从2019年版国家基本医保目录的调整浅议医疗机构抗菌药物的分类遴选与使用管理(1)
摘 要 目的：為医疗机构抗菌药物的分类遴选与应用管理提供参考。方法：介绍2019年版《国家基本医疗保险、工伤保险和生育保险药品目录》(以下简称“《新版目录》”)中有关抗菌药物目录的调整情况，对医疗机构抗菌药物遴选调整政策依据和分类遴选原则进行梳理，并对其可能为医疗机构药事管理和临床应用所带来的挑战进行探讨。结果与结论：《新版目录》中抗菌药物新增了3个品种，包括多西环素注射剂、法罗培南颗粒剂和甲硝唑口服常释制剂;调出了9个品规，如四环素口服常释制剂、地红霉素口服常释制剂等;修改了19个品规的适应证和/或适应证的限制范围，如部分抗菌药物要求限用于有明确药敏试验证据或重症感染的患者等。医疗机构对抗菌药物进行分类遴选时应以现有政策文件为依据，严格执行抗菌药物管理有关规定，优先满足国家各种处方集和药品目录品种的要求，遴选循证治疗依据充足且质量和安全保障充分的药品，同时还需兼顾药品使用的方便性、经济性，药品生产、流通企业的供应保障服务能力，以及本地病原菌耐药情况。《新版目录》调整也对医疗机构的抗菌药物应用和管理带来了挑战，例如《新版目录》针对许多抗菌药物品规都强调了“限有药敏证据”，但若临床机械地按照药敏试验结果选药而忽略了抗感染治疗中的经验治疗，也可能会造成另一种“滥用”;此外，有关多粘菌素B和抗敌素(硫酸黏菌素)的适应证限制完全不同的规定也值得进一步考证。
关键词 抗菌药物;国家基本医保目录;医疗机构;分类遴选;管理;合理使用
ABSTRACT OBJECTIVE： To provide reference for classification， selection and management of antibacterial drugs in medical institutions. METHODS： The adjustment of antibacterial drug list in 2019 edition of National Basic Medical Insurance， Work Injury Insurance and Maternity Insurance (called “New List” for short) was introduced. The politic reference of selection and adjustment of antibacterial drugs and the principle of classification selection in medical institutions were sort out. The challenges which may bring to pharmaceutical administration and clinical use in medical institutions were investigated. RESULTS & CONCLUSIONS： Three new varieties of the antibacterial drugs in the New List have been added， including Doxycycline injection， Faropenem granules and Metronidazole oral regular-release preparations. Nine product specifications were excluded， such as Tetracycline oral regular-release preparations， Dirithromycin oral regular-release preparations， etc. The limitation of indications and/or indications of 19 regulations was modified， and some antibacterial requirements were limited to patients with clear evidence of drug sensitivity test or severe infection. When classifying and selecting antibacterial drugs， medical institutions should take the existing policy documents as the basis， strictly implement the relevant provisions of antibacterial drug management， give priority to meeting various national prescription sets and drug list varieties， select drugs with sufficient evidence-based treatment basis， drug quality and safety， and take into account the convenience and economy of drug use， supply guarantee service capacity of drug production and circulation enterprises and local situation of pathogenic bacteria resistance. The adjustment of New List also brings challenges to use and management of antibacterial drugs in medical institutions. For example， New List emphasizes “limited drug sensitivity evidence” for many antibacterial specifications. But if the clinicians choose drugs mechanically according to the drug sensitivity results and ignores the experience treatment in anti-infection treatment， another type of “abuse” may be abused; in addition， the indications of myxomycetin B and colistin (sulfate myxomycetin) are completely different， which also deserves further study., 百拇医药(陈勇川)
关键词 抗菌药物;国家基本医保目录;医疗机构;分类遴选;管理;合理使用
ABSTRACT OBJECTIVE： To provide reference for classification， selection and management of antibacterial drugs in medical institutions. METHODS： The adjustment of antibacterial drug list in 2019 edition of National Basic Medical Insurance， Work Injury Insurance and Maternity Insurance (called “New List” for short) was introduced. The politic reference of selection and adjustment of antibacterial drugs and the principle of classification selection in medical institutions were sort out. The challenges which may bring to pharmaceutical administration and clinical use in medical institutions were investigated. RESULTS & CONCLUSIONS： Three new varieties of the antibacterial drugs in the New List have been added， including Doxycycline injection， Faropenem granules and Metronidazole oral regular-release preparations. Nine product specifications were excluded， such as Tetracycline oral regular-release preparations， Dirithromycin oral regular-release preparations， etc. The limitation of indications and/or indications of 19 regulations was modified， and some antibacterial requirements were limited to patients with clear evidence of drug sensitivity test or severe infection. When classifying and selecting antibacterial drugs， medical institutions should take the existing policy documents as the basis， strictly implement the relevant provisions of antibacterial drug management， give priority to meeting various national prescription sets and drug list varieties， select drugs with sufficient evidence-based treatment basis， drug quality and safety， and take into account the convenience and economy of drug use， supply guarantee service capacity of drug production and circulation enterprises and local situation of pathogenic bacteria resistance. The adjustment of New List also brings challenges to use and management of antibacterial drugs in medical institutions. For example， New List emphasizes “limited drug sensitivity evidence” for many antibacterial specifications. But if the clinicians choose drugs mechanically according to the drug sensitivity results and ignores the experience treatment in anti-infection treatment， another type of “abuse” may be abused; in addition， the indications of myxomycetin B and colistin (sulfate myxomycetin) are completely different， which also deserves further study., 百拇医药(陈勇川)
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