ProjectLazarus WilkesCounty,NorthCarolina Page|0

PROJECTLAZARUSWilkesCounty,NorthCarolina

PolicyBriefingDocument

Preparedfor:NorthCarolinaMedicalBoard

Inadvanceof:

PublicHearingRegardingPrescriptionNaloxone

Wednesday,November14,2007

Raleigh

Ifyouevergetinameetingwithsomeprofessionaltypepeople,tellemthat,youknow,peoplelikeusno,werenotprofessionals,butifwehaveitathandwecansavesomebodyslifewiththisstuff[naloxone]

...itsalifesaver,theresnoquestion.

FromaprogramparticipantinChicagoMaxwellS,etal.JAddictDis.2006;25(3):8996.

ProjectLazarus WilkesCounty,NorthCarolina Page|1

EXECUTIVESUMMARY

WhatisthetargetpopulationforProjectLazarus?WhatwilltheNCprogramlooklike?[Page3]InWilkesCounty,25ormoreresidentshavediedannuallyinthepastseveralyearsfromunintentionaldrugoverdoses.Themajorityofdeathswereduetorespiratorydepressionfromunintentionalopioidoverdoses(technicallycalledunintentionalpoisoning).ProjectLazarusisapilotprograminWilkesCounty,NCfortheprescriptionanddistributionofintranasalnaloxone(adrugthatreversesrespiratorydepressionthatoccursfromopioidoverdoses)forthepurposeofpreventingdeath.Whileparallelmeasuresarebeingundertakentoimprovetheprescriptionofopioidsforpainmanagementandtoreducetheillicitabuseoftheseessentialmedications,ProjectLazarusisaimedatreducingfatalitiesamong13subpopulationsthatareatincreasedriskofabusingormisusingnarcoticsanddyingfromafataldrugoverdose.ProjectLazarusincludesa20minutestructurededucationalinterventionthatteacheshowto:1)recognizethesignsofanopioidoverdose,2)understandtheimportanceofcalling911,3)performrescuebreathing,4)administerintranasalnaloxone,and5)obtaintreatmentofsubstanceabuseandmisuse.TheProjectalsoincludesaprotocolfordocumentingthemedicalencounter(followingtheparadigmforinfluenzavaccination)andprovidesakitcontainingprefilledsyringesofnaloxonewithadaptersfornasaladministration.

Aretheregroupswhoareopposedtotheprogramandwhy?[Page10]

NoorganizedgroupshavevoicedoppositiontoprescriptionnaloxoneinNorthCarolina.Despiteinitialconcernsinothercitiesandcountriesthatthedistributionofmedicationstoreverserespiratorydepressionafteranunintentionaldrugoverdose,noevidenceofincreasedabuseofstreetdrugshasbeendocumentedwheretheseprogramsareinplace.

Byourapproval/allowingthisprogramtogoforwardareweabettingillicitdruguse?[Page10]

ProjectLazarusisnotabettingillicitdruguse.Experiencinganoverdoseisatraumaticeventthatelicitscomplexemotionalreactions.Thereisevidencetosuggestthatoverdosesurvivorsarereceptivetobehaviorchangeandthatsurvivinganoverdosemayserveasanopportunitytodiscussdrugtreatmentoptionswiththevictim,familyandpeers.OtherprescriptionnaloxoneprogramsintheUShaveobserveddecreasesininjectiondruguseandincreasedentryintosubstanceusetreatmentinthemonthfollowingnaloxoneadministration.

Arethereunintendeddeleteriouseffectsofapproval?[Page11]

Therearerelativelyfewdeleteriouseffectsfromtheadministrationofnaloxoneafteradrugoverdose.Adverseeventsassociatedwithnaloxoneadministrationareconsistentwithacuteopioidwithdrawal,which,albeitunpleasant,arebetterthandeath.Returnofrespiratorydepressionmayoccurwithlongactingopioidandcontrolledreleaseformulations.Educationandsupplementalnaloxonevialsareprovidedtomitigatethisrisk.

ProjectLazarus WilkesCounty,NorthCarolina Page|2

WhatisthenarcoticoverdoserateforNCand/ortheproposedservicearea?Howmanylives/hospitalizationswouldbesavedbythisprogram?[Page13]WilkesCountyhasarateofaccidentalopioidpoisoningdeathsnearlyfivetimesgreaterthanthenationalaverage,andthreetimeshigherthanthestateaverage.In2005,18deathsresultedinarateof27.4per100,000peryear;20deathsreportedin2006gavearateof30.5per100,000peryear,predominatelyduetomethadone.In2007,themortalityrateshavebeensimilar,with13accidentalopioidpoisoningdeathsinWilkesCounty,with2pendinginvestigations.ThecostofinpatienthospitalizationsaloneforopioidpoisoninginNorthCarolinaismorethan$20millionperyear,halffromuninsuredandMedicaidpatients.ForeachoverdosepreventedthroughProjectLazarus,therewillbea$20,000to$30,000savingsinmedicalexpensesandlostproductivity,suggestinghighpotentialforafavorablecosteffectivenessbenefit.

WhatisthelegalstatusofprescriptionnaloxoneprogramsinNorthCarolina?[Page15]PrescribingnaloxonetoopioiddrugusersinNorthCarolinaisfullyconsistentwithstateandfederallawsregulatingdrugprescribing.Anylegalrisksindistributingnaloxoneinthisstatearenotsubstantialandcanbemitigatedbyinformedprogramdesign;therisksofmalpracticeliabilityareconsistentwiththosegenerallyassociatedwithprovidinghealthcare.

ProjectLazarus WilkesCounty,NorthCarolina Page|3

WhatisthetargetpopulationforProjectLazarus?WhatwilltheNCprogramlooklike?

Context

InWilkesCounty,theprescriptionnaloxoneprogram,ProjectLazarus,isonecomponentofamultifacetedresponse(theChronicPainInitiative,seebelow)toanepidemicofthemisuseandabuseofprescriptionopioidsthathasresultedinanunprecedentedincreaseinfatalunintentionalpoisonings.Fataldrugoverdosesoccurfromlegallyprescribednarcotics,suchasfentanyl,hydrocodone,methadoneandoxycodone,aswellasfromstreetdrugssuchascocaineandheroin.Inthisdocument,themisuseofanarcoticreferstheinappropriatemedicaluseofaprescribednarcoticbyapatient(suchasnonadherencewhenapatientdoesnotfollowaprescribersrecommendedusage/dosage).Abusealwaysreferstothenonmedical(i.e.,recreational)useofanarcotic.Bothlegalprescriptionandillegalstreetdrugscanbeabused.

Project Lazarus, Wilkes County, North Carolina

Context

o IncreasingnumberofdeathsfromunintentionaloverdosesofprescriptionopioidsinWilkesCounty.

o ChronicPainInitiativebalancesadequatepainmanagementwithpreventionofharmfromprescriptionopioiduse.

Educationalintervention

20minuteeducationaltrainingthatincludes:

1)recognizingsignsandsymptomsofopioidoverdose2)understandingtheimportanceofcalling9113)learningrescuebreathing4)theappropriateuseofnaloxone5)optionsforsubstanceusetreatment

Kitwith2dosesof1mg/mLnaloxonehydrochlorideinprefilledneedlelesssyringes,nasaladaptors,instructions,referralstolocalsubstanceabuse/dependencetreatment

Followinginfluenzavaccineparadigm,recordkeepingformedicalencounter

Targetpopulations:medicalandnonmedicalusersofprescriptionopioids,withknownriskfactorsforopioidpoisoning.

Evaluationofpilotprogram

ProjectLazarus WilkesCounty,NorthCarolina Page|4

TheChronicPainInitiativeissponsoredbytheNorthwestCommunityCareNetwork.Theothercomponentsoftheresponseinclude:casemanagementofanddatacollectiononpatientsinitiatingopioidtherapy,establishmentofapharmacyhomesystem,collaborationwithmentalhealthplanning,bettermanagementofpatientsintheemergencydepartment,utilizationofthecontrolledsubstancesreportingsystem,andphysicianeducation,includingdevelopmentanddisseminationofatoolkitonopioidprescribingandpainmanagementforprescribers.

ThegoalsoftheChronicPainInitiativeareto:decreaseED(emergencydepartment)utilizationbydrugseekers,decreaseuseofmultipleprescribersandmultiplepharmacies,improveHCP(healtcareprovider)efficacyinchronicpainmanagement,encourageappropriatepainclinicreferrals,encouragecomanagementmodelforpartnershipwithpainclinic,reducenumberofunintentionalpoisoningsfromdrugoverdoses,anddecreasecostsassociatedwithimproperuseofprescriptionopioids.Itisourintentiontodevelopareproducible,comprehensiveapproachtochronicpainmanagementthatmaybeduplicatedbyothersinNorthCarolina.

TargetPopulations

Justasthephysiologicalandanatomicalbasesforpainandaddictionsharecommonpathwaysinthecentralnervoussystem,thecommunitylevelresponsetoprescriptionopioiduseproblemsmustaddresspainandabuse/addictionsimultaneously.Thedistinctionbetweenmedicalandnonmedicaluseofprescriptionopioidscanchangeovertimeforagivenindividual.Apatientwithalegitimateacutepainconditioncouldkeepleftoveropioidmedicationforatalaterpainfulcondition;atthatpointalegitimatepainpatientisconsideredtobeabusingthemedication.Patientswithhistoryofalcoholusedisordermayrespondwelltoopioidtherapyandcompletemedicationusewithoutuntowardincident.Whileillicitdrugs(heroin,cocaine,methamphetamine)maybeinvolvedinapoisoningevent,itisjustaslikelythatlegalprescriptionmedications(benzodiazepines,TCAandSSRIantidepressants)willalsobeimplicated.

Thetreatmentofseverechronicpainisnowclearlyrecognizedbythemedicalcommunityasacompellingneedinthepracticeofmedicine.Thepatientpopulationisbroad,astherecipientsofpainmanagementshouldnotberestrictedtothosewithterminalcancerorwhoareunderthecareofahospiceprogram.OpioidsarethemainstayofpharmacologicmanagementofmoderatetoseverechronicpainintheUnitedStates.Inrecognitionoftheirvitallyimportantplaceinmedicalpractice,opioidsforuseinpainmanagementandthepharmacotherapyofopioiddependencehavebeenplacedontheWorldHealthOrganizationsListofEssentialMedicines(Herget2005).Nevertheless,itisalsorecognizedthatchronicpainisoftendifficulttotreatintheoutpatientsetting.AlthoughprescribersshouldfollowthepainmanagementrecommendationspostedbytheNCMedicalBoardontheirwebsite(also,Trado2004),itdoesnotguaranteethattheirpatientswillfollowinstructionsorthattheirpatientsdonotalsohaveacomorbiddependencedisorderthatgreatlyenhancesthecomplexitiesencounteredbythemedicalcommunity.Thesetwoverydifferentissuescanleadtobothmisuseandabuseoftheprescribeddrug,sometimesatthesametimeoratdifferenttimes.Examplesofmisuseandabusearewhenapatientexperiencesinadequatepaincontrolandtakesmoretabletsthanprescribed(misuse)ortakespartoftheprescriptionasprescribedandthenusestheremainingpillsfornonmedicalreasons(abuse).Tocomplicatethesituationfurther,peoplewithabuse/dependencedisordersfrequentlysufferfromseverechronicpainthuscomplicatingthestrategiesfortreatingbothconditions.Effectivestrategiesforopioid

ProjectLazarus WilkesCounty,NorthCarolina Page|5

therapyinpatientswithahistoryofsubstanceusehavebeenelaborated(SchnollandWeaver2003),andhealthcareprovidershaveadutytoreducepainfulconditionsinsuchpatients.