Healthcare Sector. - Upcoming legislations - GS1 standards. Ann Luyckx Healthcare Manager. Phi Data Event 2018

Transcription

1 Healthcare Sector - Upcoming legislations - GS1 standards Ann Luyckx Healthcare Manager Phi Data Event 2018

2 Anti-trust GS1 Belgium & Luxembourg will not enter into any discussion, activity or conduct that may infringe, on its part or on the part of its members and participants, any applicable competition laws. By way of example, members and participants shall not discuss, communicate or exchange any commercially sensitive information, including non-public information relating to prices, marketing and advertisement strategy, costs and revenues, trading terms and conditions and conditions with third parties, including purchasing strategy, terms of supply, trade programs or distribution strategy. This applies not only to discussion in formal meetings but also to informal discussions before, during or after meetings

3 Disclaimer This training is intended to demonstrate the use of GS1 standards for UDI and Serialisation. It does not provide any guidance or advice regarding regulatory compliance. Please consult your internal regulatory staff for compliance questions. Neither GS1 nor its member organizations nor their staffs have real or apparent authority to speak for the regulatory authorities or grant exemptions. GS1 offers advisory services focused on the GS1 standard after a supplier s staff including its internal regulatory experts have determined the correct path to compliance. GS1 is a voluntary organization and its members have and must continue to determine their own course of action. GS1 provides recommendations. GS1, GS1 member organizations and GS1 staff assume no liability for members actions taken upon its advice. 3

4 Topics Who is GS1? Upcoming legislations Use of GS1 standards in the Healthcare Sector 4

5 Who is GS1?

6 Each product has its own ID 6

7 Each package level has its own ID 7

8 GS1 Universal Language GS1 is a global standards organisation Neutral and not-for-profit User-driven and governed Global and local Inclusive and collaborative Not-for-profit Member Organizations Over one million user companies Member driven Over 6 billion transactions a day 8

9 Sectors Retail Healthcare Transport & Logistics Foodservice CPG/Grocery Apparel Fresh Foods General Merchandise

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11 GS1: standardization between business partners 11

12 Upcoming legislations Healthcare sector

13 Pharmaceutical Products

14 Background EU- Codes medicines 14

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16 Background Increase in Falsified medicines

17 EU Anti-Falsified Medicines Legislation: Directive 2011/62/EU Source: Presentation Jerome Lepeintre. GS1 HC Congress Beijin, October

18 EU FMD: safety features on the package Feb. 9 th, 2019 EU FMD Unique Identifier 4 data-elements: Product code Batch/Lot Number Expiry Date Serial Number Data Carrier DataMatrix ECC200 GS1 Standards Identification Use of GS1 Application Identifiers (AI) GTIN, Global Trade Item Number AI(01) Batch/Lot Number: AI (10) Expiration Date: AI (17) Serial Number: AI (21) D 2D GS1 DataMatrix Source: Presentation Jerome Lepeintre. GS1 HC Congress Beijin, October

19 Medical Devices 19

20 Issues medical devices

21 UDI: Unique Device Identifier UDI US FDA/ UK NHS/ EU GS1 Standards DI Device Identifier PI Production Identifiers GTIN Global Trade Item Number Dynamic data (GS1 Application Identifiers) Batch/Lot number: AI(10) Production date: AI(11) Expiration date: AI(17) Serial number: AI(21) DI + PI = UDI 21

22 US / UK / EU UDI Levels UDI at every level of packaging except at the logistic unit level 22

23 EU - UDI: the EU roadmap (provided that EUDAMED is functional) 2012 EC proposals MD & IVD Regulation s 2013 EC Recommendation to MS 5 May 2017 EU Regulations published 26 May 2020 UDI assignment, registration and EUDAMED 2021 UDI marking Class III 2023 UDI marking Class II 2025 UDI marking Class I development of EUDAMED 26 May 2022 UDI assignment, registration and EUDAMED 2023 UDI marking Class D 2025 UDI marking Class B & C 2027 UDI marking Class A + 2 years for DPM, when applicable

24 Summary legalisations up to 2020 Internationale deadlines: , 2016, 2020 (Sept. 24): U.S. FDA - UDI regulation for medical devices , 2018, 2019 (Sept. 30): UK s NHS (May 25): EU - Medical Device Regulation (MDR) (Feb. 9): EU - Falsified Medicines Directive (FMD) : Medical devices regulations China, Japan, Canada, Australia Result: - Labels with barcodes - Providing data

25 Use of GS1 standards in the Healthcare Sector

26 Identification of products 26

27 Product (trade item) identification: GTIN GTIN = Global Trade Item Number Structure GTIN-13 GS1 Belu company prefix (54 M1 M2 ) and product code (N1 N2 ) Check Digit 5 4 M 1 M 2 M 3 M 4 M 5 N 1 N 2 N 3 N 4 N 5 C 5 4 M 1 M 2 M 3 M 4 M 5 M 6 N 1 N 2 N 3 N 4 C 5 4 M 1 M 2 M 3 M 4 M 5 M 6 M 7 N 1 N 2 N 3 C 5 4 M 1 M 2 M 3 M 4 M 5 M 6 M 7 M 8 N 1 N 2 C Structure GTIN-14 Indicator GS1 Belu company prefix (54 M1 M2 ) and product code (N1 N2 ) Check Digit M 1 M 2 M 3 M 4 M 5 N 1 N 2 N 3 N 4 N 5 C 5 4 M 1 M 2 M 3 M 4 M 5 M 6 N 1 N 2 N 3 N 4 C 5 4 M 1 M 2 M 3 M 4 M 5 M 6 M 7 N 1 N 2 N 3 C 5 4 M 1 M 2 M 3 M 4 M 5 M 6 M 7 M 8 N 1 N 2 C 27

28 Trade Item: GTIN-13 / GTIN-14 Example 1 GTIN-13: or GTIN-1004: GTIN-13: GTIN-13: or GTIN-14: GTIN-13: or GTIN-14: Example 2 GTIN-13: GTIN-13: or GTIN-14: GTIN-13: or GTIN-14:

29 Dynamic product data Static data GTIN Dynamic data Lot number Expiration date Production date Serial number, AI = Application Identifier 29

30 GS1 Application Identifiers How does it work? (01) (17)160927(10)ABC123(21)987POI AI GTIN AI Exp. Date AI Batch/Lot AI Serial number AI Data content Format 01 Global Trade Item Number (GTIN) N2+N14 17 Expiration Date (YYMMDD) N2+N6 11 Production Date (YYMMDD) N2+N6 10 Batch or Lot Number N2+X Serial number N2+X..20

31 GS1 Data Carriers Healthcare Barcode: GS Product Identifier (GTIN) Expiration Date Barcode: GS1 DataMatrix 3 4 Batch/Lot Number Serial Number

32 Example Turkey 32

33 GS1 Data Carriers Healthcare 33

34 Identification package level Efficient management of the products 34

35 Identification primary package level of drugs Position paper identification and labelling avoiding errors e.g. sound-alike or look-alike need: IT system, prescription-dispensation-administration processes enabling safer processes at the point of care Endorsed by: 35

36 Other Identification Keys 36

37 Identification of Locations GLN: Global location numbers 37

38 GLNs in the hospital / hospital network GLN 1 GLN 2 GLN 4 GLN a: delivery dpt GLN b: general stock GLN c: pharmacy stock GLN d: ward stock GLN 3 38

39 Benefits GS1 standards Improve inventory management Standards: - ID keys: GTIN, GLN - Automatic capture information, including lot, s/n and exp., using barcodes Across various hospital storage locations Make products available when needed Better avoid or mitigate out-of-stock scenarios: identifying other locations as an alternative source => less time spent to handle out of stock situations allows clinical staff to allocate more time focusing on quality of care e.g. at the bedside. 39

40 Example logistic process Scan GLN of initial stock location Scan of GTIN and s/n Link between GTIN, s/n and GLN Identification of the logistic person Transport to new location Scan GLN of arrival location - check right delivery/ place 40

41 Benefits GS1 standards Reduction of medical errors GS1 Standards: - ID keys: GTIN, GSRN - Automatic capture information, including lot, s/n and exp., using barcodes Reduce medication errors by more than 50% 1 Facilitate positive patient identification at all points of care Enable accurate information about medical products to be recorded in electronic medical records 1 McKinsey report, Strength in unity: The promise of global standards in healthcare 41

42 Benefits GS1 Standards Ensure traceability of products to patients Reduce waste and increase accuracy of ordering processes Achievement of efficient, accurate and targeted recalls Spent more time with the patients (care) Case studies: - Improving traceability in the operating theater at Bernhoven Hospital, NL - Increasing bedside scanning implementation at Charing Cross Hospital, UK - Improving supply chain management at Dijon University Hospital, FR - Preventing medication administration error at Gelre Hospitals, NL - Improving patient safety & quality of care at the National Centre for Hereditary Coagulation Disorders, St James s Hospital, IRE - Improving general inventory control at Portsmouth Hospitals NHS Trust, UK - Improving Electronic Data Interchange (EDI) at Ramsay Health Care - Ensuring surgical instrument traceability at Robert Ballanger Hospital, FR 42

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44 Contact Ann Luyckx Healthcare Manager GS1 Belgium & Luxembourg E aluyckx@gs1belu.org T W 44

45 Data uitwisseling

46 Exchange master data Today 46

47 Data Exchange Standards: GUDID, EUDAMED To ONE access point

48 Which data exchange through GDSN? Core data Logistical/B2B data Consumer/B2C data Other GTIN Brand SubBrand Measurements (height, width, dept) Weights (gross weight, net weight, ) Tax information Hierarchy information Label information: ingredients, allergens, nutridate, Other consumer relevant information... Digital assets: images, videos, manuals, SDS sheets, 48

49 ECHO ECHO (European Collaboration of Healthcare Organisations) GS1 MOs, Manufacturers, Hospitals ECHO datamodel: - Legal requirements (FDA, NHS, Eudamed) - Business requirements (hospitals, wholesalers, GPOs, ) 2018: phase 1 - ECHO mandatory data-attributes for medical devices, based on the US FDA legal requirements and the UK NHS requirements Roadmap Determination business needs: alignment between the stakeholders - Pharmaceutical products 49