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.
Subject(s)China , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Pharmacovigilance
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".
Subject(s)China , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Reference Standards
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.
Subject(s)Beijing , China , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription Drugs , Pharmacovigilance
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.
Subject(s)Capsules , China , Consensus , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs
Objective:To comprehensively analyze the diagnosis and treatment programs and prevention and treatment programs on tratidional Chinese medicine (TCM) for coronavirus disease-2019 (COVID-19), and to provide suggestions for further development of TCM clinical guidelines. Method:Diagnosis and treatment programs on TCM for COVID-19 pneumonia, as well as prevention and treatment programs, clinical practice guidelines and expert consensus, were retrieved till Feb 19, 2020. The information about TCM syndrome differentiation, state of disease, and TCM treatments (decoction and Chinese patent medicines) were extracted and analyzed. Result:A total of 24 TCM programs/guidelines were included containing 23 diagnosis and treatment programs or prevention and treatment programs and one rapid advice guideline. Of the 23 TCM programs, 14 programs described the classification of TCM syndromes and the stages of disease，22 programs described the composition of the TCM decoction; seven programs described how to add and subtract the herbs according to different TCM syndromes,17 programs described the weight/volume of the herbs of TCM decoctions, three programs described the decoction method，six programs described the usage and dosage of TCM decoction， two programs clarified the course of treatment; none of the 23 programs indicated the source of evidence. The TCM treatment within the rapid advice guideline was in reference to the fourth edition of the COVID-19 pneumonia TCM diagnosis and treatment program issued by the National Health Commission. A total of 41 Chinese patent medicines were recommended in 23 programs, of which 12 Chinese patent medicines were off-label recommended. Conclusion:In most TCM programs, TCM decoction and Chinese patent medicines are recommended based on TCM syndrome differentiation in combination with the state of disease, and the dosage of the TCM decoctions are clearly described. Some Chinese patent medicines in the TCM programs are off-label recommended. Expert experience and opinions are valued when developing TCM programs/ guidelines. All of these provide reference for developing TCM programs/guidelines in future.