On February 21, the "China Infusion Expert Consensus" jointly compiled by six associations including China Health Promotion Foundation, China Nursing Association, China Pharmaceutical Packaging Association, and China Pharmacists Association was held in Beijing. The consensus will be published in May.

This is the first time that China has informed the world of the situation of large infusion. Under the background of increasing global attention to drug use and antibiotic resistance, the consensus of large infusion will cause the public, clinical diagnosis and treatment and infusion industry to focus on the quality improvement and rational use of infusion products.

Comprehensive review of infusion

The preliminary final version of the "Chinese infusion expert consensus" is divided into six parts, including the current situation of China's infusion use, infusion quality and evaluation, infusion packaging material quality and evaluation, the quality and evaluation of infusion in various countries, the harm of unreasonable use of infusion and rational use of infusion policy recommendations.

According to the data, the National Health and Family Planning Commission has achieved remarkable results since it launched the "Special Rectification Work for the Rational Use of Antimicrobial Drugs" in 2011, but the 2014 "National Adverse Drug Reaction Monitoring Annual Report" showed that adverse reactions (ADR) occurred by intravenous injection accounted for 57.8 of the total number of adverse reactions.

Zhao Zhigang, the main advocate of the "Expert Consensus", from the Department of Pharmacy of Beijing Tiantan Hospital, said that the main problem in the current use of injections in my country is excessive dependence on infusion methods. Infusion administration has almost become the preferred method of administration for doctors and patients regardless of major diseases and minor diseases. In recent years, the National Health and Family Planning Commission has issued a series of anti-resistance documents, which have played a positive role in infusion and preventing the abuse of antibiotics. However, patients and even doctors still have limited understanding of infusion, especially the use of infusion in primary medical institutions is still very large, resulting in hidden dangers of adverse reactions to infusion.

Visible foreign bodies, insoluble particles, endotoxin, etc. are the main causes of adverse reactions caused by infusion. At present, according to the general rules of the 2015 edition of the Chinese Pharmacopoeia, the visible foreign matter inspection method can detect metal chips, glass chips, fibers with a length of more than 2mm, blocks with a maximum particle size of more than 2mm, and smoke-like particulate deposits visible to the naked eye when gently rotating after standing for a certain period of time. The test results of sterile preparations for injection were determined as fine visible foreign bodies, with the limit of chemical drugs ≤ 4, biochemical drugs, antibiotics and traditional Chinese medicines ≥ 2g ≤ 10, and ≤ 2g ≤ 8. Professor Yu Li of Beijing Institute of Drug Administration said that limited to detection methods and technologies, cilia and particle group counting cannot be accurately detected at present, and instruments will need to be introduced to replace human eye inspection in the future.

Zhao Zhigang said that objectively speaking, there is no absolute purity of infusion, the existence of insoluble particles in the liquid is normal, and insoluble particles can be superimposed, therefore, from the source control, the rational use of large infusion is essential to reduce the incidence of adverse reactions. At present, the principle of "oral administration without intramuscular injection, intramuscular injection without infusion" is generally followed internationally.

Infusion introduces a long-term mechanism

The "Chinese Infusion Expert Consensus" was written by most of the first-line clinical experts. It also absorbed the content provided by experts from China Pharmaceutical Packaging Association, China Medical Equipment Engineering Association, ADR Center of the State Food and Drug Administration, and China Medical Insurance Research Association. The first draft is about 250000 words.

Zhao Zhigang said that after the release of the "expert consensus", a series of activities will be carried out throughout the country to implement infusion. Including the proposal to set up an "infusion day"; Compile the "Guiding Principles for Reasonable Use of Infusion", clarify the clinical indications of unnecessary use of infusion, incorporate it into the target responsibility system of hospital management, organize regular inspections and supervise the rational use of infusion in medical institutions; Promote and popularize the knowledge of rational use of infusion to doctors, nurses, pharmacists and the public; Carry out quality evaluation of post-marketing infusion drug preparations, and implement the principle of survival of the principle to ensure infusion quality; organize experts to compile and publish the "Guidelines for Clinical Application of Infusion"; establish a hospital intravenous infusion management system and management committee, establish a long-term mechanism for intravenous infusion management; promote the rational use of infusion at the medical insurance level.

Cai Hong, Secretary General of China Pharmaceutical Packaging Association, said that the role and significance of infusion in clinical practice can not be ignored. We should neither overuse nor talk about the color change of infusion. We should grasp it moderately. At present, the main causes of infusion are unreasonable use and problems in the production quality of individual products. It is recommended to establish effective drug risk assessment and clinical reevaluation.

The infusion industry will be upgraded

The reporter noted that the first draft of the consensus of China's transportation experts has a more detailed introduction to the current medical packaging materials and equipment used for infusion, and gives special recommend to the new packaging materials, equipment and production technology, and warns not to use backward products. Among them, the infusion BFS technology introduced by China Resources Shuanghe from abroad in recent years has been written into the consensus as a recommend product. The biggest bright spot of the product is the integration of blow potting, which can improve the quality, and its insoluble particles can be controlled below 5 microns, which is much higher than the national pharmacopoeia standard. BFS technology is also applied to large infusion products for the first time in China.

Gu Weijun, secretary-general of the China Medical Equipment Engineering Association, said that in recent years, many new processes, new technologies, and new products have emerged in the field of pharmaceutical production, which can greatly improve the quality of infusion, but the promotion work has a long way to go, lack of clinical recognition and guidance, and only clinical and industry Only by forming a benign interaction can infusion be truly improved.

A pharmaceutical expert from a medical institution said that in the face of new products, both medical institutions and the public are faced with the problem of selectivity or price. Therefore, my country's medical insurance payment needs to be reformed and explored. Recently, health insurance in the study of payment price unification, regardless of the product level to pay a certain price, more than part of the individual to bear.