Remediation of antimicrobial drug management is more important than the directory itself

The new management measures do not stipulate that the restriction on the number of antibacterial drugs does not mean that regulation is relaxed, but it is to better reflect the scientific nature and seriousness. Antimicrobial drug management should not only be reflected in the simple number of restrictions, but should pay more attention to the application of quality standards and regulatory standards.

The simmering "Administrative Measures for the Clinical Application of Antibacterial Drugs (Draft for Solicitation of Comments)" finally began to solicit opinions in the industry for months of speculation. The new version of the consultation draft intends to continue the three-tier management of non-restricted, restricted, and special-use grades of antibacterial drugs. The obvious difference is that the number of 35 and 50 varieties of antibacterial drugs purchased by second- and third-tier hospitals has not been clearly defined. Instead, the authority to assign hierarchical directories was delegated to the provincial health administrative department.

The Ministry of Health explained that the new management measures do not stipulate that the restriction on the number of antibacterial drugs does not mean that regulation is relaxed, but it is to better reflect the scientific nature and seriousness of management methods. Indeed, antibacterial drug management should not only be reflected in the simple number of restrictions, but should pay more attention to the application of quality standards and regulatory standards.

Long-term management

To promote the clinical application of antibiotics, the Ministry of Health issued the Guiding Principles for the Clinical Application of Antibacterial Drugs as early as 2004. In 2008, the Ministry of Health issued the “Notice on Further Strengthening the Clinical Application and Management of Antibacterial Drugs,” which was issued in 2009. Notice on Issues Concerning the Management of Clinical Applications of Antimicrobial Agents." As of January 2011, the Ministry of Health has also issued the Guidelines for the Prevention and Control of Multidrug Resistant Nosocomial Infections, repeatedly requesting the establishment and improvement of the classification management system for antimicrobials, clarifying the prescription authority for physicians to use antimicrobial agents, and preventing and correcting the improper use of antimicrobials. The phenomenon of drugs.

At the same time, the Ministry of Health has established "National Clinical Application Monitoring Network for Antibacterial Drugs," "National Bacterial Drug Resistance Surveillance Network" and "National Rational Drug Use Monitoring System", emphasizing rational drug use and reducing the abuse of antimicrobial drugs. As a series of principles, notices, and guidelines mostly stay at the level of technical guidance and administrative constraints, they have not risen to administrative regulations and follow-up remediation. As a result, the normative awareness has gradually increased, but the implementation results have been far from satisfactory.

The key to clinical application management is to allow antimicrobial drugs not to be abused or wasted, but also to maximize their effectiveness.

Regulating the use of “limited” measures to limit the number of samples, rather than adopting measures such as limiting total usage, total amount, and guiding rational use of the sample, is likely to cause the hospital to use certain types of antibiotics. New resistance issues. Affected by the objective differences in the level of infection and resistance among patients in different regions, the treatment of complex and difficult-to-infect situations may also affect the effective and timely treatment due to the limited number of varieties.

To this end, the Ministry of Health announced in April the "National Antibacterial Drugs Clinical Application Special Remediation Campaign Plan" in April has marked "in principle," the number of varieties of restrictions, special circumstances can apply for filing adjustment. The new version of the ED does not impose rigid restrictions on the use of antibacterial drugs in terms of variety and quantity, but it is more scientific, rigorous, and meticulous in terms of management quality requirements. For example, strict control over the use of high-priced drugs, detailed provisions of the provisions of the doctor's responsibility to investigate non-compliance; basic medical institutions can only use the list of antibiotics included in the basic drug directory; medical institutions, in principle, the supply of antimicrobial drugs directory not less than 1 year. Replacement and retired antibiotics must not be re-entered within 12 months.

The anti-bacterial drug abuse rectification campaign, as a ground-breaking initiative to implement the management measures, was initiated in May this year. It will last for three years and will be summarized and improved each year. It is a propelling device that really promotes the effectiveness of the management approach. To a certain extent, continuous regulation of antibacterial drugs is more important than cataloguing, because the long-term mechanism for clinical application management can be perfected, and the clinical rational application ability and management level can be continuously improved.

Many "stimuli"

In 2010, the “super bacteria” incident in Europe and the United States once again sounded the alarm for the rational use of antimicrobial drugs. Due to the unreasonable use of antibiotics, the economic losses caused to countries in the world amount to more than 6 billion U.S. dollars each year. Every year, due to the abuse of antibiotics, our country also leads to unreasonable growth of medical expenses, which brings undue medical problems and economic burdens to patients and society. The theme of this year's World Health Day is "Control of antibiotic resistance - no action today, no medicines will be available tomorrow", and it also sets off a new round of regulatory climax for the application of antibacterial drugs in the world.

In November 2010, the Indian Drug Surveillance Agency agreed with the Drug Review Committee to adopt new regulations to regulate the sale of antibacterial drugs. Through the addition of separate requirements under Article H of the "Drug, Cosmetics Regulations," in response to being named New Delhi resistance beta- The superbug event of the amidase NDM1 caused controversy after panic attacks. The new rules clearly implement the copy prescription system and require that patients must purchase antibiotics on two prescriptions, one of which is to be examined by the pharmacist and kept for one year. For those who violate the regulations, they will be punished by Rs 20000, or a maximum sentence of 2 years. The ultimate goal is to stop the abuse of antimicrobial drugs.

According to the statistics of the “two networks” of the clinical monitoring network of antibacterial drugs and the clinical monitoring network of bacterial drug resistance, 154 antibacterial drugs were used in 174 tertiary care hospitals in China from 2005 to 2009, far exceeding the international normal indicators and the intensity of antibiotic use. Up to 80.1DDD, which is more than twice the average strength of the world, the combined use rate of antibacterial drugs reached 37% to 50%, which is 1 times higher than that of foreign countries.

For this reason, the drafts for the review of antibacterial drug specific remediation programs and management methods all impose a clear declining ratio on the clinical use rate, intensity, and ratio of prophylactic drugs, requiring hospitalized patients to use less than 60% and outpatient prescriptions to use less than 20 %, use intensity control at 40DDD and so on. At the same time, the rectification activities have greatly increased the penalties and will severely investigate and deal with the irrational use of antibiotics. For those doctors with clinical irrational application of antibacterial drugs, the health administrative department or medical institution shall, in accordance with the circumstances, be warned in accordance with regulations and be rectified within a time limit. Suspend prescription rights, cancel prescription rights, downgrade usage, and revoke the "Practitioner's License for Practitioners"; if a crime is constituted, criminal responsibility shall be investigated according to law.

The abuse of antibiotics in China has stimulated the competition between pharmaceutical companies, but also affected the sense of incorrect consciousness of the majority of patients, and promoted the over-prescription of medical institutions under the mechanism of “taking drugs to support medical care”. While guiding the production and management companies to take initiative and rational marketing, cooperate with medical organizations at all levels to promote them rationally, and promote the scientific use of drugs by the public, it is increasingly important to strengthen antibacterial drug remediation in medical institutions. This is also to safeguard the healthy operation of medical institutions and protect the antibacterial drug industry. Sustainable development.

As pointed out by Professor Wu Yongpei, chief pharmaceutical expert of the Ministry of Health, in preaching the clinical application of antibacterial drugs and thinking about the development of the enterprise, rational use of antibiotics and protection of public health resources for antibacterials are the common responsibility of everyone living on the earth. The business and the medical community have a responsibility to do practical and good things for future generations. The new measures and rectification activities may have a negative impact on the antibacterial pharmaceutical industry in the short term, and the sales of some varieties may decline. However, in the long run, it will be of far-reaching significance to promote the sound development of China's antibiotic industry, such as structural adjustment and technological quality innovation.