RFID/EPC in Healthcare

Seoul, 25 April 2008Michel van der Heijden President,

Healthcare

Global Healthcare User Group

GS1 Healthcare is a voluntary, global user community

bringing together all healthcare stakeholders

Including: manufacturers, wholesalers, distributors, hospitals,

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Including: manufacturers, wholesalers, distributors, hospitals, pharmacies, regulatory bodies, trade associations

GS1 Standards Group

200820072006

Packaging/Direct Marking

Carrier

2009

AutoID Data

GTIN Allocation

Serialisation

Global Standards Development Roadmap

©2008 GS1

Schedule for deliverables to the GS1 GSMP (GS1’s standards development team)

Version 1.6 -- January 2008

GS1 Standards Group

Healthcare Data Synch

AIDC Application Standards

Traceability Healthcare Product Traceability

Classification

Data Synchronisation

Work in progress Work finalised or near closure

GS1 Healthcare Mission & Vision

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.

Our Mission

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To become the recognised, open and neutral source for regulatory agencies, trade organisations and other similar stakeholders seeking input and direction for global standards in healthcare for patient safety, supply chain security & efficiency, traceability and accurate data synchronisation.

Our Vision

Global Healthcare User GroupHospitals/GPO• Chelsea & Westminster NHS Hospitals• Comparatio University Hospital Group• Consorta• Marienhospital Herne• Mayo Clinic• McKesson• Mount Sinai Medical Center• Network of French University Hospitals • Novation• Premier• Tokyo Medical University• University Hospital of Leeds• University Hospital of Geneva• …

Solution Providers

Transport & Logistics

• Aexxdis• DHL• Exel • FedEx• …

Retail• CVS• Walgreens Company• Wal-Mart• Wegmans• Sobeys Pharmacy Group • …

Assocations

Manufacturers• 3M• Abbott Laboratories• Aesculap/B.Braun• Alcon Laboratories• Amgen• Astra Zeneca• Baxter• BD• Boston Scientific• B.Braun• Bristol Myers Squibb• Cook• Covidien• Edwards Lifescience• Glaxo Smith Kline

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Solution Providers• Accenture• Aegate Ltd• Avery Dennison• Axway• CapGemini• Deloitte• Domino UK Ltd• Hewlett-Packard• IBM• Infosys Technologies Ltd• Motorola Inc.• NEC Corp.• Oracle Corp.• SAP• SupplyScape• Unisys• VeriSign• Zebra Technologies• …

• AdvaMed • ANA – American Nurse Association• EGA • Eucomed • GIRP• HDMA • IHF• NACDS• ...

Regulatory Bodies• Australia NEHTA• Canada : PHAC • Japan Ministry of Health• New Zealand Ministry of Health • UK Ministry of Health • US FDA

Universities – Auto-ID Labs• MIT (US)• Cambridge (UK)• St Gallen (Switzerland)• ICU (Korea)• Fudan (China)• Adelaide (Australia)• Keio (Japan)

• Glaxo Smith Kline• Johnson & Johnson• Kimberley Clark• King Pharmaceuticals• Medtronic• Merck & Co.• Novartis• Pall Medical• Pfizer• Smiths Medical• St. Jude• Terumo• Roche Diagnostics • Sanofi Aventis• Schering-Plough• …

Wholesaler/Distribution• Amerisource Bergen Corp.• Cardinal Health• Celesio• McKesson• Pharmdata• Phoenix• …

Supply Chain Challenges

Challenges in the Healthcare supply chain

• Medication errors result in additional treatments, disabilities and even loss of life

• Counterfeiting is an increasing global threat

• Traceability from manufacturer to patient is unworkable

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unworkable

• Product recalls are difficult to manage

• A lot of manual interventions in the healthcare supply chain decrease its efficiency and accuracy

Ensuring the 5 Patient Rights

The right patientThe right route

The right product

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The right doseThe right time

How to reduce medication errors?

Automatic identification solutions (bar codes and/or RFID) reduce the possibility of human error

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Automatic identification up to and at the point of care

reduces medication errors

Automatically match patient data, product data

and treatment data

RFID Pilot in German hospital

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PickingUnit-dose labelled with RFID tags

TransportTracked throughout the hospital

DispensingVerificiation at the point-of-care

“RFID is increasing the quality of care”University Hospital of Jena (Germany)

Fighting Counterfeiting

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A counterfeit medicines

« factory »Which is counterfeit?

Global traceability

• Counterfeit drugs are an increasing global threat

• The WHO estimates 10% of all drugs worldwide to be counterfeit – sales estimated at 32 billion $ in 2005

• The introduction of a unique identification for drugs or

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• The introduction of a unique identification for drugs or medical devices, where appropriate, will enable authentication and traceability systems that will make it much more difficult for counterfeiters to intrude into the Healthcare supply chain

RFID Pilot at Pfizer

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RFID as part of the solution to fight counterfeiting of Pfizer’s

most highly counterfeited product: Viagra

Mass Serialization at Pallet, Case and Item Level via RFID/EPC and BarcodesA unique ID is associated with every Viagra bottle, case and pallet distributed in the US

Improving Supply Chain Efficiency

• Administrative costs along supply chains in Healthcare constitute roughly 30-40% of Healthcare costs - compared to 3-6% in the grocery industry

• Inaccurate and inconsistent data in the Healthcare supply chain add billions of $ in costs

• More than 20% of stock-on-hand in most hospitals beyond their central storage is obsolete

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their central storage is obsolete

Managing assets with RFID in a

French hospital

Hospital Laundry

Linned closets equipped

with RFID tags (GRAI)

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Truck equipped with a RFID

scan and a GPRS drive case

RFID enables 500 closets to be efficiently tracked and

traced throughout 15 locations at CHU Dijon (France)

Regulatory Challenges

• GS1 Healthcare is member of the World Health Organisation IMPACT Work Team « Technology »

• GS1 Healthcare is working with the Global Harmonisation Task Force about Unique Device Identification

Working with international organisations

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Identification

• GS1 Healthcare is working with the European Commission on the issue of patient safety

• BRIDGE Project

• The Council of Europe is recommending global harmonisation in Healthcare with GS1 Standards

Working with Local Stakeholders

Australia

Canada

France

Hong Kong

Japan

Korea

NeHTA National Product Catalogue / Monash eCOM

Canada Public Health Agency / CareNET

eProcurement Platform

Central Drugs Repository

Ministry of Health & JFDMA Bar code guideline

Ministry of Health Bar code Regulation

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Korea

Netherlands

New Zealand

Ministry of Health Bar code Regulation

ZorgDas / G-Standard

Medication Safety Project Ministry of Health

Working with Local Stakeholders (2)

Spain Switzerland

Turkey

UK

USA

Regional Health Authorities

SmartLog Project

UBB (Turkish DataBank)

« Coding for Success » Department of Health

FDA / HSCSC / Department of Defense

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and more …

FDA / HSCSC / Department of Defense

Conclusions

RFID brings value to Healthcare• Improving patient safety

• Enabling traceability & authentication solutions

• Increasing supply chain efficiency

©2008 GS1

• Increasing supply chain efficiency

RFID and bar codes will co-exist

and complement each other