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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
See “Medication Safety,” Next Page
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.
APSF NEWSLETTER Spring 2010 Volume 25, No. 1 PAGE 3
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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
“Medication Safety,” From Preceding Page
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
APSF NEWSLETTER Spring 2010 Volume 25, No. 1 PAGE 4
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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
“Medication Safety,” From Preceding Page
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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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