IMID Medical Journal

Introduction
The ability to identify individual objects is essential in many application scenarios, such as manufacturing, logistics, and anti-counterfeiting. It is contributing substantially to assert the concept of Internet of Things (IoT). The core idea of the concept of IoT is to collect any useful information about objects of the physical world and to use this information in various applications during the objects' life cycle. This feature can help organizations to improve existing internal and external business processes and also to create new ones.
The item-level traceability is able to guarantee complete transparency in every step of a supply chain for products and goods; this is a key factor for many people whose life style is strongly conditioned by several intolerances. Some examples of these supply chains, more influenced by traceability, are pharmaceutical and agro-food. In fact, it is well known that a patient affected to multiple intolerances has to pay attention for the choice of medicines and goods. In particular, it is very important that a tracing system is able to provide details related to the composition of these.
The pharmaceutical supply chain, with millions of medicines moving around the world each year that have to be traced at item-level, represents a very interesting application scenario. Its fragmentation, represented by the overwhelming growth of intermediate wholesalers and retailers involved in drug flow, are resulting on a decrease of transparency of the supply chain and an increase of difficulty to track and trace medicines. Furthermore, the growing counterfeiting problem raises a significative threat within the supply chain system.
The Radio Frequency Identification (RFID) technology is fundamental but not sufficient to create a global Internet of Things. Currently, there are still some technical and economic barriers that are retarding this complex revolution. Some initiatives are facing these challenges obtaining substantial successes. The asserting of some international standards related to goods traceability, as EPCglobal (Thiesse et al. 2009), GS1 (Global Standard 1) and ebXML (Electronic Business using eXtensible Markup Language), are only some interesting examples.
A recent practical experience has been gained on an item-level tracing system for the pharmaceutical supply chain. The implemented software architecture exploits the main advantages of the RFID technology to trace at item-level drugs on the whole supply chain. Furthermore, it is conform to traceability standards (e.g. EPCglobal), and e-business messages interchange standards (e.g. ebXML).
This software platform may be easily extended in order to include additional services related to patient clinic database. The ability to merge the data contained in a tracing system of drugs with those contained in a digital clinic record system is, of course, very useful to improve the life style of millions of patients affected to multiple intolerances. Some details related to this extension of the tracing system are reported in the last part of the paper.

RFID technology
RFID (Finkenzeller 2003) technology is a very powerful innovation to guarantee the ability to trace and track individual object in a global scenario controlled by pervasive computing systems. This auto-identification technology has recently seen growing interest from a wide range of application sectors such as retail, logistics, supply chain, healthcare, and pharmaceutical.
The RFID transponders, often called “tags”, can be of three types: passive, semi-passive and active. The passive ones are used in most tracing systems due to their higher-range and very low-cost, since they require no battery to operate. A typical passive RFID tag consists of an antenna and an integrated circuit chip in Application Specific Integrated Circuit (ASIC) technology. In a passive RFID system, the reader transmits a modulated RF signal, which is received by the tag antenna. The RF voltage generated on the antenna is converted into DC (Direct Current). This voltage powers up the chip, which sends back the information that it contains. Passive RFID tags can be classified taking into account the different frequency band used (e.g. LF, HF, and UHF) and the type of coupling (magnetic or electromagnetic) between tag antenna and reader antenna. Recent works (Uysal, Emond, Engels 2008) highlighted that passive UHF tags represent the best solution for item-level tracing systems in the whole supply chain. Unfortunately, UHF tags could occasionally encounter problems, causing performance degradation (De Blasi 2009), when they are used in presence of materials like liquids and metals that absorb RF energy. However, some recent research results (Catarinucci 2010) have allowed to mitigate or to resolve these problems.

EPC Network architecture
The EPCglobal consortium, mainly represented by the GS1 organization, defines the standards for developing a universal identification system and an open architecture able to guarantee interoperability and data sharing in a complex multi-vendors scenario. In particular, it proposes the EPCglobal network architecture (Floerkemeier, Roduner, Lampe 2007), whose main feature is represented by the use of the Electronic Product Code (EPC), a code able to univocally identify each item. This architecture is composed of a set of standards for hardware devices (e.g. reader), software systems, network services, and data interfaces that allow EPCglobal network to play a very important role in traceability systems. The EPCglobal architecture is able to guarantee effectiveness, flexibility, and scalability. Furthermore, it is important to observe that this architecture was designed to exploit all advantages of the RFID technology, but it continues to be valid also in presence of others automatic identification solutions. In fact, it is able to provide most network services even if a linear or two-dimensional barcode is used.
The EPCglobal (Traub et al. 2005) defines a full protocol stack to enable item-level data sharing related to products that move in the whole supply chain. The EPCglobal architecture is mainly based on the EPCIS (EPC Information Service), which contains information of each single product provided by the manufacturer and the various stakeholders, and on the ONS (Object Naming Service), that provides functionalities similar to Domain Name Service of the Internet. The EPCglobal architecture was created to develop an efficient and universal distributed database that can be queried to obtain easily and quickly every fragment of information related to the complete supply chain or lifecycle history of a given object. In order to improve this querying procedure, the EPCglobal framework foresees the use of a Discovery Service (DS) mechanism. It is useful to allow different organizations to collect and store information relating to a particular product, to control the stored information and to decide how many and what information render available to other organizations. It also takes into account the key principle of information sharing within a community according to which data ownership must be respected. This means that each organization can collect information within their own systems and is not required to route that information to any other organizations.
Finally, in order to maximize the advantages obtained by the availability of new software and hardware solutions for the automatic tracing and tracking of items on the whole supply chain, a traceability system should be integrated with standard business data interchange solutions. There are consolidated standards that have given an answer to the needs of Supply Chain Management (SCM) improvement from an e-business perspective. An interesting approach aims both to provide a high degree of freedom in the business process design and in the formalization of the specific business message, and to suggest to the companies the use of only one technology of interchange that is flexible and easy to integrate with the company’s information system. The combined use of the ebXML, as data interchange standard, and the UBL (Universal Business Language) (Tolle 2008) standard, for the definition of e-business documents, is often suggested to support effectively the integrated business data interchange on the whole supply chain.

Description of a research project on the traceability
The research work summarized in this paper represents a part of the results obtained by a recent research project performed in the IDA Lab of University of Salento (Italy) in collaboration with different actors of pharmaceutical supply chain. The title of this pilot project is “Tracing and tracking pharmaceutical items using innovative EPC-aware technologies”. In this paper, practical experiences gained by this project related to item-level traceability of drugs are summarized in order to show main advantages obtained by the use of these innovative technologies.
The defined software architecture was designed by merging the two main components: EPCglobal protocol stack and the ebXML for messaging services. In this way, the overall system is able to answer the requests from the factory users by sending reports and information about a specific product, marked by an EPC code, or providing the possibility to perform messaging operations such as, for example, sending an order.
The overall system is based on two open-source implementations provided by the scientific community: a) the e-business message exchange sub-system modelled by the freebXML project, an open-source implementation of the ebXML standard, and b) the identification and traceability sub-system modelled by the Fosstrak framework, an open-source RFID software platform that respects exactly the current standards provided by EPCglobal. This framework is full compatible with the RFID hardware used as auto-identification solution. In particular, the defined tracing platform reads the EPC codes applied on the medicines by using the passive RFID technology in UHF band (i.e. tags, reader antennas, and reader).
In order to appreciate the main benefices that the implemented overall system is able to provide to all actors of the pharmaceutical supply chain, a use case, shown in Fig. 1, has been defined and used to carry out an experimental validation campaign in a controlled test environment able to simulate the main steps of the pharmaceutical supply chain.

Let us observe that an item-level tracing system of drugs starts just after the packages are filled during the manufacturing process. In this step, each tagged product is scanned individually on the conveyor belt and then cased to be sent to the wholesalers. The wholesaler separates the products according to their identifiers and place them onto the shelves. Wholesalers receive orders from retailers. These orders often consist of small quantities of different products; they may contain a large number of items. The products in the orders of the retailers are picked and put into some large envelope bags that are scanned and confirmed before their distribution. Upon receipt, the retail pharmacy scans the contents of each bag without opening it.
The experimental phase has been defined in order to validate mainly the capability to provide a data interchange and traceability system proper to every actor of the supply chain (i.e. manufacturer, wholesaler, and pharmacy retailer). In order to simulate the pharmaceutical scenario, a controlled laboratory environment has been created.
Furthermore, this pilot project on the drugs traceability has stimulated further research topics, mainly focused to address the technical barriers that still are retarding the deployment of these innovative technologies in large-scale application scenarios. Among these, the evaluation of potential effects of these RFID systems on the molecular structure of drugs is very interesting. Recently, in order to analyze these possible alterations on biological drugs, a scientific collaboration between the IDA Lab and the Di.S.Te.B.A. department of University of Salento has been activated.

The drugs traceability supports clinic and nutritional applications
A drugs tracing system, as well as offering significant improvements for logistic aspects, can be easily extended in order to provide innovative services to support clinical and nutritional applications.
The interest to implement these new services comes from the desire to satisfy basic needs of a particular category of patients, as those affected to multiple intolerances. It is well known that such patients often encounter serious difficulties to choose a pharmaceutical product because it may be composed of substances incompatible with the clinical profile. This impacts negatively both on the lifestyle of these patients and on the work of doctors and pharmacists that have the responsibility to suggest the more appropriate product.
The idea to extend our traceability system aims to provide these new and innovative services; one key factor concerns the ability to allow an automatic cooperation between the system containing the patient information and the tracing system of drugs.
In order to reach the above goal, the traceability system should be able to query automatically a system of digital clinic records, preferably compatible with international standards (e.g. HL7 standards). In this way, the new system is designed in order to satisfy the requests of a patient, affected to multiple intolerances, for a given symptomatology. More specifically, when a specific patient goes to a doctor or a pharmacist, just showing the own healthcare card, containing a unique code stored in a passive RFID tag, will provide them the possibility to consult, in real time and with a specific level of authorization, the own clinic profile. For example, a pharmacist could automatically detect the intolerance codes of the patient. At this point, the system always in fully automatic mode is able to select the set of pharmaceutical products for a given pathology compatible with the intolerances profile of the specific patient. This system certainly represents a useful tool in the hands of doctors and pharmacists, but at the same time is able to guarantee a significant improvement of the lifestyle of patients with multiple intolerances. The IDA Lab group is currently completing the implementation and validation of these new services designed to support the choice of drugs for patient with multiple intolerances. The next step is to export this platform on the agro-food sector, in order to guarantee same services in the choice of food.