我国将全链条为改革完善短缺药品供应保障开出“药方”

我国将全链条为改革完善短缺药品供应保障开出“药方”

For domestic children with acute lymphoblastic leukemia, clinically necessary medications, domestic thiopurine tablets have suffered shortages in many places, the relevant person in charge of the National Health and Family Planning Commission said on the 21st that according to the previous key monitoring situation, the first batch of emergency production inspections has been completed on the 20th 2.95 million tablets of mercaptopurine have been shipped. All localities will quickly coordinate and organize the procurement and distribution work, and directly procure online to ensure the supply.

Why has the shortage of medicines become more frequent in recent years? Let the doctors and patients no longer give up their "heart-saving" for "life-saving drugs" and respond to the medical concerns of the people's livelihood. China will make efforts to make the "one medicine no longer difficult" by improving the entire chain of monitoring and early warning, optimizing the drug development process, and strengthening supply and demand coordination. begging".

What is the shortage of medicines? 130 drugs have been added to the shortage monitoring list

Protamine, a necessary medicine for clinical operations of heart disease, digoxin oral solution for treating children with heart failure ... The National Health and Family Planning Commission summarized and analyzed the monitored and reported varieties in various places and commissioned the Chinese Pharmaceutical Association to investigate and find that the shortage of drugs in China is concentrated in low Valuable drugs and specialists, urgent (grabbing) rescue drugs.

In June this year, the National Health and Family Planning Commission and other 9 departments jointly issued the "Opinions on the Implementation of the Reform and Improvement of the Drug Supply Guarantee Mechanism for Shortages", which proposed the establishment of a coordinated response mechanism for shortage drug supply guarantees and the implementation of precise measures for classified drug supply guarantees. Responsible persons said that 130 urgently needed medications such as protamine and mitomycin, which have a high degree of social concern, have been included in the list management.

"This time the shortage of mercaptopurine tablets can quickly restore the market supply, which is due to the gradual establishment and improvement of the shortage of drug monitoring networks." Zhang Feng, deputy director of the Department of Pharmaceutical Affairs of the National Health and Family Planning Commission, said that according to relevant requirements, the health and family planning department is near The shortage drug monitoring network established in the past two years has detected the early warning of the shortage risk of thiopurine. Since August, it has responded through measures such as accelerating GMP certification of related companies. According to the general law of drug production and distribution, if there is no early warning monitoring, it will take about half a year to restore supply.

Relevant person in charge of the National Health and Family Planning Commission said that China adopted a one-to-one solution to carry out a pilot program for matching shortages in the drug market, launched a joint mechanism for consultations on the national shortage of drug supply guarantees, and resolved a large number of items in the monitoring list. The shortage of some medicines.

Drug shortages are complicated due to multiple reasons

By 2020, China will build a “five-in-one” working pattern of collecting shortage drug information, collecting and analyzing information, coordinating departments, responding to different levels, and guiding the industry to form a shortage drug supply guarantee system with Chinese characteristics. Looking at the whole chain, what is the "crux" of structural and local shortages of drugs?

Niu Zhenggan, Vice President of China Pharmaceutical Enterprise Management Association, pointed out that medicines are special commodities and they are “just needed” for patients. Relying solely on the market, the cost of drug production rises, profit margins decline, and pharmaceutical companies are unwilling to produce, and low-price, low-dose drugs tend to be in short supply.

"In terms of source, China is a major producer and exporter of bulk drugs. Generally speaking, the bulk drug industry is a fine chemical industry with many production processes, large investment and high energy consumption. At the same time, the market's dependence on bulk drugs High. "According to industry insiders, at present, there are 3 domestic manufacturers of mercaptopurine API approval number, but only 1 is actually in production; while the main preparation companies are in the process of suspending production due to the rapid rise in the price of the API and accelerating production As a result, the supply of mercaptopurine tablets is in short supply.

Zeng Yixin, deputy director of the National Health and Family Planning Commission, said that in the event of a market failure, the government "underpinning" the information communication platform will play a good role of "coordinator".

From the perspective of structural reforms on the supply side of the pharmaceutical industry, capacity and structural shortages have become the “throttles” for insufficient “stability” in some areas of the pharmaceutical industry. The "Implementation Opinions on Reforming and Perfecting the Supply Mechanism for the Shortage of Drugs" proposes to encourage drug R & D and innovation, and to give priority to review and approval of applications for clinically needed shortages of drug registration. Since 2016, the Food and Drug Administration has listed 17 situations for priority review, including drugs that are urgently needed and have market shortages in the priority review.

Recording of discontinued production and sentinel move forward: the whole chain went out of fire-fighting governance

The reporter learned that from the 22nd, the National Health and Family Planning Commission, the Food and Drug Administration and other departments will start from the 22nd to address the 27 kinds of difficult medicines on the list of shortage drugs such as dapsone. How to promote the early closing of "Finding Medicine"?

——Improve monitoring and early warning, build a multi-source information collection and supply business collaboration application platform for shortage drugs. Relevant responsible person said that China will expand the scope of monitoring, based on the monitoring sentries of more than 500 medical institutions, to extend to key links such as production and distribution, and promote full coverage of information monitoring. "Movement from the" use end "to the" industrial end "will help directly realize" planning ahead. "Xiao Lu, deputy director of the Science and Technology Development Center of the Chinese Pharmaceutical Association, said that in the future, it is necessary to accelerate the shortage of drugs and APIs proposed by the competent authorities The record system for production suspension of production enterprises shortens the "time gap" between actual occurrence of shortages and activation of response mechanisms.

——Dynamic adjustment and improvement of the shortage drug list. According to experts, the disease spectrum, the clinical medication needs of key populations, and the emergency protection needs are constantly changing processes. "Solving the shortage of drugs is not a day's work." In the future, China should also improve the dynamic determination mechanism of drug shortage standards and scientifically establish a normal drug storage mechanism using big data analysis and other means.

——Strengthening the linkage of medical and health system reform. Industry insiders pointed out that to solve the problem of cheap and necessary medicines "appropriate or not," it is necessary to promote the reform of medical insurance payment methods at the same time, mobilize the enthusiasm of medical institutions to use cheap "life-saving medicines"; also establish a scientific public hospital performance evaluation system to guide medical staff Use cheap and high quality medicines.




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