978-1-4673-0878-6/12/$31.00 ©2012 IEEE April 19-22, 2012 Cappadocia, Turkey 24 TURKISH PHARMACEUTICALS TRACK & TRACE SYSTEM Serap Malc ¸ok Altunkan, Alper Yasemin, ˙ Ismail Taha Aykac ¸, and Elgin Akpınar T¨ urkiye ˙ Ilac ¸ ve Tıbbi Cihaz Kurumu S¨ o˘ g¨ ut¨ oz¨ u Mahallesi 2176. Sokak. No:5 P.K. 06520 C ¸ ankaya/ANKARA phone: +90 (312) 2183000, fax: +90 (312) 2183460, email: its@iegm.gov.tr web: http://www.iegm.gov.tr/ ABSTRACT The Turkish ’Pharmaceuticals Track & Trace System’ (as ˙ Ilac ¸ Takip Sistemi or abbreviated as ’ ˙ ITS’ in Turkish) is an implementation of Track & Trace methodologies in the phar- maceutical area. ˙ ITS suppresses commitment of offence or attempts to falsified medicines, by tracking pharmaceuticals in the supply chain individually. Thus, public health and wealth are secured. In addition, recall of harmful drugs has been achieved in very short time (more specifically in sec- onds) comparing to older bureaucratic procedure, resulting in prohibition of the drug. At the same time ˙ ITS provides smooth communication among stakeholders by determining the rules between transactions. Therefore, ˙ ITS provides the occurrence of the ethical behaviours in business and sup- ply chain. More specifically, ˙ ITS ensures the reliable sup- ply of drugs to patients, prevents sale of spurious/falsely- labelled/falsified/counterfeit drugs and barcode scams and supports rational drug use, supplies data to control market. 1. INTRODUCTION Product tracebility or, as it is more commonly called, Track and Trace, is the ability to know the physical location of an item at any time (Track) and the ability to know where the item has been (Trace) in the past. [1] In this document ”Product Traceability” is synonymous with ”Track and Trace”. The abbreviated equivalent for ”Pharmaceuticals Track and Trace System” in the Turkish language is simply known as ˙ ITS. Beginning with Universal Declaration of Human Rights [2], health innovation process is trying to reach the ideal. Besides, providing public health services, which deal with the diagnosis and treatment of disease, or the promotion, maintenance and restoration of health, has been searching for common solutions, for common problem of the whole world, such as spurious, falsely-labeled, falsified or counter- feit drugs. Product traceability constitutes the foundation for a higher level of patient safety by giving the ability to control drug diversions and counterfeiting of pharmaceutical products. These illegal practices pose a threat to the consumer/patient by introducing potentially dangerous drugs into the market [1] [3]. US and European government regulators are creating opportunities for the adoption of new technologies in the health care sector to improve patient safety [1] [4]. From the immemorial, man has been associated with greed and ways to cut corners. Fake herbs such as Cinchona bark existed in the 1600s, there was incidence of fake quinine in the 1800s and counterfeit penicillin was found in post-war Vienna in 1948. The World Health Organization (WHO) first addressed this situation in 1958 and officially started fighting counterfeit drugs in 1980 when the issue became a major threat [5]. The ultimate solution for the drug counterfeit problem should be the responsibility of everyone from consumers to governments. Everyone needs to work together to try to eliminate the problem completely. Just decreasing the incidence rate is a good starting point, but the goal should be total elimination: even a single case of a counterfeit drug should not be acceptable [5]. We are aware of the fact that, in addition to the cost in human lives, preventable medical errors cost money: Pharmacoeconomics is defined as a social science con- cerned with the description and analysis of the costs of pharmaceutical products and services and their impact on individuals, healthcare systems and society. Because phar- macoeconomics is a social science substantially concerned with the events in clinical practice, it overlaps with a branch of medicine called outcomes research. Pharmacoeconomics is that subset of economics that deals with pharmaceuticals and includes economic outcomes [6]. As a result of studies, conducted for the benefit for public health and public wealth, UK tried to use the track and trace system. UK based company, Aegate, pilots a 3 month observational study involving 44 pharmacies and 5 pharmaceutical companies across England and Wales. The pilot uses mass serialisation technologies; RFID, 1D and 2D barcodes to authenticate at the point of dispensing, scanning 180,000 individual medicines in total [7]. Since then, many countries, that attempted to use a track and