A silent crisis exists where inefficiencies and a lack of visibility in the pharmaceutical supply chain are taking a crippling toll on society. Every year companies and economies are facing increasingly heavy financial losses, and devastatingly, countless lives are being jeopardized. The traditional pharma supply chain faces a multitude of challenges not least of which is the lack of visibility and transparency. Among the many negative effects, this can result in expired medications sitting in warehouses while patients wait frustratedly, complaining about a stockout of the exact same medication. On top of inadequate tracking and tracing, the ever-increasing threat of counterfeiting further compounds the difficulties of getting the right medicine to the right person, at the necessary time. That particular scenario paints a concerning picture not just for profitability, but more importantly for patient safety.
A Call for Transparency
Counterfeiters, mislabeling of drugs, and fraudulent packaging have severely damaging impacts. According to one EUIPO report, counterfeit medicines cost the global economy billions of dollars annually, while causing hundreds of thousands of fatalities and detrimentally affecting countless others.
Shocking figures like these have caused the opaque nature of the pharmaceutical supply chain to be under intense scrutiny. Regulatory bodies like the FDA, who enforce the Drug Supply Chain Security Act (DSCSA), the European Medicines Agency (EMA), working closely with national competent authorities across Europe, and numerous other national and regional authorities have been tightening supply chain regulation to ensure the safety of the people they are responsible for.
As patients become increasingly aware of the dangers of counterfeit and substandard medicine, they’re demanding transparent information about the origin and movement of their medications, adding even more pressure. These forces combined are pushing pharmaceutical companies to prioritize traceability solutions that enhance patient safety, build trust, and comply with evolving regulations.
Obstacles in Visibility
Achieving a fully transparent pharmaceutical supply chain faces several hurdles. The sheer complexity of the system itself presents a seemingly insurmountable challenge. Numerous parties, from manufacturers and distributors to wholesalers ,pharmacies and healthcare dispensers, participate in the medical supply chain. These stakeholders often possess varying levels of technological infrastructure and know-how, making it difficult to implement a standardized digital traceability solution across the board.
Complicating matters even further is the lack of data standardization. Information about pharmaceuticals is currently captured in a number of formats, impeding smooth information sharing. For instance, a manufacturer may be using metric units and the term “active ingredient” while a distributor utilizes imperial measurements and the wording “primary component”. Furthermore, these differing proprietary data formats employed by some stakeholders create information silos, additionally fueling inefficiencies and impeding continuous visibility of product flow.
Integration costs pose another significant obstacle, particularly for smaller stakeholders in the chain. Implementing robust traceability solutions can be a sizable investment, requiring new hardware, software, training and probably system upgrades. This financial burden can deter smaller companies from participating, creating gaps in the overall connectivity and robustness of a shared system.
Perhaps one of the most critical challenges in the digital age is finding the right balance between data security and transparency. While traceability requires capturing and sharing detailed information about pharmaceutical products, ensuring patient privacy and protecting sensitive data remains paramount. Optimizing for both these two priorities is essential for gaining trust and ensuring widespread adoption of traceability solutions.
Overcoming these obstacles requires innovative solutions that can bridge the gap between disparate systems and data formats. Fortunately, advancements in technology, particularly the advent of digital twins, offer a promising path forward.
Digital Twins: A Look at Virtual Counterparts
A digital twin is essentially a virtual counterpart to a physical object, constantly mirroring its behavior and performance. The concept of utilizing real-world data from a physical system to create a digital replica first emerged in aeronautics, where full-scale mockups of spacecraft were used to diagnose problems. Today, digital twin technology has transcended its origins, finding itself in applications across various industries including healthcare.
It’s important to distinguish digital twins from digital simulations, as they are not at all the same thing. Typically, simulations are designed and used during the development of a product and most often do not have a direct real-world counterpart. In contrast, digital twins are constantly updated with real-time data, providing a dynamic reflection of the physical system or object they represent.
Specific to pharmaceutical supply chain traceability, we are talking about digital twins that are virtual counterparts to a physical drug or its packaging. It’s a digital representation of a specific medication, encompassing all the data points collected throughout its lifecycle. Sensors embedded in packaging or placed strategically along the supply chain can track factors like temperature, location, and even potential tampering. This real-time data continuously feeds into a computer model, creating a constantly evolving virtual twin.
The benefits of leveraging digital twins in pharmaceutical supply chains are numerous. For one, they enable improved monitoring and analysis of critical processes like storage and transportation. Additionally, digital twins can be used to conduct supply chain scenario simulations. By modeling various situations, companies can proactively predict potential disruptions and optimize logistics for maximum efficiency. Ultimately, these data-driven insights empower better decision-making, leading to a more streamlined and secure supply chain for everyone.
Building a Transparent Supply Chain
Unfortunately, the advent of digital twins alone will not solve the pharmaceutical supply chain issue of visibility and security. The path to a fully transparent pharmaceutical supply chain will need to be paved with a combination of cutting edge technologies.
To start, serialization, assigning unique identifiers to individual drug packages, forms the foundation for traceability. These identifiers contain key information about the medicine’s origin, batch number, and validity or expiration date and are tracked throughout the entire supply chain. From raw materials to finished products, they act as the bridge, linking each physical product to its corresponding digital twin. This can help to identify bottlenecks or inefficiencies in the production process and can also provide valuable data for inventory management and forecasting.
Next, Blockchain enters the equation, offering a secure and tamper-proof solution for data collection, transmission and encrypted storage. The blockchain in simple terms is an immutable digital record book that meticulously tracks the movement of these digital twins throughout the supply chain. Every handoff from manufacturer to distributor to pharmacy is permanently documented, ensuring complete transparency and preventing any manipulation of the data.
Meanwhile, the Internet of Things (IoT) acts as the constant source of real-time information with sensors embedded in everything from packaging to storage facilities feeding data into the digital twin. This data stream can include environmental conditions, vibration levels, even light exposure – all contributing to a comprehensive picture of the supply chain end to end. These data points can reveal potential issues early on, allowing for proactive interventions to safeguard product quality and maintain optimal conditions and security throughout the supply chain.
All this data becomes fuel for Artificial Intelligence (AI). By analyzing the vast amount of information collected from serialization, and IoT sensors, AI can identify potential risks. For example, AI can detect unusual anomalies such as temperature fluctuations that might compromise drug efficacy, or flag inconsistencies that could indicate counterfeit products or the occurrence of product diversions. By enabling the prediction of potential issues, proactive decisions can be made, safeguarding patient safety and minimizing economic losses.
Beyond Twins: Uniting the Ecosystem
The modern, complex web of the pharmaceutical supply chain leaves all of us vulnerable to unpredictable delays and potential quality control issues. In this commercial landscape, traceability is indispensable for complying with regulations and ensuring safety and is undeniably a critical aspect of responsible, ethical healthcare practices.
It’s clear that by accurately tracking the production, distribution, and dispensing of pharmaceuticals and medical devices, healthcare strategists can identify and address issues in real-time, mitigating the risk of harm to patients and reducing negative economic impacts.
However, data standardization and integration across diverse industry players remain the largest hurdles. As such, manufacturers, distributors, wholesalers, and pharmacies must work together to establish standardized data formats and embrace these new technologies. By working together, the healthcare industry is capable of building a future where everyone benefits.
A Call for Collaboration
The PharmaLedger Association is tackling the issue of healthcare supply chain traceability by proposing feasible solutions through a dynamic and inclusive Digital Trust Ecosystem in Healthcare (DTE-H).
Our Supply Chain Traceability approach exemplifies the cutting-edge initiative we are taking toward our current focus; to augment visibility and resilience in the pharmaceutical supply chain. For that to be successful, we see that collaboration rather than competition is the only way forward. Together with our Associates we are working to create a secure platform that can facilitate end to end tracking of medicines. Read here to learn more about our Finished Goods and Supply Chain Traceability project.
This commitment is aligned with our broader mission to solve problems in healthcare that cannot be solved by a single party, contributing to a more safe, resilient, and trustworthy Healthcare 4.0.
Join us as we set out on this transformative journey toward a future where healthcare works better for everyone. Your voice is not only welcome; it is integral to shaping the future of healthcare logistics. Lend your expertise, share your insights, work together, benefit together.