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Research on the application of pharmaceutical cold chain logistics based on blockchain Technology

Time : 23/05/2022 Author : 0kegmy Click : + -
        With the dual drive of policy and market and the rapid growth of domestic pharmaceutical e-commerce market, pharmaceutical cold chain logistics, as a segment of the cold chain logistics industry, has gradually entered the public's vision in recent years, and the social demand for pharmaceutical cold chain logistics has also ushered in explosive growth. However, at present, there are a series of problems in China's pharmaceutical cold chain logistics, such as the lack of perfect traceability mechanism and standardized real-time monitoring system, the existence of information barriers in the industry, and the difficulty of logistics coordination and supervision. Optimizing pharmaceutical cold chain logistics has become an important issue that needs to be solved at present. Blockchain is a new application mode integrating distributed data storage, point-to-point transmission, consensus mechanism, encryption algorithm and other computer technologies.
        Blockchain technology has been widely explored and practiced in supply chain management, information sharing, privacy protection, risk identification and other fields because of its decentralized, open and transparent information, data can not be tampered with and forged, traceable and other characteristics. The application of blockchain technology can well solve the problems existing in the development of pharmaceutical cold chain logistics, optimize the integrity environment of the pharmaceutical cold chain industry, promote the cost reduction, efficiency increase and collaborative governance of the pharmaceutical cold chain industry, and promote the development of China's pharmaceutical cold chain logistics industry in the direction of lean, informatization, standardization and intelligence. Pharmaceutical cold chain refers to a systematic project that refrigerated pharmaceuticals are always in the specified low-temperature environment from production, storage, transportation to distribution, so as to ensure the effectiveness of drugs to meet the needs of people for disease prevention, diagnosis and treatment.
        Relevant data show that the scale of China's pharmaceutical cold chain logistics industry has maintained a sustained growth trend. According to incomplete statistics, the sales volume of China's cold chain market in 2020 was 390.34 billion yuan, with a year-on-year increase of 14.97%. The scale of pharmaceutical cold chain logistics costs has increased year by year from 13.014 billion yuan in 2018 to 17.317 billion yuan in 2020, an increase of 25.81% year-on-year. In addition, in 2020, China's pharmaceutical cold chain infrastructure investment gradually expanded, the pharmaceutical cold chain logistics network system gradually strengthened, and related new technologies and intelligent equipment are also emerging.
        With the centralized mass listing of covid-19 vaccine and the accelerated expansion of the pharmaceutical e-commerce market, China's pharmaceutical cold chain logistics industry is bound to usher in innovation and change. Medical safety is a people's livelihood problem that cannot be ignored, and drug logistics is very important for medical safety. With the increasing popularity of the pharmaceutical cold chain, society has put forward higher requirements for the standardization of the pharmaceutical cold chain logistics system. The pharmaceutical cold chain should not only meet the timeliness of terminal needs, but also meet the complexity and uncertainty in the circulation process. While the pharmaceutical cold chain logistics industry has ushered in huge development space, there are also problems and challenges. In the production and circulation of pharmaceutical products, due to the lack of refrigeration and transportation infrastructure and improper operation of relevant personnel, drug pollution and deterioration, loss of supply, and mixing of inferior drugs into the market often occur.
        Most enterprises lack a relatively perfect drug anti-counterfeiting and traceability mechanism, which leads to the inability to trace the source of drugs, and it is often difficult to determine the responsibility when there are problems in drug quality. At present, the anti-counterfeiting and traceability of drugs requires the terminal to scan static identifications, which record the production information and logistics information of drugs. However, these data and information are usually stored in a centralized form, and the anti-counterfeiting data are often mastered by individual enterprises. The relevant information is not open to consumers, and there is a chaos of data monopoly. In addition, due to the lack of measures to prevent malicious changes to the information, the data is easy to tamper, the credibility of the drug details data obtained by the end user is not strong, and the drug quality status is difficult to identify.
        During the production, storage and transportation of cold chain pharmaceuticals, there are usually certain requirements for temperature, light perception and humidity. The impact of temperature conditions beyond the drug standard on the drug quality is irreversible. The chain breaking of temperature controlled transportation is the important cause of drug quality problems. At present, most enterprises still have problems of manual recording of various data indicators, large recording time interval, inconsistent recording standards and so on, resulting in deviation and discontinuity of temperature control data records, which makes it impossible to give real-time warning and timely response when the efficacy of the cold chain changes, and the potential safety hazards cannot be investigated in time. Relevant large enterprises also use Internet of things technology to monitor cold chain logistics, and obtain real-time temperature and vehicle information through RFID, GPS and other technologies.
        However, the whole cold chain needs to integrate a large number of sensor devices. Due to the weak storage and computing power of IOT devices, it is difficult to achieve centralized storage of a large amount of data generated, and it is easy to be attacked by hackers. The efficient integration of pharmaceutical information and cold chain data is an important path to optimize the development of pharmaceutical cold chain logistics industry. Pharmaceutical cold chain logistics often involves related pharmaceutical enterprises, cold chain logistics companies, cold chain logistics common distribution centers, industry regulators and other entities. Due to the low level of informatization in the industry, there is no unified information management platform in the links of pharmaceutical manufacturing, transportation, storage, distribution and so on, it is difficult to carry out a lot of information interaction and collaborative communication between entities.
        In addition, the relevant data in the pharmaceutical cold chain process is in the charge of a separate enterprise, and there is no comprehensive database to record the information of all links of cold chain logistics. The interoperability between enterprises is weak, and the connection between non adjacent entities is often poor, resulting in serious information asymmetry. This not only increases the management and control costs of enterprises, but also leads to the imbalance between supply and demand in the cold chain when faced with some emergencies or sudden demands. In addition, there are also information barriers between enterprises and regulatory departments. For the drug quality problems in the cold chain and the environmental problems brought by the cold chain, the relevant regulatory departments, as external channels, are difficult to intervene, and the regulatory efficiency is low.
        To improve the anti-counterfeiting and traceability mechanism of drugs, establish a reliable whole process monitoring system of the cold chain, and promote the interconnection of the logistics cold chain, in addition to ensuring the authenticity and reliability of data collection, we also need a data storage and information analysis system with high fault tolerance. Blockchain system has the characteristics of distributed high redundant storage, time series data, data can not be tampered with and forged, decentralization, high security and so on. It has a wide range of application scenarios in logistics monitoring, traceability system, solving trust problems and so on. It can alleviate the shortcomings in the current development of pharmaceutical cold chain logistics, and help relevant enterprises deal with complex application scenarios and solve key cold chain logistics problems, The technical advantages of blockchain technology applied to pharmaceutical cold chain logistics are shown in Table 1.
        The traceability of drugs should be traceable. By providing distributed ledgers jointly maintained by all participants in the cold chain, blockchain records all information from drug production to circulation in the form of data in the blockchain. All participants can participate in the storage and maintenance of data. The relatively closed information in all links of cold chain logistics is placed on an open and transparent platform, which effectively solves the problem of data centralized storage in the cold chain of medicine. At the same time, the blockchain adopts asymmetric encryption and timestamp to ensure that the information is not tampered with and cannot be forged, so as to realize the traceability and anti-counterfeiting of cold chain drugs. By combining with blockchain technology, all links in the pharmaceutical cold chain can be traced, relevant enterprises can store certificates and trace the source of drugs, and consumers can judge the quality and authenticity of drugs.
        When a problem is detected in a drug, the relevant subject can find the root of the problem by relying on the traceability information on the blockchain, and at the same time, it can also prevent the mixing of fake and shoddy drugs to the greatest extent. Internet of things technology is an important means to realize the whole process tracking, monitoring and early warning of the cold chain. It realizes the collection of relevant information through a large number of sensors, bar codes, chips and positioning devices, simplifies the cold chain operation process, and reduces the recording errors and recording delays caused by manual operations. The combination of blockchain and Internet of things technology can realize the distributed management of Internet of things devices through the consensus mechanism, and operate and process all kinds of information with the help of digital signature and smart contract technology, so as to provide a more secure monitoring mechanism and more efficient early warning services.
        With its anti attack and distributed characteristics, blockchain can alleviate the data storage and processing capabilities of the Internet of things, ensure that the Internet of things is not attacked and manipulated by hackers, and ensure the use safety of the Internet of things. This can ensure the real-time tracking and continuous and accurate transmission of cold chain information, realize the real-time monitoring of drug cold chain, and avoid the blind spot of cold chain logistics. When the equipment and temperature control operation are detected to be abnormal, the early warning is automatically realized, and at the same time, it can also provide support for managers to analyze and make decisions in time. The pharmaceutical cold chain must provide multiple parties with the authority of data sharing and timely updating to ensure that the information is rich, unified, timely and effective. Blockchain integrates a wide range of information through distributed databases, and data can be authorized by multiple parties to establish, add and share, so that information transparency and information sharing can be achieved among all parties involved in the cold chain, and the bottleneck of information asymmetry in the cold chain logistics link can be broken.
        This can not only provide valuable information services for enterprises, but also reduce the cost of resources and manpower, reduce transportation and storage costs, improve vehicle transportation efficiency, and increase the utilization of relevant equipment. For sudden demand, it can also speed up the update of sudden information, so that all parties can coordinate and communicate in time, implement emergency plans and coordinate supply and demand [5]. The regulatory department can check the quality inspection report, business qualification and other information of relevant drugs at any time, and make rectification measures for relevant problems in a timely manner. In addition, blockchain can write policies and regulations, industry standards, transportation rules and environmental protection measures into smart contracts, which helps to form a standardized industry order.
        The pharmaceutical cold chain digital platform integrates all participants into the blockchain platform according to the process of pharmaceutical cold chain logistics. Based on distributed ledgers and P2P networks, data storage and sharing are realized, smart contracts automatically process relevant perceived information, and data security verification mechanisms and identity authentication ensure the quality of drugs and the safety and reliability of data. Compared with the traditional pharmaceutical cold chain management platform, this platform has the advantages of efficient collaboration, safety and reliability. It is suitable for multi-stage tracking management of pharmaceutical cold chain from drug production, storage, logistics to distribution. Each main node inputs, maintains and uses data in a chain structure, and integrates functional modules such as traceability and anti-counterfeiting, cold chain monitoring, interconnection, industry supervision, etc., to achieve full link coverage.
        Its architecture is mainly divided into four levels: cold chain data layer, network consensus layer, smart contract layer and function application layer. The framework of blockchain based pharmaceutical cold chain digital platform is shown in Figure 1. Now the operation mechanism of the platform is described. The cold chain data layer is composed of the blockchain database, which is responsible for maintaining the blockchain database and realizing the storage, update and tamper proof of data. After the data is collected by many parties, the institutional signature verification is carried out first, and then a new encryption key is generated and connected to the blockchain to form a distributed ledger. In this link, the data is encoded as hash function value to avoid tampering, and timestamp is introduced to increase the traceability of medical information.
        The network consensus layer mainly realizes the dissemination and verification of data by encapsulating the blockchain consensus algorithm, networking mode, data verification mechanism and propagation protocol. With full consideration of the business performance and requirements of the cold chain, make the data pass the common authentication and consensus mechanism verification, realize the dissemination and update on the chain, improve the efficient and safe transmission of data between nodes, and complete the connection with the functional application layer. In addition, the network consensus layer uses asymmetric encryption technology to encrypt the data, and stores the data through the hash algorithm conversion format, so that it forms an interrelated chain database to prevent the data from being tampered with. The smart contract layer mainly encapsulates a series of smart contracts and script codes, enforces the contract terms when the conditions are met according to the preset algorithms and rules, and the whole process is subject to public supervision and will not be changed by external network attacks, providing a flexible and reliable data operation environment for blockchain.
        With the help of automatic discrimination mechanism, smart contracts can analyze the authenticity of data in real time by controlling the whole cold chain process. In the smart contract, different thresholds of different standards are set for different types of drugs. When the threshold range is exceeded, an alarm will be given, and the relevant data will be quickly fed back. In addition, the smart contract layer can write policies and regulations, industry standards, operation specifications and environmental protection measures into the smart contract, so that the routine operations such as drug production, abnormal alarm of temperature control operation, industry supervision can be automated and intelligent, and the efficiency of pharmaceutical cold chain logistics can be improved. The functional application layer integrates a variety of application scenarios to provide users with operation and visual interfaces. Authorized personnel access the system through apps, applets or other devices. Information sharing and information connectivity between different entities can be achieved across regions, industries and enterprises.
        According to different permission levels, the manufacturing enterprises can input and maintain the delivery information of drugs, and the cold chain logistics enterprises can upload and maintain the real-time data in transportation. At the same time, they can realize the traceability query of historical data, the real-time monitoring of cold chain links and the release of relevant requirements. Consumers can trace the source of anti-counterfeit drugs, feed back relevant problematic drugs, and relevant departments can realize the quality inspection of drugs and the supervision of enterprises. The main roles of blockchain in the pharmaceutical cold chain logistics link mainly include production enterprises, logistics enterprises, distribution centers, regulatory departments and end consumers. Around the specific process of pharmaceutical cold chain logistics, the operation process of the blockchain based pharmaceutical cold chain digital platform is shown in Figure 2.
        Drug production involves raw material supply, drug research and development, drug testing and mass production. The data involved in this link include raw material information and procurement electronic contracts provided by raw material suppliers, drug R & D parameters provided by drug R & D centers, qualified drug testing reports of drug inspection centers, and various production information recorded by manufacturers. After the data is uploaded by different entities, the platform stores and updates the data in the blockchain distributed ledger through the processes of verifying the signature of the institution, parsing the original data, generating encryption keys, etc. Relevant enterprises undertaking warehousing, transportation and distribution business are important connecting parties of the whole pharmaceutical cold chain. The whole link needs to enter the details of logistics enterprises such as warehousing, transportation and distribution, logistics order information, temperature information collected by sensor equipment, positioning information collected by GPS and relevant information of each responsible person in the circulation process.
        After the information is collected, it is first signed by the verification authority, and then the relevant data is encrypted and stored. The platform realizes the identification and verification of the identity of the user through asymmetric encryption technology. The verified subject can timely grasp the real-time status and historical status of drugs and equipment through the blockchain platform. Relevant entities sign smart contracts through private keys. When there are conditions such as excessive temperature and abnormal equipment, the platform sends early warning information to different entities according to different permission settings, so as to deal with abnormal events in a timely manner. The platform verifies the authenticity of the identity by checking the digital certificate of the subject, so as to carry out different authorization. Among them, cold chain traceability mainly includes the traceability of raw materials by drug manufacturers, the anti-counterfeiting traceability of medical drugs by consumers, and the traceability of problematic drugs by regulatory authorities. Manufacturers can trace the planting, processing, testing, logistics and distribution information of raw materials or medicinal materials for drug production. Consumers can query the authenticity of drugs and the information of drugs in production, storage, transportation, distribution and other links through source tracing.
        When a medical safety accident occurs, the relevant regulatory authorities obtain the information of the overall process of drugs from production to consumption through blockchain, so as to efficiently and accurately locate the problem link, find the root cause of the problem and recall the problem drugs. With the rapid development of pharmaceutical e-commerce, the demand of pharmaceutical cold chain market continues to increase. The pharmaceutical cold chain market has great development prospects, and the pharmaceutical logistics industry has a long way to go. With the continuous innovation and application of blockchain technology and the continuous improvement of blockchain market policy and industry supervision, blockchain
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