GS1 Standards and the Falsified Medicines Directive

Transcription

1 GS1 Standards and the Falsified Medicines Directive Domino s EU FMD Conference 24 th January 2013, Barcelona Janice Kite, Traceability Director Healthcare GS1 Global Office

2 Agenda Who we are and what we do The case for global supply chain standards Our members and why they endorse GS1 Standards Enabling EU FMD regulatory compliance The momentum of implementation gathering pace 2

3 About GS1 GS1 is a not-for-profit organisation dedicated to the design and implementation of global standards to improve the efficiency and visibility of supply chains globally and across sectors. Key facts & figures: 40 years of experience Neutral forum for all supply chain stakeholders Over a million member companies doing business across 150 countries Enabling over 6 billion transactions a day 3

4 GS1 is local GS1 Member Organisations in over 100 countries Speak the local language(s) Understand local requirements and developments Support local implementation Work with national and regional governmental bodies and other stakeholders Underscore local needs in global standards development process 4

5 GS1 is global GS1 Global Office Supports the global standards development process Manages a global, neutral forum for all stakeholders to meet and agree on standards Promotes global harmonisation 5

6 The GS1 System Track T R A C E A B I L I T Y Trace Authentication Pedigree Returns Recalls 6

7 Standards why do we care? Regulations emerge worldwide Supply Chain costs increase Electronic Health Records Medication errors Brand Protection Counterfeiting EU Falsified Medicines Directive 7

8 Lack of standards in daily life is inefficient and annoying 8

9 Lack of standards in Healthcare is inefficient and adds risk 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 9

10 The Need for Global standards in Healthcare Diverging country requirements Manufacturing headache Additional cost and risk

11 The Need for Global standards in Healthcare Diverging country requirements Requires (re-)barcoding by the hospital (or a 3rd party provider)

12 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

13 Reduce complexity Speak one language

14 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.

15 GS1 Healthcare User Group Supply-side Organisations

16 Leading healthcare organisations pave the way Buyer/Provider-side Organisations going global France Germany Netherlands Hong Kong Switzerland Austria Germany USA Austria USA Ireland Netherlands France USA USA

17 Members global user group Manufacturers 3M Abbott Laboratories Alcon Labs Amgen Astra Zeneca Baxter Becton Dickenson B. Braun Cook Covidien Edwards Lifescience Fresenius GE Healthcare Genzyme GlaxoSmithKline Johnson & Johnson Medtronic Merck & Co. Pall Medical Pfizer Purdue Pharma Smiths Medical TEVA Zimmer Solution provider Advanco Axway GHX Seidenader Excellis Health Tracelink Oracle GS1 Healthcare around the World Distributors/Healthcare providers/gpos/t&l Cardinal Health (U.S.) CH Aulnay sous Bois (France) Comparatio Health (Germany) DHL Exel Supply Chain Erasmus MC Rotterdam (NL) UNI.HA (representing 17 French university hospitals) Hong Kong Hospital Authorities McKesson (U.S.) Novation (U.S.) Orthopädisches Spital Speising Wien (Austria) Premier (U.S.) St. James Hospital, Dublin Marienhospital Herne (Germany) UMC Groningen (NL) University Kentucky Healthcare (U.S.) 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 Purdue Pharma St. Jude Medical Stryker Teva Pharmaceuticals Terumo UCB Upsher-Smith Distributors/Wholesalers Aexxdis Amerinet Amerisource Bergen CH2 Depolabo Galexis GAMMA Wholesale Geodis McMahon Owens & Minor And many more Healthcare providers/retailers Alfred 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.) Associations AHA (U.S.) CIP/ACL (France) CHeS (U.S.) EFPIA (Europe) Eucomed (Europe) FENIN (Spain) GIRP (Europe) HDMA (U.S.) International Hospital Federation JFMDA (Japan) Medical Industry Association of Australia NACDS (U.S.) Patient Safety Foundation (U.S.)

18 Recognised, open and neutral source And many more

19 GS1 and Joint Initiative Council (JIC) in Healthcare International Organisation for Standardization European Committee for Standardization Health Level 7 international International Health Terminology SDO Clinical Data Interchange Standards Consortium Integrating the Healthcare Enterprise World Health Organization World Customs Organization International Society for Blood Transfusion European Association of Hospital Pharmacists European Association of Medical Device manufacturer International Society for Quality in Healthcare

20 GS1 Standards for Healthcare

21 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

22 GS1 Standards for Healthcare Standards development continues, but global standards are ALREADY available to build on: 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 & Caregiver Identification

23 Actual AIDC work item Level Below the Each Work Group WR# Level Below Each: Provide guidance on "Level Below the Each" identification & marking for GS1 Healthcare solutions Started June 2011 now entering solution phase 23

24 GS1 Standards enabling Traceability

25 Traceability in Healthcare I (TH-I) DELIVERED: Global Traceability Standard for Healthcare (GTSH) PUBLISHED 27 th February pdf GTSH Implementation Guideline PUBLISHED 24 th April _Healthcare.pdf 2011 Copyright GS1 GS1 AISBL, All Rights Reserved. 25

26 GS1 Standards linked to Regulations that are driving implementation of Traceability

27 The move towards harmonisation and GS1 standards in Europe

28 Serialisation of pharmaceuticals = country requires serial number = country developing requirement for serial number

29 Canada: Vaccines Switzerland: SmartLog Pilot Brazil: Traceability pilot successfully completed ANVISA regulation Argentina: Traceability regulation DataMatrix on pharmaceuticals Spain: Pilot US: Pilot on Vaccines France: AFSSAPS regulation (2011) Belgium: Pilot project unit dose marking Netherlands: pharma hospital requirement (2013) Austria: Cytostatics Serbia: Pilot Turkey: Regulatory requirement (2010) Korea: pharma regulatory requirement (2012) Slovenia: pharma regulatory requirement (2015) Algeria: pharma regulatory requirement (2013) India: Tender requirement for October 2011 = country requires DataMatrix Exported drugs from 2012/13 = country using DataMatrix in pilots and/or developing requirement for DataMatrix

30 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 characters Expiry Date: 6 digits (YYMMDD) Batch Number: up to 20 alpha-numeric characters + minimum requirements on quality of randomisation Example: GTIN: (01) Batch: (10) TEST5632 Expiry: (17) S/N: (21) Specifications provided in EFPIA s: European Pack Coding Guidelines 35

31 Capturing the identification key and beyond Some data carriers can carry more detailed information about that specific unit Item identifier Expiry date (21)123 Batch number Serial number

32 Global standards enable Compliance with regulations, effective and efficient implementation of traceability systems in Healthcare Such as: Track & Trace, Authentication, UDI = Visibility* *Visibility = What, When, Where & Why

33 Physical Event Data - Recall What: what physical objects were involved (e.g. sgtin in a GS1 Carrier) e.g. (01) (21)12344(10)A1345B When: when the event took place (timestamp) e.g (22 nd September 2011) Where: where the event took place (e.g. GLN) e.g (Goods In, The General Hospital) Why: what business process step was being carried out (e.g. receiving, shipping ) Receiving The 4 W s 2011 Copyright GS1 GS1 AISBL, All Rights Reserved.

34 Turkey Ministries of Health, Finance and Social Security National databank for medical devices GDSN compliant Track and Trace for pharmaceuticals based on GS1 standards GS1 DataMatrix with GTIN, lot/batch number, serial number and expiry date already functional

35 Recent Announcement in the UK Raising our game Sir David Nicholson, CEO NHS demands all trusts take action to implement GS1 in NHS Procurement: 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. 40

36 Hospitals across the world Big movement in US GLN and GTIN sunrise supported by all major hospital groups/gpo s and other stakeholders Continous 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 Hong Kong Hospital Authorities work on identification and clean data with their suppliers Nehta continues to lead the implementation on GS1 standards for product catalogues in Australia Spanish hospitals have been driving GS1 standards since years Japanese hospitals implement GS1 in striving to use latest technology And so many more..!!! 41

37 The move to implementation 1. Regulations are in force 2. Key standards are in place 3. Numerous and increasing case studies published 4. Numerous pilots have and continue to be undertaken 5. Healthcare organisation s ARE IMPLEMENTING Case Studies here: The move to implementation has started!

38 23 rd Global GS1 Healthcare Conference April 2013, Buenos Aires, Argentina Join us! You will learn How GS1 global standards can help improve patient safety and supply chain efficiency How GS1 global standards get implemented in the supply chain worldwide What initiatives of regulatory bodies and stakeholders are taking place across the world 3 rd Think Tank for regulatory bodies planned, to be hosted by ANMAT

39 New McKinsey Report: Strength in unity: The promise of global standards in healthcare 44

40 New McKinsey & Company report quantifies supply chain issues in Healthcare 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 Source: Available at: or eport_strength_in_unity.pdf 45

41 Huge cost savings and patient safety benefits when adopting a single global standard in healthcare 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

42 Ultimately, it s all about PATIENT SAFETY! 47

43 Contact Details Janice Kite Traceability Director Healthcare GS1 Global Office Brussels E janice.kite@gs1.org W