The first phase of the antibacterial drug restriction order points to 2013 or promotes the re integration of pharmaceutical enterprises

Source: China Securities News, Aug 11, 2011, core tip: due to the severe situation of excessive use of antibacterial drugs in China, the management of antibacterial drugs will be increasingly strict, and the first phase of remediation is expected to reach 2013 At present, the new version of "management measures for clinical application of antibiotics" still takes "no more than 50 varieties purchased by tertiary hospitals and no more than 35 varieties purchased by secondary hospitals" as the core control index, "no looseness at all" The final draft will be released in September Wu yongpei, director of pharmaceutical management and research department and chief pharmaceutical expert of the Hospital Management Research Institute of the Ministry of health, said Thursday that due to the severe situation of excessive use of antibacterial drugs in China, the management of antibacterial drugs will become increasingly strict, and the first phase of remediation is expected to reach 2013 At present, the new version of "management measures for clinical application of antibiotics" still takes "no more than 50 varieties purchased by tertiary hospitals and no more than 35 varieties purchased by secondary hospitals" as the core control index, "no looseness at all" The final draft will be released in September Recently, the Ministry of health officially announced the measures for the administration of clinical application of antimicrobial drugs In the new draft, the severe measures of "no more than 50 kinds of third level hospitals and no more than 35 kinds of second level hospitals" proposed in May were cancelled, The authority to formulate the Classified Management Catalogue of antimicrobial drugs is delegated to the provincial health administrative departments As a result, the market is expected to turn around significantly Many research institutions have issued reports that the new management method is more moderate than before, and excessive pessimism is expected to be repaired, which is good for companies affected by excessive adverse effects However, this view was denied by Wu yongpei He pointed out that the "control indicators" were not deleted and the management methods were not relaxed Because the "control indicators" may be adjusted according to the clinical practice every year, they were placed in the "special treatment plan", compared with the "management methods for clinical application of antibiotics" in the form of ministerial order, Therefore, the modification and improvement of the remediation plan will be more flexible, which is conducive to the annual increase or decrease of control indicators In different provinces, 50 and 35 kinds of antimicrobial drugs are still selected as classification management catalogue At present, the third level hospitals in the leading provinces and cities select 50 kinds of antibacterial drugs by themselves and submit them to the provincial health management department The provincial department formulates the final catalog according to the needs of the hospital and then transfers it to the hospitals under its jurisdiction Although the freedom of hospital choice becomes larger, the upper limit of 50 kinds will not be broken According to the research on the frequent occurrence of industrial securities, the restrictive measures point out that the power to formulate the hierarchical management catalogue is delegated to the provincial health administrative departments, which has won the flexibility for the operation of pharmaceutical enterprises But UBS's report said it was more difficult to estimate the impact of policies on the antimicrobial industry because of the flexibility of local governments in implementing them The Research Institute of GF Securities holds the same view, pointing out that at present, Sichuan, Beijing, Jiangsu and other places have issued relevant detailed rules Due to the large differences in detailed rules and implementation, it will be more difficult to judge the specific varieties Wu yongpei said that the purpose of decentralization is to better consider the characteristics of local drug use If the local provinces and cities fail to do well, it is still possible for the Ministry of health to issue a hierarchical management catalogue In the future, more measures will be taken to regulate the drug promotion of pharmaceutical enterprises At present, the Ministry of health has drafted the management measures for "drugs beyond the specification" and is seeking the opinions of relevant departments The next step may be to regulate the infusion behavior as the focus of the treatment of excessive use of antibiotics However, considering the characteristics of fewer drug types for children, the new "management method for clinical application of antimicrobial drugs" will not limit it and allow medical institutions to increase the variety and product specifications of children's drugs according to actual needs In the measures to restrict or promote the integration of pharmaceutical enterprises, antibacterial drugs are divided into three levels: unrestricted use, restricted use and special use Due to the different authorities of doctors, the influence of drugs selected into different use levels is not consistent It is reported that some fourth generation cephalosporin products may be classified into special use level At present, antibiotics account for 25.38% of the total drug share in China, of which antibiotics account for more than 75%, while cephalosporins account for nearly 50% In foreign countries, lipid-lowering drugs and antipsychotic drugs account for the majority, while cephalosporins and antibacterial compound agents account for only 2% Among the top 10 drugs sold in China, four are antibiotics, and most of them are cephalosporins, They are ranked first, second, fourth and fifth respectively But in foreign countries, there are no antibiotics in the top 10 drugs sold Wu yongpei pointed out that the excessive use of antibacterial drugs in China is very serious, and the homogeneous production of pharmaceutical enterprises is regarded as one of the driving forces It is imperative to improve the structure of drug production by limiting the use of antibiotics Industry insiders said that the antimicrobial restrictions may promote the integration of pharmaceutical enterprises At present, there are about 1070 enterprises that produce the most drugs, resulting in vicious competition and indirectly promoting overdose In the view of health authorities, through the introduction of restrictions, it can inhibit the reduction of low-level repetitive production behavior, and inhibit the rapid rise of drug-resistant bacteria Wu yongpei said that by 2013, if the treatment of antibacterial drugs is effective, it will be strengthened and consolidated, in which the more important is to strengthen the regulation of doctors' medication At present, there are about 1600 pharmaceutical manufacturing enterprises in China, many of which are small in scale, poor in equipment and lack of quality awareness Therefore, it is not suitable to expand the number of enterprises If the existing enterprises can be properly integrated, the quality of antimicrobial production is favorable Wu yongpei thinks that the number of 4500 pharmaceutical enterprises is suitable