The pharmaceutical industry loses up to $200 billion every year due to counterfeit drugs and patient safety issues, and now it is discovered that blockchain technology may be able to reverse this situation.
Blockchain has the potential to revolutionize the healthcare industry, especially in the medical and pharmaceutical supply chain. The pharmaceutical industry loses up to $200 billion every year due to counterfeit drugs and patient safety issues, and now the application of blockchain technology may reverse this situation.
Distributed ledger technology can provide legislative, logistical and patient safety assurance for pharmaceutical supply chain management. From the perspective of U.S. regulatory regulations, blockchain technology and structural functions are very consistent with the core requirements of the Drug Supply Chain Security Act.
DSCSA has constructed a framework spanning 10 years, including drug traceability, product verification, and stakeholder notification of prohibited drugs. Realize classified information sharing and ensure that every step is within the basic block of blockchain technology.
Professor Kevin from the School of Health Sciences at Lipscomb University commented: Logically, blockchain is consistent with the federal government’s global chain security strategy.
From a patient safety perspective, the biggest advantage of blockchain can help curb the impact of so-called SSFFC drugs, that is, fake (), fake (), falsely labeled (), fake () and fake () drugs, and prevent them from happening. Continue to cause trouble and corrupt rules in the pharmaceutical supply chain.
Curb counterfeit drugs
Tapan Mehta, head of healthcare and life sciences services at DMI, a mobile technology and services company, said: “Reducing counterfeit medicines is a prime example of the application of blockchain in the medical field.”
“Globally, counterfeit drugs of all types cause losses of up to US$200 billion every year. Ensuring the integrity of the pharmaceutical supply chain may be the most extreme application of blockchain technology in this field. A blockchain-based pharmaceutical supply system can ensure Accurately document chain of custody and track every step of the supply chain at the individual drug or product level."
The application potential of blockchain in the pharmaceutical industry is being explored and exploited. Taking First as an example, it uses distributed digital ledgers to support and manage the drug research and development life cycle and solve the problem of incomplete drug supply chains.
Mehta believes that “additional features such as keys and smart contracts can be used as part of supply chain integrity. Smart contract functionality on the blockchain software defines the terms of the agreement and the terms of execution, which can help reduce fraud and reduce costs. "".
Transparency and traceability are key to the application of blockchain in pharmaceutical supply chains. If a drug is interrupted or lost in transit, data stored on a public ledger can provide parties with a way to quickly track information and determine who last handled the shipment. The public can use the ledger to track every drug and even the origins of its raw materials.
The decentralized structure of the ledger will make it impossible for any party to gain ownership of the ledger and tamper with the data to benefit itself.
Four important application cases
IBM's chief scientific officer believes that four application cases of blockchain are particularly suitable for the pharmaceutical supply chain. The specific analysis is as follows:
First, pharmaceutical quality and safety regulations require compliance with traceability principles. DSCSA regulations require an electronic, interoperable system to identify and track prescription drugs sold in the United States. Other countries are implementing similar management approaches. The FDA requires all prescription drug manufacturers, distributors, and pharmacies to adhere to this principle.
Second, regarding controlled substances. The federal government is gradually supporting the pharmaceutical industry in monitoring the supply chain, monitoring illegal and irregular orders for Schedule II drugs (opioids, etc.), and imposing financial penalties on non-compliant distributors. Manufacturers are also concerned about joint and several liability.
The third is about cold chain monitoring. In accordance with regulations and guidelines from the FDA, USP-NF, EU GDP and WHO, the entire supply chain must ensure cold chain transportation of pharmaceuticals. Cold chain shipments are expected to grow by 52% from 2014 to 2020.
Fourth, protect the active ingredients of drugs. Monitor the origin and origin of active pharmaceutical ingredients in raw materials at the raw material stage, production stage and final product stage. The raw material process for active pharmaceutical ingredients ends at the beginning of the process covered by the Drug Supply Chain Security Act.
Two key opportunities
Blockchain offers two key opportunities for the pharmaceutical supply chain: combating counterfeit drugs and optimizing the pharmaceutical supply chain, said the project director of emerging communities and initiative development.
The pharmaceutical distribution model in the United States consists of three major trading partners—manufacturers, wholesalers, and various pharmacies. Current pharmaceutical supply chain infrastructure is siled, fragmented, and always attempts to leverage a patchwork approach that integrates traceability and tracking technologies with other outdated methods.
Fragmented infrastructure provides a breeding ground for counterfeit drug transactions in Internet + pharmacies, where counterfeit drugs are sold through the Internet. There is no substantial way for patients or health care providers to trace the origin of medications.
The nature of the pharmaceutical distribution model forces all three trading partners to have equal transparency in auditing and tracking inventory to ensure medicines reach patients as safely and quickly as possible.
A common need among all three parties is supply chain visibility and the ability to scrutinize a drug from production to patient consumption. If every party in the supply chain could see inventory and audit drug distribution, it would be difficult for counterfeit drugs to enter the medical market.
everything you can do
Currently, drug manufacturers, wholesalers, and pharmacies use a variety of tools to assist in these processes. However, blockchain can do things that other technologies cannot:
For example, large pharmaceutical companies use many different software and databases to manage their drug supply. Mehta said, “The introduction of the blockchain system will enable each participant to control a node on the network, and every transaction will require consensus. This will revolutionize the pharmaceutical supply chain.
The decentralized management of blockchain also sets it apart from other technologies. Most pharmaceutical companies use centralized databases to manage drug supply chains, which have system administrators who can edit, modify, or delete records.
Through blockchain, records are permanent and cannot be changed in any way, ensuring the security of data transmission. Therefore, pharmaceutical companies can use blockchain technology to prevent human errors, logistics delays, and reduce costs. "
It is obvious that blockchain has unique advantages. All clients work with the original, unchangeable source of information.
Every timestamped transaction is copied to the blockchain and cannot be modified. All partners in the supply chain are aware of this fact. This allows all parties involved in the collaboration to easily verify the source of the information.
True end-to-end supply chain management
A professor at Lipsko University pointed out that blockchain provides a unified solution for pharmaceutical supply chain management. Its distributed structure truly enables end-to-end supply chain management, allowing multiple stakeholders to participate without the need for the current age-old patchwork database approach.
One of the biggest challenges is interoperability issues with legacy systems. In the short term, it is still necessary to retain the old management system, which is also the significance of supply chain research simulation compatibility.
Today, the pharmaceutical supply chain has become a series of interrelated and independent disciplines. Supply chain actors often buy back data to understand market usage or consumption of their own products.
Ward, executive director of the Health Company, believes that blockchain technology allows all parties to obtain a common record and the drug supply chain is no longer mysterious (the company is an innovative company focused on using blockchain and distributed accounting technology to accelerate technology Innovation and application of blockchain technology in healthcare).
Ward pointed out: "Blockchain is a networked solution. It is impossible for a company to build its own blockchain independently. They are just participants in building networked solutions to solve a certain problem or process. If the rules are in Once consensus is established, trust can be transferred to the level of a cooperative agreement.
Unlike other solutions, blockchain participants retain control over their data, including choosing who to open it to. Trading partners can share the data needed to complete a transaction while retaining information priority.
Simplify processes and increase data volumes
How can blockchain help streamline processes or increase the amount of data in the pharmaceutical supply chain? There are many ways to do this.
“In a linear, transparent transaction process, we can clearly see who adds value to the transaction and who is just a ‘rent-seeker.’ Intermediaries are forced to prove their value or are protected from losses during the transaction process.
Mehta added: “Big pharma companies operate through complex and outdated centralized systems that reduce optimal supply chain efficiency. Using blockchain technology, companies can streamline drug development, testing and distribution processes, making supply chain management more efficient. Made easier. More flexibility, transparency and security.
The future blockchain technology is an efficient decentralized structure that can realize massive transaction processing of complex relationships between a large number of users. Simply put, the ability of blockchain to track and distribute data across the entire chain allows us to see an unprecedented data inventory and sharing mechanism.
Using blockchain technology, manufacturers can better predict drug shortages, target timely drug recalls, and more. The autonomous and decentralized nature of blockchain streamlines pharmaceutical supply chain operations, eliminating payments, invoicing and possible human error.
Improve data integrity
Depending on the specific blockchain protocol and its accompanying features, the immutability of blockchain can enhance data integrity, thereby reducing the load on data management functions.
In the past few years, six companies have been working on the development of blockchain drug supply chain security compliance platforms, including Block, /, Modum and.
In short, in the field of pharmaceutical supply chain, just like in other fields of medical insurance, the application prospects of blockchain technology are unlimited. The huge potential of blockchain will allow more companies to enter this field. Most companies are struggling to generate revenue. Blockchain technology may help reduce costs by a third, which is unmatched by other methods.
At present, the application of blockchain in the pharmaceutical supply chain is still in its early stages and will be another rising technology service industry in the next 2-3 years.
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标签： #Drugs #Blockchain #Supply chain system #Supply chain logistics #Counterfeit drugs
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