St Louis AM FINAL - Allergy and Asthma Network · dispense the drug. Some states also provide...

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Allergy&AsthmaNetworkistheleadingnonpro�itorganizationwhosemissionistoendtheneedlessdeathandsufferingduetoasthma,allergiesandrelatedconditionsthroughoutreach,

education,advocacyandresearch.

Sponsoredby

15M31 1

USAnaphylaxis Summits o 4yearsofSummitso Uniqueinterac�veconferenceso  Interprofessionala�endees

– Allergists,pediatricians,nurseprac��oners,physicianassistants,Schoolnurses,Officenursesaswellaspa�entsandpa�entadvocates

Why are YOU here? o  Pleasesharewithmewhatbroughtyouto

thisconferenceonthisdayo AskYOURques�onso LetYOURvoicebeheard

Agenda   Preventative Drug Lists –

Counteracting Unintentional Consequences of High Deductible Health Plans

  Anaphylaxis Legislation & Forecast

  Anaphylaxis Research Update

  Implementing Strategies for Emergency Anaphylaxis Care: From Emergency Medical Services to Emergency Department to Outpatient Follow-up

  Going National with a Regional Food Allergy Management & Education Program

  Farm to Table: Food & Latex Allergies

  Understanding Risk-Taking Behavior in Adolescents & College Students with FA

  School FA and Anaphylaxis Management for the Pediatrician – Extending the Medical Home with Critical Collaboration

Housekeeping & Introduction o Pleasesilencecellphoneso Coffeebreaksandlunch

o BrendaSilvia-Torma–USAnaphylaxisConferencePlannerandACEsProgramManager

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EVOLVING LANDSCAPE OF HEALTHCARE

WorkingTogetheronSolutions

TonyaWinders,President&CEOAllergy&AsthmaNetwork

Evolving Landscape of Healthcare

o ACA–6yearsin---RVAnalogyo EMR’so PhysicianPaymentModelso HospitalPenal�eso CostBurden 18%GDPisnotsustainable

Sponsoredby

Changes in Healthcare o Shi�ofCostsfromPayers&toPa�entso Shi�ofCostsfromEmployers&toEmployeeso Ul�matelyResultsinConsumerMindsetvsPa�entMindset

Introduction of High Deductible Health Plans

o >30MAmericansnowhaveHDHPo >$2500peryearoutofpocketforhealthcareo Somefamiles>$8-10,000peryearo Pharmacy&MedicalBenefitssubject

EpiRage 2016 o PerfectStorm

– Timing– PainPoint– Frustra�on–  InadequateCorporateResponse– Media&Government&Interven�ons

Recent FARE Survey o  >30%reportthattheirinsurancecompanyhasdenied

coverageforEAIo  Almost50%reportthattheirinsurancelimitstheirabilityto

getthefullnumberofauto-injectorstheyneedo  >20%whopurchaseEAI’sspendmorethan$500peryearout

ofpocketo  Nearly25%havele�EAIprescrip�onunfilledatthepharmacyo  >40%havesplitupatwo-packtokeepEAI’sinseparate

loca�onso  >50%havekeptEAI’spasttheexpira�ondateduetocost

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Focus on Solutions o Drug Price Transparency o Preventive Drug Lists

  Government---USPSTF   Commercial

Eliminates/Limits out-of-pocket expense

Drug Price Transparency

Epinephrine Access & Affordability Task Force

o 6organiza�onso One-yearPlano USPSTFo Top8CommercialPlanso Result=>90%ofAmericansgetmedica�onfor

li�leornoOOP

Don’’t Lose Sight of… o  In2015,nearly80%ofcommerciallyinsuredpa�ents

usingtheMyEpiPenSavingsCard®receivedEpiPen®Auto-Injectorfor$0

o  SincethestartoftheEpiPen4Schools®ini�a�vein2012,morethan700,000freeEpiPen®Auto-Injectorshavebeendistributed,andmorethan65,000schools,approximatelyhalfofallU.S.schools,havepar�cipatedintheprogram---Morethan1,000livessavedlastyearalone!

Why are we here?

o >15MAmericansimpactedbyLTAo Economic&SocialBurdencon�nuestogrowo >2AmericansdiedailyfromLTAo  Ittakeusall!

ANAPHYLAXIS LEGISLATION

2017Forecast–SchoolStockEpinephrine,2017LegislativeForecast

CharmayneAnderson,DirectorofAdvocacyAllergy&AsthmaNetwork

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AdvocacyUpdate

Sponsoredby

AdvocacyUpdate  Federal

–  Legisla�on  SchoolAccesstoEmergencyEpinephrineActof2013(PublicLaw113-48)  FederalAvia�onAdministra�onreauthoriza�on–  Regulatoryma�ers  State–  SchoolStockLawsandImplementa�on–  PublicEn�tyLaws–  Otherbills  OtherIssues–  U.S.Preventa�veServicesTaskForceandInsurers(recogni�onandclassifica�onof

epinephrineasapreventa�vemedicine)

SchoolAccesstoEmergencyEpinephrineAct(PublicLaw113-48)

  SignedintolawonNovember13,2013  Undesignatedepinephrineauto-injector  Emergencyuseforstudentssufferingfromana�ack  Trainingofpersonnel  Limitedliability  Incen�veforstates

  Inall50statescompetentstudentsmaycarryandself-administertheirownepinephrineatschoolintheeventofanemergency.

  49statesstockepinephrineautoinjectors.

  Schoolsrequireannualrenewalofthestudentauthoriza�on.

  Theparentorguardianhassignedareleaseofliability.

  Schoolsmaydesignatetrainedstaffwhomayadministerepinephrine.

  Schoolsshouldhavestandingordersfortreatmentaswellasstockepinephrine.

StateSchoolStockLaws

Prior to 2013 Federal Law

2014 2015 2016

Law passed 23 41 46 49

Pending 4 1 0

Without law 5 3 1

  Therearenow49stateswithschoolstockepinephrinelaws,aswellastheDistrictofColumbia.

  Hawaiihadlegisla�onpendingpriortotheendofthestate’slegisla�vesession.Nofurtherac�onexpectedthisyear.NextsessionbeginsJanuary2017.

Common Concerns with State School Stock Laws

  Costs  LiabilityProtec�on  UnderstandingofLaw/Implementa�on

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Public Entity Stock PublicEn�tyStockEpinephrineLegisla�on

  Thislegisla�onpermitsvenues(e.g.,recrea�oncamps,youthsportsleagues,restaurants,amusementparks,sportsarenasanddaycarefacili�es)tomaintainanepinephrineauto-injector,withtheinten�onofreducingthe�meittakestogetlife-savingepinephrinetoapersonhavingasuddenanaphylac�creac�on.

  Currently,27stateshavepublicen�tylaws,includingAlaska,Alabama,Arizona,Arkansas,Colorado,Florida,Georgia,Idaho,Indiana,Iowa,Kentucky,Maine,Michigan,Minnesota,Nevada,NewJersey,NewHampshire,NorthCarolina,Ohio,Oklahoma,Oregon,RhodeIsland,Tennessee,Utah,Washington,WestVirginiaandWisconsin.Therewere11stateswithpendinglegisla�onpriortotheendoftheirrespec�velegisla�vesessionsthisyear.

  All27stateswithlawsrequireen��estoadopttrainingprogramspriortostockingandadministeringepinephrine.Moststatelawsallowthestatehealthdepartmenttoestablishtheirownprogramoruseana�onallyrecognizedorganiza�ontoestablishatrainingprogram.

  Eachstateprovidesliabilityfromnegligenceclaims.Thisliabilityprotec�onisfortheen�tyadministering,employeesinvolvedintheapplica�onofepinephrine,andhealthcareprofessionalswhoprescribeanddispensethedrug.Somestatesalsoprovideliabilityprotec�onfortheorganiza�onsthattrainindividualsintheadministra�onofepinephrine.

MissouriStockLawsSchools

 InJuly2006,HB1245becamelawandauthorizedschoolnursestomaintainasupplyepinephrineauto-injectors. Theprescrip�onmustbewri�enbyalicensed

physicianlis�ngtheschooldistrictasthepa�ent,includethenurse’sname,andbefilledatalicensedpharmacy. Aschoolnursemayuseanepinephrineauto-

injectoronanystudentbelievedtobehavingalifethreateninganaphylac�creac�onbasedonthenurse'straininginrecognizingananaphylac�cepisode.

PublicEn��es Missouridoesnothaveapublicen�tystocklaw. InAugust2015,theComprehensiveEmergencyMedicalServicesSystemsActbecamelawandauthorizeduseofepinephrineauto-injectorsforfirstaidoremergencytreatmentby“anambulanceservice,oremergencymedicalresponseagency,acer�fiedfirstresponder,emergencymedicaltechnical-basicoremergencymedicaltechnician-paramedicwhoisemployedby,oranenrolledmember,person,firm,organiza�onoren�tydesignatedby,ruleofthedepartmentofhealthandseniorservicesinconsulta�onwithotherappropriateagencies.” 15MO.REV.STAT.§190.246.1

FederalAvia�onAdministra�on(FAA)Reauthoriza�onLegisla�on

  Senatebill,H.R.636,includedprovisionsdirec�ngtheFAAto:1)evaluatethemedicalequipmentandsuppliesrequiredonairlineflights,and2)ensurethattherequireditemsmeettheemergencymedicalneedsofchildren.TheSenatebillspecificallymen�onedepinephrineauto-injectors.Housebill,H.R.4441,didnotincludethislanguage.

  OnJuly15,2016,PresidentObamasignedintolawashort-

termFAAauthoriza�onbill,FAAExtension,Safety,andSecurityActof2016(PublicLaw114-190).

  Thefinalbillincludessomepolicychanges,butavoidsmanysignificantchangestheHouseandSenatehadbeenpursuing,includingepinephrineauto-injectorsinaircra�emergencymedicalkits.

  Congresswillconsideralong-termFAAauthoriza�onbillnextyear.

OtherIssuesREGULATORY FDA2015-N-5017,BannedDevices.ProposaltoBanPoweredSurgeon’sGloves,PowderedPa�entExamina�onGlovesand

AbsorbablePowderforLubrica�ngaSurgeon’sGloves;finalruleispending.STATE CaliforniaSB1067,RetailFoodCodeCleanUp.AmendsCalifornia’sRetailFoodCodetocomplywithchangesmadebytheFoodand

DrugAdministra�on(FDA)toupdatetheFoodCode*in2013;Requirespersonsinchargeoffoodproviderstohaveadequateknowledgeoffood-relatedallergiesandtoprovidepropereduca�onforemployees.BillsignedintolawonAugust25,2016.

*Thefederalfoodcodeisaguidelineforsafeguardingpublichealthandensuringfoodispure,hasnoinferioraddedsubstancesandishonestlypresentedwhenofferedtotheconsumer.ItrepresentsFDA’sbestadviceforauniformsystemofprovisionsthataddressthesafetyandprotec�onoffoodofferedatretailandinfoodservice.(h�p://www.fda.gov/Food/GuidanceRegula�on/RetailFoodProtec�on/FoodCode/ucm374275.htm)

 CaliforniaSB1258,theFoodAllergySchoolPolicy.Requireseachlocaleduca�onalagencytodevelopandhaveinplace,beginning

withthe2017–18schoolyear,acomprehensivepolicywithspecifiedprotocolstoprotectpupilswithfoodallergies.BillwasheldinSenateCommi�ee;nofurtherac�onexpected.

 HawaiiSB911,Rela�ngtoLatex.Prohibitstheuseoflatexglovesbypersonnelworkinginfoodestablishments,dentalhealth,

healthcarefacili�es,orbypersonnelprovidingambulanceoremergencymedicalservices.BillsignedintolawonJuly1,2016.OTHERU.S.Preventa�veServicesTaskForceandInsurers Recogni�onandclassifica�onofepinephrineasapreventa�vemedicine.

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Contactinforma�on:CharmayneAnderson,DirectorofAdvocacy

Allergy&[email protected]

703-641-9595/800-878-4403

Ques�ons?

ANAPHYLAXIS RESEARCH UPDATE

Empowerment,QualityofLife,AnaphylaxisRegistry,IssuesandTrends

Dr.RuchiGupta,AssociateProfessorNorthwesternUniversityAttendingPhysician,Ann&RobertH.LurieChildren’sHospital

AnaphylaxisResearchUpdateRuchiS.Gupta,MD,MPH

AssociateProfessorofPediatricsDirector,FoodAllergyOutcomesResearchProgram

NorthwesternMedicineAnn&RobertH.LurieChildren’sHospitalofChicago

Overview

1.  FoodAllergyEpidemiology2.  EconomicImpact3.  BuildinganAnaphylaxisRegistryintheED4.  QualityofLife5.  FoodAllergyLabeling6.  FoodAllergyandSiblings7.  Peer-to-PeerVideos8.  SchoolPolicy

Prevalence8%ofU.S.childrenhaveafoodallergy

(Twokidsperclassroom)

Ofthosewithfoodallergy,30%wereallergictomul�plefoods

GuptaRS,SpringstonEE,WarrierMR,SmithB,KumarR,PongracicJ,HollJL.Theprevalence,severity,anddistribu�onofchildhoodfoodallergyintheUnitedStates.Pediatrics2011Jul;128(1):e9-e17.

PrevalenceMostcommonfoodallergens:

C23690-003-r05_NeuralTube.pptxPage2GuptaRS,SpringstonEE,WarrierMR,SmithB,KumarR,PongracicJ,HollJL.Theprevalence,severity,anddistribu�onofchildhoodfoodallergyintheUnitedStates.Pediatrics2011Jul;128(1):e9-e17.

3300%%

2255%%

2200%%

1155%%

1100%%

55%%

00%%

PPeeaannuutt 2255..22%%

MMiillkk 2211..11%%

SShheellllffiisshh 1177..22%%

TTrreeee NNuutt 1133..11%%

EEgggg 99..88%%

FFiinn FFiisshh 66..22%% WWhheeaatt

55..00%% SSooyy

44..66%%

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PrevalenceVaria�onbyage:


Peanut Shellfish TreeNut Milk Egg Wheat

0–2years(n=5429) 22.2 7.5 5.4 31.5 15.8 4.0

33 –– 55 yyeeaarrss (n=5910) 30.3 12.9 14.3 22.1 13.7 5.0

66 –– 1100 yyeeaarrss (n=9911) 25.5 17.1 14.3 19.6 11.1 5.0

1111 –– 1133 yyeeaarrss (n=6716) 28.1 20.4 15.2 17.7 6.6 8.2

≥≥ 1144 yyeeaarrss (n=10 514) 20.2 23.8 13.4 18.4 4.1 3.3

PrevalenceofAnaphylaxis

•“Studiesfoundwidedifferencesintherates(from1/100,000popula�ontoashighas70/100,000popula�on)ofhospitaliza�onoremergencydepartmentvisitsforanaphylaxis.”•“Thepropor�onofanaphylaxiscasesthoughttobeduetofoodsvariesbetween13%and65%.”

-NIAID

Boyceetal.“GuidelinesfortheDiagnosisandManagementofFoodAllergyintheUnitedStates:ReportoftheNIAID-SponsoredExpertPanel.”JAllergyClinImmunol.2010;126:S11-S12.

Associa�onsofRace&Income

*AllP<.05

BlackandAsianrace

Hispanic

Householdincome<$50k

  Higheroddsofhavingafoodallergy(BlackraceOR=1.8;AsianraceOR=1.4)

  Butloweroddsofbeingdiagnosedbyaphysician(BlackraceOR=0.8;AsianraceOR=0.7)

  Loweroddsofbeingdiagnosedbyaphysician(OR=0.8)

  Loweroddsofhavingafoodallergy(OR=0.5)  Loweroddsofbeingdiagnosedbyaphysician(OR=0.5)

USFoodAllergyAnaphylaxisFatalities

55%26%

13% 6% Peanut

TreeNuts

Milk

Shrimp

Datawerecollectedfrom2001-2006

BockSA,Muñoz-FurlongA,SampsonHA.Furtherfatali�escausedbyanaphylac�creac�onstofood,2001-2006.JournalofAllergyandClinicalImmunology.2007Jan4;119(4):1016-8.

GeographicVariability

Usingthesamedata,describedgeographicvariabilityintheU.S.:

C23690-003-r05_NeuralTube.pptxPage2Gupta,R.S.,Springston,E.E.,Smith,B.,Warrier,M.R.,Pongracic,J.,&Holl,J.L.(2012).GeographicvariabilityofchildhoodfoodallergyintheUnitedStates.Clinicalpediatrics,51(9),856-861.

  North-to-Southdeclinenotobserved

  Oddsoffoodallergysignificantlyhigheratmoresouthernandmiddlela�tudescomparedtonorthernstates(OR1.5,95%CI1.3-1.8&OR1.3,95%CI1.1-1.5)

Instead,popula�ondensitycorrespondedwithprevalence,from6.2%inruralareasto9.8%inurbancenters

Table1.RegionalFAprevalence,overallandbymostcommonallergens(n=38,467)

UrbanCenters9.8%

MetroCi�es9.2%

UrbanOutskirts7.8%

SuburbanAreas7.6%

SmallTowns7.2%

RuralAreas6.2%

Peanut2.8%

Peanut2.4%

Peanut1.8%

Peanut2.0%

Peanut1.6%

Milk1.5%

Shellfish2.4%

Milk1.8%

Shellfish1.5%

Milk1.5%

Milk1.4%

Peanut1.3%

Finfish1.8%

Shellfish1.4%

Milk1.4%

Shellfish1.2%

Wheat1.1%

Shellfish0.8%

Milk1.8%

Treenut1.3%

Treenut1.0%

Treenut1.2%

Shellfish1.0%

Treenut0.6%

Egg1.3%

Egg1.0%

Finfish0.7%

Wheat0.8%

Treenut0.9%

Egg0.5%



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UrbanCenters9.8%

MetroCi�es9.2%

UrbanOutskirts7.8%

SuburbanAreas7.6%

SmallTowns7.2%

RuralAreas6.2%

Peanut2.8%

Peanut2.4%

Peanut1.8%

Peanut2.0%

Peanut1.6%

Milk1.5%

Shellfish2.4%

Milk1.8%

Shellfish1.5%

Milk1.5%

Milk1.4%

Peanut1.3%

Finfish1.8%

Shellfish1.4%

Milk1.4%

Shellfish1.2%

Wheat1.1%

Shellfish0.8%

Milk1.8%

Treenut1.3%

Treenut1.0%

Treenut1.2%

Shellfish1.0%

Treenut0.6%

Egg1.3%

Egg1.0%

Finfish0.7%

Wheat0.8%

Treenut0.9%

Egg0.5%





UrbanCenters9.8%

MetroCi�es9.2%

UrbanOutskirts7.8% SuburbanAreas7.6% SmallTowns7.2%

RuralAreas6.2%

Peanut2.8%

Peanut2.4%

Peanut1.8%

Peanut2.0%

Peanut1.6%

Milk1.5%

Shellfish2.4%

Milk1.8%

Shellfish1.5%

Milk1.5%

Milk1.4%

Peanut1.3%

Finfish1.8%

Shellfish1.4%

Milk1.4%

Shellfish1.2%

Wheat1.1%

Shellfish0.8%

Milk1.8%

Treenut1.3%

Treenut1.0%

Treenut1.2%

Shellfish1.0%

Treenut0.6%

Egg1.3%

Egg1.0%

Finfish0.7%

Wheat0.8%

Treenut0.9%

Egg0.5%



Severity


39%Childrenwhohaveexperiencedaseverereac�on

Severity

Gupta,RuchiS.,etal."Theprevalence,severity,anddistribu�onofchildhoodfoodallergyintheUnitedStates."Pediatrics128.1(2011):e9-e17.

Propor�o

n

ComparingWTP&MeasureofActualCostAnnualCosts,US$

95%CI

Characteris�c Total(inBillions)

PerChild Total(inBillions)

PerChild

WTP 20.8 3504 (15.7-25.7) (2652-4344)

Costsbornebyfamilies

Out-of-pockettreatment

5.5 931 (4.7-6.4) (793-1080)

Lostlaborproduc�vity 0.77 130 (0.53-1.0) (89-175)

Opportunity 14.2 2399 (10.5-18.4) (1771-3104)

Total

Reportedcostsbornebyfamilies

20.5 3457 (16.7-24.9) (2816-4208)

Directmedicalcosts 4.3 724 (2.8-6.3) (472-1063)

Reportedcosts 24.8 4184 (20.6-29.4) (3475-4960)

Gupta,R.,Holdford,D.,Bilaver,L.,Dyer,A.,Holl,J.L.,&Meltzer,D.(2013).TheeconomicimpactofchildhoodfoodallergyintheUnitedStates.JAMApediatrics,167(11),1026-1031.GuptaRS,HoldfordD,BilaverL,DyerA,HollJ,MeltzerD.ThehigheconomicimpactofchildhoodfoodallergyintheUnitedStates.JAMAPediatricsSept201316,publishedonlinebeforeprint.C23690-003-r05_NeuralTube.pptxPage2

TToottaall AAnnnnuuaall CCoosstt IInn tthhee UU..SS..::

$24.8 billion

TToottaall AAnnnnuuaall CCoosstt ppeerr CChhiilldd::

$4,184

EconomicImpact:ComparingWillingness-to-PaytoCost

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CostofFoodAllergyMedicalVisits

  Dataanalyzedfrom1,623UScaregiverswithafood-allergicchild

  Childreninthelowestincomestratumspendtwoandonehalf�mestheamountonemergencydepartmentandhospitaliza�oncostsasaresultoftheirfoodallergythanhigherincomechildren($1,021,SE±$251versus$416,SE±$99).

  Spendingonspecialistsvisitswerelowerinthelowestincomegroup($228,SE±$22)comparedwiththehighestincomegroup($311,SE±$18).

SocioeconomicDispari�esintheEconomicImpactofChildhoodFoodAllergy.AmericanJournalofPublicHealth.2015.UnderReview.

AllergicReac�onRegistries  Wearecurrentlypilo�ngandrefiningthreeseparateallergicreac�onregistries:–  EmergencyDepartment(ED)– GeneralPublic

  www.reportmyreac�on.com–  Schools

  Thegoaloftheseregistriesistobe�ertrackandunderstandwhatarecausingallergicreac�ons,includinganaphylaxis,wherethesereac�onsareoccurring,andthecarethatindividualsarereceiving

EDAnaphylaxisRegistry

  Background:ImplementedclinicaldecisionsupporttoolsinapediatricEDtobe�erstandardizedata–  .EDANAHPIand.EDANACOURSE

  Objec�ve:Tobe�ertrackandunderstandwhatarecausingallergicreac�ons,includinganaphylaxis,wherethesereac�onsareoccurring,andthecarethatindividualsarereceiving

  Methods:A�eroneyear,weanalyzedassocia�onsbetweenpa�entcharacteris�csandreceiptofpre-EDepinephrineanddiphenhydramine(Benadryl)

EDAnaphylaxisRegistry-Results  Results:209cases  FewerHispanicchildrenreceivedpre-EDepinephrine

comparedtootherchildren(p=0.002)–  Morewhitechildrenreceivedpre-EDepinephrinecomparedto

childrenofcolor(p=0.003)  ChildrenwithMedicaidalsoreceivedpre-EDepinephrine

lesscomparedtochildrenwithprivateinsurance(p=0.006)  Childrenyoungerthan12yearsoldreceivedpre-ED

Benadryllesscomparedtoolderchildren(p=0.001)–  Only19%ofHispanicchildrenreceivedBenadrylcomparedto

38%ofotherchildren(p=0.01)

SchoolRegistry

  PilotedthisregistryinthreeprivateK-12thgradeschoolsinChicago  Registrydatacaptured:

–  Studentdemographics–  Typeofallergen–  Loca�onwheresymptomsoccurred–  Symptoms– Medica�on(s)given– WhetherthestudentwenttotheEDa�erexposure

SchoolRegistry-Results

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What about ORGANIC Peanut Butter?

It's a slightly more expensive risk of

anaphylaxis.

J

  Foodallergiesimpactqualityoflifeinavarietyofdomains.Theseinclude:–  Daycareandschool–  Socialinterac�ons–  Familyrela�onships–  Finances

GuptaRS,SpringstonEE,SmithB,KimJS,PongracicJA,WangX,HollJ.Foodallergyknowledge,a�tudes,andbeliefsofparentswithfood-allergicchildrenintheUnitedStates.PAI2010;21:927-34.

FoodAllergyandQualityofLife

LabelingStudy  Togatherpreliminaryinforma�onregardingconsumerperspec�veoffood

allergenlabelingprac�cesfrommul�plecountries

  Tosharesummarydatatohelpadvancethedialogueamongstkeystakeholders(i.e.foodindustry,foodscien�sts,cliniciansandresearchers,governmentregulators,andpa�entgroups)

  Subjectsincludedthosewithfoodallergy,thosewithfamilymemberswithfoodallergy,andcaregiversofthosewithfoodallergy

  Surveycapturedinforma�onabouttheprevalenceofspecificfoodallergies,severityofreac�on,buyingprac�cesinresponsetodifferenttypeoflabelingsuchas‘maycontain’

Marchiso�oMJ&HaradaL;KamdarO,SmithBM,KhanK,SichererS,TaylorS,LaFeminaV,MuraroA,WasermanS,GuptaRS.FoodAllergenLabelingandPurchasingHabitsintheUSandCanada.JAllergyClinImmunolPract.2016.InPress.

LabelingStudyObjec�vesandMethods

  6,684respondents:5,507(82.4%)fromtheU.Sand1,177(17.9%)fromCanada

  Upto40%ofrespondentspurchasefoodwithcommonprecau�onaryallergenlabeling(PAL)

  Severeallergicreac�onhistorymaderespondentslesslikelytopurchasefoodscontainingPAL

  Canadianshadhigheroddsofbuying“maycontainallergen”labeling

  TheUShadloweroddsofbuyingproductsthatu�lizedthe“manufacturedinafacilitythatalsoprocessesallergen”or“manufacturedonsharedequipmentwithproductscontainingallergen”


LabelingStudyResults


Variable Frequency,%(n)AllRespondents(US&Canada)

UnitedStates Canada

PurchaseProductwiththeFollowingLabel:

“MayContainAllergen”

Never 87.7%(5,574) 89.9%(4,730) 77.2%(844)

Some�mes 11.3%(716) 9.4%(492) 20.5%(224)

Always 1.0%(63) 0.7%(37) 2.4%(26)

“ManufacturedinaFacilitythatAlsoProcessesAllergen”

Never 59.7%(3,795) 58.9%(3,098) 63.5%(697)

Some�mes 34.2%(2,174) 35.0%(1,841) 30.4%(333)

Always 6.1%(389) 6.1%(322) 6.1%(67)

“ManufacturedonSharedEquipmentwithProductsContainingAllergen”

Never 83.3%(5,301) 83.0%(4,375) 84.7%(926)

Some�mes 14.2%(904) 14.5%(762) 13.0%(142)

Always 2.5%(160) 2.6%(135) 2.3%(25)

RespondentPurchasingBehavior

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Variable Frequency,%(n)AllRespondents(US&Canada)

UnitedStates Canada

FoodSourceNamesofMajorAllergensRequiredbyLaw

True 71.7%(4,522) 70.7%(3,740) 72.7%(782)

False 17.2%(1,092) 17.6%(929) 15.2%(163)

Don’tKnow 11.8%(749) 11.7%(618) 12.2%(131)

AdvisoryLabelRequiredbyLaw

True 28.8%(1,831) 25.6%(1,355) 44.1%(476)

False 54.4%(3,460) 57.9%(3,061) 37.0%(399)

Don’tKnow 16.9%(1,075) 16.5%(871) 18.9%(204)**

AdvisoryLabelNotBasedonAmounts

True 63.3%(4,024) 63.3%(3,345) 63.3%(679)

False 8.5%(539) 8.3%(441) 9.1%(98)

Don’tKnow 28.2%(1,746) 28.4%(1,501) 27.5%(295)

RespondentKnowledgeaboutLabelingLaws

FoodAllergySensi�za�onandPresenta�oninSiblings

  Objec�ve:determineprevalenceofsensi�za�onandtruefoodallergyamongsiblingsoffoodallergicchildren

  Par�cipants:Eligiblefamilieswerethosehavingeitheroneorbothparentswithatleastonebiologicalchild(ages0–21years)withfoodallergy

GuptaRS,WalknerM,GreenhawtM,LauC,CarusoD,WangX,PongracicJA,SmithBM.FoodAllergySensi�za�onandPresenta�oninSiblingsofFoodAllergicChildren.JAllergyClinImmunolPract.2016.

FoodAllergySensi�za�onandPresenta�oninSiblings

  Theprevalenceoffoodallergyamongsiblingsoffood-allergicchildrenwas13.6%

  Milkallergywasthemostcommonamongsiblingsoffood-allergicchildren(5.9%),followedbyeggallergy(4.4%)andpeanutallergy(3.7%)

  Theprevalenceofsensi�za�ontoanyfoodamongsiblingswas53.0%

  Sensi�za�ontowheat(36.5%)wasthemostcommonamongsiblingsoffood-allergicchildren

GuptaRS,WalknerM,GreenhawtM,LauC,CarusoD,WangX,PongracicJA,SmithBM.FoodAllergySensi�za�onandPresenta�oninSiblingsofFoodAllergicChildren.JAllergyClinImmunolPract.2016.

Peer-to-PeerEduca�on

  Tosolicitrecommenda�onsfromchildrenwithfoodallergyregardingdesiredcontentandformatforaseriesofthreepeerfoodallergyeduca�onvideos

  Todevelopandproducethefirstofthesethreepeerfoodallergyeduca�onalvideos

StudyObjec�ves SurveyFindings:Demographics

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SurveyFindings:Percep�onsofPeerFoodAllergyKnowledgeandSupport

  QUESTION:Whataresomethingsyouwishyourfriendsandclassmatesknewaboutfoodallergy?

  QUESTION:Whatinforma�onaboutfoodallergiesdoyouthinkshouldbeincludedinavideo?

  SeriousnessofFA“TheyaredangerousandnotfunnyandIdonothaveachoice.Iamnot

picky.”  Cross-contact“ifoneofmyfriendswereea�ngnutsandthenItouchedsomethingthey

touchedIcangetsickeventhoughIdidn'teatit“

  WayspeerscansupportkidswithFA:“Thatwes�llliketoplaythesamethings,runaroundjustlikethem,theonlythingdifferentiswhatweeat,andithurtsourfeelingswhenwesitalone.”

  FAsymptomrecogni�on:“Howtorecognizeareac�on.Howtohelpyourfriendifhe'shavingareac�on.”

SurveyFindings:Top4VideoContestPreferences

  QUESTION:Ifyoucoulddirectyourownvideotoeducateyourclassmatesaboutfoodallergyhowwoulditlook?Whatwouldyoudotomakesureyourclassmateslikedit?

  RECURRINGTHEMESAMONGPRE-KTHROUGH3rdGRADERS:–  Useanima�onand/orcartoons,usehumorouscharacters,“makeitupbeatandhelpful,notscary”

  RECURRINGTHEMESAMONG4THTHROUGH8THGRADERS:–  “Userealkidsinitthathavefoodallergy”,filmitatschool,makeitrealis�c,“adayinthelifeof

ME”,“keepitinteres�ngbyhavingcommonques�onsbeansweredduringthevideo”,nottoolong,“startatalunchtable,thescariestplaceforallergicchildren”,“haveanallergydoctorexplainingthings”

SurveyFindings:VideoFormatPreferences FoodAllergyVideosand

ResourcesLinktovideos:

–  h�p://www.ruchigupta.com/kidstalk/

CurrentSchoolFoodAllergyPolicySurvey

  Objec�ve:todeterminecurrentfoodallergypolicies,includingschool-wide,classroom,cafeteria,andextracurricularac�vitypolicies.

  Byunderstandingwhatfoodallergypoliciesareworkingbest,wecanmakestrongerrecommenda�onstoschoolstoimprovefood-safetyforallchildren

SchoolPolicy-Methods

  Administeredashortonlinesurveyregardingfoodallergypoliciestoschoolnurses/administratorswhoworkinbothprivateandpublicK-12schoolsystems.

  Askedaboutcurrentpoliciesthatareintheirschools,ifthepolicywasneeded/effec�ve,andanybarriersforthepolicybeingimplemented

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SchoolPolicy-Results  Demographics:

– 286totalrespondents– 92%ofrespondentswerenurses– Majority(85%)workattheschooltheyreportedon

5daysaweek– Meanstudentpopula�on:5,102students– Peanut(93%)andTreenut(80%)werethetop

allergensreported–  Inthepastyear,64%ofrespondentshad0severe

allergicreac�onswhile21%had1allergicreac�on

SchoolPolicy-Results

  SchoolWide:–  52%reportedthattheirschoolshadallergy

awarenessprogramsandevents.  94%thoughtthatthisprac�cewashelpful.  Timewasthebiggestbarriertohavingthisprac�ceusedinschoolsthatdidnothaveawarenessprogramsorevents.

– 81%ofrespondentsreportedthatstockepinephrinewasavailable  Ofthosewhoreported“no”thebiggestbarrierswereadministra�on/staffresistance(42%)andmoney(40%)

SchoolPolicy-Results  Lunchroom-specific:

–  65%ofreportedschoolshavelunchmenuswithallergeninforma�on  96%believedthatitwashelpful  Ofthosewithoutthispolicy,77%believethatitwasneeded  Barriers:limitedstaff(43%)and�me(37%)

–  62%reportedthatthereweredesignatedareasforstudentswithfoodallergytositandeatlunch.  Avastmajority(83%)believedthatthiswashelpful  87%reportedthattherewastrainingoflunchroomstaffaboutfoodallergies  96%believedthatitwashelpful


Lunchroom-specific:–  46%respondentsreportedthatfooditemsinthe

lunchroomwerenotlabeledwithallergeninforma�on  61%believethatthispolicyisneeded  Barriers:limitedstaff(42%);�me(38%)

–  83%respondentshaveclearcleaningproceduresinthelunchroom  97%believethatthisprac�ceishelpful

SchoolPolicy-Results  Classroom-specific:

–  59%reportedthattherearestrictfoodguidelinesintheclassroom  95%believethatthisishelpful

–  66%reportedthattherearestrictfoodguidelinesforcelebra�ons(holidayandbirthdaypar�es)  93%believethatthisisahelpfulprac�ce  Topschoolrecommenda�ons:Foodwithaclearingredientlabelisallowed(52%);Nofoodisallowed(25%)

SchoolPolicy-Results  StaffTraining:

–  96%reportedthatthereisallergyreac�on/anaphylaxistraining  Thetrainingisin-personaccordingto89%ofrespondentsthathavethistraining  97%believethatitishelpful

–  Oftherespondentsthatdonothavethistraining,89%believethatitisneeded

»  Barriers:lackofstaffeduca�on(67%)and�me(44%)

–  96%reportedthatthereisepinephrineauto-injectortraining  Almostall(98%)believethatitishelpful  Nurses(92%)andadministrators(75%)arethemostlikelytobetrained

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  A�er-SchoolAc�vi�es:–  Almosthalf(49%)reportedthatstockepinephrineisnotavailable

duringa�er-schoolac�vi�es  Ofthosehalf,48%believethatisneeded  Iden�fiedbarriers:limitedstaff(41%)andmoney(32%)

–  Ifstudentsaretraveling,64%ofrespondentsreportedthatstockepinephrinedoesnottravelwiththem  Only31%believethatthispolicyisneeded  Moneyisthelargestbarrier(55%)

  Transporta�on:

–  Overhalf(58%)oftherespondentsreportedthatthereisanadultonthebusthatistrainedonhowtouseanepinephrineauto-injectorand/orhowtorespondtoanallergicreac�on

.

Thankyou!

[email protected]

BREAK

IMPLEMENTING STRATEGIES FOR EMERGENCY ANAPHYLAXIS CARE

Fromemergencymedicalservicestoemergencydepartmenttooutpatientfollow-up

Dr.W.ScottRussell,AssistantProfessor,DepartmentofPediatrics,,MedicalDirector,Ped.ED,MedicalUniversityofSouthCarolina

Dr.J.WesleySublett,Board-Certi�iedPediatricAllergist,FamilyAllergyandAsthma

Summit

2016StrategiesforEmergency

AnaphylaxisCare

W.ScottRussell,MD

DanaV.Wallace,MD

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Summit


AnaphylaxisCare

W.ScottRussell,MD

StanFineman,MD

Summit


AnaphylaxisCare

W.ScottRussell,MD

WesSublett,MD

Question1

Isitimportantincaringforpatientsandinthedevelopmentofan“AnaphylaxisTreatmentPlan”toseparatepatientswhohavehadpreviousanaphylaxis(2systemsofinvolvement,hypotension,orupperairwayedema)fromthosewhohavehadasystemicreaction(1systemofinvolvement),vs.those“atrisk”foranaphylaxis?

Welackformaldefinitionsofsomekeyterms

  Foodallergy:adversereactiontoafoodallergencausedbyimmunologicmechanisms.1

  Systemicreaction:anallergicreactionwhichisnotimmediatelylifethreatening,islimitedtoasingleorgansystem,andhascutaneous/mucosalsymptoms,ifpresent,extendingbeyondtheimmediateareaofallergencontact.(speaker'sdefinition)  Anaphylaxis:asevere,potentiallylife-threateningsystemichypersensitivityreaction.2

  Allergicreaction:alocalorgeneralizedimmunologicalreactionfollowingcontactwithaspecificallergentowhichonehasbeenpreviouslyexposedandsensitized.(speaker’sdefinition)

1.Muraroetal,Allergy2014;69:1046-57;2.Muraroetal,Allergy2014;69:1026-45

ClassificationofHumanAnaphylaxis

Simons FER, et al. J Allergy Clin Immunol. 2010;125:S161-S181.

Human Anaphylaxis

Non-Immunologic Immunologic

Idiopathic IgE, FcεεRI Non-IgE, Non-FcεεRI Physical Other

Foods, venoms, latex, drugs

Dextran, OSCS, contaminants

in heparin, transfusion reactions

Exercise, cold

Radiocontrast media, aspirin, opioids,

NSAIDs

IgE, immunoglobulin E; FcɛRI,high-affinity IgE receptor; NSAIDs, nonsteroidal anti-inflammatory drug; OSCS, oversulfated chondroitin sulfate.

ANAPHYLACTOID

NIAID/FAAN:ClinicalCriteriaforDiagnosingAnaphylaxis

OR OR

Sampson HA, et al. Ann Emerg Med. 2006;47:373-380.

Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both

≥≥2 of the following that occur rapidly after exposure to a likely allergen (minutes to several hours):

Reduced BP after exposure to known allergen (minutes to several hours):

AND AT LEAST 1 OF THE FOLLOWING

Respiratory compromise (eg, dyspnea, wheeze- bronchospasm)

Reduced BP or associated symptoms of end-organ dysfunction

a)  Involvement of the b)  skin-mucosal tissue

(eg, generalized hives, c)  itch-flush, swollen d)  lips-tongue-uvula)

e)  Respiratory compromise f)  Reduced BP or associated

symptoms g)  Persistent gastrointestinal

symptoms (eg, crampy abdominal pain, vomiting)

a.  Infants and children: Low SBP* (age specific) or >30% decrease in SBP

a.  Adults: SBP of <90 mm Hg or >30% decrease from that person’s baseline

*Low systolic blood pressure (SBP) for children is defined as <70mm Hg from 1 month to 1 year, <70 mm Hg plus (2x age) from 1 to 10 years, and <90 mm Hg from 11 to 17 years.

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AHigherProportionofSubsequentReactionsAreSevereandRequire

Epinephrine

Sicherer SH, et al. J Allergy Clin Immunol. 2001;108:128-132.

**

*

**

1st reaction 2nd reaction 3rd reaction

Severe Epinephrine Severe Epinephrine Peanuts Tree Nuts

60

50

40

30

20

10

0

Perc

ent (

%)

*Indicates a reaction significantly greater than prior reaction (P<.05). Data from the 1st 5,149 patients in a voluntary registry for peanut and tree nut allergy.

Question2

Physiciansandpatientsdelaytheadministrationofepinephrineforthetreatmentofseriousallergicreactions,inpart,duetofear.Isthefearofthesideeffectsofepinephrine,administeredintramuscularly,justified?

FearpreventstheappropriateuseofEpinephrine! TheFacts:EpinephrineFatalEvents

inTreatingAnaphylaxis

Age Physiological effect

Dose Route

Given for Overdose

13 Pulmonary Edema 3.5

mg IV Mild

Symptoms

Yes

63 Pulmonary Edema

2.5 mg IV Antibiotic

Rx Yes

Infant

Fluid overload

Multiple

doses

?? Persistent Pallor

Yes

38 Aspiration of

vomitus

1.0 mg

IV Vomiting from nuts

Yes Pumphrey RS. Clinical and experimental allergy: journal of the British Society for Allergy and Clinical Immunology 2000;30:1144-50.

Mildadverseeffectsofepinephrine:MaybeGOOD

  Transientpharmacologiceffectsafterarecommendeddoseofepinephrine

  byanyrouteofadministrationinclude:  Pallor,tremor,anxiety,palpitations,dizziness,andheadache.

  Thesesymptomsindicatethatatherapeuticdosehasbeengiven.

  Seriousadverseeffects:  Ventriculararrhythmias,hypertensivecrisis,andpulmonaryedemapotentially

  occurafteranoverdoseofepinephrinebyanyrouteofadministration.

  Typically,seriousadverseeffectsarereportedafterintravenousepinephrinedosing

SimonsER.WorldAllergyOrganJ.2011Feb;4(2):13–37.

Question3

  Whentoadministerthefirstdoseofepinephrine?

  Atwhatstageofanallergicreactionshouldphysiciansadministerepinephrine?

  Atwhatstageofanallergicreactionshouldphysiciansinstructpatientsorparentstoadministerepinephrine?

  Atwhatstageofanallergicreactionshouldschoolpersonneladministerepinephrinewithastudentpreviouslydiagnosedtohavehadanaphylaxis?

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GuidelinesPositionEpinephrineasFirst-lineEmergencyTreatmentof

AnaphylaxisWAO

Anaphylaxis Guidelines

  Epinephrine has a primary role in the management of anaphylaxis   Prompt

intramuscular injection of epinephrine, the first-line medication, should not be delayed by taking the time to draw up and administer adjunctive medications, such as antihistamines and

l ti id

Anaphylaxis Practice

Parameter

  Epinephrine is the drug of choice for the treatment of anaphylaxis   The

appropriate dose of epinephrine should be given promptly at the onset of apparent anaphylaxis

NIAID-Sponsored Expert Panel on

Food Allergy

  Epinephrine is the first-line treatment in all cases of anaphylaxis   When there is

suboptimal response to the initial dose of epinephrine dosing remains first-line therapy over adjunctive treatments   Upon

discharge, 2 doses of epinephrine autoinjector

ICON; Food Allergy

  Epinephrine is the first-line treatment for anaphylaxis   Upon

discharge, 2 doses of epinephrine autoinjector should be prescribed   Patients must

be educated on when and how to use the epinephrine autoinjector device

Simons et al 2011. Lieberman et al 2010. Boyce et al 2010. Burks et al 2012

IMEpinephrine:OnsetofEffect

MaximumPDeffectoccursbefore10minutes

  Systolicpressure  Diastolicpressure  Heartrate

Adapted from Simons FER, et al. J Allergy Clin Immunol. 1998;101:33-37.

Blo

od P

ress

ure

(mm

Hg)

/ H

eart

Rat

e (b

pm)

Time (mm)

160

140

120

100

80

60

40

20

0 10 20 30 40 50 60

Systolic pressure Diastolic pressure Heart rate

FatalAnaphylacticReactionsAreOftenAssociatedWith:

  Delaybetweentimeofsymptomonsetandadministrationoftreatment

  Historyofasthma

  Adversetherapeuticevent  Fatalreactionscanbeunpredictable

Pumphrey, Curr Opin Allergy Clin Immunol 2004 Sampson et al, N Engl J Med, 1992 Pumphrey, Clin Exp Allergy, 2000

TryptaseandHistamineDynamics

  Tryptaselevelsprovideamoreprecisemeasureofinvolvementofmastcellsthanclinicalpresentation1

  Totalserumtryptasemayremainelevatedacutelyfor6+hours2

  Peaksat1hour:obtainbloodsamplewithin3hours

  Normalserumtryptasevalueis<10ng/mL;thehigherthevalue,thehigherthesensitivity3

  Positivepredictivevalueofserumtryptasecanbe92.6%3

  Negativepredictivevalueisonly52%

  Plasmahistaminebeginstorisewithin5minutesbutremainselevatedfor30to60minutes4

  Becauseoflongerhalf-life,serumtryptaseispreferred

1. Schwartz LB, et al. Immunol Clin North Am. 2006;26:451-463. 2. Lieberman P, et al. J Allergy Clin Immunol. 2010;126:477-480. 3. Tanus T, et al. Ann Emerg Med. 1994; 24:104-107. 4. Laroche D, et al. Anesthesiology. 1991;75:945-949.

  PAFmeasuredin41ptswithanaphylaxisandin23controls.

  Grade1:skinonly,Grade2:mild-moderate,Grade3:severe,bp<90,dyspneaetc.

Vadas et al. N Engl J Med 358;1:28-35

PAFinAnaphylaxis

Vadas et al. N Engl J Med 358;1:28-35

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ReasonsPatientsReportWhyTheyDidNotUseanAuto-injector

  Notprescribedbyphysician

  Notaffordable/notfilled  Notaccessiblewhenreactionoccurred

  Previousreactionimprovedquickly

  Currentreactionseemedmildorimprovedquickly

  Usedanothermedicationtotreatepisode

  Patienttakinganothermedicationthatinterfered

  Didn’twanttogotoED  Patientwasunsurewhentoinjectorinjectedtoolate

  Rapidprogressionofreaction

Simons KJ, Simons FER. Curr Opin Allergy Clin Immunol. 2010;10:354-361. Simons FER, et al. J Allergy Clin Immunol. 2009;124:301-306.

Q4

  Useofantihistaminesandcorticosteroidsforasystemicreactionoranaphylaxis

  Whatistheroleofanantihistamineand/oracorticosteroidinthetreatmentofasystemicreactionoranaphylaxis?

  Shouldanantihistaminebeincludedonan“AnaphylaxisActionPlan?

PharmacokineticsandPharmacodynamicsofH1-antihistaminesH1-antihistamine tmax Onset of action

Diphenhydramine 1.7 + 1 h 2h

Hydroxyzine 2.1 + 0.4 h 2h

Cetirizine 1 + 0.5 h 1h

Desloratadine 1-3 h 2h

Fexofenadine 2.6 h 2h

Levocetirizine 0.8 + 0.5 h 1h

Loratadine 1.2 + 0.3 h 2h

AdaptedfromMiddleton’sAllergyPrinciples&Practice7thedition,Table8

AntihistaminesTakeTime

Timeto50%SuppressionofHistamine-inducedFlare

51.7

79.2

101.2T 5

0 Min

utes

Jones DH, et al. Ann Allergy Asthma Immunol. 2008;100(5):452-456.

Anaphylaxis-apracticeparameterupdate2015

  Antihistamineandcorticosteroidpharmacodynamicactivitywouldnotpreventcardiorespiratoryarrestordeath

  Antihistaminesonlyantagonizetheeffectofhistamine,whereasthereisampleevidencethatothermediatorssuchasplateletactivatingfactorandkininsareassociatedwithsevereandpotentiallyfatalreactions

Liebermanetal.AnnAllergyAsthmaImmunol115(2015)341-384

Anaphylaxis-apracticeparameterupdate2015

 NeveradministerH1andH2antihistaminesorcorticosteroidsasinitialtherapyforanaphylaxisinsteadofepinephrineandconsidertheseagentsoptionaloradjunctivetherapy.

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Question5

  Initialdiagnosisofasystemic/anaphylacticreactionintheEmergencyDepartment

 Whatdiagnosticstudies,ifany,prescriptions,education,andreferralsarereasonabletobecompletedintheEDsetting?

Diagnosis

  Textbookdefinitiongreatforallergists  Clinicaldefinitiongreatforretrospectivestudies  GutcheckdefinitionbestbetforEDpractitioners

R.L.Campbell,etal.AnnAllergyAsthmaImmnunol2014;113:599-608.

NIAIDGuidelinesStandardofCare

1)UseofIMepiastreatmentofchoice

2)Educationalinstructionatdischarge

3)PrescriptionforanEpiautoinjector(EAI)

4)Referraltoaspecialist

Sidhuet.al.PediatricEmergencyCare2016;32(8):508-513.

DoWePracticeWhatWePreach?  Michlesonet.al.VariationandTrendsinAnaphylaxisCareinUnitedStatesChildren’sHospitals.2016AcademicEmergencyMedicine23(5):623-627.

  PediatricHealthInformationSystem(PHIS)database1/1/09-9/20/13

  10,442patientswithICD-9diagnosiscodeforanaphylaxis  35Children’sHospitals  RateofEDdiagnosisrosefrom5.7-11.7patientsper10,000EDvisits

  DIDNOTMEASUREEPIUSAGE…variatonsmeasuredinadjuctivetreatment.

DoWePracticeWhatWePreach?

  Russellet.al.AnaphylaxisManagementinthePediatricEmergencyDepartment:OpportunitiesforImprovement.PediatricEmergencyCare,2010.26(2):71-76.

  124patientswithclinicalanaphylaxis  54%epinephrinedosingrate

  Antihistaminedosingrateof92%

  Corticosteroiddosingrateof78%

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DoWePracticeWhatWePreach?

  Sidhuet.al.EvaluationofAnaphylaxisManagementinaPediatricEmergencyDepartment.PediatricEmergencyCare,2016.32(8)508-513.

  Prevalenceoffoodallergyamongchildrendoubledfrom1997-2007  Pre-andpost-guidelineepiuseintheED57%and41%,respectively  IMrouteusepre-andpost-inED6%and46%,respectively

  Antihistamineusepre-andpost-inED92%and93%  Steroidusepre-andpost-inED75%and73%

WEDONOTPRACTICEWHATWEPREACH!!!!

PracticalConsiderations

  Diagnosisbias?  CostofEAI  Accesstosubspecialtycare  Timeinvestmenttoproperlyeducate

  Tryptaselevel?  Concernforlitigation?

Q6

  Recognizingthatmostpatientsself-recoverevenwithouttreatmentandthatfewepisodeofanaphylaxisarefatal,shouldthetreatmentofasystemic/anaphylacticreactionvarybaseduponthetimethathaspassedsincetheonsetofthesystemicreaction?Assumethereisnohypotensionorupperairwaycompromise.

Case1

  A2yearoldfemale,withknowneggandmilkallergy,attendsacountyfairwithherparentswheresheingestadinnerrollpurchasedfromafoodvendor.Within30minutes,herparentsnotesheisveryirritable,hasdevelopedflushing,andhasseveralepisodesofemesis.Shealsoappearstobescratchingherfacearoundthemouth.

  Historyofallergicrhinitis,asthma,andatopicdermatitis

Case2  A8yearoldmale,withknownpeanutallergy,isonaschoolfieldtrip.Histeachersandschooladministratorsareawareofhispeanutallergy.Heingestacupcakewhichweregiventothestudentsduringthefieldtrip.Within10minutes,hereportstohisteachershisstomachhurtsandneedstousetherestroom.Onthewaytotherestroom,thechildhasseveralepisodesofemesisandappearstohaveseveralurticariallesionsonhisface.TheteacherfearinganallergicreactioncallsEMS.WhenEMSarrives,thechildstillappearsflushed,hasmildurticariallesionsonhisface.Thestudentreportsheisfeelingbetter.


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Case3  A14yearoldasthmaticfemale,withknowntreenutallergy,isatschoolwithfriendssettingupastandtosellcandyasabandfund.Herteachersandschooladministratorsareawareofhertreenutallergyandasthma.Sheingestacoffeeflavoredchocolatecoveredproteinbarwhichwasgiventoherbyafriend.Within30minutes,shereportsherstomachhurtsandneedstousetherestroom.Onthewaytotherestroom,shehasseveralepisodesofemesisanddevelopschesttightnessandshortnessofbreath.SheapproachesateacherwhocallsEMSfearingsheishavingproblemswithherasthma.WhenEMSarrives,thechildstillappearsflushedandtachypneic.EMSsuppliessupplementaloxygen,andthestudentreportsithelpsherbreathing.UponarrivaltotheER,thestudent’ssymptomshavenotchanged.


AnaphylaxisDeaths

  From2006to2009,theoverwhelmingmajorityofhospitalizationsorEDpresentationsforanaphylaxisdidnotresultindeath,withanaveragecasefatalityrateof0.3%

  Althoughanaphylacticreactionsarepotentiallylife-threatening,theprobabilityofdyingisactuallyverylow.

MaLetal.JAllergyClinImmunol.2014;133:1075-83.

AnaphylaxisProgressesRapidly  Themediantimetorespiratoryorcardiacarrestwas30minforfoods

  Themediantimetorespiratoryorcardiacarrestwas15minforvenom

  Themediantimetorespiratoryorcardiacarrestwas5minforiatrogenicreactions

PumphreyetalClinicalandExpAllergy.2000Aug;(8)

EpiFirst,EpiFast

  Inaretrospectivechartreviewoffatalandnearfatalfoodreactions,4of6childrenhadmildsymptomsfor1hourormorebeforesevererespiratorycompromisedevelopedanddeathoccurred

Sampsonetal,NEnglJMed1992;327:380-384.

Question7Realizingthatinthecommunitysetting,patientsrarelyarediagnosedwithbiphasicreactionsfromfoodorinsectsystemicreactionsandthatweareunsurehowtopreventbiphasicreactions,howimportantisittotreatforthispossiblecomplication?Ifitisimportant,whatisthetreatment,forhowlongshoulditbecontinued,andwhatistheevidencethatthetreatmentworks?

Antigen Exposure

Treatment Treatment

8to12hours1

Classic Model

New Evidence

30minutesto72hours2

Time

Sym

ptom

Sco

re

1st Phase 2nd Phase Asymptomatic

BiphasicAnaphylaxis

 126 1. Lieberman P. J Allergy Clin Immunol. 2005;115:S483-S523.

2. Lieberman P. Allergy Clin Immunol Int. 2004;16(6):241-248.

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PracticeParameterSummary:ClinicalImpactofBiphasicResponse

  Patientsmayrequire≥2dosesbecauseofseverity,biphasicreactions,orprotractedcourse

  Theneedfor≥2dosesoccursin~15%to35%ofpatientswhoreceivedepinephrine

  A2nddosecanbeadministeredwithinthe1st5minutesofthepreviousdose

  Thereisnowaytopredictwhowillrequire≥2dosesbasedontheseverityofpreviouseventsalone

Lieberman P, et al. J Allergy Clin Immunol. 2010;126:477-480. Rudders SA, et al. Pediatrics. 2010;125:e711-e718.

EvidencethatDelayinEpinephrineisaRiskFactorinBiphasic

Anaphylaxis  Ofthosewhohadabiphasicreactions,themediantimefromtheonsetofsymptomstotheinitialadministrationofsubcutaneousepinephrinewas190minutes,versus48minutesforthosewithoutabiphasicreaction

 Whencomparingpatientswithuniphasicandbiphasicanaphylaxis,therewasasignificanthigherrateofepinpehrineuseintheuniphasicgroup2

  Atimedelaytoepinephrinetreatmentlongerthan90minutesfromtheonsetoftheinitialreactionwassignificantlyassociatedwithabiphasicreaction31.LeeJM,GreenesDS.Pediatrics.2000;106:762–766.

2.AKEllis,JHDay.AnnAllergyAsthmaImmunol.2007;98:64–69.3.W.Alqurashietal.AnnAllergyAsthmaImmunol115(2015)217-223

Question8 WhatdoseofepinephrinewouldthephysicianintheEDorintheclinic/officesetting,useforchildrenbelowage16?

 Forprescribingepinephrineauto-injectionswouldyoualwaysfollowpackagelabelingastodosingguidelines?Ifnot,howandwhywouldyouvarythatdose?

  Ifapatientcannotaffordtopurchaseanepinephrineauto-injector,e.g.,noinsurance,can’taffordthedeductible,whatwouldyoudo?Iftheycanonlyaffordonetwo-pack,wouldyoueverdividesothatoneisatschoolandoneisathome?

Whatisthebestandsafestdoseofepinephrine?  Emergencydepartmenttreatmentdoseofepinephrine(1:1000):  0.01mg/kgupto0.30mlforchildrenandupto0.05foradultsadministeredIM

  Auto-injectorspackagelabelinginUSA  0.15mgforchild15-30kg

  0.30mgforchild>30kg

  Maybesafertotreatchildren<15kgwithauto-injectorthanwithasyringeandbottleofepinephrine,aserrorscanbemadebycaretakers  Optimaldosingregimenisunknown

Lieberman,P,etal.AnnAllergyAsthmaImmunol.2015Nov;115(5):341-84.SimonsFE.JAllergyClinImmunol.2001;108(6):1040

AmericanAcademyofPediatrics  CALCULATIONS:  Fora10kgchild,the0.15mgautoinjectordeliversa1.5-foldoverdose

  Fora20kgchild,the0.15mgautoinjectordeliversa1.3-foldunderdose,andthe0.3mgautoinjectordeliversa1.5-foldoverdose

  Fora25kgchild,the0.15mgautoinjectordeliversa1.7-foldunderdose,andthe0.3mgautoinjectordeliversa1.2-foldoverdose

  RECOMMENDATIONS:  Forchild10kgto25kg:0.15mg

  Forchild>25kg:0.30mg

  ForChildbetween15kgand25kgwithseverepastepisodesofanaphylaxis:consider0.30mg

  CanadianPediatricSocietymakesverysimilarrecommendations

SichererS.Pediatrics.2007;119(3):6.SimonsFE.JAllergyClinImmunol.2004;113(5):837.

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Epinephrineforchild<10kgDifferentopinions

  EAACIGuidelinessayifchildis>7.5kg:0.15mgauto-injector1

  CanadianPediatricSociety:  Children<10kg:physiciansandfamilieswillneedtoweighthebenefitsandrisksofadministeringepinephrineviasyringesafterbeingdrawnupbyafamilymemberfromsmallampules.

  Thismethodhasbeenshowntobebotherroranddelayprone,andfamilymembersmustbefullycompetentbeforechoosingthismethodofadministration2

1.MuraroA.Allergy.2014Aug;69(8):1026-45.Epub2014Jun9.2SichererSH.AnnAllergyAsthmaImmunol2001;86:597-8.

Isiteverbetterto“overdose”epinephrineinchildren?

  Theidealdosebestonweightandavailableepinephrineauto-injectorsisunavailableformanychildren

  Consider“overdosing”withthe0.30mgdosewhen:  Asthmaisaconcurrentdiagnosis

  Culpritfoodispeanut,treenut,milk,egg,fish,orseafood

  Pooraccesstoemergencymedicalservices

  Dysfunctionalfamilysituation

  Historyofpreviouslife-threateningreaction  Ininfants,the0.15mgdoseispreferredtonoEAIatall

SimonsFE.TheJournalofallergyandclinicalimmunology2004;113:837-44.

EpinephrineAuto-injectors---HowMany?

  Multipledosesofepinephrineareneededbypatientswithsevereorprotractedanaphylaxissymptomsthatarenotrelievedbytheinitialdoseandbythosewithbiphasicormultiphasicanaphylaxis

  Intwoprospectivestudiesofanaphylaxisafterallergenimmunotherapyinjections1,2  Patientsreceivedepinephrineinjectionspromptly

  Biphasicreactionsoccurredin23and10%1,2ofthepatients

  Additionalepinephrinewasnotgiventoanypatient  RetrospectiveEDstudy,allcausesanaphylaxis:>1epinephrineinjectionin13%3

  RetrospectiveEDstudy,children,food-induced:>1epinephrineinjectionin12%41.  ScrantonSE.JAllergyClinImmunol2009;123:493–498. 2.Confino-Cohen R.

Asthma Immunol 2010; 104:73–78.3. Manivannan V. Ann Allergy Asthma Immunol 2009; 103:395–400. 4. Rudders SA. 4. Pediatrics 2010; 125:e711–e718

AmericanJointTaskForceofPracticeParameters  “Twoauto-injectorsshouldbeprovidedbecauseupto

30%ofpatientswhodevelopanaphylaxiswillrequiremorethanonedoseofepinephrine”

  “…emphasizetheyshouldcarrytwoepinephrineautoinjectorswiththematalltimes”[Strongrecommendation]

Liebermanetal,AAAI2015;115:341-84.WAO2011paperneedto

“…morethanoneepinephrineinjectionisneededinupto23%ofadultsreceivinganepinephrineinjectionforanaphylaxis;therefore,considerprescribingmorethanoneepinephrineauto-injector.

WorldAllergyGuidelines

Epidemiologicalevidencebehindguidelinerecommendations

  Statement:considerprescribing2EAIs.1

  Evidence:asingledoseofadrenalineisnotalwayssufficient.2-6

1.Muraroetal,Allergy2014;69:1026-45;2.NoimarketalCEA2012;42:284-92;3.Gold&SainsburyJACI2000;106:171-76;4.JarvinenetalJACI2008;122:133-8;5.Simonsetal,JACI2009;124:301-6;6.Uguzetal,CEA2005;35:746-50;AAIadrenalineauto-injector;IM

l

StrongIndicationsforasecondEAI  Coexistingunstableormoderatetoseverepersistent

asthma&afoodallergy

  Co-existingmastcelldiseasesand/orelevatedbaselinetryptaseconcentration

  Lackofaccesstomedicalassistancetomanageanepisodeofanaphylaxisduetogeographicalorlanguagebarriers

  Previousrequirementformorethanonedoseofepinephrinepriortoreachinghospital

  Previousnearfatalanaphylaxis  Ifavailableauto-injectordoseismuchtoolowforbodyweight

EAACIGuidelines1

1.Muraroetal,Allergy2014;69:1026-45

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StrongIndicationsforasecondEAI  Children:

o Inchildren,twodevicesperprescriptionareroutinelyrecommended.

o Thisallowsonedevicetobewiththepatient(orforparentaluseathomeforyoungerchildren)andonedevicetobeavailableforuseatchildcareorschool.

  Highschoolstudentsandadults:o Previoushypotensiveornearfatalanaphylaxiso Needformorethanoneadrenalinedosetotreatpreviousanaphylaxisepisodes

o Limitedaccesstomedicalcare(e.g.travelorresidenceinremoteareas,perhapsoverseastravelinsomecircumstances

o Patientswithsystemicmastocytosiso Wherehighbodymassindicatesthattheroutine0.3mgadrenalinedosewillprovideaninsufficientdoseforadequatetreatment

Australian(ASCIA)Guidelines

1.

Lowcostepinephrinesolutionsdon’treallywork

  Drawingupepinephrinefromanampuletakestoolongandthedoseisofteninaccurate1

  Usinganunsealedsyringeprefilledwithepinephrinebythepatient'sphysicianhasashelf-lifeofonly3–4months2

1.SimonsFER.JAllergyClinImmunol2004;113:837–844.2.Rawas-QalajiM,SimonsFER,CollinsD,SimonsKJ.AnnAllergyAsthmaImmunol2009;102

DifficultyDrawingEpinephrineFromanAmpuleintheRealWorld

141

260 240 220 200 180 160 140 120 100

80 60 40 20 0

Simons FER, et al. J Allergy Clin Immunol. 2001;108:1040-1044.

Tim

e (s

econ

ds)

Parents Physicians General Duty Nurses

Emergency Dept Nurses

Controls

P< .05 vs all control groups

Question9

 Patientsdonotalwayscarrytheirepinephrineauto-injectors.Isitimportantforpatientstoalwayscarrytheirauto-injector,e.g.,goingtoapartybutwillnotbeeating?Whatcouldcliniciansdotoincreasecompliance?

AnaphylaxisinAmericaSurvey:CurrentEpinephrinePractices

*Reportedreactionswerecategorizedasthoseinvolving≥1system.

**Confirmedreactionswerecategorizedasthoseinvolving≥2systemswithrespiratoryand/orcardiovascularsymptomsorthoseleadingtolossofconsciousness,evenifonlythatsinglesystemwasinvolved.

Wood, RA, et al. J Allergy Clin Immunol. 2014;133:461-7.

CurrentEpinephrinePractices Reported*(N=344)

Confirmed**(N=261)

Carrybuthaveneverused 21% 22%

Carryandhavepreviouslyused 20% 21%

Prescribedinthepastbutneverusedanddonotcurrentlycarry

7.8% 7.7%

Noneoftheabove 52% 50%

AnaphylaxisinAmericaSurvey:LocationofReaction




Locationofreaction Reported*(N=344)

Confirmed**(N=261)

Home 54% 51%

Hospital/Clinic 13% 14%

Family/Friend’sHome 6.4% 7.3%

Work 6.1% 6.1%

Restaurant 6.1% 6.1%

Outdoors 4.4% 3.1%

Traveling 3.8% 4.6%

School 2.9% 3.4%

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AnaphylaxisinAmericaSurvey:ActionPlans




ProvidedwithanAnaphylacticEmergencyActionPlan(IfPrescribedEpinephrine)

Reported*(N=344)

Confirmed**(N=261)

Yes 43% 48%

No 46% 42%

Donotknow/refusedtoanswer 12% 10%

“ShowusyourEpi”SurveyofPatientsinaPrivate

AllergyClinic

 387ptspreviouslygivenRxforEAI HadEAIatvisit:75%

 Had2dosesofEAIatvisit:49%

 Pts>18yowithEAI:79%

 Pts<18yowithEAI:70%

Dr.StanFineman'spracticesurvey

Howcanweimprovepatientcare?Action:

  Reviewuseofepinephrinewitheachvisit  Asktoseepatient’sepinephrineauto-injector  Reviewpatient’sknowledgeofauto-injectoruse  Anaphylaxisactionplanforallpatientsatrisk  Encouragefamilymemberstocometoappointments.

Question10Whatisthebestprotocolforschoolsandothercommunitysettings,whenpatientnon-specificepinephrineauto-injectorsareavailable,astoWHENtheyshouldbeusedforapatientwhodoesnothaveapreviousdiagnosisofanaphylaxis?Shouldanantihistaminebepartoftheprotocol?

CaseExample

  10yearoldmaledevelopscoughandwheezeandcollapsesontheplaygroundwhileplayingflagfootballduringrecess.Patientwithhistoryofasthmabutnohistoryofallergicreaction.Norash,nauseaorvomiting.

  TeacherrunstopatientwithanAEDandanEAI…

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SchoolStockEpinephrineLaws PublicSpaceStockEpinephrine

Laws

IllinoisDepartmentofPublicHealth

Emergency

EpinephrineActPhysicianToolkit

http://www.idph.state.il.us/pdf/

epinephrine_toolkit_8_13_12%20release.pdf

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