordertooperatewithanylevelofstability.

ThatittakesanepidemictochangeperceptionsandlawsacrosstheUnitedStatesisunfortunate,butitisunlikelytochangesoon.Thereare,however,reasonstobelievethatsupervisedinjectioncanoccurmorerapidlythanothersocialchangeinthepast,andperhapsevenmorequicklythanneedleexchangeandnaloxoneaccesshavehappened.

Inthelegislativearena,manyharmreductionorganizationsareexpertsinlobbying.Mostoftheseorganizationshelpedpushthroughtheirstate’ssyringeexchangelawsand,veryrecently,naloxoneaccessprovisions;since2001,46stateshavepassedatleastonelawallowingmoreaccesstonaloxonebylaypeople.(NetworkforPublicHealthLaw2016)Clearly,harmreductionorganizationsandotheradvocatesfordrugusersaresavvyveteransofthelegislativeprocess.Somehavereliablechampionsinstatelegislatures.Furthermore,therearetwonationalorganizations,theHarmReductionCoalitionandtheDrugPolicyAlliance,thatassiststateefforts.Supervisedinjectionislikelytohavemanyofthesamebackersaspreviousproposals,soliningupsupportforthiscontroversialeffortmaybelessdifficultthananovellegislativeeffort.

Inaddition,therearealreadyplacesthatviolatefederallawwhereColoradoanscanusedrugs.Sincelegalizationofmarijuanain2014,privateclubscreatedexpresslyforusingmarijuanahaveexistedwithoutinterferencefromlocalorfederalauthorities.Whileinhalingmarijuanadoesnotapproximatetheriskofinjectingheroin,marijuanapurchaseanduseisillegalunderfederallawandthussubjecttothesametwostatutesmentionedabove.Thissetsaprecedentofsortsforsupervisedinjection,particularlygiventhepotentialhealthbenefitsofthelatter(Anleu2015).

Furthermore,supervisedinjectionisnotexplicitlyprohibitedbystatelaws.Asstatedabove,theprimarylegislativebarrierstosupervisedinjectionarefederal.Therefore,establishingaSIFshouldnotrequirerepealofanybansatthestatelevel.Thiscouldmakelegislatorsmorelikelytosupportsuchabillbecauseitwillnotfloutanyexistingstatelaws.Infact,thefewmovementstowardsupervisedinjectionhaveraisedthepossibilityofcircumventingthelegislativesystemandutilizinglocalpublichealthemergencyfunctionstoauthorizesupervisedinjection.

Whileitdoesnotrelatedirectlytolegislation,supervisedinjectionisalsonotexplicitlyineligibleforfederalfunding.Whilethefederalgovernmentwasexpresslybannedfromfundingneedleexchangeforover20yearsunderReagan-eradruglaws,supervisedinjectionsitesmaybeimmediatelyeligibleforfunding.

Legislatively,Coloradohasprovenparticularlyprogressiveondrugpolicy.Coloradoisoneofonlyfivestatestomeetallthecriteriaforidealnaloxoneaccess.ThestatealsorecentlyexpandeditsGoodSamaritanlawstoexemptpeoplefromarrestiftheycall911incaseofanoverdose.Andofcourse,Coloradowasoneofthefirsttwostatestolegalizemarijuanaforrecreationaluseafterleadingthewayinmedicalmarijuana.

Whilelawenforcementmayneversupportsupervisedinjectionwholeheartedly,itismoreacceptablenowthaneverbefore.Federally,thecountryisnolongerinthethroesoftheWaronDrugs.Infact,recentexecutiveandfederallegislativeactionsgivehopethatthegovernmentisfollowingthepopulaceinacceptingamedicalviewofdruguse.PresidentObamahasmadenumerouschangestodrugpolicytoaddresstheopioidcrisis,includingexpandingaccesstotreatment,improvingmentalhealthinsurancecoverage,andapprovingfederalfundingforsyringeexchanges.Veryfewofthesechangeshaveinvolvedenforcementofexistinglawsagainststreet-leveldrugusersorincreasingpenaltiesfordruguse(WhiteHouse2016).

Medically,syringeexchangehasbeenshowntobeeffectiveatreducingthespreadofHIVandhepatitis.Healthcareworkersmaybemorelikelytosupportsupervisedinjection,hopingthatSIFsprovethemselveseffectivejustassyringeexchangeshave.Thereisreasontobelievethatthismightbethecase,sinceoneoftheprimarygoalsofsupervisedinjection—decreasedoverdose—iseasytoachieveifnaloxoneisgivenintime.

Publicacceptanceofsupervisedinjectionisalsoontherise.AsIfoundinmyinterviews,manyresidentsofagentrifyingcityoftenapproveofeffortstomovepublicnuisancesoutofthepubliceye.Manyofthemaresimultaneouslyawareoftheneedtoprovidesocialservicestoallcitizens.Supervisedinjectionmaybeseenasaprogressive,mutuallybeneficialsolutiontotheproblemofpublicinjection.Furthermore,farmorepeopleperceivethattheyarepersonallyaffectedbythecurrentcrisisduetothewidecross-sectionofthecountryaffectedbyopioids.

Thisperceptionisinfluencedbothbyfactsaswellasmediaportrayals.Ofalargesampleofpeopleenteringtreatmentforheroinaddiction,onlyabouthalfofthepeoplewhotriedheroinpriorto1980werewhite.Butofpeopleenteringtreatmentinthepastdecade,90%ofthepeoplewhotriedheroinforthefirsttimewerewhite.Whilehighlightingthisdisparityisnotuniversallypopular,themediahaveundoubtedlypushedinjectionandoverdoseintothepubliceye(Cohen2015).

Socially,harmreductionactivitieshavebecomefarmorevoguishinthecurrentopioidcrisis.Thisisprobablyattributabletoimprovedunderstandingofthenatureofdruguseandaddictionaswellasthechangingdemographicsofthecurrentepidemic.Medicalprofessionalsandthelaypublicalsodemonstrateimprovedknowledgeandacceptanceofaddictionasamedicaldisease(Woodetal,2013).

FuturestudiesofthistopicinDenvershouldassessthedetailsofSIFoperation,includinghours,operatingprocedures,andstaffingrequirements.TheycanalsorefinethestatisticalvalidityofthedemographicsofSIFusersandexpandintoothergroupsofPWID,includingthosewithstablehousingandtheseverelymentallyill.ThesegroupscompriseasignificantportionofPWIDandwereundersampledinthissurvey.Furthermore,futurestudiesshouldinvestigatewhethergroupsathighestriskfordiseasetransmissionandoverdose—thosewhohaveHIV,HepatitisC,orahistoryofoverdoses—aremorelikelytouseasupervisedinjectionfacility.

DrawingonexploratorystudiesfromOttawaandTorontocanprovidefuturedirectionforSIFeffortsinDenver.“Stakeholdersstressedthatanimplementationplanshouldincludeanassessmentoftheexistingscientificevidenceforsupervisedconsumptionfacilities,considerationofthegeneralizabilityofthisevidencetolocalcircumstances,aclearexplanationofthefacility’sgoals,communityconsultations,andaservicemodeldesignthataddressestheuniquesocialandpoliticalenvironmentsofeachcity”(BayoumiandStrike,2012).

However,DenverhasitsownuniqueaspectsthatmakeitdifferentfromcitieswhereSIFsexistalready.Thisishighlightedbythecontrastincost-effectivenessfindingsbetweenDenverandVancouver.Pinkerton(2010)foundthatInsiteprevents83.5HIVinfectionsayear,butacarefulreadingofthestudyshowsthatthesupervisedinjectionpartofInsitepreventsamere2.8infectionsperyear,withtherestcomingfromotherserviceslikeneedleexchange.Thisfindingisaboutanorderofmagnitudehigherthanmyfindingthat,evenwithveryliberalestimates,lessthanoneHIVinfectionwouldbepreventedinDenvereachyear.

HepatitisCisadifferentstory,however.ThehigherprevalenceofhepatitisCmakeitlikelythataSIFmaybebothcost-effectiveandcost-savingduetopreventionofhepatitisCalone.ThisagaincontrastswithfindingsfromotherstudiesthatsuggestSIFsarenotcost-effectivethroughpreventionofhepatitisC.Thismayrelatetothediseaseprevalenceinthetwolocations;Denver’shepatitisCprevalenceisintherangeof60%,whileitisvirtuallyendemicinVancouverPWIDatover80%.

SeveralotherstudiesofpotentialCanadianSIFsandInsiteusemathematicalmodelingtoshowthatsecondaryeffectslikeareductioninsyringesharingcanmakeaSIFcost-effective.Insomeofthesecases,retrospectivedataareavailablebutnotused.Forinstance,dataforHIVandhepatitisCinfectionareavailablefrompre-andpost-Insiteeras,buttheauthorsstillutilizemodelingtechniques.(AndresenandBoyd,2008)Furthermore,thesemodellingtechniquesdonotreflectreality.TheyassumethatmoreSIFswouldincreaseutilizationofSIFstothepointwhereveryfewpeopleareinjectingoutsideofSIFs,whichdoesnotcorrespondwiththefindingthatonlyhalfofeligiblePWIDintheneighborhoodofInsitehaveeverusedthefacility.

WhilestudiesofpotentialSIFusersinTorontoandOttawarevealthatpotentialSIFusersengageinsomeriskierbehaviors,suchaspassingneedles,theyalsoshowthattheSIFmightnotreachsometargetpopulations,likemarginallyhousedpeopleandnewlyinitiatedinjectors.TheonlysignificantdifferencesinthesestudieswerethatlikelySIFclientsweremorelikely(PublicHealthAgencyofCanada,2006andLeonard,DeRubeis,andStrike2008)tobehomelessortoinjectinpublic.Whilethesearepromisingfindings,theybynomeansdemonstratethatpotentialSIFusersareextremelyhigh-riskinjectors.Ifthisistrue,thenperhapssupervisedinjectionfailstoreachthetargetpopulation,aprimarylitmustestofpublichealthinterventions(Kass2001).Overall,mycost-effectivenessanalysisaswellasareviewoftheliteraturesuggestthatcost-effectivenessandcostsavingsfromaSIFarebynomeansguaranteed.

Thispaperincludesanexhaustivestudyofthescientificevidenceforsupervisedinjection;ashighlightedpreviously,thesedataarelimitedbythefactthattheyhavebeenlargelycollectedfromSydneyandVancouver.Thus,thegeneralizabilityofthescientificevidencetotheUSA,wheredrugpolicyisstilllargelyfocusedonabstinenceandpunishment,isuncertain.ThefacilitygoalsmusttakeintoconsiderationprimarilythehealthbenefitsandhumanrightsofPWID.However,thegoalsalsohavetotakeintoaccounturbanattractivenessandpropertyvalueconcernsofurbanresidents.Localsocial

serviceproviders,lawenforcement,legislators,andcommunitymembersallmustagreeonaSIFforittobesustainable.

Limitations

Thestudywaslimitedbyasmallsamplesize.However,asanexploratorystudy,itwasnotintendedtohavethepowertodetectsmalldifferencesinsurvey-takers’opinions.Iwaslimitedbytimeandresourcestothenumberofthesurveysadministered.

Thesurveywasalsolimitedbyselectionbias.UsingaconveniencesamplefromtheHarmReductionActionCentersignificantlyimprovedconfidentialityandrecruitmentefforts,butattheexpenseofdiverseopinions.ItisverylikelythattheclientsIinterviewedtendtowardheavierusethantheaveragePWID,andrespondentswerealmostcertainlydifferentintheirhealthbehaviorsthanPWIDwhodonotpatronizesyringeexchange.However,thenature,direction,andmagnitudeofthesedifferencesareunknown.

Itislikelythatmysampleneglectedseverelymentallyillandextremelymarginalizedpersons.WhilePWIDarecertainlyamarginalizedgroup,participationintheintakeenrollmentanddrop-inrequirethatparticipantsmaintainameasureofdecorum.Furthermore,participationintheinterviewrequiredthatparticipantsremainawakeandattentiveforthirtytofortyminutes.ThiswasasignificantbarriertoparticipationforsomeHRACclients.

Therefore,itislikelythatIundersampledpeoplewithextremelyproblematicdrughabitsandseverementalillness.Thispopulationcouldpotentiallybenefitfromsupervisedinjection,asthosewithseverementalillnessesoftenengageinthemostriskyinjectionbehaviors(Mackesy-Amiti2014);supervisedinjectionfacilitiescouldalsohelpengagemarginalizedPWIDinsocialservices,harmreduction,mentalhealth,orsubstanceabusetreatmentefforts.

ItisalsoverylikelythatIundersampledPWIDwithhousing.Theomissionofthisquestion,whilewell-intentionedtohelpavoidthestigmatizationofdiscussinghomelessness,wassignificant.SinceItendedtoaskpeoplewhowereseatedatHRACtoparticipateintheinterview,Iwaslesslikelytosamplepeoplewithstablehousing.Often,clientswhoarestablyhousedsimplyenter,exchange,andleave,spendinglesstimeatthedrop-inthanclientswhoarehomelessorunstableintheirhousing.Furthermore,clientswithcarshavenowheretoparkandoftenrushouttoavoidaticket;therefore,mysurveyprobablycapturedfewerpeoplewithcarsaswellashousing.

Havingabetterestimateoftheprevalenceofsyringesharingwouldhaveincreasedtheaccuracyofcost-effectivenessandcost-benefitanalysesforhepatitisCandHIV.Whilesomedataareavailableintheliterature,theavailabilityofsterilesyringesvarieswidelybetweencities.Iwasabletomakeawideadhocestimateofsharingprevalence,buthavingmoreestimatescouldhavenarrowedthisrangeand,potentially,changedthefindingsintheseanalyses.

Forcommunitystakeholders,Iwaslimitedbytheunwillingnessoflawenforcementtoparticipateinthestudy.Businessownersandhealthcareprofessionals,whohavelesshierarchicalsupervisorystructures,wererelativelyeasytorecruit.Citygovernmentofficialswerealsoreadyparticipants.However,lawenforcementprovedverydifficulttocontact.Severalcitedthepermissionsinvolvedasbarrierstoparticipation.Itispossiblethattheillegalnatureofinjectiondrugusedissuadedlawenforcementofficersfromparticipating.Recognizingthis,Ihighlightedtheconfidentialnatureoftheresearch,

unsignedconsent,andCertificateofConfidentialityinmyintroductoryemails.Reachingmorelawenforcementofficerscouldhavebetterelucidatedthiskeygroup’sbeliefsonsupervisedinjection.

Itisalsopossiblethattherelativelysmallfinancialincentive,lunch,preventedsomecommunitystakeholdersfromparticipating.While$10wasalargeincentiveforHRACclients,thisamountwastrivialforothers,especiallybusinessownerswhomayhavelostbusinessduringtheinterview.

Cost-effectivenessanalysismaynotbeaneffectivemethodforapilotstudyofsupervisedinjection.CEAentails,necessarily,severalassumptionsthatwillremainunknownuntilwellintoaSIF’slifespan,ifever.EvenHealthCanada,whichoverseestheoperationofInsitethroughtheVancouverCoastalHealthAuthority,statesthat“theEAC(ExpertAdvisoryCommittee)werenotconvincedthattheseassumptionswereentirelyvalid”regardingthemathematicalmodellingstudiesandtheydonotgivemuchweighttothem.

Thereisanadditionalaspecttothecost-effectivenessstudythatIwasunabletocomplete.Perhapsthemostfinanciallydrainingaspectofinjectiondruguseisnotbloodbornediseaseoroverdosebutskinandsofttissueinfections(SSTI).ArecentstudyofasinglecountyhospitalinFloridasuggestedthatinjection-relatedSSTIscostnearly$1millionamonth,with17deathsovertheyearofthestudy(Tookes2015).

ManybelievethataSIFcouldpreventSSTIfarmoreeffectivelythaneitherHIVorhepatitisCbecausetheseSSTIusuallyresultfromcarelessandhurriedinjections.SIFsallowPWIDtotakethetimetoprepareinjectionsproperlyand,intheory,havethepotentialtoreducetheseinfectionssignificantly.However,therearenodataaboutthespecificlikelihoodsofSSTI,thereductionofSSTIthroughbetterpractices,ortheprobabilitiesofmortalityfromSSTI.Therefore,acost-effectivenessstudyonSSTIwouldbeashotinthedarkcomparedtootherconditionsforwhichbetterdataexist.

Finally,theauthorsofseveralcost-effectivenessstudiesinVancouveracknowledgethat“thelargestobstacletoimplementingaSIFinOttawaisstrongoppositionfromthelocalmunicipalgovernmentandpoliceforceaswellasthefederalgovernment.”Inthefaceofsuchresistance,evenrobustcost-effectivenessdatawouldbeperipheralatbesttoasuccessfulargumentforaSIF.AnotherkeydifferenceinAmericaisthediffusenatureofpaymentforhealthcareservicesandothercommunityresources.Cost-benefitanalysisisfarmorerelevantinCanada,whereasingleentitypaysforbothpreventativeandtherapeutichealthoutlays.InAmerica,preventionisrarelycoveredbythesameentityasmedicaltreatment.Thustheconstructofcost-effectivenessmaybelessvalidthanothermodelsforanalyzingandadvocatingforaSIF.ThisisanotherkeydifferencethatshouldberespectedasDenvermovestowardestablishingaSIF.

V. Conclusion

Theroadtosupervisedinjectioncannotbeconstructedbyasingleentity.Ineveryinstancewhereasupervisedinjectionfacilityhasbeenestablished,therehasbeenalongperiodofdiscussionandnegotiationbetweenvariousstakeholdergroupstoestablishexpectationsandsetregulations.Whilethisnegotiationwillnecessarilyinvolvegovernmentorganizations—particularlyinhealthcare,legislation,andlawenforcement—thereisanincreasingrecognitionthat“cooperationbetweengovernmentalandnon-governmentalagencies”hasresultedina“blurringoftheboundariesbetweenthepublicandprivatesector”(KublerandWalti,2001).

Citiesandstatesareoftenattheforefrontofprogressondrugpolicy.FederalgovernmentsinNorthAmericaandWesternEuropelegislatedrugregulations,butcitiesandstatescarryoutmostofthelawenforcementandhealthcarefordrug-relatedproblems.However,boththesedomainsrequirefinancialresources.Thus,thewilltochangedrugpolicieswithincitiesandstatesisoftendeterminedbythefinancialstatusofthecity(KublerandWalti,2001).Notethatthisworksbothways;pathwaystoliberalizationofdruglawshavealsobeenpromptedbytheincreasedrevenueassociatedwiththecreationoflegaldrugmarketplaces.

RegardingtheestablishmentofaSIF,Denverwouldseemalogicalplaceforsuchaprogressivedrugpolicy.KublerandWalti,intheirdiscussionofthe“attractivenesspolicy”ofthegentrifiedpost-industrialcity,positthat"thepresenceofthesociallymarginalizedfunctionsasanegativeexternality….Ifthegentrifiedcityistofunctionproperly,sociallymarginalizedindividuals,andsocialproblemsingeneral,shouldnotbeseen.”Atthesametime,though,liberalsocialpolicyrequiresthatcitiesofferagenerouswelfarepolicy.

DenvermostdefinitelymeetsthecriteriaforwhatNeilSmith(1996)calledthe“revanchist”city,wherethemiddleandrulingclassesmobilize“againstthesupposed‘theft’ofthecity,adesperatedefenseofachallengedphalanxofprivileges,cloakedinthepopulistlanguageofcivicmorality,familyvaluesandneighborhoodsecurity.”Recentlarge-scaleevictionsofhomelesspeoplefrompublicspacesindicatethatDenverisatatippingpointinitsstruggletodefineitsbalanceofattractivenessversussocialwelfare.KublerandWaltipositthatthisstruggleistwofold.

Thereisadirectconflictbetweensociallymarginalizedpeopleandthepopulationsofgentrifiedneighborhoods.Thereisalsoahiddenconflictbetweennongovernmentalactorsandcity/stateagencies,primarilylawenforcement.Thisconflictfrequentlyinvolvesredundantandevencounterproductiveefforts,especiallyinharmreduction;forinstance,syringeaccessprogramsdistributeneedlesthatmayleadtosearches,charges,andpossiblyincarceration,causingnonprofitlegalservicestoexpendtimeassistingclientswithdrugchargesandcreatingacycle.

Inareaswithmoresuccessfuldrugpolicies,citygovernmentshavefosteredcoordinationschemesthat“startedacollectivelearningprocess,duringwhichthevariousactorsmutuallyadjustedtheirpracticesinordertoreducethecounterproductiveeffectsofformerlyuncoordinatedactivities.”ThishasthepotentialtoshapeamoreefficientNashequilibriumwherenonprofitsandgovernmentactorsminimizetheircounterproductiveefforts.Adoptingasocialpublic-orderregime,ratherthanazero-tolerancepolicy,towardpublicdisturbancesmayprevent“potentiallyconflictualsituationsbyactingsimultaneouslyontheurbanbehaviorofdeviantindividualsaswellasonneighborhoodattitudes.”

Denveralsoalreadyhastheorganizationalinfrastructureinplacetohandleasupervisedinjectionfacility.AswithmanyEuropeancitiesthatsuccessfullydealwithdrugs,DenverhasboththeDenverOfficeofDrugStrategyandtheDrugStrategyCommission.Theformeristhemayoralofficechargedwithdevelopmentofdrugstrategyandthelatterisabroad-basedcommunitycoalition.

KublerandWaltioutlinethreeprinciplesthatseemtoberequisiteforsuccessfuldrugpoliciesinadozenEuropeancities.First,policymakingtakesplaceatalllevelsofoperationinthelocalgovernmentstructures.Second,effortsengagerepresentativesofthepoliceandsocialservices.Third,noneofthecommissionsandcommitteeshaveformaldecision-makingpower.TheDenverDrugStrategyCommissionmeetsthisdescription,butitsutilityvariesdependingonthemayoralregimeinpower.

Moreimportantlythananyoftheabove,Denverhasdemonstrateditswillingnesstobeattheforefrontofharmreductiondrugpolicy.

AspublichealthworkersinDenvermovetowardaSIF,itisimportanttorecognizethatharmreductionefforts“meetpeoplewherethey’reat.”Thisusuallyregardsclients,butitisequallyusefultoanalyzepoliticalandsocialsupportinthisway.Justassomeneedleexchangesmayoperateunderahandshakeagreement—Boulder,Coloradodidjustthatfor22years(Miller2011)—supervisedinjectionwillprobablyexistinagrayareapriortooutrightacceptanceandpropagation.

However,itisalsoimportanttomovesupervisedinjectionalongapace,becausethespotlightonopioidaddictionandharmreductionwillnotlast.Kingdon’s“PolicyWindowsofOpportunity”modelstatesthatpolicywindowsoccurwhenthereisawell-definedproblem,apossiblesolution,andthepoliticalwilltoact.Supervisedinjectionactuallyaddressestwomajorproblemssimultaneously.SIFcandecreaseoverdoseandpublicinjection.Framingsupervisedinjectionasadualsolutiontotheseproblemshasthepotentialtocreatemorepoliticalwillthanasingleproblem;furthermore,thesetwoargumentsmayswayentirelydifferenttypesofstakeholders.

ThisanalysisintermsofKingdon’smodelshowsthattherearetwodesirablegoalsforsupervisedinjection.Whilesomestatementsaboutsupervisedinjectionreflectthebeliefthatitwillbeapanaceaforinjection-relatedproblemsbothinPWIDandsocietyatlarge,itisfarmorehelpfultohaveanarrow

goalandKingdon’smodelsuggeststhatthisgoalistwofold:decreasepublicinjectionanddecreaseoverdose.

Recommendations

Partnering:OperatingevenasmallSIFwouldrequirehiringmedicalprofessionals,significantriskassessmentsandnewfacilities.ThesefunctionsarebeyondthecurrentcapacityofHRAC.Furthermore,communitysupportforaSIFwouldbenefitgreatlyfromdirectbuy-infrompartners.Particularly,healthcareprofessionals,academicresearch,treatmentproviders,andcityagenciesliketheDenverDrugStrategyCommissionwouldbeimportanttoenlistaspartners.

Themostnotableandbest-studiedSIFintheworld,Insite,survivesinpartduetoitsgroundbreakingresearchonSIFs.Havingaworld-classacademicresearchinstitutenearbyprovidesanobviouspartnerforaprospectiveSIFasithelpstocreateitsownevidencebase.HavinghealthcareprofessionalandtreatmentprovidersonboardpriortoestablishmentoftheSIFwillnotonlylegitimizetheadvocacyfortheSIFbutalsoprovideapoolofwillingprofessionalswhomightdeveloppolicyfortheestablishmentorevenstafftheSIF.Finally,veryfewSIFsexistwithoutcloseinvolvementwithcityagencies;mostoftheseinEuropeincludealocaldrugpolicyboard.InDenver,theanalogousbureauwouldbetheDenverDrugStrategyCommission.

AnothergroupthatstandstobenefitgreatlyfromaSIFisdowntownbusinessowners.Theyshoulderadisproportionateburdenofdruginjection.Mostbusinessesarenotpreparedtodealwithinfectiouslitterandunrulyindividuals.Occupiedbathroomsfrustratepayingclients.ThusitwouldbebeneficialtocultivaterelationshipswithbusinessownerswhocanhelpadvocateforaSIF.

Preparing:ManypeoplewilldeterminetheirsupportforapotentialSIFbasednotonfactsfromprioreffortsbutontheirbeliefsandmorals.IntheabsenceofdefinitiveinformationonSIFpolicies,organizationsthatdonotsupportharmreductionactivitiesmayintroducebaselessorbiasedinformationintothisvoid.Therefore,ensuringthatkeySIFpoliciesareformulatedwellpriortotheonsetofadvocacyisimportant.

Forinstance,IfoundinmysurveyofcommunitystakeholdersthatmanywouldcompromiseontheirmisgivingsaboutaSIFifithelpedpeopleenterdrugtreatment.Therefore,ensuringthatthefacilitycouldhaveonsiteoreasilyaccessible,seamlesstreatmentwouldbeideal.Preferably,clientscouldstartmedication-assistedtreatmentondemand.

Otherpolicieswouldprobablyrequirecompromise,especiallyattheofficiallevel.ThesharingorsplittingofdrugsonsiteishighlycontroversialatotherSIFsandthecontroversyoverthiswouldbestbeavoidedforthisfledglingeffort.Therefore,itmightbebesttostate,atleastattheonset,thatclientswillnotbeabletosplitdruginthefacility.Thiscouldheadoffprematureaccusationsofon-sitedealing.Whilenotalldetailsneedtobedecidedsofarinadvance,certainkey,hot-buttonpoliciesshouldbesetpriortoanypublicitysothatpotentialobjectionscanbeaverted.

Framing:Withmanypartiesinterestedindrugpolicy,someofthemquitenewtothescene,SIFadvocacyeffortsmustensurethattheyareinapositiontorespondtoavarietyofargumentsandappealtoasmanygroupsaspossible.AnticipatingobjectionstoaSIFandtailoringmessagestothosegroupsthatmaybeundecidedabouttheirsupportforaSIFcouldgiveadvocatesthefirst-moveradvantagewhileopponentsregroup.

Thisfirst-moveradvantageisparticularlytrueinthisinstancebecause,todrawfrommarketing,thisisanentirelynewmarketsegment.Manypeoplehavenotevenheardofsupervisedinjectionandhavenotformulatedanyopinionsonit.Therefore,aneffectiveinitialmessagetargetedatkeystakeholderscouldconvertpotentialopponentsintosupporters.

Timing:AsHRACanditscommunitypartnersmovetowardestablishingaSIF,thereisatrade-offbetweenactingsoonerandlater.Iftheannouncementcomestoosoon,theeffortisopentopoliticalblowbackandlosestheelementofsurprise.However,adelayedannouncementrisksmissingtheaforementionedwindowofopportunity.Itisimportanttolineupsupportforthiseffortsoonandhavetalkingpointsattheready.Ahigh-profileoverdoseorotherdrug-relatedeventcouldgalvanizesupportforthiseffort,similartorecentcelebritydeathsthatresultedinmediasaturation,mostofitsupportiveofdrugtreatment.Tocapitalizeonthismomentum,SIFadvocatesshouldprepareacommunityforumtointroducealternativestopublicinjection.

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ServiceLearning/CapstoneExperienceReflection

TheHarmReductionActionCenterisColorado’slargestpublichealthagencythatdealswithinjectiondruguse.Itistheleadingsyringeaccessprograminthestate,providingadvocacyforpeoplewhoinjectdrugsandleadershipformunicipalhealthdepartmentsandotherharmreductionagenciesfromaroundthestate.

ThecenterislocatedacrossfromthecapitolbuildinginDenverincloseproximitytoopendrugmarketsandcommonsitesforpublicinjection.Thestaffcomprisesfivefull-timeemployeesandonepart-timehealtheducator.Inadditiontoprovidingsyringeaccess,thecenterfunctionsasamorningdrop-incenterforhomelessandmarginallyhousedclients.

DuringmytimeatHRAC,Iperformedmyriadfunctionsfromhumblebathroomcleanertoconsultantfacilitatingthestrategicplan.Thisallstartedwiththehumblestoffunctions:bathroomattendant.WhenIstartedatHRAC,theyhadtwobathroomsandtheywereoftenmisused.Thenewestvolunteerorinternusuallytakesturnssupervisingthebathroomtoensurethatnooneisspendingtoolonginthebathroom,becausethishasresultedinon-siteoverdosesbefore.

Throughthishumbleposition,Icameintocontactwithmanyoftheclientsandspentalotoftimeinthehallwaychattingwiththem.Afterachangeinthestructureofthebathrooms,Iearnedapositionatthetable,exchangingsyringeswithclientsforseveralweeks.Fromthere,Imovedintoassessingclients’woundsandreferringthemfortreatmentasneeded;developinghealthinformationpamphletsforclients;trainingstaffonassessmentofcommonskinconditions;andrepresentingourorganizationatcommunitymeetings.Igraduallygainedthetrustofstaffandclientsandwasrewardedwithresponsibilityaccordingly.

Finally,IstarteddoingmyownresearchprojectafterIRBapproval.Ifoundtheexperienceswithdirectclientserviceinvaluable,asIalreadyknewsomeoftheresearchsubjects.Iwouldhavehadfarmoredifficultyenrollingclientsandcommunitystakeholdersalikehaditnotbeenfortheirfamiliarityandtrust.ThetrustofstaffwasalsoimperativeasIenrolledsubjects,sincethestaffmembersoftenhelpedwithreferralsforclientsandcommunitystakeholders.

Inadditiontomyresearchproject,whichwillprovideHRACwithmostoftheirSIFadvocacymaterialsoverthenextfewyears,mylargestcontributionwasthefacilitationofthestrategicplan.Iwasextremelypleasedthattheyaskedmetofacilitatethis,becauseIhopedtogetexperiencestrategicplanning.Thisplanwillhavealastingeffectontheorganization.Italsotaughtmealotaboutworkingwithgroups,leadership,andcreativity.IfeltlikeIbroughtalotofenthusiasmandanoutsiders’perspectivetothiseffortinadditiontoinstrumentalknowledgeabouthowtoformulateastrategicplan.Thisprojecthasbenefittedmebyallowingmetonetworkwithnonprofitleadersandpresentatangibledeliverabletoprospectiveemployers.

Thebiggestchallengesofmycapstoneexperienceoccurredveryearlyandverylateduringtheyear.Atfirst,Iwasgivensolittleresponsibility—IfeltlikeIgotoverruledevenduringmybathroomsupervision—thatIgotfrustratedandthoughtaboutfindinganotherservicelearningsite.However,Iseenowthattherearelargedisparitiesinenthusiasmandpreparednessforinterns.Everyonestartsoutwithmenialdutiesandtheyearnmoreresponsibility.Inowexpectthistobethecasewithmycareer.Evenwithgraduatedegreesandanimpressiveresume,Iwillhavetoprovemyselfinmywork.

Laterintheyear,Ihadagreatchallengefacilitatingthestrategicplan.AslongasIwasdoingthework,itproceededprettyrapidly.However,intheinterestsoffinishingmycapstoneproject,gaininginputfromothersonthestrategicplan,andinvolvingboardmembers,Idelegatedgoalformationtothestaffandboard.Inthelongrun,Ihopethatthiscollaborationwillcreatebuy-infortheplanandleadtofutureboard-staffcollaboration,butintheshortrun,theextremedelays(ithasbeenabouttwomonthssinceIdeliveredthenearlyfinishedplantothegroups)havebeendifficultandattimesIhavewantedtotakeoverthegoalformulationmyself.

However,Ithinkbothofthesedifficultieshavethecommoneffectofshowingmethevirtueofpatienceandteamwork.Thesesvirtueswerenotnearlyasemphasizedinmedicalschool,whererapidityandindependencewereessential.Ithinkthesevirtuesaretransferableintonearlyanyfield,butpublichealthinparticularemphasizesthemultidisciplinaryaspect.

Anotherimportantinsightfromthisprojectregardsthenatureofnonprofits,government,andcorporationsinAmerica.Thereisatendencyofnonprofitsandcorporationstoprovidesomeservicesthatwerepreviouslyprovidedbygovernments.Alongwiththiscomessomeduplicationofeffortsandevencounterproductivity.Forinstance,theHarmReductionActionCenteradvocatedforabillthatmakesitlegaltocarrynewandusedsyringes.However,lawenforcementcontinuetoconfiscatePWID’ssyringes.Thiswastesbothresourcesatthenonprofitaswellastimeforlawenforcement.Simplyreducingthecounterproductiveeffortsbetweenorganizationsandthegovernmentcouldresultinlessantagonisticrelationshipsaswellasbetterresourcemanagement.

Myviewofpublichealthpracticehaschangedinlinewiththislastinsight.Iseethenecessityofengagingavarietyofstakeholderstosolvepublichealthproblems.Forinstance,atHRAC,verylittlecouldhappenwithoutlegislativeaction,whichrequiresbothgovernmentandfor-profit(i.e.lobbying)efforts.HRACalsopurchasessyringesfromfor-profitcorporationsviaanonprofitbuyingcollective.Thisvariegationoftheactorsinthepublichealthrealmallowsforcreativesolutionsandpartnerships;however,italsoresultsinsignificantduplicationofeffortsandinefficiencies.Iwillbemoreawareofthedifficultiesofworkinginpublichealthasaresultofthiseffort.

Inconclusion,workingwithanextremelymarginalizedpopulationinanonprofitsettinghasreaffirmedmycareergoalofimprovingaccesstoandfunctionoftheAmericanhealthcaresystem.

Application of Public Health Competencies

Core/Cross-Cutting Domains

Competency, Activity/Application1, 2

Reflection of Competency Strength/ Professional Growth3

Committee Assessment4

Competency 6.C. Communicate accurate public health information with professional and lay audiences

Activity/Application: Colorado Rx Consortium; development of information pamphlets for clients

Reflection: I represented HRAC on the Colorado Rx Consortium’s data and research workgroup, working with professional researchers to present my research and critique theirs. This reminded me that often several versions of a project may be needed to satisfy disparate stakeholders’ viewpoints or levels of readiness to change. We also worked with a board member who does professional marketing campaigns. He helped us identify and tailor our messages to specific demographic groups that might be amenable to supporting HRAC. Finally, I developed informational pamphlets on health conditions common in PWID. I had to word these to be technically correct but also comprehensible by clients with low absolute and health-related literacy.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent

Uncertain

Competency 8.A. Identify linkages with key stakeholders

Activity/Application: Strategic planning

Reflection: Throughout my capstone project, I communicated with a disparate group of community leaders with varying levels of support for our mission. I also facilitated a revamp of the way we cultivate partnerships through our strategic plan. Also through the strategic plan, I helped our organization re-emphasize the value we place on client participation through both volunteerism and strategic guidance. I revitalized our client advisory board and led this for the last six months.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent

Uncertain

Overall Assessment of Core/Cross-Cutting Domains (completed by Committee Chair with input from Committee Members)4

Comments regarding student’s progress and professional growth in the above core competency areas, including current strengths/weaknesses: JK has the competency of identifying different involved stakeholder groups, and communicating accurate public health information with various levels including healthcare providers, community leaders as well as lay audiences.

Core/Cross-Cutting Domains Competency, Activity/Application1, 2

Reflection of Competency Strength/ Professional

Growth3 Committee Assessment4

Competency 8.B. Identify different levels of community engagement and participation Activity/Application: Qualitative survey analysis, advisory board

Reflection: Respondents to the survey often cited conflicting priorities in their different identities: work, family, personal, professional. For instance, I had a survey respondent who gave three answers to a question: as a father, as a small business owner, and as a pharmacist. This gave me insight into people’s willingness or unwillingness to support harm reduction. I also led a revitalization of our PWID advisory board. This consisted of leading discussions about the service provided by HRAC. It reminded me that public health organizations serve their clients and that it is vital to involve them in service and planning efforts.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent

Uncertain

Competency 10.B. Articulate how ethical principles apply to public health practice

Activity/Application: Advocacy and policy development for the vulnerable population of injection drug users

Reflection: I read several ethnographic analyses of injection drug use prior to starting my project and realized that this particular project, and public health in general, is inextricable from the subjects therein. I often related my own stories of medical practice and with research subjects as we conversed. However, I also remember the strict confidentiality rules that governed my work at HRAC and on my capstone, upholding them above all, even when survey respondents wanted to waive such protections. I also reaffirmed my desire to make public health practice part of my career working to improve the health care of underserved Americans.

NotCompetent

SomewhatCompetent

CompetentXHighlyCompetent

Uncertain

Concentration Domains

Competency, Activity/Application1, 2

Reflection of Competency Strength/ Professional

Growth3 Committee Assessment4

Competency 1.A: Demonstrate knowledge of public health policy formulation and implementation strategies Activity/Application: Developing advocacy materials and strategic planning within HRAC, discussion and recommendations for capstone

Reflection: Internally, I facilitated our strategic plan, requiring extensive work to formulate metrics and implement changes within our organization. Externally, I have started networking with the power brokers in Denver to build knowledge about and support for supervised injection facilities. I utilized my knowledge of several public health frameworks to develop recommendations for my Capstone project, including Bronfenbrenner’s Ecological Framework for Human Development and Kass’ Ethics Framework for Public Health. These help me structure what otherwise was an incredibly unstructured project.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent

Uncertain

Competency 1.B. Collect, analyze, and synthesize information about health policy problems and issues. Activity/Application: Application and IRB preparation

Reflection: The preparation of my IRB application required extensive collection of research and background information regarding supervised injection. In my write-up, I was required to develop future research directions on supervised injection. I also communicated directly with several of the authors I cited and other people working in harm reduction to understand more fully the barriers to supervised injection.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent Uncertain

Assessment of Concentration Competencies (completed by Committee Chair with input from Committee Members)4 Comments regarding student’s progress and professional growth in the above concentration competency areas, including current strengths/weaknesses:

JK was successful in public health policy formulation and implementation strategies as well as collection nd analysis of relevant information. He is very competent is synthesizing the information into understandable format that helps him to communicate effectively with various stakeholder groups.

Concentration Domains Competency, Activity/Application1, 2

Reflection of Competency Strength/ Professional

Growth3 Committee Assessment4

Competency 1.C. Develop alternative policy options for specific public health issues and assess their economic, political, legal, and social implications

Activity/Application: Capstone analysis, discussion and conclusions

Reflection: This competency was achieved par excellence. I analyzed supervised injection from economic, political, legal, and social viewpoints. During my economic analysis, I realized that supervised injection is, unfortunately, unlikely to be highly cost-saving and perhaps not even cost-effective. However, I also recognized that cost is not the primary barrier to supervised injection. Therefore, our efforts to develop a SIF will appeal more to urban quality of living, human rights, and welfare concerns.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent

Uncertain

Competency 2.A.Evaluate the effectiveness of public health policy using formal methods of policy analysis and program evaluation

Activity/Application: Research project: surveys and semi-structured interviews

Reflection: As seen I the prior competency, I utilized formal economic analysis including cost-effectiveness and cost-benefit analyses to evaluate supervised injection. I also ensured the validity of my survey findings by utilizing previously validated questions from similar research projects.

NotCompetent

SomewhatCompetent

Competent

XHighlyCompetent

Uncertain

Assessment of Concentration Competencies (completed by Committee Chair with input from Committee Members)4 Comments regarding student’s progress and professional growth in the above concentration competency areas, including current strengths/weaknesses: JK has developed his competency in looking at various policy options in the context of the political and social perspective. This allows him to develop alternative policy options for the public health issues at hand.

Acknowledgements

Thiscapstoneandservicelearningprojectwouldnothavebeenpossiblewithoutthegraciousassistanceofsomany.ThankyoutoalltheinstructorsandadministratorsatUNMCforhelpingmealongtheselastfiveyears!Morethananyone,Ithankmycapstonecommitteefacultymembers,RebeccaAnderson,J.D.,M.S.,C.G.CandNizarWehbi,M.D.,M.P.H.,M.B.A.fortheirinvaluableandtimelyassistance.

ThankyoutoChristineDumont-Heinrich,M.P.H.,whomadethefortuitousconnectiontoChrisBui,J.D.,M.P.H.,whoarrangedmymeetingwithLisaRaville,HRACexecutivedirector.ManythankstothestaffandboardatHRACwhoassistedmesomanytimesoverthepastyearandhelpedcritiquethiseffort.ThankstotheColoradoRxConsortium,particularlythedataandresearchworkgroup,andevenmorespecificallytotheOpioidResearchConsortiumforallowingmetovetmysurveyandresults.ThankstoEmiliaVolz,M.P.H.andRobynBriggs,HRACinternsandvolunteerswhoassistedwiththisprojectandothers.SpecialthankstoAliaAl-Tayyib,Ph.D.forsharingherdataandexpertise.JeremiahLindemannassistedwiththemapsandprovidedmewithaccesstohissoftware.

Finally,Iwanttoacknowledgethoselosttooverdoseandtheirfamilymembers,aswellasthosestillusingdrugs,thattheymightfindtheirownserenity.Asacommunity,wehavemadeprogresstowardbetterunderstandingofdrugusebutwestillhavealongwaytogotoalleviatethelargelypreventableconsequencesofaddiction.

AppendixA—ClientSurvey.

ThiswasthesurveyforHRACclients.Forcommunitystakeholders,onlysection2questionswereasked.

Age:Gender:DOC:Intersectionnearwhereyouspendthemosttime(house,camp,park,shelter)(Allquestions,ifnototherwisenoted,applytothelastsixmonths)

1.1 Whatdrugshaveyouinjectedinthepastsixmonths(Chooseallthatapply)?CocaineHeroinRxopioidsOtherRxdrugsMethamphetamineSpeedballsGoofballs

1.2 Whatdrughaveyouinjectedmostfrequently?CocaineHeroinRxopioidsOtherRxdrugsMethamphetamineSpeedballsGoofballs

1.3 HaveyoubeendiagnosedwithHIVorAIDS?YesMaybe/don’tknow/choosenottoanswerNo

1.4 HaveyoubeendiagnosedwithhepatitisC?YesMaybe/don’tknow/choosenottoanswerNo

1.5 Howmanytimeshaveyouoverdosedinthepastsixmonths?NeverOnceTwiceThreeormoretimes

1.6 Howoftendoyouinject?IcurrentlydonotinjectLessthanweeklyAboutonceaweekAfewtimesaweekDaily1-3timesdaily3+timesdaily

1.7 Howoftendoyouinject?AlwaysUsuallySometimesNever

1.8 Whenyouinjectingroups,howlargearethosegroups?2(justmeandanotherperson)ItvariesUsuallylargegroupsof4ormorepeople

1.9 Howoftendoyoureuseyourowninjectionequipment?AlwaysUsuallySometimesNever

1.10 Howoftendoyouusesomeoneelse’sinjectionequipmentaftertheyhaveusedit?AlwaysUsuallySometimesNever

1.11 Wherehaveyouinjectedinthepastsixmonths(chooseallthatapply)?HouseorapartmentCampStreet/AlleyCarPublicBathroomShelterDetox/RehabAbandonedHouseHotel/MotelRiver

1.12 Wherehaveyouinjectedmostfrequentlyinthepastsixmonths?HouseorapartmentCampStreet/AlleyCarPublicBathroomShelterDetox/RehabAbandonedHouseHotel/MotelRiver

1.13 Ifyouusedpublicbathrooms,wheredidyouusemostfrequently?McDonald’sBurgerKingKingSooper’sStarbucksLibraryAuraria

2.1Haveyoueverread,seen,orheardofsupervisedinjectionfacilities,orsafeinjectionfacilities?YesMaybeNo

2.2Doyouthinkthatasupervisedinjectioncanachievethefollowinggoals?EncouragesaferinjectionpracticesReduceHIVandHepatitisCIncreaseaccesstohealthcareImproveneighborhoodproblems

2.3WouldyouacceptaSIFinyourneighborhood?YesNo

2.4Inyouropinion,howdoestheproblemofpublicinjectinginDenvercomparetoothercities?WorseinDenverAboutthesame/don’tknowBetterinDenver

2.5Doyousupportmarijuanalegalization?YesMaybe/don’tknowNo

2.6Doyousupportlegalizationordecriminalizationofotherdrugs?YesMaybe/don’tknowNo

2.7Howwouldyoucharacterizeyourlevelofsubstanceuse,includingalcohol,pot,andotherdrugs?AbstinentRareModerateHeavy

3.1Woulduseasupervisedinjectionfacility?YesMaybeNo

3.2IftherewereaSIFnearyou,howfrequentlywouldyouuseit?NeverAfewtimesamonthAfewtimesaweekAtleastdaily

3.3IfyouweretooverdoseataSIFandwerenolongerbreathing,wouldyouwanttogetnaloxone?YesDon’tknow/maybeNo

3.4WhataresomereasonsyouwoulduseaSIF(Checkallthatapply)?BesafefrompoliceBesafefromcrimeGetsterileequipmentBeabletouseinprivatePreventandtreatoverdoseSeehealthprofessionalsGetreferralstootherservices

3.5WhataresomereasonsyouwouldnotuseaSIF?Notinjectinganymore/tryingtoquitIdonotliketoinjectaroundotherpeopleIonlyuseathomeIwouldfeelunsafeataSIFDistance

3.6WouldyoutakepublictransportationtouseaSIF?YesMaybeNo

3.7WouldyoubeworriedaboutpeoplelikeyourbossorfamilyseeingyouneartheSIF?YesMaybeNo

SubjectivequestionsWhataresomereasons,otherthanthosementionedabove,thatsupervisedinjectionfacilitiescouldbeagoodidea?Whataresomereasons,otherthanthosementionedabove,thatsupervisedinjectionfacilitiescouldbeabadidea?Ifyousupportsupervisedinjection,whatinformationmightdissuadeyou?Ifyoudonotsupportsupervisedinjection,whatinformationmightconvinceyou?Whatwouldbethebestlocationforasupervisedinjectionfacility?Ifyouinjectwithothers,whydidyouinjectwiththeminsteadofinjectingalone?Arethereanyotherreasonsyouwoulduseasupervisedinjectionfacility?Whatwouldbeagoodwaytopreventoverdoseinourcommunity?WhatwouldbethebestwaytopreventpublicoverdoseinDenver?

AppendixB:NIDACertificateofConfidentiality

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institute on Drug Abuse

CONFIDENTIALITY CERTIFICATE

UNIVERSITY OF NEBRASKA COLLEGE OF PUBLIC HEALTH

conducting research known as

"PAVING THE POLICY PARKWAY FOR THE NATION'S FIRST SUPERVISED INJECTION FACILITY"

In accordance with the provisions of section 301(d) of the Public Health Service Act 42 U.S.C. 241(d), this Certificate is issued in response to the request of the Principal Investigator, Ms. Rebecca Anderson, to protect the privacy of research subjects by withholding their identities from all persons not connected with this research. Ms. Rebecca Anderson is primarilyresponsible for the conduct of this research, which is funded by the Harm Reduction ActionCenter.

Under the authority vested in the Secretary of Health and Human Services by section 301(d), all persons who:

1. are enrolled in, employed by, or associated with University of Nebraska College of PublicHealth and its contractors or cooperating agencies, and

2. have in the course of their employment or association access to information that would identify individuals, who are the subjects of the research, pertaining to the project known as “Paving the Policy Parkway for the Nation's First Supervised Injection Facility”,

3. are hereby authorized to protect the privacy of the individuals, who are the subjects of that research, by withholding their names and other identifying characteristics from all persons not connected with the conduct of that research.

The purpose of this exploratory mixed methods study is to obtain information about supervised injection facilities, where people can use injection drugs under medical supervision, and potential clients of such facilities in Denver, Colorado. Measures collected include clients’ injection drug use patterns, and beliefs and knowledge about injection drug use among government officialsand law enforcement officers.

for

A Certificate of Confidentiality is needed because sensitive information will be collected during the course of the study. The certificate will help researchers avoid involuntary disclosure that could expose subjects or their families to adverse economic, legal, psychological and social consequences Subjects are coded alphanumerically. Consent forms will be stored in locked files. All information is kept on a password-protected hard drive, with no transfer to other devices. Digital voice prints will only be kept until material is transcribed, and the digital voice recorder will be destroyed immediately upon completion of the study.

This research begins on 12/28/2015, and is expected to end on 05/28/2017.

As provided in section 301 (d) of the Public Health Service Act 42 U.S.C. 241(d):

"Persons so authorized to protect the privacy of such individuals may not be

compelled inany Federal, State, or local civil, criminal, administrative, legislative, or

other proceedings to identify such individuals."

This Certificate does not protect you from being compelled to make disclosures that: (1) have been consented to in writing by the research subject or the subject’s legally authorized representative; (2) are required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or regulations issued under that Act; or (3) have been requested from a research project funded by NIH or DHHS by authorized representatives of those agencies for the purpose of audit or program review.

This Certificate does not represent an endorsement of the research project by the Department of Health and Human Services. This Certificate is now in effect and will expire on 05/28/2017. The protection afforded by this Confidentiality Certificate is permanent with respect to any individual who participates as a research subject (i.e., about whom the investigator maintains identifying information) during the time the Certificate is in effect.

Sincerely,

Signed Date: 02/12/2016 Nora Volkow M.D. Director

National Institute on Drug Abuse