Implementing a national track & trace system
By Kevin O'Donnell,

“The globalization of drug manufacture and distribution has given rise to many concerns about supply chain integrity in the U.S. With more foreign facilities supplying the global market than ever before, there is an increasing volume of imported products, more outsourcing of manufacturing, more complex supply chains, and manufacturing occurring in countries with less developed regulatory systems — all leading to greater opportunities for economic fraud.” These were the opening remarks of Ilisa Bernstein, Pharm.D, and acting director, Office of Compliance, Center for Drug Evaluation and Research (CDER) at the U.S. Food & Drug Administration (FDA) at a recent U.S. Pharmacopeia (USP) Workshop on Supply Chain Integrity at the USP Meeting Center in Rockville, MD.

Several global regulators repeated similar comments during the two-day workshop. Many countries, the U.S. among them, struggle with incomplete information about their supply chains, including who the players are and where the vulnerabilities lie. Additionally, gaps in regulatory standards needed to increase corporate responsibility and accountability add to the complexity of foreign, federal, state and local oversight of product safety.  Many countries are also grappling with incomplete enforcement tools, are resource-strapped and suffering from misaligned workloads, or are out of step with public expectations. 

But there is one country that has met these and other supply integrity issues head-on and has recently implemented a system on a national level to curb waste, corruption, counterfeiting, smuggling, falsification, bar code scamming, diversion and the distribution of grey market drugs within their supply chain: the Republic of Turkey.

At the USP Workshop on Supply Chain Integrity, a presentation was made on behalf of the General Directorate of Pharmaceuticals and Pharmacy from the Turkish Ministry of Health by Taha Yayci, the principal developer of the software infrastructure used in its track & trace system.

Struggling with waste and corruption in medical expenses in the government-controlled distribution of drug products, Mr. Yayci explained how the Turkish Ministry of Health started the Pharmaceutical Track and Trace System, called İlaç Takip Sistemi (ITS), the first successful application of a national pharmaceutical track & trace system in the world.

The scope of this project was enormous. It kicked-off in October 2007 and was in full implementation 26 months later. The system was developed to satisfy needs and requirements across the entire supply chain, maintaining the relationship between the package (or container) and its contents. 

It begins by assigning a GS1 Global Trade Item Number (GTIN) and a unique serialization number to every single secondary packaging of drug product imported or manufactured in-country. A unique data matrix code (instead of a bar code) is given to each unit to ensure its identity and pinpoint its location in the supply chain. Each stakeholder in the process affected by an ITS step or action is also identified with a unique Global Location Number (GLN) created by GS1. This information is transferred via a Package Transfer System (PTS) shared among stakeholders. The platform is equipped with modules to prevent fraud and ensure security and safety. All the information is centrally aggregated, registered and stored at a web-based server to provide traceability.

The ITS supports a population of nearly 73 million people through 250 drug manufacturers, 739 wholesalers, 7,277 hospitals, 24,315 pharmacies, and 41 reimbursement companies. To date, the system has tracked nearly five billion prescriptions from production through consumption. The program is a model and benchmark for other countries looking to protect public health through a secure drug supply chain. It has proven to reduce drug thefts dramatically, deter fraudulent repackaging and relabeling of drug products, prevent tax fraud and the sale of illicit, grey market and counterfeit drugs. In addition, with an average system response time of 0.02 seconds, the national program allows for immediate notification and action in the event of a recall of drug products and allows for effective and accurate dynamic reporting for market control, public health management, stock, supply, sales and trending data. 

Mr. Yayci would not say what the cost was to develop, pilot, and implement the system for the Turkish Ministry of Health. However, he did mention that the government’s return on investment was made within the first 18 hours after the program was up and running. 

One argument I hear as a potential drawback to such a program is patient privacy — every patient in the system is uniquely identified and access to his or her personal information may be accessible to unauthorized parties, or information gathered on individual patients may be used for other reasons without their knowledge. I find this to be a somewhat hollow argument, as information about us is continuously gathered by federal and state authorities, along with private and public companies every day in census records, income reporting and tax payments, school and insurance records, job and credit applications, and even parking violations. Credit card companies, banks and retailers gather and track our spending habits: where we shop, what we buy and how much we spend, and use this information to their advantage to target our consumer habits and spending. And more than 700 million people worldwide voluntarily provide a constant stream of personal and “private” information on Facebook and other social media sites. 

Personally, I would welcome a unique patient identifier meant to ensure the safety of the drugs I take — because right now there isn’t much that stands between drug safety and disaster. We could do a lot worse than follow Turkey’s lead. We have come to expect the track & trace system at a MacDonald’s drive-up window to work flawlessly when we order (and complain when it doesn’t). Is it too much to ask for the same level of verification for the medications we take?  

Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He can be reached atkevin.odonnell@exelsius.us.

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