Here’s How Blockchain And IoT Are Going To Impact The Pharmaceutical Cold Chain

1_pharma.jpeg

The term “cold chain” or temperature controlled logistics refers to a temperature-sensitive supply chain — that is, a supply chain in which the products being shipped must be maintained within a specified temperature range. And that temperature needs to be monitored.

As an example, Walmart and a group of food companies recently teamed up with IBM to use blockchain technology to solve for some of the challenges they face with their perishable supply chains. What we as consumers tend to forget is that the meats and other perishables we buy in the store have to go through a rigorous process in order to be supplied all across the country without spoiling. And even though we don’t like to think about it, the truth is food-borne illnesses and spoilage are quite common in the perishable space.

What this coalition of food companies is looking to do with blockchain is improve their ability to monitor temperate conditions of meats and produce to ensure quality control. While this is not necessarily our main focus at Chronicled in terms of cold chain projects, it is recognizably similar to the challenges we are addressing in the pharmaceutical space. In pharma, the temperature at which drugs are kept needs to be closely monitored — and the value and volume of drugs that need to be closely monitored will only increase in the next five years.

When this occurs, shipments valued in the millions can be lost, due to inadequate temperature management, or worse, patient safety could be at stake.

When pharmaceuticals are shipped between suppliers and distributors, temperature control within licensed ranges is a must. If, during the shipping process, there is a temperature excursion outside of these ranges, the quality of the drug can be impacted. When this happens, shipments valued in the millions can be delayed or even lost as the excursion is investigated. This could result in supply interruptions, negative customer impact and patient safety and outcome concerns especially in the case of personalized medicines and limited supply.

These are very clear issues that blockchain technology can solve for, and are where the majority of our focus has been.

The Solution

The current market standard in the pharmaceutical industry for monitoring the cold chain is Sensitech’s TempTale. The product is slightly smaller than a smart phone (and can be as large as a router) and they generally use a USB connection to download the data of a shipment. It’s then attached to a pallet or case and sent throughout the entire supply chain. The logger can take up valuable payload space as well. Once the shipment arrives at the destination, an individual at the warehouse is tasked with the responsibility of taking all the TempTale loggers out or off the cases, plugging them into computers, downloading the data, and then generating a report to review and send back to the company.

It can be an extremely cumbersome process.

To simplify this process, one of the products we have created specifically is an NFC Temperature Logger — which means Near Field Communication — and a BLE Temperature Logger, which uses Bluetooth and a mobile phone to configure temperature parameters and read associated data. These loggers are credit card size and will not displace valuable pharma payload.

How It Works

Instead of downloading the data with a computer, you can just tap it with a smart phone and get all the information, instantly — along with the signature of the person downloading the data, with that event then logged and registered to the blockchain.

With this technology, there is a complete log of the data so the logger is an encrypted microchip, as opposed to just an IoT device.

There are some added benefits: the DOE Temperature Logger can utilize Bluetooth to download data for all devices at once. For example, when a shipment of packages arrives at a warehouse, there can be a router or trigger at the door that will know when all the other sensors are within range, and then automate the data download. Instead of having a human take the loggers off of every pallet, open the boxes, and then download all the data, the BLE Temperature Loggers can stay within the boxes and all their data can be uploaded to the blockchain simultaneously.

The Big Shift

While these innovations are certainly exciting (and we’re thrilled to be at the forefront of it all), the big shift that’s happening is a move from hardware to software.

As it stands, the pharmaceutical industry is a very analog space. It’s filled with hardware companies that have taken an analog approach to problem-solving, creating big, box-like loggers with LED displays that capture and read data. This technology has not had a major breakthrough in years and with need for secure data sooner, the industry is ready for change.

This is the first time that, coming in as a software company, we have both innovated the hardware to produce smaller and more effective components, and also created software solutions that open new doors of opportunity.

It’s one thing to put sensors on products and make the hardware smaller, faster, and more effective. But what we’re most excited about is the prospect of collecting all that data automatically, analyzing it, and then making decisions based off that information.

Let’s look at an example:

A great example in today’s pharmaceutical space is the complex shipping lanes that drugs travel though where the logistics risks can be high due to multiple hand-offs, unexpected delays at connection points, inadequate training, customs hurdles, etc. This is both where the challenge has always been, and where a very clear opportunity is emerging. The reliability and security of temperature and other data in the temperature controlled pharmaceutical supply chain is not only a goal, it is a must for patient safety.

Let’s say two pharmaceutical companies are shipping the same drug, but have slightly different processes. Company A says that if a drug’s shipping container drops below a certain temperature, it’s required to be sent back to the facility for quality testing. Company B, however, has a protocol in place that says if the drug was only “out of temperature bounds” for five minutes, it’s still okay — and should be sent to the next step of the supply chain.

With blockchain technology, you can automate these processes along the way, so there are triggers to alert personnel when a drug nears an “out of bounds” temperature zone. If the trigger is set within a delivery truck, you could set the air conditioning unit in the back to immediately turn on, or you could at least alert the driver to stop and fix the situation.

These might sound like simple fixes, and they are, but in the grand scheme of big pharma, these are the tiny adjustments that can end up having a lasting impact. These drugs being shipped from warehouse to warehouse need to stay within certain temperature bounds, otherwise it’s considered a temperature excursion, spoiling the drug.

So it’s not just that blockchain technology can help verify where these shipments are coming from and confirm their authenticity, it can also help steward these products from one destination to the next effectively and efficiently.

And finally, since all of these processes and checkpoints are being tracked on the blockchain, it then becomes possible to sift through large amounts of data to make better business decisions and pinpoint troublesome parts of a process.

Let’s start a discussion today to disrupt your current practices and create a secure and reliable cold chain now with Chronicled.