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Mary Thompson - GS1 Australia - Australian Impact from International Developments in the use of Global Standards

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Mary Thompson delivered the presentation at the 2014 National Hospital Procurement Conference. …

Mary Thompson delivered the presentation at the 2014 National Hospital Procurement Conference.

The 2014 National Hospital Procurement Conference explored a number of cost-saving measures in the hospital procurement ecosystem. Highlights included sessions on improving efficiency, savings and patient safety within Australian Hospitals.

For more information about the event, please visit: http://bit.ly/hosprocurement14

Published in: Leadership & Management

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  • 1. Australia International Developments Driving Australian Use of Standards Mary Thompson Senior Advisor – Healthcare GS1 Australia
  • 2. © 2009 GS1 Australia Agenda • Why talk standards and why GS1? • International standards • Key drivers • International regulations – Medicines – Medical Devices • What does this mean for Australia? • How can Australian healthcare organisations benefit? 2
  • 3. © 2009 GS1 Australia A reminder: Lack of standards in daily life is inefficient and annoying… 3
  • 4. © 2009 GS1 Australia ..in Healthcare it is dangerous and inefficient! 4 • 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
  • 5. © 2009 GS1 Australia Speak one language Reduce complexity
  • 6. © 2009 GS1 Australia About GS1 6 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
  • 7. © 2009 GS1 Australia GS1 and Joint Initiative Council (JIC) in Healthcare International Organisation for Standardization European Committee for Standardization Health Level 7 international International Society for Blood Transfusion International Health Terminology SDO European Association of Hospital Pharmacists European Association of Medical Device manufacturer Clinical Data Interchange Standards Consortium World Customs Organization World Health Organization Integrating the Healthcare Enterprise European Association of Pharmaceutical Manufacturer
  • 8. © 2009 GS1 Australia 8 GS1 in Healthcare: global system of standards to ensure visibility
  • 9. © 2009 GS1 Australia Agenda • Why talk standards and why GS1? • International standards • Key drivers • International regulations – Medicines – Medical Devices • What does this mean for Australia? • How can Australian healthcare organisations benefit? 9
  • 10. © 2009 GS1 Australia Hospital supply chains…can they assure “patients rights”? The right patient The right dose The right time The right route The right product
  • 11. © 2009 GS1 Australia Patient safety – the right medication? 11 In the U.K., the NHS has calculated that approximately 60 patients die each day due to adverse drug errors. In New Zealand, the Ministry of Health estimated that each year about 5,000 patients are subject to medication errors. As a result about 150 patients die, over 400 are permanently disabled and nearly 3,500 are disabled for less than one year. In the U.S., the Institute of Medicine estimated that medication errors injured 1.5 million people each year, of which 400,000 in hospitals costing at least $3.5 billion in extra medical expenses. Medication errors in hospitals result in preventable adverse events with 7,000 patients dying per year.
  • 12. © 2009 GS1 Australia The right product? Pharmaceutical counterfeits Which is counterfeit?
  • 13. © 2009 GS1 Australia Patient safety … faulty devices
  • 14. © 2009 GS1 Australia The healthcare supply chain needs global standards • Medication errors result in additional treatments, disabilities and even loss of life • Counterfeiting is an increasing global threat • Traceability from manufacturer to patient is problematic • Product recalls can be difficult to manage, in particular for healthcare providers • Manual interventions in the healthcare supply chain decrease its efficiency, accuracy and increase costs
  • 15. © 2009 GS1 Australia Agenda • Why talk standards and why GS1? • International drivers of standards • Key drivers • International regulations – Medicines – Medical Devices • What does this mean for Australia? • How can Australian providers benefit? • Q&A 15
  • 16. © 2009 GS1 Australia EU Commission proposal • 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. 16
  • 17. © 2009 GS1 Australia • European Stakeholder Model (ESM) EFPIA /GIRP/PGEU/ EAEPC • A pan-European end-to-end system enabling medicines to be verified at point of dispensing • Run on a non-profit basis; costs to be borne by Manufacturing Authorisation Holders Pharma: The European Stakeholder Model Driver: To address counterfeiting (falsified medicines), prevent them reaching the patient 17 Source ESM presentations
  • 18. © 2009 GS1 Australia The world aligns towards GS1 DataMatrix 18 GTIN – Global Trade Item Number Plus attributes • Lot number • Expiry date • Serial number (2016) In a GS1 DataMatrix Argentina Saudi Arabia Jordan Brazil India Korea Algeria EUEU USA
  • 19. © 2009 GS1 Australia US Federal Drug Quality and Security Act (DQSA) …as part of U.S> Drug Quality and Security Act H.R. 3204 • New programme on securing the identity of parties in the supply chain, specially new license program for wholesalers • Migration path: First phase lot bases, serialisation (SNI) after four years (2017), full track & trace after 10 years (2023) • The Global Unique Device Identification Database (GUDID) holding ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database
  • 20. © 2009 GS1 Australia Agenda • Why talk standards and why GS1? • International drivers of standards • Key drivers • International regulations – Medicines – Medical Devices • What does this mean for Australia? • How can Australian healthcare organisations benefit? 20
  • 21. © 2009 GS1 Australia What is Driving the Need? Current systems of product catalog numbers include duplicate identifiers for the different products across manufacturers Current system allows product re-identification by every stakeholder in the supply chain, making product tracking efforts extremely difficult Manufacturer Product # 305905 Distributor Product # MT305905 Hospital or Healthcare Provider Product # M-5905 Manufacturer Catalog# Description Medtronic 305905 Mosaic ® 305 Porcine Heart Valve …………. BD 305905 3mL BD SafetyGlide ™ Syringe ……….. J & J 305905 Protectiv ® IV Catheter System ……….. Source, Jackie Elkin, Medtronic
  • 22. © 2009 GS1 Australia Long expected The final UDI rule of the US FDA 22 GS1 was accredited as first issuing agency by the FDA
  • 23. © 2009 GS1 Australia Unique Device Identification 1. A standardized system to develop Unique Device Identification numbers (UDI) 2. UDI in human readable and bar code/RFID on the device label 3. Data to be submitted to the UDI Database 23
  • 24. © 2009 GS1 Australia UDI in GS1 terms
  • 25. © 2009 GS1 Australia Manufacturers are able to provide data to all UDI databases and their customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with one single connection. One connection to UDI databases, Providers and other data recipients Data is provided to the FDA GUDID by the Source Data Pool NPC
  • 26. © 2009 GS1 Australia Manufacturer Distributor Hospital or Healthcare Provider The future of UDI “The UDI System is intended to provide a single, globally harmonized system for positive identification of medical devices” - IMDRF UDI System for Medical Devices Regulator Source: Jackie Elkin, Medtronic
  • 27. © 2009 GS1 Australia Agenda • Why talk standards and why GS1? • International drivers of standards • Key drivers • International regulations – Medicines – Medical Devices • What does this mean for Australia? • How can Australian healthcare organisations benefit? 27
  • 28. © 2013 GS1 Australia is already identifying its products 28 Item identifier = Logistics unit identifier = Location identifier = And more … GTIN SSCC GLN Global Trade Item Number Serial Shipping Container Code Global Location Number
  • 29. © 2013 GS1 Capturing the identification key … and beyond DataMatrix & GS1 128 carry a lot of information Item identifier Expiry date Batch number Serial number (21)123
  • 30. © 2013 GS1 Electronic Product Catalogue Unit / Unit dose Secondary Case Pallet Primary Automatic Identification & Data Capture Electronic Data Interchange Traceability Point of Care Applications Interdependence Complexity Gradually expand management of supply chain data and improve patient safety A secure healthcare supply chain
  • 31. © 2009 GS1 Australia Hospitals and Retail Pharmacy – reduce margin for error 31 Opportunity: • match product to patient • reduce medication errors • monitor expiry dates • determine procedure cost per patient
  • 32. © 2009 GS1 Australia Agenda • Why talk standards and why GS1? • International standards • Key drivers • International regulations – Medicines – Medical Devices • What does this mean for Australia? • How can Australian healthcare benefit? • Q&A 32
  • 33. © 2009 GS1 Australia Patient Benefits • 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 • More time for patients
  • 34. © 2009 GS1 Australia Supply Chain Efficiency • Increase efficiency and save costs • Improve order and invoice process • Optimise receiving • Reduce inventory & improve shelf management • Increase productivity • Improve service levels/fill rate • Improve benchmarking and management of supply cost • Efficiently document treatment in patient’s Electronic Health Record
  • 35. © 2013 GS1 Adopting a single global standard in healthcare represents huge cost savings and patient safety benefits 35 “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 2012
  • 36. © 2009 GS1 Australia Thank you Mary Thompson Senior Advisor - Healthcare GS1 Australia Lakes Business Park Unit 4B, 2-4 Lord Street Botany NSW 2019 36 T 1300 BARCODE F +61 2 9695 2221 E mary.thompson@gs1au.org W http://www.gs1au.org