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1.
Article in Chinese | WPRIM | ID: wpr-927970

ABSTRACT

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
2.
Article in Chinese | WPRIM | ID: wpr-927969

ABSTRACT

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
3.
Article in Chinese | WPRIM | ID: wpr-873213

ABSTRACT

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.

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