What is track and trace?
The tracking and tracing of the passage of prescription drugs through the entire supply chain, from manufacturing to dispensing, is intended for regulators and companies to determine the authenticity, identity, and whereabouts of a specific product. It's a move designed to make it harder for counterfeit drugs to enter the pharmaceutical supply chain, and if they do, make it simpler for authorities to identify at exactly which point they infiltrated the system. In order to track and trace a product, it must first be serialized – or have a unique serial number to mark its identity.
What is serialization?
Serialization is the assignment of unique, traceable serial numbers to individual items or saleable units. In today’s society, we attach unique identifiers to many things: newborn babies receive a national identification, or social security number; new cars are assigned a vehicle ID and then a license plate. For pharmaceutical companies, serialization involves identifying each prescription drug product, at the saleable unit, with unique data, and then accounting for that data over the next several years. Serialization will impact every segment of the supply chain, and its requirements vary depending on the country where the product is sold.
Across the globe, ever-evolving regulation enforcing the use of advanced technologies to tighten up and standardize the distribution of pharmaceutical drugs is expected to shore up safety and shift out counterfeit drugs from the supply chain.
When was TraceLink founded?
TraceLink was founded in 2009.
What does TraceLink do?
At TraceLink, we are blending decades of knowledge in technology, the life sciences, and supply chain business process with a clear vision for advancing the healthcare industry with disruptive, unconventional software solutions. Today, our Life Sciences Cloud is the world’s largest and only track and trace network for connecting the pharmaceutical supply chain, in order to eliminate counterfeit drugs from the global marketplace and enable real-time information sharing for better patient outcomes.
How did TraceLink become involved with track and trace for pharmaceuticals?
TraceLink Founder and CEO Shabbir Dahod recognized early on where and how traceability technology could be used to strengthen the life sciences supply chain and make a significant impact on saving lives, years before the U.S. and 40 other countries around the world began mandating a tightening of the drug distribution system. In the early 2000s, while working with MIT Auto-ID Labs (which germinated the concept of Internet of Things (IoT) in 1999), he was alerted to a series of incidents where counterfeit drugs made their way to unsuspecting patients across the U.S. Moved by the gravity of human lives at stake, and immersed in IoT research, Dahod had the idea to lift the journey of a pharmaceutical product up into the digital cloud; its footprint would be managed digitally, thereby securing the movement of safe medicines from manufacturer to patient and all steps in between.
In 2003, fueled by a desire to protect patients, Dahod started a Cambridge, Massachusetts-based company, SupplyScape, whose engineers designed a software solution that was able to safeguard the supply chain by creating a “pedigree” for each drug product. In 2005, SupplyScape launched an ePedigree compliance solution, delivering end-to-end track and trace capabilities for states like California, Florida, and Nevada. Ensuring drug supply throughout the supply chain at the state level helped blaze the track and trace trail by setting the course for how the Drug Supply Chain and Security Act (DSCSA) would later work at the federal level. DSCSA was passed by Congress and signed into law by President Barack Obama in 2013, requiring every company in the U.S. pharmaceutical supply chain to track the path of pharmaceutical products, and creating new regulations for pharmaceutical manufacturers, wholesale distributors, hospitals, and pharmacies
A few years before DSCSA became law, Dahod evolved SupplyScape into TraceLink, and introduced the Life Sciences Cloud, a cloud-based software platform that has now become the world’s largest and only track and trace network for the life sciences supply chain.
What is the TraceLink Life Sciences Cloud?
TraceLink Life Sciences Cloud is the world’s only network-based global traceability platform for the life sciences industry, hosted by Amazon Web Services, which many global companies depend on for security, stability, and massive scalability. Its unique network architecture leverages on-demand computing resources and database architectures custom-designed to handle massive sets of data in ways that traditional, on-premises systems cannot.
Today it connects over 250,000 trading partners—from pharmaceutical companies to corner drug stores— and tracks more than 2 billion units of medicine. Through a single connection to TraceLink Life Science Cloud, any authorized user—be it a pharmaceutical company, wholesale distributor, hospital, or other supply chain member—can link to and share compliance-related events (serialization data, transactions, product movements, production status, inventory levels, etc.) with all members of their global supply network.
How does the Life Sciences Cloud help combat counterfeit drugs?
Governments around the world are enacting tougher safeguards for combating counterfeit drugs. But every country does it differently; there is no global standard. This means pharmaceutical businesses must contend with dozens of varying regulatory laws for all of their products, across every touchpoint in their global distribution. That can quickly multiply into tens of millions of transactions that need to be reported accurately to stay in compliance. The massive scale of this challenge is met with the TraceLink Life Sciences Cloud, on which all players across the supply chain work together to keep medicines moving safely.
How prevalent is drug counterfeiting?
The World Health Organization (WHO) estimates 10 percent of medicines worldwide – and up to 50 percent of the drugs consumed in developing nations – are counterfeit.
The international counterfeit drug market amasses $200 billion a year. Internet sales make up $75 billion of that market. Most counterfeits are made in China and India. In the United States, 80 percent of counterfeit medicine is brought into the country from outside.
The FDA believes the growth in the counterfeit drug market may be due to the escalating costs of prescription drugs, advanced technologies to develop counterfeit drugs, and the anonymity and ease of the Internet. Studies show that about 90 percent of drugs purchased online come from a different country than what the website claims, and Internet pharmacies often buy drugs from countries with lax regulatory systems.*
*From Health Research Funding
Who are TraceLink’s customers?
TraceLink customers encompass organizations across the entire pharmaceutical supply chain, ranging from large pharmaceutical companies to small independent pharmacies.
Specifically, TraceLink customers include:
Large pharmaceutical companies
Mid-size pharmaceutical companies
Biopharmaceutical companies in Phase 3 of their FDA approvals
Contract manufacturing organizations
Contract packaging organizations, Re-packagers
Third-party logistics providers (3PLs)
Acute care facilities
Retail pharmacy chains
How many countries have regulations to track prescriptions through the supply chain?
By the year 2020, track and trace regulations will cover more than 80 percent of the global drug supply. Every year, more countries introduce laws that will have an impact on companies producing, distributing, or dispensing pharmaceuticals across the globe. Five emerging markets with regulation developments underway are Australia, Egypt, Russia, Saudi Arabia, and Taiwan. The global landscape continues to evolve.
What is the Drug Supply Chain Security Act (DSCSA)?
The Drug Supply Chain Security Act (DSCSA) was signed into U.S. law on November 27, 2013 to prevent counterfeit and adulterated drugs from entering the nation’s drug supply chain. With a 10-year timetable for step-by-step implementation, DSCSA will allow for instant, electronic tracking of prescription drug products as they are distributed in the United States.
All trading partners involved in the sale or purchase of prescription drugs within the United States, including manufacturers, repackagers, wholesale distributors, pharmacy dispensers, and third-party logistic providers, need to comply with U.S. DSCSA.
What is the European Union Falsified Medicines Directive (EU FMD)?
The European Union Falsified Medicines Directive (EU FMD), designed by the European Parliament and EU regulators and adopted in 2011, aims to stop falsified medicines reaching the open market within the EU by enforcing a series of pan-European safety and control measures for prescription medicines and some high-risk over-the-counter drugs.
On February 9, 2016, the Delegated Act on safety features for the EU FMD was published, outlining how pharmaceutical companies, parallel importers, wholesale distributors, and pharmacies must track and trace medications within the EU. Such measures include unit-level serialization, government reporting, and verification components.
For more information on EU FMD, how it will impact supply chain segments, how it compares to U.S. DSCSA, and important terminology, download our eBook here.
How is EU FMD different from U.S. DSCSA?
Both regulatory mandates share many common factors, such as the requirement for four common data elements: product, batch/lot, expiry date, and serial number. Both also share the primary goal of getting the right drug to the right patient at the right time, while stopping the movement of counterfeit drugs through the supply chain.
However, there are deadline, market, and regulatory differences between EU FMD and U.S. DSCSA requirements. To find out the six top differentiators, download our eBook here.
What will happen if trading partners don’t comply with the regulations by deadline?
For U.S. supply chain partners, failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.
Pharmaceutical manufacturers failing to comply with any aspect of the EU FMD directive, from February 2019 onwards, will have to withdraw their products from the European market.