Zhao Zhigang: using 18 indexes to evaluate the quality difference of infusion products

Source: xinhua.com May 20, 2016 China is a big infusion country, the quality of infusion products is directly related to the life and health of the people With the development of science and technology, although the infusion products of different enterprises have reached the national standards, there are still large quality differences How to evaluate the infusion products scientifically? Recently, "guard the safety on the tip of the needle"—— The blue book of transfusion safety and protection research in China (hereinafter referred to as the blue book) was officially released As the initiator of the blue book, Professor Zhao Zhigang, director of Clinical Pharmacy Department of Capital Medical University and Pharmaceutical Department of Beijing Tiantan Hospital, said in an interview with xinhuanet.com that high-quality transfusion products are the first condition to ensure the safety of transfusion, and national standards are only the foundation of transfusion products Standard: to find out the "high quality" infusion, we can evaluate the infusion products through 18 indicators on the basis of national standards "This evaluation method is applicable to the evaluation and verification of basic infusion products by medical institutions, and provides reference catalogue for hospital selection and evaluation of infusion." It is well known that "high quality" infusion standard is higher than the national standard Infusion directly enters the blood circulation system and does not pass through the gastrointestinal absorption link It is a rapid and effective treatment method, but there are certain safety risks The World Health Organization has long established the principle of "oral administration without intramuscular injection, intramuscular injection without infusion" "However, many patients and medical staff do not know enough about the infusion risk and pay more attention to the infusion quality, so that they do not use the infusion properly at many times." Zhigang Zhao said frankly Zhao Zhigang said that restricted by the production conditions, a bottle of infusion products meeting the current GMP standards and national infusion quality standards will still contain insoluble particles and endotoxin, and occasionally infusion will not cause obvious harm, but long-term infusion patients will accumulate over time, and adverse reactions can appear At present, most countries have no specific requirements for the quantity of 5-10 μ m insoluble particles in infusion However, in some infusion products, there are nearly 10000 5-10 μ m particles per ml "The smallest diameter of human capillaries is only 4-7 μ m, and 5-10 μ m particles will block the capillaries If the particles move to the lungs, they will form granuloma after long-term accumulation, which will cause the loss of respiratory exchange function of the lungs, and even lead to death." Zhao Zhigang reminded that the more particles accumulated, the greater the probability of long granuloma, the more granuloma, and the longer the process "Even if qualified infusion products still have risks, so it is necessary to choose high-quality infusion when infusion is needed." Zhao Zhigang stressed It is reported that the national pharmacopoeia has corresponding requirements for the number of particles in infusion Zhao Zhigang said that this requirement is the basic standard for enterprises to produce infusion products If they want "high quality" infusion, the executive standard of infusion products should be higher than the national pharmacopoeia standard The quality difference of infusion products can refer to 18 evaluation indexes With the progress of technology, the quality of infusion products has been improved, but there are still large quality differences among infusion products from different manufacturers As the main body of drug use and purchase, how should medical institutions choose infusion products? "On the basis of the national pharmacopoeia and according to the needs of the clinic and patients, a set of perfect and comprehensive basic infusion quality evaluation methods which can be used in clinic should be established, so as to better guarantee the applicability of infusion products and promote the healthy development of infusion industry." Zhao Zhigang said At the same time, in the notice on the implementation and improvement of the guiding opinions on centralized drug procurement in public hospitals issued by the national health and Family Planning Commission, it is also clearly stated that we should accelerate the construction of a comprehensive evaluation system for clinical drugs (consumables) focusing on essential drugs To evaluate the cost-benefit of the safety, effectiveness, rationality, compliance and economy of drugs (consumables), so as to provide clinical technical support for standardizing the purchase and use of drugs, promoting the standardization of drug dosage forms, specifications and packaging In this regard, the "blue book" is attached with the evaluation guide for clinical use of basic infusion, through 18 evaluation indicators to distinguish the quality differences of infusion products These 18 The indexes include: enterprise quality system, safety of infusion package, compatibility, leakage rate, residual amount of liquid medicine, number of insoluble particles, needle dropping of rubber plug, infusion mode, clarity, integrity and identification of label, transparency of container, puncture force of dosing needle, retention force of infusion set, pressure infusion, edge smoothness of soft bag, load-bearing force of lifting ring, packaging design The scientific and convenient design, the protection of the outer packaging, the convenience of the storage management, etc Taking the packaging of infusion products as an example, Zhao Zhigang introduced that the surface of an infusion product looks like a plastic bag or a plastic bottle, but the safety factors of infusion products with different materials are different "Some materials have an adsorption effect on drugs, and some materials may contain substances that may be released, leading to toxic and side effects Therefore, it is necessary to have relevant literature data to prove the safety of packaging materials, which can be the research results of enterprises or the data of other research institutions, and take this as the standard to evaluate the quality of infusion products " To improve the safety of infusion, we should fully understand the risk points of infusion According to the introduction, more than 30 units participated in the preparation of the blue book, which took more than one year to complete after the detailed division of labor and extensive communication by the expert group "There are a lot of materials in the blue book, which can provide reference for relevant departments to make policies." Zhao Zhigang said When asked how to improve the safety of infusion, Zhao Zhigang suggested that: first, both patients and medical staff need to have a scientific understanding of the treatment advantages and potential risks of infusion, and when it is necessary to select infusion clinically, they should give priority to high-quality infusion products; second, for enterprises, they should actively use scientific and technological achievements to improve production technology and select safer and applicable products Packaging materials, the implementation of high requirements of internal control indicators, and constantly improve product quality to ensure the safety of infusion; third, for hospitals, we should strengthen the rational use and management of infusion, strengthen patient education, and clearly tell patients which diseases are suitable for infusion treatment "In addition to the risks of infusion itself, the risks of infusion will be increased if all links such as packaging materials, production technology, transportation, use and hospital configuration are not strictly controlled If relevant departments can control these risk points, they will reduce the occurrence of risk " Zhao Zhigang pointed out Speaking of the follow-up work plan, Zhao Zhigang said that in recent years, some domestic brand enterprises have done a lot of work to improve the quality of infusion products, such as BFS infusion products Through the technological innovation and application of the production process, they have made a great breakthrough in the control of small particle size insoluble particles and endotoxin and other important indicators "The foundation is preparing to conduct a comparative study on the differences of infusion products of different enterprises by referring to the 18 indicators for evaluation of infusion quality in the future, so as to provide a reference for clinical selection of hospitals." Secondly, in order to attract wide attention, we call on the state to establish "infusion safety day", through the activities of infusion safety day, let the public know infusion correctly and use infusion reasonably In addition, in the future, medical staff and the public will be given more publicity and education to increase the scientific awareness of infusion (original title: Zhao Zhigang: using 18 indexes to evaluate the quality difference of infusion products)