Benefits of Pharmaceutical Track and Trace

The pharmaceutical industry is under immense pressure to ensure patient and drug safety while operating within a complex web of global and national regulations. Still, without effective technology, the supply chain remains vulnerable despite these stringent measures. The World Health Organization's disturbing findings underscore this vulnerability: an estimated 10% of medicines circulating in low and middle-income countries are counterfeit or substandard! This data clearly highlights the urgent need for stronger pharmaceutical tracking systems. By effectively fighting against counterfeit drugs and protecting millions of lives, ensuring patient and drug safety is the primary benefit of implementing such powerful systems. 

To clarify, think about the real-life equivalent of this statistic: a family who invests all their money in their child's treatment, unaware that the drugs are substandard or counterfeit. Against these unacceptable situations, many countries have tried to develop pharmaceutical track and trace software and systems as crucial defense lines, tracking the pharmaceutical supply chain from production to end-users.  

The real power of comprehensive pharmaceutical track and trace systems goes beyond efficiency; it's their extraordinary capacity to protect population health and save countless lives that truly stands out. Here at Tiga Healthcare Technologies, we, too, developed an innovative drug traceability system with significant complementary benefits for patient and drug safety, such as a clean supply chain, rational drug use, effective recall management and many more against counterfeit drug dangers. 

As Tiga, we launched the world's first end-to-end pharmaceutical tracking system in Türkiye as an item-level tracking model in 2012: The Pharmaceutical Track & Trace System, branded as DrugXafe. While traditional models mainly focus on initial and final stakeholder control, DrugXafe tracks and traces each single drug box throughout the entire supply chain. By significantly enhancing pharmaceutical security and delivering substantial benefits for drug and patient safety, our end-to-end approach establishes new global standards. Its benefits and successes are poised to inspire global adoption as a best practice. 

In this blog, we'll explore the world of pharmaceutical track and trace systems. We'll examine their benefits and potential and then highlight DrugXafe's benefits! 

What is Track and Trace in Pharma? 

What is the main aim and main difficulty facing the pharmaceutical supply chain on a global scale? The aim and the challenge are the same: ensuring the reliable supply of drugs to patients. However, a significant challenge hinders this in most countries, which is the threat of illegal activities. Many dangers like counterfeit drugs, reimbursement fraud and smuggling have the potential to seriously impact population health and safety. Then, we ask again: what is the track and trace system in pharma? They are the main healthcare IT solutions against these dangers. 

In essence, tracking and tracing in the pharma industry is about monitoring the movement of drugs to guarantee drug safety and supply chain transparency efficiently. By assigning unique identifiers to individual items or specifying other control points, these systems give a valuable piece of mind in the ongoing battle against counterfeit drugs. 

How Do Pharmaceutical Track and Trace Systems Work?  

At the heart of pharmaceutical tracking systems are databases containing critical drug information. Technologies such as barcodes and 2D Data Matrix codes allow this information to be easily created, read by scanning and updated in the database. By utilizing this barcode and 2D Data Matrix codes, every drug box is assigned a unique serial number, ensuring that each one is distinct. This compatibility ensures complete traceability of drugs throughout their entire lifecycle. 

Let's take 2D Data Matrix codes, which we also use in DrugXafe, as an example. These codes are indispensable as they compactly encode necessary drug information such as the Global Trade Item Number (GTIN), Expiration Date (XD), Serialization Number (SN) or Batch Number (BN) into a scannable format. Present on every drug in the DrugXafe system; these codes function like mobile libraries, providing stakeholders with the required information. 

Scanners capture these codes throughout the supply chain, feeding real-time data and triggering notifications. This functionality allows for precise tracking and verification of individual products, significantly reducing the risk of counterfeits and optimizing inventory management. 

This drug data is essential for adhering to rigid regulatory requirements and standards, ensuring drug safety and efficacy. The pharmaceutical industry operates in a zero-tolerance environment governed by a complex web of regional, global and national regulations.  

For example, the Drug Supply Chain Security Act (DSCSA) in the United States outlines a standardized approach to identifying and tracking prescription drugs at the package level. Japan's Pharmaceutical Affairs Law mandates regulations for pharmaceuticals, quasi-drugs and medical devices to increase efficacy and safety. As a regional example, the European Union's Falsified Medicines Directive (FMD) imposes strict product serialization and security requirements, including unique identifiers and tamper-evident packaging. Countries with advanced pharmaceutical tracking systems can maintain the highest safety standards to meet these regulatory demands. 

As one of the complementary examples of these efforts at the global level, the World Health Organization's Medication Without Harm initiative and related projects see medication traceability as a critical component of patient safety. Addressing medication-related issues as avoidable harm and supporting potent pharmaceutical track and trace systems, the initiative seeks to prevent medication errors, counterfeit drugs and adverse drug reactions. Focusing on traceability aims to enhance patient outcomes and create a safer global healthcare environment. Then, the next question is, if implementing pharmaceutical tracking systems is almost mandatory, what are the technical and operational challenges in fulfilling this obligation? 

Pharmaceutical Track and Trace Challenges  

The rewards of these systems are substantial but so are the challenges. There are considerable obstacles to implementing and maintaining effective pharmaceutical tracking systems. The intricate nature of global supply chains and a patchwork of heavy regulations create a challenging environment.   

Overcoming barriers to developing required technologies that seamlessly integrate various stakeholders requires addressing several issues. For instance, ensuring smooth interoperability between different systems while protecting sensitive drug data is crucial. Let’s explore the main challenges step-by-step. 

Supply Chain Complexity 

The complexity of pharmaceutical supply chains in this global era exemplifies a significant challenge in tracking and tracing drugs. With multiple stakeholders, including manufacturers, wholesalers, distributors, retailers and patients, various links introduce changing regulatory, logistical, data management and safety issues.  

Each link in the chain adds a layer of complexity and complicates achieving real-time visibility and coordination. It's essential to ensure accurate and consistent tracking of drugs in a comprehensive way that integrates diverse data sources and streamlines communication across all parties involved. Addressing this complexity is crucial for maintaining the integrity and safety of the pharmaceutical supply chain. 

Interoperability Issues 

Interoperability issues are another major challenge, specifically in the serialization phases of pharmaceutical track and trace solutions. In most countries, achieving a unified national standard is a fundamental problem, complicating efforts to ensure consistent drug tracking systems across different systems. Therefore, comprehensive end-to-end control in pharmaceutical tracking systems is crucial. The goal is to establish a common standard to harmonize industry practices globally, streamline compliance and improve traceability.  

The most important aspect of this interoperable approach is its technological side. By implementing a comprehensive pharmaceutical tracking solution, various systems within the healthcare and pharmaceutical ecosystem, including reimbursement institutions, insurance companies, pharmacy and hospital software and identification and terminology systems, achieve seamless interoperability through stronger data infrastructures and effective integrations. 

Security & Privacy Concerns 

Pharmaceutical tracking systems should be designed to be highly secure to ensure drug safety and supply chain integrity. Let's take barcode technology, for instance. Advanced tracking technologies based on serialization with 2D Data Matrix codes provide unparalleled protection against counterfeit drugs.  

Protecting sensitive patient data is also a milestone of trustworthy pharmaceutical practices. Implementing strict security measures is essential to maintaining public confidence in the pharmaceutical industry and preventing the harmful consequences of counterfeit drugs.  

Technological Barriers 

Many systems are based on advanced technologies such as serialization, data encryption and real-time data integration, which can be complex and, more importantly, costly. Additionally, integrating these technologies across diverse platforms and stakeholders often requires overcoming compatibility issues. Otherwise, these technological obstacles lead to delays, increased costs and potential gaps in traceability. Addressing these barriers involves investing in scalable, interoperable solutions and ensuring that all parties in the supply chain have the necessary technology and expertise.

Stakeholder Resistance 

Another operational barrier is stakeholder resistance against track and trace pharmaceuticals. Various stakeholders may need help adopting new technologies due to concerns about costs, troubles with existing processes or the complexity of integration. This resistance can stem from a reluctance to change or fear of functional impacts, leading to delays and inconsistencies in system implementation.  

One of the most critical elements in facilitating stakeholder participation is the proactive role and contribution of regulatory bodies and public authorities. Their approach to the issue, combined with their contributions and potential implementation of control mechanisms, significantly influences overall participation. Therefore, early engagement of stakeholders in the transition process for these changes is crucial, as well as providing clear benefits of the new system and offering support, training and time to facilitate a smooth transition. 

Now is the perfect time to examine DrugXafe, which offers specific solutions to each of these challenges, implementation strategies, security measures and an inclusive approach! 

Tiga's Global Role in Pharmaceutical Tracking System 

We launched DrugXafe in 2010 for the Turkish Ministry of Health, a major step for the track and trace solutions for the pharmaceutical supply chain. As the world's first end-to-end pharmaceutical tracking system, DrugXafe has radically transformed drug tracking and control by offering complete visibility and real-time data at the item/box level with unique 2D Data Matrix codes. This innovation earned DrugXafe two United Nations - WSIS awards for its successful implementation in both Türkiye and Saudi Arabia.  

Currently, it operates across three countries, serving over 65,000 stakeholders, such as pharmacies, consumption centers, wholesalers, manufacturers, exporters and reimbursement institutions. With a track history of handling more than 35 billion pharmaceuticals, we continue to expand our reach globally. Let's explain how we reached this! 

https://www.youtube.com/watch?v=wwCLhB7OzRo&t=78s 

2D Data Matrix Codes for Product Serialization

DrugXafe establishes a comprehensive digital record for each drug box using 2D Data Matrix codes for serialization. These codes are two-dimensional barcodes that store information in both vertical and horizontal dimensions, allowing for a higher data density. They are highly compact and can encode a significant amount of data in a small space, making them ideal for applications where space is limited, such as labeling pharmaceuticals. In DrugXafe, these codes include detailed drug information like Global Trade Item Number (GTIN), Serialization Number (SN), Expiration Date (XD) and Batch Number (BN) for consistent national-level tracking and tracing. Then, what are the real-life results of serialization with these efficient codes? 

DrugXafe has significantly reduced counterfeit drugs countrywide by identifying sources and preventing resale. The system ensures drugs are authenticated before reaching patients, blocks expired products and improves inventory management. It also assists in tracing recalled products and supports rational drug use policies with a central database. Thus, it's now the golden standard for pharmaceutical tracking, enhancing transparency and information sharing across the supply chain via effective serialization. Let’s investigate its benefits in detail. 

Benefits of DrugXafe  

Secure and effective, DrugXafe revolutionizes drug safety by ensuring comprehensive tracking and authenticity verification. Let’s get into the details! 

Blocking Counterfeit and Substandard Drugs 

Serialization via 2D Data Matrix codes is a guaranteed way of meticulously tracking each drug's path from production and importation to patient delivery. Every drug has a unique digital fingerprint, from production and importation to patients' medicine cabinets.  

This secure system is like a defense line, blocking counterfeit and substandard drugs and ensuring only genuine medication reaches patients. DrugXafe plays a crucial role in protecting the health of the population. 

Reimbursement & Insurance Processes Enhancement 

As we said, every drug gets its own unique digital ID or, in other words, a barcode that's usable only once. This means no more double reimbursements. DrugXafe keeps tabs on every drug, from the moment it's made to its final sale. We're building a wall against reimbursement fraud by tracking production, sales, costs and returns. The best part for insurance companies is the opportunity to verify everything digitally, making the process smoother and safer for everyone involved. 

Effective Stock and Inventory Management 

With DrugXafe, stock management becomes effortless instead of overwhelming. Our real-time tracking system provides a view of the entire drug inventory. Stakeholders know what they have, where they are and when they need to restock. This means no more running out of essential drugs or being stuck with expired stock. DrugXafe ensures patients get the drugs they need when they need them. 

Drug Recall Management 

If a drug is recalled due to safety concerns, DrugXafe springs into action. Whether it's a faulty batch, an expired product or unexpected side effects, the system swiftly initiates the removal process of of those drugs from the market. Our system ensures that only safe and effective drugs make it to patients. 

Data Management and Rational Drug Use 

DrugXafe isn't just about tracking drugs; it’s about transforming healthcare by turning data into powerful insights. The system offers valuable data for healthcare authorities and managers to create detailed analyses, reports, policy recommendations and insights. There are more gains, such as disease maps, predicting drug shortages, developing fast responses to pandemics and, above all, rational drug use. We're giving health authorities the tools to build a smarter, stronger and more resilient healthcare system. 

Tracking and Tracing of Specific Drugs for Enhanced Safety 

DrugXafe has a responsible control approach to further strengthen patient safety and rational drug use benefits. The comprehensive control of the entire pharmaceutical supply chain and the database formed in line with the acquired data facilitate the tracking and tracing of specific drug groups, such as narcotics and psychotherapeutics. We have prevented the abuse of those specific drugs by continuing this tracking and tracing policy in the prescription process with Central e-Prescription, thanks to its real-time alerts for unusual prescription patterns.

The pharmaceutical industry is undergoing significant changes driven by technological advancements and emerging trends. We lead in this manner by updating DrugXafe and our Drug Traceability product family. DrugXafe Mobile App enables patients to check their drugs' status by scanning the 2D Data Matrix or entering drug identifiers manually. This way, patients can access information about expiration dates, recall information, drug prices, adverse reaction notifications, announcements and the nearest pharmacies in seconds. 

For simplified box-package-pallet scale control, the Aggregation Management System streamlines product bundle notifications in response to stakeholder feedback. By processing the product information into 2D Data Matrix codes, this system effectively complements DrugXafe for pharmaceutical tracking. As global efforts push for standardized practices to fight counterfeit drugs and streamline processes, our Drug Traceability product family is conducting the charge to enhance supply chain resilience and agility. 

To summarize, tracking and tracing in the pharma industry processes are essential in addressing the global challenge of counterfeit drugs, improving safety and enhancing industry efficiency. DrugXafe exemplifies this by offering advanced features that optimize tracking the entire supply chain and stock management, ensure compliance and boost operational effectiveness. Its transformative potential can significantly reshape the pharmaceutical landscape, making it a vital tool for the industry's future. Let's shape the future together through advanced pharmaceutical tracking and tracing for improved drug safety!