Jeff Webber, Intelliguard

Real-world data enhances medication safety and supply chain efficiency.

 By collecting and applying data from manufacturing through administration, stakeholders can optimize inventory, track usage trends, and improve predictive analytics to ensure medication availability and safety.

Advanced tracking technologies like RFID improve visibility and reduce risks.

 Continuous, real-time monitoring enables more accurate inventory management, helps prevent tampering or temperature breaches, and supports better coordination across the supply chain—especially for sensitive or high-risk medications.

RWD supports resilience during disruptions and reduces waste. 

Intelligent medication management systems using RWD help hospitals forecast demand, respond to crises, and minimize medication expiration and loss, ultimately improving patient care and operational efficiency.

From the moment pharmaceuticals are manufactured, through the complex journey they take to administration, stakeholders generate and acquire a wealth of data. The FDA oversees over 23,000 prescription drug products approved for marketing in the US

 and ultimately, an estimated 361.3 million drugs are given or prescribed annually in hospital emergency departments alone.

When transformed and channeled into the right tools, this raw data can help ensure medications are safe and well-managed. Drug tracking data, purchasing information, and usage trends can all be meaningfully applied to build models that generate actionable insights that enhance efficiency, ensure that therapies are available when and where they are needed, enable smarter inventory control, and improve predictive analytics.

Applied correctly, approaches driven by real-world data (RWD) can benefit the entire medication supply chain and facilitate an improved focus on patient-centered care.

The path between drug manufacturers and end-users is fraught with opportunities for medicines to be tampered with, go missing, or be mismanaged. RWD is at the center of efforts to make supply chains safer and more transparent, including increased regulatory requirements. The Drug Supply Chain Security Act, for example, requires enhanced pharmaceutical traceability through the collection and sharing of data related to the movement of medications. This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Together, these requirements create a foundation of RWD that stakeholders can leverage to improve supply chain operations and safety.

Enhancing supply chain visibility through real-time data tracking

Traditionally, tracking medicine inventory relies on manual barcode scanning as products pass specific checkpoints. While this technology is the industry standard, it can leave blind spots between scans where medications are largely unaccounted for. Thus, advancing technologies that allow for continuous monitoring of meds are becoming more common in pharmaceutical supply chains. Radio frequency identification (RFID) technology, for example, uses small radio frequency identification devices to track and identify products. RFID tags don’t have to come into a direct line of sight with sensors, allowing tags to be counted and logged with minimal effort and high accuracy.

Importantly, rapidly advancing RFID technology could also unlock additional security and safety capabilities by monitoring and reporting changes in temperature or possible tampering. This is especially critical for temperature-sensitive biologics and vaccines, where maintaining proper storage conditions ensures product viability and regulatory compliance.

Enhanced, continuous supply chain visibility is one of the most important elements of a safe, intelligent medication ecosystem. Real-time tracking technologies and continuous monitoring data can improve supply chain efficiency by providing up-to-the-minute insights on drug shipment logistics and creating a clear chain of custody. This is particularly important for sensitive medications such as controlled substances, which can be at a higher risk for counterfeiting and diversion. This data can also enhance cooperation across the supply chain, feeding software systems to generate trend analyses and optimization opportunities. For example, a hospital system could enact conservation protocols for a frequently used drug, based on data from a supplier that some medicines may be entering a shortage due to increased demand.

Demand forecasting during public health crises and supply chain disruptions

Over the last five years, it’s become clear that medication supply chains will continue to be disrupted, and patients will continue to need their treatments. Disruptions such as pandemics and natural disasters pose a major challenge for hospitals. In some cases, these events might be entirely unpredictable, forcing them to adapt product strategies with little to no advanced preparation. Luckily, intelligent medication management software can play a crucial role in responding to disruptions.

Similar to cybersecurity incident responses, advanced algorithms (such as multi-integer linear programming) can model and mitigate disruptions; incorporating RWD can improve these models. Historical data, such as real-time supply chain and inventory data and information about past drug shortages, is essential to enabling models to generate accurate and actionable insights. In the same way that inventory-tracking data is critical for manufacturers and distributors to ensure the safe transport of medications, information about their status and location within a facility or system is critical to hospitals. Armed with these insights, hospitals can optimize resource distribution in emergencies, adjust supply forecasts, predict recovery patterns, and develop strategies to mitigate future risks.

In addition to ensuring they have the right medications during a supply chain disruption, hospitals need to optimize inventory and mitigate waste during normal operations. Many hospitals must pay for expired drugs in their possession, even if they aren’t used. As a result, pharmacies will walk a thin line, maintaining just enough of the therapy to avoid running out but not so much that it is at risk of expiring before it can be used. Tracking the status of medication inventory—including which ones are closest to expiration and where they are—is an essential element of hospital pharmaceutical management.

However, this is not always a simple task. Large hospital systems, for example, have medications distributed among many different pharmacies and departments. They also experience some of the same problems that manufacturers and distributors face, like spotty tracking information due to the manual processes associated with barcode scanning of drugs.

To manage this, healthcare organizations are increasingly implementing proactive medication management strategies, blending hardware updates (such as improved RFID tags and smart cabinet systems) with software upgrades that can maximize RWD insights. Data generated from RFID tracking enables close monitoring of lot numbers and expiration dates, allowing facilities to optimize inventory usage and efficiently respond to recalls. In the case of managing near-expiry stock, hospitals can ensure they use medications close to expiry first and redistribute stock accordingly. Longer-term insights from RWD-powered analytics can save hospitals millions of dollars annually by minimizing waste, optimizing operational efficiency, and preventing costly errors.

The future of RWD in pharma supply chain management

To fully leverage RWD moving forward, pharmaceutical and healthcare organizations must embrace opportunities to strengthen and improve their models. This includes participating in data-sharing initiatives and contributing to centralized datasets. While synthetic data can be used for model training, real-world data is crucial for accurate predictive analytics, and cooperation between the industry at large can vastly improve the quality and robustness of data sets. Additionally, advancements in AI and cloud computing present opportunities to enhance supply chain intelligence. Preparing for the future of medication supply chain management includes anticipating these technologies while putting necessary security and protections in place.

The integration of RWD into the pharmaceutical supply chain management is an exciting development. It offers opportunities for cost reduction, efficiency gains, and a shift to more patient-focused care. As computational power continues to grow, life sciences organizations can harness these advancements to build more resilient and adaptive supply chains.

Jeff Webber is Chief Technology Officer at Intelliguard.

https://www.fda.gov/economics-staff/fda-glance

2. Therapeutic Drug Use. Centers for Disease Control and Prevention’s National Center for Health Statistics.

 https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

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Approaches powered by RWD can clear the way for a greater focus on patient-centered care.

Building Intelligent Pharma Supply Chain Management with Real-World Data

Digital transformation is a non-linear journey. New technologies are introduced, but there are often growing pains and delays before they’re fully functional and integrated. Fortunately, we’re at a pivotal time in the healthcare industry. Data and technology such as artificial intelligence (AI) are uniting to up-level our processes, capabilities, and—most importantly—patient care. Below is a look at some of the major shifts happening in the delivery of care and the management of medications navigating their way through complex supply chains and into hospital systems.

From basic automation to intuitive, responsive, and visual assistance

The use of automation technology in healthcare has exploded in the 21

 century. However, early versions are not without their challenges. Within hospital pharmacies, many efficiencies have been realized, yet the technology has created another issue: communication overload.

A lot of systems were built to provide communication, but some may have been configured by teams that didn’t fully understand how hospitals and healthcare systems work at a fundamental level. The result is a lot of unnecessary communication. That, in turn, creates staff burnout. We see this quite a bit, especially in the pharmacy where staff are inundated with competing notifications and messages that aren’t relevant to them or that they don’t draw any value from. There’s a real need to invest in systems that are more adaptive to how a person wants to interact.

Technology is inching toward that goal. Now, with AI, technology can be readily customized to the user. The features and notifications won’t be designed around what the developer knows the tool is capable of—they’ll respond to what the user actually wants and needs.

We see this as the next frontier in hospital-based digital transformation. The information is still there, but the access to the information and how we interface with the technology will change.

Individuals outside of the healthcare industry may question why this customization is critical. Consider an anesthesiologist in an operation room. They may be juggling more than a dozen different tasks in parallel. They need to interact with the patient’s electronic health record (EHR), while keeping track of their vitals and how the drip they administered is progressing to ensure the patient is adequately sedated—the list goes on. All that information is currently coming from different sources. We need to take that information and serve it to the provider, how and when they need it. The long-term vision is for technology to be an extension of the provider, with innovations such as virtual reality and augmented reality glasses that can empower them in real-time with the information they need.

Unleashing the power of predictive forecasting and inter-hospital collaboration

Accurate forecasting and management of pharmaceuticals are critical for both business success and patient well-being, yet even the most seasoned pharmacists may struggle to find the daily balance between over-ordering and stock-outs.

Unfortunately, drug shortages continue to be a major issue in the healthcare industry. The American Society of Health-System Pharmacists (ASHP) tracked a record-high 323 active drug shortages in the first quarter of 2024.

 On the flipside, hoarding critical supplies can have far-reaching consequences (a lesson we all learned during the COVID-19 pandemic). Nowadays, excess products may expire, or hospitals simply carry the cost of that inventory for an extended period of time.

Supply chain management and forecasting are a natural fit for machine learning (ML) models. It all starts with data centralization. This involves integrating technologies across a health system so that data can be pooled into a single unified repository. This repository of standardized data can then serve as the single source of truth for inventory, including pharmaceuticals. Pharmacists are able to gain real-time visibility into every corner of their facilities, as well usage trends, expirations and recalls, and many other important attributes. 

ML algorithms thrive when exposed to this holistic data. These models can transform usage data into analytical insights and predictive modeling to anticipate future needs and guide optimal ordering. Pharmaceuticals can be dispersed more efficiently through hospital systems and pharmacists can focus more attention on individual patient care—the outcome that matters most. It’s early days, but with AI, there is near-limitless potential for building on those kinds of operational insights.

Thinking bigger, there’s an opportunity to collaborate across hospital systems as technology moves to the clouds. Five to 10 years ago, all of a hospital’s data was siloed in a data center. The only entity that had visibility of that information was the hospital itself. By expanding into the cloud and expanding into data centers without borders, we can operate with patients and communities at the forefront of decision-making. It's mutually beneficial, especially when it comes to managing sometimes unpredictable pharmaceutical supply chains. Often, the larger health systems with greater buying power have preferential access to pharmaceuticals in limited supply. If they end up excessively stockpiling, the smaller hospitals may miss out, while much-needed products sit idle in the bigger hospital across town. It’s inefficient for everyone, and it risks patient safety.

If there was shared visibility, potentially life-saving therapies could be shared during shortages and emergencies. Moving data out of silos into more centralized locations can enable that visibility right now. It creates an additional safety net, helping to reduce the fear that drives the hoarding of supplies.

The key for hospitals entering this new phase of digital transformation is to ensure they have an adequate plan for cybersecurity. Nobody wants to introduce technology that breaks trademarks, doesn’t do what it’s supposed to, or that discloses sensitive patient information. Unfortunately, software bugs and breaches are commonplace today, as noted by the HIPAA Breach Reporting Tool, which lists 864 combined breaches reported in 2023 and 2024.

 Part of the challenge is AI models finding and exploiting backdoors in software quicker than our existing tools.

Hospitals must be incredibly vigilant around software and vendors—both new and old. Oftentimes, technology already in hospitals is built on legacy systems that don’t attract the same scrutiny as new software and tools because they don't have competition. In addition to vetting the technology, it’s important to hire the right people and establish cybersecurity governance, risk, and compliance (GRC) programs to make sure all the technology operating in the hospital—and in the cloud—is appropriately vetted. Likewise, all vendors ought to be in compliance.

When done thoughtfully and safely, this digital transformation can do everything from increasing operational efficiency through better medication management, to alleviating stress on staff, allowing them to focus more on the clinical aspect of their responsibilities. That, in turn, benefits patient care. If we can make the patient experience better within hospitals, that's the biggest win of all.

Jeff Webber is the Chief Technology Officer of Intelliguard, a provider of hospital medication management and data intelligence solutions.

1. ASHP reports record high number of drug shortages. 

https://www.aha.org/news/headline/2024-04-12-ashp-reports-record-high-number-drug-shortages#:~:text=ASHP%20tracked%20a%20record%20323,demand%20for%20essential%20drugs%20spikes

US Department of Health and Human Services Office for Civil Rights

https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf

Despite challenges surrounding communication overload, drug shortages, and cybersecurity risks, this term is revolutionizing medication management and patient care through the use artificial intelligence and predictive forecasting. 