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1. Research background and current situation
1. Research background
Medicine occupies an important position in people’s lives, but the recent continuous occurrence of unqualified vaccines has sounded the alarm for people. The quality control of the drug transportation process has also been paid more and more attention, and most of the drugs are in Refrigeration is required during transportation, so the cold chain logistics of medicines has become the focus of attention.
Compared with developed countries, the development of my country’s medical cold chain transportation is quite backward. There are great deficiencies in terms of transportation conditions and quality control. There are few studies in this field, and the relevant national standards are not perfect. This leads to many shortcomings and deficiencies in the entire medical cold chain logistics process, which restricts the development of my country’s medical cold chain logistics.
2. Research status
The definition of cold chain in the national standard “Logistics Terminology” is “to maintain the quality of fresh food and frozen food, so that it is always in a low temperature state from production to consumption in a logistics network equipped with special equipment”, The warehouse area whose temperature is kept within the range of 0℃-10℃ is defined as the refrigerated area, and the warehouse area whose temperature is kept below 0℃ is the freezing area. The cold chain includes four aspects: low temperature processing, low temperature transportation and distribution, low temperature storage, and low temperature sales. The schematic diagram of the cold chain is shown in the figure:
Abroad, the concept of cold chain was first proposed by the American Albert Barrier and the British JA Ruddich in 1984. “Supply chain includes all activities related to the flow and transformation of goods from the raw material stage to the end-user stage. Supply chain management is to integrate these activities by enhancing the relationship between supply chain members to achieve the strategic advantage of sustainable development.” This definition better defines the elements of supply chain management from the strategic level or from the operational level. In terms of the research, management and technology of cold chain transportation of medicines, the supply chain system of refrigerated medicines in Japan has begun to take shape, and the management is very mature. Suppliers and distributors of upstream products can realize information sharing, and barcode technology is used in the medicine logistics industry. Widely used, the logistics center has achieved standardization and standardization, coupled with highly automated storage and picking equipment, easy-to-operate and powerful warehouse management, to ensure high efficiency in the logistics operations of refrigerated medicines and reduce logistics costs.
A pharmaceutical group in the United States uses RFID electronic tags in its supply chain to evaluate its actual effectiveness. The United States established the Cold Chain Association as early as 2002 to specify standardized guidelines for the transportation of temperature-controlled goods. In 2008, the association issued the “Cold Chain Quality Index”, covering various industries including cold chain logistics of refrigerated medicines, to test the reliability, quality and proficiency of companies that transport, handle and store perishable goods. And laid the foundation for the certification of the entire supply chain of perishable goods. In addition, various countries have generally established cold chain logistics industry associations, which act as bridges and bonds between governments and enterprises, and play an important role in the process of improving industry management.
As a branch of the logistics industry, medical cold chain logistics specifically refers to a systematic project from producer to user of refrigerated drug entities for the purpose of disease prevention, diagnosis and treatment of people, including its production, transportation, A series of links such as storage and use. Foreign advanced experience and methods provide a powerful reference for policy formulation and healthy development of my country’s pharmaceutical cold chain logistics and even the entire cold chain logistics industry. Learning advanced technologies from developed countries is of great significance to my country’s improvement of the pharmaceutical cold chain system.
2. Market analysis and existing problems of my country’s pharmaceutical cold chain logistics
1. Market analysis of drug cold chain logistics
The pharmaceutical industry is an important industry for the development of the national economy and society. It is recognized as one of the most promising high-tech industries in the world. It is directly related to the people’s health and quality of life. In my country, there are currently about 16,500 pharmaceutical wholesale companies, nearly 140,000 retail companies, and more than 6,300 pharmaceutical manufacturers. Taking vaccines as an example, the prevention-oriented new medical reform mentioned in the “Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening the Reform of the Medical and Health System” and the “Recent Implementation Plan for the Reform of the Medical and Health System (2009-2011)” issued in 2009 It will inevitably bring great opportunities and markets to the vaccine market. The article also lists the standards and goals of basic public health services in detail. In 2009, the per capita funding standard for basic public health services was not less than 15 yuan, and in 2011 it was not less than 20 yuan. Yuan. The central government provides subsidies to difficult areas through transfer payments. It is reported that in 2009, China’s basic public health service funding reached 19.5 billion yuan, and in 2011 it is estimated to reach 26 billion. Calculated according to the total growth rate, the expansion of the vaccine market will reach more than 30%.
It can be seen that the vaccine industry has a bright future, and the demand for medical cold-chain logistics, which is inseparable from it, has also increased significantly, and the prospects are promising. However, as a whole, the development of my country’s pharmaceutical cold chain logistics is relatively lagging. The characteristics of the resources of the pharmaceutical cold chain logistics industry are “small, scattered, and idle”. Many resources are not fully utilized, causing serious waste. Compared with foreign countries, there is a big gap in my country’s pharmaceutical logistics.
Therefore, in order to cater to the development of the domestic situation, perfecting the relevant systems and standards of the pharmaceutical cold chain logistics, and perfecting the pharmaceutical cold chain logistics system have become the main problems facing. Nowadays, although my country has a relatively high level in the pharmaceutical R&D and production links, there are still big problems in the pharmaceutical cold chain logistics.
2. Problems in my country’s pharmaceutical cold chain logistics
Through the analysis and research of my country’s medical cold chain logistics, this article summarizes the problems existing in the medical cold chain transportation process and summarizes them into the following aspects:
(1) The medical cold chain logistics system is not sound
The entire cold chain of refrigerated drugs is an inevitable requirement. However, due to management mechanisms and other reasons, many drugs that require refrigeration are often “broken” in the entire chain from the factory to the patient’s use. It is reported that my country’s existing cold chain logistics capacity only accounts for 20% to 30% of social demand, and many drugs that require refrigeration cannot meet the cold chain requirements due to storage and transportation conditions, which may lead to potential hazards. In terms of hardware, the cold chain facilities and cold chain logistics equipment of my country’s pharmaceutical cold chain logistics are insufficient; in terms of railways, refrigerated trucks account for only about 2% of the total, and most of them are old mechanical quick-frozen wagons, and the transportation volume is less than railway freight. 1% of the total; on the highway, there is a serious shortage of modern refrigerated trucks. There are about 30,000 insulated vehicles in my country, while the United States has more than 200,000 and Japan has about 120,000. The share of refrigerated and insulated vehicles in my country is extremely low, only 0.3% of the proportion of freight vehicles, 0.8% to 1% in the United States, 2.5% to 2.8% in the United Kingdom, and 2% to 3% in Germany; while the volume of refrigerated vehicles in European countries It accounts for 60% to 80%, and China’s automobile refrigerated transportation volume accounts for only 20%. In terms of cold storage capacity, my country’s total cold storage capacity is more than 7 million cubic meters. Many cold storages are limited to frozen storage of meat and fish. When production is off-season and raw material resources are insufficient, cold storages are often idle and energy-consuming.
(2) The related technology of pharmaceutical cold chain logistics is backward
At present, my country’s medical cold chain transportation lacks expertise in refrigeration and cannot realize real-time monitoring of temperature. It lacks strict temperature control during transportation, which results in the inability to solve the problems in the transportation process in time and cannot guarantee the medical cold chain. The quality of transported medicines. Although some logistics companies use the method of manually confirming the temperature for temperature management, this method is limited to measurement during shipment and purchase, and lacks continuous temperature control data for the transportation link. This method is quite backward. At present, there are mainly two kinds of latest technologies applied in cold chain transportation: RFID and GPS+temperature control cold chain management system. my country’s current medical cold chain logistics has not formed a scale, and the application of technology is quite lagging behind, and the lag of technology is also one of the main reasons for the lag of my country’s cold chain logistics system.
(3) The relevant standards of pharmaceutical cold chain logistics are not perfect, and the supervision system is not in place
At present, there is no national or industry specific standard for the implementation of medical cold chain logistics in my country. The main regulatory standards are the “Regulations on the Administration of Vaccine Circulation and Vaccination” promulgated by the State Council in 2005 and the “Pharmaceutical Circulation” promulgated by the State Food and Drug Administration in 2007. “Supervision and Management Measures”, the lag in the formulation of cold chain logistics refrigeration standards for pharmaceutical cold chain logistics is an important factor for the backwardness of the entire cold chain industry. For example, the lack of clear standards for the size of refrigerated trucks, tray sizes, and cold storage sizes affects the efficiency of loading and unloading and leads to irregular storage and transportation of refrigerated drugs. For example, in 2002, more than 3,000 people in Xuzhou, Jiangsu had an adverse reaction due to the injection of hepatitis B vaccine that was not stored in accordance with the standard. In 2005, the hepatitis A vaccine incident in Si County, Anhui was caused by the deterioration of the product because the cold chain transportation conditions of the vaccine did not meet the specifications.
As we all know, any system needs corresponding regulatory measures, especially the pharmaceutical industry. However, in the pharmaceutical cold chain logistics process, there is a lack of a complete supervision system. There are relevant standards for the tracking and assurance of drug quality in the cold chain process, but the implementation is not satisfactory. Most of the standards are only used for Seen, it has not really been implemented. The lack of a clear attribution of responsibility is one of the main reasons for its inadequate implementation. Due to the relatively high cost of cold chain transportation, how to reduce logistics costs has become a major problem for all companies. The level of cost determines the profitability of the company and determines whether the company can occupy a strong position in the fierce competition. At this time, due to the inadequate supervision, many companies have a fluke mentality. They do not follow the transportation regulations during the transportation process, do not fully comply with the transportation standards, and only pursue profitability and ignore other things. This is a cause of the existence of medical cold chain logistics. Very important question.
3. Analysis of my country’s pharmaceutical cold chain logistics countermeasures
In view of the many problems in my country’s pharmaceutical cold chain logistics, in order to establish a complete and systematic cold chain logistics system, the relevant opinions and suggestions are listed below.
1. Vigorously develop third-party pharmaceutical cold chain logistics enterprises
As the name suggests, third-party logistics provides logistics services to third parties independent of the supplier and the demander. Third-party cold chain logistics refers to third-party logistics companies engaged in cold chain transportation. From the perspective of the development trend of the cold chain logistics industry, the demand orientation of the market and the long-term development of the company, professional third-party cold chain logistics companies are the main players to participate in the cold chain logistics market competition in the future. Specifically, the introduction of third-party logistics into the medical cold chain field has the following advantages.
(1) Reduce costs
Third-party cold-chain logistics can save pharmaceutical companies a lot of early-stage investment. The cold-storage tools and equipment in the cold-chain transportation process are provided by third-party logistics companies. Companies do not need to consider operational and management issues and outsource pharmaceutical transportation to the first Tripartite cold chain enterprises can save a lot of manpower, material resources and financial resources.
(2) Improve operational efficiency
The third-party cold chain logistics can provide medical enterprises with special refrigeration equipment and has a complete cold chain logistics operation system. Due to its independence of operation, it can greatly avoid the redundant steps in the general medical cold chain logistics and shorten the work. Time, simplify the logistics process, and better realize the whole cold chain tracking, better guarantee the quality of medicines, and better improve efficiency through professional and systematic services.
(3) Integrate resources
In addition to better integration of various hardware resources, third-party logistics can also combine similar but not competing companies to jointly serve customers and expand the geographical coverage of services to customers. This can speed up the development process of pharmaceutical cold chain logistics, and is more conducive to the establishment of a complete, systematic and comprehensive pharmaceutical cold chain logistics system.
2. Adopt advanced cold chain logistics equipment and technology
(1) Cold chain logistics equipment improvement
my country’s medical cold chain transportation is mainly divided into small batches of cold chain transportation and large batches of medical cold chain transportation. The former is mainly concentrated in the self-employment of some drugs, while the latter is mainly large and medium-sized enterprises. Different transportation scales have different requirements for transportation equipment and should be treated differently to achieve the effect of reducing costs on the premise of ensuring the quality of medicines.
①Small batch medical cold chain transportation
For the cold chain transportation of medicines in small batches, the existing cold chain transportation and storage equipment should be updated, and small grouped refrigerated trucks suitable for small batches and multiple varieties should be developed to meet the market’s needs for the transportation of multiple varieties and small batches. The development of mechanical cold plate refrigeration and refrigerated containers will put my country’s small batch of pharmaceutical cold chain transportation on the right track and promote the development of the pharmaceutical logistics industry.
②Cold chain transportation of large quantities of medicines
The characteristics of a large-volume pharmaceutical cold chain are that there are many refrigerated drugs and a large amount of transportation. It is necessary to establish a refrigerated drug turnover warehouse, that is, a turnover cold storage. The cold storage, especially the large-capacity air-conditioned cold storage, has the characteristics of large initial investment and high operating cost. Therefore, industry associations should actively coordinate all parties in the cold chain of pharmaceuticals to form strategic alliances, jointly build a database, share benefits, and jointly assume risks. It is necessary to vigorously research and develop advanced, reliable, low-cost domestic refrigeration systems and refrigerated trucks to better serve the cold chain of pharmaceuticals.
(2) Introduction to advanced technology of cold chain logistics
Only by vigorously promoting the progress of cold chain logistics technology and improving the modernization level of cold chain logistics technology and equipment can the progress of cold chain logistics be realized in essence. At present, the more advanced technologies in the refrigeration cold chain technology are RFID cold temperature management system and GPS (Navigation Satellite Timing And Ranging Global Positioning System, navigation satellite timing and ranging global positioning system) + temperature control cold chain management system.
①RFID system
RFID (Radio Frequency Identification), that is, radio frequency identification, commonly known as electronic tags. RFID radio frequency identification is a non-contact automatic identification technology, which automatically recognizes the target object and obtains related data through radio frequency signals. The identification work does not require manual intervention and can work in various harsh environments. RFID is a simple wireless system. It has only two basic components, namely an interrogator (or reader) and many transponders (or tags). It can identify high-speed moving objects and can identify multiple tags at the same time.
The RFID cold chain temperature management system uses advanced RFID technology to record temperature changes on the “RFID tag with temperature sensor”, which can simply and easily solve the problem of deterioration in the circulation of medicines. In the cold chain supply chain, RFID temperature tags can be used to record the temperature throughout the transportation process of fresh food and beverages, medicines, blood bags and other items from the place of origin to the final destination. In this way, the monitoring of temperature changes in the supply chain can be completed to determine the quality of the goods in the delivery process, and it can also trace the information and define the responsibility when the goods are damaged due to abnormal temperature.
Because the system has the advantages of stable performance, large recording capacity, high accuracy, simple operation, strong anti-interference, etc., its application prospects in the cold chain logistics of refrigerated medicines are promising. Therefore, it should spare no effort to promote its application. An important technical means of chain logistics has made great contributions to ensuring the quality of medicines and protecting people’s medical and health care.
② GPS (Navigation Star Time and Ranging Global Positioning System) + temperature control cold chain management system
The GPS system is a satellite-based radio navigation system with multiple functions such as omnipotence (land, sea, aviation, aerospace), global, all-weather, continuous, real-time navigation, positioning, and timing. It can quickly provide various services such as precise instantaneous three-dimensional space coordinates, velocity vectors, and precise timing for all kinds of static or high-speed users. At present, the GPS system has been used in logistics. Logistics companies install GPS locators on their transport vehicles, which can not only monitor the vehicles in real time, master a large amount of dynamic information, but also grasp the status of goods in transit at any time, ensuring that the vehicles and The safety of cargo improves work efficiency.
In cold chain logistics, GPS satellite global positioning system is used for vehicle scheduling and tracking. Special temperature trackers and on-board temperature controllers are installed on refrigerated trucks and insulation trucks. When used with GPS, it can meet the needs of refrigerating medicines during transportation. Conditions, the temperature during transportation can be adjusted in time to ensure transportation quality.
Therefore, the application of GPS system with temperature control cold chain management system is also an effective technical means for ensuring the quality of medicines during the cold chain transportation of medicines.
3. Improving the relevant standards and regulatory systems for pharmaceutical cold chain logistics
Cold chain logistics is an industry that requires high capital, management and technology. The construction of a country’s cold chain guarantee system for refrigerated drugs requires the cooperation of the government, industry organizations and enterprises. In view of the serious lack of industry standards for cold chain logistics of refrigerated drugs, my country should formulate cold chain logistics standards for refrigerated drugs that are in line with international standards as soon as possible to achieve a monitoring system from production to use. And establish an effective regulatory mechanism to closely monitor the operation of vaccines and other refrigerated drugs in all links of the cold chain.
I personally believe that the relevant standards should clarify the requirements for transportation conditions during the cold chain transportation of medicines and the requirements for related equipment. At the same time, the person in charge of each process should be clearly specified, and the responsibility should be assigned to the individual, so that when problems occur, they can be avoided Relevant personnel can avoid each other, and at the same time, putting the responsibility to the individual can also increase everyone’s sense of responsibility, and they will definitely work hard to do well where they are exactly responsible.
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