Blockchain and Pharmaceutical Supply Chain Verification
By Nigel J Smart PhD
With the Globalization of pharmaceutical supply ever intensifying, verification of the origins of a medicines’ ingredients is becoming an increasing area of importance.
Today, supply chains are made up of multiple vendors with multiple sources of materials of their own and this adds to the complexity of how a particular drug, therapeutic or medical device is manufactured. At a time when therapeutics and other products of all types, categories and dosage forms are being made by third party CMO’s, in-house company facilities and at a varying scale around the globe, keeping track of all the various data sets for each case can turn a profitable enterprise into a logistical nightmare.
With increasing scrutiny by regulatory agencies to produce a level of control that can certify the security of each of the various steps and components, industry is starting to embrace such approaches as a must have, if not a mandatory requirement.
Enter the idea of Blockchain Technology, which provides the opportunity to close this gap and provide companies with secure supply chain data sharing capability.
Information sharing is always a problem and doing this in a secure way has challenges, which until recently, have prevented a smooth Lean approach to operational data sharing and access.
One of the keys to the success of blockchain technology is the use of a time-stamp tracked approach, which accurately records all the events associated with a drugs manufacture and distribution. The beauty of this approach is that it negates the need for trust between or among the various contributors to the data file and it allows for a seamless exchange of the database information from a common place to parties that must have access for various reporting channels.
The key security factor which makes this all possible is that the operations are protected by cryptography. With this effectively guaranteeing the system security, it’s possible for a network of data nodes to operate through a common data ledger without this requirement for a trust condition to exist between various node contributors.
Through this mechanism, the validated information (referred to as “blocks”), that’s entered into the ledger (referred to as the “chain”), can be trusted and its reliability assured.
It is important to note that this evolution of a sort of “digital passport” associated with a product, contains all the key information to enable the possibility of an ideal situation, to assure brand reliability and patient safety.
Historically this has been a problem from a tracking perspective, but using Blockchain technology, individual medicines can be tracked and followed right from the manufacturer, through the distribution system and into a dispensing retail pharmacy.
This is a logistical home run, because one advantage provided by blockchain is that its interfaceable with other technologies, including but not limited to “The Internet of Things.” Through this approach, it is possible to create many other important gains, such as secure documentation of data sets for the drugs journey.
Such as example might include transport temperature profiles as the product is transported from site to site and then on to a distribution warehouse, before eventually arriving at the pharmacy.
In summary, some benefits of blockchain include but are not limited to:
1. There is only one correct set of data that is accurate and accepted across all the various nodes.
2. The entries into the common ledger are self-validated to ensure that agreed upon rules are enforced.
3. There is the possibility of a reduction in operating costs through streamlining
4. The audit trail is in place and the possibility exists to improve reporting accuracy and business practices.
This is a Future State technological advance that’s happening now, but which will become increasingly important and relevant as both operating costs and quality compliance standards are squeezed to produce more efficient systems and greater quality reliability.