Securing Pharma

 GLOBAL PHARMACEUTICAL SHIPMENTS 01

Securing the global pharmaceutical supply chain requires increased oversight and sensor technology.
– By Jeff Newman

The demand for pharmaceuticals is booming in the United States, driven by a rapidly aging population and new enrollees under the Affordable Care Act. As the need for personalized medicine intensifies, manufacturers must rethink their approach to supply chain management. 

By 2023, the Drug Supply Chain Security Act will require that the industry implement end-to-end traceability. The purpose is to prevent quality issues and recalls by leveraging data that has been proactively organized throughout a product’s journey, rather than engaging in a lengthy and often costly effort to model the information backward in order to determine the root cause of failure. 

 This is easier said than done. While automation has allowed manufacturers to move away from batch technology to small unit production, they struggle with ensuring product consistency as units get broken down and handed off. Human intervention is costly and not easily scaled for global operations. For manufacturers to reap ROI on continuous models, they must implement tracking features that enable rapid-response decision-making. 

The first step to securing the global supply chain is tackling its weakest link - human error during the handoff process. Since many medicines have only a 48 to 72-hour window to get from one controlled environment to another, it’s critical to ensure shipment integrity - from the package to pill level. The need for oversight and tightly-controlled environmental conditions will increase over the next decade as large molecule treatments become significantly more popular than small-molecule treatments. These medications are typically fragile, have a short shelf life and often require specialized tracking.

The next step to ensure transparency and traceability is to tag shipments from point of pack to a customer’s door. Via smart tags and Bluetooth sensors, distributors can coordinate millions of items across multiple storage sites - easily expediting shipments or adjusting logistics to avoid theft, inadequate supply and tainted deliveries. Smart tags eliminate the need for line-of-sight identification and allow you to identify entire truckloads of product at a time. They are extremely difficult to counterfeit and can be easily integrated with your data management software of choice. You can also cut warehouse rental and maintenance costs by staging products at on-demand virtual cold storage units, airports and other shipping facilities to enable expedited delivery around-the-clock. 

To execute time-critical processes and decision-making, tagging and sensor tech must be integrated onto a secure command platform. For example, rapid alerts might trigger automated commands to dynamically reroute and repartition time-sensitive products. Due to a sudden policy change, medication may be unapproved overnight and left sitting on a tarmac too long to be shipped to its destination within a safe window of use. Within hours, it may be repackaged for sale for local consumers.

Over time, granular visibility across multi-modal shipping routes will enable you to proactively manage factors that may be affecting your bottom line on a seasonal basis. With automated reports and real-time alerts, operators will have greater bandwidth to focus on optimizing environmental conditions, rather than panicking about them. 

In addition to myriad business benefits, advanced sensors and tracking technologies enable manufacturers to better adapt to the evolving behavior and information needs of today’s physicians. Adherence (patients taking medication) is one of the biggest pain points in the pharmaceutical industry and can be easily addressed via programmable tags. Physicians can use tags to communicate dosage and usage instructions to consumers via their smartphone. They can also log interactions and reports in real time to illustrate how patients are interacting with surveys and marketing campaigns. Environmental and distribution data can be further leveraged to provide alerts to customers who may have acquired less-than-ideal products and monitor possible medication mismanagement down to the pill level.

Amidst the national opioid epidemic, sophisticated sensors and trackers ultimately streamline the supply chain to manage medications for millions of consumers. They protect against illegal tampering, the inclusion of foreign materials and can help track down entire truckloads of missing medications. At the pharmacy level, these technologies prevent mix-ups and over-prescription – significantly cutting down liabilities. 

Too often, manufacturers place greater emphasis on optimizing packaging rather than addressing environmental fluctuations and human errors. With advanced sensors and smart tags, data can be gathered down to the driver level, allowing you to gauge whether anomalies were caused by unforeseen circumstances or could be avoided with training and education. 

While advances in sensor tech and location tracking are enabling a safer global pharma supply chain, relationships are still key to their success. There is no technological substitute for clear communication and collaboration. From day-to-day sampling to data breaches and disaster response, technology must be fully integrated with internal policies to ensure smooth decision making. Develop proactive guidelines on the ideal as well as less than ideal scenarios, such as equipment malfunctions, natural disasters and other crises – and make sure that documentation is fully compliant with the latest regulations. 

Failure to communicate along the supply chain is a risk to your bottom line but, more critically, public safety. When a handful of suppliers are responsible for serving a region, a production snag can have far-reaching consequences. Take for example the intravenous saline shortage after Hurricane Maria. When U.S. suppliers do not have the inventory to serve the public’s needs, providers are forced to seek medications from countries where oversight is not as strong. 

As the on-demand pharmaceutical market grows, the need to ensure product integrity and an intact chain of custody will increase. Packaging alone cannot spot nonconforming elements and nefarious behavior. The solution? Sensor and communications technologies combined with cloud-based analytics. Diseases and natural disasters are not a one-time occurrence. To prepare the entire pharmaceutical ecosystem for the challenges of tomorrow, manufacturers must invest in the latest technologies today.

 

Jeff Newman, vice president of business development for CalAmp. Newman has over two decades of experience as an early pioneer within the M2M wireless industry.

 

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