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Meng YingChang,RaghavendranMohan
ImpactofDrugSupplyChainSecurityActonUSPharmaceuticalIndustryUnderDecentralizedInformationFlow
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• DrugSupplyChainSecurityAct(DSCSA)• ImplementationSolutionDesign▫ PhysicalFlow▫ InformationFlow• SupplyChainImpactEvaluation▫ Scenarios▫ OperationsCost▫ ITInvestment▫ CAPEX▫ OverallImpact• Conclusion&FutureResearch
Agenda
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FightingCounterfeitDrug
10% oftheUSpharmaceuticalproducts
50% aresoldthroughwebsites
60% don’thaveactiveingredients
17% haveinaccuratedosages
16% haveincorrectingredients
$75B businessworldwide
*2011datasource
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DrugSupplyChainSecurityAct(DSCSA)
SerializeProduct• Allprescriptiondrugsshouldhaveauniqueserial#attheunitlevel
TS/TI/TH• Recordsneedtobemaintainedatserial#levelwhenthereisatransferofownership
FDATracingRequest• Allrequestsforrecordsregardingaserial#needstobeaddressedwithin48hours
OverviewofU.S.DrugSupplyChainManufacturer DispenserDistributor
PatientRepackager5
DSCSAImplementationTimeline
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ImplementationSolutionDesign
• UnitLevelModel• AlldrugsareserializedbutthereisnomappingtohigherUOMs
• Matryoshka Model
PhysicalFlow
SerialNo.&LotNo.
SerialNo.&LotNo.
CaseInfo
SerialNo.&LotNo.
CaseInfo
PalletInfo
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InformationFlow
CentralizedModel DecentralizedModel
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To-BeProcessMap- Matryoshka Model
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To-BeProcessMap– UnitLevelModel
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To-BeDecentralizeDataExchangeModel
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SupplyChainImpactEvaluation
EvaluationScenarios
PhysicalFlowCentralized
vsDecentralized
InformationFlowUnitlevelmodel
vsMatryoshka model
• Centralizedinformationflowwith“Matryoshka”nestingofdata• Decentralizedinformationflowwith“Matryoshka”nestingofdata• Centralizedinformationflowwithunitleveldata,nonesting• Decentralizedinformationflowwithunitleveldata,nonesting
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OperationsImpact- Turnaroundtime
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Ø ImpactonInboundprocessislowerastheDSCSAonlymandatesverificationonasample(10%volume)Ø Outboundshipmentimpactcanbereducedbyeffectiveinventorymanagement,whichisnotinscopeforthis
thesis
ITImpact– InitialInvestment&RecurringCost
Centralized(3rdparty)Matryoshka
Centralized(3rdparty)UnitLevel
Centralized(Manuf)Matryoshka
Centralized(Manuf)UnitLevel
Centralized(Govt.)Matryoshka
Centralized(Govt.)UnitLevel
DecentralizedMatryoshka
DecentralizedUnitLevel § Decentralisedmodelsrequireleastinvestmentandrecurringcostastheywillbebuiltonexistingdatainterfaces
§ Centralisedmodelsrequiremostinvestmentasnewdataexchangeshavetobuiltfromscratch
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FinancialImpact- CAPEX
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Matryoshka UnitLevel
100%
62%
§ Matryoshka modelrequiremoreCAPEXinlabellingequipment
§ UnitlevelmodelrequirelessCAPEXfrom manufacturersandwholesalers
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OverallComparison
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Conclusion&FutureResearch
Conclusion
• InformationflowsolutioncanbebuiltonexistingITinfrastructure• Ensuresbusinessprivacyanddatasecurityforindividualplayers
AdvantagesofDecentralizedModel
• Matryoshka +Decentralizedmodelhasleastfinancialimpact• Loweroperationscost&ITrecurringcost
LeastImpactScenario
• Difficulttostandardizeimplementationacrossthewholesupplychain• Hybridmodelwouldincreasecomplexityofexecution
TheHybridReality
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FutureResearch
• Numberofunitsincreasesignificantly.• Difficultyinmappinginboundserialnumberswithoutboundserialnumbers
ComplexityforRepackager
• ImplementCloudservicefordecentralizeddatastorage• ApplyRFIDinproductpalletization• LeverageBlockChaintoverifyincomingdata
NewTechnologyApplication
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Meng YingChang,RaghavendranMohan
ImpactofDrugSupplyChainSecurityActonUSPharmaceuticalIndustryUnderDecentralizedInformationFlow