Pharmacist ’s T o o l k i t forImplement ingBarcode Medicat ionAdministrat ion

ThistoolkitwasdevelopedwithgrantsupportfromOmnicell®®Incorporated

Theinformationcontainedinthistoolkitisconstantlyevolvingbecauseofongoingresearchandimprovementsintechnologyandissubjecttotheprofessionaljudgmentandinterpretationoftheinvolvedhealthcareprofessionals.TheASHPResearchandEducationFoundation(ASHPFoundation),theexpertpanel,authorsandexternalpeerreviewershavemadereasonableeffortstoensuretheaccuracyandappropriatenessoftheinformationpresented.However,anyreaderofthisinformationisadvisedthattheASHPFoundation,theexpertpanel,authorsandtheexternalreviewersarenotresponsibleforthecontinuedcurrencyoftheinformation,foranyerrorsoromissionsand/orforanyconsequencesarisingfromtheuseoftheinformationinthetoolkitinanyandallpracticesettings.AnyreaderofthisdocumentiscautionedthattheASHPFoundationmakesnorepresentation,guaranteeorwarranty,expressorimplied,astotheaccuracyandappropriatenessoftheinformationcontainedinthistoolkitandwillbearnoresponsibilityorliabilityfortheresultsorconsequencesofitsuse.

©2016ASHPFOUNDATION

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TableofContents

TableofContents1-Contributors ...................................................................................................................................5

2-AboutthisToolkit ............................................................................................................................5

3-Introduction ...................................................................................................................................6

4-Glossary .........................................................................................................................................7

5-TechnicalBackground......................................................................................................................8

5.1 UnderstandingBarcodes................................................................................................................................................8

5.1.1Barcodes–ATechnicalReview...................................................................................................................................8

5.1.2MisconceptionsaboutManufacturers’BarcodesandNDCs .....................................................................11

5.1.3BarcodingTipsforthePharmacy ............................................................................................................................. 12

5.2 SystemArchitecture..................................................................................................................................................... 12

5.2.1Integratedvs.Interfaced............................................................................................................................................. 12

5.2.2SystemServers.............................................................................................................................................................. 13

5.2.3ComputerWorkStationsandHandheldDevices.................................................................................................13

5.2.4Printers............................................................................................................................................................................ 14

5.2.5Scanners[4]....................................................................................................................................................................... 14

5.2.6ReplacementBatteriesandChargers...................................................................................................................... 14

5.2.7EquipmentTrackingandAccountability ................................................................................................................. 14

5.3 DataRequirementsforaBCMASystem................................................................................................................. 14

5.3.1DataFlowingfromaPharmacySystemtoaBCMASystem............................................................................. 15

5.3.2SystemandInterfaceTesting.....................................................................................................................................16

5.3.3IntegrationofaBCMASystemwithInfusionPumps........................................................................................... 16

6-PlanningforaBarcodeMedicationAdministrationSystem[5] .....................................................17

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6.1 RecommendedReading............................................................................................................................................. 17

6.2 CreatingaCultureforPatientSafetyandAwareness.......................................................................................... 18

6.3 AssessingExistingMedicationUseProcesses........................................................................................................ 18

6.4 FormingMultidisciplinaryProjectTeams................................................................................................................ 18

6.4.1AssessmentTeam........................................................................................................................................................ 18

6.4.2OversightTeam............................................................................................................................................................. 19

6.4.3ActionTeams.................................................................................................................................................................19

6.5 PreandPost-ImplementationDataCollection......................................................................................................21

6.6 PharmacyConsiderations........................................................................................................................................... 22

6.6.1Manufacturers’Barcodes........................................................................................................................................... 22

6.6.2OutsourcedUnitDosePackaging............................................................................................................................. 22

6.6.3PharmacyOn-siteUnitDosePackagingandBarcoding...................................................................................... 23

6.6.4SpaceConsiderations................................................................................................................................................... 29

6.6.5StaffingConsiderations................................................................................................................................................ 29

6.6.6QualityControl............................................................................................................................................................... 30

6.6.7MedicationDatabaseManagement..................................................................................................................... 30

6.6.8RevisingOrderEntryProcedures.............................................................................................................................. 32

6.6.9DownTimeProcedures.............................................................................................................................................. 33

6.6.10 PharmacyStaffTraining..................................................................................................................................33

6.6.11 SystemEvaluation(POST-Implementation).............................................................................................. 34

6.6.12 RegulatoryConsiderations............................................................................................................................. 35

6.7 NursingConsiderations[11],[12],[13] ................................................................................................................................ 35

6.7.1NursingWorkflow........................................................................................................................................................ 35

6.7.2BarcodingthePatient .................................................................................................................................................. 36

6.7.3NurseStaffing.................................................................................................................................................................36

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6.7.4NurseTraining................................................................................................................................................................ 37

6.7.5Go-LiveandOngoingSupport ...................................................................................................................................37

6.7.6SpaceConsiderationsforNursing............................................................................................................................. 38

6.7.7ElectronicCharting........................................................................................................................................................ 38

6.7.8MedicationsAdministeredbyNon-NursingPersonnel....................................................................................... 39

6.7.9InfectionControl............................................................................................................................................................ 40

6.7.10 SpecialtyNursingAreasandOtherSpecialSituations............................................................................. 40

6.7.11 ManagementofHardwareDevices............................................................................................................ 41

6.7.12 PrivacyandHIPAA............................................................................................................................................ 41

6.7.13 OccupationalHazards.....................................................................................................................................42

6.7.14 NursingDownTimeProcedures.................................................................................................................. 42

7.1 TheDevelopmentPhase ............................................................................................................................................ 42

7.2 TheRoll-Out...................................................................................................................................................................43

8-SpecialConsiderations ................................................................................................................43

8.1 DataAnalysis[15].............................................................................................................................................................. 43

8.1.1ImportanceofDataManagement........................................................................................................................... 43

8.1.2DataCollection............................................................................................................................................................... 44

8.1.3DataInterpretation....................................................................................................................................................... 44

8.1.4Reporting........................................................................................................................................................................ 44

8.1.5Data-DrivenProcessImprovement.......................................................................................................................... 44

8.2 GeneralDownTimeProcedures............................................................................................................................... 44

8.3 UniqueHospitalCharacteristics.................................................................................................................................45

9-References...................................................................................................................................46

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1-ContributorsTheASHPFoundationthanksthemembersoftheBCMAExpertPanelandallcontributorsfortheirsupportofthisimportantproject.Clickheretoseeacompletelistofpanelmembers.TheASHPFoundationgratefullyacknowledgesthefollowingforcontributionstothisproject:

SpecialthankstoWasp®BarCodeTechnologies,1400TenthStreet,Plano,TX75074www.waspbarcode.comforprovidingthecomplimentarycopyofWaspBarcodeFontWareusedtocreatetheexamplelinearbarcodesforthisproject.[1]Two-dimensionalandGS1Databarexamplesforthisprojectwerecreatedusingthefreedownloadable

demoversionofBartender®7.1bySeagullScientific,Inc.,1616148thAve.SE,Bellevue,WA98007-6848www.seagullscientific.com.[2]

2-AboutthisToolkitThisisthesecondtoolkitaboutbarcodingdevelopedbytheAmericanSocietyofHealth-System

Pharmacists®ResearchandEducationFoundation.BothweremadepossiblebygrantsfromOmnicell®.Tobegindevelopmentofthefirsttoolkit[3],inAugust2003,theFoundationassembledapanelofexpertsontheapplicationofbarcodingtopreventmedicationerrors.Thatpanelestablishedaninitialframeworkforthefirstdocumentandservedasreviewers.Asecondpanelofexpertswasconvenedin2013toreviewandupdatethedocument,resultinginthissecondtoolkit.Theobjectiveofthistoolkitistoprovideinformationabouttheplanningandimplementationofaverificationsystemformedicationslabeledwithmachinereadablecoding.TheFoundationrecognizesthatbarcoding–althoughcurrentlyseemingtobeastandardapproachformachinereadablecoding–isonlyonetypeofmachinereadabletechnology.Othertypesoftechnologies,includingsmartchipsandradiofrequencytechnologiesexistnow(ormayevolve)duringthepracticallifeofthisdocument.However,tomakethistoolkiteasiertounderstand,theterm“barcode”isusedthroughouttoberepresentativeofmachinereadablemedium.Itishopedthatthereaderofthistoolkitwill:1.Gainorstrengthenageneralunderstandingofmachinereadabletechnologyforuseinabarcode

medicationadministration(BCMA)system.2.BebetterpreparedtoplanandimplementaBCMAsystem.

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3-IntroductionHospitalandotherhealth-systempharmacistsandnurseshavelongappliedautomatedsystemstoresolvecommon problems inherent in medication use processes. Unit dose dispensing and the need toindividually package unit doses of medication stimulated the development of countertop packagingmachines. Inefficiencies and inaccuracies in manual controlled substances processes led to thedevelopmentofautomatedward-basedvendingcabinets.Thelaborintensityof(andthepotentialforerrorsin) unit dose cart filling, fueled the development of robotic cart filling systems. Pharmacy informationsystemscomputerizedpatients’medicationprofileslongbeforesuchautomateddevicesevolved,whichlaterallowedautomatedmedicationprofileinformationinterfacestoimprovethesafetyofmedicationuse.As medication use technologies matured, each became more robust in its capabilities, providingopportunitiesforautomatingmoreaspectsofmedicationuseprocess.Computerizedpatientprofilesledtocomputerized clinical screening tools for pharmacists and to electronically generated medication dosescheduling and medication administration records (eMARs) for nursing. Ward-based vending cabinetsbecameinterfacedwithcomputerizedpharmacysystemsandenabledremotetriggeringbypharmacistsaftermedicationorderreviews.Thisledsometoadoptsuchcabinetsasareplacementforcartdeliveryasaprimarymethodfordistributingmedications.Roboticsystemsbecamefasterandaddressedprocessessuchasmedicationpackagingandsterilesyringefilling.Whenproperlyappliedandmanaged,thesetoolscanbeefficientandhighlyaccurate.Hence, implementing automated systems applied to medication use processes in hospitals is not new.Therefore, itmight seem that implementing aBCMA systemwouldbemuch like the implementationofroboticsorautomatedvendingcabinets. ThecontributorstothistoolkiturgedthatBCMAsystemsnotbeapproachedwith thatmindset. There aremanymore challenges inherent in successfully implementing aBCMAsystem.Inaddition,unlikeimplementationsofsomeautomatedsystemsthataremanagedby(orco-managedwith) vendors’ field representatives,BCMA systems require full ownershipand intense (andsustained) engagement by both pharmacy and nursing. Contributors to this toolkit - practitionersexperiencedwithbarcodedmedicationuseandpharmacyautomationingeneral–compiledthethoughts,considerations,andrecommendationsinthistoolkitbasedonreal-lifeexperience.

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4-Glossary

Term Definition

5-Rs Termusedtodescribethefiverightsofmedicationadministration.Determiningtheserightspriortotheadministrationisagoalofthemedicationprocess:rightpatient,rightmedication,rightdose,rightroute,andrighttime…

Barcode Aprintedsymbolmadeupofblackandwhitelinesorbarsarrangedinaspecificpattern;themostcommontypeofmachinereadablecodethatprovidesamethodfordatainputintoanautomatedsystem.

Checkdigit Adigitattheendofthedatastringinabarcodethatiscalculatedbasedontheother characters in the data string. The check digit is a technical way ofensuringagainstmisreadingbyascanningdevice.

CPOE ComputerizedProviderOrderEntryorComputerizedProviderOrderManagementisasystemwhereprovidersenterpatientcareorderselectronically,typicallyforhospitalizedpatients.

EHR AnElectronicHealthRecordorElectronicMedicalRecordisasystematiccomputerizedrecordformanagementofapatient’smedicalinformationandinstructionsforcare.EHRsmayincludearangeofdata,includingdemographics,medicalhistory,medicationandallergies,immunizationstatus,laboratorytestresults,radiologyimages,vitalsigns,personalstatisticslikeageandweight,andbillinginformation.

eMAR Anelectronicmedicationadministrationrecordusedtodocumenttheadministrationoforderedmedications,usuallybynursing.TheeMARisonecomponentoftheElectronicHealthRecord(EHR)

BCMA Barcodemedicationadministrationsystem,aprocessutilizingbarcodescanningtoinsurethe5-RsofmedicationadministrationandfacilitatethedocumentationofadministrationintheeMARsystem.

NDC TheNationalDrugCodeidentificationnumberassignedtoaspecificcompany,product,andpackagesizebytheU.S.FoodandDrugAdministration(FDA).

PharmacyModule

Apharmacymoduleisanintegratedsystemfortrackingandmanagingpatientmedicationrelatedorders.ItistypicallyamodulethatisintegratedwithinanEHR.

Symbology Anytypeofmachinereadablesymbol,suchasabarcode,usedtocommunicatedatatoanautomatedsystem.

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5-TechnicalBackground5.1 UnderstandingBarcodesThis section isabasic reviewofbarcodes. Othersymbologies,aswellasalternativemachine readabletechnologies,arecertaintoevolveforusewithmedicationpackages.Inthissection,barcodingisreviewedinsomedetailasanexampleofthemostcommonmachinereadableform.5.1.1 Barcodes–ATechnicalReview

Barcodesare themostwidely recognizedmachine readablemediums. There are numerous types andformats of barcodes, but each does the same thing. It represents a series of characters, includingnumbers,letters,andspecialcharacters.Together,thecharactersrepresentinformationtobeconveyedtoanelectronicsystem,whenthebarcodeisread.Forexample,thedatastoredinamedicationbarcodewill contain a unique number such as an NDC number to identify a manufactured medication, or ahospital-specificcodetorepresentasingledosepackagedbythepharmacy.Barcodescanningissimplyafast,highlyaccuratemethodofinputtingandcapturingdata.A barcode ismadeupofa seriesofblackandwhite spaces. Whendescribing a linear barcode, everycharacterisrepresentedbyadifferentpatternofbarsandspaces.Whenascannerbeamisprojectedontoabarcode,theblackbarsabsorblight,andthewhitebarsreflectit. Thereflectedlightiscapturedbyaphotosensitivedetectorinthescannerwhichthendecodesthearrayofbarsandspaces,turningthemintoanelectronicsignal,whichitsendstoacomputer.Asoftwareapplicationrunninginthesystemlooksupthedata inadatabaseand finds relatedstored informationabout the scannedproduct - in this case amedicationproduct.Thefoundinformationthencanbeusedbythesoftwareprogramtoperformtasks,suchastoverifyanddocumentwhetherthescannedmedicationmatchestheoneprescribedandwhetherthedoseanddosageformmatchwhatwas intended. Interfacedwithan informationsystemthat includesdataaboutapatient’smedicationallergies, it can check todeterminewhether the scannedmedicationmaybeaknownallergicorcontraindicatedmedication.Itcantriggernotificationstocaregiversaboutappropriatewaystoadministerthemedication.Certaintypesofbarcodesinclude“startandstopcharacters”toindicatethebeginningandendofthedatastring.Forexample,aCode39barcodemustbeginandendwithanasterisk(*)characterinordertobeproperlyreadbyascanner.Althoughstartandstopcharactersareincludedinthesebarcodes,theyarenotconsideredpartofthedatawhenthebarcodeisread.

Tip:Ifabarcodelabelprintedonsiteforapplicationtoadosecannotbereadwithascanner,itmaybebecauserequiredstartandstopcharacterswereomitted.

Therearenewertypesofbarcodesthatofferadvantages,suchassmallersizeandmoredatacapacity.However,sometypesofbarcodesthatweredevelopedmanyyearsagoarestillcommonlyused. Therearethreegeneralcategoriesofbarcodesymbologiescommonlyseenonmedications:1.Linear(1-D)2.Two-dimensional(2-D)Matrix3.GS1DataBar,formerlyCompositeReducedSpaceSymbologyBarcodedensityreferstothenumberofcharactersperinchthatabarcodecanrepresent. Withcertain

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typesofbarcodes,acheckdigitisanaddedcharacterattheendofthebarcodethatiscalculatedbasedontheothercharactersusingadefinedmathematicalrule. It isusedbythescannertoensureanaccuratescan.Barcodesthatcanbescannedeitherlefttorightorrighttoleftareconsideredbi-directional.Othersareomni-directionalandcanbescannedfromanyangleanddirection.5.1.1.1Linear(1-D)BarcodesThere are several types of linear barcode symbologies, but only some are used by medicationmanufacturers or are appropriate for use in pharmacy packaging. Currently,most of the barcodes onmanufacturedmedications are linear barcodes, but other types of barcodesmay be required tomeetexpandeddocumentationrequirementsbasedonevolvingregulations.Formatsforlinearbarcodesaredefinedbystandard-settingorganizationssuchasGS1USandtheHealthIndustryBusinessCommunicationsCouncil(HIBCC).Linearbarcodesymbologieslooksosimilarthatitisdifficulttotellonetypeofsymbologyfromanotheronvisualexamination.Currently,alinearbarcodeisagoodchoice forpharmacy-basedpackagingandlabeling, ifaBCMAsystemunderconsiderationsupportstheidentificationofaproductbasedonNDC,ahospital-specificcode,orsomeotheruniqueidentifier.2-Dbarcodesmaybebeneficialforpharmacypreparedproducts,butitwilldependuponthecapabilityofthescannersutilized.Twokeyfactorsindecidingwhichtypeoflinearbarcodetouseare(a)characterlengthandthemaximumdensity (which determine label space required) and (b) character types supported– alpha, numeric, orboth. Theseare importantbecause thebarcodesusedmustbe small inorder to fit onto limitedspace,especiallywithunitdosemedicationpackages.Thefollowingtablecomparesthesizesoftypesofbarcodesusingdifferentidentifiersthatmightbedesiredforon-sitebarcodelabelinginthepharmacy.

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LinearBarcodeType

10-DigitNDC*

6-digitbillingcode(numeric)

6-digitmnemonic(alpha/numeric)

Code 0573-2620-48 635412 AVT10TCode39

Code128C/A

(Code128C)

(Code128C)

(Code128A–allowsalpha)

Code93

Interleave2of5

(Evennumberofdigitsrequired)

(Evennumberofdigitsrequired)

Doesnotallowalpha

characters

Codabar

Doesnotallowalphacharacters

(+-/.$:areok)EAN–13

Musthave12-13numericcharactersandprefix=3

Doesnotallowalpha

characters

UPC-A

Musthave10-12numericcharactersandprefix=3

Doesnotallowalpha

characters

*EncodedhereistheactualNDCforAlavert™OrallyDisintegratingTablet10mg.

Someunitdosepackagingdevicesallowthepharmacisttochoosethetypeoflinearbarcodetobeused.Optionsmaybelimitedtobarcodesthatwillfitonpackagesforwhichthedeviceisdesigned.Fortunately,today’sbarcodescannersreadmultiplelinearbarcodeformats.Therefore,itlikelywillbepossibletomixbarcodetypes forvarious labelingapplications inorder toobtainthe smallestusable labels. Scanningallinventoryproductswilldemonstratemedicationsandpackagesthatcouldbeproblematicatthepointofcare.Asrequirementsanddateelementsforabarcodehaveexpanded,theutilityofalinearbarcodeisoftenlimiting.Alinearbarcodemightbecometoolargeformedicationpackagesandpotentiallytoolargetoscan.5.1.1.2GS1DatabarsReduced Space Symbology (RSS) was developed for storing more data in a small barcode. Since itsdevelopment,thenamehasformallybeenchangedtoGS1DataBar. AGS1DataBarcodecanbeaverysmalllinearbarcodecontainingonlyanNDCnumber,orastackedcombinationoflinearand2DbarcodescontainingtheNDC,lotnumber,andexpirationdate,andevenmore.ThefollowingtableshowsafewofthekeytypesofGS1DataBarsymbolsanddescribestheirdatacapacitywhenusedformedications.

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NDC: 0573-2620-48 Exp. Date: 12/31/00 Lot: A123B456C789 Encoded as: (01)057326204

BarcodeType 10-DigitNDC LotNumber ExpirationDate

Code 0573-2620-48 A123B456C789 12/31/00DataBarexpanded

√

-

-

DataBarStacked

√

√

√

DataBarStacked

OmniDirectional

√

√

√

5.1.1.32-DMatrixBarcodesIncaseswhereitisdesirabletohaveabarcodewithalargecharactercapacity,a2-Dmatrixbarcodemaybe appropriate. Data Matrix barcodes typically provide a small symbol and therefore may be moresuitableforsomemedications. Ratherthanusingarowstructure,thissymbologyspiralsoutwardfromthecenterofthesymbolandusessquaresordotsratherthanbars.Typicallyseenassquares,DataMatrixbarcodesalsocanbeusedinarectangularformat.ThefollowingisanexampleofaDataMatrixbarcodeusedtoencodeanNDC,lotnumber,andexpirationdate.

DataMatrixBarcode

8(17)001231(10)A123B456C789

5.1.2MisconceptionsaboutManufacturers’BarcodesandNDCsSomecommonmisconceptionsexistrelatedtotheuseofbarcodesonmanufacturedmedications.Misconception #1: The medication database of a BCMA system must contain a barcode symbol thatmatches the barcode symbol on the product. In fact, no symbols are stored in the BCMA database.Instead,itstoresonlythebarcodedata–thestringofcharactersthatthesymbolrepresents–ScanCode.The scanner reads the barcode and, as explained above, converts the symbol into data; then theassociatedsoftwareprogramlooksforthedata,notthesymbol,inthedatabase.

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Misconception#2:Thedatainamanufacturer’smedicationbarcodeisalwaystheproductNDCnumber.FDAregulationsstipulatethatcertainhumandrugandbiologicalproductlabelsmusthavealinearbarcodethatencodes,ataminimum,theproduct’sNDCnumber.Thereareafewexceptionstotherule,however.Forexample,someover-thecounterproductsthatarenotcommonlyusedinhospitalsareexemptfromtherule.Manufacturersmaychoosetoencodelotnumbers,expirationdates,otherinformation,oranycombinationofinformationinadditiontoNDCsaslongastheNDCinformationiscontainedinalinearbarcode.Misconception#3:Thebarcodeontheoutermanufacturer’spackagingisthesameasthebarcodeontheunitofusepackaging.ThelastsegmentoftheNDCisapackageidentifier.Thelabelingandbarcodeontheouterpackageisforallofthedosesinapackage(e.g.,25vials,100unitdoses),whereasthelabelandbarcode on the individual contents represents the smaller packages. Therefore, they use differentcharacterstoidentifyeach-changingthelast2digitsoftheNDC.Thisbecomesimportantwhencheckingtodeterminewhetheraparticularbarcode is readableorapplicablewithinaBCMAsystem. StoringbothbarcodeswithintheBCMAsystemwillallowforagreaterchanceofasuccessfulscanatthepointofcareorduringpharmacyinventoryactivities.5.1.3 BarcodingTipsforthePharmacy

InsettingupaBCMAsystem,thepharmacistwillhavetodecidewhatproductidentifierwillbeembeddedinthebarcodeforon-site-packagedmedicationsandanyothermanuallybarcodedproducts,suchassmallinjectables and multi-dose items. For example, such pharmacy-applied barcodes might contain theproduct NDC (from the original container), the hospital’s medication identification (sometimes amnemonic),orabillingcode.Thefollowingshouldbekeptinmind.• ItisessentialtoknowthebarcodehandlingcapabilityoftheBCMAsystem(includingthescannersused)

andtoconstructcodesthatarecompatible.• Withcertaintypesofbarcodes,mixingalphaandnumericcharactersincreasesthesizeofthebarcode.

Ashortnumericdatastringworkswell.• Itiswisetotrydifferenttypesofbarcodes.• The size of the barcode compared to available label spacemust be considered. Samples of labels

should be printed, applied to actual medication packages, and scanned tomake certain theyworkquicklyandaccuratelywithoutthenecessityofmultiplescanningattempts.

• The barcode label must fit onto the unit dose or unit of use packaging that will be dispensed andhandledbycaregiversadministeringthemedication.

5.2 SystemArchitecture5.2.1 Integratedvs.Interfaced

A hospital information system may include integrated modules that provide medication-relatedfunctionality, for example computerized prescriber order entry (CPOE), order entry into a pharmacysystem,pharmacyorderapprovalandprofiling,anelectronicmedicationadministrationrecord(eMAR),aBCMA system, and an electronicmedical record (EMR). Another architecturemodel is for a separateBCMAsysteminterfacedwithahospital’sexistingeMARorwithitsowneMARapplication.Interfaced systems typically use Health Level Seven (HL7) standard messages to communicate dataamongsystemsforadmission-discharge-transfers(ADT),CPOE,pharmacyorders,andtheBCMAprocess.

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An integrated approach involves using application programming interfaces (APIs) to input and extractdataamongsystems.Some interface service vendorsuse screen “scraping”or keystrokeemulation toobtaindata fromonesystemand input intoanother. Forexample,CPOEorpharmacyorder information canbe taken fromscreensinaPharmacysystem,convertedtoaHL7message,andtransmittedtoaseparateBCMAsystem.Inturn,theBCMAsystemcansendmedicationadministrationinformationviaHL7toaninterfaceservicevendor that then emulates a caregiver’s keystrokes and mouse clicks to input data into anEMR/EHR/eMAR.Suchinterfacesarecommonlyusedfornon-medicationinterfacesinhospitalsandcanbe very effective for BCMA system interfaces as well. However, changes to the screens or otherrequirementsofsystemscanthencauseaneedtomakechangestoandretesttheinterfaces.Whencomparingintegratedandinterfacedapproaches,aBCMAprojectteammustconsidertheoverallprosandconswhilekeepingafocusonmedicationusesafety.Forexample,employingaBCMAsystemprovidedbythesamevendorthatsuppliesthehospital’sEMRtypicallymeansthatonlyonemedicationformularydatabasehastobemaintainedtosupportallmedicationusemodules.UsingaseparateBCMAsystem may require maintenance of a separate or duplicate formulary database. The project teamshould weigh issues such as a potential impact on pharmacy workflow along with potential safetybenefits,caregiverworkflowandrelatedbenefits,andpotentialbroaderapplicationsofaseparateBCMAsystemthatmayhaveitsownintegratedEMRandeMAR.Currently,mostinstitutionshaveimplementedan integrated BCMA system, so a stand-alone system is less common. Formulary database interfacesusingHL7messages,specificallyvia“masterfilenotification”orvendors’APIs,alsomaybeavailableifthevendorsinvolvedarewillingtoworktogethertomeetthehospital’spatientsafetyandworkflowgoals.Whether interfaced or integrated approaches are used, the flow of data throughout a hospital’sinformation systems can be very complex. At the beginning of a BCMA project, a thorough diagramshowingmessageandinformationflowcanbehelpfultoensurethatallonthehospital’sBCMAteam,aswell as the vendors involved, have a clear and consistent understanding of necessary informationexchanges.5.2.2 SystemServers

ABCMAsystemmayresidewithinthesamecomputerserversasahospital’sotherinformationsystems,or itmay require its own servers. Either way, additional separate serversmay be required, or spacewithinsharedserversmaybesetupasvirtualmachines(virtualservers).ThisaspectofaBCMAprojectismanaged by the hospital’s information systems staff, which will determine server specifications inconsultationwithanyinvolvedvendors.However,pharmacyandnursingshouldknowwhetherthereisabackupserverthatwillkickinifthemainservergoesdown,howandwhentheliveserverwillbebackedup,whetherthere isamirrored liveservertokick in if themainserver fails,andwhethertherewillbeadditionalserversforongoingtestingofupdatesandongoingusertraining.5.2.3 ComputerWorkStationsandHandheldDevices

A BCMA systemmay require the use of portable or stationary computers for nursing areas aswell aspharmacy. If the hospital provides this hardware, the vendor should provide hardware specificationsincluding operating system, processor type and speed, memory and hard disk requirements, and anyother computer parameters required by the system. In some cases, computers already in place (e.g.,mobile workstations running the hospital’s eMAR system) may be suitable for running BCMA system

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applications.Computerworkstationsoftenaremountedonrollingcartsorstandslocatedateachpatient’sbedsideorusedjustoutsideapatient’sroom.ThelayoutofthefacilityandmedicationprocessworkflowsshouldbeconsideredwhendecidingthelocationsforBCMAsystemcomputerworkstations.SomeBCMAsystemsmayenablemoreportability for caregiversbyusinghandhelddevices rather than stationary computerwork stations. Handhelddevices requirea location for rechargingbays ineachdepartment. Whetherusing computer work stations or charging bays for handheld, these devices used for a BCMA systemshould be plugged into emergency power outlets. The use of wireless scanners (WIFI or Bluetoothenabled) shouldbeevaluated inall areaswhere scanningwill beutilized toensure connectivity to theBCMAsystem.Theuseoftetheredscannersmaybedesirableinareaswherethewirelessconnectivityissuboptimal. Trialingdifferentdevices in ICUs, clinics, andgeneralwardswill allow for amixof devicesthatwillmeettheworkflowneedsofthecareproviders.5.2.4 Printers

Printers,mostlikelyresidingonthehospital’sinformationsystems,willhavetobeaccessibletoaBCMAsystemforprintingmedicationworksheetsandmedicationadministrationdocumentsfornursingwhenneeded,suchasduringdowntimesorwhentransferringapatienttoapatientunitthatisnotyetusingtheBCMAsystem.Thevendorshouldprovideprinterspecifications;existingprintersmaybeadequate.5.2.5 Scanners[4]

There aremany types and categories of barcode scanners. Themost commonare laser scanners andimage scanners. There is plenty of technical information on the Internet about how these types ofscanners work. Due to the variety of barcode symbologies used formedications, pharmacists shouldmakesurethatscannersusedarecapableofreadingmanydifferentbarcodetypes.5.2.6 ReplacementBatteriesandChargers

Batteriesandchargers forhandhelddevicescanaddsignificantcost toaBCMAsystemandtoongoingsystem maintenance. The specifications, estimated life, sources, and cost for replacement batteries,whetherdisposableorrechargeable,andthesameparametersforchargersshouldbeprovidedinwritingbyaBCMAsystemvendor.5.2.7 EquipmentTrackingandAccountability

Some components of a BCMA system, such as Bluetooth® or tethered scanners andmobile handhelddevices,mayhavevalue forpersonaluseoutsideof thehospital. Lossof thesedevicescould result insignificant replacement costs. During BCMA systemplanning, the hospital should consider how itwilltrackequipmentandmanageaccountabilityformissingcomponents.5.3 DataRequirementsforaBCMASystemInorderforaBCMAsystemtoensurethe5-Rsforallmedicationtherapy,itmust,atminimum,includedatasetsfor(a)patientadmissions,discharges,andtransfers,(b)allergyinformation,and(c)ordersformedications and intravenous fluids (IVs). Enhanced functionalitymay be enabled if other information(suchasclinical laboratoryordersandresults) isshared. IfaBCMAsystemis interfacedtoahospital’s

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overallelectronicmedicalrecord(EMR)system,additionalworkmayberequiredfortheBCMAsystemtoaccessdesireddata.5.3.1 DataFlowingfromaPharmacySystemtoaBCMASystem

5.3.1.1PatientAdmissions,Discharges,andTransfersABCMAsystemwillrequirepatientadmission,discharge,andtransfer(ADT)informationinordertotrackcurrentpatientsandtheirreal-timebedlocations.Ifaninterfaceisinvolved,thismaybesimpleandeasytoestablishbecause it shouldbe identical toADT interfacesalreadyused in thehospital’s informationsystems. ADT information typically will come through an EMR system but in some cases may comedirectlyfromaseparatehospitaladmissionssystem.5.3.1.2PatientAllergyInformationCheckingforallergieselectronicallythroughaBCMAsystematthebedsideisasignificantpatientsafetyenhancementoveramanualallergycheckingprocess.Electronicallergycheckingisperformedbasedonmedicationandallergycodesestablishedbymedicationdatabasevendors.Althoughthisisimportant,itoftenrequiresfurtherbuildandcustomizationontheorganization’ssidetoenablethepointofcareallergychecking.Considerationsformedicationsadministeredpriortopharmacistverificationwillneedtobemanuallycheckedforallergies.TheuseoffreetextallergieswithintheEMR/EHRshouldbeavoidedandonlycodedallergiesshouldbeutilized.

5.3.1.3OrdersforMedicationsandIntravenousFluidsTherecanbeconfusionamongthestaffofpharmacy,informationsystems,nursing,andsystemvendorsregardingwhatcomprisesa“medicationorder”vs.an“IVorder.”Although,pharmacologically,allIVs(ofany volume) aremedications, this toolkit recommends using the term “IVs” to describe large-volumeintravenous solutions administered based on a rate of infusion and duration, and using the term“medications” for all other items (including injections) orderedbasedon dose and schedule (includingsupplemental IVmedications (less than 100ml) such as IV piggybacks). Therefore, to avoid confusionwhensettingupautomatedsystemsandinterfaces,piggybacksshouldbeclassifiedas“medications”andnotas“IVs.”OrderentryprocessesinCPOEandpharmacysystemscommonlyapproachthisissueinthatway.ABCMAsystemmustreceiveallpatientmedicationandIVordersfromapharmacyorCPOEsystem.Thisincludesneworders,ordermodifications(e.g.,infusionratechanges),cancellations,anddiscontinuationsforallorders.Futurecapabilitiesofautoprogramminginfusiondevicesandutilizingbarcodetechnologiesforpump,medication,andpatientassociationwillbecomemoreimportantashospitalsadoptthisclosedloopintegrationoftechnologies.5.3.1.4ClinicalLaboratoryResultsOneofthegoalsofaBCMAsystemistoprovideinformationtothenurseatthepointofcare.Obviously,havingaccess toclinical laboratory resultsandapplying recent results toguideappropriatemedicationuseatthetimeofadministrationhassignificantvalue.However,itmaybedesirabletoapproachaBCMAprojectinphases,withmedicationandIVverificationofthe5-Rsalongwithallergycheckingcomprisinga

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firstphase.Additionalclinicalfeaturessuchasincorporatingclinicallaboratoryresultscouldbeadoptedlater.Inputfromthelabisimportantonselectingdevicesiftheuseofbarcodescanningforspecimensisbeing considered. Capturing glucose test values prior to insulin administration is often requireddocumentationonthepatient’seMAR,sotheprocesswillneedtofitthenurse’sworkflow.5.3.1.5MedicationAdministrationDocumentationA BCMA system is designed to domore than just scanmedications to ensure the 5-Rs at thepoint ofadministration.ThesystemisdesignedtorecordmedicationandIVadministrationinrealtime,leadingto amore complete and accuratemedication administration documentation in the eMAR . Ideally, aBCMAsystemshouldnotallowacaregivertobypassscanningexceptinextremesituationssuchasduringsystemdowntime.Ifbypassscanningoccurs,theBCMAsystemshouldasktheuserfora“reason”.It is typical for a separate BCMA system to communicate information in real time about medicationadministration transactions to the hospital’s EMR and eMAR systems and to the systems that handleorderentry forCPOEandpharmacyprocessing. SeparateBCMAsystems typicallyoffer theirownself-containedeMARs. IfusingaseparateBCMAsystem,thehospital’sprojectteamshouldconsiderwhicheMARoptionmakesthemostsenseformedicationdocumentationanddataanalysis.5.3.2 SystemandInterfaceTesting

IfaBCMAsystemis integratedwithahospital’sEMRsystem, interfacesbetweenthetwosystemsmaynotbenecessary.However,ineithercase,thoroughtestingshouldinclude:• EnteringalltypesofmedicationandIVorders• PerformingallexistingfunctionsofCPOEandpharmacysystemorderentry• Ordermodificationsandtimechanges/rescheduling• Orderstoholdandresumeadministrations• Deleting,canceling,ordiscontinuingorders,includingauto-discontinuation• Ordersfornon-formularymedicationsandpatients’ownmedications• Rangedosing,ifallowed(e.g.,50-100mg)• Multi-componentorders(e.g.,aparenteralnutritionfluidplusapiggybackmedication)• Multipleunitsperdose(e.g.,usingtwotabletsforonedose)• Partialunitperdose(e.g.,½tablet)• Taperingorders• Messagesandwarnings• Accuratedocumentationofalltypesofone-time,scheduled,andas-neededdoses.• Editingoforcancelingpreviousdocumentation• Scanningamedicationforadministrationpriortopharmacyorderreviewandapproval• Determineaprocessforscanningofnon-medicationsornon-pharmacysuppliedproducts.Thiscould

includenutritionalfeedingsandwoundcareanddressings.System(orinterface)testingrequiresateameffort.Apharmacist,anurse,andaninformationsystemsrepresentative from the hospital should all play an active role in the testing process. Pharmacy andnursing should work with other departments to ensure that scanners purchased for BCMA may beutilizedforotheruses(i.e.,Bloodcollection,Bloodadministration,orenteralformulas).5.3.3 IntegrationofaBCMASystemwithInfusionPumps

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Smart pumps and BCMA systems both make important contributions to safety in medication use.ProspectiveBCMAsystemvendorsmayalreadyhaveinterfacedsuccessfullywithsmartpumps.Ifso,itisimportanttodiscoverwhatdataareshared,whatfunctionalitiesofeithersystemareaffected,andwhichother hospitals are using the system integrated with smart pumps. Standardization of infusionconcentrations, pharmacy dispensing practices, and nursing administration practices are essential tomakethesesystemsbeneficial.

6-PlanningforaBarcodeMedicationAdministrationSystem[5]AdecisiontoimplementaBCMAsystemmaybedrivenbyatriggeringevent,aninfluentialindividualorgroupof individuals,ormaybeanorganization’sapproachtoachieving“meaningfuluse,”aspartofanincentiveplanstipulatedbytheU.S.federalgovernment.[6]Useofanelectronichealthrecord(EHR)andassistive technologies is specified in stage 2 of the government’s meaningful use incentive program.Typically planning, justification, and administrative approval will be required to commit appropriateresourcesforaBCMAsystem.ThissectionoffersguidanceaboutmanagingaBCMAproject.6.1 RecommendedReadingThese references areespecially recommendedbefore launchinga formalplanningprocess for aBCMAsystem.

• ASHPStatement:Bar-CodeVerificationDuringInventory,Preparation,andDispensingofMedications

• ASHPStatement:Bar-Code-EnabledMedicationAdministrationTechnology• Pathwaysformedicationsafety:assessingbedsidebar-codingreadiness.AmericanHospital

Association,HealthResearchandEducationalTrustandtheInstituteforSafeMedicationPractices.Washington,D.C.andHorsham,PA;2002.

• NeuenschwanderM,CohenMR,VaidaAJ,etal.Practicalguidetobarcodingforpatientmedicationsafety.AmJHealthSystPharm.2003;60:768-79.

• LeungAA,DenhamCR,GandhiTK,etal.Asafepracticestandardforbarcodetechnology.JPatientSaf.

2014Mar10. • GuidanceforIndustry:BarCodeLabelRequirements,FoodandDrugAdministration • KoppelR.,WetterneckT.,TellesJL,andKarshBT.Workaroundstobarcodemedicationsystems:their

occurrences,causes,andthreatstopatientsafety.JAmMedInformAssoc.2008:15(4):408-23.

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6.2 CreatingaCultureforPatientSafetyandAwarenessPatientsafetyisaparamountgoalinahealthcareorganization,fromfront-linenursesandpharmaciststotheorganization’schiefexecutiveofficer.Moreover,hospitalandhealth-systemcareiscomplexandfast-pacedandrequires intensiveexpertise. Medicationsused inthosesettingsare inherentlycomplexandrisky.Anerror-monitoringculturethatfocusesondiscoveringandeliminatingsystemvulnerabilitiesthatcouldallowerrorsand inwhichcaregiversarefreeof fearofreprisal frommanagersandpeersaftersystem-related errors is a prerequisite to the foundation of an effective medication safety program. Such aculture can result in better monitoring of errors, and the resulting information can be used to makeappropriatesystemchanges. Organization-wideawarenessoftherootcausesofmedicationerrorscandrive the allocation of resources to make necessary changes. The financial costs to the organizationassociatedwithseriousmedicationerrors,especiallythosethatresultinlitigation,couldexceedthecostofimplementingnewtechnologiesandprocessesthatcouldavoiderrors.6.3 AssessingExistingMedicationUseProcessesAddinglayersofautomationwithoutsufficientstudy,integration,andplanningmayportendashakystartto a BCMA system. An important first step should be a thorough review and assessment of existingmedication use processes. This should be done as a basis for determining the extent to whichautomationmightenableimprovements.Merelyautomatingexistingprocessesmaynotbeenough.Itisimportant thatallprimarystakeholders inmedicationuseprocessesbethoroughlyengaged inaBCMAproject.ProjectmanagementprinciplesshouldgoverntheimplementationoftheBCMAproject.6.4 FormingMultidisciplinaryProjectTeamsTwokeymultidisciplinaryteams inaBCMAsystemimplementationwillbeanassessmentteamandanoversight team. A pharmacy and a nursing representative should serve as co-chairpersons of theseteams. Together they should schedule routine (e.g., weekly) meetings of the teams with plannedagendasanddocumenteddecisions.6.4.1 AssessmentTeam

Anassessmentteamshouldthoroughlyanalyzeexistingsystemdesignsandworkflowsforbothnursingandpharmacy.Tovisualizethis,thefollowingsystemcomponentsshouldbedepictedanddescribedinprocessflowcharts.• Medication system physical components present in nursing areas, such as stationary medication

carts, mobile medication carts, patient-unit-based medication vending cabinets, controlledsubstancesstorage,IVstorageareas,andbedsidestorage.

• Medication system physical components in pharmacy, such as robots, other automated devices,inventoryreceiving,packagingmachines,andadmixtureservices.

• The current pharmacy distribution processes, such as cart filling, supplemental dispensing (e.g.,between times of normal unit dose cart deliveries), cabinet replenishment, robotic systemreplenishment,admixedIVdistribution,anddeliverymethodsandtimes.

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• Nursing workflow for medication administration, including medication administration times,administration documentation, witness procedures (e.g., for insulin doses), and pre-bedsidemedicationpreparation(e.g.,nursingIVadmixture).

• Clinical decision support in pharmacy and nursing, such as pharmacy medication profiles, careprotocols, medication-related rules based on clinical laboratory values, and other pertinent careprocesses.

Existing medication system physical components and processes may vary from one patient unit ordepartmenttoanother.Therefore,multipleviewsofsystemdesignsandworkflowsmaybenecessary.Onceexistingmedicationprocessesareclearlyunderstood.TheutilityofvariouspotentialBCMAsystemphysical components for nursing, such as portable and handheld devices, work stations on wheels orstands, and bedside devices can be better assessed. In that assessment the need for changes inmedication distribution, storage, access, and administration for each nursing area as well as relatednursingworkflowandpharmacyworkflowwillbecomeclearer.6.4.2 OversightTeam

An oversight team should include (but not be limited to) a sub-set ofmembers from the assessmentteam.Havinggonethroughtheassessmentprocess,thoseleaderswillalreadyhaveanappreciationforsomeofthechallengesahead.MembersofanoversightteamultimatelywillbeagentsofchangeforaBCMA project and, therefore, should be individuals who are reliable, responsible, respected, andeffectivemembersof theirdepartments. Anoversight teamshouldminimally includedecision-makersfromeachofthefollowingdepartments:• Pharmacy(co-chair)• Nursingpractice(co-chair)• Informationsystems• Nursingeducation• QualitymanagementArepresentativeofthefollowingshouldbeassignedaspermanentoradhocteammembersasrequired:• Respiratorytherapy• BCMAsystemvendor• Purchasingandmaterialsmanagement• Centralsupply(ifdistributingIVs)• Other hospital and outpatient departments (e.g., emergency department, anesthesia, procedure

units,radiology)Thenumberofpersonsontheoversightteamshouldbelimitedtoareasonablenumber(e.g.,maximumof 6-8). Smaller teams can be created to address specific aspects of the project and to involvemoreprocessexperts.6.4.3 ActionTeams

Somehospitalshavereportedsuccessinformingmultidisciplinaryactionteamstotargetspecificprojectaspects.[7],[8]Usingsuchteamsreflectsaqualityimprovementapproachthatcanresultinmoreeffective

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analysisandplanning.Eachactionteamshouldhaveateamleaderthatisresponsibleforteamtasksanddeadlines.Examplesofpotentialactionteamsare:ABarcodingteamcould

• Developaunitdosebarcodingstrategyfortheorganization.• Developasystemforbarcodedatabasemanagementforallsystemsusedwithinthepharmacy,

forexampleBCMA,ADC,andmedicationstoragedevices(e.g.,carousels).• Assessmedicationprocurementpathstoensurethatallproductsarebarcoded.• Identifypurchasingchangestoprocureproductsthatarealreadybarcoded.• Assessandmakerecommendationsforon-sitepackagingandlabelingequipment.• Identify a method for developing custom barcodes for compounded unit dose items (e.g.,

suspensions,liquids,andIVadmixtures).• Assesstheneedforbarcodesonpharmacylabels.• Ensureprocessesthatresultinbarcodingofallmedicationsdispensed.

Apharmacypolicyandprocedureandeducationteamcould

• Assistwithsystemtesting.• Identifyneededorderentryandorderverificationpracticechanges.• Draftneworrevisedpoliciesandprocedures.

An employee and patient identification team (including representatives from admissions and humanresources)could

• Determine whether existing barcodes (if any) on employee badges can be used to identifyworkers to a BCMA system. If necessary, explore methods and make recommendations forbarcodingemployeebadges.

• Identifyhospitalareaswherepatientwristbandsareused.• Identifyoptionsandmakerecommendationsforasystemofstandardizedbarcodedwristbands.

Awirelessnetworkteamcould

• Identifywirelessavailability inallareasthatwillbeservedbyaBCMAsystem,includingpatientcareareas,pharmacy,andtrainingrooms.

• Testsignalstrengthinthoseareasandmakerecommendationsforenhancements.

Aninterfaceteamcould

• Plan,implement,andtestinterfacesforADT,othersystems,andallmedicationandIVorders.• Proposedowntimeandothertechnicalsupportpolicies.

Anursingeducationteamcould

• Serveasahospital’snursingexpertsabouttheBCMAsystem.• Planandconductnursingusertraining,includingfornewlyhiredstaff.

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Animplementationteamcould

• Participateinsupportcoverageduringthedevelopmentphase.• Plan,schedule,andprovidesupportduringtherollout.

Asystemevaluationteamcould

• Collectorgatherpre-implementationdataonworkflowsandmedicationerrors.• Evaluate BCMA system charge-on-administration capabilities and the potential impact on

finances.• Developandmaintainpost-implementationprojectassessments.

Apurchasingandaccountingteamcould

• ProvidesupportforacostanalysisofaBCMAsystem.• Assistwithdevelopmentofarequestforvendors’proposalsandacontract.• Support other teams by identifying sources for materials and disposables, such as labels,

packagingfilm,andwristbands.Apublicrelationsteamcould

• Investigatethepublicrelationsopportunitiesinimplementinganimprovedpatientsafetysystem.• Prepareapressreleaseattheendoftheinitialevaluationperiod.• Preparethehospitalforpossiblemediainterest.

Otheractionteamscanbeestablishedwhenrequiredtoidentifyandaddressspecialchallenges.Nursingeducatorsoftenmakeidealparticipantsontheseteams.Specialactionteamsmayinclude:

• Pediatrics,neonatalintensivecare,laboranddelivery• Emergencydepartment• Intensivecareandcardiaccare• Operatingroomsandanesthesia• Post-anesthesiacare• Respiratorytherapy• Psychiatry• Infusioncenters• Outpatientdepartments

6.5 PreandPost-ImplementationDataCollectionData related to medication errors and the processes for collecting the data before and after systemimplementation should be identified. Such data could include patient barcode scanning rates,medicationbarcodescanningrates,andBCMAsystemflags,includingnearmisses.Thesedatawillbethebasisofqualityassurancemeasurement to indicatehowthe system isaffectingmedicationuse safety.Additionally, if the organization chooses to use a charge-on-administration process, charge capturereportsshouldbecreatedandreviewedregularly.Collection of post-BCMA system data most likely will be automated by the BCMA system itself. The

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processforcollectingpre-BCMAsystemdata,ifnotalreadyinplace,shouldbeinitiatedwellinadvance(e.g., 2-3 months) of a BCMA system implementation. Pre-BCMA system data should be carefullycollected through the hospital’s medication error reporting system as well as by direct observation.Observationmaycatchanerrorornearerrorthatwouldhavegoneundetectedorunreported.6.6 PharmacyConsiderationsTherearevariousmethodstoachievebarcodingofallmedicationdoses.Theyincludebuyingunitdosebarcodedmedicationsfrommanufacturers,usinganoutsourcedlicensedre-packager,andbarcodingunitdoses in-house. Developingaunitdosebarcodingstrategy isuniquetoeveryorganizationandoften isdrivenbyorganizationsize,pharmacystorage,andfunding.AdditionalStafforallocatingpharmacistorpharmacytechniciantimetohandleBCMAissuesliketrainingnewbarcodesortrouble-shootingnursingbarcodesproblemreportsmayberequired.6.6.1 Manufacturers’Barcodes

In2004,FDAestablishedaregulationrequiringmanufacturerstobarcodeallmedicationpackageswithalinear barcode containing, at a minimum, the product NDC number. [9] The FDA released a guidancedocument in 2011 that addresses some of the complexities in adding a barcode to pharmaceuticals.Whilethisregulationwasagoodstep,ithadseverallimitations.• It specified that the NDC number be used in a linear barcode. Many manufacturers incorporate

additional data and/or characters into the barcode, which may change the barcode with everypurchasemadebyapharmacy--effectivelyrequiringthehospital’smedicationusedatabasestobeupdatedwitheachnewpurchase.Changes to thedataencodedwithin thebarcodedonotchangefrequently,buthospitalsmayneedtoscanproductsuponreceipttocapturethesechangespriortodispensingorcompounding.

• Therewasnorequirementto includelotnumbersorexpirationdates inthebarcodes.SomeBCMAsystems, though, may have the ability to read lot numbers and expiration dates from barcodes(typicallyDataBartype),ifthisinformationisincludedinthebarcode.

• There was no requirement in the regulation manufactures are required to produce unit dosepackages.Manufacturesbearanexpensetobarcodeunitdoses,sotheyare“disincentivized”todoso.Therefore,somechoosetoproduceonlymulti-dosepackages.

• Specification that the barcode must be linear limits the character potential of the barcode andcreatesa label-spaceburdenonpackages.Manymanufacturershaveelectedtousereducedspacesymbology (RSS) typebarcodes (DataBar) toaddNDC-containingbarcodeson smallproducts (unit-dosepackages,ampules,suppositories,etc.).

Agrouppurchasingorganization(GPO)contractedwithahospitalmaymakebarcodingarequirementforvendor qualification. However, situationsmay arise inwhich a contracted preferred vendor does notprovidebarcodeditemsthatanoff-contractvendorofthesamemedicationcanprovide.Insuchcases,itwill be necessary to decidewhether to barcode (in-house) the contracted “brand” or to purchase off-contract products until the preferred vendor provides barcodes. In making this decision, one mustconsider the differences in product costs, labor, packaging materials, as well as the importance ofsupporting a GPO contract. It is important to know a GPO’s vendor qualification policy related tobarcodingandunitdosebarcoding.6.6.2 OutsourcedUnitDosePackaging

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Licensedoutsourcedservicesareavailabletopackageandbarcodeunitdoses.Wholesalerscanprovideinformation on the options available, sometimes directly from the wholesaler or through an affiliate.Duringoutsourcing,inventorypurchasedbyapharmacytypicallyisfirstshippedtothepackagingcenter,packaged there and labeled with barcodes, and then shipped to the pharmacy. While such servicesprovideanoptionforgettingbarcodesontoproducts,pharmacistsshouldbemindfulofthefollowing.• Istheservicelicensedforrepackaging?• Thecostperdose.Thismustbeevaluatedcarefullyagainstthecostofon-sitepackagingequipment,

labor,andmaterials.• Thefinalpackage:Willthefinalpackagebeanoverwrap,ablister,orsomeotherformusableinan

organization’smedicationuseprocesses? Willpackagesizesbecompatiblewith theorganization’smedicationdistributionsystem?Willpackagesbeuserfriendlyandacceptabletonurses?

• Isthebarcodeofgoodquality(e.g.,abilitytoresistsmudging)?• Are there adequate quality assurance procedures in place at the repackager? What is the

repackager’serrorrate,andhowareerrorsreportedtocustomers?• Willsuchaservicehavebenefitforselectitemsorallitemsneedingbarcodes?6.6.3 PharmacyOn-siteUnitDosePackagingandBarcoding

Sincemanymedicationsarenotcommerciallyavailableinaunitdosepackagewithabarcode,andsinceoutsourcing such packagingmay be costly, packaging unit doses andmanually labeling products withbarcodes in-house likely will be an important part of a BCMA program. The additional pharmacyresources required for these processes will vary depending on the pharmacy’s current barcodingpractices.Forexample,apharmacyalreadybarcodingmedicationsforaroboticfillingsystemislikelytorequirelessnewbarcodingthanasimilarpharmacywithoutsuchasystem.Whenchoosingunitdosepackagingapproaches,pharmacyshouldconsiderwhetherchangesinpackagesizes will affect the storage capacity of decentralized vending cabinets. For example, a change thatresultsinalargerpackagethatreducesthestoragecapacityofakeyitemmaynecessitatemorefrequentreplenishmentofthatitemandthereforemorelabor.In setting up a BCMA system, pharmacy will have to decide what unique product identifier will beembedded in the barcode for pharmacy packaged products. Decisions will be required about labelmaterials, software, and hardware for these processes. The following sections discuss the use ofbarcodinginon-sitepackagingaswellasmanualbarcodingofsomemedicationsthatdonotrequiresuchpackaging.6.6.3.1Manual(Non-Automated)PharmacyPackagingManual packaging is the simplest of the unit dose packaging options. Software provided for usewithmanual packaging equipment should be capable of printing barcodes. The size and type of barcodesavailable through the system should be configurable. Manual systems do not involve the equipmentexpenseofmoresophisticated,automatedpackagingsystems.Theyhaveutilityasafirst-linepackagingapproach or as a supplemental system for low volume packaging, such as for specially obtained non-formularymedications.An oral solid unit dose packaging process typically involves the use of a card of unsealed unit dose

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blisters, a base tray inwhich the blister card is fitted during the filling and labeling process, sheets ofprintableadhesivelabels,andasoftwareprogramfordesigningandprintingthelabels.Theusercreatesthe label in the system’s software by entering information about the medication to be packaged,including the medication’s name, lot number, expiration date, and a product identification barcodeembedding a NDC or a hospital-assigned number. The labels are then printed in sheets. The usermanuallyplacestheoralsolidsintotheblisters,removesthebackingfromtheadhesivelabelsheet,andthenplacesthelabelsheetontotheblistercard(anactionthatsealsthedosesintotheblisters).Manualpackagingsystemsforunitdoseoralliquidsareavailable.Someinvolveaplasticcuptowhichanadhesivesealorcrimpedlidisappliedtosealthecontents.Theuserinsertstheamountofliquiddesiredintotheunitdosecontainerusingamanualpump,permanentlycapsandsealstheunit,and labelstheproduct with a label that contains a barcode. Others use a syringe-like single dose container (oralsyringe) which, despite looking somewhat like a syringe for injection, does not allow a needle to beconnected.Anadapterisinsertedintothemouthofthereservoirliquidmedicationbottleandindividualoralsyringesarethenfilledbywithdrawingliquidthroughtheadapter.Theoralsyringeisthenlabeled,includingbarcoding.Manual packaging of unit dose syringes can be done by drawing appropriate volumes into individualsyringesfromanampuleormulti-dosevial.6.6.3.2AutomatedCountertopPharmacyPackagingAutomated countertop packaging systems for unit dose oral solids can bemore efficient thanmanualpackaging systems, especiallywhen packaging large numbers of doses. These systemsmay provide ahigherqualitypackage thanmanualpackaging systems. Oral solid systemsprovideeitheramanualorsemi-automatedfeedoftabletsorcapsules. Thetabletsorcapsulesarefedbetweentwofilms,oneofwhichisopaqueandlabeledwiththeproductinformationandbarcode. Theotherfilmsidetypically istransparent,allowingforvisualexaminationofthepackagecontent.Thefilmsareheatsealed,andthestripisperforatedtoallowseparationofindividualpackages.Automatedcountertopsystemsfororalliquidsandmultiple,syringefillingareavailableandcanbemoreefficientthanmanualpackagingsystems,especiallywhenpackaginglargenumbersofdoses.The size of the equipment, storage of supplies, final product configuration, cost of equipment andsupplies,finalproductquality,anddatabasemanagementallshouldbeconsideredwhenchoosingaunitdosepackagingsystem.6.6.3.3InterfacedAutomatedPharmacyPackagingPackagingsystemsforunitdosesexistthataremuchmoresophisticatedthancountertopmodels.Thesesystems can package and label, including barcodes, based on an interface with a pharmacy system,centralizeddispensingsystem,anddecentralizedvendingcabinets.Thesesystemsarefaster,larger,andmorecostlythancountertoppackagingsystems. However,dependingontheoverallpharmacyvolumeandautomationplan,thistypeofsystemmaybethemostefficient.6.6.3.4PrintingBarcodestoBeManuallyApplied

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ApharmacysystemorBCMAsystemmayhavetheabilitytoprintbarcodelabelsformanualapplicationontoproductsthatdonothavecommercialbarcodes.Fourthingstoconsiderare:• Decidingwhatidentifiertoputintothebarcode• Findingalabelpaperbackedwitha“pharmacy-grade”adhesivewithtemplatesavailableforprinting

verysmallbarcodelabels• Selectingasoftwareapplicationforprintingthebarcodes• Selectingaprinter6.6.3.5WhatDataGointoaManuallyAppliedBarcode?In order to determine the type of barcode symbology and barcode content to be used in manuallyapplied barcodes, it is important to understand the capabilities of the BCMA system with respect tobarcodes.Oncesystemcapabilitiesareknown,itisbesttoemployaconsistentbarcodecontentstrategythatcanbeeasilytaughttopharmacypackagingandlabelingpersonnelandincorporatedintopharmacypoliciesandprocedures.Dependingonthesizeoftheitembeinglabeled,thesymbologyofthebarcodemayvary.6.6.3.6Multi-UseContainersMulti-useproductsareintendedtobeutilizedforonepatientusedmultipletimesorforthedurationoftheir hospitalization. Althoughmanymulti-use containers, such as inhalers, topicals, and ophthalmics,comeinanouterboxorpackagethatisbarcoded,theouterpackageoftenwillbediscardedthefirsttimetheproduct isused. Therefore, itwill benecessary tomanually applybarcodeson innerpackages forcertain multi-use products. When determining barcode label placement, nursing input should beobtained to be sure that the barcode is applied in an easily accessible place. The use of a systemgeneratedbarcodeforadministrationpurposesmaybeeffective,buteducationwiththenursingstafftoensurethecorrectbarcodeisutilizedforadministrationisessential.Manycollapsiblecreamandointmenttubeshavecommercialbarcodesonthem.Althoughscanningthecommercial barcode may pose some inconvenience when these tubes collapse, commercial barcodesmay be preferable to manually applied barcodes during the use-life of the product. Some inhalantcanistersarebarcoded,but thebarcodemaynotbeaccessible for scanningonceacanister is insertedintoamouthpiece.6.6.3.7Vials,Ampules,Syringes,andRespiratoryMedsUntil items with a small label area (such as many small vials, ampules, syringes, and single doserespiratory medications), are barcoded by manufacturers, they will require manual barcoding bypharmacy. The use of DataBar/RSS barcode symbologies has made it rare for pharmacies to addadditional barcodes to these products. On occasion, it stillmay be necessary to repackage or re-labeltheseproductstoensureapositivescan.6.6.3.8LargeVolumeIntravenousFluidsThereadabilityofbarcodesonIVvendors’flexiblecontainersshouldbetestedusingtheactualscannerthat will be used at the bedside and in the pharmacy. Several containers of various sizes should bescanned.Ifthebarcodesdonotreadonthefirstscanatleast90%ofthetime,manuallybarcodingthese

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itemsshouldbeconsidered.SomeIVproductsmayhavemorethanonemanufacturer-appliedbarcodeoneachitem.Insuchcases,knowingwhichbarcodetoscanbecomesateachingpointforworkers.Thescanabilityoftheseproductshasimprovedwithchangestotheplacementofthebarcodeontheinfusionbag and the use of alternative style barcodes. Confusion may exist with the nursing staff if multiplebarcodesareontheinfusionbag.If IV solutions are distributed by a department other than pharmacy, such as central supply, it isrecommended that pharmacy oversee the process of barcode database maintenance and manuallyaffixing barcodes to containers or outer wrappings. If a manual barcode is to be used instead of amanufacturer’sbarcode,itisimportanttoconsiderplacementofthebarcodeontheproduct.Ingeneral,manually applied barcode labels should be applied over the commercial barcode(s). Complicating thescanning of large volume infusion solutions is the backorders and drug shortages of products. Care isrequired to ensure that all solutions being utilizedwithin an institution have a barcode that has beenaddedtotheBCMAorpharmacymoduletoensureproperscanning.6.6.3.9Patient-SpecificDosesOneofthebiggestchallengesisbarcodingpatient-specificmedications.Theseinclude:• Amedicationoradmixturecustomprepared inanexactdoseorvolume to fulfill a specificpatient

order• Aprepareddosemadeupofmultiplemedicationlineitems(eachofwhichmustbedocumentedand

billed),suchasanadmixedIVoranoralliquidmixture• Anon-formularymedicationthat isnotpartofthepharmacysystemandBCMAsystemmedication

database• Apatient’sownmedicationthatisauthorizedtobeusedwhileaninpatientOften,thesepatientandorder-specificdosescannotbeadequatelyidentifiedusingamedication-specificbarcode. Therefore, an alternate method must be used that associates the prepared dose with theintendedpatientandtheappropriateorder.Theapproachesdescribedbelowhavebeenused.Eachhasadvantagesanddisadvantages.• Thebarcodecontainsthepatient identifierandthepharmacysystemordernumberseparatedbya

delimiting character. This approach allows a BCMA system to match the scanned dose with thepatient and pharmacy system order that it is intended to fulfill. Unlike the method above, thismethodiseffectiveevenifpharmacysystemordernumbersoverlapwithotherbarcodeidentifiers.However,likethemethodabovethatisbasedontheordernumber,thisbarcodingapproachwouldrequire already dispensed medications to be barcoded again with a new order number when amedicationscheduleischangedorwhenamedicationisdiscontinuedandreordered.

• Thebarcodecontainsapatientidentifier,medicationorderidentifier,anddose,eachseparatedbya

delimitingcharacter.ThisapproachallowsaBCMAsystemtomatchascanneddosewiththepatient,theorderedmedication,andthespecificdoseordered.Thebenefitofthisapproachisthatachangein the order number, such as when a medication schedule is changed or when an order isdiscontinuedand the samemedicationanddoseare reordered (e.g.,whenapatient is transferredbetweenunits),willhavenoeffect,anddosesdispensedforthepreviousordercanbescannedandacceptedtofulfilltheneworder.Unfortunately,thismethodmayresultinalongbarcodewhenallthreedataelementsareincluded.Italsowouldbedifficulttoimplementforamultiple-medication

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product.• Thebarcodecontainsthepharmacysystemordernumber.ThisapproachallowsaBCMAsystemto

matchthescanneddosewiththepharmacysystemorderthat it is intendedtofulfill. Thismethodcansucceedifpharmacysystemnumbersdonotoverlapwithotherbarcodeidentifiers,suchastheNDC number, hospital formulary database identifier, or hospital billing code. However, if thepharmacysystemgeneratesanewordernumberwhenamedicationschedule is changedorwhenthemedication is discontinuedand reordered (e.g.,whenapatient is transferredbetweenpatientunits),thisbarcodingapproachwouldrequirethatmedicationsalreadydispensedbebarcodedagainwith a new order number. Unfortunately, the process of changing the barcode on an alreadydispenseddosemaybeimpracticalorimpossibleinsomepracticesettings.

Theprosandconsoftheaboveapproachesshouldbeweighed.PharmacyshouldworkwiththeBCMAvendortodesignthebarcodingapproachandrelatedprocedures.Otherimportantconsiderationsrelatedtotheseapproachesare:• Thepharmacy systemautomaticallyprovidesabarcoded label forpatient-specificmedicationsand

IVsusingabarcodethatcontainsallthedesiredelements.Thiswouldeliminatetheadditionalworkofmanuallycreatingbarcodesfortheseitems.

• Ifapharmacysystemusesproductorordercategories, itmightbepossible for thedesiredtypeofpatient-specific barcode to be printed on pharmacy system labels. However, caution should beexertedtoensurethataproductdoesnotbearmorethanonebarcode.

• In all cases, themedication contents of the barcoded package or container should appear in text-readableformat.

• The different label types the pharmacy system can create should be researched: with barcode,withoutbarcode,andwithdifferentlabelsizes.

• The types of labels used for printing and the placement of the barcode on the label should beinvestigated.Isitacontinuouslabel?Candie-cutlabelsbeused?

The followingare important considerations foraBCMAproject teamandshouldbe raisedearly in theplanningprocess.6.6.3.10PartialDosesFollowingaretwowaystohandlemedicationsthatareorderedinhalftabletdoses.• Ahospitalidentifiercanbeassignedtothehalftabletitemandenteredintoapharmacysystemanda

BCMA system as a distinct line item. This line item can be used to order half tablet doses in thepharmacysystem.Tobarcodethehalftablet,thetabletcanbecutintohalvesandpackagedasahalftabletperpackage.Auniquebarcodewillthenbeassignedforthehalf-tabletproduct.

• Themedicationcanbeorderedinapharmacysystemusingthelineitemforafulltabletandentering

thedoseamountofhalfa tablet. A full tablet isdispensed. ThentheBCMAsystemcanbeset tonotify the nurse that the tablet must be broken in half to achieve the prescribed dose and theremaininghalftabletwasted.

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Both options have advantages and disadvantages. The first option is more labor intensive for thepharmacy;howeveritismoreinkeepingwiththeconceptofunitdosedispensing.Itreducesthechanceformedicationerrorduetoconfusionaboutthehalftabletdose.Thisapproachmayworkwellforitemsusedfrequentlyinhalftabletdoses,butitbecomesdifficultwhenanunanticipatedorderforahalftabletdoseoccurs.ThesecondoptionassumesthatapharmacysystemandaBCMAsystemhavethenecessaryfeaturestosupport half tablet ordering and notification to the nurse. This method places the responsibility ofbreakingthetabletontothenurseandreliesonthatpersontocomplywithaBCMAsystemwarning.Ifthis approach used, it is recommended that the nurse be required to acknowledge the notification byindicatingthatahalftabletdosewillbegiven.Consistency isan important factor inaccuracyandsafety. Ifpossible,astandardapproachtohandlinghalf tabletdosesshouldbeestablished. ABCMAprojectteamshouldgivecarefulconsiderationtotheaboveoptionsinconjunctionwiththefeaturesetsofavailablepharmacyandBCMAsystemstodecideonthebestapproach.6.6.3.11InsulinThe lessmedication preparation (e.g., pouring and drawing up doses) that occurs before going to thebedside,thebetterandsaferaBCMAsystemwillbe.Tobestsupportthisprocess,pharmacyshouldunitdose and barcode virtually everything, including oral liquids and injectables. However, in certainsituations,providingaunitdoseorevenapharmacy-preparedpatient-specificdosemaybeimpossible.Insulin is a prime example. There aremultiple dispensingmethodologies for insulin, including use ofpatient-specificpens,patient-specificvials,ormultiple-dosevialsformanypatients.Dosesmayhavetobedrawnupbasedonbedsidedeterminationsofbloodglucoselevels.Inpreparationforadministration,it iscommonforinsulindosestobedrawnupinamedicationroomratherthanatthebedside. Inthispractice,whatbarcodecouldthenursescan,andhowcanthedoseadministeredbedocumentedintheeMAR?6.6.3.12IsolationPatients

WhatwillbetheBCMAprocessfornursesadministeringmedicationstopatientsinisolation?Therearenoperfectanswerstotheseissuesotherthantorecommendthatpatientsafetymusttakepriorityoverworkflowconvenience.Themovementofa“dirty”scannerfromonepatient’sroomtoanothershouldbelimited. The hospital policy and procedures for patient isolation should be followed with medicationscannersconsistentlyasotherequipment.6.6.3.13InvestigationalMedicationsDependingonthetypeofhospital,thescanningofinvestigationalmedicationsatthebedsidemaybeasubstantialcomponentofmedicationuse.Evenifinvestigationalmedicationsareusedonlyoccasionally,establishing a barcoding method for handling them is important. To facilitate proper tracking anddocumentation of investigational medications as well as medication safety, the following arerecommended.• Allinvestigationalmedicationdosesshouldbeunitdosepackagedandbarcoded.• The BCMA system vendor should be consulted for recommendations about use of investigational

medications.

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• Auniquelineitemandhospitalidentifiershouldbeassignedtoeachavailablestrengthorsizeoftheinvestigationalmedication inboththepharmacysystemandBCMAsystem. Ifhalftabletdosesarerequired, a unique line item for half tablets should be assigned, and the processes above aboutpartialdosesshouldbefollowed.

• Patient-specificmeasureddosesshouldbepreparedwhennecessaryusingtheordernumberinthebarcode as suggested in the section about products requiring manually applied barcodes. Theestablished investigationprotocolmustbefollowedatall times. BarcodingandBCMAsystemscanbeaddedtotheinvestigationprocesswithoutjeopardizingprotocols.

6.6.4 SpaceConsiderationsTheimplementationofaBCMAsystemmayhavesomepharmacyspaceimplications.Floorandcounterspaceforthefollowingshouldbeplanned.• Abarcode-enabledunitdoseoralsolidpackagingsystem(countertoporfloormodel)• Abarcode-enabledunitdoseliquidpackagingsystem(countertop)• Abarcode-enabledsyringefillingsystem• Workareasforpackagingoralsolids,oralliquids,andsyringes• File space, such as for production records and storing pre-printed barcode labels for manual

application• Aworkareaforapplyingandcheckingmanuallyappliedbarcodes• AspaceforaBCMAsystemworkstation• Aworkareaforscanningcommercialbarcodesuponreceiptofshipmentsintoinventory6.6.5 StaffingConsiderations

PreparingthepharmacyforaBCMAsystemmayrequireasignificantinvestmentofpharmacystafftime.Thiswill includemedicationdatabasepreparationandmaintenance, inventoryandpurchasingchanges,packaging and barcoding of medications, development or alteration of standard order entry orverificationprocedures,andtraining. One360-bedhospitalreportedthat600hoursofstafftimewererequired initially for this process.[10] In addition, pharmacy staff timewill be required to support thesystemonanongoingbasis. Someof thisstaff timemaybeoffset, suchas incaseswherebillingbyaBCMAsystemformedicationsadministeredmighteliminatecurrentbillingandcreditingtasks.5Someimportantconsiderationsare:• Pharmacy technicianswill ordinarily handle purchasing, packaging, and barcoding functions. They

willbeengagedindispensingandbarcodereadingofunuseddosesreturnedtostock.Iftechniciansareusedinanorderentryprocess,theyshouldbeincludedinredesigningtheorderentryworkflowandshouldbetrainedabouttheprocesschanges.

• Pharmacistswillberesponsible forconsistent-and insomecasesnew-orderentryorverificationpractices and other activities such as quality assurance of barcoding (checking of packaging andmanuallyappliedbarcodes)andbarcodingofpatient-specificdoses,non-formularymedications,andpatients’ownmedications.

• Pharmacistscanbearesourceformanagingandfacilitatingmedicationschedulingchanges.• Apharmacy-based nurse dedicated to a BCMA system can be a significant asset. This person can

serve as a formal liaison betweenpharmacy andnursing. The nurse can help both pharmacy andnursing with workflow and process issues, troubleshoot procedural problems, monitor eMAR

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documentation,andfocusonmaximizingsystembenefits.• Astaffmembershouldbeassigned responsibility fordatacompilationandanalysiswith respect to

reportingaboutthesystem’simpactonmedicationerrorprevention.• Organizationsthathaveateachingprogramshouldconsiderhowtoincorporatepharmacystudents

orresidentswithaBCMAsystemimplementationandongoingoperation.Vendorsmaybe able to provide resources to support barcodingby thepharmacy. If thepharmacy isinterestedintheseservices,theyshouldbespecifiedinarequestforproposal.6.6.6 QualityControl

ABCMAsystemnecessitatesatleastthreenewqualitycontrolstepsforpharmacy.• Thecheckprocessforunitdosespackagedon-siteshould includeascanofthepackagebarcodeto

verifythatthebarcode,textlabeling,andmedicationcontainedinthepackagesareallcorrect.Thecompletionofthisstepshouldberecordedinapackaginglog.

• Non-barcoded products to which a barcode is thenmanually applied should be checked, and thecheck process should be documented using the same record-keeping system used for on-sitepackagedmedications.

• Purchasedproducts thathavebarcodesshouldbescannedas incomingshipmentsarrive toensurethat the necessary product information is present in the pharmacy system and BCMA systemdatabases.

Qualitycontrolscanningshouldbedonewiththesamedevicethatwillbeusedtoscanmedicationsatthepointofadministration.Thefirsttwoactionsabovecanbemodifiedtoincludeascanofthefirstandlastpackageinarun.Again,arecordofthecompletionofthisshouldbemaintained.Thethirdactionaboveisintendedtocatchchangesinthemanufacturersofgenericitemsshippedbyawholesalerwherethe“brand”andbarcodehaveneverbeforebeenused. Italsohelpscatch instanceswhereamanufacturerhaschangeditsbarcodecontent.6.6.7 MedicationDatabaseManagement

6.6.7.1ExistingPharmacyAutomatedSystemsAmedicationdatabaseusedbyanautomatedsystemcanbeviewedashavingtwopotentialcomponents– a master medication database and an active medication database. A master medication database,typicallyalmost100,000medication line items, isprovidedbyadatasuppliersuchasFirstDataBankTM,MediSpan®, or CernerMultum®. Depending on the type of data required to support a particularautomatedsystem,themasterdatabasemayincludemedicationdescriptions(genericandbrandname,strength, volume, and dosage form), NDC numbers, allergy codes, medication interactions, genericequivalencies, therapeutic classes,pricingupdates,drugproduct images, andmore. Masterdatabasesareupdatedregularly, suchasmonthlyorquarterly. Notallpharmacyautomatedsystemsrequire theuseofamastermedicationdatabase.Theactivemedicationdatabaseisahospital-specificmedicationdatabaseoftypicallybetween1,000and3,000approvedformularyproducts.Theactivemedicationdatabasemaybeastand-alonedatasetorit

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maybeasubsetofamastermedicationdatabasewithlinkstothemasterdatabase’sdruginformation.Theactivemedicationdatabasetypicallyincludesshortenedmedicationdescriptionsaswellashospital-specific medication identifier codes by which medications are ordered and identified. Certaincomponentsofanautomatedsystem’sactivemedicationdatabase,suchashospital-definedmedicationdescriptions,maybeeditedorupdated freelyby thepharmacywithoutaffecting themasterdatabase.Theabilitytocreateshortenedmedicationdescriptionsforeachformulary line itemis important,sinceautomatedsystemstypicallyhavetechnicalorpractical limitationsaboutthe lengthof thedescriptionstheycanhandle.Theactivemedicationdatabasewillallowuniquefunctionalitysettingstogovernhowthe systemmanages each line item. For example, a line item in the activemedicationdatabase for adecentralized vending cabinet system may be set to require entry of a count each time the cabinetmedicationisaccessedbyauser.Insomecases, integratedsystemsprovidedbythesamevendormaysharethesamemasterandactivemedicationdatabases.However,inmostcasesadatabaseseparatefromthemastermustbeestablishedandmaintainedbythepharmacy.Asasafetymeasure,itisrecommendedthatmedicationdescriptionsbethesameacrossallsystemsthatarepartofmedicationuseprocesses.Indoingthis,userswillnotbeconfrontedwith inconsistentmedication descriptions appearing on eMARs, pharmacy systemdisplays,on-site packaged medication labels, decentralized vending cabinet displays, and in a BCMA system.Ongoingmaintenanceofmedicationdatabasesinvolves:• Regularlyupdatingthedatasupplier’smastermedicationdatabasefiles(ifapplicable)• Enteringanewmedicationintoallactivemedicationdatabaseswhenit isapprovedforformulary

status• Adjusting settings for an existing formulary item in a system’s activemedication databasewhen

necessaryIngeneral, thebroaderahospital’s formulary is, themore labor intensive theongoingmanagementofmedicationdatabaseswillbeforrelatedautomatedsystems.

6.6.7.2BCMASystemsToagreatextent,themedicationdatabasesofaBCMAsystemhavethesamecharacteristicsasinotherpharmacy automated systems. However, the activemedication database of a point of care scanningsystem requires twoadditionaldata components forevery item– thebarcode identifier and theNDC.Unfortunately, barcode identifiers arenot included in themastermedicationdatabases available fromdata suppliers, and there is no official global source for such data. Therefore, inmost instances, thepharmacy must supply and maintain medication barcode information for a BCMA system’s activemedication database. Somewholesalers are developing services thatmay provide a file of purchasedbarcodes (tiedtonecessaryrelated informationdata)andready for import intoaBCMAsystem.Therearealsocommercialsystemsthatresideinthescanningsystemthatcan“translate”avendor’sNDCandverifyaproduct.DuringtheinitialinstallationofaBCMAsystem,thepharmacywillhavetoscaneverybarcodedshelfitemininventorytoproperlyassociateitsbarcodewithalineiteminthesystem’sactivemedicationdatabase.Unlikeotherdataassociationswhereaone-to-onerelationshipexists,suchasaformularylineitemandits hospital identifier code, generically equivalent inventorywith items and their barcodes can have amany-to-one relationship with a single line item in the activemedication database. This information

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must bemaintainedon anongoing basis as new shelf items are received; otherwise itemswill not beidentifiablewhenscanned.6.6.8 RevisingOrderEntryProcedures

TheuseofanintegratedCPOE,pharmacyandBCMAsystemisthecurrentdesiredstatetoensurethatallsystemsareperforminginasafeandefficientmanner.PharmacyorderverificationformaCPOEsystemshould occur prior to a nurse administering amedication with a BCMA system. Therefore, if a BCMAsystemschedulesdosestobeadministered,thenursewillbeadministeringmedicationsbasedonthoseorder entries. The use of standard frequencieswith defaulted start timeswill improve the schedulingwithin the BCMA system, but exceptions will need to be considered based on patient preference orcondition.Forthisreason,someorderentrypracticesmayhavetobeadjustedtoaccommodatenursingandpatientneeds. Inadditiontothesituationsdescribedinprevioussections,thefollowingshouldbeconsidered.• Firstdose scheduling. Orderentryorverificationoftenwilldefault the first scheduleddose to the

nextstandarddosingtimebasedonthehospital’sdefineddosingschedules.However,thenursemayhavetoadministerafirstdosebeforetheorderentryprocesscancreatesuchascheduleorbeforeanext regularly scheduled time. Pharmacy and nursing should establish amethod for handling thisscenario.Possibleresolutionsinclude:

o Pharmacy enters a special first dose order and a routinely scheduled order. For example,

pharmacymayhavetoenterorders (a) foradosenowand(b) fordosestwiceadaytoenableadministrationofbothdosesonthefirstday.

o The nurse administers the first dose as a non-ordered or “override” dose before the firstscheduled time. Efforts shouldbemade tominimize any administrationofmedicationprior topharmacistverification.

• Schedulechanges. Thenursemaydecidethatscheduledtimes foraspecificmedicationshouldbeadjusted. Nursing and pharmacy should establish a standard means for communicating the timeexceptions.

• Non-formularymedication. Rather thanadda formulary line item fora rarelyusednon-formularymedication, insomeBCMAsystems,pharmacycanentertheorder intoapharmacysystemusingavirtual line item called “non-formulary medication.” It may be possible to describe the exactmedicationinacommentarea,andthatdescriptionthencanappearonthelabelandintheeMAR.Ifthis processwere followed in a point of care scanning environment, this itemmight be dispensedwithoutabarcode(undesirable).Ifanon-formularymedicationistobeutilizedandBCMAisdesired,itshouldbeaddedtothepharmacymodule.

• Patient’s own medication. A patient’s own medications, if allowed by hospital policy, should bebarcodedandscannedlikeallothermedications.Themedicationthencanbehandledroutinelybasedonitsformularystatus.o If the medication is a formulary item. The order can be entered and the medication can be

dispensedfrombarcodedpharmacystock,oramedication-specificbarcodecanbeappliedtothepatient’smedicationcontainer.

o Ifthemedicationisnotaformularyitem.Theordercanbeenteredandthebarcodingprocessfornon-formularymedicationscanbeused.

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• Procedures should be established for handling medications obtained by an override process bynursing,suchasfromanautomatedvendingcabinet.

It is important that detailed,written pharmacy order entry and verification procedures be developed.Theseproceduresmustbeuseduniformlybyallmembersofthepharmacystaffandshouldbeusedasatoolfortrainingnewstaffmembers.6.6.9 DownTimeProcedures

Occasionalplanneddowntimeisnecessarywithanyautomatedsystem.Problemsthatsometimesoccurduring planned down time can be avoided through coordination and communication amongdepartments.If unplanned system down time occurs, it is essential to follow a pre-decided standard contingencyproceduredesigned tominimize adverseeffectsonpatient care. Adown timeprocedure for aBCMAsystemmaybesignificantlydifferentifthepharmacysystemalsoisdown.Insuchacase,thepharmacysystemdowntimeprocedureshouldbefollowed.Neworderswillhavetobetrackedmanuallyandthenenteredintothepharmacysystemassoonaspossiblewhenserviceresumes.Ifthepharmacysystemisoperational and only the pharmacy system’s interface to the BCMA system is down, nursingmust beinformed immediately that patient and order information in the BCMA system is not current. BCMAsystemsshouldbedesignedtonotifyuserswhentheinterfacewithapharmacysystemisdownorslow.IncaseswheretheBCMAsystem(butnotthepharmacysystem)isdown,pharmacyprocessesrelatedtotheelectronicmanagementofbarcodedinventory,suchasbarcodescanningofincomingitems,scanningafterproductsarepackagedand labeled,andBCMAformularydatabaseupdates,shouldbesuspendeduntiltheBCMAsystemreturnstoservice.Ifbarcodesonnewlyreceived,on-sitepackaged,orrelabeledproductsmustbechecked,thepharmacyshouldmanuallyverifybarcodesbasedonthetextdescriptionofthebarcodecontentthatusuallyappearsjustbelowthebarcodesymbol.Barcodesforeachnewitemandeachprocessedbatch(e.g.,on-sitepackaged)shouldbescannedforreadabilityandqualitywhentheBCMAsystemreturns toservice. Thisapproach is importantbecausesafetydependsonall thosedatabeing complete and any data that flows through into the BCMA process being correct. In short, thepharmacyandBCMAsystemsmustbesynchronized.Finally,thepharmacyandinformationsystemsdepartmentshouldkeepanadequatebackupsupplyofBCMAdevicesavailableifapharmacyscannerorBCMAsystemdevicefails.6.6.10PharmacyStaffTraining

As with other automated systems, effective training of the pharmacy staff is crucial for success andconsistency. Followingare some recommendations that,working closelywith aBCMAsystemvendor,willhelpachieveasuccessfultrainingexperience.• Introduction to the BCMA system should include a focus on hospital patient safety initiatives, the

Joint Commission (TJC) recommendations, and regulatory requirements that support the need forminimizingerror-pronecircumstances.

• Training tools, such as user guides, videos, and other training aids, should be obtained from theBCMAsystemvendor.

• Apharmacist,suchastheoversightteamco-chairperson,andtheBCMAsystemvendorshouldjointly

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conductanearlytrainingsessiontofocusspecificallyonthenecessarypharmacyactivities.• Ifexperiencedconsultantsareavailable,theirinputshouldbeobtainedabouttrainingcontent.• PharmacymanagersshouldincorporateBCMAsystemtrainingintotrainingfornewlyhiredstaff.• AtimeandplacemustbechosenforBCMAsystemtraining.Accesstofullyfunctionalequipmentwill

berequiredatthatlocation.• In addition toBCMApharmacy training, thepharmacy staff should receive thenurseuser training.

Newstepsinthemedicationuseprocess,suchastheneedfornursingtorequestapharmacysystemschedulechangeonamedicationorder, shouldbe identified,andpharmacy responsibilities shouldbedefined.

• Areasonableamountoftimeshouldbescheduledforthetrainingsession,includingtimeforhands-onpracticeandaquestionandanswerperiod.

• Certificatesofcompletionshouldbeissuedforthetraining,andthetrainingshouldbedocumentedineachemployee’seducationrecord.

• Allchangestocurrentpoliciesandproceduresshouldbeaddressed,including:o Proceduresforplannedandunplanneddowntimeo On-sitepackagingandbarcodingprocedureso Orderentryprocedureso Troubleshootingprocedures,includingidentifyingandloggingproblems,assessingproblemsand

attempting resolution (if applicable), contacting internal (e.g., information systems)or external(vendor)helpdeskswhennecessary,anddocumentingproblemresolution.

• Pharmacy staff should be providedwith a clear understanding of the privilege levels and controlsinherentintheautomatedsystems.o Key privileges, such as creating users and editing formulary items, should be restricted to a

limitednumberofpeople(e.g.,two).o Otherfunctions,suchasverifyingbarcodesonincomingshipments,likelywillbeapplicabletoall

users.o Pharmacyshoulddetermineprivilegeassignmentsinadvanceoftraining.

Avendorrepresentative,preferablysomeonewithclinicalexperience,shouldassistwithtrainingandbeavailable to answer questions. However, it is recommended that a pharmacist conduct and overseepharmacy training. Pharmacy needs to understandnursingworkflows to best trouble shoot any issuesthatarisewhenhe/sheadministersamedication.Having thepharmacistson theproject teamattendsnursing training, and someof thenurses attendpharmacy training couldhelpaddress issues thatmayarisepostgo-live.The information systemsdepartment shouldbemadeawareof theclinicaland safety importance thattheBCMAsystemhastonursing,pharmacy,andpatients.It isrecommendedthatinformationsystemsstaffattendapharmacytrainingsessiontogetanoverallunderstandingofthepharmacycomponentsofthe system and related pharmacy procedures. Such a session can be scheduled in conjunction withpharmacytrainingorindependently.6.6.11SystemEvaluation(POST-Implementation)

AsystemevaluationactionteamshouldcloselymonitorfortheproperuseoftheBCMAsystemandallrelatedprocesses.Todosoeffectively,aprocessflowmeasurementsystemcanbedeveloped.Processflow measurement should identify process problems and work-arounds that may develop that maydiminishsafetybenefits.

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Examplesofwork-aroundsthathavebeenseenwithpointofcaremedicationscanningsystemsinclude:• Extrabarcodedpatientwristbandsarecreatedtoavoidhavingtoscanthepatient-wornwristband.

Insomecases,thesearetapedtoabedrailorwallinthepatientroom.Inothercases,theyarekeptinthemedicationroomsothattheusercanscanmedicationsbeforegoingtothepatient.

• Medicationsare removed frombarcodedpackages inamedication room,and theemptypackagesarescannedlateraftermedicationsareadministered.

• Medicationscanningisbypassedaltogetherandmedicationsaredocumentedlater.• A medication is administered by indicating it is a “non-barcoded medication” (a feature of some

systems)whenthemedicationis,infact,barcoded.Themonitoringprocessshouldhelpidentifytheprocessissuesthatcauseuserstodevelopwork-arounds.As an example, if no process existed for a nurse to initiate a schedule adjustment for a scheduledmedication, thenursemayhavegiventhemedicationbutscanned itasgivenata standardtime. Thisprocessproblemshouldbeaddressed.ClearproceduresshouldbeestablishedforallusersoftheBCMAsystem,andreportsshouldbegeneratedandreviewedtoidentifytrendsinusingthesystemeffectively.6.6.12RegulatoryConsiderations

FDAregulationsexistforbarcodingofmedicationsbymanufacturers,buttheydonotapplytopharmacyon-sitepackaging.Stateboardsofpharmacy,nottheFDA,regulatepharmacypractice.Theadditionofabarcode toahospital-preparedmedicationpackage shouldnotaffect thepharmacy’sability to complywithexistingstateregulations. Ifoutsourcedpackagingandbarcoding isneeded,thepharmacyshouldcontractwithalicensedmedicationrepackagerforthisservice.Non-24-hour pharmacy service will necessitate those doses for medication orders written during offhours be scanned and administered prior to pharmacy order entry the followingmorning. Pharmacyshouldworkwithnursingtoestablishaproceduretoreconcilesuchdoseswithorderswrittenduringoffhoursandtheordersthatareeventuallyentered.6.7 NursingConsiderations[11],[12],[13]6.7.1 NursingWorkflow

Theprocessofordering,confirming,preparing,dispensing,andadministeringamedicationhasmultiplepotential points of failure. There are many steps in nursing medication administration, and somemedications require extra steps to administer them. Nurses work at the final check point betweenaccuratemedication therapyandpotentialmedicationerrors. Therefore,a thoroughunderstandingofthenursingmedicationprocessesshouldbedevelopedbeforeimplementingaBCMAsystem.Asnotedin6.4.1,arecommendedfirststepinaBCMAsystemselectionandimplementationistomapand study the current medication administration process using flowcharts. Differences in theadministration of various types ofmedications should be understood. Wheremedications are stored,retrieved, and prepared should be depicted. Necessary retrieval of non-pharmacy items and patientinformation, including clinical information that the nurse must collect and document duringadministration(e.g., fingerstickbloodsugarcheckedbefore insulinadministration,ordigoxin leveland

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apical heart rate checked prior to digoxin administration) should be noted. Existing policies andprocedures formedication administration shouldbeup to-date and available for referenceduring thisanalysis,andanassessmentofwhetherornot theseproceduresarebeing followed isessentialbeforeproceeding. Updatedpoliciesandprocedurescanserveasavaluablepointof referenceforevaluatingBCMAtechnologythatmaybeagoodmatchfornursingprocesses.Spacelimitationsmayaffectprocesschangesandshouldbeidentified.High-riskmedicationworkflows require special attention sinceerrorswith thesemedicationsaremorelikelytocauseseriousadversedrugevents.TheInstituteforSafeMedicationPracticeshasidentifiedthefollowingashighalertmedicationsorcategories.ISMP’sListofHighAlertMedications.[14]• IVcalcium(asgluconateorchloride)• Antineoplastic(“chemotherapy”)agents• Chloralhydrateandmedicationsusedforpediatricambulatorysedation• Digoxin• Heparin• Hypertonicsaline• Insulin• PotassiumchlorideFinally,workflowsmustbeconsideredfornon-nursingpractitionerswhoadministermedications,suchasphysicians and respiratory therapists. It is recommended that these practitioners follow the samemedicationverificationanddocumentationpracticesasnurses.6.7.2 BarcodingthePatient

A BCMA system will require that a barcoded wristband be attached to each patient at the time ofadmission. Many hospitals limit the area/location or personnel who may print patient ID bands tominimize extra bands or incorrect bands being utilized. The wristband barcode should be scanned toidentifythepatientpriortotheadministrationofeachmedicationorduringeachgroupofmedicationstobe administered. Theremay be patient populations thatwillmake attaching a barcode to the patientdifficult (premature infants, burn patients, behavioral health patients), so each institution shouldevaluatetheirpatientpopulationanddevelopalternativestrategiesifthesepatientsaretobeadmitted.A process needs to be determined to ensure that the correct patient receive the correct barcoded IDband.6.7.3 NurseStaffing

A BCMA system that includes alerts and other decision support tools to reduce errors should notsignificantlyimpactstaffing.SinceBCMAsystemsautomaticallydocumentmedicationadministrationasitoccurs, it is likely to reduce charting timeaftermedicationadministration in comparison tomanual orotherelectronicchartingmethods.Therewillbetimeandlaborcosts,however,associatedwithsettingupand implementingaBCMAsystem. Someongoingnursing labor investment related to trainingandsupportshouldbeexpected.

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6.7.4 NurseTraining

The time required for training staff nursesmay vary based on the design and user-friendliness of theBCMA system selected. Following are some recommended approaches that, working closely with aBCMAvendor,willhelpachieveasuccessfultrainingexperience.• Introduction to the BCMA system should include a focus on hospital patient safety initiatives, TJC

recommendations, and regulatory requirements that support the need forminimizing error-pronecircumstances.

• Training tools, such as user guides, videos, and other training aids, should be obtained from theBCMAsystemvendor.

• BCMAsystemequipmentshouldbereservedforongoingusertraining.• Hospitalnurses,suchasnursingeducationinstructors,andtheBCMAvendorshouldjointlyconduct

initialtrainingsessionswhilethetechnologyisbeinglearned.Duringsystemrollout,nursingshouldgraduallyassumethetrainingrolewithlesshelpfromthevendor.

• Ifexperiencedconsultantsareavailable,theirinputshouldbeobtainedabouttrainingcontent.• NursingeducationinstructorsshouldincorporateBCMAsystemtrainingintotrainingfornewlyhired

staff.• AtimeandplacemustbechosenforBCMAsystemtraining.Accesstofullyfunctionalequipmentwill

be required at that location. A location away from the patient care area is recommended foruninterrupted learning. Training before or after regularwork shifts should be considered, even ifovertimeapplies.

• Areasonableamountoftimeforthetrainingsessionshouldbeallotted,includingtimeforhands-onpracticeandaquestionandanswerperiod.

• Certificatesofcompletionshouldbeissuedforthetraining,andthetrainingshouldbedocumentedineachemployee’seducationrecord.

• Allchangestocurrentpoliciesandproceduresshouldbeaddressed,includingproceduresforplannedandunplanneddowntime.

• Explanation of theHealth Insurance Portability andAccountability Act of 1996 (HIPAA) regulationsshouldbeincludedrelatedtoBCMAsystemtechnology.

6.7.5 Go-LiveandOngoingSupport

SupportofaBCMAsystemduringago-livephaserequiresacollaborativeeffortbyinformationsystems,nursing, pharmacy, and the BCMA vendor. Care should be taken to accommodate userswith varyinglevelsoftechnicalexperience.Appropriate support-staff levels should be considered during the first several days if not weeks ofimplementation,sincemuchlearningwillbegainedfromrealpatientcareexperience.Staffnurseshavereported stress when first using a BCMA system in the presence of patients, so having support helpavailableisimportanttouseracceptanceintheearlystages.AnongoingnursingsupportplanfortheBCMAsystemshouldbedeveloped,communicated,andclearlyunderstood by the nursing staff. It should specify whom a nurse should contact when proceduralquestionsarise,whentroubleshootinghelpisneeded,orwhensystemfailuresoccur.Thesupportplanshouldincludeanescalationprocess,beginningwithinternalhospitalsupportandescalatingtoareadilyaccessiblevendorcustomersupportdepartmentwhennecessary.

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6.7.6 SpaceConsiderationsforNursing

SinceBCMAsystemsareusedatvariouspointsinmedicationadministration,specialattentiontonursingunitandbedsidespaceconstraintsshouldbeconsideredwhenselectingBCMAsystemequipment.Spaceavailability at each step of themedication administration process should be examined. For example,theremaybesufficientspaceforrequiredBCMAsystemequipmentatthebedsidebutnotenoughspaceinamedication room fornecessaryBCMAequipmentwhen thenurse ispreparingmedicationsor IVs.Additionally, equipment will require a designated storage place with access to an emergency-powerelectricalsourceforrechargingbatteriesandforstoragewhennotinuse.Thespaceschosenshouldnotinterferewithotheractivitiesandmustmeetsafetyrequirementsestablishedforpatientcareareas.WorkstationsonrollingcartsorstandswerecommonintheearlygenerationsofBCMAsystemsinthemid-1990s and still exist today. These devices typically include a laptop computer with wirelessnetworkingcapabilityandatetheredorBluetooth®barcodereader. Somethingstoconsiderwithsuchdevicesare:• Howeasilytherollingcartsorstandsfitthroughdoorways• Spaceavailableinpatientroomsandatthebedside• Spaceavailableinotherareaswheremedicationsareprepared(ifapplicable)• Electricalsources• Thenumberofdevicesrequiredtoservethenursingunit• Storagespacewhennotinuse• Whether the BCMA system vendor will load software onto the hospital’s own computers (e.g.

laptops)andwhetheritwillbepossibletorunotherapplicationsonthesamecomputerstohelpsavespace

• Whetherhandhelddeviceswillbeusedwhencircumstancespreventtheuseofrollingcartsorstands• HowcleaningwillbedoneandinfectioncontrolstandardswillbemaintainedSomeBCMAsystemsusewirelesshandhelddevices. Sometimeswhenhandhelddevicesareused, therequirementforthenumberofothercomputersislessthanwithsystemsusingstationaryworkstationsorworkstationsonrollingcartsorstands.SomeBCMAsystemsuseastationarycomputeratthebedside.Flat-screencomputerscanbemountedonawallorstandnearthebedside. TetheredorBluetooth®barcodescannersmaycommunicatewiththese stationary components. Stationary bedside components may require supplemental handhelddevices for usewhenmedicating ambulatory patients. Handheld devices require dedicated space forstorageandrechargingwhennotinuse.Thesedevicesmaybecapableofuseforotherpurposes,suchasCPOEandothernursingdocumentation.PerHIPAA,theprotectionofpersonalhealthinformationfromviewbyvisitorsandotherpatientsmustbeconsideredwhenanysystemsareused.6.7.7 ElectronicCharting

ItisimportanttoensurethatallthecomponentsthatmakeuptheeMARcometogetherinoneviewthatwillbecomethepermanentpatientrecord.ItisessentialthattheeMARfacilitatethedocumentationofmedication administration. The use of an EHR will allow for other disciplines to view medication

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administration in a view that will facilitate assimilation of that information to drive patient care.Determining the documentation comments and exception comments for BCMA should be consideredwhendesigningthesystem.6.7.7.1IdentifyingthePatientThe patient must be recognized by the system electronically. Therefore, the admitting process mustidentifyallpatients,whethertheyenterthehospitalsystemasinpatients(fullyadmittedoradmitted“forobservation”) or outpatients, in the same electronicmanner (usually barcoding). Patient information,including key identifiers such as a medical record number and unique visit number, must be sharedthrough an admissions-discharges-transfers interface with a BCMA system. When a patient medicalrecordnumberingsystemisused,auniquepatientvisitnumberisassignedforeachincidentofcare.Itmustbedecidedwhetherthebarcodeonthepatientwristbandwillcontainthepatient’smedicalrecordnumber,visitnumber,orbothforproperidentificationofthepatientbyaBCMAsystem.ItisrecommendedthatnursingstriveforconsistencyofformatforbothinpatientandoutpatienteMARs.6.7.7.2IdentifyingtheCaregiverAneMARmustaccuratelyidentifyandrecordthecaregiverforallmedicationadministrations.Therefore,all caregivers that administer medications to patients have to be identified electronically to a BCMAsystem.AlthoughemployeeIDbadgesoftencontainmagneticstripes,abarcodeontheemployeebadgeismaybeused foruser identificationbyaBCMAsystem.Manyhospitalsuseproximity readersand/orbiometricstodeterminetheidentityofthenurseduringmedicationadministration.TheuseofauserIDandpasswordaretypicallystillrequiredtogainaccesstotheEHRsoftwarepriortothenursebeginsanyactionsintheBCMAmodule.6.7.7.3DataabouttheMedicationAdministrationEventSince clinical observations and assessments happen at the same time asmedication administration, aBCMAsystemshouldallowuserstocapturethosedataduringadministrationtoberecordedintheEMR.Typically,nursingpoliciesandproceduresarealready inplacetodefinetheclinicaldatathatshouldbecaptured. When planning for a BCMA system, a thorough review of these charting requirements isnecessaryinordertoensurethatthenecessaryinformationcanbecaptured.It is useful for a BCMA system to enable reconciliation between what is dispensed and what isadministered. It also is useful for a BCMA system to capture real-time billing information aboutmedicationsadministered,basedontheNDCsofscannedproductsinordertofulfillbillingrequirementsoftheCentersforMedicareandMedicaidServices(CMS).6.7.8 MedicationsAdministeredbyNon-NursingPersonnel

A BCMA system and related processes must support non-nursing practitioners that administermedications. As noted earlier, for example, in some hospitals, physicians may administer certainmedications topatients. Again, it ishighlydesirable forphysicians toverifyanddocumentmedicationadministration in the samemanner as nurses. Considerations should be determined formedical staffthat routinelyadministersmedications, suchasanesthesiologists.PhysiciansadministeringmedicationsaspartofaprocedureorforsedationmayrequiretrainingforuseoftheBCMAsystem.Iftheseproviders

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donotusetheBCMAsystem,thepatient’snursemayberequiredtodocumenttotheadministrationofthe medication on the eMAR by proxy. Other providers may have a limited scope of medicationadministration,but shouldalsobe included in theuseof theBCMAsystem (i.e., radiology technicians,respiratorytherapists,perfusionists,etc.).In a teaching institution, student nurses pose a challengewith BCMA systems. In addressing this, therelationshipbetweentheschoolofnursingandthehospitalshouldbeclearlyunderstood.Insomecases,students aswell as the instructorswho oversee themmay have to use a BCMA system to administermedications.ItisimportanttoknowwhethertheBCMAsystemcanprovideprivilegelevelcontrolsthatwillallowstudentnursestoadministermedicationsunderthedirectionofastaffnurse.Anexampleofsuch a privilege level control would be to require a documented witness before finalizing a studentnurse’smedicationadministrationtransactions.It is recommended that respiratory therapists use the BCMA system for verifying and documentingmedications used during respiratory treatments and to document patient training about the use ofinhalation devices. The medications used by respiratory therapists may be dispensed by pharmacydirectly for a patient, or they may be provided to the respiratory therapy department as stockedmedications. In either case, point of care administration and clinical data gathering for respiratorymedicationeventsshouldbeconsistentwithnursingmedicationpractices.6.7.9 InfectionControl

Infectioncontrolchallengesexistwhensharedequipmentismovedinandoutofpatientrooms.ABCMAsystemisnoexception.ItisimportantthatBCMAsystemdevicescanbecleanedusingeffectivehospital-gradecleaningagents.Alsoitisimportantthatthecleaningprocedureisfollowedafterdevicesareusedin isolation rooms. TheBCMAsystemvendor shouldbeasked for customdisposable coversor similarbarriersfordeviceswhenusedforisolationpatients.6.7.10SpecialtyNursingAreasandOtherSpecialSituations

Althoughmedicationsadministered inspecialtydepartmentssometimesmustbeadministeredwithoutentry of an electronic medication order, the hospital should consider having all departments wheremedicationsareadministereduse thesameBCMAsystemand followthesamegeneralprocedures formedication administration and documentation. For example, areas like a post-anesthesia care unit,radiology,anemergencydepartment,andacardiaccatheterizationlabshouldusetheBCMAsystemandeMARforrecordingmedicationsadministeredduringprocedures.Althoughanautomatedcheckforthe5-Rs isnotpossiblewithoutanelectronicorderentry, therestillarevaluablesafetychecksthatcanbegainedbyusingtheBCMAsystemintheseareas,suchasscreeningforallergies,appropriatedoseranges,andmedicationinteractions.Inaddition,thecaptureofaccurateCMSbillinginformationatthepointofcareinthesedepartmentsmaybeabenefit. Therefore,itshouldbeconsideredhowtheBCMAsystemcouldbeused inspecialtyareasandmay impactworkflowthere. Processchangesmayberequiredtomaximizethebenefits.Inspecialcircumstances,suchasacardiopulmonaryresuscitationorotheremergencysituationsdefinedby the hospital, scanning of a barcode at the actual time of administration may not be possible orpractical. Asecondarymethod forelectronicallydocumentingmedicationsusedduring these incidentsshouldbedevised.

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6.7.11ManagementofHardwareDevices

Althoughdevicemanagement isnot anewchallenge forhospitalsor fornursing, aBCMAsystemmayrequire some additional controls. Certain BCMA equipment may have a potential for diversion. Forexample, certain mobile devices may have personal utility if they can operate applications likespreadsheets, calendars, and word processors. In these cases, the hospital should consider using amechanismfortrackingandupdatingthesedevicesremotely.6.7.12PrivacyandHIPAA

TheHealthInsurancePortabilityandAccountabilityActof1996(HIPAA)wasestablishedtoregulatethewayhealthcare facilities transmit,store,andaccesspersonalhealth information. SincethecompliancedateofOctober16,2003,hospitalshaveimplementedstepstoprotecttheconfidentialityofhardcopyandelectronicmedical recordcontentwithin thehospitaland, ifapplicable,outside the facility. Thesestepshaveincludedimplementationof:• Physicalsafeguards,suchas

o Controlsforelectronicmediao Maintenanceandproperdisposalofrecordso Workstationaccesssecurity

• Securityadministrationsafeguards,suchaso Datatrendinganalysiso Disasterrecoveryplanningo Backupplanningo Passwordmanagemento Incidentprocedureso Securityawarenessandtrainingo Workforceclearance

• Technicalsafeguards,suchaso Systemtestingandrevisionso Auditcontrolso Strictcontroloverremotesystemaccesso Systemdesignintegrityo Dataencryptionanddecryptiontechniques

• Strategy,assessment,andremediationsteps,suchaso CorporatecompliancewithHIPAAregulationso Riskassessmento Gapanalysestoassesscompliancewithregulations

• Informationsystemsstandards,suchaso Standardsfortransactiondatao Establishingcodesetsandidentifierso Consents,authorizations,anddisclosureso Privacynotificationpracticeso Adherencetoprivacylaws

• CPOEconsiderations,suchaso Requirementsanddesignstosupportprivacyo Medicationdecisionsupport

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• Patientsafetyandreductionofmedicationerrorefforts,suchaso UsingBCMAsystemstoverifythe5-Rso Improvingprocesssophisticationo CompliancewithFDAregulationsaboutbarcoding

TwogeneralquestionsshouldbeaskedwhenevaluatingBCMAsystemsfornursinguserelatedtoHIPAA.• WhatfeaturesandattributesdoesaBCMAsystempossessthatdemonstrateitissensitivetopatient

privacy?• Whatresponsibilitieswillthehospitalhavetomaintainpatientprivacywithinthesystem?6.7.13OccupationalHazards

Anotherfactortounderstandishowthephysicaluserinterfaceoccurs.Anysystemrequiringrepetitivebody motions on the part of a user should be carefully studied. Evaluation, and perhaps researchthroughspeakingwithexistingusersinothersettings,willhelpdeterminewhetherthereisariskofinjuryduetorepetitivetasks.SomeBCMAdevices,suchaslaptopcomputersonrollingcartsorstands,mayposeariskinsomeworkareasby crowding theworkenvironment and therefore causing encumbrancesor a trippinghazard topatients, visitors, or healthcare providers. Assessing the space in these areas and choosing the righthardwarewillhelpreducehazards.6.7.14NursingDownTimeProcedures

Occasionalplanneddowntimeisnecessarywithanyautomatedsystem.Problemsthatsometimesoccurduring planned down time can be avoided through coordination and communication amongdepartments.If unplanned system down time occurs, it is essential to follow a pre-decided standard contingencyproceduredesignedtominimizeadverseeffectsonpatientcare. Thedowntimeprocedureshouldcallfornursestoimmediatelyreverttoamanualmethodofmedicationverificationanddocumentation.Thismanualmethod shouldbedescribed in detail in a relatedprocedure. Nursingmust have a consistentmedication information source (electronic or paper) to guide medication administration if a systemfailureoccurs.Features for retrospectivelydocumentingadoseadministeredduringadown timemaybeavailable insomeBCMAsystems.Forexample,thesystemmayprovideanoptiontodocumentadministrationofamedication outside of the usual bedside barcode scanning process. Such a featuremay help capturemedication events that occur during planned and unplanned down time. However, if usedinappropriately,suchacapabilitycancreateanopportunityforwork-arounds.7-ManagingtheImplementation7.1 TheDevelopmentPhaseThe impact of a BCMA system on organizational workflow is different for every organization and

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sometimesdifferentfordifferentdepartmentswithinanorganization.Therefore,itmaybeappropriatetoemployadevelopmentphase ina limitedarea(e.g.,onenursingunit)beforeformallysigningoffonacceptance and expansion of a BCMA system. The term “development phase” is preferred over“evaluation”or“trial”becauseitavoidsimplicationsthatthetechnologymightbetemporaryandbetterdefinesthepurposeoftheprojectphase.The development phase is important for validating the system’s technical capabilities, usability, useracceptance,andrelatedworkflow. Duringthedevelopmentphase,systemand interfaceproblemscanbe resolvedby thevendor,andprocessadjustmentscanbemadeby thehospital. This isa significantstepintheimplementationprocessandshouldnotberushed.ApatientunitthatutilizesmanymedicationsandIVsofvaryingtypes,suchasamedical-surgicalunit,isagoodchoiceasaninitialgo-liveunit.Specialtyunits,suchasintensivecareunitsorpediatrics,probablyshouldbeavoidedasfirstgo-liveunitsbecausetheypresentspecialissuesthatwillbeeasiertoaddressonceexperiencewiththesystemisgained.Inadditiontosupportfrompharmacy,nursing,andinformationsystems,thevendorshouldprovidebothtechnicalandclinicalon-sitesupportattheinitiationofaBCMAsystem’sgo-live.Ago-livesupportteamshouldprovidecoverageonnightandweekendshiftstoassistuserswhoworkonlythoseshifts.There is no recommended length for a development phase. Instead, the number and depth of issuesidentifiedwilldetermineitsduration.However,theoversightteamshouldconsiderestablishingalengthoftime(e.g.,twoweeks)duringwhichnomajorissuesarefoundbeforethedevelopmentphasewillbeconsideredended.7.2 TheRoll-OutAroll-outplanshouldbefinalizedduringthedevelopmentphasesothat,oncethatphasehasconcluded,roll-outcanbeginalmostimmediately.Tominimizethetimeduringwhichtwosystemsareinuse,andtobegintakingadvantageofthesafetybenefitsofaBCMAsystem,rollouttotheentirehospitalshouldbecompletedasrapidlyaspossible.Theroll-outplanshouldincludeweeklyexpansiontoadditionalareas,scheduledpatientunitconferencesandtraininginnewareastheweekbeforethego-livedate,andsupportstaffing.

8-SpecialConsiderations8.1 DataAnalysis[15]8.1.1 ImportanceofDataManagement

ProperdatamanagementandanalysisarecriticaltothecontinuedsuccessandoptimizationofaBCMAsystem. Data gleaned from a BCMA system should be integrated with traditional performanceimprovementmethodstoprovidetheinformationnecessarytoachievethegoalofsafemedicationuse.

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8.1.2 DataCollection

Priortoimplementation,amultidisciplinarygroup,suchasasystemevaluationactionteam(madeupofrepresentatives from pharmacy, nursing, and performance improvement), should determine theperson(s)responsibleforcollectingandreviewingapplicabledata.Thecontentofreportsavailablefroma BCMA system can be used to decide who should be responsible for reviewing, analyzing, anddisseminatingeachreport.InformationfromaBCMAsystemwillrevealopportunitiesforimprovement.8.1.3 DataInterpretation

ErrorpreventiondatawillbeproducedbyaBCMAsystemintheformofwarningmessages(wrongdose,wrong medication, order status, dose omitted, etc.). It is imperative to understand the factors thatinfluencethetypesandnumberofwarningsgenerated.Therewillnotbeadirectone-to-onecorrelationbetweenwarnings received and errors prevented. Daily review of the data combinedwith consistentapplicationofmethodstoeliminatefalsepositiveswillbeessentialforcapturingmeaningfulinformation.Thisisespeciallycrucialifmultiple individualsareresponsiblefordatacollectionandinterpretations.Itshould be possible for data to be exported from a BCMA system for trending and further analysis ifneeded.8.1.4 Reporting

ReportsdetailingtheimpactofaBCMAsystemonmedicationadministrationactivitiesandpatientsafetycanbeuseful topharmacy,nursemanagers, respiratory therapy,andasystemevaluationactionteam.Established hospital groups such as the Pharmacy and Therapeutics Committee, Nursing ExecutiveCommittee,PatientSafetyCommittee,andPerformanceImprovementCommitteemaybeinterestedinreceivingquarterlysummariesofmedicationsafety information. Thesereportsshould include,butnotbe limitedto,thenumberofdosesadministeredanderrorspreventedeachmonth,thetypesoferrorsprevented, the potential severity of errors prevented, the medications involved, and the processimprovementsmade.8.1.5 Data-DrivenProcessImprovement

Information derived from BCMA system reports can be utilized on an ongoing basis tomake processimprovements. Forexample,rootcauseanalysisofthedatamay indicatethatareviewofpoliciesandprocedures relating to medication administration is needed. Similarly, an analysis may identifyproblematic medications or issues with the medication distribution system. The data should help topinpoint additional training needs for pharmacy or nursing and can be used to identify workflow orstaffingissues.Applicationofaseverityindex,suchastheNationalCoordinatingCouncilforMedicationErrorReportingandPrevention (NCC-MERP) severity scale, toerrorsoccurringandpreventedwill helpstratifydataforfocusedprocessimprovements.It is important for organizations to set clear requirements for use of a BCMA system and hold staffaccountableforadherence.8.2 GeneralDownTimeProceduresSincehospitals haveused computer technology for years,most hospitals haveprocedures for planned

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and unplanned down times for both overall networks and for individual systems. Understanding thedifferences between planned and unplanned down time is necessary to properly plan for theiroccurrence.Planned down time requires multi-department collaboration and a planned sequence of events.Occasionally, the information systems department, sometimeswith system vendors, will take systemsdowntoperformroutinemaintenance,toimproveperformance,toupgradehardwareorsoftware,ortomoveequipmenttoanewlocation.BCMAsystemsarenoexception.The process for plannedBCMA systemdown times should beginwith adequate notification of systemusers to allow them to plan ahead. For example, nurses will have to know during which period’smedicationadministrationmustbe scheduledanddocumentedmanually andwhen the systemwill berestoredinordertocarryoutnecessarytasks.ForaBCMAsystem,itisrecommendedthatatleastthreedays’noticebegiventopatientcareareasandtopharmacybeforeaplanneddowntimeoccurs.The information system department should be sensitive about scheduling planned down time duringperiods of high system use, such as times when medication administration is occurring and when apatientcensusishigh.Schedulingplanneddowntimeonaweekendduringthelateeveningoratnightwhenfewerdosesarebeingadministeredshouldbeconsidered.Departmentalpoliciesandproceduresshouldclearlydescribetheprocesstobefollowedforunplanneddowntime,bothforhardwareorsoftwaredowntime.8.3 UniqueHospitalCharacteristicsCertainhospitalcharacteristicswillaffectaBCMAsystemandshouldbeconsideredwhenplanninganddevelopingpoliciesandprocedures.Examplesofsuchcharacteristicsinclude:• Pharmacyservicehours.Ifthepharmacyisnota24-hourservice,pharmacysystemorderentrywill

notoccurduringoffhoursandthereforetheorderinformationthatdrivesaBCMAsystemwillnotbecurrent. In such a case, the BCMA systemwill have to allow the administration of “non-orderedmedications”with a feature for retroactively associating the doses administeredwith orders afterorderentryhasoccurred. Inaddition,pharmacyshouldensurethatmedicationsarebarcodedthatmaybeaccessedtofulfillaneworderduringhourswhenthepharmacyisclosed.

• Outsourcedpharmacyservices–Ifthepharmacyusesoutsourcedservices,suchasanIVadmixtureservice,after-hoursorderentryservice,orrepackagingservice,thoseservicesshouldbeinvolvedinplanningforbarcodingtosupportaBCMAsystem.

TheuseofBCMAoutsidethe inpatientnursingunitshouldbeconsideredbasedonthetypesofclinics,departments,andproceduralareasexistingwithintheinstitution.Thepre-existenceofpharmacyservicesin theseareasmayensurea smooth implementationofBCMA.Thepatient volumes, throughput, andtypes ofmedications being utilized should be studies prior to any implementation. Equipment that issuitableforinpatientuse,maynotbeusefulintheseotherenvironments.

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9-References1. Technologies,W.B.InventorySoftware&System-AssetTracking-BarcodeScanners|

WaspBarcode.com.2016[cited2016August8];Availablefrom:http://www.waspbarcode.com/.2. Scientific,S.Label&BarcodeCreationAutomation|BarTenderbySeagullScientific.2016[cited

2016August8];Availablefrom:http://www.seagullscientific.com/.3. Foundation,A.R.a.E.Pharmacist’stoolkit:Implementingabarcodedmedicationsafetyprogram.

2004.4. Inc.,W.D.TheBarCodeHeadquarters.2016[cited2016August08];Availablefrom:

http://www.barcodehq.com/.5. Neuenschwander,M.,etal.,Practicalguidetobarcodingforpatientmedicationsafety.American

JournalofHealth-SystemPharmacy,2003.60(8):p.768-779.6. Technology,O.o.t.N.C.f.H.I.MeaningfulUseDefinition&Objectives.2016[cited2016August];

Availablefrom:https://www.healthit.gov/providers-professionals/meaningful-use-definition-objectives.

7. Shortell,S.M.andS.J.Singer,IMprovingpatientsafetybytakingsystemsseriously.JAMA,2008.299(4):p.445-447.

8. Wetterneck,T.B.,A.S.Hundt,andP.Carayon,FMEATeamPerformanceinHealthCare:AQualitativeAnalysisofTeamMemberPerceptions.JournalofPatientSafety,2009.5(2):p.102-108.

9. Administration,U.S.F.a.D.BarCodeLabelRequirements.2016[cited2016August08];Availablefrom:http://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/advertisinglabelingpromotionalmaterials/barcodelabelrequirements/default.htm.

10. J.,N.,UnderstandingandApplyingMedicationBarCodeTechnology:PharmacyChallenges,inAmericanSocietyofHealthSystemPharmacistsMid-YearClinicalMeeting.2004:NewOrleans,LA.

11. SONG,L.,B.PARK,andK.M.OH,AnalysisoftheTechnologyAcceptanceModelinExaminingHospitalNurses’BehavioralIntentionsTowardtheUseofBarCodeMedicationAdministration.CIN:Computers,Informatics,Nursing,2015.33(4):p.157-165.

12. Kelly,K.,etal.,CreatingaCultureofSafetyAroundBar-CodeMedicationAdministration:AnEvidence-BasedEvaluationFramework.JournalofNursingAdministration,2016.46(1):p.30-37.

13. Savage,B.A.,etal.,BCMAScanningStars:ASustainableBestPractice:ASustainableBestPractice.CIN:Computers,Informatics,Nursing,2014.32(9):p.413-419.

14. Practices,I.f.S.M.ISMPListofHigh-AlertMedicationsinAcuteCareSettings.2014[cited2016August08];Availablefrom:https://www.ismp.org/Tools/institutionalhighAlert.asp.

15. Larrabee,S.,UnderstandingandApplyingMedicationBarCodeTechnology:PharmacyChallenges,inAmericanSocietyofHealthSystemPharmacistsMid-YearClinicalMeeting.2004:NewOrleans,LA.

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Thefollowingvendorwebsiteswerevisitedduringthecourseofthisproject:Allscripts-http://www.allscripts.comBarcoding,Inc.-http://www.barcoding.com/hospital-acute-care-facility-data-capture-solutions.shtmlBD/CareFusionCorporation-http://www.carefusion.com/CapsaSolutions-http://www.capsasolutions.com/CernerCorporation-http://www.cerner.com/CliniComp,Intl-http://www.clinicomp.com/CodeCorporation-http://www.codecorp.com/healthcare.php CPSI-http://www.cpsi.com/Epic-http://www.epic.com/GEHealthcare-http://www3.gehealthcare.com/enGS1US-http://www.gs1us.org/HealthIndustryBusinessCommunicationsCouncil-http://www.hibcc.org/Hospira,Inc-http://www.hospira.com/en/MEDITECH-http://home.meditech.com/en/d/home/NetsmartTechnologies-http://www.ntst.com/Omnicell,Inc-http://www.omnicell.com/QuadraMedCorporation-http://www.quadramed.com/SiemensHealthcare-http://usa.healthcare.siemens.com/infrastructure-itSoftwriters,Inc-http://www.softwriters.com/SwisslogHealthcareSolutions-http://www.swisslog.com/healthcareTalyst,Inc.-http://www.talyst.com/ZebraTechnologies-https://www.zebra.com/us/en/solutions/healthcare-solutions.html

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10–Contributors

2013ExpertAdvisoryPanel

ThomasCooley,R.Ph.,M.B.A.DirectorofPharmacyInformaticsandSupportServicesBrighamandWomen'sHospital/PartnersHealthcareBoston,MA

PaulSeelinger,R.Ph.HealthcareTechnologyConsultantRedondoBeach,CA

AshleyDalton,Pharm.D.PharmacyManagerUniversityofCalifornia,SanDiegoHealth-SystemSanDiego,CA

DaphenShum,R.Ph.AssociateChief/InformaticistVAMarylandHCSPerryPoint,MD

EricPoon,M.D.,M.P.H.VicePresidentandChiefMedicalInformationOfficerBostonMedicalCenterBoston,MA

TinaSuess,B.S.N.,R.N.ManagerMedicationSafetyIntegrationLancasterGeneralHospitalLancaster,PA

MarkSiska,B.S.Pharm.,M.B.A./T.M.ChiefPharmacyInformaticsOfficerPharmacyServicesMayoClinicRochester,MN

ContentDevelopmentandReview

DanielCobaugh,Pharm.D.,DABAT,FAACTEditorinChief,AJHPBethesda,MD(FoundationStaff,2013/Reviewer,2014)

MarkSiska,B.S.Pharm.,M.B.A./T.M.ChiefPharmacyInformaticsOfficerPharmacyServicesMayoClinicRochester,MN(LeadAuthor&Reviewer,2013)

KarlF.Gumpper,MMI,BCPS,FASHP,PharmacyInformaticsManager,BostonChildren’sHospital,Boston,MA(ASHPStaff,2013/DevelopmentandReview,2016)

RayburnVrabel,Pharm.D.MedicationSystemsStrategyConsultingSanDiego,CA(Reviewer,2013)

PaulSeelinger,R.Ph.HealthcareTechnologyConsultantRedondoBeach,CA(Reviewer,2013)

AllieWoods,Pharm.D.ASHP,Director,SectionofPharmacyInformaticsandTechnologyBethesda,MD(Reviewer,2014)