Vaccines are fragile biological compounds that require safe, efficient, and monitored cold-chain delivery from manufacturer to end patient. With healthcare becoming global, the expectation is that pharmaceuticals and vaccines, as well as other temperature sensitive products and foods will move from origin to destination intact and undamaged. At this time, the end to end supply chain for these lifesaving products has a number of points where current methods of monitoring and safe storage fail. Systems are not consistent between manufacturing plants, distributors, storage depots, and transportation and storage to the end user. There is no real-time and on-demand visibility, and many biologicals do not have unique identifiers except on exterior packaging, making counterfeiting and adulteration easy. With monitoring and tracking systems not able to communicate with each other, or cover the entire supply chain, dark spots exist where products are not monitored, and the entire system relies on an honor system of communication if there appear to be problems. With the risk of both intentional and accidental damage so high, and current systems so ineffective in guaranteeing a safe delivery, several issues with the system need to change.
There are over 271 vaccines in use, and include many new pharmaceuticals in addition to the vaccines for infectious disease that have been most commonly used. We have cancer vaccines, vaccines against neurological disorders, allergy vaccines. New products are coming out of the discovery pipeline rapidly. Genomic research has expanded the use of genetically modified human T-cells, and their use in a number of vaccine-like products will be gaining rapid acceptance. In addition to vaccines, chemotherapy, biological medications, implantable and long-acting drug delivery devices, and many other types of drugs and medical devices require a cold-chain from the factory to the patient. At this time, over 90% of vaccines need a properly functioning and monitored cold-chain.
From end to end, the vaccines are either in storage or in transport. In looking at the current system, there are several places where monitoring goes dark. Each piece of the chain is responsible for their own piece. So the shipping provider is responsible for monitoring and maintaining a proper environment during shipping, but when the vaccines are off-loaded at a storage depot, responsibility transfers with the vaccines. Each time this responsibility transfers, the vaccines are physically being moved from one type of storage to another, and that point of movement and handling is a risk area.
So the two areas within the cold-chain system that need to be improved are systems accountability and communication, and the physical monitoring of environmental conditions, especially during transfers or when the system goes dark. The first piece for both changes to work includes unique identifiers on the products.
Vaccines come in several physical forms, from frozen solutions stored in plastic to dried biological materials in glass vials that will need to be rehydrated before use. The majority are liquid in glass vials. They can be multi-dose systems or individual units. Some have the delivery system, such as an injection device, as part of the vaccine when made and shipped. They are almost all sensitive to light as well as heat. Identifying lot numbers give information on the maker, the date made, and the formulation or type of vaccine. Identifying information at this time doesn't give any data on storage, shipping, or handling of the vaccine from factory to patient.
Using integrated wireless IoT technology and specific identifiers on packaging, the temperature, light, and stability of materials can be monitored and noted. Each unique environmental condition can be accounted for and all members of the supply chain can have access to this information. In addition, this information can be available on demand and in real-time. This transparency of environmental conditions across the supply chain can be accomplished through use of a distributed ledger. Engineers may develop an inexpensive monitoring device that can be incorporated into packaging and that will stay with the product during the entire process to end-user.
Distributed ledgers can provide a number of solutions to current issues with the cold chain. Theft and counterfeiting is occurring during the parts of the system where supervision goes dark, such as transfers to storage warehouses or movements between responsible parties. Using blockchain to keep all participants in the system being monitored and documented means a break in the system can be pinpointed with accuracy.
If there are faults in the system, such as from weather events or poor infrastructure in the developing world, blockchain technology can allow the next user in a supply chain to alert users of the system that medications and vaccines are about to be lost without intervention. Vaccine recalls can be managed quickly and quietly. With no central point of entry for hackers, the systems are believed to be safer from external manipulation than current methods, which are spread over multiple companies and systems. Inventory management will be improved. If there is a break in the system, such as from a faulty refrigeration unit at a remote health clinic, the source of the problem can be pinpointed and fixed before significant loss. These problem areas can be resolved if they are identified early enough, and a party who can track the vaccines in real-time through the various systems can problem-solve anticipated systems failures.
Challenges remain, specifically getting all members of a global supply chain working with the same system and speaking the same language. Communication technology and communication infrastructure development is proceeding rapidly in the developing world, driven by e-commerce. Many emerging economies still face significant challenges with transportation and energy infrastructure, and these two issues will impact the supply chain for biological medications and vaccines.
Accountability and communication within a supply system for fragile and perishable biologics such as vaccines is critical to avoid the public perception of mistrust that occurs when there is news of vaccines being rendered ineffective by poor supply chain management. When ineffective or frankly counterfeit vaccines have been given to patients, the concerns over the efficacy of vaccines expand to include new worries about the way they are stored, shipped, and handled. Public trust in any medical therapy which is designed to prevent a possible illness or condition, and which involves a painful procedure such as injection, is already a challenge. Anything that erodes the public trust in the practices or procedures will cause more people to stop getting these life-saving treatments.