impact of drug supply chain security act on us ... · pharmaceutical industry under decentralized...

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