apsf hosts medication safety conference - anesthesia patient

NEWSLETTERThe Official Journal of the Anesthesia Patient Safety Foundation

www.apsf.org

®

Volume 25, No. 1, 1-20 Circulation 84,122 Spring 2010

See “Medication Safety,” Page 3

• Ready-to-usesyringesandinfusionsshouldhavestandardizedfullycompliantmachine–readablelabels.

Technology• Everyanesthetizinglocationshouldhaveamecha-

nismtoidentifymedicationsbeforedrawinguporadministeringthem(barcodereader)andamecha-nismtoprovidefeedback,decisionsupport,anddocumentation(automatedinformationsystem).

Pharmacy/Prefilled/Premixed• Routineprovider-preparedmedicationsshouldbe

discontinuedwheneverpossible.• Clinicalpharmacistsshouldbepartoftheperiop-

erative/operatingroomteam.• Standardizedpre-preparedmedicationkitsby

casetypeshouldbeusedwheneverpossible.

Culture• Establisha“just culture”forreportingerrors(includ-

ingnearmisses)anddiscussionoflessonslearned.• Establishacultureofeducation,understanding,and

accountabilityviaarequiredcurriculum,CME/CE,anddisseminationofdramaticstoriesintheAPSF Newsletterandeducationalvideos.

• EstablishacultureofcooperationandrecognitionofthebenefitsofSTPCwithinandbetween

OverviewOnJanuary26,2010,theAnesthesiaPatientSafety

Foundation(APSF)convenedaconsensusconferenceof100stakeholdersfrommanydifferentbackgroundstodevelopnewstrategiesfor“predictablepromptimprovement”ofmedicationsafetyintheoperatingroom. The proposed new paradigm to reducemedicationerrorscausingharmtopatientsintheoperating room is based on Standardization, Technology, Pharmacy/Prefilled/Premixed, and Culture (STPC).Thisnewparadigmgoesfarbeyondtheimportantbuttraditionalemphasisonmedicationlabelformatandtheadmonitionto“alwaysreadthelabel.”Smallgroupsessionsoneachofthe4elementsofthenewparadigm(STPC)debatedandformulatedspecificrecommendationsthatwereorganizedandprioritized by all the attendees. The resultingconsensusrecommendationsinclude:

Standardization• Highalertdrugs(suchasphenylephrineand

epinephrine)shouldbeavailableinstandardizedconcentrations/diluentspreparedbypharmacyinaready-to-use(bolusorinfusion)formthatisappropriateforbothadultandpediatricpatients.Infusionsshouldbedeliveredbyanelectronicallycontrolledsmartdevicecontainingadruglibrary.

institutions,professionalorganizations,andaccredi-tationagencies.

Itwasagreedthatanesthesiaprofessionalswilllikelysurrendersomeoftheir“independence,”adaptingtheirmedicationpreparationanddeliverypreferencesandhabitsintomorestandardizedprac-ticepatterns(involvingguidelinesandchecklists),utilizingmorestandardizedandpremixedmedica-tions(inputandsupplybypharmacyservices),andrelyingmoreontechnology.Facilitiesandtheiradministratorsthataresensitivetotheeconomicvalueofsafety(returnoninvestment)arecriticaltotheeffort,forbothmoralsupporttodotherightthingandforprovisionoffinancialsupportforchange.Practitionersintheoperatingroommaytakesomeconvincing,butcultureandpatient safetycanimproveandmedicationerrorscausingmorbidityandmortalitycanbedramaticallyreduced—justashappenedwithintraoperativemonitoringyearsago.

CONFERENCE REPORTPersistentreportsofmedicationaccidentsoccur-

ringintheoperatingroomwithresultantharmorpotentialharmtopatientspromptedtheAPSFtocon-veneaconsensusconferenceof100stakeholdersfrommanydifferentbackgroundsonJanuary26,2010,in

APSF Hosts Medication Safety ConferenceConsensus Group Defines Challenges and Opportunities for Improved Practice

by John H. Eichhorn, MD

— AN EXCERPT REPRINTED WITH THE PERMISSION OF THE ANESTHESIA PATIENT SAFETY FOUNDATION —

— AN EXCERPT REPRINTED WITH THE PERMISSION OF

THE ANESTHESIA PATIENT SAFETY FOUNDATION —

Phoenix,Arizona.Thegoaloftheconferencewastocreateactionablestatementsthatcouldresultin“pre-dictablepromptimprovement”ofmedicationsafetyintheoperatingroom.

Multiplereportsandanalysesof“syringeswaps”andincorrectsyringelabels,look-alikelabels,look-alikemedicationvialsandampoules,incorrectinjec-tionsites(intoepiduralorarterialcatheters),andinfusionpumpconfusionorprogrammingerrorshaveappearedintheAnesthesia Patient Safety Foundation Newsletterandotherjournalsinrecentyears.1-3APSFconductedits2008AnnualWorkshopon“InnovationsinMedicationSafetyintheOperatingRoom,”withthereportofthismeetingbeingpublishedintheWinter2008-09APSF Newsletter.3Otherreviewsandeditorialshaveconsidereddistinctivelabelformatformedicationcontainersandsyringes,uniformdruglabelingstandards,andamoreuniversalroleofphar-macyservices.4-7Whileallthosearerelevant,little,ifanything,haschanged.Operatingroommedicationerrorscontinuetooccur,manywithsignificantmor-bidityand/ormortality.Anesthesiaprofessionalsintheoperatingroomhaveauniqueroleandresponsi-bilityinthattheyaretheonlymedicalpersonnelwhoprescribe,secure,prepare,administer,anddocumentmedications—aprocessthatcantakeupto41steps—usuallywithinaveryshorttimeinterval.2Inadditionthesestepsoccurinrealtime,autonomously,ofteninadistractingenvironment,andtypicallywithoutstan-dardizedprotocols.

Becausepasteffortstoimprovemedicationsafetyhavenotbeenparticularlysuccessful,thepurposeofthis conference was to develop new ideas andapproaches.ReferencewasmadetothequotationpopularlyattributedtoEinsteinthatthedefinitionofinsanityisdoingthesamethingoverandoverandexpectingadifferentresult.Theconferencetitlewas“MedicationSafetyintheOperatingRoom:Time for a New Paradigm.”Thethemeofthe“newparadigm”had 4 elements: Standardization, Technology, Pharmacy/Prefilled/Premixed and Culture (STPC),representinganew4-prongedapproach to thepersistentproblemsofmedicationsafety in theoperatingroom.

Robert K. Stoelting, MD,APSFpresident,servedastheoverallmoderatorfortheintense1-dayconfer-ence.HeopenedwiththevideoBeyond Blame, pro-ducedin1997anddistributedbytheInstituteforSafeMedicationPractices.Thevideocontainsinterviewswithananesthesiologist,anICUnurse,andapharma-cist,eachofwhomwasinvolvedwithafatalmedica-tionerror.Thevideostresses,“Itcouldhappentoanyone.”Despitethepassageof13yearstheissuesinthevideoremainedhighlyrelevant in2010.Dr.Stoeltingalsonotedtheoften-citedstatisticthatthereis1significantanestheticmedicationerrorinevery133anestheticsadministeredand,ofthoseerrors,1outof250isfatal.1Thistranslatestonearly1000deathsayearintheUnitedStates.Acknowledgingthe

generalvalueofevidence-basedmedicine,hestressedthatthetraditionalapproachinvolvingmultipleran-domlycontrolledprospectiveblindedtrialssimplycannotapplytopreventingrareunpredictableadverseevents—andthatwaitingorhopingforsuchresultscanactuallybecounterproductiveforsafety.Heemphasizedthatsafety isdoing theright thingbecauseitmakessense.Dr.Stoeltingnotedthatanes-thesiasafetyhasbeenimprovedbymanysmallstepsovertheyears,thathavemadeabigdifferenceintheaggregate.

Dr.Stoeltingintroducedanovelformatconsistingof20invitedspeakersfromwidelyvaryingdisciplinesandbackgrounds(clinicalanesthesia,research[includ-inghumanfactors],surgery,operatingroomnursing,administration,pharmacy,regulators,andthepharma-ceutical/medicationdeviceindustry).Eachspeakerhada15-minutetimeslot—butallwiththesametopic:“Time for a New Paradigm: Standardization, Technology, Pharmacy, Culture.”Eachwasaskedtoaddressrelevantelementsoftheparadigmfromtheirspecialperspec-tive.Followingthese20presentationstheentireassem-blywasdividedbyinterestandexpertiseinto4smallgroupbreakoutsessions,oneforeachcomponentoftheSTPCparadigm.Theassignmenttoeachgroupwastogeneratealistofactionableitemsinorderofimpactthat,ifimplemented,wouldproduce“predictablepromptimprovement”inoperatingroommedicationsafety.Afinalcombinedsessionsetthestagefordevel-opmentofconsensusstatementsastheprimaryprod-uctoftheconference.

World Class ExpertsThekeynotespeakerwasAlan F. Merry, MBChB,

headofanesthesiologyattheUniversityofAuckland,NewZealand,formerchairofthePatientSafetyCommittee of the World Federated Societies ofAnesthesiologists,andfounderofSaferSleep,LLC,acompany thatprovides technology intended toincreaseanestheticmedicationsafety.Hecitedtherecent ly adopted “Guide l ines for the Sa feAdministrationofInjectableDrugsinAnaesthesia”fromtheAustralianandNewZealandCollegeofAnaesthetists that focus on standardization ofmedication administration as opposed to thet r a d i t i o n a l a p p ro a c h o f e a c h p r a c t i t i o n e rindependentlymakingthesedecisions.HealsonotedthattheInternationalStandardsOrganizationmostrecentpublicationregardingcontentofadhesivesyringelabelsincludestheclassofdrug(“inductionagent,”“musclerelaxant,”)aswellasthedrugnamealongwithspacetowritetheconcentrationanddateand, also, a bar code. Another component ofstandardizationisintheanesthesiaworkspace,inthathesuggestsauniformarrangementofmedications,syringes,emptydrugcontainersforeverycasebyeveryprovider.Becauseofhumannature,errorswilloccuratpointsinthedrugadministrationprocess,andDr.Merrysuggestedorientationtowardmanagingpredictableerrorsratherthanthefutileattempttoeliminateallerrors.Havingasatellitepharmacyinthe

operating roomarea isa forwardstep.Havingmedicationcontainerscomeintotheoperatingroomwithattachedpeel-offdetailedlabelsreadytogoonthesyringeisanotherrelatedstep.Applicationoftheincreasinglyeffective“checklistmentality,”especiallyifasecondpersonoradevicesuchasabar-codereaderwithspokenvoicerepetitionofthenamechecksthedrugabouttobegiven,wasemphasized.Finally,froma“culture”perspective,henotedthatanesthesiaprofessionalsmayexhibitproblemswithdenialandalsobelievetheyareallaboveaverage,butthatthesefeaturesmustbeovercomewithagenuinereportingsystemthatrecognizesandrecordserrors,enablinganalysisandsubsequentsystemmodificationtopreventrepetition.

Medication Safety Conference Develops New Strategies“Medication Safety,” From Page 1

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Donald E. Martin, MD

Systematicimprovementofthehumanperfor-mancerequiredinanestheticdrugadministrationwasthethemeofDonald E. Martin, MD,fromPennStateCollegeofMedicine.Theusualhumanfactorsassoci-atedwithaccidents,ledbyinattention(butalsofail-uresofmemory,knowledge,ormotivation),areassociatedwithdrugerrorsintheoperatingroom.Hepresentedananalysisofthe41stepsinvolvedinfirst-timeadministrationofadrugduringananestheticandnoted36wereautomaticbehaviorwithmusclememoryand5requiredconsciousattention,deci-sions,andjudgment—asetupforinattentiontothe5criticalsteps.Waystohelpdirectattentionbytheanesthesiaprofessionaltothekeypartsofdrugadministrationwerepresented,includingbothergo-nomicsoftheanesthesiaworkspace(arecurrentpointfrommanypresentations)andlargerandlouderstim-ulitotargetmultiplesenses.Dr.Martinmadeanalo-giestofunctioninthecockpitofacommercialairliner,particularlynotingthebeneficialuseofchecklistsandalsotheconceptofthe“cultureofsafety”whereindi-vidualautonomyofactionissurrenderedandthepre-scribed“standardoperatingprocedure”istheonlyacceptablebehavior.Heendedwithapleatoinvolvetheentireoperatingroomteamin theeffort toimprovemedicationsafety.

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Robert A. Caplan, MD,memberoftheAPSFExecutiveCommitteeandmedicaldirectorofQualityatVirginiaMasoninSeattle,inaparticularlypoignantpresentation,emphasizedtheimportanceofthe“cul-ture”ofmedicationlabelingbyrecountingatragicaccidentthatoccurredinhisorganizationin2004.Apatientwhowasundergoinganinterventionalradiol-ogyprocedureaccidentlyreceivedafatalinjectionofchlorhexidine(aprepsolution)insteadofcontrastdyebecausebothsolutionswereinsimilar,unlabeledcon-tainersontheproceduretable.Asaresultofthisevent,theleadershipandsafetyteamsatVirginiaMasonmadeseveralkeydiscoveriesabouttheexisting“cul-ture”ofmedicationlabeling.First,medicationlabel-ingwasregardedasdesirablebutnotmandatory.Second,thestrongestmotivationfornotlabelingwasconvenience.Andthird,itwasnotpossibletojustifynon-labelingbehaviorwithclinical,ergonomic,oreco-nomicarguments.Asaresult,VirginiaMasondevel-opedanexplicit,standardizedprocessformedicationlabeling.Theprocessisnowusedthroughouttheorganization.Dr.Caplannotedthatthiseventanditsassociatedlessonshaveacceleratedtheimplementa-tionofotherrelatedsafetystrategies.

Roots of the ProblemAdifferentaspectofthequestionwasaddressed

byMaria Magro, CRNA,whoisamemberoftheAPSFExecutiveCommitteeandprogramdirector,NurseAnesthesia,attheUniversityofPennsylvaniaSchoolofNursing.ShedescribedthenationalsurveyofCRNAtrainingprogramssheand2colleaguescon-ductedregardingformaltraininginanesthesiamedi-cation safety practices. Results revealed theimpressionthatdrugerrorsobservedorcommittedbyCRNAstudentsareunder-reportedandthatmedi-cationsafetycanbeastrongercomponentofthecur-riculum.The44%oftrainingprogramsthatdidnothaveaformalmedicationsafetymodulereportedsuchreasonsasthese:medicationsafetywasnotaproblem,incidentsatclinicalsiteswouldbehandled

there,andtheICUnursesenteringtheprogramwouldalreadyhavemedicationsafetyskills.Supportwasgeneratedthroughthesurveyprocessforanationallystandardizedcurriculumaswellasgener-oususeofsimulationtoteachsafetyskillsformedica-tionadministrationtoCRNAstudents.

withbarcodereadersaspartofelectronicanesthesiarecordsandinformationmanagementsystemswouldbecentraltoeffortstoimprovemedicationsafetyintheoperatingroom.Heconcludedwithapleaforstudiestogeneratedatatoguideimplementationandalsostimulateappropriatestandardsandregulationsthatwillgovernpractice.

AdifferenttakeonhumanfactorsengineeringwasprovidedbyJohn W. Gosbee, MD,oftheUniversityofMichiganwhopresentedanelaborate“equation”describingoperatingroommedicationerrors,inwhichtheprobabilityofconfusionwastheproductof6fac-tors:“soundalike,lookalike,locationexpectation,locationtrust,workflowexpectation,andworkflowtrust.”Heanalyzedandprovidedexamplesofeachfactorintheanesthesiaworkstationenvironmentinatypicaloperatingroom.Moreemphasiscameonthecontextofmedicationuseintheworkareathanonlabelingitself.Hesuggestedthatverysimplefactorssuchasstrictstandardizationoftheanesthesiaworkspace,especiallythelocationofstoredmedications,wouldhelpimprovesafetynowwhilemorecomplextechnologicsolutionsinvolvingbarcodes,readers,andcomputerizedrecordsaredevelopedandrigorouslytestedforefficacy.

Allied PerspectivesThepublicpolicycomponentwasprovidedby

Nancy Foster,vicepresidentforQualityandPatientSafetyPolicyfortheAmericanHospitalAssociation.Shenotedthatfacilityadministratorsarealwaysinterestedinpatientsafety,butcliniciansneedtobemoreskilledatpresentingsafetyproposals,particu-larlyinvolvingresourceallocation,asimperativesthatleadto“win-win”situations.Shesuggestedoneusefulstrategyisto“engage”administratorsbyincludingthemonqualityimprovementteamsandsafetytaskforcesandthengivethemspecificgoalsandassignmentsthatareachievable,thusreinforcingtheirstake inestablishingasafetycultureandimprovementofoutcome.Also,Ms.Fosternotedthetrendofgreaterintegrationofhealthprofessionals,physiciansinparticular,intotheinternalinstitutionalorganization,whichshouldincreasethereceptivityofadministratorstosafetyproposals.Sheconcludedwithareminderthatadministratorsaresensitivetothepublic’sperceptionoftheirfacilityandthatthepublictodayfindsfailuretoattempttoimprovepatientsafetyastotallyunacceptable.

AsurgicalperspectiveonORmedicationsafetywasofferedbyamemberof theAPSFBoardofDirectors,William P. Schecter, MD,fromUCSFandSanFranciscoGeneralHospital.Hefunctionallypro-videda“morbidityandmortalityconference”basedonoperatingroommedicationerrorshehadwit-nessedovertheyears.Attheoutset,henotedtheten-sionandcomplexinteractionbetweenhumanerrorandsystemfailureandhowthiscouldrelateto

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Maria Magro, CRNA

Experts Offer Insight into Causes of Errors

Jerry A. Cohen, MD

See “Medication Safety,” Next Page

Jerry A. Cohen, MD,firstvice-presidentoftheAmericanSocietyofAnesthesiologistsandfromtheUniversityofFlorida,statedthatfragmentationoftheapproachtomedicationsafetyproblemsisitselfasig-nificantproblem.Hemaintained,theSwiss-cheesemodelofhumanerrorandaccidentsnotwithstanding,thatattemptingtoisolaterootcausesobscurescom-plexinteractivepathways(systemfunction)thatleadtoerrors.Hecitedahostofindividualfactorsthatcancontributetomedicationerrors,particularlyfailuretostandardizetheoperatingroomenvironment,espe-ciallytheanesthesiaworkarea,whichleadstochaosanddistractionandanequallylonglistofbarrierstoimprovement,especiallyresistancetochecklists,com-municationsilos,andproductionpressure.Dr.Cohensuggestedthatwidespreadstandardizationandalsotheuseofpharmacy-preparedbarcodedmedications

Robert A. Caplan, MD

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differenttypesofmedicationerrors(wrongdrugordoseorroute,andadversereactions).HealsoappliedtheSTPCparadigmtoeachcasetodissectoutcausesthatcouldbecorrectedwiththoseelements.Inallcases,therewerebothhumanfactorsandsystemcomponentsasrootcauses.Innearlyallthecases,standardizationofpracticeandprotocolswouldhavehelpedtopreventtheerror.Theeerilyfamiliarthemeofaccidentalinjectionofatoxicsubstanceintoaninappropriateinjectionportwithcatastrophicout-comefiguredin3ofthecases.Adherencetostrictlabelingpoliciesandphysicalsegregationoftoxinswerethesuggestedremedies.

TheInstituteforSafeMedicationPractices(ISMP)wasrepresentedbyAllen J. Vaida, PharmD,itsexecutivevicepresident.TheISMPfocusisonthesystemcausesofmedicationerrorsandresultingsystemchangesthatmustbeimplementedalongwitheducationtopreventrecurringpatterns.Dr.Vaidastressedemployinganopenenvironmentofsharingerrors in terna l ly and ex terna l ly to sa fe tyorganizationsforlearning,sharing,andbringingaboutchange.Henotedrelativelypoorcompliancewithlabelingpoliciesandproceduresduringdrugadministrationandalsoshowedmanyexamplesofstriking look-alike drug vials (and noted thedisproportionatelygreatnumberof look-alikeaccidents involvingmusclerelaxants).Healsostressedthatclinicians(workingtoachieveconsensuswith pharmacists and manufacturers) need toestablishandaccepta relatively limitedsetofstandardizedconcentrationsfordrugs.Ata2008nationalconsensusconferenceon thesafetyofintravenousdrugdeliverysystems,therewasaclearpreferenceformanufacturer-preparedcompletelyready-to-useIVmedicationinallsettings,althoughincreasedcostandpotentialinapplicability(suchasforseldom-usedbutnecessarydrugsintheanesthesiaoperatingroomarmamentarium)aredrawbacksofthatapproachifstandardizationisnotagreedupon.Dr.Vaidaalsonotedaclearpreferenceforsatellitepharmaciesinoperatingroomsuitesbutnotedthatwhenthatisnotpossible,theremustbeorganizedinvolvementfrompharmacyforanesthesiaservicesintheoperatingroomtosupportmedicationsafety.

Pharmacy PracticesPhilip J. Schneider, RPh,associatedeanofthe

UniversityofArizonaCollegeofPharmacy,notedthatevidence-basedbestpracticesknowntoimprovemedicationsafety,particularlyunitdosing,havebeeninplaceformedicationadministrationinhospitalsfordecades,butthoseconceptsarenotappliedintheoperatingroom.Henotedthatallofthekeypartsofthemedicationadministrationprocess(prescribing,transcription,dispensing,andadministration—thepointsatwhichmistakesoccur)aretheresponsibility

oftheanesthesiaprofessionalintheoperatingroom,preventingthetraditionalsafetycheckspresentinothersettings.Hesuggestedthatproviding“ready-to-use”medicationsintheoperatingroomwheneverpossiblethatarepreparedbyoutsourcespecialtycompanieswhodothatexclusivelyshoulddecreasemedicationerrorsintheoperatingroom.

Patricia C. Kienle, RPh,anindustryrepresenta-tiveholdingthepositionofdirector,AccreditationandMedicationSafetyforCardinalHealth,Inc.,stressedtheneedforstandardizationofallthekeyfunctionsintheverycomplextaskofanestheticmedi-cationadministrationintheoperatingroom,illustrat-ing her point with multiple photos of actualanesthesiaworkstationswithwhatseemedlikequasi-chaotichodgepodgesofmedicationstorageandadministration.However,sheassertedthatcolor-codingofmedicationcontainersmaynotbeahelpandmayactuallybeadetrimentinsomecases.ShealsonotedtheUSPpracticestandardforsterilityof“compoundedpreparations”andsuggestedthatthetraditional100mlbagofphenylephrinemadeupfromanampoulebymanyanesthesiaprofessionalsatthestartofaworkdaydoesnotmeetthatstandard.

Andrew J. Donnelly, PharmD, director ofPharmacyattheUniversityofIllinoisMedicalCenteratChicago,emphasizedthatcostofmedicationsandassociatedpersonnelisahugeissuetodayforhealthcareinstitutionsfacingbudgetconstraints.Further,healsonotedthattheuniquemedicationuseprocessforanesthesia in theoperating roomhasminimalinvolvementofpharmacyandlacksthenormalchecksandbalances.Headvocatedforamuchmorerobustpresenceofpharmacyserviceintheoperatingroom,evenwithoutasatellitepharmacy,inordertogainthebenefitofateamapproachwiththepharma-cistfunctionallyasthe“PerioperativeMedicationSafetyOfficer”inculcatingacultureofsafety.Thiswouldinvolveallergyverification,disseminationofdruginformation,formularymanagement,facilita-tion(shortages;look-alike,sound-alike),qualityimprovementprojects,andevenresearchprojects.Dr.Donnellycitedsurveyresearchshowingthat“ready-to-use”medicationsarestronglypreferredbypracti-tioners,leadingtotheideathatcollaborationbetweenanesthesiaprofessionalsandtheirpharmacistsshouldleadtoconsensusonwhichmedicationsareprovidedinready-to-useforminthatoperatingroom.Healsofavoredstandardizationofmedicationsandconcentrations,throughoutaninstitutionandevenacrosstheentireindustry.Hecommentedonthelargenumberandquantityofmedicationsintheusualanesthesiaworkstation,suggestingthisisoftenwastefulandpotentiallydangerouslyconfusing—thepreferablealternativebeinggreaterrelianceonandinteractionwithpharmacyservice,evenifitisanautomateddispensingmachineora“smartpump”foraready-to-useinfusionmedication.

Anotheradvocateforimprovingoperatingroommedicationsafetyby“teamingupforinno-vation”withpharmacistsandmakingthemanintegralpartoftheoperatingroomteamwasBona E. Benjamin, RPh,whoisdirectorofMedication-UseQualityImprovementfortheAmericanSocietyofHealth-SystemPharmacists,anorganizationthatrecentlyheldan“IVSafetySummit.”Shecitedsev-eralstudiesshowingthecostandoutcomebenefitsofpharmacistinvolvementinmedicationadministra-tion,includingspecificallyonelarge2007studyofsurgicalpatientsshowingthosewithoutpharmacist-managedantimicrobialprophylaxishad52%higherdeathratesfromsurgicalsiteinfections,10%longerlengthofstay,and7%higherdrugcharges.Noting

Pharmacists Weigh in on Medication Error Prevention

See “Medication Safety,” Next Page

Bona E. Benjamin, RPh

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syringelabelalsohasabarcodethatisread(withvisualandaudibleconfirmation)andrecordedbytheassociatedcomputerizedanesthesiaautomatedrecord/informationmanagementsystem(AIMS).ThissyringebarcodeiseasilyintegratedwithAIMSsothatatthetimeofadministration,thebarcodeisscannedtoconfirmthedrugnameandconcentration,patientallergies,ifthesyringehasexpired,andifthesyringehasalreadybeenusedforanotherpatient.Dr.Levinedetailedhowthissystemcanalsobeinte-gratedasthesafetysystemforseamlessusewithready-to-useprefilledsyringes.Henotedthatinhisinstitutionwheresomeroomshavethetechnologyandothersdonot,practitionerswhohaveworkedwiththesystemalwaysrequesttobeassignedtoroomswiththecomputerizedsystem.Heconcludedwith thebelief that technologycombinedwithincreasedpharmacyserviceswillleadtobest(safest)operatingroommedicationpractices.

Industry PerspectiveTodd N. Jones, RN, directorofMarketing,

CentralAdmixturePharmacyService(CAPS),abusi-nessunitofB.BraunMedical,Inc.,describedtheroleofacompoundingpharmacyinenhancingoperatingroommedicationsafety.Hesuggestedthereisevi-dencethatstandardizingconcentrationsanddiluentsimprovemedicationsafety,bothingeneralandpar-ticularlywhentransferringpatientsonlife-sustaininginfusionsfromtheoperatingroomtopostoperativecare.Further,hemaintainedthatpremixedsolutionsandprefilledsyringes(whetherpurchasedfromanoutsourcedcompoundingpharmacylikeCAPSorpreparedinthefacilitypharmacy)relieveanesthesiaprofessionalsofthepreparationsteps,allowingthemtofocusmoreonthepatientintheoperatingroom.Anothersafetyissuehecommentedonwasthepotentialforwrongsite/portinjection,particularlyofdangerousmedicationsaccidentlyinjectedintoanepiduralcatheter.Thepotentialforseparatedistinctlyincompatibleconnectorstohelppreventsuchacci-dentswaspresented.

thattheoperatingroomisthemostmedication-inten-siveareaofthehospital,Ms.Benjaminsuggestedthatnowisagreatopportunitytocoordinatewhatanes-thesiaprofessionalswant(medicationsreadytouse,readilyavailable,andeasytostore,identify,adminis-ter)withwhatpharmacistswant(effectiveevidence-basedprocessesthatareefficient,safe,andcompliantwithregulatoryandaccreditationstandardsandthatpromotesafetythroughstandardization,bestprac-tices,security,andcontrol).Sheconcludedwithalistofbenefitspharmacistscanbringtoenhancemedica-tionsafetyintheoperatingroom:formularymanage-ment;developmentofevidence-basedstandardprotocols;reviewofplanned/orderedmedicationsforpotentialproblems;analysisofdrugusepatternstoidentifyopportunitiesforimprovement;participa-tioninemergenciesandmaintenanceofantidotesup-plies; support of compliance with regulatory,accreditation,andorganizationalrules;educationonmedications,safetyprograms,anderrorprevention;andateamcultureapproach.

Relevant ExamplesAnexampleofasafetyinitiativethatcouldbe

adaptedtooperatingroommedicationsafetycon-cernswasofferedbyBruce D. Spiess, MD,fromVirginiaCommonwealthUniversityandalsochairoft h e F O C U S g r o u p ( F l a w l e s s O p e r a t i v eCardiovascularUnifiedSystems)oftheSocietyofCardiovascularAnesthesiologists(SCA).SCAisengagedinacomprehensivelongitudinalprojecttostudyeveryconceivableaspectofcardiovascularanesthesiapracticeutilizingreal-timeobservationaswellasliteraturereviewtodeterminewhyerrorsoccuranddevelopbestpractices(withchecklists)emphasizingsystems,humanfactors,andtheteamapproachtopreventthoseerrors.Aparallelprojectforoperatingroommedicationsafetyimprovementwasproposedthatwouldutilizethesamedesign.

Amoredirectexamplewaspresentedby Wilton C. Levine, MD,clinicaldirector,DepartmentofAnesthesia,CriticalCareandPainMedicineattheMassachusettsGeneralHospital.Havingparticipatedinanexhaustivestudyofoperatingroommedicationpractices,hebecameoneofthedevelopersofananes-thesiamedicationmanagementsystemthatemploysasmallprinterineachanesthesiaworkstationandareaderthatidentifiesamedicationbythebarcodeonitscontainerandprintsacorrespondingfullycompli-antandwaterproofsyringelabelinrealtime(“SmartLabel”).Hesuggesteditisimpracticaltohave100%“ready-to-use”pre-filledsyringesforallmedicationsanesthesiaprofessionalsuseinallanesthetizingloca-tionsandthattheautomatedlabelprinteristheappli-cationofatechnologyinplaceofhavingasecondpersoncheckandverifyallmedicationsdrawnupandadministeredbyananesthesiaprofessional.The

Rich Kruzynski, RPh,presidentofPharMEDiumServices,LLC,outlinedtheextensivemarketresearchhiscompanyhasdoneonmedicationadministrationintheoperatingroom.Asaresult,hiscompanyoffersstandardizedsetsofanesthesiamedicationspre-sentedinastandardizedarrayintraysandcartswithcomprehensivefullycompliantlabels.EverythingisbarcodedandcompatiblewithreadersutilizingAIMS.Includedamongthebenefitshecitedforthisapproacharefullregulatorycompliance,lowercost,andthehopeforincreasedmedicationsafety.

Mary Baker, PharmD,medicalmanager,GlobalMedicalAffairsforHospira,Inc.,addressedthechal-lengesofinjectabledruglabeling.Shesuggestedthatcolor-codinghasdrawbacksandthateffortsshouldbedirectedatmakingtheinformationintheprintingmoreeffectivelycommunicatedbythelabel.Barcodingisessentialandstandardizationoflabelingpoliciesiscritical,sheemphasized.

Timothy W. Vanderveen, PharmD,vicepresi-dent,CenterforSafetyandClinicalExcellenceforCareFusionCorp.,alsostressedtheuniquechallengeoftotalmedicationmanagementbyasingleanesthe-siaprofessionalintheoperatingroomwhousuallyreliesonpersonalhabitsandexperiencetoexecutetheprocess.RemindersofthewidelypublicizedIndianadeathsfromheparindosageerrorsinnew-bornsandthestoryofanOhiopharmacistsentencedtoprisonafterthedeathofachildduetoacom-poundingerrorservedtoemphasize thegreatresponsibilityinvolvedinpreparingandadminister-ingIVmedications.Hesuggestedthatbarcodingtechnologyandautomateddrugdispensingcabinetsineachoperatingroomwouldhelporganizeandstandardizemedicationpractice,promotingmedica-tionsafety.Henotedtheaddedbenefitofsuchacom-puterizedsystemfortrackingcontrolledmedicationsandmaintainingvigilanceforanypotentialdrugdiversionbycaregivers.Anotherbeneficialtechnol-ogywithbeneficialsafetyimplicationsissmartinfu-sion pumps that decrease chances for dosecalculationerrors,smoothtransitionstoandfromtheoperatingroomforpatientsoncriticalinfusions,andthatperhapssomedayintheUnitedStateswillbeutilizedtoadministertarget-controlledinfusions.

ThefinalpodiumpresentationwasfromMark W. Vaughan,globalproductdirector,HospitalInfusion,SmithsMedicalNorthAmerica,whoadvo-catedforsmartinfusionpumpsandtechnologyuti-lizing standardized drug concentrations thatsimplifythefunctionoftheinfusionpumps(whichsoonwillbewireless).Traditionalpumpsarepronetoprogrammingerrorsthatcouldendangerpatients.Healsopromoteduniqueconnectorsthatwouldpre-ventaccidentalcrossinjectionsamongIV,epidural,andenteralinfusionlines.Withtheadmonitionthat“pharmacyisyourfriend,”heagainstressedstan-dardizationofmedicationpreparationsaskeytoimprovingORmedicationsafety.

“Medication Safety,” From Preceding Page

Industry Advises on Prevention of Medication Mistakes

See “Medication Safety,” Next Page

Figure 1. Look-alike medications; left medication is dexamethasone and right vial is glycopyrrolate.

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Small Groups, Big AssignmentsPredictably,eachofthe4groupbreakoutses-

sions:Standardization, Technology, Pharmacy/Prefilled/Premixed, and Culture,generatedintensedebate.Therewasaspecificassignmenttogenerateupto3primaryactionablerecommendationsthatcouldproduce“predictablepromptimprovement”inoperatingroommedicationsafety.Therewasalsotherequirementtobalancetheoftencontradictorycon-siderationsoftheclearlyidealtop-prioritybeneficialmeasuresvs.therealisticpracticalityofpotentialforimplementationintheshort-termfuture.Thus,the

discussionsinvolvedagreatmanyback-and-forthswingsofargumentandopinion.

TheStandardizationGroup,ledbyPatricia A. Kapur, MD,APSFExecutiveCommitteemember,consideredwhatdegreeofstandardizationwouldbeachievableforwhichcomponentsoftheoperatingroommedicationprocessandhowthatcouldbeaccomplished.TheTechnologyGroup,ledbyGeorge A. Shapiro,APSFexecutivevicepresident,eventu-allydecidedtoleavetheissueofconfigurationofmedicationcontainerstotheStandardizationGroupandfocusonhardwareandsoftwarethatcouldpre-ventdrugerrors.ThePharmacyGroup,ledbySorin J. Brull, MD,chairoftheAPSFScientificEvaluation

Committee,struggledwiththebalanceofrolesbetweentheanesthesiaprofessionalintheoperatingroominrealtimeandtherelatedsupportingpharma-cistasfarasmaximizingsafetyofmedicationproce-dures.TheCultureGroup,ledbyRobert C. Morell, MD,editoroftheAPSF Newsletter,debatedwhatwouldbethebesttargetmindsettopromoteoperat-ingroommedicationsafetyandthenhowbesttoachievethatgoal.

Consensus BuildingAfterthebreakoutsessionsthe4groupsreas-

sembledinthemainmeetingroomforthefinal

Table 1: Consensus Recommendations for Improving Medication Safety in the Operating Room

Standardization

1. Highalertdrugs(suchasphenylephrineandepinephrine)shouldbeavailableinstandardizedconcentrations/diluentspreparedbypharmacyinaready-to-use(bolusorinfusion)formthatisappropriateforbothadultandpediatricpatients.Infusionsshouldbedeliveredbyanelectronically-controlledsmartdevicecontainingadruglibrary.

2. Ready-to-usesyringesandinfusionsshouldhavestandardizedfullycompliantmachine–readablelabels.

3. Additional Ideas:a. Interdisciplinaryanduniformcurriculumformedicationadministrationsafetyto

beavailabletoalltrainingprogramsandfacilities.

b. Noconcentratedversionsofanypotentiallylethalagentsintheoperatingroom.

c. Requiredread-backinanenvironmentforextremelyhighalertdrugssuchasheparin.

d.Standardizedplacementofdrugswithinallanesthesiaworkstationsinaninstitution.

e. Convenientrequiredmethodtosaveallusedsyringesanddrugcontainersuntilcaseconcluded.

f. Standardizedinfusionlibraries/protocolsthroughoutaninstitution.

g.Standardizedroute-specificconnectorsfortubing(IV,arterial,epidural,enteral).

Technology

1. Everyanesthetizinglocationshouldhaveamechanismtoidentifymedicationsbeforedrawinguporadministeringthem(barcodereader)andamechanismtoprovidefeedback,decisionsupport,anddocumentation(automatedinformationsystem).

2.Additional Ideas:a.Technologytraininganddeviceeducationforallusers,possiblyrequiringformal

certification.

b.Improvedandstandardizeduserinterfacesoninfusionpumps.

c.Mandatorysafetychecklistsincorporatedintoalloperatingroomsystems.

Pharmacy/Prefilled/Premixed

1. Routineprovider-preparedmedicationsshouldbediscontinuedwheneverpossible.

2. Clinicalpharmacistsshouldbepartoftheperioperative/operatingroomteam.

3. Standardizedpre-preparedmedicationkitsbycasetypeshouldbeusedwheneverpossible.

4. Additional Ideas:a.Interdisciplinaryanduniformcurriculumformedication

administrationsafetyforallanesthesiaprofessionalsandpharmacists.

b.Enhancedtrainingofoperatingroompharmacistsspecificallyasperioperativeconsultants.

c.Deploymentofubiquitousautomateddispensingmachinesintheoperatingroomsuite(withcommunicationtocentralpharmacyanditsinformationmanagementsystem).

Culture

1. Establisha“just culture”forreportingerrors(includingnearmisses)anddiscussionoflessonslearned.

2. Establishacultureofeducation,understanding,andaccount-abilityviaarequiredcurriculumandCMEanddisseminationofdramaticstoriesintheAPSF Newsletterandeducationalvideos.

3. EstablishacultureofcooperationandrecognitionofthebenefitsofSTPCwithinandbetweeninstitutions,professionalorganizations,andaccreditationagencies.

“Medication Safety,” From Preceding Page

Conference Leads to Consensus Recommendations

See “Medication Safety,” Next Page

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implementationatatimebeforethosemonitorsbecameundisputeduniversalstandardsofcare.Opinionsfromparticipantsweremixedregardingapossiblesimilarapproachtoprogramsformedicationsafetyintheoperatingroom.Likewise,widelydiver-gentviewswereexpressedabouttheconceptof“sell-ing”improvedmedicationsafetystrategiesandmanagementsystemstofacilityadministratorsonthefinancialgroundsofincreasingefficiency,production,andrevenue—withpatientsafetyimprovementasalmostasidebenefit.Thatideawasopposedbysomeattendeeswhobelievedthatmedicationerrorreduc-tionandimprovedpatientsafetyaretherealgoalsthatshouldremaintheprimaryconsiderationforeveryone,administratorsincluded.Onecommenttothispointrelatedtothebeneficialimpactofstandard-izationonquality;ifaprocessisstandardized,itcanbeintegrated,itcanbetaught,anditcanbemeasuredinordertoimproveefficiencyandsafety.

Aproposalwasfloatedthatpracticeguidelinesinvolvingchecklists(analogoustotheWorldHealthOrganizationSurgical Safety Checklist)aretheclearest,mostdirectwaystoimprovemedicationsafetyintheoperatingroom.8Thisapproachallowspractitionerstoknowwhatisexpectedofthemandallowscompli-ance,and,particularly,changetobemeasuredbyanobjectivebenchmark.Further,eventhoughculturalattitudesoneducation,accountability(“justculture”),andcooperationarehardertoputintoguidelinesandthenmeasure,itwasnotedthattheU.S.AgencyforHealthcareResearchandQualityhassurveytoolstomeasuresafetyculture.

Wrap-Up and Future DirectionsDr.Stoeltingprovidedclosingremarks,which

evolvedintoadiscussionwithcontinuedlivelyaudi-enceparticipation.Onethemewastheperceivedneedtoconvinceleadersofrelevantmajornationalorganizations(professionalsocieties,industrial,regu-latory,standards,qualityimprovement,government,foundations)tobecomeinvolvedaschampionsforimprovedmedicationsafetyintheoperatingroomandasasourceofconsensustohelpachieveit.APSFwasviewedasthelogicalentitytoleadthiseffort,beginningwithdisseminationofthisreport.

Therewaswidespreadagreementthatindividualanesthesiaprofessionals,bydefinition,willpossiblyhavetosurrendersomeoftheir“independence”andwillneedtoadapttheirpersonalpreferences,styles,andhabits(regardingmedicationpreparationanddelivery)intomorestandardizedpracticepatterns(likelyinvolvingguidelines,protocols,andcheck-lists)utilizingmorestandardizedmedications(involvinginputfrompharmacyservices)withmorerelianceontechnology.Theinvolvedhealthcarefacil-itiesandtheiradministratorsarecriticaltotheeffort,forbothmoralsupporttodotherightthingandfinancialsupporttohelpmakeithappen.Itispossi-blethefront-linepractitionersintheoperatingroomwilltakesomeconvincing,butculturecanchange,

“consensusdevelopment”sessionthatwaschairedbyDr.RobertACaplan,MD.Eachgroup’sspokesper-sonpresentedthatgroup’slistofaction-itemrecom-mendationsandthenalltheattendeesvotedonsettingpriorities.Duringeachofthe4small-grouppresentations,theattendeeshad2voteseachandDr.Caplanwasrigorousinenforcingtheideathatanattendeecouldonlyvotefor2ideasonthelistfromeachbreakoutgroup,thusfacilitatingtheestablish-mentofthetoppriorityrecommendations.

Becausethecentralpremiseofthisconferencefocusedondevelopingmeasuresaboveandbeyondthebasicsofmedicationlabelformatthathavebeen discussed for years, it was nonethelessemphasizedinthefinalconsensus-developmentsessionthateveryoneinvolvedmustneverlosesightofthestartingfoundationconceptthattheremustbefullycompliantlabelingofallmedicationcontainersandsyringesusedintheoperatingroomasthenucleusofmedicationsafetyefforts(seealsothe American Society of Anesthesiologists ’“StatementontheLabelingofPharmaceuticalsforUseinAnesthesiology”).3-5However,therole,utility,andfeasibilityofcolorcodingrequiresadditionalstudyandconsensusbuilding.

Due to conceptual overlap some ideas formedicationsafety“actionitems”werecombinedortransferred.Theresultinglistoftheactionitems(practicalrecommendationsfor“predictablepromptimprovement”inoperatingroommedicationsafetyintheimmediateshort-term)ispresentedinTable1.

Intheconsensussessiontherewasagreementthatfacilityadministratorsmustbeinvolvedinallmajorsystemimprovementsandshouldbeincludedoncommitteesandtaskforcesthataddressmedicationsafetyintheoperatingroom.Itwasnotedthatadmin-istratorstendtopayparticularattentiontoregula-tionsandstandards,especiallythosefromCMSandTheJointCommission,becauseofthepotentialsub-stantialfinancialimplicationsofnon-compliance.Thus,onemajorthemewastheperceivedneedtoconvinceregulatoryandstandard-settingbodiestorecognizeandfocusonmedicationsafetyintheoper-atingroom.

Significantdebateoccurredregardingtheconceptofincentivesforengagingandimprovingmedicationsafetyintheoperatingroom.Thefactthatanesthesiaprofessionalsare“fiercelyindependent”andthusreluctanttochangetheirindividualpracticehabits(asrelatedtomedicationpreparationanddelivery)tofitastandardizedprotocolwasnoted.Aquestionaboutthepossiblevalueofindividualfinancialincentivestopractitionersevokedareferencetotheinitialpushinthemid1980sforadoptionofpulseoximetryandcapnographyforcontinuouspatientmonitoring.Variousmalpracticeinsurersgavetheirclientspre-miumdiscountsforsigningacontracttoalwaysusethemonitors,whichclearlyhelpedincreasetheir

“Medication Safety,” From Preceding Page

Breakout Sessions Develop Practical Recommendationsjustasitdidregardingintraoperativemonitoringyearsago.

Today,noanesthesiaprofessionalbeginsananes-theticwithoutcomplyingwithuniversallyacceptedapproachestointraoperativemonitoring.APSFsup-portsasimilarapproachformedicationsafetyintheoperating room that includes theparadigmofStandardization, Technology, Pharmacy/Prefilled/Premixed and Culture (STPC).Thehopeisthischangewillresultinadramaticreductioninthestill-persistentmedicationerrors,whichresultinpatientmorbidityandmortality.

John H. Eichhorn, MD, Professor of Anesthesiology at the University of Kentucky, served as the first editor of the APSFNewsletter beginning with its initial publication in March 1986. He remained as editor until 2002 and contin-ues to serve on the Editorial Board and is a consultant to the APSF Executive Committee.

References

1. Stabile M, Webster CS, Merry AF. Medicationadministrationinanesthesia:Timeforaparadigmshift.APSF Newsletter 2007;22(3):44-6.

2. MartinDE.Medicationerrorspersist:Summitaddressesintravenoussafety.APSF Newsletter2008;23(3):37-9.

3. EichhornJH.SyringeswapsinORstillharmingpatients.APSF Newsletter (Winter)2008;23(4):57-9.

4. ASTMD4267-07,Standardspecificationforlabelsforsmall-volume(100mLorless)parenteraldrugcontainers;ASTMD4774-06,Standardspecificationforuserapplieddruglabelsinanesthesiology;ASTMD6398-08,Standardpracticetoenhanceidentificationofdrugnamesonlabels.Availableatwww.astm.org.AccessedMay10,2010.

5. Anaestheticandrespiratoryequipment–user-appliedlabelsforsyringescontainingdrugsusedduringanaes-thesia–color,designandperformance.Availableatwww.iso.org.AccessedMay10,2010.

6. AmericanSocietyofAnesthesiologists.Statementonthelabelingofpharmaceuticalsforuseinanesthesiology.(lastamendedOctober21,2009).Availableathttp://www.asahq.org/publicationsAndServices/standards/38.pdf.AccessedMay10,2010.

7. HealthIndustryBusinessCommunicationsCouncil.AmericanNationalStandardsInstitute/TheHealthIndustryBarCode.ANSI/HIBC2.3-2009:Supplierlabel-ingstandard;ANSI/HIBC1.2-2006:Providerapplicationsstandard;ANSI/HIBC3.0-2008:Positiveidentificationforpatientsafety-part1:medicationdelivery;ANSI/HIBC4.02009:RFIDHIBCforproductidentification.Availableathttp://www.hibcc.org/AUTOIDUPN/standards.htm.AccessedMay10,2010.

8. TheWorldHealthOrganization.WHOLaunches“SafeSurgerySavesLives.” APSF Newsletter (Summer)2008;23(2):21-6.

Toemphasizetheurgentneedforchangesinmedicationsafetypracticebothnationallyandinternationally,pleaseseetheLettertotheEditor,page 9, "Accidental Intrathecal Injection ofTranexamicAcidforCesareanSection:AFatalMedicationError."

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