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© 2011 GS1 www.isqua.org
GS1 Standards - Enabling the Vision for Traceability in Healthcare ISQUA Webinar – 8 th May 2013 Janice Kite, Traceability Director Healthcare GS1 Global Office
© 2011 GS1 Agenda Who is GS1 Who is GS1 Healthcare What we do Development of GS1 standards for healthcare (patients, products, places and transport) so far! Drivers of Traceability Emerging trends across the globe 3
© 2011 GS1 Who is GS1? GS1 a neutral, not-for-profit, international organisation dedicated to the design and implementation of global standards to improve the efficiency and visibility of supply chains globally and across sectors GS1 Global Office (Brussels) and local offices in 111 countries around the globe
© 2011 GS1 Global reach, local presence Close to 2 million companies around the world use GS1 Across 150 countries Over 6 billion transactions a day
© 2011 GS1 Global automatic identification standards GS1 Standards … 6 billion ‘beeps’ per day Product identification in Healthcare should be as ubiquitous as it is in the retail and grocery industries
© 2011 GS1 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.
© 2011 GS1 GS1 Healthcare User Group Supply-side organisations engaging further
© 2011 GS1 Leading healthcare organisations pave the way… Buyer/Provider-side organisations going global France Switzerland Hong Kong Netherlands Germany USA Germany Austria USA Austria France Netherlands Ireland USA Macedonia Saudi Arabia
© 2011 GS1 GS1 Healthcare around the World Manufacturers 3M Abbott Laboratories/Abbvie Alcon Labs Amgen Astra Zeneca B. Braun Baxter Bayer Becton Dickenson Cook Medical Covidien Edwards Lifescience Fresenius GE Healthcare Genzyme GlaxoSmithKline Johnson & Johnson Medtronic Merck & Co. Pall Medical Pfizer Purdue Pharma Smiths Medical Takeda TEVA Zimmer Solution provider Advanco Axway GHX Seidenader Excellis Health Tracelink Oracle 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 Authorities King FAISAL Specialist Hospital & Research Center (Saudi Arabia) McKesson (US) Novation (US) Orthopädisches Spital Speising Wien (Austria) Premier (US) St. James Hospital (Ireland) Marienhospital Herne (Germany) UMC Groningen (NL) UNI.HA (representing 17 French university hospitals) University Kentucky Healthcare (US) 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 Manufacturers 3M Bayer Becton Dickinson Boehringer Ingelheim Coloplast Draeger Medical Genzyme Hospira Kimberly-Clark Novo Nordisk Purdue Pharma St. Jude Medical Stryker Teva Pharmaceuticals Terumo UCB Upsher-Smith Distributors/Wholesalers Aexxdis Amerinet AmerisourceBergen CH2 Depolabo Galexis GAMMA Wholesale Geodis McMahon Owens & Minor Healthcare providers/Retailers Alfred Hospital (Australia) Ascension Health (US) Capital District Health (Canada) CHU de Québec (Canada) CHU Dijon (France) HUG Geneva (Switzerland) London Drugs (UK) Mayo Clinic (US) Sisters of Mercy (US) Sobeys Pharmacy (UK) UHCS Augusta VA (US) Walgreens (US) Walmart (US) Associations AHA (US) CIP/ACL (France) CHeS (US) EFPIA (Europe) Eucomed (Europe) FENIN (Spain) GIRP (Europe) HDMA (US) International Hospital Federation JFMDA (Japan) Medical Industry Association of Australia NACDS (US) Patient Safety Foundation (US) Members global user groupLocal participation … And many more …
© 2011 GS1 And many more… Recognised, open and neutral source
© 2011 GS1 GS1 and Joint Initiative Council (JIC) in Healthcare International Organisation for Standardization European Committee for Standardization Health Level 7 international International Society for Blood Transfusion International Health Terminology SDO International Society for Quality in Healthcare European Association of Hospital Pharmacists European Association of Medical Device manufacturer Clinical Data Interchange Standards Consortium World Customs Organization World Health Organization Integrating the Healthcare Enterprise
© 2011 GS1 13 GS1 in Healthcare: global system of standards
© 2011 GS1 14 GS1 in Healthcare: global system of standards Track Trace Authentication Pedigree Returns Recalls
© 2011 GS1 Lack of standards in daily life is inefficient and annoying… 15
© 2011 GS1 Lack of standards in Healthcare is inefficient and adds risk… 16 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
© 2011 GS1 The Need for Global standards in Healthcare Diverging country requirements Manufacturing headache Additional cost and risk Country A Country B Country C Country D Country E
© 2011 GS1 Speak one language Reduce complexity
GS1 Standards for Healthcare
© 2011 GS1 Global work groups AIDC Application Standards Global Data Synchronisation & Product Classification Traceability in Healthcare Public Policy Healthcare Provider Advisory Council* Meet bi-weekly via conference calls * HPAC Monthly
© 2011 GS1 GS1 Standards for Healthcare AIDC Application Standards for 90% of medical products AIDC Application Standards for small instruments Healthcare extension in next GDSN release Global Traceability Standard for Healthcare GTIN Allocation Rules for Healthcare Guideline for plasma derivatives Patient and Caregiver Identification AI for National Healthcare Reimbursement Number (NHRN) Standards development continues, but global standards are ALREADY available to build on:
GS1 Standards - Enabling the Vision for Traceability in Healthcare
© 2011 GS1 © Copyright GS1 AISBL, 2012. All Rights Reserved. 23 Traceability in Healthcare I (TH-I) Global Traceability Standard for Healthcare (GTSH) PUBLISHED 27 th February 2009 http://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare. pdf GTSH Implementation Guideline PUBLISHED 24 th April 2009 http://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Implementation _Healthcare.pdf DELIVERED:
© 2011 GS1 24 Regulations emerge worldwide Supply Chain costs increase Electronic Health Records Medication errors Counterfeiting Brand Protection Key Drivers for traceability
© 2011 GS1 GS1 Members Vision for Traceability in Healthcare 25 Full, End to End, actionable visibility of finished pharmaceuticals and medical devices in healthcare globally, from Point of Production 1 to Point of Use 2 All authentic items are identified with the appropriate GS1 Identification Keys (e.g. GTIN) and appropriate Application Identifier (AI, e.g. Serial No. AI(21)), if applicable, at point of production Supply chain identifiers are associated with the patient and remain with/on items throughout their intended useful life All physical locations are identified with the appropriate GS1 Identification Key (e.g. GLN) across the entire supply chain All patients and care givers, when in a care giving environment, are identified with the appropriate GS1 identification Keys (e.g. AI 8017; AI 8018) Agreed master data is captured and shared (e.g. via GDSN) amongst trading partners Agreed transactional data is captured and shared (e.g. via business-to-business messaging) amongst trading partners Agreed event data is captured and shared (e.g. via EPCIS) amongst trusted traceability stakeholders, based on data sharing/security policies SO THAT: 1.The terms production or producer can also mean commercially available, manufacture(r), creation(or), compounding(er)… 2.The terms use or used can also mean consumed, infused, implanted, destroyed
© 2011 GS1 Full, End to End, actionable visibility of finished pharmaceuticals and medical devices in healthcare globally, from Point of Production 1 to Point of Use 2 SO THAT: Items can be tracked (forward / downstream) across the entire supply chain (production to use) in real time Items can be traced (backward / upstream) across the entire supply chain (from current location back to the producer) in real time Item identification is available for use at patient bedside to ensure the Patient Rights 3 are achievable Patients Electronic Health Records (EHRs) are updated with agreed traceability information, including Care Giver identification Counterfeit products are detected when entering the legitimate supply chain A product recall would be fast, efficient and effective 26 1.The terms production or producer can also mean commercially available, manufacture(r), creation(or), compounding(er)… 2.The terms use or used can also mean consumed, infused, implanted, destroyed 3.Pharmaceuticals (5): Right patient, right drug, right dose, right route, right time. Medical Devices (8): right device, right location, right time, right condition, right procedure, right anatomic site, right patient, right user GS1 Members Vision for Traceability in Healthcare
© 2011 GS1 GTSH “One up, One down” Flow of goods Physical Flow Information Flow Flow of Info Traceability Partner
© 2011 GS1 Pharma – Different emerging models… US 28 Driver:To address counterfeiting: many actors in the supply chain, legitimate/illegalblurred (background? Read: Dangerous Doses, Katherine Eban (2005, ISBN 0-15-603085-3)) Numerous US States have enacted laws, e.g. Nevada, Florida California most ‘notorious’ because it specifies an ePedigree Model (aka: Chain of Custody/Chain of Ownership) Desire to identify and prosecute perpetrators Enforcement date continuously pushed out, currently starts 2015
© 2011 GS1 Pharma – Different emerging models… Turkey 29 Driver:Reimbursement Fraud; pharmacists claiming more than once for dispensed product Government developed and controlled, Centralised Track & Trace system (iTS) Enforcement date 2010, live 2+ years (the only live system globally!) Phase 1: Manufacturers published data to MoH central database (2010) Phase 2: Distributors (2012) Future phases: ePrescriptions, Patient access ROI in ONE YEAR! Reimbursement fraud eliminated Examples of counterfeits being detected entering legitimate supply chain Prosecutions… …Argentina
© 2011 GS1 Pharma – Different emerging models…Europe (1) 30 Driver:To address counterfeiting (falsified medicines), prevent them reaching the patient Two emerging (competing?) models: EDQM & EFPIA: 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 given also patients access to authenticate product Developed by EDQM
© 2011 GS1 Pharma – Different emerging models…Europe (2) 31 Driver:To address counterfeiting (falsified medicines), prevent them reaching the patient EFPIA /GIRP/PGEU/ EAEPC European Stakeholder Model (ESM) 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 Effective system expected in 2017 Verification upon Dispense to Patient Patient Pharmaceutical Manufacturer Unique Serialisation with Random Numbers 2D Data Matrix Code on 2 nd Pack Upload Number Medicines Verification Repository Pharmacist Wholesaler Product Flow Wholesaler Voluntary Verification Product # Batch Expiry S/N Authenticate Number
© 2011 GS1 Global standards enable… *Visibility = What, When, Where & Why Compliance with regulations, effective and efficient implementation of traceability systems in Healthcare Such as: Track & Trace, Authentication, UDI = Visibility*
© 2011 GS1 33 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_R eport_Strength_in_Unity.pdf New McKinsey & Company report quantifies supply chain issues in Healthcare Source: http://www.mckinsey.comhttp://www.mckinsey.com
© 2011 GS1 Huge cost savings and patient safety benefits when adopting a single global standard in healthcare 34 “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) SOURCE: McKinsey report, “Strength in unity: The promise of global standards in healthcare”, October 2012
© 2011 GS1 Ultimately, it’s all about… 35 PATIENT SAFETY! Global standards enable patient safety worldwide !
Contact Details Janice Kite Traceability Director Healthcare GS1 Global Office Brussels E email@example.com@gs1.org W www.gs1.org/healthcarewww.gs1.org/healthcare
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