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Traceability in the global supply chain Masterclass GDP Séverine Dewerpe, Healthcare Manager, GS1 Belgilux March 5 th , 2015

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  • Slide 1
  • Traceability in the global supply chain Masterclass GDP Sverine Dewerpe, Healthcare Manager, GS1 Belgilux March 5 th, 2015
  • Slide 2
  • GS1 Belgium & Luxembourg 2015 Agenda Why global standards? Developments on traceability across the world Global regulatory developments Benefits of traceability in the vaccines supply chain Q&A
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  • GS1 Belgium & Luxembourg 2015 Why global standards? 3
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  • GS1 Belgium & Luxembourg 2015 Why global standards? Lack of standards in daily life is inefficient and annoying 4
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  • GS1 Belgium & Luxembourg 2015 Why global standards? 5 in healthcare it is dangerous and inefficient ! Multiple bar codes on one package which one to scan? Different types of bar codes inconsistency; incompatibility No bar code need to bar code; re-package; re-label
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  • GS1 Belgium & Luxembourg 2015 Re-bar coding by the hospital (or 3rd party provider) The need for global standards in healthcare 6
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  • GS1 Belgium & Luxembourg 2015 Speak one language Reduce complexity 7
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  • GS1 Belgium & Luxembourg 2015 An international standard organisation GS1 8 Not-for-profit 111 Member Organisations Over one million user companies (from SME to global companies) Member driven 150 countries served; 20 different domains 2,500 people helping us Over 6 billion transactions a day
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  • GS1 Belgium & Luxembourg 2015 A voluntary, global Healthcare User Group GS1 Healthcare To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies. 9
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  • GS1 Belgium & Luxembourg 2015 GS1 Healthcare Global User Group
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  • GS1 Belgium & Luxembourg 2015 GS1 Healthcare around the World Manufacturers 3M Abbott Laboratories/Abbvie Actavis Pharma, Inc Actelion Pharmaceuticals Ltd Alcon Labs AMAG Pharmaceuticals, Inc Amgen Astra Zeneca B. Braun Baxter Bayer Becton Dickenson Cook Medical Covidien Edwards Lifescience Eli Lilly and Company F. Hoffmann-La Roche Ltd Fresenius GE Healthcare Genzyme Gilead GlaxoSmithKline Johnson & Johnson Medtronic Merck & Co. Novartis Pall Medical Pfizer Purdue Pharma Smiths Medical Takeda Teleflex TEVA Zimmer Solution provider 1WorldSync, Inc. Advanco Axway Blue Sphere Health Ltd. Dirk Rodgers Consulting, LLC Excellis Health GHX Marsh Consulting Ltd. OCS Checkweighers GmbH Oracle Seidenader Tracelink Distributors/Healthcare providers/GPOs/T&L AmerisourceBergen (US) Cardinal Health (US) CH Aulnay sous Bois (France) Comparatio Health (Germany) DHL Exel Supply Chain (UK) Erasmus MC Rotterdam (NL) Filip Vtori (Macedonia) Hong Kong Hospital Authority HUG Geneva (Switzerland) King FAISAL Specialist Hospital & Research Center (Saudi Arabia) McKesson Novation (US) Premier (US) St. James Hospital (Ireland) UMC Groningen (NL) UNI.H.A (representing 17 French university hospitals) UPS Wiener Krankenanstaltenverbund (Austria) Non-voting members AHRMM Cladimed EDQM Council of Europe FDA USA Instituto Brasileiro de tica Concorrencial ETCO Public Health Agency of Canada US DoD Manufacturers 3M Bayer Becton Dickinson Boehringer Ingelheim Coloplast Draeger Medical Genzyme Hospira Kimberly-Clark Novo Nordisk Pierre Fabre Purdue Pharma Sanofi Aventis Smith and Nephew St. Jude Medical Stryker Terumo Teva Pharmaceuticals UCB Upsher-Smith Distributors/Wholesalers Aexxdis Alliance Unichem (Netherlands) Amerinet AmerisourceBergen Brocacef (Netherlands) CH2 Depolabo Galexis GAMMA Wholesale Geodis McMahon Mediq (Netherlands) Owens & Minor Healthcare providers/Retailers AMC Amsterdam (Netherlands) Antonius Ziekenhuis Nieuwegein (Netherlands) Ascension Health (US) Bernhoven Ziekenhuis Uden (Netherlands) Capital District Health (Canada) CH Ren Dubos Pontoise (France) CHI Robert Ballanger (France) CHRU Strasbourg (France) CHU de Qubec (Canada) CHU DIJON (France) Deventer Ziekenhuis (Netherlands) Erasmus Medical Center (Netherlands) HealthShare NSW Health HUG Geneva (Switzerland) London Drugs (UK) Maxima Medisch Centrum (Netherlands) Mayo Clinic (US) Sisters of Mercy (US) Sobeys Pharmacy (UK) UHBS (Switzerland) UHCS Augusta VA (US) UMC Nijmegen (Netherlands) UMC Utrecht (Netherlands) VU medical center (Netherlands) Walgreens (US) Walmart (US) Associations AHA (US) CHeS (US) CNOP (France) EFPIA (Europe) Eucomed (Europe) FENIN (Spain) GIRP (Europe) HDMA (US) International Hospital Federation JFMDA (Japan) LEEM (France) NACDS (US) Patient Safety Foundation (US) SNITEM (France) Others GCS UNI H A (France) NEHTA (Australia) RESA IDF (France) Members global user groupLocal participation And many more
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  • GS1 Belgium & Luxembourg 2015 12 GS1 in Healthcare: global system of standards to ensure visibility
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  • GS1 Belgium & Luxembourg 2015 GS1 Identification Keys Unique Non-significant International Secure Foundational 13 Item identifier = Logistics unit identifier = Location identifier = And more GTIN SSCC GLN Global Trade Item Number Serial Shipping Container Code Global Location Number
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  • GS1 Belgium & Luxembourg 2015 Some data carriers can carry more detailed information about that specific unit 14 Capturing the identification key and beyond Item identifier Expiry date Batch number Serial number (21)123
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  • GS1 Belgium & Luxembourg 2015 0901234567001 ERP Entries GTIN: 0901234567001 EXPIRATION: 21.Mai 201 BATCH/LOT: 123456 SERIAL: 12345 NHRN: Scanning & AIs in action... 01108576740020171714112010NYFUL0121192837713A1B2C3D4E5F6G ? 21192837 NYFUL01 192837 713A1B2C3D4E5F6 A1B2C3D4E5F6 0110857674002017 17141120 10NYFUL01 20 Nov 2014 10857674002017
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  • GS1 Belgium & Luxembourg 2015 DataMatrix on pharmaceuticals country requires DataMatrix country using DataMatrix in pilots and/or developing requirement for DataMatrix Belgium: Pilot project unit dose marking Brazil: Traceability pilot successfully completed ANVISA regulation France: AFSSAPS regulation (2011) South Korea: Pharma regulatory requirement (2012) Spain: Pilot Serbia: Pilot Switzerland: SmartLog Pilot Turkey: Regulatory requirement (2010) Canada: Vaccines Austria: Cytostatics India: Regulatory requirement for drug exports 2013 Argentina: Traceability regulation US:Traceability Regulation (2017) Colombia: Pilot of INVIMA on traceability Jordan: Pharma regulatory requirement (2015) Algeria: Pharma regulatory requirement (2014) Saudi Arabia: Pharma regulatory requirement (2015) Ukraine: Pharma regulatory requirement (2013) Copyright GS1 AISBL, 2012. All Rights Reserved.
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  • GS1 Belgium & Luxembourg 2015 Traceability Building blocks for traceability Unique Identification - Products - Logistics units - Location & Legal entities Unique Identification - Products - Logistics units - Location & Legal entities Data Capture - Barcodes - EPC/RFID Data Capture - Barcodes - EPC/RFID Data Communication - Share data - Retrieve data Data Communication - Share data - Retrieve data Links Management - Physical flow - Information flow Links Management - Physical flow - Information flow Traceability
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  • GS1 Belgium & Luxembourg 2015 18 Regulations emerge worldwide Supply Chain costs increase Electronic Health Records Medication errors Counterfeiting Brand Protection BUT Traceability is complex, multi-sectorial and cross border, but it is not always recognized as such Traceability is becoming a necessity, but one that is addressed by an endless number of isolated solutions GS1 Standards can help Key Drivers for traceability
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  • GS1 Belgium & Luxembourg 2015 Physical Event Data - Recall What what physical objects were involved (e.g. sGTIN in a GS1 Carrier) e.g. (01)10222222333334(21)12344(10)A1345B When when the event took place (timestamp) e.g. 110922 (22 nd September 2011) Where where the event took place (e.g. GLN) e.g. 1234567890128 (Goods In, General Hospital) Why what business process step was being carried out (e.g. receiving, shipping) The 4 Ws
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  • GS1 Belgium & Luxembourg 2015 Global standards enable Compliance with regulations, effective and efficient implementation of traceability systems in Healthcare Such as: Track & Trace, Authentication, UDI = Visibility *Visibility = What, When, Where & Why 20
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  • GS1 Belgium & Luxembourg 2015 EU Commission proposal The composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date. Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level. The repository containing the unique identifiers will be set up and managed by stakeholders. National competent authorities will be able to access and supervise the database. 21
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  • GS1 Belgium & Luxembourg 2015 The move towards harmonisation and GS1 standards in Europe Copyright GS1 AISBL, 2012. All Rights Reserved.
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  • GS1 Belgium & Luxembourg 2015 A pan-European end-to-end system enabling medicines to be verified at point of dispensing Developed by the stakeholders who will use it on a day-to-day basis Run on a non-profit basis; costs to be borne by Manufacturing Authorisation Holders Pilot in Germany - SecurPharm Pharma Different emerging models 23 Driver:To address counterfeiting (falsified medicines), prevent them reaching the patient EFPIA /GIRP/PGEU/ EAEPC European Stakeholder Model (ESM) Source ESM presentations
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  • GS1 Belgium & Luxembourg 2015 Pharma Different emerging models 24 Driver:To address counterfeiting (falsified medicines), prevent them reaching the patient European Directorate for the Quality of Medicines & HealthCare (EDQM) eTACT Part of the Council of Europe; EDQM members 37 European countries, bigger than EU Traceability from manufacture to the patient, ultimately give also patients access to authenticate product MoU with Ukraine
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  • GS1 Belgium & Luxembourg 2015 US Federal Drug Quality and Security Act (DQSA) 25 as part of U.S> Drug Quality and Security Act H.R. 3204 Preempts all state laws including California New programme on securing the identity of parties in the supply chain, specially new license program for wholesalers Migration path: First phase lot bases, serialisation (SNI) after four years (2017), full track & trace after 10 years (2023) Instead of pedigree now transaction until 2017 either paper or electronic: 1.Transaction Information (TI) 2.Transaction History (TH) 3.Transaction Statement (TS)
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  • GS1 Belgium & Luxembourg 2015 Major deadlines/requirements 26 2015 For each change of ownership all three transaction information (TI, TH and TS) need to be provided Request for info by FDA needs to be fulfilled in 48 hours Authorized trading partners Lot-based information flow 2017 Serialisation added on package and case 2D DataMatrix on package, linear or 2D on case Transaction information in electronic format Information on product ID plus serial number in 24 hours 2023 Interoperable electronic tracing and exchange of transactions Traceability on item level (secondary package level) Still a lot of open questions recent request for comments by FDA until 21st April
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  • GS1 Belgium & Luxembourg 2015 WHO VPPAG recommendations for vaccines 27 VPPAG* Recommendations on use of bar codes on vaccine packaging to be included in the next WHO Generic Preferred Product Profile (gPPP) Project in Tanzania proving the benefits of bar coding for vaccines will be launched this year *Vaccine Presentation and Packaging Advisory Group http://www.who.int/immunization/policy/committees/vppag/en/index2.html
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  • GS1 Belgium & Luxembourg 2015 Proof of principle in Tanzania 28 Tracking vaccines from manufacturer to recipient Reduce wastage and spoilage by improved inventory management and logistics information Tracking down to the district level Final objective link the vaccine to the child
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  • GS1 Belgium & Luxembourg 2015 Pilot in the US 29 National Childhood Vaccine Injury Act (NCVIA) requires documentation of manufacturer and lot number of vaccines Project from Sept 2011 to Aug 2013 Participants: 2 Vaccine Manufacturers 8 vaccines 217 Immunizers 10 Immunization Information Systems Products with GTIN, Lot and expiration date
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  • GS1 Belgium & Luxembourg 2015 Results 30 Preliminary results confirm a positive effect on vaccine data accuracy and completeness Providers have positive perceptions regarding impact of 2D barcoding on efficiency and accuracy Providers are willing to adopt practices to incorporate 2D barcode vaccine use but not until the majority of vaccines are 2D barcoded Detailed information at http://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/ http://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/
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  • GS1 Belgium & Luxembourg 2015 Report quantifies supply chain issues in Healthcare New McKinsey & Company 31 New McKinsey report Strength in unity: The promise of global standards in healthcare Highlights the cost savings and patient safety benefits of adopting a single global supply chain standard in healthcare Available at: http://www.gs1.org/healthcare/mckinseyhttp://www.gs1.org/healthcare/mckinsey or http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_ Report_Strength_in_Unity.pdf Source: http://www.mckinsey.comhttp://www.mckinsey.com
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  • GS1 Belgium & Luxembourg 2015 Implementing global standards across the entire healthcare supply chain could save 22,000-43,000 lives and avert 0.7 million to 1.4 million patient disabilities Rolling out such standards-based systems globally could prevent tens of millions of dollars worth of counterfeit drugs from entering the legitimate supply chain [We] estimate that healthcare cost could be reduced by $40 billion-$100 billion globally from the implementation of global standards Adopting a single set of global standards will cost significantly less than two (between 10-25% less cost to stakeholders) Huge cost savings and patient safety benefits when adopting a single global standard in healthcare 32 New McKinsey & Company SOURCE: McKinsey report, Strength in unity: The promise of global standards in healthcare, October 2012
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  • GS1 Belgium & Luxembourg 2015 Country-by-country solutions are not sufficient nor effective Global standards 33 The need for global standards Healthcare is local Healthcare providers are local Regulations are local Healthcare is global - Healthcare supply chains often cross borders
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  • GS1 Belgium & Luxembourg 2015 Save the date: 9 March, Brussels, Tour & Taxis Please join us! You will learn How GS1 global standards get implemented worldwide and help to improve patient safety and supply chain efficiency About new regulations on traceability and UDI (Unique Device Identification) across the world Use cases and implementation at manufacturers, wholesalers and hospitals GS1 Belgilux Healthcare Day
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  • GS1 Belgium & Luxembourg 2015 Imagine a world 35
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  • GS1 Belgium & Luxembourg 2015 GS1, One language, one voice Global GS1 standards will make this a reality get engaged and support the ongoing efforts! 36 IMPROVE PATIENT SAFETY
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  • GS1 Belgium & Luxembourg 2015 Contact 37 Sverine Dewerpe Healthcare & Barcodes Manager GS1 Belgium & Luxembourg E [email protected]@gs1belu.org T +32 2 290 57 73 W www.gs1belu.orgwww.gs1belu.org
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  • GS1 Belgium & Luxembourg 2015 Questions? 38