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Application spotlight: Ensuring a proper chain-of-custody for pharmaceuticals

Posted by Peter West on 04/25/2014

pharmacustodyIt’s no secret that supply chain management is one of the most fruitful end-applications for M2M technology. It comes in many flavors, often driven in the U.S. by homeland security regulations. For example, the container shipping industry implements automated container identification, cargo monitoring and security alerting schemes that notify in the case of tampering. M2M-enabled devices are even starting to “sniff out” explosive and hazardous waste materials and issue alerts to local authorities in the case of detection. Overall, the sheer volume of cargo entering the country from overseas and crossing the Mexican and Canadian borders has boosted the profile of M2M asset tracking as a valuable security solution.

To be sure, M2M tracking probably shines most brightly in the pharmaceutical supply chain. Or, more specifically, it offers a straightforward means to ensure proper visibility and chain-of-custody conformance throughout the entire production, storage and delivery cycle for prescription drugs. The pharmaceutical supply chain is complex and the ability to track and trace products is essential not only for public safety, but also to eliminate loss events via theft or degradation from improper handling, both of which can—and do—contribute to the spiraling cost of healthcare.

In short, M2M devices provide automated, serial-level traceability of individual packages of medicines, giving each package its own history—or electronic pedigree. This provides robust proof of the chain-of-custody, from manufacture through distribution to pharmacies. An e-pedigree effectively secures the supply chain from counterfeit, misbranded, adulterated or diverted prescription drugs, because it is very difficult to falsify the information trail.

The real beauty of M2M for theft prevention is the instantaneity of its alerting mechanism. Even if a truck starts to slow down at an unexpected time or place, the device can be set to alert local authorities. And going beyond that, pharmaceuticals that are particularly susceptible to theft and black market resale, such as oxycodone, can be set to broadcast their every move down to the individual pill bottle. Gone are the days when the mafia could hold up a liquor truck on a back road somewhere … they wouldn’t stand a chance against electronic tracking.

Even beyond theft or chain-of-custody issues, certain cold chain biologics must remain within very tight environmental parameters throughout transport. A notable case from several years ago involved a foreign-made cancer drug that arrived at a doctor's office as a “gooey mess” because the parameters had been eclipsed at some point. When people’s lives are on the line, such mistakes simply cannot take place.

Trouble is, what’s to say that a given trailer in fact maintained its proper temperature across an entire journey, beyond the word of the truck’s operator? This is where M2M comes into play. Not only will a connected monitoring device be able to detect if conditions are approaching their outer boundaries, but it will send a signal to the operator in the cab and the pharmaceutical company’s logistics manager, product manager or anyone else that needs to be notified. And potential issue can be investigated, and adjustments made, on the spot before conditions cross the threshold into “bad news.”

Some may be skeptical that these trackers can actually remain in contact across an entire supply chain journey. Deliveries are bound to hit some dead spots along the way, right? I mean, if I was to hold a conversation on my mobile while driving across town, the call would likely drop three times over the course of the short trip. For KORE, this challenge veritably defines why we imbue our network, and the devices on it, with multi-mode cellular certifications (GSM and CDMA) as well as satellite connectivity that automatically kicks in to cover any terrestrial pocket where cellular may not reach, no matter how miniscule. Devices on the KORE network are, quite literally, always on.

We like to say that connectivity is king, and in the case of maintaining a secure pharmaceutical supply chain, it is most definitely the single component that cannot be compromised.

Topics: Industry Specific