Base drug catalog should be adjusted to predict new access opportunities from 2018 base drug catalog

Recently, a letter on soliciting policy suggestions related to national essential drugs drafted by the Chinese society of traditional Chinese medicine has been circulated in the industry, which triggered the author's thinking on the adjustment of the catalogue of essential drugs In 1977, an expert group of the World Health Organization prepared a list of standards for the first time, providing a model for Member States to adapt to their own needs The list is revised every two years to reflect current health challenges [1] In principle, the adjustment of China's essential drug catalogue will not exceed three years According to the last edition, it will be 2018 Next year, 2020 will be the time for the new essential drug catalogue to be re published This year, the World Health Organization (who) released the list of essential drugs in 2019 (the 21st Edition), marking that the world's health management departments will refer to this update, and gradually improve the list of essential drugs suitable for their own disease spectrum According to the international practice, who's list of essential drugs has reference significance for the world health management organizations to make their own list of essential drugs According to the local disease burden and the status of existing medical and health services, the national essential drugs catalogue provides a good framework for countries to plan and implement testing services and required drugs [1] 28 adult drugs and 23 children's drugs have been added to the list of essential drugs, and 26 products have been listed for new uses [2], with a total of 460 products, which are considered necessary to meet major public health needs There are certain international standards for the identification of essential drugs The catalogue of essential drugs refers to a kind of drugs with clinical efficacy, safety, comparative cost-effectiveness, sufficient availability at any time, and quality, whose price is a priority drug that can be accepted by individuals and society and selected by the state [2] The catalogue of essential drugs is the protection of people's health rights and interests by the state From the "outstanding basic" of the general requirements of the 2018 edition of the catalogue of essential drugs, it can reflect the protection of people's basic medical needs Secondly, the drug list represents the standard of a country's basic treatment Drugs have the characteristics of efficacy, safety, economy, sufficient access, high quality and priority application Thirdly, it is the responsibility and commitment to provide people with the right to health on behalf of the state The release of the essential drugs catalogue will provide the most basic treatment drugs for the majority of patients, and ensure the treatment of common diseases Finally, for pharmaceutical enterprises, the drugs that enter the basic drug catalog can be preferentially entered into the national medical insurance catalog, which can cover more patients Since 520 drugs were selected from the 2012 version of the basic drug catalog, the public's understanding of the basic drug catalog is insufficient, or even lagging behind 1 The basic drug catalog is not the basic drug catalog The most common is to think that the directory is the basic drug directory, which is called the basic drug directory for short At first, the basic drug directory is mainly restricted in the basic hospitals to ensure the use of drugs in the basic medical institutions Therefore, many people think that the basic drug directory is the basic drug directory 2 Think that the basic drug list is the list of low-cost drugs or low-cost drugs It is indeed cheap to include the early essential drugs catalogue in the products, but with the migration of disease spectrum in China and the need for more treatment by the majority of patients, the essential drugs catalogue is no longer a basic or cheap drug catalogue For example, in the 2018 version of the basic drug catalog, AstraZeneca's digrid will be included According to the query database of pharmaceutical intelligence's bid winning information, the highest bid price of digrid in Zhejiang is 228 yuan 3 The value of the basic drug catalog is not very big It has been 10 years since the first formulation of the basic drug catalog When the 2019 version of the national medical insurance catalog was adjusted, 11 basic drugs that did not enter the national medical insurance catalog were included in the catalog The previous basic drug catalog was not implemented very well at the implementation level, so the impression of the basic drug catalog was that it had little effect The WHO essential medicines catalogue is a sample of national catalogues developed by countries In 2002, who made a comprehensive definition of "what is essential drugs" The working committee of essential drugs updated the catalogue of 2018 edition, adjusted and improved it on the basis of the catalogue of 2012 edition, mainly in terms of quantity, structure, dosage form, traditional Chinese medicine and clinically necessary varieties 1 Increased the number of varieties From 520 species to 685, including 417 western medicine and 268 Chinese patent medicine, 165 varieties were increased, including 126 chemical medicine, accounting for 76.4% 2 The structure is optimized The previous drug catalog did not emphasize on cancer and children's drugs In recent years, with the widespread concern of tumor diseases and the rapid marketing of tumor drugs, the number of tumor drugs increased by 12 in 2018 version, accounting for 9.5% of the total number of specific drugs Secondly, the number of drugs for special groups such as children was also reflected in 2018 version: 22 kinds of drugs for children in urgent need of clinical use were increased, accounting for 17.5% of the total number of specific drugs At the same time, sudden The basic drug demand of common diseases, chronic diseases, heavy burden, serious diseases and public health, etc 3 Further standardize dosage forms and specifications 685 drugs involve more than 1110 dosage forms and 1810 specifications 4 We will continue to attach equal importance to both Chinese and Western medicine It increases the scope of functional indications and covers more clinical symptoms of traditional Chinese medicine 5 Clinically necessary There are 11 non-medical insurance drugs, mainly clinically necessary drugs with definite curative effect For example, silymarin is a commonly used drug for liver disease treatment, with definite clinical curative effect and low adverse reactions With the importance of essential drug catalogue in the world, especially in the developed countries, the essential drug system with essential drug catalogue as the core has been established to improve the management level of national medicine and health, so that the national medicine system tends to be reasonable and standardized 1 The catalogue of essential drugs is the form and connotation of national drug system Thirty years ago, the concept of a national essential drug policy was unfamiliar to most countries Today, more than 100 countries have formulated or are in the process of formulating relevant policies These policies can be used as a framework to promote the reform of the pharmaceutical sector The health management departments of many countries practice the basic drug system in different degrees In the future, with the continuous improvement of the basic drug system, the functions of the basic drug catalog and the medical insurance catalog are increasingly similar, and may be merged into one trend in the future The basic drug system not only helps the state to establish the list of key drug use, which is helpful to regulate and rational drug use, but also greatly reduces the cost of drug use 2 The list of essential drugs has been transformed from the list of basic drugs to the list of essential drugs for hospitals at all levels According to the opinions on further ensuring the supply and price of drugs in short supply in 2019, to increase the proportion of basic drugs, the proportion of basic drugs in basic medical and health institutions, secondary public hospitals and tertiary public hospitals should not be less than 90%, 80% and 60% in principle, respectively, so as to promote medical institutions at all levels to form a "1 + X" dominated by basic drugs ("1" as the national basis This drug catalog and "X" are non essential drugs, which are determined by each region according to the actual situation) The number of essential drug products used has become an important part of the performance indicators of the hospital Therefore, the important role of essential drug catalog will be more prominent in the future pharmaceutical market [4] 3 It is very important for the enterprise to enter the essential drugs catalogue, and it is also necessary to guard against being transferred out Entering and being called out of the essential drugs directory will release a signal The entry indicates that the product may become a treatment trend through expert demonstration, and the transfer out also indicates that the clinical will no longer be needed According to the requirements of the management measures for national essential drug catalogue, the measures were jointly issued by nine ministries and commissions in 2015 Refer to WHO essential drug list and relevant national (regional) drug list selection procedures and principles It has been more than 40 years since the formulation of the essential drug system of the World Health Organization Therefore, referring to the process and principles of who, we can quickly improve the scientificity, accuracy and applicability of the essential drug system in China According to the disease spectrum and drug characteristics in China It should not only refer to the world, but also conform to the reality The Working Committee on essential drugs frequently solicits expert opinions and the migration of disease spectrum of patients in China, and makes timely adjustments to the catalogue of essential drugs in China Fully consider the current basic national conditions and security capacity Previously, the list of essential drugs was rejected by the Standing Committee of the people's Congress for many times, mainly due to the increase of too many exclusive varieties, and the rapid growth of the number of essential drugs After several updates on the basis of the 2012 version, it took seven years to complete the new version of the directory of essential drugs The standard of transferring in and out of essential drug catalogue was defined based on the experience of making and adjusting catalogue in the past Dynamic adjustment is a major feature of the current catalog formulation, and also in line with national conditions Therefore, enterprises should seize the opportunity of dynamic adjustment and fully elaborate the characteristics of variety efficacy, safety, economy and necessity The transfer in and transfer out standards of the 2018 version of the basic drug catalog can also be used as a reference for the adjustment of the new version of the catalog [5] In the listed drugs, we should combine the disease spectrum rank, incidence rate, disease burden, etc., to meet the common diseases, chronic diseases and heavy burden, serious diseases and critical illness, public health and other basic drug needs Second, traditional Chinese medicine and domestic innovative drugs Drugs whose standards have been replaced A drug whose approval number has been revoked by the drug regulatory department There are significant adverse reactions, allergic reactions or secondary reactions of poisoning and other drugs; for example, dirithromycin, which is called out of the list of basic drugs in 2018, is a drug prone to adverse reactions Drugs that are not economical Drugs identified by experts of the essential drugs group This part is very important The working place of the Working Committee on essential drugs is set in the health committee With the public distribution of the three major catalogues in 2019, the first batch of national key monitoring drugs for rational use, the national basic medical insurance, industrial injury insurance and maternity insurance drugs catalogue and the first batch of encouraged generic drugs catalogue (released on the basis of the management opinions on shortage drugs), the basic drugs catalogue as an important part of the national basic drug system will carry more functions Yes, in the part of which the function cannot be realized, other directories shall be issued separately to supplement 1 The list of essential drugs should highlight the basic In addition to taking into account the clinical needs, the essential drugs catalogue also needs to consider the public health needs, such as vaccines, anti AIDS and tuberculosis drugs, to ensure the supply and accessibility of hospitals at all levels For some drug manufacturers, or the supply process is not smooth, the country can give fixed-point production and distribution In September 2019, the general office of the National Health Commission and the office of the State Administration of traditional Chinese Medicine issued the opinions on further ensuring the supply and price stability of drugs in short supply, which is a powerful supplement to the list of essential drugs 2 Priority should be given to the use of essential drugs For the establishment of national essential drug system, priority should be given to the use of essential drug catalogue drugs, to ensure the proportion of essential drug catalogue products, and to strengthen the guidance for clinical rational use of drugs On July 1, 2019, the general office of the National Health Commission and the office of the State Administration of traditional Chinese Medicine issued the first batch of national key monitoring and rational use of drugs catalogue, which is to strengthen the basic drug catalogue, strengthen the management of auxiliary drugs, avoid abuse, and make the structure of national clinical treatment drugs reasonable 3 Reduce the burden of essential drugs catalogue Products in the basic drug catalogue and adjustment in the medical insurance Department