Track-And-Trace Solutions: Domino Welcomes FDA's Vote Of Confidence In Hybrid Track-And-Trace Solutions
Implementation of ‘pedigrees' in distribution system will encourage combination of RFID with alternative data carriers
Domino's Integrated Solutions Group has welcomed the recent Compliance Policy Guide announcement by the US Food and Drug Administration (FDA) as a major boost to the implementation of hybrid product traceability solutions combining RFID with existing data-carrier technology to provide counterfeit-proof ‘e-pedigrees' throughout the pharmaceutical supply chain.
Says Simon King, Director of Domino's Integrated Solutions Group: "In our view, the FDA is spot on in its assessment of where track-and-trace technology is now – in particular, in its understanding that the electronic pedigrees needed to prevent counterfeiting are achievable now by using existing data-carriers such as 2D and composite barcodes, especially Data Matrix with EPC. As part of the team that recently developed the world's first 100% track-and-trace EPC solution trial for the pharmaceutical industry, we know that such hybrid solutions work, and it's very encouraging to see the FDA confirming this – the FDA's decision to implement e-pedigrees from December this year is a huge vote of confidence in these technologies.
Continues King: "Recent research by ABI indicates that drug counterfeiting may cost the worldwide pharmaceutical industry more than $30 billion annually. Providing pedigrees will certainly help in preventing counterfeit products enter and remain undetected within the supply chain. RFID technology, with particular reference to the implications for data management and transfer throughout the supply chain, will bring new, exciting capabilities that further enhance the security of the required solutions and the FDA is absolutely right to emphasize this. However, it is important to note that RFID is only one part of a multi-layered approach to developing a 100%-secure supply chain that can track and trace products from manufacture through distribution to consumption – authenticating the product at any point beyond the manufacturing stage – as well as enabling compliance with the FDA's pedigree requirements."
He continues: "We fully support the FDA's recommendation to use RFID; however, there is also the important issue of developing global standards for RFID inter-operability that need to be considered before moving to global adoption. RFID technology can be ideal for particular applications, but different data carriers, such as Data Matrix codes are also highly regarded for their robust structure and the volume of data that it can encode into a very small area. Such data carriers may be preferable and more cost effective for applications such as item level or unit-dose level coding."
"The recent explosion of track and trace technologies presents manufacturers with a serious challenge as they strive to come to terms with the steep learning curve. The delay in mandating RFID in the pharmaceutical industry offers manufacturers a chance to step back and evaluate their systems requirements.
"Companies can expend huge amounts of effort and potentially make expensive misjudgments as they strive to develop RFID enabled product security programs – hence the need for experienced systems integration capabilities to evaluate and combine the myriad of technology offerings into a complete solution. We are a big supporter of RFID but understand that it is a single technology not a complete solution and typically represents only part of an organization's complete coding and traceability system."
Domino's IS Group recently 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 Hemophilia patients of St James's Hospital in Dublin, Ireland. The integrated EPC technology (electronic product code), embedded in a two-dimensional Data Matrix code, 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 from the point of manufacturer through to the individual patient in their home.
The use of unique serialized numbering and bar coding on each vial box enabled automatic electronic data collection and processing which resulted in safer patient treatment and 100% traceability and accountability of every drug and patient involved in this critical treatment process.
Project managed by Domino and GS1 Ireland, the pilot concentrated on end to end traceability of Hemophilia products in Ireland, allowing secure deliveries and stock optimization in full respect of cool chain logistics and patient safety. The drug track and trace system uses GS1's latest electronic bar coding technology to trace expensive and time-sensitive Clotting Factor Concentrates (CFCs), the product used to treat hemophiliacs.
Having proved that full traceability can be reality without the use of RFID technology but with data still 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 individual patient to scan the 2D Data Matrix or linear barcode from the drug pack when administrating the product. This process is capable of automatically updating the patient's records at the hospital and prevents any manual errors in recording data.
Says Simon King: "This exciting and challenging trial in Ireland has proven the concept, namely that we are already able to successfully provide a more secure and safe pharmaceutical supply chain by implementing end to end track and trace technology.
By managing individual product data from the point of product manufacture, aggregating this at different levels of packaging and then building a verification system that operates across the multiple ‘touch points' throughout the supply chain, we know that we have a model that can be built upon for the future. We are already developing a more extensive pilot for the healthcare supply chain within Europe that again incorporates EPC but this time utilizes RFID technology. The intention is to further demonstrate the benefits offered as part of a pedigree program that can enable product authentication and hence significantly improve the security associated with products as they flow from partner to partner across international boundaries."
Domino Printing Sciences plc
Headquartered in Cambridge, UK, Domino Printing Sciences is a world-leader in ink jet and laser technologies offering total coding, direct product marking and printing solutions. Domino has established a global reputation for the continual development and manufacture of ink jet and laser printing technologies.
In 2005 Domino had a turnover in excess of £192m. It employs 1,800 people worldwide and sells to more than 120 countries through a global network of 16 subsidiary offices and more than 75 distributors. Domino's manufacturing facilities are situated in the UK, Germany, USA, China and India and include group companies Sator and Wiedenbach. The North American market is served by three subsidiaries: Domino Amjet Inc. in Gurnee, Illinois, USA; Domino Printing Solutions Inc, Canada; and Domino Printing Mexico S. A de C.V.
Domino Integrated Solutions Group
The Integrated Solutions Group of Domino Printing Sciences Plc is a leading innovator of technologies and full solutions that provide robust traceability and product security systems. Domino offers a full integration service that extends from initial needs based consultation, technology evaluation and testing through to full system implementation. By integrating the leading AIDC (automatic identification and data capture) technologies available and combing these with a data management platform that extends from control over data flows within the enterprise, to transfer to external parties, the company offers an extensive range of modular and scalable track & trace systems. Configurable RFID packages are available that can provide immediate cost benefit and enable customers to avoid unnecessary costs associated with RFID implementation programs.
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.
Working with customers from initial concept analysis, project migration planning through to full implementation of in-line automated RFID track and trace systems, and combined with its open-platform approach, Domino's Integrated Solutions Group has the technical and project management expertise to deliver the most appropriate and effective solution to suit individual customer needs.
Domino recently acquired Texas-based Enterprise Information Systems, Inc. (EIS), a leading automatic identification and data capture systems integration specialist, which operates within Domino's Integrated Solutions Group.