Access to Naloxone: Evidence- Based Overdose Response …...Access to Naloxone: Evidence-Based...
Transcript of Access to Naloxone: Evidence- Based Overdose Response …...Access to Naloxone: Evidence-Based...
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AccesstoNaloxone:Evidence-BasedOverdoseResponseStrategy
ErinL.Winstanley,Ph.D.AssistantProfessorUCCollegeofPharmacy,DivisionofPharmacyPrac8ce&Administra8veSciences
UCCollegeofMedicine,DepartmentofPsychiatry&BehavioralNeuroscience
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ObjecDves
1) Iden(fystrategiestopreventanopioidoverdose
2) Understandthesafetyandefficacyofnaloxoneinreversinganopioidoverdose
3) Describehowpoliciescanbeusedtoexpandaccesstonaloxone
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DefiningAnOpioidOverdose
• Hallmarksymptomofanopioidoverdoseisrespiratorydepression• Respiratorydepressiondefinedas<13breathsperminute• Signsofopioidtoxicity:apnea,stupor,andmiosis
SOURCE:Boyer(2012)NEJM
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DrugOverdose• AccordingtotheCDC,thereisanepidemicofdrugoverdosefatali(es
• DrugoverdoseistheleadingcauseofinjurydeathintheU.S.,surpassingdeathsfrommotorvehicleaccidentsin2007
• Prevalenceamongdrugusers:73%havewitnessedanoverdose&45%experiencedanon-fataloverdose
• Inlong-termfollow-upstudiesofpa(entswhoreceivedaddic(ontreatment,overdoseisaleadingcauseofdeath
• Overdoseises(matedtocost$20.4billionin2009
SOURCES:Walleyetal.(2013)JSubstAbuseTreat;Hseretal.(2006)JSubstAbuseTreat;Saitzetal.(2007)JUrbanHealth;Martensetal.(2016)APHA
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OverdoseDeathsinU.S.
SOURCE:NYTimesJan.19,2016:hdp://www.ny(mes.com/interac(ve/2016/01/07/us/drug-overdose-deaths-in-the-us.html
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StateswithHighestRatesofOverdose(2014)
1. WestVirginia(35.5deathsper100,000)2. NewMexico(27.3)3. NewHampshire(26.2)4. Kentucky(24.7)5. Ohio(24.6)
2014hadthehighestrateofoverdosefatali(eseverrecordedintheUnitedStates
SOURCE:MMWRJan2016
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CausesofOverdoses
16,235
8,257
• 74%weredeemeduninten(onal&17%weresuicides• Approximately61%ofoverdosedeathsinvolvedanopioid
Hydrocodone&oxycodone
SOURCES:CDChLp://www.cdc.gov/nchs/data/databriefs/db190.htm;MMWRJan2016
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Fentanyl-relatedDeaths• In2013therewere84fentanyl-relatedoverdosesinOhio,in2014thatnumbergrewto502
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HeroinAdulterants&Diluents• Benzodiazepines• Cocaine• Procaine–localanesthe(c• Quinine–an(paras(c(treatsMalaria)• Caffeine-s(mulant• Paracetamol–acetaminophen• Lidocaine-anesthe(c/an(arrhythmic• Mannitol-diure(c• Lactose-filler• Starch-filler• Dextrose-filler• Diphenhydramine/Caffeine-An(histamine• Diphenhydramine/Thiamine
SOURCE:Brosusetal.(2016)ForensicScienceInterna(onal
Asklocaltoxicologist/coronersforlocaldata
NovelSynthe(cOpioids:ü Fentanylü Fentanylanalogsü W-18ü U-4700ü AH-7921ü MT-45
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RiskFactorsforFatalRxOpioidOverdose
Demographic• Male• Middle-aged(Rx
opioids:45-54yrs;heroin:25-34yrs)
• Livinginnon-metropolitanareas(Heroinmetroareas)
• Low-income(RR:2.1-5.7)
• Non-Hispanicwhite
BehavioralHealth• Historyof
substanceabuse(60-78%)
• Historyofmentalillness(42-57%)
• IVdruguse(22%)• Previousoverdose
(17%)
PhysicalHealth• Historyofchronic
pain(82%)• Havingaprescrip(on
(75%prescrip(onopioidvs29%formethadone)
• Signs of non-medical use (51%)
• Greaternumberofprescribers(RR:2.8)
• Greaternumberofprescrip(ons(RR:8.2)
• Highdailydose(>80mgmorphineequivalentdose)
SOURCES: Paulozzi, FDA, 2012; Hall et al, JAMA, 2008; Lanier et al, CDC, 2010 ; Jones et al. (2013) JAMA
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SOURCE:Binswangeretal.(2007)NEJM
DrugOverdoseistheLeadingCauseofDeathAmongFormerInmates
12.7greaterriskofdeath
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OVERDOSEPREVENTION
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OverdoseEducaDonDelivery
• Delivery:– 1:1in-person– Group– Video– Educa(onalmaterials/brochures
• Lengthvariesfrom10-60minutes• Maybelegisla(verequirementsthatoverdosepreven(oneduca(onisrequiredtodistributenaloxone
SOURCE:Clark,Wilder,Winstanley(2014)JAddictMed
Goodtodiscussineffec(veresponsestooverdose
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SymptomsofanOpioidOverdose
• Breathingisslow&shalloworhasstopped• Vomi(ng• Faceispale&clammy• Blueorgrayishlips&fingernails• Slow,erra(cornopulse• Chokingorloudsnoringnoises(“deathradle”)• Willnotrespondtoshakingorsternumrub• Skinmayturngray,blueorashen
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OverdosePrevenDon• Donotmixopioids,benzodiazepines&alcohol• Peoplewhohavestoppedusingforaperiodof(me&trytouseagain
• Quality&adulterants(forexample,fentanyl)• Usingalone• Makeanoverdoseplanwithafriend• Age&physicalhealth(forexample,respiratoryproblemslikeasthmaorCOPD)
• Learntorecognizeoverdoseasdecreasedrespira(on• Call911andadministernaloxone
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EducaDononFentanyl
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WhenisitanOverdose?
SOURCE: Boston Department of Public Health
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ResponsestoanOverdose
• Clientsmayhavemisunderstandingofhowtorespondtoanoverdose
• Anecdotalexperiencesthathaveworkedtoreverseanoverdose
• Unresponsivepersonrequiress(mulus
76%ofclientshadwitnessedorexperiencedanoverdose,butonly53%hadheardofnaloxone
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OverdoseEducaDonAmongDrugUsersAmongclientsinaddic(ontreatmentforopioidusedisorders,overdosepreven(oneduca(onlargestimprovementsin:• Sternumrub(52%improvement)• Placingpeopleintherecoveryposi(on(37%)• Notgivings(mulants(29%)• Snore-likegurglingnoisesymptomofoverdose(29%)• Performrescuebreathing(27%)• Donotwalksomeonearoundtheroom(25%)• Administernaloxone(24%)• Donotinjectthemwithsalineorwater(22%) SOURCE:Winstanleyetal.(2015)unpublishedreport
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OverdoseReversal• Naloxonehydrochloride(brandnameNarcan),FDA-approved
in1971,isashort-ac(ngcompe((vemuopioid-receptorantagonist,andtheonlyagentthatcanreverseanopioidoverdose
• Firstsynthesizedin1960
• Well-establishedefficacyandsafety
• UsedbyEMS&hospitalsforover40years
• Veryspecificmechanismofac(on
• Doseupto700/xrecommendeddosewithoutseeingadverseevents
SOURCES:Boyeretal.2012;Buajordetetal.2004;Clarkeetal.2005;Dahanetal.2010
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NaloxoneDosingMedicalsesng:• Recommendedstart0.04mg,increaseevery2-3minutesatrate0.5mg,2mg,4mg,10mg,15mg–un(ladequaterespira(on
• Onsetwithin2minutes,dura(on20-90minutes;administeredIV/IM/IO/IN
• Observe4-6hoursstandard,atleast8hoursiflong-ac(ngopioidused(methadone,fentanylpatch)
Communitysesng:• Twodosesperclient• Moredosesmaybenecessaryinareaswhereheroinisknown
tobeadulteratedwithfentanyl
SOURCES:Boyeretal.2012;Buajordetetal.2004;Clarkeetal.2005;Dahanetal.2010
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• Confusion• Headache• Gastrointes(nalproblems• Aggressiveness• Tachycardia• Shivering
Naloxone Side Effects? • Swea(ng• Tremor• Seizures• Naloxonesensi(vity• Cardiacarrest• Pulmonaryedema• Renarco(za(on
• Manysymptomsthoughttobeadributabletonaloxoneresultfromopioidwithdrawal
• Long-termdrugusemayincreasetheprobabilityofanadverseevent(AE),reflec(nganunderlyingmorbidity–NOTnaloxoneAE
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NaloxoneAdministraDon• FDAapprovedIV/IMadministra(onofnaloxone• April2014FDAapprovedauto-injector(0.4mg/0.4mL)Evzio(~$575)withaudioinstruc(ons
• November2015FDAapprovedanasaldevice(4mg/1mL)fromAdaptPharma($75)
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• Basedonnaloxonedistribu(onto20%ofheroinusers
• Es(mated6%overdosedeathsaverted• 1saveper227naloxonekitsdistributed• Incrementalcost$53• Eachdeathpreventedbydistribu(onofnaloxonekitswillcost$438(ICER)
• HIGHLYCOSTEFFECTIVE
NaloxoneCostEffecDveness
SOURCE:Coffin&Sullivan(2013)AnnalsofInternalMedicine
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ModeofNaloxoneAdministraDon
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ModeofNaloxoneAdministraDonNasalnaloxoneorAuto-Injector:
• Non-druguserswithoutmedicaltraining• Peopleinrecoveryfromopioidaddic(on,avoidneedleasapoten(al“trigger”
Intramuscular:• Individualwithmedicaltraining• Ac(veinjec(ondrugusers• Par(cularlyimportantifheroinknowntobeadulteratedwithfentanyl
Intramuscular/IV:• Medicalsesngsonly(ambulance,emergencydepartment)• Par(cularlyimportantifheroinknowntobeadulteratedwithfentanyl
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OverdosePrevenDon
The only evidenced-based intervention that has demonstrated to prevent heroin overdose, is medication assisted treatment with methadone or buprenorphine
SOURCES: Darke & Hall, 2003; Sporer & Kral 2007.
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SOURCES: Schwartz et al. (2013) American Journal of Public Health
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OpioidOverdosePrevenDonProgramsBeganin1996&thekeycomponentsare:
1) trainingonhowtoiden(fythesymptomsofanopioidoverdose
2) howtorespond,includingadministra(onofnaloxone(bystanderadministra(on)
SOURCES:Sporer&Kral2007;Enteenetal.2010;Baca&Grant2007
Whyimportant:• Manypeopledon’tcall911• EMT-Basics&firstresponderscannot
administernaloxoneinsomejurisdictions
• InruralOhio,itcantakeEMS17-18minutestorespond
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SOURCE:MMWR6/19/15
DistribuDonofOOPPsbyStateMajority of programs are nested within
harm reduction programs
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1) Laypersonscanandwilladministernaloxone2) Overdosesarecommonamongac(vedrugusers,aswellas
peopleseekingtreatmentfordrugusedisorders3) Mixedevidenceregardingwhetherpeople,asaresultof
overdoseeduca(on,aremorelikelytocall9-1-14) Noevidencetosuggestthatnaloxoneencouragesdruguse5) Non-medicalpersonscanincreasetheirknowledgeofthe
signsandsymptomsofanoverdose
ReviewofOOPPs
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OOPPsinOhio
SOURCE:Winstanleyetal.(2015)SubstAbus
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BarrierstoOOPPsImplementaDon
SOURCE:Winstanleyetal.(2015)SubstAbus
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Improving&ExpandingOverdosePrevenDon
• Affordability&accesstonaloxone• Point-of-caredistribu(onofnaloxone• Tailoringeduca(ontodifferentat-riskpopula(ons• Co-prescribingofnaloxoneforpersons:1)highdoseofopioids,2)
co-prescribedbenzodiazepines,&3)opioids+an(depressants• Medica(onsafetyforallpa(entsreceivingopioids• Outreach&educa(onforac(vedrugusers(e.g.,syringeexchange
programs)• Increaseaccesstomedica(onstotreatopioidusedisorders• Naloxonedistribu(ontoallpa(entsleavingAMAfromresiden(al
addic(ontreatmentprograms
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POLICYISSUES
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LegalIssuesinPrescribing/AdministeringNaloxone
SOURCE:hdp://lawatlas.org/query?dataset=laws-regula(ng-administra(on-of-naloxone
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LegalIssuesState-levelvaria(oninwhether:
1. Immunityforpersonwhocalls9-1-1and/oradministersnaloxone
2. Civil&criminalprotec(onsforphysiciansthatprescribenaloxone
3. Protec(onforlaypersonscarryingnaloxone
NewMexicowasthe1ststateinU.S.topasslegislaDonin
2007
SOURCE: Davis et al. (2013) Journal of Law, Medicine & Ethics
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RegulatoryIssues
• RhodeIslandBoardofPharmacyapprovedacollabora(veprescrip(onagreement
• Massachusedsexpandedaccessbyusingastandingorder
• BasiclevelfirstrespondersmaynotbeabletoadministerIV/IMmedica(onswhichispar(cularlyproblema(cinruralareas
• Somestatesdonotallownaloxonetobeprescribedtoathirdparty
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OhioHB4
• Expandedaccesstonaloxone– 3rdpartyprescribing– Pharmaciescanadoptastandingordertoprovidenaloxonetocommunitymemberswithoutaprescrip(on
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MythsVersusFacts
Myth:PeoplewillusemoreheroinbecausetheyknowNarcancanbeusedtosavethemiftheyoverdose.
Fact:PeoplewilluseheroinwhetherornotNarcanisavailable.Themajorityofpeopleusingdrugsdonotwanttodie,theyarestrugglingwithaddic(on.AdministeringNarcanmeansthatsomeonemayhaveanotherchancetoentertreatment.
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ConcludingRemarks• Overdoseisapreventable
causeofdeath• Educa(on&provisionofMAT
canpreventanoverdosefromoccurring
• Naloxoneisasafe,efficaciousandcost-effec(vemedica(onthatcanpreventanoverdosefatality
• Furtherregulatoryandlegalchangesareneededtoexpandaccesstonaloxone&ensure911iscalled