The reporter Xue Yuan recently announced that the Ministry of Health has issued the “Administrative Measures for the Clinical Application of Antimicrobial Drugs (Draft for Soliciting Opinions)†and the “National Program for the Remediation of Clinical Applications of Antibacterial Drugs in 2011â€. A three-year national special treatment of clinical application of antibacterial drugs officially kicked off.
Wu Yongpei, chief pharmaceutical expert of the Ministry of Health and director of the Pharmaceutical Affairs Research Department of the Hospital Management Institute of the Ministry of Health, told reporters that the abuse of antibiotics in China is very serious. There are many varieties and large quantities of use, resulting in an increase in drug-resistant “super bacteriaâ€. Will face the dilemma of no medicine available. This issue has attracted the attention of many ministries such as the Ministry of Health. This special rectification campaign is an important part of the “Medical Quality Miles†and “Three Goods and One Satisfaction†activities. The effectiveness of the rectification will be promoted as the dean and department director. The important indicator.
The amount of antibacterial drugs used is limited. “The most difficult part of the remediation standard is to reduce the number of antibiotics to less than 50, and it is necessary to fully communicate with the directors of each clinical department and do a good job of selection together.†Director of the Department of Pharmacy at the top three hospitals The reporter told reporters that there are currently hundreds of kinds of antibacterial drugs in the hospital, and it is very difficult for those who choose to choose.
The draft of the Opinions proposed that the number of antimicrobial drugs in tertiary hospitals should not exceed 50 in principle, and that of secondary hospitals should not exceed 35 in principle. No more than 2 generic injections and oral dosage forms, 1 or 2 compound preparations with the same prescription composition; 3 or 4 generations of cephalosporin (compounds containing oral preparations) oral dosage forms of no more than 5 prescriptions , Injection dosage form does not exceed 8 gauges, carbapenem antibiotic injection type does not exceed 3 gauges, fluoroquinolone antibacterial oral dosage forms and injection dosage forms do not exceed 4 gauges each, deep antifungal antibiotics Not more than 5 items.
Wu Yongpei said that according to the findings of the Ministry of Health, at present, there are 150 to 160 antibiotics used by medical institutions in China, but some are already eliminated abroad, and they do not meet the safe, effective, and economic principles of drug selection.
It is understood that there are 18 kinds of quinolone antibacterials in China, and only 6 in many countries can meet the clinical needs. Beta-lactamase inhibitors are also very confusing, Wu Yongpei said that many of these drugs add enzyme inhibitors are meaningless, and researchers rely on their own imagination, lack of scientific evidence. The use of such drugs by patients not only causes toxic side effects, but also increases the incidence of drug resistance.
While limiting the variety, it is more important to control the dosage. In response to this, the draft of the Opinions proposed that the use rate of antibacterials in hospitalized patients in medical institutions should not exceed 60%, the proportion of antibiotics in outpatients should not exceed 20%, and the use of antibacterials should be controlled below 40DDD.
DDD is a unit of measure for the daily limited dose of adults, and can be used to reflect the frequency of use of the drug, regardless of the drug sales price, packaged dose, and different daily doses of various drugs. Wu Yongpei explained that according to the World Health Organization (WHO) regulations on the daily dose of each drug, taking one drug according to regulations is a DDD, and the higher the DDD, the worse the rationality of the drug. The requirement for 40DDD in China refers to the frequency of antibiotic use per 100 people per day. This is also the WHO standard. It is understood that the average frequency of antibacterial drugs used in hospitals in China has reached 81 DDD, and there is still a big gap to achieve.
After having a clear stipulation on DDD, will it guide medical organizations to choose to use advanced antibiotics? He explained that simply limiting DDD is indeed a shortcut. However, the Ministry of Health also has requirements for the proportion of antibacterial drugs in the total amount of drugs, and this trend is avoided through “combination of boxingâ€.
The antibiotic treatment “drug pathway†is expected to be published. Before the draft of the draft for consultation, relevant departments conducted investigations on the specific aspects of the irrational use of antimicrobial drugs. The results of the survey found that antibacterial drugs are unreasonable in preventing drug use. For example, type I incisions can be used without antibacterials. Some patients use antibiotics more than 2 hours before surgery and have lost their preventive effect.
In order to regulate the use of antibiotics, the new regulations have also made corresponding quantitative provisions. The proportion of prophylactic antibacterial drugs used in patients undergoing type I incision should not exceed 30%; the duration of antibiotic use for surgical prevention in inpatients should be controlled from 30 minutes to 2 hours before surgery; and the time to prevent the use of antimicrobial drugs should not exceed 24 hours in patients undergoing type I incision surgery.
Wu Yongpei said that the abuse of antibiotics not only refers to the use of large amounts, and the unreasonable selection of drugs is also a form of abuse. He found in many hospitals that he can use cefazolin, a common formulation, and often use anhydrous preparations for patients in clinical practice. The effect is not significantly different, but the cost is much more expensive. Relevant departments are also considering the development of technical specifications for the use of 1 to 2 antimicrobial agents, similar to the clinical pathway. However, he admitted that the "drug route" is more complex, the indications are not very clear, there are many drugs that can be selected, and how to regulate it still needs to be explored.
In particular, he emphasized that the purpose of the use of antibiotics should be clear for doctors. They should not use antibacterial drugs instead of cleansing before and after surgery, and they should not replace infection control of surgical operations.
In the new regulations, it is also proposed to establish a hierarchical management system for antibacterial drugs and classify antibacterial drugs into three categories: unrestricted use, restricted use, and special use. Antibacterial drug classification management directory is soliciting opinions, and will be introduced in the near future.
The new regulations lead to hospital drug companies linked to the First Affiliated Hospital of Harbin Medical University, Department of Pharmacy Director Ma Man Ling said in an interview with reporters that the hospital now has about 100 kinds of antibiotics, according to the regulations need to cut nearly half. At present, the hospital is mainly emphasizing the rational use of drugs, and the selection of varieties has not yet begun. "Foreign hospitals have less than 50 antibacterial drugs, and they are still sufficient. Our hospitals have 800 kinds of living space, and the key lies in the government's rectification efforts." Chen Shicai, director of the Department of Pharmacy at Luohe Hospital in Tongzhou District, Beijing, also said that although the work on prescription reviews has been done, many therapeutic principles for antibiotics have not yet been fully implemented. This remediation is a good opportunity to strengthen the standard.
In a site where clinical pharmacists gather together, the special rectification of antibacterial drugs is the hot topic recently. Many netizens hope that this rectification will increase efforts to reverse the status quo.
Ma Manling believes that the stipulations on the drafts and remediation plans for quantification of many indicators are very necessary, and the objectives of the medical institutions are more clear. Clinically, however, there is a problem of "hidden infection" in pacemaker implantation and brain surgery, and this problem exists even in aseptic surgery. If the use of antibacterial drugs does not reach three hours, the operation may fail or even be life-threatening. This information is also being collected.
The preparation of the hospital was "in full swing" and the company was not so calm.
A sales manager of a foreign company in charge of the Beijing market lamented that the company recently met every day to arrange countermeasures for this special rectification. According to him, the company has already said hello to every medical representative and if they are responsible for the medicine being "taken" by the hospital, they are asked to resign automatically. The supervisor believes that special rectification is a good fortune for the company. If it is successful, the market share will increase.
A person in charge of a pharmaceutical company based in Jiangxi that produces antibiotics said that they have long been concerned about the management of antibacterial drugs. As for the restrictions on breeds, he felt that "this is not so much competition between breeds and enterprises as it is between the background of agents." Those who are "taken away" are probably domestically produced drugs.
Ma Manling expressed her views from the perspective of pharmacy professionals on the unfavorable position of domestic antibacterial drugs. She believes that from the point of view of clinical use, foreign companies' drugs do have advantages and are more obvious. With the exception of profit drives, doctors are willing to choose their products from the perspective of patient safety and treatment effectiveness. Patients with better economic conditions also have such needs. It seems that in addition to practicing channels, state-owned enterprises have to work hard.
Wu Yongpei, chief pharmaceutical expert of the Ministry of Health and director of the Pharmaceutical Affairs Research Department of the Hospital Management Institute of the Ministry of Health, told reporters that the abuse of antibiotics in China is very serious. There are many varieties and large quantities of use, resulting in an increase in drug-resistant “super bacteriaâ€. Will face the dilemma of no medicine available. This issue has attracted the attention of many ministries such as the Ministry of Health. This special rectification campaign is an important part of the “Medical Quality Miles†and “Three Goods and One Satisfaction†activities. The effectiveness of the rectification will be promoted as the dean and department director. The important indicator.
The amount of antibacterial drugs used is limited. “The most difficult part of the remediation standard is to reduce the number of antibiotics to less than 50, and it is necessary to fully communicate with the directors of each clinical department and do a good job of selection together.†Director of the Department of Pharmacy at the top three hospitals The reporter told reporters that there are currently hundreds of kinds of antibacterial drugs in the hospital, and it is very difficult for those who choose to choose.
The draft of the Opinions proposed that the number of antimicrobial drugs in tertiary hospitals should not exceed 50 in principle, and that of secondary hospitals should not exceed 35 in principle. No more than 2 generic injections and oral dosage forms, 1 or 2 compound preparations with the same prescription composition; 3 or 4 generations of cephalosporin (compounds containing oral preparations) oral dosage forms of no more than 5 prescriptions , Injection dosage form does not exceed 8 gauges, carbapenem antibiotic injection type does not exceed 3 gauges, fluoroquinolone antibacterial oral dosage forms and injection dosage forms do not exceed 4 gauges each, deep antifungal antibiotics Not more than 5 items.
Wu Yongpei said that according to the findings of the Ministry of Health, at present, there are 150 to 160 antibiotics used by medical institutions in China, but some are already eliminated abroad, and they do not meet the safe, effective, and economic principles of drug selection.
It is understood that there are 18 kinds of quinolone antibacterials in China, and only 6 in many countries can meet the clinical needs. Beta-lactamase inhibitors are also very confusing, Wu Yongpei said that many of these drugs add enzyme inhibitors are meaningless, and researchers rely on their own imagination, lack of scientific evidence. The use of such drugs by patients not only causes toxic side effects, but also increases the incidence of drug resistance.
While limiting the variety, it is more important to control the dosage. In response to this, the draft of the Opinions proposed that the use rate of antibacterials in hospitalized patients in medical institutions should not exceed 60%, the proportion of antibiotics in outpatients should not exceed 20%, and the use of antibacterials should be controlled below 40DDD.
DDD is a unit of measure for the daily limited dose of adults, and can be used to reflect the frequency of use of the drug, regardless of the drug sales price, packaged dose, and different daily doses of various drugs. Wu Yongpei explained that according to the World Health Organization (WHO) regulations on the daily dose of each drug, taking one drug according to regulations is a DDD, and the higher the DDD, the worse the rationality of the drug. The requirement for 40DDD in China refers to the frequency of antibiotic use per 100 people per day. This is also the WHO standard. It is understood that the average frequency of antibacterial drugs used in hospitals in China has reached 81 DDD, and there is still a big gap to achieve.
After having a clear stipulation on DDD, will it guide medical organizations to choose to use advanced antibiotics? He explained that simply limiting DDD is indeed a shortcut. However, the Ministry of Health also has requirements for the proportion of antibacterial drugs in the total amount of drugs, and this trend is avoided through “combination of boxingâ€.
The antibiotic treatment “drug pathway†is expected to be published. Before the draft of the draft for consultation, relevant departments conducted investigations on the specific aspects of the irrational use of antimicrobial drugs. The results of the survey found that antibacterial drugs are unreasonable in preventing drug use. For example, type I incisions can be used without antibacterials. Some patients use antibiotics more than 2 hours before surgery and have lost their preventive effect.
In order to regulate the use of antibiotics, the new regulations have also made corresponding quantitative provisions. The proportion of prophylactic antibacterial drugs used in patients undergoing type I incision should not exceed 30%; the duration of antibiotic use for surgical prevention in inpatients should be controlled from 30 minutes to 2 hours before surgery; and the time to prevent the use of antimicrobial drugs should not exceed 24 hours in patients undergoing type I incision surgery.
Wu Yongpei said that the abuse of antibiotics not only refers to the use of large amounts, and the unreasonable selection of drugs is also a form of abuse. He found in many hospitals that he can use cefazolin, a common formulation, and often use anhydrous preparations for patients in clinical practice. The effect is not significantly different, but the cost is much more expensive. Relevant departments are also considering the development of technical specifications for the use of 1 to 2 antimicrobial agents, similar to the clinical pathway. However, he admitted that the "drug route" is more complex, the indications are not very clear, there are many drugs that can be selected, and how to regulate it still needs to be explored.
In particular, he emphasized that the purpose of the use of antibiotics should be clear for doctors. They should not use antibacterial drugs instead of cleansing before and after surgery, and they should not replace infection control of surgical operations.
In the new regulations, it is also proposed to establish a hierarchical management system for antibacterial drugs and classify antibacterial drugs into three categories: unrestricted use, restricted use, and special use. Antibacterial drug classification management directory is soliciting opinions, and will be introduced in the near future.
The new regulations lead to hospital drug companies linked to the First Affiliated Hospital of Harbin Medical University, Department of Pharmacy Director Ma Man Ling said in an interview with reporters that the hospital now has about 100 kinds of antibiotics, according to the regulations need to cut nearly half. At present, the hospital is mainly emphasizing the rational use of drugs, and the selection of varieties has not yet begun. "Foreign hospitals have less than 50 antibacterial drugs, and they are still sufficient. Our hospitals have 800 kinds of living space, and the key lies in the government's rectification efforts." Chen Shicai, director of the Department of Pharmacy at Luohe Hospital in Tongzhou District, Beijing, also said that although the work on prescription reviews has been done, many therapeutic principles for antibiotics have not yet been fully implemented. This remediation is a good opportunity to strengthen the standard.
In a site where clinical pharmacists gather together, the special rectification of antibacterial drugs is the hot topic recently. Many netizens hope that this rectification will increase efforts to reverse the status quo.
Ma Manling believes that the stipulations on the drafts and remediation plans for quantification of many indicators are very necessary, and the objectives of the medical institutions are more clear. Clinically, however, there is a problem of "hidden infection" in pacemaker implantation and brain surgery, and this problem exists even in aseptic surgery. If the use of antibacterial drugs does not reach three hours, the operation may fail or even be life-threatening. This information is also being collected.
The preparation of the hospital was "in full swing" and the company was not so calm.
A sales manager of a foreign company in charge of the Beijing market lamented that the company recently met every day to arrange countermeasures for this special rectification. According to him, the company has already said hello to every medical representative and if they are responsible for the medicine being "taken" by the hospital, they are asked to resign automatically. The supervisor believes that special rectification is a good fortune for the company. If it is successful, the market share will increase.
A person in charge of a pharmaceutical company based in Jiangxi that produces antibiotics said that they have long been concerned about the management of antibacterial drugs. As for the restrictions on breeds, he felt that "this is not so much competition between breeds and enterprises as it is between the background of agents." Those who are "taken away" are probably domestically produced drugs.
Ma Manling expressed her views from the perspective of pharmacy professionals on the unfavorable position of domestic antibacterial drugs. She believes that from the point of view of clinical use, foreign companies' drugs do have advantages and are more obvious. With the exception of profit drives, doctors are willing to choose their products from the perspective of patient safety and treatment effectiveness. Patients with better economic conditions also have such needs. It seems that in addition to practicing channels, state-owned enterprises have to work hard.
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