GS1 Healthcare – worldwide implementation for patient safety Ulrike Kreysa, VP Healthcare, GS1 Global Office GS1 Portugal Healthcare seminar, Lisbon 5th June 2014

© 2014 GS1

2

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

© 2014 GS1

3

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. © 2014 GS1

GS1 Healthcare Global User Group

© 2014 GS1

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

© 2014 GS1

• • • • • • •

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 …

36 Local Healthcare user groups driving adoption of GS1 standards worldwide

© 2014 GS1

7

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. © 2014 GS1

8

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

+ minimum requirements on quality of randomisation

Example: GTIN: Batch: Expiry: S/N:

(01) 07046261398572 (10) TEST5632 (17) 130331 (21) 19067811811

Specifications provided in EFPIA’s: “European Pack Coding Guidelines” © 2014 GS1

Pharma – The European Stakeholder Model Source ESM presentations

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 • Successful pilots in Sweden and Germany 10

© 2014 GS1

The move towards harmonisation and GS1 standards in Europe

© 2014 GS1

© Copyright GS1 AISBL, 2012. All Rights Reserved.

The world aligns towards GS1 DataMatrix

Argentina

Saudi Arabia

Jordan

Brazil

India

Korea

Algeria

Turkey

EU

USA EU

GTIN – Global Trade Item Number Plus attributes • Lot number • Expiry date • Serial number (2016) • In a GS1 DataMatrix

© 2014 GS1

12

Long expected – and requested! The final UDI rule of the US FDA

GS1 was accredited as first issuing agency by the FDA

© 2014 GS1

13

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.

© 2014 GS1

14

UDI system… overall System at a glance UDI/UDID - System

UDID

UDI

(database) Static Data Elements

• DI (static data)

• PI (dynamic data)

• DI = primary access key

•… •…

AIDC Machine – readable Data Carrier

• Linear Bar Code • 2D Bar Code • RFID •…

DI = Device Identifier PI = Production Identifiers 15 © 2014 GS1

UDI in GS1 terms

© 2014 GS1

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. © 2014 GS1

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

© 2014 GS1

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

© 2014 GS1

NHS Procurement

“WE WILL MANDATE THROUGH CONTRACTS THE USE OF GS1 CODING IN THE NHS”

© 2014 GS1

20

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 • • • • © 2014 GS1

Vigilance & surveillance Recall procedures Decision making on national health policies Purchasing and tendering processes 21

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 http://www.imdrf.org/

© 2014 GS1

22

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 © 2014 GS1

Contact Details Ulrike Kreysa Vice President Healthcare GS1 Global Office E [email protected] W www.gs1.org/healthcare