Global Track & Trace requirements for better and safer Healthcare

Transcription

1 Global Track & Trace requirements for better and safer Healthcare Ulrike Kreysa, VP Healthcare, GS1 Global Office Riyadh, 6 th December 2016

2 Counterfeiting - The Impact According to Interpol more than one million people die each year from counterfeit drugs! In some areas of Asia, Africa and Latin America counterfeit medical goods can form up to 30% of the market. Fake medicines cost the EU pharmaceutical sector EUR 10.2 billion each year and the loss of jobs. 2

3 Increasing Healthcare costs Costs for Healthcare are increasing quicker than GDP could be in % of France s GDP, 35% of the US s according to OECD Health statistic (2013, Institute for Health Metrics and Evaluation,) Some reasons 3

4 Medication errors Medical errors are third leading cause of death in United States after Heart disease and cancer - claiming 251,000 lives every year more than strokes, accidents, diabetes, Alzheimer! Source: BMJ 2016;353:i2139 4

5 Recalls Product recalls in Healthcare are painful for all stakeholders 2061 drugs were recalled by US FDA in 2013 and 2014 Recall based on GTIN 5

6 Track & Trace Good reasons for regulatory bodies to take action. Most of them have chosen GS1 standards for the implementation of traceability! 6

7 Working with many regulatory bodies across the world And many more

8 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.

9 GS1 Healthcare: an expanding, committed community of globally engaged stakeholders and there are many more companies working with GS1 at a local level in 38 local user groups!

10 GS1: global system of standards to ensure visibility

11 Building blocks for traceability Unique identification 1 3 Links management Products Physical flow Logistics units Information flow Locations & legal entities Etc. Traceability Data capture Bar codes EPC/RFID Data communication Share data Retrieve data 2 4

12 12 How to share data different models One up one down Central database Distributed model

13 Regulatory requirements and global developments 1

14 Copyright Notice Copyright GS1 AISBL, All Rights Reserved This presentation contains material protected under Belgian and international Copyright Laws and Treaties. Any unauthorized reprint or use of this material is prohibited. No part of this presentation may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system without express written permission from GS1 AISBL.

15 Delegated Regulation (EU) 2016/161 of the EU falsified Medicine Directive a. Technical characteristics of the unique identifier (UI), an unique sequence carried by a 2D barcode allowing the identification and authentication of the individual pack on which it is printed b. Verification of the Safety Features c. Repositories system for the UI d. Lists of exceptions from bearing/not bearing the safety features NOT specifying the ATD anti-tampering device left to the discretion of manufacturer CEN standard EN 16679:2014 to consider

16 The Unique Identifier in the DA Source: EU Commission Stakeholder Meeting, February 2016

17 GS1 linear and 2D barcode Item identifier Expiry date (21)123 Batch number Serial number 1 7

18 European Stakeholder Model (ESM) A pan-european end-to-end system enabling medicines to be verified systematically at point of dispensing. Source ESM presentations 41

19 England NHS Objectives: Deliver efficiency and productivity gains Improve data, information and transparency Re-think clinical engagement in procurement Improve trust capabilities in procurement Actions: Mandate through contracts GS1 standards GTIN, GLN and GDSN inclusion in tenders Six large NHS trusts as demonstrator sites Standards for eprocurement Standards for datasets/classification Strong implementation support

20 A lot of activities in the MEMA region Product Identifier (GTIN) Serial Number Expiry date Saudi-Arabia as first country - March Lot/Batch number Egypt Jordan Oman purchasing requirement Iran in progress of implementation UAE, Algeria, Tunisia and Lebanon (2017) working on regulation in line with global harmonisation Copyright Quatar GS1 AISBL, with purchasing All Rights Reserved. requirements 2 0

21 And also in Asia Pacific India central DB testing, requirements for domestic market under development China suspended national traceability system working with stakeholders on future approach Pakistan under development Chinese Taipei Draft requirements implementation by 2018 (tbc) New regulation for prescription drugs - September 2020 Philippines under development

22 GS1 Healthcare aims for harmonization of regulatory requirements across the world A global standardized system is needed for unique identification numbers to ensure world-wide supply chain compatibility and traceability. The result: Prevent counterfeit drugs entering the market, gain efficiency, have the right product in the right place at the right time, more effective recalls and more

23 31 st Global GS1 Healthcare Conference 4 to 6 April 2017, Berlin, Germany Traceability, Unique Device Identification (UDI) and global regulatory developments Use cases and implementations from manufacturers, wholesalers and hospitals what are the experiences, the benefits Patient safety and quality of care how to improve those ThinkTank for regulatory bodies Followed by side visits

24 And ultimately it is all about PATIENT SAFETY! For everyone, our families, friends, neighbours, colleagues - every patient in the world

25 Contact Details Ulrike Kreysa GS1 Global Office, Brussels E ulrike.kreysa@gs1.org T W