Ensuring Patient Safety Through Pharmaceutical Traceability: The Need for an Enhanced Tracking System

 

Pharmaceutical Traceability

The need for tracking pharmaceutical products

The global pharmaceutical industry produces billions of dosage units every year that end up in the hands of patients worldwide. However, the supply chain that moves these products from manufacturers to distribution centers to pharmacies and hospitals is quite complex. There are many steps involved where errors or issues can potentially arise. The lack of proper pharmaceutical traceability can compromise patient safety if defective or counterfeit drugs make their way into the supply system unintentionally. A robust traceability system is required to accurately track each individual product throughout the supply chain and quickly identify the source of any quality or authenticity issues that may surface.

Current pharmaceutical traceability challenges

Currently, most pharmaceutical manufacturers only have tracking at the batch level. This means that while production lots can be traced back to the manufacturing facility, individual items within those lots cannot be uniquely identified. This poses challenges for targeted product recalls when only a small subset within a larger batch needs to be removed from distribution. It also limits the ability to pinpoint counterfeiting activities that may involve only a small number of units. Many countries also lack interoperable track and trace systems that can seamlessly share data across national and regional borders as drugs often change ownership in complex global supply networks.

Manual record-keeping and lack of standardized tracking technologies further compound these issues. With paper-based batch or lot level records alone, it can take weeks or months to fully trace a product back through multiple supply chain touches and identify the source of any quality or authenticity problems. This delay poses serious risks, especially for safety-critical medications. There is an urgent need for industry-wide adoption of automated item-level Pharmaceutical Traceability leveraging harmonized global standards.

New technologies enabling enhanced traceability

Fortunately, advanced tracking technologies now make it feasible to uniquely identify and monitor individual drug products. Solutions like RFID and 2D barcodes provide a cost-effective way to uniquely serialize each unit at high volumes during production. When combined with cloud-based track and trace systems, these identifiers enable real-time visibility and trace-back/trace-forward capabilities across the global supply chain in seconds instead of weeks.

Batch-level tracking is being replaced by serializing at primary, secondary and even retail-ready packaging. Manufacturers can embed unique serial numbers into product labels, cartons or ampoules which are scanned and recorded at each touchpoint. Cloud platforms then capture this event data to build a complete lineage for any given item. If issues emerge, investigations no longer rely on incomplete and inaccuracies-prone paper records. Instead, all related entities can access a shared, immutable record of each product’s journey within minutes.

Implementation of harmonized standards

For a global track and trace network to function seamlessly across borders, adoption of harmonized standards is essential. Fortunately, organizations like the GS1 are driving consolidation around common EPC/RFID and barcodesymbologies, data attributes and interoperability guidelines. Most countries are also replacing country-specific regulations with the GS1 global standards to ensure pharmaceutical traceability systems are interoperable worldwide. This allows trading partners globally to speak a common “language” and exchange credible pedigree event data in real-time.

Challenges remain around process and system integration as well as change management across the vast pharmaceutical ecosystem. However, pioneers in each region are demonstrating the operational and financial benefits that come with an integrated, continuous traceability approach to better ensure patient safety. As regulatory drivers and technology costs decline, adoption is accelerating industry-wide with many countries now mandating item-level serialization and electronic tracing for prescription drugs and high-risk biologics.

Securing complex global supply chains

Perhaps the greatest value of full pharmaceutical traceability lies in securing increasingly complex global pharmaceutical supply chains against counterfeiting and diversion. While batch-level tracking reveals where falsified products emerged from a particular plant, electronic item-level traceability opens up a new level of visibility. It empowers supply chain forensic analysis capabilities that can pinpoint counterfeiting or theft down to specific transactions, distributors or even dispensing pharmacies.

This creates a strong deterrent effect that discourages would-be criminal actors from attempting to infiltrate legitimate supply networks. At the same time, it gives authorities and brand owners the digital evidence needed to rapidly and securely remove illicit products if an infiltration attempt succeeds. By enhancing overall supply chain integrity and resilience, pharmaceutical serialization protects patients worldwide from unsafe or ineffective medicines while bolstering confidence in leading brands.

Overcoming remaining barriers

With compelling benefits established, the biggest challenge now lies in overcoming implementation barriers across global markets and ensuring interoperable systems are in place. Investments are ongoing to simplify onboarding processes, lower costs through scale and drive greater harmonization. Efforts continue amongst consortia to define common global item identifiers, data transfer standards and protocols. Regulatory agencies are also coordinating roadmaps and timelines for mandating compliance.

As the benefits of full electronic item-level pharmaceutical traceability become clearer, adoption barriers will continue falling. Technologies that address real challenges around safety, security and efficiency will gain widespread support. With appropriate piloting and change management support for supply chain partners globally, a future with truly continuous traceability from factory to patient becomes achievable. This will revolutionize quality monitoring and ensure patients worldwide can trust that the medications they receive are authentic and unadulterated. Most importantly, it will establish a baseline level of protection for health systems against threats of counterfeiting or diversion.

Get more insights on Pharmaceutical Traceability