Today, many countries and organizations have been implementing studies about pharmaceutical traceability. The most important purpose of these studies is to fight anti counterfeiting that will directly affect the health of patients. Moreover, these studies are also aimed to find solutions to the issues such as misuse of medicines, abuse, traceability of country drug stocks, and quick reimbursement activities. This subject, which is still evolving in many countries, has fully been implemented in countries, the number of which does not exceed five fingers of one hand. It is thought that many countries will have had an infrastructure about pharmaceutical traceability by the year 2025 by completing their research.
Pharmaceutical Traceability in Turkey
The History of Pharmaceutical Traceability in Turkey
Turkey is the first country that has successfully completed the end to end pharmaceutical traceability that covers the whole pharma industry.
This project started in 2008 and was completed in 2012. Currently, Turkey is considered to have the most comprehensive and sustainable LEVEL 5 (Country Level) system among the countries and organizations that are working on pharma traceability. This project was financed and managed by the TİTCK (Turkish Medicines And Medical Devices Agency) institution which is affiliated to the Ministry of Health of the Republic of Turkey. Hence, TİTCK wanted to work with the private enterprise for the installation of this system, and a Turkish software company undertook the installation and operation of the system.
How does the Pharmaceutical Traceability System Work?
The system has used the GTIN, GLN and SSCC standards which were defined by GS1. However, software designers have developed another standard which is more suitable for their purpose instead of EPCIS defined by GS1. Important data operations such as verification and sharing of drugs by stakeholders have also been carried out by TİTCK systems. All data are being processed via web services with a secure SOAP interface. The Pharmaceutical Traceability project is called with the acronym İTS (İlaç Takip Sistemi). All Pharma manufacturers, importers and exporters, pharmacy warehouses, pharmacies, and hospitals have to obey the regulations defined by İTS.
Turkish pharma track and trace system has a packet transfer system PTS which enables the sharing of data aggregation. This system is aimed at the sharing of hierarchical data created through parent-child relations. Turkish pharma track and trace stakeholders do not pay any money to the authorities when they use the İTS and PTS system.
The Turkish pharmaceutical industry consists of approximately 300 drug manufacturers and importers, 700 pharmacy warehouses, 40,000 pharmacies and over 1000 hospitals. Some of these stakeholders are huge and some are small and medium-sized businesses. Although this is the case, each stakeholder completely fulfills its responsibilities within the system. Anyway, a successful pharma track and trace can only be successful if each stakeholder fully fulfills its duties and commitments. All stakeholders belonging to the Turkish pharmaceutical industry have established project teams for the success of the project and shared the results with the authority. In this way, the entire pharmaceutical industry has achieved a sustainable pharma track and trace system preventing anti counterfeiting.
Commitments of Stakeholders
The duties and functions of the stakeholders have been described below.
TİTCK : TİTCK prepares legislations about traceability, makes tender that will enable the administration of the central system and it also ensures the safety of data.
PHARMA COMPANY (Manufacturers, Importers and Exporters) : The pharma serializes and aggregates each drug and they also organize the actions of İTS and PTS.
WAREHOUSES : Pharmacy warehouses distribute their purchased products to the pharmacies and fulfill the notifications according to the rules of traceability during the supply chain.
PHARMACIES : The pharmacy is the only authority that can sell medicines to the patients. The pharmacies have to declare each sold medicine to the TİTCK system.
HOSPITALS : It is the responsibility of the hospitals to declare the medicines prescribed to the patients to TİTCK.
VISIOTT has produced solutions to the Turkish pharma industry about pharmaceutical traceability with its AGE brand since 2008. VISIOTT has designed, improved and completed the solutions that it has produced according to the requirements of the industry. Please, click the link below in order to review the software and hardware solutions of VISIOTT on serialization and aggregation.
Since the pharmaceutical traceability project which has been implemented in Turkey is more comprehensive, simple and sustainable as compared to the other implementations in the world, it is trying to be applied by other countries in the world.