EU Traceability Pilot in Pharmaceutical Supply Chain. Henri Barthel, GS1 Global Office Washington DC, 18 June 2009
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1 Building Radio frequency IDentification solutions for the Global Environment EU Traceability Pilot in Pharmaceutical Supply Chain Henri Barthel, GS1 Global Office Washington DC, 18 June 2009
2 The BRIDGE Project A 3 years project Started on July 1st Partners 15 work packages Total budget: 13 millions European Union funding: 7,5 millions 2009
3 BRIDGE Partners GS1 Labs/ Universities End users Solution Providers Global Office (Coordinator) Cambridge ETH Zürich Bénédicta Carrefour AIDA Centre AT4 wireless China France Germany Poland Spain UK Fudan TUG Graz UPC Barcelona Covap gardeur Kaufhof Nestlé UK Northland Sony BT CAEN Confidex Domino JJ Associates Melior SAP UPM Raflatac Verisign UK
4 Building Radio frequency IDentification solutions for the Global Environment Horizontal Activities WP15: Innovation policy and public policy WP14: Project management WP13: Dissemination & Adoption Tools WP12: Training Platform, Courseware & Certification Business Applications Technical Development WP4: Security WP3: Serial-Level Supply Chain Control WP2: Serial-Level Lookup Service WP1: Hardware Development 2009
5 Pharma traceability objectives Implement a complete supply chain traceability system for pharma products in a real life operational environment Multi-application support capability e.g. Electronic pedigree Product authentication Recall Inventory management Financial reconciliation Compliant with open standards (GS1) Easy to use, robust system 2009
6 Pharma traceability scope CPG Logistics Kent Pharma Movianto Distributor Tjoapack 3PL Transporter UniChem Contract Packer Wholesaler Manufacturer Traceability kernel Hospital Pharmacy Actavis Athlone Labs. Sandoz Application interface Barts and The London NHS Trust Authentication Recall Application environment Electronic Pedigree (anti-counterfeit) Inventory management Financial reconciliation 2009
7 Pharma Traceability Pilot participants: solution and technology suppliers Provision and deployment of the inline equipment and printing solution Provision of standards and RFID consultancy J J A S S O C I A T E S Project management, business consulting & marketing Independent E lectronic C om m erce C onsultants 1 J J Technical design and software development EPCIS database provision 2009
8 Pharma Traceability Pilot participants: End Users Manufacturers Actavis (UK) Athlone Laboratories (Ireland) Sandoz (UK) Contract packer Tjoapack (The Netherlands) Pre-wholesaler CPG Logistics (UK) Distributor/Storage Actavis (UK) Kent Pharmaceuticals (UK) Transport & Logistics Movianto (integrated) and others Wholesaler UniChem (UK) Hospital Barts and The London NHS Trust (UK) KENT Pharmaceuticals Athlone Laboratories 2009
9 AUTHENTICATION ID DENTIFICATION MANUFACTURING DISTRIBUTION LOGISITICS PHARMACY information collection using EPCIS SYNCHRONISATION INFORMATION ANALYSIS & SUBSCRIPTION 2009
10 Nine supply chain end users involved 19 product lines selected Major Achievements one years pharmacy stock ordered and manufactured Different packs and forms, includes 2 controlled drugs Production line encoding/printing equipment specified, acquired, configured and installed at Contract Packer and one Manufacturer Application software specified, developed and implemented 2009
11 Pilot Products 19 lines Product Form Pack Aqueous Cream 500mg Tubs 1 Warfarin 1/3/5mg Tabs 28 Clindamycin 150mg Caps 24 *Dihydrocodeine 30mg Tabs 28 Prednisilone E/C 5mg Tabs 28 *Co-Codamol 8/500mg Tabs 30 Flucloxacillin 250 / 500mg Caps 28 Penicillin V 250mg abs 28 Amoxicillin 125 / 250mg Susp/Sugar Free 100ml Amoxicillin 250 / 500mg Caps 21 Penicillin 125 / 250 mg Susp/Sugar Free 100ml Flucloxacillin 125 / 250mg Susp 100ml * controlled substances 2009
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24 Lessons learned Inline production equipment installation is a complex, precise and resource intensive operation Data Matrix / RFID operates effectively in hybrid environment & generally provided good quality reads Integration of traceability data into back office systems is key For inventory management, exploiting batch & expiry date data For financial reconciliation order/goods received/invoice For product recall For traceability purposes product locations, sales made, consumption 2009
25 Conclusions Business Case varies according to supply chain role & function Clear patient safety benefits: all parties buy- in to that Electronic chain of custody as counterfeit combatant Recall systems, increased efficiency, inventory management, financial reconciliation are all integration dependent Supply chain wide traceability totally feasible with Good planning & resourcing User commitment (senior level) and prioritisation Easy to use, intuitive, robust user systems and processes Clear policy on integration with in-house systems Good user training for all operatives involved Full trading partner collaboration & communication 2009
26 Thank you for your attention! Contact details Henri Barthel GS1 Global Office E henri.barthel@gs1.org T
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