Project Lazarus description FINAL - Reviewed literature/Project Lazarus, North... · Project...
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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.