Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

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.

Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

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".

Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List / 中国药房

OBJECTIVE：To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ，and to provide reference for rational drug use and instruction revision. METHODS ：Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ，including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ，were collected ，and the labeling rate and content problems of drug instructions were counted. RESULTS ：Of the 465 instructions，86.88％ were labeled with cautions. The labeling rates of ADR ，pharmacokinetics，contraindications，drug interactions ， clinical trials ，pharmacological toxicology and pharmacological action were low ，being 20.64％，0.21％，30.1％，1.07％，2.36％， 8.81％，1.93％. All other items were labeled. Incomplete description of ingredients ，incomplete information of decoction pieces and excipients accounted for 2.15％ and 48.81％，respectively；the expression of functional indications was varied ，and there were 12 expression methods ，among which 16.5％ of indications lacked TCM indications ；specifications were not uniform ，and there were 5 expression methods ；usage and dosage were not clearly marked ，and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ，ADR，matters needing attention and contraindications were not fully described with no substantive content ；only 0.64％ marked interaction with chemical medicine and 12.68％ marked contraindication content. CONCLUSIONS ：There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ，such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ，and introduce policies to support enterprises to carry out basic and clinical research after listing ；and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ，guided by the theory of traditional Chinese medicine ，combined with the latest research results ，so as to further improve the contents of Chinese patent medicine instructions.

Analysis of 221 Chinese Patent Medicine Instructions Based on the Patient's Concern Survey of Oral Medication / 中国药房

OBJECTIVE:To provide reference for the improvement of Chinese patent medicine instruction.METHODS:The outpatients were selected randomly from a Third Grade Class A hospital.A questionnaire survey was conducted on the attention degree of the outpatients to Chinese patent medicine instructions when taking medicine orally.The concern content label of patients in 221 Chinese patent medicine instructions were counted,analyzed and graded according to survey results.RESULTS:A total of 515 questionnaires were distributed,and 498 effective questionnaires were collected with effective recovery rate of 96.7％.The results of questionnaire survey showed that the highest concern from the patients was usage and dosage (92.4％),followed by attentions and taboos (88.0％,70.3％).The following items were drug interaction,pregnant and lactating women medication,children medication and the elderly medication (56.2％,46.4％,45.2％,42.4％).Among the description of medication methods (usage and dosage) in 221 Chinese patent medicine instructions,203 prescriptions clearly marked medication times (91.9％),160 clearly marked drug dosage (72.4％) and 36 clearly marked medication course (16.3％).In matters of taboos (attentions,taboos,pregnant and lactating women medication,children medication and the elderly medication),124 prescriptions clearly marked population taboos (56.1％),82 clearly marked symptom taboos (37.1％) and 71 clearly marked diet taboos (32.1％).According to the scoring statistics of 221 Chinese patent medicine instructions,there were 52 instructions with score of 6,followed by 47 instructions with score of 8;there were only 4 instructions with full score (12).CONCLUSIONS:At present,related contents of medication methods highly concerned by the patients are well marked in Chinese patent medicine instructions,especially its guidance is basically able to meet the requirements in respect of medication times.The related contents of medication taboos,which is next only to attention degree of medication methods by patients,is poorly marked.Its guidance remains to be improved.