A global standard will change the world

Ulrike Kreysa, VP Healthcare

GS1 Global Office, Brussels

10 April 2013

© 2012 GS1

WHY?

© 2012 GS1

Patient safety !

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• 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

© 2012 GS1

Patient Safety – more…

Tuberculosis

• 8 million people get sick every year, in 2011 1,4 million died from it

• Recently research team collected samples of two commonly used medicines, isoniazid and rifampicin, from neighborhood pharmacies and markets in 17 countries where tuberculosis is pervasive

• Nearly one of every 10 pills failed to meet basic quality standards. In African countries, one in six pills was substandard.

• Consequences: People die - resistance is developing, which could be a global threat

Source: Roger Bates in New York Times 5 Febr. 2013

© 2012 GS1

Patient safety…more!

© 2012 GS1

GS1 Standards in Healthcare

• Enable automatic identification

systems

• Enable traceability systems

• Enable « clean » data

GS1 Standards in Healthcare improve patient safety worldwide

© 2012 GS1

At the beginning…

...we dealt with the famous chicken and the egg problem!

© 2012 GS1

GS1 Healthcare - 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.

© 2012 GS1

GS1 Healthcare User GroupSupply-side Organisations

© 2012 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

USAUSA

Macedonia

© 2012 GS1

31 Local Healthcare user groups driving adoption of GS1 standards worldwide

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© 2012 GS1

GS1 Healthcare around the World

Manufacturers3MAbbott LaboratoriesAbbVieAlcon LabsAmgenAstra ZenecaBaxterBayerBecton DickensonB. BraunCookCovidienEdwards LifescienceFreseniusGE HealthcareGenzymeGileadGlaxoSmithKlineJohnson & JohnsonMedtronicMerck & Co.Pall MedicalPfizerPurdue PharmaSmiths MedicalTEVAZimmerSolution providerAdvancoAxwayGHXSeidenader

Distributors/Healthcareproviders/GPOs/T&LCardinal Health (U.S.)CH Aulnay sous Bois (France)Comparatio Health (Germany)DHL Exel Supply ChainErasmus MC Rotterdam (NL)Filip Vtori hospital (Macedonia)UNI.HA (representing 17 French university hospitals)Hong Kong Hospital AuthoritiesMcKesson (U.S.)Novation (U.S.)Orthopädisches Spital SpeisingWien (Austria)Premier (U.S.)St. James Hospital, DublinMarienhospital Herne (Germany)UMC Groningen (NL)University Kentucky Healthcare (U.S.)Wiener Krankenanstaltenverbund(Austria)

Non-voting membersAHRMMCladimedEDQM – Council of EuropeFDA USAInstituto Brasileiro de ÉticaConcorrencial – ETCOPublic Health Agency of CanadaUS DoD

Manufacturers3MBayerBecton DickinsonBoehringer IngelheimColoplastDraeger MedicalGenzymeHospiraKimberly-ClarkNovo NordiskPurdue PharmaSt. Jude MedicalStrykerTeva PharmaceuticalsTerumoUCBUpsher-Smith…Distributors/WholesalersAexxdisAmerinetAmerisource BergenCH2DepolaboGalexisGAMMA WholesaleGeodisMcMahonOwens & Minor…

Healthcare providers/RetailersAlfred Hospital (Australia)Ascension Health (U.S.)Capital District Health (Canada)CHU de Québec (Canada)CHU Dijon (France)HUG Geneva (Switzerland)London Drugs (U.K.)Mayo Clinic (U.S.)Sisters of Mercy (U.S.)Sobeys Pharmacy (U.K.)UHCS Augusta VA (U.S.)Walgreens (U.S.)Wal-Mart (U.S.)…AssociationsAHA (U.S.)CIP/ACL (France)CHeS (U.S.)EFPIA (Europe)Eucomed (Europe)FENIN (Spain)GIRP (Europe)HDMA (U.S.)International Hospital FederationJFMDA (Japan)Medical Industry Association)LIF (Sweden)NACDS (U.S.)Patient Safety Foundation (U.S.)…

Members global user group Local participation

And many more…

© 2012 GS1

Main drivers for implementation

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Customer request

Regulation

© 2012 GS1

Establishing a UDI System

1. A standardised system to develop the unique device identification numbers (UDI)

2. Place the UDI in human readable and/or bar code/RFID on a device, its label, or both

3. Create and maintain the UDI Database

4. Implementation and adaption

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© 2012 GS1

UDI System at a glance

DI = Device IdentifierPI = Production Identifiers (i.e. lot/batch no., serial no., expiry [use by] date, date of manufacture)

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UDI

• DI

(static data)

• PI(dynamic data)

Static Data Elements

• DI = primary access

key

• …• …• …

AIDC

Machine –readable Data

Carrier

• Linear Bar Code

• 2D Bar Code

• RFID

•…

UDID(database)

UDI/UDID - System

© 2012 GS1

UDI in the GS1 system of standards

UDI (Unique Device Identification)

. DI = Device identifier = GTIN allows the unambiguous identification of a specific medical device

. PI = Production Identifier = Application Identifier AI (XX) for lot/batch no., serial no., expiry date, in any combination in combination with GTIN

UDID (Unique Device Identification Database)

The GDSN network enables feed to UDI databases via data pools across the world

AIDC (Automatic Identification and Data Capture)ISO compliant machine-readable data carrier on the product or it’s packaging, which contain the UDI : linear or 2D barcodes, RFID

UDI

UDID

AIDC

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© 2012 GS1

UDI MarkStatic part = DI

Device identifier (GTIN)

Dynamic part = PIProduction identifier (serial or lot

number, & expiry date)

Example UDI

© 2012 GS1

UDI: 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

• Supply chain security/anti-counterfeiting

• Reduction of medical errors

© 2012 GS1

UDI: 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

© 2012 GS1

European Commission & UDI26.09.2012

• UDI included in the EU Medical Device legislation recast :

• 3 Directives …

– Directive 90/385/EEC on active implantable medical devices

– Directive 93/42/EEC on medical devices

– Directive 98/79/EC on in vitro medical devices

• … merged into 2 new Regulations:

– Regulation on medical devices (AIMD+MD): EC proposal published end of September and transmitted to the EP and Council (co-decision)

– Regulation on IVD

• Proposals include provisions on identification and traceability

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© 2012 GS1

Time line for UDI implementation in EU

Revision proposal (26th September 2012)

Recommendation a common UDI System in the EU (March 2013)

Ordinary legislative procedure (1/2 to 2 years)

Adoption of the New REGULATION(2Q 2014)

Adoption of detailed traceability requirements(Starting from 2014)

Source: Presentation EU Commission at GS1 Global Forum

© 2012 GS1

UDI Database: Open Issues

UDID

??

UDID

?? EU UDIDEudamed)

GUDID

USA UDID

AP ??

NETWORK

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IMDRF/UDI WG: Now concentrating on the issue of exchange of informations between UDID”s

© 2012 GS123

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

PatientPharmaceutical Manufacturer

Unique Serialisation with Random Numbers

2D Data Matrix Code on 2nd Pack

Upload Number

MedicinesVerificationRepository

PharmacistWholesaler

ProductFlow

Wholesaler

VoluntaryVerification

Product #BatchExpiryS/N

Authenticate Number

© 2012 GS1

European Federation of Pharmaceutical Industries and Associations (EFPIA) Recommendation for Coding of

Pharmaceutical Products in Europe

Data Matrix – Coding proposal derived from GS1 standards (EAN 128 syntax with Application Identifiers; DataMatrix ECC200)

Manufacturer Product Code (GTIN or NTIN): 14 digits Unique Serial Number (randomized): up to 20 alpha-numeric charactersExpiry Date: 6 digits (YYMMDD)Batch Number: up to 20 alpha-numeric characters

+ minimum requirements on quality of randomisation

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

Example:

GTIN: (01) 07046261398572Batch: (10) TEST5632Expiry: (17) 130331S/N: (21) 19067811811

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© 2012 GS1

Hospitals as Customers

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• Big movement in US – GLN and GTIN sunrise supported by all major hospital groups/GPO’s and other stakeholders

• Continuous implementation and engagement in Canada with hospital groups, endorsement by Patient Safety Group

• French University hospitals get GS1 France members, implementing traceability

• Amgros in Denmark is driving implementation of lower level marking

• Dutch university hospitals request GS1 standards

• UK NHS includes GS1 standards in tender

• Spanish hospitals have been driving GS1 standards since years

• Hong Kong Hospital Authorities work on identification and clean data with their suppliers

• Japanese hospitals implement GS1 in striving to use latest technology

• Nehta continues to lead the implementation on GS1 standards for product catalogues in Australia

And so many more…..!!!

© 2012 GS1

Recent Announcement in the UK

Raising our game

Sir David Nicholson, CEO NHS demands all trusts take action to implement GS1 in NHS Procurement:

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“A requirement for trusts and suppliers to adopt standard bar-coding (GS1), to improve

procurement data and enable price comparisons whilst improving stock control and

patient safety .”

© 2012 GS1

Level Below the Each Work Group

• WR# 10-000301 - Level Below Each:• Provide guidance on "Level Below the Each" identification &

marking for GS1 Healthcare solutions

• Started in 2011 – now NEARLY FINALISED!

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The needs of Healthcare go beyond those in the retail sector

© 2012 GS1

A world of information…

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Implementations

Case studies

Articles

News

http://www.gs1.org/healthcare

© 2012 GS1

Global standards enable patient safety worldwide !

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© 2012 GS1

WayPaver Award for GS1 Healthcare

For the first time, The unSUMMIT for Bedside Barcoding of The TerraPharmaProject, is honoring a global organization, GS1 Healthcare, with its WayPaver

Award. The award honors exceptional contributions of individuals and

institutions, which have helped clear the path and accelerate the adoption of bar-code-enabled point-of-care (BPOC) safety systems in healthcare.

Mark Neuenschwander, cofounder of The unSUMMIT: “Because of GS1

Healthcare’s path-clearing efforts, inestimable harm will be avoided to patients around the world, and countless lives will be spared death from preventable

medication errors.”

http://www.unsummit.com/gs1-global-healthcare-to-be-honored-at-the-eighth-

annual-unsummit-for-bedside-barcoding/

Congratulations to all of us!

Contact DetailsUlrike Kreysa

GS1 Global Office Brussels

E ulrike.kreysa@gs1.org

W www.gs1.org/healthcare