Analysis and considerations on revision of instructions for traditional Chinese medicine injections / 中国中药杂志

According to the notice on revision of the instructions for traditional Chinese medicine injections(TCMIs) issued by the National Medical Products Administration(NMPA) from January 2006 to May 2020, the revised contents in the instructions for 29 varieties involved in the notice were sorted out, and the existing problems in the instructions for TCMIs were analyzed, so as to provide the basis for dynamic revision of the instructions. It was found that the revised items of instructions for 29 varieties all involved adverse reactions, contraindications and precautions, and warnings were added for 82.76% of 29 TCMIs preparations, indicating that all the revised contents were related to safety issues. In addition, 33.33% of the drugs risks mentioned in the precautions were not indicated in the adverse reactions; 82.76% instructions did not indicate drug interactions; 17.24% instructions lacked medication notes for special populations; 48.28% instructions did not indicate traditional Chinese medicine(TCM) syndromes of the main disease; 44.83% instructions did not indicate the type and stage of indication; and 86.21% instructions did not indicate the course of treatment. It could be concluded that the instructions for TCMIs have known risks of drugs that are not fully reflected in adverse reactions and the effective information is not comprehensive. The risk control measures proposed in the precautions need to have aftereffect evaluation and there is a lack of drug interactions and medications for special populations. As an important part of the full life-cycle management of drugs, the revision of instructions for TCMIs should be continuously improved to provide the basis for safe and reasonable application of TCMIs. Based on the above problems, it is proposed that the marketing license holder as the main body of the revision of instructions should actively carry out post-marketing basic and clinical research in accordance with the characteristics of TCM, combine the updated research with the guidance of TCM theory and improve the revision level of instructions for TCMIs to provide the basis for post-marketing evaluation.

Investigation and Analysis of Pedi atric Medication Information of Microecological Preparations in China / 中国药房

OBJECTIVE： To provide suggestions for improving pediatric medication information in drug instructions of microecological preparations in China. METHODS： Using text analysis method， the pediatric medication information in the instructions of 36 approval number of microecological （29 varieties from 23 enterprises） is statistically analyzed. RESULTS： Among the 36 microecological preparations， there were 2 medicines for children （5.56％）. There were 2 granules （5.56％）， 9 dispersants （25.00％）， 9 tablets （25.00％） and 16 capsules （44.44％）； there were 6 national essential medicines （16.67％）； there were 13 products in the list of national essential medical insurance （36.11％）； there were 22 OTC products （61.11％）. The proportion of children’s indications， children’s usage and dosage， child-related adverse reactions， taboos and matters needing attention in the drug instructions for children were 19.44％， 55.56％， 2.77％， 5.56％ and 8.33％， respectively. The proportion of specific information about children’s drug use marked in the item of  “children’s drug use” was 25.00％. CONCLUSIONS： There is a lack of information on pediatric medication in the instructions of microecologial preparations in China， and there are some problems such as unclear wording， scattered labeling position of the medication information for children， and the content is not practical. It is recommended that medical institutions should strengthen the rational use of medical guidance for medical personnel， implement the scientific management process of over-instruction medications； the relevant departments should introduce more incentive policies， encourage enterprises to improve the basis of children’s medications， and make standardized labeling of children’s medication information in drug specifications. In addition， a database of information on children’s medications can be established to provide a reference for rational use of pediatric drugs.

Study on the Management System of OTC Drug in Taiwan Are a of China Based on Consumer Guidance Perspective / 中国药房

OBJECTIVE： To provide reference for the improvement of OTC drug management system in mainland China. METHODS： By analyzing the classification， registration management， conversion procedures and supporting measures， instructions and packaging management of OTC drugs in Taiwan area of China， and considering the current situation and problems of OTC drug management in mainland China， suggestions for improving OTC drug management system in mainland China were put forward. RESULTS & CONCLUSIONS： OTC drugs of Taiwan area could be divided into drugs instructed by physicians and pharmacists （hereinafter referred to as “instructed drugs”） as well as patent drugs. The registration management of instructed drugs was implemented in accordance with the Criteria for the Review of Instructed Drugs. The criteria not only regulated the active ingredients， dosage forms， indications， usage and dosage， side effects， matters needing attention and warnings of instructed drugs， but also stipulated the requirements for labeling， instructions and outer-of-the-box printing of instructed drugs. Taiwan area had also established a mechanism for evaluating drug conversion to expand the variety range of prescription drugs converted to OTC drugs， and had equipped a series of supporting measures to reduce the safety risks arising from drug conversion. In 2016， Taiwan area also formulated the Format and Relevant Standards for Outer-of-the-Box of Generic Western OCT Drug， and revised the drug instructions and the outer-of-the-box. The format was more standardized and the terminology was easier to understand， which made it easier for the public to read. It is suggested that mainland China should refer to the experience of Taiwan area， set up special registration channels for OTC drugs and simplify the requirements for examination and approval， pay attention to and improve the matching measures for the conversion of prescription drugs to OTC drugs， encourage brand building and improve intelligibility of OTC drug instructions， so as to build an effective OTC drug management system.

Current situation and principles of off-label drug uses / 中国小儿急救医学

Drug instructions are medical documents with legal effect. Off-label drug use exists widely worldwide,especially in cancer patients,children,pregnant women and the elderly,including unlabeled indica-tions,populations,usage and dosage. However,the government should formulate relevant laws and regulations to carry out scientific and standardized administration. To ensure the rights and interests of both doctors and patients,off-label uses should follow the corresponding principles in clinical practice.

Investigation and Analysis of Medication Information on Pregnant Women in 166 Drug Instructions of An-ti-diabetic Drugs / 中国药房

OBJECTIVE:To provide reference for specified labeling of medication information on pregnant women in drug in-structions of anti-diabetic drugs. METHODS:All of drug instructions of anti-diabetic drugs in DXY Drugs Information were collect-ed, the medication information labeling on pregnant women was analyzed. RESULTS:Among 166 drug instructions, 147 (88.55%)had listed the item ofdrug use for pregnant and lactating womenalone,and labeled with the drug information on preg-nant women;14(8.43%)had listed the item too,but labeled with no or limited clinical data,and whether pregnant women could use or not was not suggested;5(3.01%)didn't have the item. About without guidance of drug use,there were 3(1.81%)drug in-structions missed guidance,and 14(8.43%)with no or limited clinical data. About with guidance of drug use,49(29.52%)were labeled with forbidden for pregnant women;40(24.1%)were labeled with can't/not suitable/should not be used for pregnant wom-en;49 (29.52%) were labeled with cautious/not recommend/weighed the pros and cons/benefits greater than the risk/consulted a doctor for pregnant women;and 11(6.63%)were labeled with being safe/being not restricted for pregnant women. In the 166 drug instructions,26,which were from foreign pharmaceutical companies,had listed the item ofdrug use for pregnant and lactating womenalone,as well as labeled the guidance of drug use for pregnant women. CONCLUSIONS:The labeling of domestic drug instructions shows inadequate drug information on pregnant women,non-uniform guidance statements,lag of update and other prob-lems,which should be attached to great importance by drug supervision and management departments,as well as pharmaceutical production enterprises.

Investigation and Analysis of the Cognition of Residents to Drug Package Inserts in Huancheng Community of Binhai County in Jiangsu Province / 中国药房

OBJECTIVE:To provide reference for developing pharmaceutical care and guiding resident'rational drug use.METHODS:The residents from Huancheng community of Binhai county in Jiangsu province were chosen as objects.The questionnaire survey was conducted,and the results of investigation were analyzed statistically.RESULTS:A total of 983 questionnaires were released,and 955 (97.15％) effective respondents were recalled.The residents who read instructions carefully read instructions occasionally never read instructions before using drugs accounted for 61.68％,36.44％ and 1.88％,respectively.There was statistical significance in reading drug instructions before using drugs among different education degrees and different occupations (P＜0.01).The respondents with high educational level read the drug instructions better,and the farmers read the drug instructions poorly.Can't fully understand was the main reason for those who didn't read instructions carefully (chosen by 285 times).The respondents paid more attention to the content of the drug instructions for indication,usage and dosage,expiration date,ADR,contraindication,matters needing attention and storage (over 60％),respectively.Only 21.57％ of the respondents could fully understand the drug instructions.There was statistical significance in understanding level of the respondents to drug instructions among interviewees with different ages,different educational degrees or different occupations (P＜0.01),respectively,young people and the residents with high education level had higher understanding level,and the understanding of peasants was lower.CONCLUSIONS:Community residents have high degree of concern about drug instructions,and their understanding level is not high.There are risks to drug use in community residents.

Investigation on the Use of Essential Medicine System Variety in Children’s Medicines and the Medication in Drug Instructions in Our Hospital / 中国药房

OBJECTIVE:To provide reference for the safe and rational drug use for children. METHODS:Information manage-ment system was used to investigate the use of essential medicines system variety in stock in 2015 and analyze the medication infor-mation for children in the drug instructionsin our hospital in 2015. RESULTS:Only 201 kinds of medicines belonged to children’s medicines in all the 685 kinds of medicines in our hospital. And 89 kinds (44.28%) of medicines belonged to essential medicine system among the 201 kinds of children’s medicines,in which,78 (87.60%) showed complete medication information for chil-dren;112 kinds(55.72%)of medicines belonged to non-essential medicine system,in which,38(33.93%)showed complete medi-cation information for children. The proportions of showing complete medication information for children in the essential medicines and in its chemicals,biological products,injections and oral preparations were higher than non-essential medicines,the differences were statistically significant(P<0.05). Only 41 kinds of medicines belonged to child-specific medicines among the 201 children’s medicines;62 showed complete medication information for children in the 73 kinds of essential medicines among the non-child-spe-cific medicines;only 13 showed complete medication information for children in the 87 kinds of non-essential medicines,the pro-portion of showing complete medication information for children in essential medicines among the non-child-specific medicines was higher than non-essential medicines,the difference was statistically significant(P<0.05). CONCLUSIONS:The use proportion of essential medicine system variety for children’s medicines is high in our hospital;but there are lacking of child-specific medicines and the medication information for children is insufficient. However,compared with non-essential medicines for children,the essen-tial medicines show better medication information for children in aspects of types,dosage form distribution and non-child-specific medicines,and it is suitable for children.

Investigation of the Item Labeling in the Instructions of Domestic Clindamycin Phosphate Injection / 中国药房

OBJECTIVE:To provide reference for the instructions of domestic Clindamycin phosphate injection. METHODS:The contents in the instructions of domestic Clindamycin phosphate injection approved the listing from Jan. 2006 to Dec. 2015 were statistically investigated according to Regulation for Drug Package Inserts and Label Management and Regulatory Guidelines for Chemicals and Biologicals,and the items with great differences in different approval number were analyzed comparatively. RE-SULTS:The labeling rate of clinical experiment in the collected 25 instructions of domestic Clindamycin phosphate injection was 0,the labeling rate of validity was 44%,the labeling rate of use for elderly patients was 68%,the labeling rate of overdosage was 76%,and the labeling rate of others was 100%. The items with great differences were mainly special populations,usage and dos-age,adverse reactions,validity,storage conditions and precautions. CONCLUSIONS:There are great differences in instructions of domestic Clindamycin phosphate injection,some items are inaccurate,incomplete and lack of scientificity,which may result in ir-rational drug use in patients and increase the risk of medication. It is suggested that the domestic enterprises should modify and per-fect the contents of the instructions of domestic Clindamycin phosphate injections referring to the instructions of foreign brand name drug;and the drug regulatory department should strengthen the monitoring of drug instructions.

Review of the Use of Aidi Injection in Our Hospital / 中国药房

OBJECTIVE:To provide reference for promoting clinical rational use of Aidi injection. METHODS:Some inpa-tient records that used Aidi injection in our hospital from Jan. to Jun. 2015 were randomly selected and statistically reviewed by us-ing Excel(2011 edition) in aspects of gender,age,tumor location,usage and dosage,solvents usage,treatment course,adverse reactions,etc. RESULTS:In the 125 patients who used Aidi injection,male was more than female,with average age of 58.4 years;the tumor location of 66 patients (52.80%) was consistent with the indications in instructions;treatment course of 30 pa-tients(24.00%)was consistent with the instructions;all solvent types were consistent with the instruction recommendation,while only 6 patients(4.80%)showed consistence in solvent usage and instructions;122 patients(97.60%)showed consistence in single dosage and instructions;7 patients had adverse reactions,mainly rash and gastrointestinal reactions. CONCLUSIONS:The use of Aidi injection in our hospital shows off-label drug use,non-standardized treatment course and inappropriate solvent usage. Physi-cians,clinical pharmacists and relevant departments should further strengthen the rational use,medical advice comments,supervi-sion and management of Aidi injection in the hospital to promote the rational drug use.

Analysis of Drug Instruction and Irrational Prescription of Anti-cold Compound Preparations for Children in Our Hospital / 中国药房

OBJECTIVE:To explore the situation of anti-cold compound preparations for children,and provide reference for clinical rational drug use. METHODS:The drug instructions of anti-cold compound preparations for children were collected from our hospital and analyzed statistically in recpects of drug components,specifications,formulations and dosages of those prepara-tions;typical irrational prescriptions from Jan. to May 2015 were also analyzed. RESULTS & CONCLUSIONS:40 kinds of an-ti-cold compound preparations for children were currently used in our hospital,including 14 chemical drugs and 26 Chinese medi-cine,in which,15 were not specified in the drug instructions for pediatric dosage (accounting for 37.5%). Anti-cold compound preparations had many kinds,varied largely in specifications and dosages. The children with same constitution and age take differ-ent drugs according to the drug instructions,the dosages of the same component are greatly different,the child dosages in the drug instructions need to be further improved. There are problems of irrational drug use in our hospital, such as repeated medication, medicine incompatibility,in appropriate dose.

Comparison Analysis of Drug Instructions between Hospital Directory and OTC Standard Model Instruc-tions in 2014 / 中国药房

OBJECTIVE:To analyze the differences of drug instructions between hospital directory and OTC standard model in-structions,and to provide reference for enhancing instruction management and reducing the safety risk of clinical drug use. METH-ODS:1 324 drugs of hospital directory in a hospital in 2014 were compared with OTC directory from CFDA websites. The instruc-tion of drug types included in OTC directory were compared OTC model instruction. According to the degree of risks which the dif-ferences may bring,differences were divided into four levels for analysis as negligible,general,important and severe. RESULTS:244 drugs belonged to OTC,of which 32.38%were different from standard model instructions. The four risk levels rates of negligi-ble,general,important and severe accounted for 29.11%,34.18%,7.59% and 29.11%,respectively. Among important risk,the difference of“indication limit”occupied the highest proportion,being 50.00%. Among severe risk,the difference of“forbidden for special disease”and“forbidden for pregnant women”accounted for 43.48% and 39.13%. CONCLUSIONS:There are problems, such as the absence of important medication information,statement conflicts. The hospital and administration departments should en-hance the standard management of drug instruction to guarantee safe and rational drug use in the clinic.

Investigation and Analysis of Children Medication Information in 580 Drug Instructions / 中国药房

OBJECTIVE:To provide reference for reasonable and safe use of drugs in children. METHODS:580 prescription drug instructions of chemical drugs and chemical product for treatment were collected from our hospital. Children information stated in drug instruction of exclusive drugs for children and special drugs,and in dosage and usage,clinical trial,pharmacokinetics and other items were all analyzed statistically ratio analysis and sequence analysis. RESULTS:The exclusive drugs for children were few,and major dosage form were injection. The instruction of special drugs were lack of children’s information. Usage and dosage based on monotonous evidence. The pharmacokinetic parameters were incomplete,and there were slender amount of data about chil-dren clinical trials. CONCLUSIONS:The drug instruction of drugs for children are looking blue. It is urgent to standard drug in-struction and complete medication information for children,so as to ensure safe and effective of drug use.

Ambiguity and Countermeasures in the Drug Instruction Manual / 中国药房

OBJECTIVE:To provide reference for clinical use and revision of drug instruction manual. METHODS:The ambi-guity in drug instructions manual was summarized and countermeasures of revision were presented based on the practical clinical conditions. RESULTS & CONCLUSIONS:The problems of drug instruction manual that may mislead the patients and medical per-sonnel were as follows as controversial main contents,unclear descriptions of instruction,unfocused contents or without key points,one instruction for multiple drugs,obvious or inaccurate translations,words without popularity and standardization and wrong sentence division or non-standard typesetting. It is suggested that the manufacturers should attach highly importance to the re-vision of drug instruction manual;the revisers should understand the meaning of drugs instruction manual and know the subjects;the premarketing instructions should be tested and investigated by necessary persons;the major and cultural quality of revisers should be improved;the approval monitoring should be strengthened and the feedback mechanism should be established to further improve the instructions,guide the medical staff and patients with accurate use of drugs and ensure the safe drug use of patients.

Network Managemant and Application of Drug Instructions / 中国药房

OBJECTIVE: To provide the latest medicinal information for medical workers. METHODS: The drug instructions were managed using computer technology, and the inquiry service for drug information was provided in the hospital network. RESULTS & CONCLUSION: The established network bridged the communication between doctors and pharmacists, and enabled them to better understand medicinal information and prescribe medicines, and therefore serve the patients better.