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According to FDA Commissioner Margaret Hamburg, “Nearly 40 percent of the drugs Americans take are imported, and nearly 80 percent of the active ingredients in the drugs in the American market come from overseas sources.” The World Health Organization estimates that "Of the approximately 4 billion prescriptions written in the U.S. in 2011, 40 million were likely fraudulent."

Now, more than ever, cold chain products manufactured within the pharmaceutical industry are subject to stringent controls. This is especially true during the ‘last mile’, or its many interpretations, of distribution. And that’s a good thing. With mounting scrutiny and pressure on manufacturers to fulfill controlled temperature requirements, health care supply chains are becoming increasingly transparent – on a global scale.

Products, including vaccines and biologic products, are sometimes handled improperly, diluted, potentially counterfeited, or made without key active ingredients. Even when proper controls are in place, the necessity to monitor products as they are transported throughout the supply chain is still critically important because of unforeseen circumstances.

Today, the range of data which can be tracked and recorded has widened, giving broader perspectives, even potentially, to the last mile statistics. Temperature data can now be processed, visualized, and compared. Companies want more than to just meet standard regulations. The focus is no longer on the logger, but rather, how data can be captured, analyzed, and presented. Which brings us to the newest evolution in software capabilities for temperature monitoring. This evolution has spurred a boost in actionable data, productivity, and improved safety.

Temperature sensors are getting more sophisticated. Some versions can detect temperature abuses in real-time, pinpointing where they occurred, their duration, and the extent of the abuse. These cold chain monitoring solutions are equipped with cloud-based software capabilities to record pertinent data (required by groups like the FDA and other regulatory agencies).

Even though each of these data logger manufacturers have their own unique data structures for reporting and storing relevant information in these cloud data bases, industry still needs, potentially, to share or integrate such services. One such company, for example, is TSS Services. This company offers full integration capabilities for any logger brand with an intuitive dashboard, and they are forging into this uncharted territory.

The trends are now moving to tracking excursions to certain lanes or carriers, forecasting and planning, and visualizing a company’s performance for more accurate and transparent cold chain information; a simple and dynamic way to review outsourced vendor KPI’s, or assessing risk areas within the cold chain.

Imagine if you could integrate temperature monitoring devices so managers can be more responsive to the changing dynamics of a shipment. Enhanced alerts convert into improvements in transportation and product safety, loss reduction, and product tracking.

As technology evolves and companies focus on compliance, GDP regulations, and overcoming challenges within the cold chain, we can either hop on board with these sophisticated devices - or miss the train.

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Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.

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