Search

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.

The formulation of expert consensus on clinical application of Chinese patent medicines, in means of exploring the effective combination of experience and evidence to form a research method in line with the characteristics of Chinese patent medicines, is an important transitional stage for clinical researches on Chinese patent medicines. Pre-searching is a new step in the formulation of expert consensus on clinical application of Chinese patent medicines. Before steps of interview and investigation on clinical application, pre-searching is conducted to collect publications and literature on certain variety and similar Chinese patent medicines; the publications on related medical classics and formulas of this variety; the recommendation condition of this variety in clinical practice guidelines and expert consensus; and the medication regimens recommended in disease-specific guidelines. Pre-searching is designed to know about the advantages of certain variety of Chinese patent medicine as well as its potential problems recorded in the literature, which is helpful to find out the clinical positioning of Chinese patent medicines, develop reasonable clinical questions and provide ideas for formal literature searching. However, it is not the direct basis for developing clinical questions. Moreover, interviews and investigations are still needed to further clarify the clinical positioning of Chinese patent medicines and develop reasonable questions. This paper took expert consensus on clinical application of Yanshen Jianwei Capsules as an example to introduce the pre-searching process and methods used during formulation of expert consensus on clinical application of Chinese patent medicines, and to further discuss the role of pre-searching to facilitate the formulation of clinical questions on selection of participants, interventions, controls and outcomes.

To analyze the development of coronavirus disease 2019(COVID-19), this study systematically retrieved relevant Chinese and English literatures from both CNKI and Web of Science database platforms by bibliometric research method and CiteSpace 5.5.R2 software to obtain information and visualize relevant literatures. A total of 695 Chinese and 446 English literatures were included in this paper. Statistics showed that China had published most of the literatures and established close cooperation with the United States and the United Kingdom. Through the analysis, Tongji Medical College of Huazhong University of Science and Technology and its affiliated hospitals published the largest number of the publications. Moreover, the highly productive journals including Journal of Traditional Chinese Medicine and The Lancet covered eight major fields, such as medicine, medical virology, radiation medicine, infectious disease, and traditional Chinese medicine. Besides, a total of 35 special COVID-19 funds were recently established to subsidize these studies. The key words and themes analysis indicated that protein structure of COVID-19, receptor targets and mechanisms of action, integration of traditional Chinese and Western medicine, screening and development of antiviral drugs from traditional Chinese medicine and Western medicine, vaccine research as well as epidemiological characteristics and prediction are current study hotspots. This study provides a reference for researchers to rapidly master main study directions of COVID-19 and screen out relevant literatures.

The development of the guidelines should not only meet the rigorous methodological requirements, but also ensure the credibility or enforceability of the guideline recommendations when they are applied in clinical practice. Based on the idea of establi-shing a perfect guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believed that a complete evaluation system of clinical practice guidelines in the field of TCM shall be divided into three parts: quality evaluation, applicability evaluation and clinical application investigation. Among them, applicability evaluation refers to the evaluation of the degree of fit between the guideline and clinical practice, that is, whether the guidelines have good readability and clinical applicability to promote clinical application. The evaluators are clinical experts in the related fields of TCM. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. Based on the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM. In this paper, the author introduces the whole list of quality evaluation, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

Based on the idea of establishing a complete guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believes that a complete guideline evaluation system of traditional Chinese medicine clinical practice should be divided into three parts: quality evaluation, clinical applicability evaluation and clinical application investigation. According to the different purposes, different evaluators, different evaluation methods and different evaluation time points in the guideline evaluation, the quality evaluation recommendation list, the clinical applicability evaluation recommendation list and the clinical application questionnaire were formed. Among them, the purpose of quality evaluation is to evaluate the methodological quality in the guideline development process, in order to measure whether the entire guideline development process is scientifically rigorous. The evaluators must be the methodologists with an evidence-based medicine background. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. By referring to the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM by considering the characteristics of TCM field. In this paper, the author introduces the whole list of quality evaluation recommendations, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

Standardization is the technical support for the development of traditional Chinese medicine(TCM), and the guidelines have become the main component of the core standards of TCM technology. With the rise and development of evidence-based medicine in China, more than 500 guidelines have been issued in China, and the number is still increasing, but the quality of guidelines still lags far behind the international level. Similarly, the formulation of evidence-based clinical practice guidelines for TCM has gradually attracted the attention of the industry, but the quality is not so good, and most guidelines are not really evidence-based guidelines. Only reliable guidelines can fully and effectively play the role of clinical guidance. In order to comprehensively improve the scientificity and credibility of the guidelines, guideline evaluation can be used as a means to improve the quality of the guidelines. For the development of traditional Chinese medicine, it has become an urgent task to establish a complete evaluation standard system of guidelines, especially the evaluation standard system that conforms to the technical characteristics of traditional Chinese medicine. In this paper, the advantages and limitations of a series of domestic and foreign guideline evaluation tools were systematically analyzed, and the thinking and difficulties to establish the evaluation system of TCM guidelines were put forward, with a purpose to further improve the quality of TCM clinical practice guidelines, so that they can be better applied in clinical practice to enhance the clinical efficacy of TCM and ensure the quality of medical services.

At present,China has issued a series of standards relating to traditional Chinese medicine(TCM). The standard system has already taken shape,but there are still some problems,such as incomplete standard system,low standard quality,inadequate application,insufficient study strength and lack of talent. This paper makes a detailed analysis of current management and development of standardization of traditional Chinese medicine in the aspects of " management mechanism and system construction" and " standards".The problems existing in the standardization of TCM are analyzed in three aspects: quality and popularization,standard research and talent reserve. At the same time,some suggestions are put forward to solve the problems. First,we shall strengthen the management of top-level design; second,we shall guide the transformation of high-quality scientific and technological achievements to standards;third,we shall consolidate the basic research of standardization of TCM; fourth,we shall focus on cultivating standardized technical talents; and fifth,we shall strengthen the standard research and development work in key fields.

The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.

In 2018,Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine to discuss and draft a series of standards for expert consensus on clinical practice of Chinese patent medicines. These standards have been made by reference to the published standards for developing expert consensus and clinical practice guidelines. These standards were made based on full consideration of the current evidence status and the history of clinical practice of Chinese patent medicines. These standards were composed of four parts,namely information summary items,normative general items,normative technical items and information supplementary items,including cover,content,preface,introduction,title,scope,basic Information of Chinese patent medicine,suggestions for clinical application,safety,conflict of interest,appendix,and references,so as to provides reference for improving the quality of expert consensus-based compilation and enhancing the applicability of expert consensus.

Chinese patent medicine is widely used in clinical practice, but improper use will not only weaken the efficacy of drugs, but even cause adverse consequences. Evidence-based medicine provides guidance for clinical practice based on the best available evidence, experience of experts and needs of patients. However, considering the situation of "insufficient evidence" or "very low quality" in Chinese medicine research, experts consensus is the main basis for clinical decision-making, but expert opinions on which the consensus depends are susceptible to various subjective biases. Therefore, a reliable and scientific consensus-making process is needed to maximally avoid bias on consensus. Unlike the clinical practice guidelines, there is no unified formulating process for consensus in the world today. This article learns from a set of formulating processes from some international consensus formulating institutions/associations, combined with the characteristics and current situation of traditional Chinese medicine, and draws up a set of standard process that is suitable for the clinical experts consensus on Chinese patent medicine, with the expect of providing evidence and reference for consensus makers, and then bringing evidence-based assistance for the clinical standardized application of Chinese patent medicines., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

The promulgation of standardized documents on traditional Chinese medicine has promoted the formulation of industrial standards of traditional Chinese medicine, including clinical practice guidelines and clinical expert consensus. In order to adapt to the current research situation of "insufficient evidence" or "very low quality" when developing clinical practice guideline in the field of traditional Chinese medicine, the author has made a retrospective study on the development of guidelines and consensus, and found that the consensus is more suitable for the current research status of Chinese patent medicine, as the stage of lack of high-quality clinical evidence will remain for a long time. However, unlike clinical practice guidelines, domestic scholars and consensus makers have insufficient understanding of the clinical experts consensus. This article will introduce the origin and status of the clinical experts consensus, the differences between clinical experts consensus and the clinical practice guidelines, and the basic principles that should be followed in the formulation of the clinical experts consensus of Chinese patent medicine, expecting to provide theory basis and reference for the normative formulation of clinical experts consensus., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

Clinical practice guideline (CPG) should be concise and readability, which can be possible to implement CPG into practice smoothly. A formal published CPG can't load its developing process and details. An editorial explanation of CPG is much useful to show details and logic process of developing CPG. Although there are many different standards for developing CPG, being nothing to do with process management of CPG. By referring to editorial explanation on international standards, a request for CPG was investigated in this study. An editorial explanation for clinical practice guideline should be transparency, logic and traceable. A good editorial explanation could make users or readers to learn what goes on behind the scenes. A standardized editorial explanation could supervise the GCP developing and improve the quality of GCP., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)