The Pharmaceutical Track and Trace System (ITS)
generally operates according to the principles stated below:
The printing of DataMatrix onto every drug unit produced or imported,
Providing the tracking and tracing of drug units with DataMatrix,
The sharing of XML files that include the hierarchical relation between the transportation unit and the drug units among the stakeholders through the Package Transfer System,
The notification of action types of the drug units and their DataMatrix information to ITS through web services.
To provide the traceability it is needed to assign a unique registration number to each drug unit. This unique registration number is attained through the combination of both the drug barcode number (GTIN: Global Trade Item Number) and serial number (SN: Serial Number). The Batch Number (BN) and the Expiration Date (XD) must also be added onto to the serialized registration data and the obtained information must be printed onto the drug unit. The printing of all the information needed by letters and numbers onto the package of the drug unit takes up a lot of space and the transfer by hand of this information to the virtual platform requires great workload. In order to abolish the problem of reading and writing, the decision was made to use DataMatrix (2D Barcode or QR code) technology through which the information can easily be retrieved by machines. This application was used for drugs for the first time in Turkey. The information which the DataMatrix contains is stated below.
Barcode Number – GTIN (Global Trade Item Number): The maximum 14 digit number which serializes products worldwide.
Serial Number – SN: The unique registration number defined by the manufacturers for each unit/package on the basis of products.
Expiration Date – XD: The last date that the product can safely be used.
Batch Number – BN: Is the registration number that distinguishes a batch from another during its manufacturing.
With the unique code that is acquired through these data the product becomes traceable. The conversion of these codes into DataMatrix and its usage on drug units, the tracking and tracing of the drugs has become obligatory since Ocotber 1, 2009.
Track and Trace
Track and Trace is the operation in which the past and current status information of each product is recorded. With the increasing of the areas that the track and trace operations are applied, the need in the branches of software, hardware and marketing has increased; thus methods like RFID and DataMatrix have been developed. EPCglobal, an international organization, has defined the structural and semantic features and security methods in determining the codes of products in the market under GS1 (Global Standards One). These standards are successfully being used in many areas nowadays and a great number of products are certified according to these standards.
With the ITS Project every drug unit in Turkey is being tracked and recorded with the Track and Trace method. All the drugs in the market are tracked on the basis of packages using keys of GS1 standards. The serialization providing the uniqueness of the units is ensured by the DataMatrix code instead of formerly used barcode. The ability to track each drug unit is provided by gathering the information of each unit in every single step and action; and traceability is provided by its pedigree. Thus the products can be traced at every phase from its manufacturing until their consumption.
Pharmaceutical Track and Trace System (ITS)
The Pharmaceutical Track and Trace System works through the notification of action types and DataMatrix information that is sent from the system stakeholders to the system center through web services. The DataMatrixes which are notified with production notifications by the manufacturer stakeholders are recorded to the system database as products able to move within the supply chain. After this registration, in other words the manufacturing notification, stakeholders like manufacturers, importers, exporters, warehouses, pharmacies, reimbursement companies, hospitals and other drug consuming centers which are part of the supply chain can move registered products according to certain rules. Transactions like buying, selling, reimbursement, recalls are notified to ITS in accordance with certain authorization and communication rules.
ITS communicates with its stakeholders through web services. All the notifications from the production of the drug until it reaches its last user are as follows; production, import, dispatch, exportation, dispatch cancellation, purchase, purchase return, consumption, deactivation and dispatch query. ITS where all this data is collected serves the collected and made meaningful information to the interrogators in terms of certain rules. With ITS notifications are made for about 2 billion manufactured/imported drug units. In addition about 7 transaction notifications are made for each drug unit within the supply chain.
Package Transfer Service (PTS)
ITS operates on the basis of single drug units. However, commercial transfers are not done by single units; instead they are done using transport units such as bundles, cases and pallets. Thus, the need to share information of the transport units among the stakeholders arose. Therefore, an XML file standard that includes the hierarchical relation between the transportation unit and the drug units has been developed with the contribution of the stakeholders. Furthermore a secondary system, ITS-PTS, operating as web services has been developed to allow stakeholders to share created XML files among each other.
ITS-PTS uses the ITS authentication system in order to share transfer files among the stakeholders. In addition it also contributes to the stock regulation and tracking since it also contains the hierarchical structure of the transfer units.
The web services are software systems which are designed to provide the interaction and compatibility of computers over a network independent from their operating environments. The web service is an XML messaging based system integration method.
Both ITS and PTS systems communicate with the other softwares of the stakeholders through the web services. For more detailed information on the ITS web services and their rules and regulations please visit the guidelines web page.