Blockchain + medical care, solving the last mile regulatory problem of pharmaceutical traceability
秦晓峰
2019-09-30 13:10
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Can traceability of vaccines eradicate vaccines?

Author | Qin Xiaofeng

Editor | Lu Xiaoming

Editor | Lu Xiaoming

Produced | Odaily

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(Champion of Ant Blockchain Contest - Yilian)

Recently, the final of the "Chain Creation · Future" Ant Blockchain Innovation Competition was successfully held at Hangzhou Yunqi Town International Convention and Exhibition Center.

After 8 months of screening, Shanghai Yilian Internet of Things Co., Ltd. (hereinafter referred to as "Easychain") won the crown of the competition and received a financial reward of 1 million yuan.

This time Yilian's entry project is called "Vaccine Cold Chain Temperature Sensing RFID Traceability Internet of Things Solution". To put it simply, "blockchain + medical care" solves the pain point problem in the medical field - vaccine traceability.

Ant Blockchain commented: "Blockchain really goes to the public, it is to face social reality and solve problems and pain points that everyone feels."

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1. Medical Pain Point: Vaccine RegulationMedical care has always been a major issue related to the national economy and the people's livelihood. However, in recent years, there have been constant problems in the medical and health field, especially the vaccine industry.July 2018,

It was revealed that there was a problem of record falsification in the production process of freeze-dried human rabies vaccine; the company had previously been exposed that the potency index of DTP vaccine did not meet the regulations.ShandongShandong

The vaccine problem also broke out. A large number of vaccines were sold to 24 provinces and cities without strict cold chain storage and transportation, involving a total amount of 570 million yuan.

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(Vaccine problems occur frequently)

The repeated vaccine issues have aroused the attention of the whole society, and also involved the nerves of the public.

Generally speaking, the current vaccine industry mainly has the following two major problems: one is the production of fake vaccines by vaccine manufacturers, which is the source of all problems and the most difficult to control. At present, it can only rely on the efforts of the regulatory authorities; The problem causes the vaccine to lose its activity (referred to as "inactivation") and become a useless vaccine.

Compared with the production link, the transportation and storage link is relatively controllable, and it is also a link where third-party companies are more likely to intervene. Yilian's "Vaccine Cold Chain Temperature Sensing RFID Traceability Internet of Things Solution" is designed for this link.

Vaccines need to be transported in the cold chain during this process. The traditional method is to place a thermometer in the vaccine box or transfer box to monitor the temperature. However, this method cannot monitor the individual conditions of each vaccine. Not in real time and not publicly available. In addition, during the transfer, the vaccine may be inactivated due to the exposure of the box to the scorching sun, and the transfer process is not open and transparent.

Once there is a problem with the vaccine, it is difficult to determine whether it is caused by improper transfer and storage of the vaccine, or a problem in the production process, and it is difficult to divide the responsibility.

Yichain's solution is to affix an RFID tag on each vaccine, and each packaged vaccine box will also be affixed with a temperature-sensitive label. During transportation and storage, the reader-writer independently developed by Yilian will synchronize the recorded temperature data to the Ant Blockchain in real time.

"There are usually dozens of boxes of vaccines in a car. Under the limit state, the reader can complete all the data at one time. The reader will also be placed in various places in the transshipment link to monitor from the beginning to the end." Professor Zhang Zhaofeng, the founder of Yichain, explained , From transportation, transshipment to warehousing of vaccines, there will be readers at each stage to upload real-time data on the temperature of vaccines.

In addition, the solution is built on the basis of the Ant Alliance Chain, and real-name authentication will be carried out for all parties on the data chain to ensure the reliability and traceability of the data.

Zhang Zhaofeng told Odaily that the on-chain data based on the ant blockchain can also make users more at ease; and all the on-chain data cannot be tampered with, and the data can be called out to divide responsibilities when there is a problem with the vaccine in the future. "Manufacturers and regulatory authorities can use the data on the chain to find out whether there is a problem in the production or transportation process, and divide the responsibilities of all parties."

After the data is uploaded to the chain, ordinary users (patients) can scan the QR code on the RFID label on the vaccine to check the temperature changes during the transportation of the vaccine and enhance the credibility of the vaccine.

Zhang Zhaofeng added that in the past six months, Yilian's medical traceability solution has been piloted in a certain city, and has run through the traceability monitoring of the operation process from the city's CDC to the vaccination site, but from the "vaccine manufacturer-provincial CDC —City Center for Disease Control and Prevention, but the link did not go through.

"In the next step, the company's development direction is to start labeling and tracing from the vaccine manufacturer link." Zhang Zhaofeng said, "Start labeling from the manufacturer link, and for manufacturers, it can also better divide responsibilities."

2. There are many bottlenecks in the project

In the interview between Odaily and Zhang Zhaofeng, he also bluntly talked about some bottlenecks faced by the current project development.

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(Zhang Zhaofeng)

Foremost among them is the issue of funding. Zhang Zhaofeng made a calculation for us. At present, the hardware cost of a vaccination site needs to be invested 100,000 yuan. A municipal CDC has 30-40 vaccination sites. There are more than 3,000 municipal CDCs nationwide.

"If we want to cover the whole country, we really can only rely on the support of the government, which is very difficult for a company." Zhang Zhaofeng said, "The 1 million yuan this time (the Ant Blockchain Competition) is a drop in the bucket for us." .”

Secondly, unboxing also has certain risks for vaccine labeling. Due to the strict management of vaccines, they cannot be unpacked at will. Therefore, small-scale pilot projects can only be carried out with the support of the government, and it is difficult to promote it to the whole country in a short period of time. The best solution is to label from the source (manufacturer), which is also the difficulty of Yichain's next step.

Zhang Zhaofeng also revealed that they are also in contact with some large pharmaceutical companies at home and abroad. Some companies are very interested in this, but require their solutions to form standards or be supported by national red-headed documents.

However, Zhang Zhaofeng said that in the future, they can reduce the cost to 0.2 to 0.3 yuan, further reducing cost input.

3. Postscript

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3. Postscript

Although the road ahead is difficult, Zhang Zhaofeng and his team still have confidence in the future.

At present, there are more than 20 people in the Yilian team, and half of the partners have doctoral degrees.

The founder, Zhang Zhaofeng, is the first batch of radio frequency integrated circuit experts independently trained by the country, doctors, doctoral supervisors, professors of the Chinese Academy of Sciences, and distinguished professors of Shanghai University of Science and Technology; he has undertaken many major research and development tasks and projects of the country and governments at all levels. Published nearly 100 articles in domestic journals and conferences, and nearly 100 patents.

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