The list of key monitored drugs is adjusted once every three years and 30 varieties are included

Medical Network, September 6 News On September 3, the General Office of the National Health Commission issued the "Regulations for the Adjustment of the National Key Monitoring and Reasonable Use of Drugs Catalogue".
There are a total of ten regulations that clarify the selection scope and adjustment of the list of key monitoring and rational use drugs.
In principle, cycle and work procedures
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Among them, the catalog update and adjustment time should not be less than 3 years in principle, and the number of varieties included in the catalog is generally 30
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All provincial health administrative departments shall, based on the 30 drug varieties submitted by the province, include them in the new version of the list of drug varieties, form a provincial-level key monitoring and rational use drug list, and report to the National Health Commission for the record in a timely manner
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The adjustment of the catalog includes four stages: start-up adjustment, local selection and recommendation, expert summary, and announcement of results
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For the drugs adjusted out of the original catalogue, the local health administrative department should continue to monitor them for at least one year
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It is worth noting that the main items included in the catalog this time are chemical drugs and biological products, and Chinese patent medicines are not mentioned
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The first batch of national key-monitored rational drug catalogues can be traced back to July 1, 2019.
The National Health Commission’s Medical Administration and Medical Administration issued the "Regarding the issuance of the first batch of national key-monitored rational drug catalogues (chemical drugs and biological products).
Notice
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The industry interprets it as the "adjuvant medication" of the sword
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The first catalogue mainly involves gangliosides, cerebroside carnosine, oxiracetam, creatine phosphate sodium, calf serum deproteinized, alprostadil, troxerutin hydrolysate, compound coenzyme, salvia and ligustrazine, Invert glucose electrolyte, mouse nerve growth factor, thymopentin, ribonucleic acid Ⅱ, edaravone, osteopeptide, cerebroprotein hydrolysate, ribonucleic acid, vinpocetine, calf blood deproteinized extract, cinnaphate maleate Zite
.
The first batch of national key-monitored drugs for rational use (chemical drugs and biological products) According to previous statistics from Sina Pharmaceuticals , 20 companies involved in key-monitored drugsThere are more than 200, of which more than 20 are listed companies, and there are many well-known companies such as Sihuan Pharmaceutical, Fosun Pharmaceutical, Livzon Group, Kunyao Group, Saisheng Pharmaceutical, and Buchang Pharmaceutical
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In addition, various provinces and cities have successively issued a list of key monitoring drugs in various regions.
According to incomplete statistics, in addition to the first batch of 20 varieties in the national version, provincial, municipal, and even medical institutions have conducted key monitoring of certain varieties, including More than 200 medicines including chemical medicine, biological medicine and Chinese patent medicine
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　　Attachment:
　　Regulations
for the adjustment of the national key monitoring and rational use of drugs catalogue Article 1 is to strengthen the management of clinical rational use of drugs in China, and to promote the formulation and adjustment of the national key supervision and rational use of drugs (hereinafter referred to as the catalog) to be more scientific and reasonable, and to continuously standardize clinical medication behavior and maintenance The health rights and interests of the people, formulate this regulation
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Article 2 The drugs included in the catalogue management should be chemical drugs and biological products that have a lot of unreasonable clinical use, abnormally high amounts of use, and have a greater impact on the rationality of drug use
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Key including adjuvant, antineoplastic agents, antimicrobials, proton pump inhibitors, glucocorticoids, parenteral nutrition drugs
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Article 3 The adjustment of the catalogue adheres to the principle of "openness and transparency, local recommendation, and dynamic adjustment", and aims to standardize clinical drug use and promote rational drug use
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Article 4 In principle, the time for updating and adjusting the catalog is not less than 3 years, and the number of drug varieties included in catalog management is generally 30
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Article 5 The National Pharmaceutical Administration and Therapeutics Committee (hereinafter referred to as the National Pharmaceutical Council) provides professional technical support for the scientific adjustment catalog, and undertakes the collection, sorting and analysis of recommended materials from various regions
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Article 6 The adjustment of the catalogue includes four stages: initiation adjustment, local selection and recommendation, expert summary, and results announcement
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(1) Start adjustment
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National health committee released the directory adjustment notice, a clear timeline, the material to be submitted, the work requirements
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(2) Local selection and recommendation
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In general hospitals above the second level, based on comprehensive factors such as clinical irrational use of drugs, use amount, clinical value, etc.
, after research and selection by the hospital's Pharmaceutical Affairs Management and Pharmacotherapeutics Committee, they will not distinguish the dosage form and use the generic name of the drug according to the recommended level from strong to For weak ranking, the information of the top 30 varieties with the strongest recommendation degree will be stamped with the official seal of the hospital and submitted to the provincial health administrative department
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The provincial health administrative department assigns corresponding scores to the 30 varieties recommended by each hospital.
That is, the first-ranked variety is assigned a value of 30, and the second-ranked variety is assigned a value of 29 points.
The 30th place is assigned 1 point
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The provincial health administrative department, based on the generic name of the drug, sums up the assignments of all the categories submitted by general hospitals above the level of jurisdiction to obtain the recommended total score for each category, and then follow the scores from high to low.
Sorting (If the score is the same, they can be sorted side by side and occupy subsequent rankings)
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The information of the top 30 drugs (including other drugs with a tie score on the 30th) will be stamped with the official seal and submitted to the Medical Administration and Hospital Administration of the National Health Commission
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(3) Expert summary
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The National Health Commission entrusted the National Pharmaceutical Affairs Commission to conduct formal review of the materials submitted by various regions and adopt the same calculation method as that of the provincial health administrative departments to obtain the top 30 varieties
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(4) Announce the results
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The National Health Commission announced the adjustment results of the catalog, released a new version of the catalog, and put forward management requirements
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Article 7 All provincial health administrative departments shall, on the basis of the 30 drug varieties submitted by the province, include them in the new version of the list of drug varieties, form a provincial-level key monitoring and rational use drug list, and report to the National Health Commission for the record in a timely manner
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On the basis of the provincial catalog, all medical institutions at all levels, combined with the actual use of drugs, form a list of drugs that the institution focuses on monitoring the rational use of drugs
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The provincial and medical institutions’ key monitoring and rational use drug catalogs shall be announced to the public in the form of government affairs disclosure, hospital affairs disclosure, and official website announcements as required
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Article 8 The health administrative departments of all localities should attach great importance to strengthening the management of pharmaceutical affairs in medical institutions, and effectively strengthen the organization and leadership and overall coordination to ensure that the rational use of drugs is in place
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Formulate and improve clinical application guidelines for related drugs, clarify drug application guidelines and dosing plans, make full use of modern information methods, and strengthen the supervision of rational drug use
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Article 9 For the drugs adjusted out of the original catalogue, the local health administrative department shall continue to monitor for at least one year, grasp the prescription reviews, usage amount, usage amount, etc.
, to promote the continuous improvement of the level of clinical rational use of drugs
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Article 10 This regulation shall be implemented from the date of issuance
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