Two changes in the implementation of the national version of the catalogue of key monitoring drugs for rational use of drugs

On the evening of January 1, the website of the national health and Health Commission released the notice on printing and distributing the first batch of national key monitoring and rational drug use catalogue (chemical and biological products) So far, the national version of auxiliary drug catalogue that the market is looking forward to has finally come into effect According to the announcement of the health care Commission, the catalogue of national key monitoring drugs for rational use (hereinafter referred to as "the catalogue") contains 20 varieties, which are mainly used for the treatment of diseases such as nervous system, digestive system and circulatory system Products related to listed companies include alprostadil and thymopentin of Harbin Pharmaceutical Co., Ltd (600664 SH), compound coenzyme of Shuanglu Pharmaceutical Co., Ltd (002038 SZ), Danshen Ligustrazine of Kangenbei (600572 SH), Lizhu group (000513 SZ), unnamed medicine (002581 SZ), shutaishen (300204 SZ), and rat nerve growth factor produced by Haite Biology (300683 SZ) In December last year, the national health and Health Commission issued the notice on the management of clinical application of auxiliary drugs, requiring all provinces and cities to report auxiliary drugs at all levels, and finally to form a national version of the catalogue of auxiliary drugs This is also the first time for the national health and Health Commission to make major measures for the management of auxiliary drugs Prior to that, the general office of the State Council issued the guidance on improving the centralized procurement of drugs in public hospitals in February 2015, which formally proposed "focus on tracking and monitoring of auxiliary drugs" Subsequently, all regions responded to the call and successively issued their own supervision catalogue of auxiliary drugs For the national key monitoring and rational use of drugs catalogue issued by the health and Health Commission, clinical experts from the hospital believe that although the final catalogue formulated by the provinces and even various medical institutions will be different from the national version, the introduction of the national version of the catalogue will provide better guidance for the hospital to strengthen the management of auxiliary drugs, "and also enable the hospital to pay more attention to this matter." Highlight 1: the name of the directory changed from "auxiliary drug use" to "key monitoring of rational drug use" After the introduction of the directory, the reporter noticed that the change of the name of the file first attracted everyone's attention Before that, the relevant documents of the health and Health Commission had been described as "auxiliary drugs" Earlier this year, some cities in Shandong, Hebei and other provinces also issued the catalogue of auxiliary drugs named after "auxiliary drugs" However, the national version of the catalogue avoided the use of the "sensitive word" of "adjuvant drugs", but changed it to "focus on monitoring rational use of drugs" "This change is also in line with expectations, because there has been a lot of controversy in the industry about how to define" adjuvant ", and enterprises are also very opposed to such a term, which should also have made suggestions to the health care Commission." "With this in mind, it is more rigorous for the health committee to choose such a name in the end," an insider told reporters "It's really difficult to define auxiliary drugs Some drugs can be classified as auxiliary drugs in some scenarios, but they are clinically necessary drugs in some application scenarios In the past, the abuse of auxiliary drugs was still due to the use of super indications, so the control of auxiliary drugs does not mean that auxiliary drugs cannot be used, because drugs are certainly useful Therefore, from the perspective of the hospital, it is necessary to change from the original extensive management to the refined management, and to limit the use of departments, doctors and patients " Director of the Pharmaceutical Department of a top three hospital in Shanghai told reporters The general office of the national health and Health Commission has given a clear answer to the question of how to define the auxiliary drugs in the performance appraisal operation manual of the national third level public hospitals According to the documents, the auxiliary drugs refer to the drugs that help to increase the effect of the main treatment drugs or increase their efficacy by influencing the absorption, mechanism and metabolism of the main treatment drugs; or on the basis of conventional treatment of diseases, the drugs that help to prevent and treat diseases or functional disorders Highlight 2: Traditional Chinese medicine injections are not affected temporarily, which is different from the previous market expectation that "after the introduction of the national version of auxiliary drugs, traditional Chinese medicine injections will be greatly impacted" The catalogue published on the night of the first day only contains chemical drugs and biological products, and there is no figure of traditional Chinese medicine varieties Earlier this year, in the catalogue of auxiliary drugs issued by some cities in Shandong, Hebei and other provinces, there are also large varieties of traditional Chinese medicine injections with annual sales of several billion yuan of Danhong injection and Shenmai injection According to the statistics of flint creation, from the perspective of the sales volume of sample hospitals, the sales volume of the first batch of national key monitoring drugs published on the evening of the 1st is quite different Among them, the highest olacetam has an annual sales volume of 1.49 billion yuan, and the lowest calf blood deproteinized extract has an annual sales volume of 190 million yuan The average annual sales of 20 drugs is 730 million yuan However, although the list does not include the varieties of traditional Chinese medicine, in a notice on the evening of the 1st, the health and Health Commission pointed out that it is necessary to strengthen the prescription management of drugs out of the list, including traditional Chinese medicine According to the document: for traditional Chinese medicine, doctors of traditional Chinese medicine category shall prescribe traditional Chinese medicine according to the guiding principles of clinical application of traditional Chinese medicine and the management standard of Chinese Herbal Pieces in hospitals, etc., and the basic principles of syndrome differentiation and treatment in traditional Chinese medicine Other types of doctors, after not less than 1 year of systematic learning of TCM professional knowledge and passing the examination, may issue prescriptions for Chinese patent medicine in accordance with the basic principles of syndrome differentiation and treatment in TCM clinical practice; those who have obtained the professional education or degree of TCM, integration of TCM and Western Medicine, and national medicine recognized by the education administrative department at or above the provincial level, or those who have participated in the approval of the provincial competent department of TCM For those who have studied traditional Chinese medicine for more than years and obtained the corresponding certificates (the total number of class hours is not less than 850), or have studied traditional Chinese medicine with their teachers for more than 3 years and obtained the certificate of graduation of traditional medical teachers according to the relevant provisions of the examination methods for the qualification of traditional medical teachers and those with certain expertise, they can not only issue the prescription of traditional Chinese medicine, but also the prescription of decoction pieces of traditional Chinese medicine "The management of traditional Chinese medicine is complex and needs a lot of adjustment Now many traditional Chinese medicine are western medicine prescriptions that do not understand traditional Chinese medicine, which will certainly cause a lot of unreasonable use of drugs, so the thinking of the health and Health Committee should be to carry out prescription management first, and then timely carry out the next step of standardization In addition, the catalogue published this time is only the first batch, and it is expected that there will be subsequent catalogs "That's what one in the industry read.