The "Administrative Measures for Clinical Application of Antimicrobial Agents" (hereinafter referred to as "Measures"), which was originally scheduled to start on July 1, has not been implemented due to delays in the classification management catalog (hereinafter referred to as the "catalogue"). According to industry sources recently, antibiotic management restrictions may be reopened in the future. Whether antibiotic abuse can achieve "brakes" will gradually form a growing question mark.

Hot variety reshuffle

In the measures (draft for solicitation) issued by the Ministry of Health in mid-May, controlling the use of varieties has become the core idea in the treatment of antibiotic abuse. The Measures stipulates that “three types of hospitals must not purchase more than 50 antibacterial drugs, and two-step applications must not exceed 35 types”, and formulate quantitative restrictions according to categories such as quinolones. According to the catalogue, antibiotics are classified into three categories: non-restricted use, restricted use, and special use.

However, there are a wide variety of antibiotics and there are about 50 types of cephalosporin antibiotics with the largest amount of use. Various types of drugs also have specific indications. It is easy to limit the quantity and it is not easy to do it.

“The understanding of the criteria for setting up a catalogue varies from place to place. Some are completely selected from national lists, while others are based on the conditions of the hospital. The number of supplemental catalogues is also different.” Mr. Shi, a national pharmaceutical distributor The reporter stated that the measures did not explicitly specify the criteria for the establishment of local directories.

In the case of the sudden rise of the antibiotic aztreonam in the past three years, the amount of consumption of antibacterial drug prescriptions at the hospital terminal in Shanghai was ranked eighth in 2010, but this time the "Regulations on the Management of Antibacterial Drugs in Key Hospitals" of Shanghai Municipality set it as a restriction class. Promotion as a special class limits its market space.

“Our production plant for aztreonam raw materials has been discontinued for more than a month.” Mr. Liu, a domestic raw material medicine company, said that the company’s aztreonan bulk drug had received no domestic orders for nearly two months.

However, this does not mean that the use of other restricted classes and special drugs has been reduced. According to the monitoring of prescriptions of key hospitals in Shanghai by the China Medical Information Center, the restricted use of antibiotics topped the list in 2009 and 2010, accounting for about 45% of the total, while the use of special use accounted for about 27%, slightly higher. Unrestricted use of class.

Did not touch the pharmacy interest chain

Since 2003, the Ministry of Health has issued at least 12 documents on the rational use of antibacterial drugs or related documents.

“Antibiotics industry is often a round of hype. The once popular varieties were gradually abandoned by the pharmacy because of the surplus of manufacturers and the strict price limit of the terminal. The approved new drugs became a new round of hot due to high pricing and large profit margins. The target of speculation, said an analyst in the pharmaceutical industry.

Industry sources told reporters that pharmaceutical companies have long been at a disadvantage in the sales right of downstream hospitals. Sales of hospital terminals are led by pharmaceutical representatives. These pharmaceutical representatives are often former employees of hospitals or persons with special relationships with hospital-related personnel.

“Enterprises first invest tens of millions of funds and spend 3 to 5 years on technical research and development. Before the year of obtaining approval numbers for drug production, it is necessary to start recruiting and training sales teams, and at the same time invite experts from large hospitals around the world to organize academics. Promotion meetings require at least hundreds of thousands of inputs per meeting. However, once they enter the hospital, they must be handed over to medical representatives, and the hard-training sales staff of pharmaceutical companies are turned into pharmacy service personnel.” Say.

In the case of Aztreonam, which has been rampant in recent years, some business people have reported that the drug is not effective in clinical use. Therefore, it is often used in conjunction with other antibiotics, but its adverse reactions are low, and the intermediate profit rate is high. The pharmacists are keen on speculation.

In view of this, antibiotics control adopts the upper limit variety and the terminal price limit, but it has never touched on the bloated pharmacy interest chain. The question remains whether the “golden age” of end-of-life antibiotics can be terminated by hierarchical management.