GS1 Healthcare worldwide implementation for patient safety
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1 GS1 Healthcare worldwide implementation for patient safety Ulrike Kreysa, VP Healthcare, GS1 Global Office GS1 Portugal Healthcare seminar, Lisbon 5 th June 2014
2 2
3 Developments across the world Regulatory bodies need to address Public Health Hospitals look for improvement in patient care and cost reduction The global GS1standards are there and can be used, BUT Deviations from a global harmonised approach make implementation costly and complex 3
4 GS1 Healthcare a voluntary, global Healthcare User Group 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.
5 GS1 Healthcare Global User Group
6 GS1 Healthcare around the World Members global user group 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 Bristol-Myers Squibb 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 USDM Life Sciences Distributors/Healthcare providers/gpos/t&l AmerisourceBergen (US) Bernhoven Hospital (Netherlands) 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) Iberia Rehab Hospital (US) 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 Ética Concorrencial ETCO Public Health Agency of Canada US DoD Local participation 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 René Dubos Pontoise (France) CHI Robert Ballanger (France) CHRU Strasbourg (France) CHU de Québec (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) And many more
7 36 Local Healthcare user groups driving adoption of GS1 standards worldwide 7
8 FMD = Falsified Medicine Directive 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. 8
9 EFPIA Recommendation for Coding of Pharmaceutical Products in Europe Data Matrix Coding proposal derived from GS1 standards (EAN 128 syntax with Application Identifiers; Data matrix ECC200) Manufacturer Product Code (GTIN or NTIN) - 14 digits Unique Serial Number (randomized) - up to 20 alpha-numeric characters Expiry Date - 6 digits (YYMMDD) Batch Number - up to 20 alpha-numeric characters Example: + minimum requirements on quality of randomisation GTIN: (01) Batch: (10) TEST5632 Expiry: (17) S/N: (21) Specifications provided in EFPIA s: European Pack Coding Guidelines
10 Pharma The European Stakeholder Model Driver: To address counterfeiting (falsified medicines), prevent them reaching the patient EFPIA /GIRP/PGEU/ EAEPC = European Stakeholder Model (ESM) Source ESM presentations 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 Successful pilots in Sweden and Germany 10
11 The move towards harmonisation and GS1 standards in Europe Copyright GS1 AISBL, All Rights Reserved.
12 The world aligns towards GS1 DataMatrix Turkey Argentina Saudi Arabia Jordan Brazil India Korea Algeria EU EUSA GTIN Global Trade Item Number Plus attributes Lot number Expiry date Serial number (2016) In a GS1 DataMatrix 12
13 Long expected and requested! The final UDI rule of the US FDA GS1 was accredited as first issuing agency by the FDA 13
14 UDI The Objective A common, worldwide system for product identification should eliminate differences between jurisdictions and offer significant benefits to manufacturers, users and/or patients, and Regulatory Authorities. 14
15 UDI system overall System at a glance UDI/UDID - System DI UDI (static data) PI (dynamic data) UDID (database) Static Data Elements DI = primary access key AIDC Machine readable Data Carrier Linear Bar Code 2D Bar Code RFID DI = Device Identifier PI = Production Identifiers 15
16 UDI in GS1 terms
17 GDSN - A single connection to regulators and customers Manufacturers are able to provide data to all UDI databases and their customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with a single connection.
18 Benefits for Patient Safety Improved recall procedure and adverse event reporting Documentation of product/patient relationship in electronic health records (EHR) and registries Visibility of inventory availability of devices Reduction of medical errors Supply chain security/anti-counterfeiting
19 Effects on Supply Chain Efficiency Reduction of inventory levels Reduction of obsolete stock Order to invoice process improved Recall procedures accelerated and facilitated Consignment goods DRG cost calculation per patient
20 NHS Procurement WE WILL MANDATE THROUGH CONTRACTS THE USE OF GS1 CODING IN THE NHS 20
21 UDI implementation in Turkey UDI implemented since a few years All medical devices are identified and marked Approximately 2.5 million approved medical devices in the Turkish database 91.8% identified with GS1 GTIN (Global Trade Item Number) Great benefits regarding Vigilance & surveillance Recall procedures Decision making on national health policies Purchasing and tendering processes 21
22 The need to align on a global UDI framework It is crucial that regulators around the world align on the IMDRF Guidelines and ensure consistency when setting-up regional or national UDI system This would ensure : highest levels of patient safety beyond borders harmonized identification systems for medical devices globally allow for consistency in UDID across countries 22
23 The need for global standards Healthcare is local Healthcare providers are local Regulations are local Healthcare is global Healthcare supply chains often cross borders Country-by-country solutions are not sufficient nor effective GS1 standards enable a global harmonised approach and are recognised and implemented worldwide
24 Contact Details Ulrike Kreysa Vice President Healthcare GS1 Global Office E ulrike.kreysa@gs1.org W
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