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China's first infusion safety expert consensus is about to be released The infusion industry enters a turning point in developme

China's first infusion safety expert consensus is about to be released The infusion industry enters a turning point in developme

   On February 21st, the  “ China Consensus Expert Consensus on Transfusion Safety ”  jointly prepared by the China Association for Health Promotion, the Chinese Nursing Association, the China Pharmaceutical Packaging Association, and the China Association of Pharmacists organized a final meeting in Beijing. The consensus will be released in May.

   This is the first time that China has informed the world about the safety of large transfusions. Under the background of growing concerns about drug safety and antibiotic resistance worldwide, the safety infusion consensus will lead to public, clinical diagnosis and treatment and infusion industries focusing on infusion product quality improvement and rational use.

   Comprehensive review of infusion safety

   The preliminary " China Consensus Expert on Infusion Safety " is divided into six parts, including the current status of infusion use in China, infusion quality and safety evaluation, quality and safety evaluation of infusion packaging materials, quality and safety evaluation of infusions in various countries,  irrational use of infusion Hazards and reasonable use of infusion policy recommendations.

   According to statistics, the State Health and Welfare Commission has achieved remarkable results since 2011 when it launched the “Special Remediation of Rational Use of Antimicrobial Agents”, but in 2014, the “Annual Report on National Monitoring of Adverse Drug Reactions” showed that adverse reactions (ADR) occur during intravenous administration. It accounted for 57.8% of the total number of adverse reactions.

   Zhao Zhigang, head of the Department of Pharmacy of Beijing Tiantan Hospital, the main advocate of Expert Consensus, stated that the main problem in the current use of injections in China is over-reliance on infusion methods. No matter how serious ailment infusion is, it is almost the preferred mode of administration for doctors and patients. In recent years, the National Health and Family Planning Commission has issued a series of limited-resistance documents to play a positive role in the safety of infusions and the prevention of the abuse of antibiotics. However, patients and even doctors have a limited understanding of the safety of transfusions. In particular, the use of transfusions at primary medical institutions is still very large, causing adverse reactions to infusion reactions.

   Visible foreign matter, insoluble particles, endotoxins, etc. are the main causes of adverse reactions caused by infusion. According to the 2015 edition of the Chinese Pharmacopoeia, it can be seen that the detection range of foreign matter inspection is metal shavings, glass shavings, fibers with a length exceeding 2 mm, blocks with a maximum particle size exceeding 2 mm, and slight rotation after standing for a certain period of time. Visible particulate aerosol deposits. The test results of sterile preparations for injection were judged as finely visible foreign substances, the chemical drug limit was ≤ 4, and the biochemical drugs, antibiotics and Chinese medicine ≥ 2g were ≤10, and ≤2g was ≤8. Professor Yu Li of the Beijing Institute for Drug Control said that due to limitations in detection methods and techniques, cilia and particle population counts cannot be accurately detected. In the future, instruments need to be introduced instead of human eye tests.

   Zhao Zhigang said that objectively speaking, infusion does not exist absolutely pure, the existence of insoluble particles in the liquid is normal, and insoluble particles can be superimposed. Therefore, from the source control, rational use of large infusion is critical to reduce the incidence of adverse reactions. At present, internationally, the principle of administration of "can be administered orally without intramuscular injection and intramuscular injection without infusion" is generally followed.

   Infusion safety introduces long-term mechanism

   Most of the writers of the “ Chinese Expert Consensus for Transfusion Safety ” were clinical first-line experts. At the same time, they also provided input from experts from the China Pharmaceutical Packaging Association, China Pharmaceutical Engineering Association, ADR Center of the State Food and Drug Administration, and China Medical Insurance Research Association. Million words.

   Zhao Zhigang said that after the release of the "Expert consensus," a series of activities will be carried out throughout the country to ensure the safety of infusion. Including the proposed establishment of "infusion safety day"; the preparation of the "guidance principle of rational use of infusion" to clarify the unnecessary use of infusion clinical indications, into the hospital management of the target responsibility system, regular inspections to supervise the infusion of medical institutions in the rational use of the situation; for the doctor , nurses, pharmacists, and the public publicize and rationalize the use of infusion knowledge; carry out postmarketing evaluation of infusion drug product quality, implement the principle of survival of the fittest and ensure the quality of infusion; organize experts to publish and publish the “infusion clinical application guide”; establish hospital intravenous infusion management system and management The committee will establish a long-term mechanism for the management of intravenous fluids and promote the rational use of infusion at the medical insurance level.

   Cai Hong, secretary-general of the China Pharmaceutical Packaging Association, said that the role and significance of infusion in clinical practice should not be overlooked. We should neither overuse nor talk about infusion changes, and we must take appropriate measures. At present, the main cause of insecure infusion is the unreasonable use and the quality of individual products. It is recommended to establish an effective drug risk assessment and clinical re-evaluation.

   Infusion industry will upgrade

   The reporter noticed that the first draft of the “Chinese Expert Consensus on Transfusion Safety” has a detailed introduction to the current use of medical packaging materials and equipment for infusions, and particularly recommended new packaging materials, equipment, and production technology, and do not use warnings for backward products. . Among them, the infusion BFS technology introduced by China Resources Shuanghe from abroad in recent years has been included in the consensus as a recommended product. The biggest highlight of this product is the integration of blowing and sealing, which can improve the quality and safety. 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 technologies, new technologies, and new products have emerged in the field of pharmaceutical production, which can significantly improve the quality and safety of infusions. However, the promotion work is a long way, lack of clinical approval and guidance, and only clinical Positive interaction with the industry can truly enhance the safety of transfusion.

   A pharmacy expert at a medical institution stated that in the face of new products, both medical institutions and the general public are faced with the problem of whether to choose safety or price. Therefore, the payment of medical insurance in China needs to be reformed and explored. Recently, Medicare has unified the research payment price, and the price paid at the product level is certain and exceeds some of the individual's commitment.