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World's first 100% track and trace solution in the pharma ...


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World's first 100% track and trace solution in the pharma ...

  1. 1. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Successful trial of fully traceable haemophilia drug administration programme in Ireland heralds new era for safe patient treatment The National Centre for Hereditary Coagulation Disorders in Ireland (NCHCD) and GS1, the global supply chain standards organisation, have announced the successful implementation of the world’s first fully integrated EPC solution for the pharmaceutical industry, involving 100% track and trace of drugs administered to Haemophilia patients of St James’s Hospital in Dublin. The significance of this pilot scheme, project managed by GS1 Ireland and the Integrated Solutions Group of Domino Printing Sciences plc, heralds a new era for future drug administration programmes in the healthcare and pharmaceutical sectors worldwide. With the advent of global supply chain standards and more legislation to regulate the whole drug supply chain from manufacture to patient, this end to end traceability solution can be adapted to resolve a whole range of patient safety and supply chain issues. The trial was the brainchild of Dr Barry White, Director of the NCHCD, whose vision was to establish a comprehensive and fully traceable drug administration programme, from manufacturer through to patient. Dr White’s concerns were in response to defects in the tracking and tracing of haemophilia blood products both nationally and internationally. These were
  2. 2. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 2 highlighted in Ireland by the publication of the Lindsay Report in 2002, which reported the infection of hundreds of haemophiliacs with HIV and Hepatitis C as a result of receiving contaminated blood products. Dr White’s vision sparked the interest of GS1 Ireland, which, together with the NCHCD started work on a project with St James’s Hospital in 2004, to introduce the latest bar coding technology to trace expensive and time-sensitive Clotting Factor Concentrates (CFCs), the product used to treat haemophilia patients. Just two years later, the trial has been successfully implemented and is ready to be rolled out nationally. Jim Bracken, Chief Executive at GS1 Ireland comments, “We are delighted to announce this ground breaking track and trace pilot which in the future will help to ensure safer delivery of haemophilia care in Ireland and across the world. The NCHCD project is being studied by an Expert Group, which includes the EU Commission, the FDA the World Federation of Haemophilia and other stakeholders.” He continues, “Using unique serial numbering and bar coding on each vial box to enable automatic electronic data collection and processing, now means that clinicians can achieve safer treatment, accountability and the ultimate goal of this project – 100% traceability of every drug and patient involved in this critical treatment process. Furthermore, the solution can be easily adapted for many other treatments, including for example - vaccinations and diabetes”.
  3. 3. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 3 The need for improved supply chains Dr Barry White, Director of the NCHCD adds, “The contamination of blood products was one of the most catastrophic medical complications of the last century and some of the infections were due to defects in the supply chain. There were considerable difficulties in identifying who had received the infected CFCs and in recalling all the contaminated products. “The introduction of electronic traceability will have an enormous impact on the treatment of our patients,” says Dr White. “Tracing CFCs accurately throughout the supply chain is absolutely vital to ensure the safer administration of Haemophilia drugs, and is a solution that will guarantee that the right patient receives the right dosage of the right blood product, at the right temperature and at the right time – every time.” The key objectives of the programme were to implement real time identification of CFCs to ensure immediate product recall, optimise stock management and save on wastage. The unique coding allocated to each drug product, and the additional data captured during the supply process will automatically validate each step of the cold chain storage and delivery process, ensuring that the correct drug is prescribed to the right patient as well as automatically update patient history and assist in ongoing diagnosis and future treatment. Validation – the key to success
  4. 4. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 4 Due to the significance of this trial for the global healthcare community, the initial project group involved leading world experts from the World Health Organisation, World Haemophilia Organisation, the European Commission and other regulatory bodies. The solution has been validated to Good Automated Manufacturing Practice (GAMP). Explains Dr White, “Working with such a high-profile consultative group means they can validate the solution during the implementation and specify the needs for a system that can be adopted globally and extended to other patient groups and vaccines.” NCHCD Haemophilia Product Tracking Trial The drug track and trace system uses EPC technology (electronic product code), which assigns a unique number to every single item that rolls off a manufacturing line, allowing every company in the supply chain to track products at the individual item of use level. A key challenge of the project was to co-ordinate the individual expertise and responsibilities of all the organisations involved in the programme, and to integrate each part of the supply chain to deliver a seamless solution. The man with that challenge was Tony Walsh, European Business Development Manager at the Integrated Solutions Group of Domino Printing Sciences Plc.
  5. 5. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 5 Says Tony Walsh, “This 100% item-level track and trace solution is a tremendous breakthrough and will undoubtedly revolutionise future logistics operations, not just in the pharmaceutical and healthcare sectors, but it can also be adapted to suit a range of applications in other industries throughout the world.” As world leaders in high-speed laser and inkjet variable data coding solutions, Domino was well placed to act as the lynchpin to manage the team of experts to deliver the trial to its successful conclusion. These expert suppliers included Baxter, the CFC manufacturers based in Belgium; EPC network provider VeriSign; software company Melior solutions; and specialist cold chain logistics suppliers Temperature Controlled Pharmaceuticals Ltd (TCP) who in turn worked with Advent Software as a local solution provider. From this complex working partnership, however, it was possible for the first time to embed EPC technology within a Data Matrix code, and present a fully workable end to end trial from original manufacture of the blood product, through to delivery to the individual patients at their homes in Ireland. Working closely with systems integrators Domino, Melior Solutions and VeriSign developed an automated solution for the creation of the EPC numbers on the Data Matrix Code which can be linked to the EPCglobal Network. In addition to a serialised number, the Data Matrix code also includes a Global Trade Item Number (GTIN) as well as a lot number and expiry date.
  6. 6. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 6 Paul Mills, Director of Melior Solutions says, “This achievement of EPC generation and networked connectivity means that no matter where the product is within the supply chain, you can see when it was made, who handled it and whether it is authentic.” Needless to say, a totally secure network to comply with patient confidentiality and privacy was a fundamental requirement for the project. VeriSign is providing critical components of the EPCglobal Network to ensure a secure, private network environment for the partners in the trial to share information between their systems. Each time a blood product passes through a new supplier, the information about its global location is fed back to the EPCglobal Network for current and future reference. “The EPCglobal Network plays a key role in the storage, discovery and sharing of information about the movement and location of items within today’s complex supply chains,” says Jeff Richards, vice president of VeriSign Intelligent Supply Chain Services. “As the manager of Root ONS services for EPCglobal and the leading provider of drug pedigree services, we are pleased to contribute our services and expertise to this important public safety initiative.” In 2004, EPCglobal selected VeriSign to manage the authoritative root directory for the EPCglobal Network, enabling organisations to locate and share serialised product information from across distributed supply networks. Based on the expertise that earned that designation, as well as in-depth
  7. 7. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 7 discussions with many players in the pharmaceutical supply chain, VeriSign is leveraging its infrastructure to develop network services supporting the unique needs of the healthcare industry, including an Electronic Pedigree Service that enables pharmaceutical manufacturers, distributors and pharmacies to securely track the movement of drugs. Being temperature sensitive, the blood product is then delivered from Baxter in Belgium, using Aexxidis as a specialist cold-chain supplier of pharmaceutical products to TCP in Ireland. TCP then stores, labels, dispenses and transports the produce under temperature controlled conditions to the individual patients. During the first stages of the trial, TCP started labelling the blood product with a two line linear bar code to enable traceability to the patient’s home or hospital. “However, what the trial has shown is that with the Data Matrix code you can apply unique serialised numbers at manufacturer level to allow full end to end traceability,” says Derek McCormack, Managing Director of TCP. “In future, we are hoping that the pharmaceutical industry will use a similar model and start applying suitable bar codes at manufacturing point.” Future progression Having proved that full traceability is now a reality, with data being captured at each product movement within the supply chain, the next step will be to introduce a handheld web-based device such as a mobile phone, which can be used by the
  8. 8. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 8 individual patient to scan the bar code on the drug when self administrating the product. This will automatically update the patient’s records at the hospital and prevent any manual errors in recording data. Adds Dr White, “As a product moves through the supply chain, manufacturers, trading partners and regulators all have access to key data which becomes invaluable when addressing issues such as product recalls, product authentication or defective ingredients, which, in the case of haemophiliacs, can mean life or death.” Concludes Tony Walsh at Domino, “This really is one of the most exciting and challenging trials that has successfully demonstrated track and trace capabilities, with huge scope for taking this one step further by introducing RFID into the process. Once this RFID technology is ready for widespread deployment, I am confident that in the next few years, we will be looking at the next ‘Holy Grail’ in terms of logistical development and traceability for a wide variety of applications.” ENDS Notes to Editors: Haemophilia is a bleeding disorder caused by a deficiency of a clotting factor, currently affecting around 2,000 patients in Ireland. On an average, 40,000 vials of CFCs are administered each year to Haemophilia patients in Ireland. To provide safer treatment of Haemophilia patients, the Irish Government
  9. 9. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 9 opened the NCHCD (National Centre for Hereditary Coagulation Disorders) in 2002 in Dublin. EPC Numbering Although it is widely believed that an EPC (electronic product code) number has to be embedded within an electronic tag (RFID tag) that can be applied to each item, this project proves that the EPC number can be embedded in a Data Matrix code rather than a RFID tag. Highly regarded for its robust structure and the volume of data that it can encode in a very small space, the Data Matrix was until relatively recently a proprietary 'branded' code and not part of the EAN.UCC/GS1 family of global, openly accessible and royalty free bar codes. This restricted its widespread adoption in high-volume markets such as FMCG and pharmaceuticals/healthcare. However, this situation changed when the rights were passed to GS1. About Domino Integrated Solutions Group From its position as a leading innovator of technologies that aid product traceability, Domino is ideally placed to understand the implications of integrating new methods and technologies into existing manufacturing processes. Domino offers modular and scalable Radio Frequency Identification (RFID) systems that provide immediate cost benefit and enable customers to avoid unnecessary costs associated with RFID implementation programmes. The successful integration of RFID and its inter-operability with common alpha/numeric and 2D symbologies such as barcodes is central to Domino’s total systems approach. By linking coding platforms from primary packages to secondary cases to tertiary pallets, and from laser marking to ink jet coding and RFID, Domino can improve the accuracy and reliability of product data that provides customers with the opportunity to seek real business improvement. With a strong systems approach, Domino can incorporate RFID into total turnkey coding solutions, which can be fully integrated within a manufacturing environment. Domino’s open-platform approach to RFID ensures that the company’s systems are compatible with RFID innovation, and that the most appropriate and effective technology is available to customers. For further information on Domino, please visit www.domino-
  10. 10. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 10 About GS1 GS1 develops and promotes open standards for supply and demand chain management. These standards, known as the GS1 System, are used by companies to help manage supply chains in an efficient and cost effective manner. The GS1 system supports technologies such as bar coding and scanning, eBusiness messaging, data synchronisation and radio frequency identification (RFID). GS1 Ireland’s Services • Provision of bar code numbers, EDI location codes and EPC Manager numbers • Provision of technical standards, guidelines and manuals • Helpdesk support • Training and advice • Industry consultation and representation “GS1 Ireland’s vision is for Irish organisations to attain world-class excellence in supply chain processes by implementing global standards. In order to make this vision a reality we drive the adoption of GS1 Standards through promotion, education and implementation support.” About Melior Solutions Melior Solutions Limited was founded in 2005 to provide a solutions oriented business with firm roots in the Healthcare Market and Supply Chain Solutions sector. Providing over ten years of experience in the packaging coding business, over three years directly associated with the Healthcare industry and over twenty years experience with data communications and data collection, Melior Solutions is ideally placed to provide creative answers to issues involving product coding and product identification both in the manufacturing environment and in the wider supply chain. Additional information about the company is available at About VeriSign VeriSign, Inc. (Nasdaq: VRSN) operates intelligent infrastructure services that enable businesses and individuals to find, connect, secure, and transact across today’s complex global networks. VeriSign Intelligent Supply Chain Services enable trusted, secure and scalable information exchange and collaboration among global supply chain participants. VeriSign’s Electronic Pedigree Service helps enable distributors, manufacturers, and pharmacies to implement their
  11. 11. World’s first 100% track and trace EPC solution for Pharmaceutical industry sets benchmark for future global implementation Page 11 compliance strategies. Additional news and information about the company is available at *** Produced by AD Communications on behalf of Domino’s Integrated Solutions Group, part of Domino Printing Sciences, plc For more information, please contact: Tony Walsh Jim Bracken European Business Development Manager Chief Executive Domino Integrated Solutions Group GS1 Ireland T: +44 (0) 1954 782551 T: +353 1 208 0660 Philippe Majois Paul Mills Packaging Technology Development Manager Director Baxter BioScience Melior Solutions Limited Tel: +32 68 272 589 Tel: +44 (0)1400 281222 Jose Morales Senior Manager, Business Development VeriSign, Inc Tel: + +1 415 703 0948