Presentation on theme: "Track and Trace PSSNY 2015 Mid-Winter Conference Al Emmans"— Presentation transcript:
1 Track and Trace PSSNY 2015 Mid-Winter Conference Al Emmans Dir/Marketing & IT Business ManagementRDC
2 What is Track and Trace? FDA regulatory compliance program Based on “Drug Quality and Security Act” (DQSA)signed into law on November 27, 201310 year implementation planGoal:“build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States”Purpose:Verify legitimacy of drugs down to individual package levelDetect and notify FDA regarding illegitimate drugsMake recalls more efficient
3 Manufacturers JANUARY 1, 2015 Manufacturers provide the “3T’s” TS Transaction Statement – statement of authenticity by FDA Authorized Trading PartnerTH Transaction History – chain of custody transfersTI Transaction Information – product information including lot numberSingle document, electronic (ePedigrees) or paperBeginning November 2017, manufacturers are required to provide 3T’s based on individual package serialization
4 Authorized Trading Distributors JANUARY 1, 2015Download the 3T’s in ePedigrees or capture paper documents at point of ReceivingCannot receive product unless the 3T’s are providedMust set up quarantine systemVerify lot informationAppend receipts to original 3T’sAdds to ePedigree, or modifies paper documentsMust store 3T’s for 6 yearsElectronic storage, scan paper-to-electronic, or physicalProvide appended 3T’s to next partyDistributors or Dispensers
5 DispensersJULY 1, 2015Dispensers download 3T’s in ePedigrees or capture paper documents at point of ReceivingDispensers verify lot numbers and product information against 3T’sDispensers cannot accept product unless 3T’s are providedMust set up quarantine systemDispensers must store 3T’s for 6 years
6 Reporting Based on FDA requests, audits, and investigations Distributors have 24 hours to respondDispensers have 48 hours to respondBoth parties must provide final T3 documentsOptions for voluntarily reporting suspected counterfeit, tampered or stolen productReport to distributorReturn to distributorReport to FDA
7 How Can Supply Chain Help? 1.) Outsource StorageAccording to FDA, dispensers may outsource storage and retrieval of 3T ePedigrees to third party companiesSome distributors providing internally built solutionsOthers contracting with “Traceability Vendors” such as Axway, TraceLink, Frequenz, rfXcel, & moreSystems must be confidentialMost likely to be web interfaceCould be direct or “cloud” storageDispenser simply signs 3rd party agreement effectively outsourcing ePedigree storage and retrieval to outside vendor
8 How Can Supply Chain Help 2.) Reduce paperDistributors can reduce paper by encouraging manufacturers to convert from paper receiving documents to ePedigreesIf manufacturers do not convert, distributors can also convert receiving documents to ePedigreesThe goal is to maximize the amount of true properly standardized T3 ePedigrees available for look-up by dispensers
9 How Can Supply Chain Help 3.) Buy direct from mfrsFor Authorized Distributors who buy directly from manufacturers, FDA does not require lot number and other specific item information to be sent to the dispenser in the Transaction Information (TI) segment (defined in section 582(26))If Authorized Distributors are not required to send lot number information on items purchased directly from the manufacturer, then the dispenser simply needs to verify receipt of product using current inbound order processesConversely, Secondary Distributors ARE required to send lot number information on items purchased from other suppliers. In this case the dispenser DOES need to verify lot information at the point of receiving, and quarantine product if incorrect
10 Questions for your Trading Partners Are you an Authorized Trading Partner, licensed with FDA?Do you buy directly from manufacturers?Do you provide the 3T’s in your pedigrees?Do you provide an ePedigree storage and retrieval solution for dispensers?If so, for how long?If so, can I produce ePedigrees within 48 hours?
11 Awaiting Guidance Is old product grand-fathered? Yes. Shipments received prior to January 1st , 2015 are not subject to Track and TraceWhat about Returns?Awaiting guidance from FDA“Word on the street” is returns are not required for 6 yearsHowever, Trading Partners may ask for T3’s on unknown productDrop Ship Rx – specialty, etc?
12 Awaiting Guidance Store Transfers? Awaiting guidance from FDA “In theory”, pharmacy is acting as a distributor role and should provide T3’s to receiving pharmacyTo err on the side of caution - both parties should document detailed transfer on original 3T’s statement as best as possible, and store for 6 yearsWhat about syringes, kits, etc.?Many are exempt from Track and TraceIndividual trading partners may provide item lists or notate on ordering systems
13 Is Product Serialization Coming? Yes. A full system conversion begins in 2017Manufacturers provide individual package ePedigreeCurrent plan is to use EPCIS 2-D scan codes standardized by GS-1 (international technology standards group)2-D Scan code will include the 3T’sWholesalers must scan every package inbound and outboundNovember 27, 2020 – pharmacies scan inboundScanning equipment linked to wholesaler ordering system and/or ePedigree storage?Download day’s receipt, scan all packages, ePedigrees appended automatically
14 SummaryWe are on the ground level of a sophisticated tracking system designed to protect consumers and eliminate counterfeits from healthcare distributionEmbrace FDA’s planDispensers begin compliance on July 1, 2015Embrace supply partner technologies for minimal disruption to your daily practiceEngage in conversations with your suppliers nowWatch for updates on continuing FDA guidance