The Health and Planning Commission strictly controls antibiotics

Accordingly, the Health and Planning Commission will in principle stipulate the number and specifications of antibacterial drugs in the tertiary and secondary general hospitals (the specifications of a drug, including dose size, dosage form, etc.). In order to reduce the proportion of abuse of antibiotics, the Health and Planning Commission also put forward rigid requirements in relation to the control of clinical application of antibacterial drugs.

Cho Chung, an analyst in the medical and pharmaceutical industry, believes that adjustments made to the anti-bacterial drug product structure will have a certain impact on the companies that directly manufacture the preparations, but will not have too much influence on companies that are already manufacturing APIs. Moreover, there is a need for further reduction in the control of the clinical application of antibiotics.

Selection evaluation system strictly controls antibiotics
The Health and Planning Commission stated that the upcoming 2013 national special application for the clinical application of antibacterial drugs will be rolled out in various medical institutions at all levels across the country, focusing on public hospitals above Grade 2 and above.

The reporter was informed that in the management of the purchase of antibacterial drugs, the Health Commission pointed out that it will establish a system for the selection and periodic evaluation of antibiotics. Among them, the level of antibacterial drugs in tertiary general hospitals does not exceed 50 in principle, and the number of antibacterial drugs in secondary general hospitals does not exceed 35 in principle. In the future, antibacterial drug selection and periodic assessment systems will be established to eliminate antibiotics or regulations that have potential safety hazards, uncertain efficacy, severe drug resistance, poor cost performance, and illegal use.

The Health and Planning Commission stressed that the same generic name should not exceed two kinds of injection dosage forms and oral dosage forms. Antibacterial drugs with similar or identical pharmacological characteristics must not be purchased repeatedly.

For specific drugs, cephamycin antibiotics should not exceed 2 specifications; for third-generation and fourth-generation cephalosporins (including compound preparations), oral dosage forms of antibacterial drugs should not exceed 5 items, and injections should not exceed 8 items; Carbopenem antibacterial drugs do not exceed 3 prescriptions; oral fluoroquinolone antibiotics and injections do not exceed 4 specifications; deep antifungal antibiotics do not exceed 5 varieties.

The reporter also learned from the Health and Planning Commission that next, it will establish an antibacterial drug selection and regular assessment system as soon as possible to strengthen the management of the purchase of antimicrobial drugs. The medical institutions dynamically manage the antibacterial drug supply catalogue, and retire antibacterial drug types or regulations with hidden safety hazards, uncertain curative effects, severe drug resistance, poor cost performance and illegal use. Retired or replaced antibacterial drugs or product specifications may not, in principle, reenter the antibacterial drug supply catalogue within 12 months.

If the medical institution needs to use antibacterial drugs other than the list of antibacterial drugs supplied by the agency for special treatment needs, the temporary purchase procedure may be initiated. Temporary procurement is submitted by the clinical department, indicating that the name, dosage form, specification, quantity, object of use, and reason for use of the purchased antibiotics have been examined and approved by the antibacterial drug administration working group of the Pharmaceutical Affairs Management and Pharmaceutical Therapeutics Committee of this institution. The department temporarily purchases and uses it.

However, the initiation of an interim procurement procedure for the same common name antimicrobial drug product may not exceed five times in principle each year. If there are more than 5 cases, it is necessary to discuss whether to include this agency's list of antibacterial drugs. The total number of varieties in the adjusted antibacterial drug supply catalogue must not increase.

Clinical application indicators still have room for downward adjustment

Zhao Zhen told reporters that from the perspective of the market's upstream and downstream conditions, the Health and Planning Commission will mainly influence the companies that produce antibiotics, represented by companies that specialize in the preparation of pharmaceuticals; The impact will not be too obvious. At the same time, the research and development of new antibiotics are trapped and more than one large company has left the market. Compared to large pharmaceutical companies, there will be a further squeeze on the profitability of a group of small companies.

In addition to stringent control of the product regulatory structure, the Health and Planning Commission has further defined the relevant indicators for the clinical application of antimicrobial drugs. The Health and Planning Commission requested that the use rate of antibiotics in inpatients in general hospitals should not exceed 60%, the proportion of antibiotics in outpatients should not exceed 20%, the proportion of antibiotics in emergency patients should not exceed 40%, and the intensity of antibacterial drugs should be controlled at 100 people per day. 40DDDs (dosage frequency) The following.

In specialty hospitals, the use rate of antibacterial drugs in inpatients in the oral hospital is no more than 70%, the proportion of antibiotics in outpatients is no more than 20%, the proportion of antibiotics in emergency patients is no more than 50%, and the intensity of use of antibacterials strives to control 40 DDDs per 100 person days. the following.

The use rate of antibacterial drugs in inpatients of oncology hospitals should not exceed 40%, the proportion of antibacterial drugs in outpatients should not exceed 10%, and the proportion of antibiotics in emergency patients should not exceed 10%. The use intensity of antibacterials should be controlled below 30 DDDs per 100 person days.

Zhao Zhen pointed out that at the time when the proportion of domestic antibacterial drugs was the highest, it once reached about 75%. It is of course good to make a downward adjustment and strict control over adjustments, but there is still some room for downward adjustment. Taking Europe and the United States as an example, the target range of indicators is between 25% and 30%, and the ideal target proposed by the World Health Organization is 15%. (