ABSTRACT
OBJECTIVE To provide reference for standardizing the labeling of medication information for pregnant women and lactating women in the instructions of antiarrhythmic drugs. METHODS The instructions of antiarrhythmic drugs were collected from the terms of “medication reference ”on official website of Yimaitong Technology Co. ，Ltd. The labeling of medication information of pregnant women and lactating women were sorted out ，counted and analyzed with reference to the Detailed Rules for Specifications of Instructions of Chemical Drugs and Therapeutic Biological Products issued by the State Food and Drug Administration. RESULTS A total of 111 instructions of antiarrhythmic drugs were collected in this study ，of which 102 instructions were marked with “medication for pregnant women ”（91.89％），of which the proportion of those with medication guidance and without medication guidance were 75.68％ and 16.22％ respectively. Eighty-eight drug instructions were marked with the item “medication for lactating women ”（79.28％），of which the proportion of those with medication guidance and without medication guidance were 70.27％ and 9.01％ respectively. Among different categories of antiarrhythmic drugs ，the best labeling of “medication for pregnant women ”was class Ⅰ antiarrhythmic drugs （100％），while class Ⅲ drugs（25.00％）were most missing ； class Ⅳ antiarrhythmic drugs （94.44％）were the best labeled for “medication for lactating women ”，while class Ⅰ（26.47％）were the most missing . There were differences in the labeling contents of “medication for pregnant women ”and“medication for lactating women ”in some drug instructions of the same variety from different manufacturers. Among the 99 drug instructions of domestic pharmaceutical enterprises ， 92 listed the items of “medication for pregnant women”and“medication for lactating women ”，and the proportions of them with medication guidance were 74.75％ and 69.70％ respectively；among the 12 drug instructions of foreign pharmaceutical enterprises ，10（83.33％）listed the items of “medication for pregnant women ”and“medication for lactating women ”，and the proportion with medication guidance was 83.33％ and 75.00％ respectively. CONCLUSIONS There are some problems in the labeling content of domestic antiarrhythmic drug instructions，such as the lack of information related to “medication for pregnant women ”and“medication for lactating women ”， the confusion of guidance expression ， the inconsistent content of drug instructions of the same variety from different manufacturers，the lag of modification and update ，and the poor standardization of drug instructions. Drug supervision and administration departments and drug manufacturers should pay attention to them and constantly strengthen the management and standardization of instructions.
ABSTRACT
OBJECTIVE：To furt her standardize and improve the drug instructions of Chinese patent medicine ，and to promote its clinical safe and rational use. METHODS ：The varieties of Chinese patent medicines with clear content revision issued by the website of the State Drug Administration from January 2010 to June 2020 were inquired. The revised contents ，characteristics and deficiencies were summarized and analyzed to put forward the revision suggestions. RESULTS & CONCLUSIONS ：Among 107 Chinese patent medicine varieties the instruction content of which were revised clearly ，safety items were the focus of revision ；106 types（99.07％）were revised in terms of “contraindications”，103 types（96.26％）were revised in terms of “precautions”，102 types（95.33％）were revised in terms of “ADR”，49 types（45.79％）were revised in terms of “warning words ”，etc. The main dosage forms involved in the revision were oral preparations ，followed by injections and a small amount of external/rectal/vaginal dosage forms. The revised content highlighted the TCM syndrome types applicable to Chinese patent medicine ，emphasized the precautions for the use of Chinese patent medicine containing toxic and chemical components and detailed the medication precautions for special groups. However ，there were still some problems ，such as lack of quantitative expression ，lack of systematic and comprehensive drug interaction tips ，and other related items that had not been revised needed to be improved. In order to promote the safe and rational use of Chinese patent medicine ，it is suggested that the revision of Chinese patent medicine instructions should focus on safe drug use ，provide clear ADR monitoring data ，clear and specific medication attention and systematic and comprehensive drug interaction.
ABSTRACT
OBJECTIVE： To analyze the situation of drug instruction revision and promote the standardization. METHODS： By reviewing the laws and regulations on the management of drug instructions in China， inquiring the official documents of drug instruction revision during Jan. 2015 to May 2019， the types of drugs involved and the revised items were analyzed， and the contents and shortcomings of the drug instructions and their revision process were summarized. RESULTS： A total of 112 revision notices were issued in 5 years （20， 28， 19， 34， 11 revision notices in 2015-2019， respectively）， involving 270 varieties. There were 109 prescription drugs， 161 OTC， 158 Chinese medicines， 105 chemicals， and 2 biological products. The revised items mainly focus on safety information such as precautions， adverse reactions， contraindications， and additional warnings， including 100， 85， 103， 52 items. However， in combination with clinical practice， the author found that there were still some problems， such as non-standard writting drug instructions， lack of supervision on the implementation of the revision， and no notification to the relevant users after the revision， which seriously threatened the safety of drug use. CONCLUSIONS： The included specifications of drug instructions are not well regulated， the implementation of the revised instructions is not doing well， the delineation of rights and obligations is confused， and the legal binding force is not strong. The standardization of drug instructions in China needs further improvement.
ABSTRACT
The use of analgesics and sedatives are mostly beyond drug instructions. In this article,we described the types,indications,populations,dosages,frequencies,and the ways of delivery of analgesia and sedative drugs which usually used in pediatrics.
ABSTRACT
OBJECTIVE: To analyze the rational behaviors of pharmaceutical companies when modifying drug instructions, and puts forward policies and suggestions for promoting these enterprises to actively modify drug instructions. METHODS: The game theory is used to analyze the game equilibrium between enterprises and the market (patients and their agents -doctors) or the relevant government departments when they modify the instructions of the pharmaceutical enterprises in China. RESULTS: Based on cost considerations, enterprises are unwilling to modify drug instructions voluntarily. CONCLUSION: The drug regulatory departments in China should improve the relevant laws and regulations, and formulate specific operational drug instructions to modify the program.These measures would reduce the cost of enterprises to take the initiative to modify the drug instructions, and encourage the patient (and also be a doctor) to actively report the problem of adverse drug reactions caused by the unmodified instructions and increase penalties for not actively modify the behavior of drug instructions.At last the pharmaceutical companies could timely and actively modify instructions.
ABSTRACT
OBJECTIVE:To compare the difference of the information about smoking affecting pharmacodynamics and pharma-cokinetics in prescription drug instructions between US and China. METHODS:The US and Chinese guidance for drug R&D and drug instructions editing,prescription drug instructions were collected;the information about smoking affecting pharmacodynamics and pharmacokinetics were retrieved from FDA drug instruction official website DailyMed and Yaozhi Network in China up to Jun. 19th,2014. The difference in related regulations and drug instruction were compared between US and China. RESULTS & CON-CLUSIONS:The guidance issued by US and China require that great importance should be attached to the effects of smoking on pharmacodynamics and pharmacokinetics,and it must be noted in drug instructions. Of 62 857 drugs recorded,smoking affected pharmacodynamics and pharmcokinetics of 34 drugs in US drug instructions,among which 9 drugs needed dose modifications;for above drugs,Chinese drug instructions pointed out great importance should be attached to the effect of smoking on pharmacodynam-ics and pharmacokinetics of 6 drugs,and only one drug(erlotinid hydrochloride)needed to be modified. The label rate of smoking affecting pharmacodynamics and pharmacokinetics was relatively low in Chinese drug instructions compared to US. It is suggested that the regulatory agent should standardize and improve related description in drug instruction,correct unsuitable content,revise the items which may result in severe consequence,and set up official website which can provide all drug instructions as soon as possible. Drug manufacturers should standardize clinical study of drugs before marketing,focus on the scientificity,completeness and normalization of drug instructions.
ABSTRACT
OBJECTIVE:To provide reference for standardizing dispensing and use of intravenous drug. METHODS:266 piec-es of intravenous drug instructions were collected in PIVAS of our hospital,and then the labeling information were statistically ana-lyzed,including dispensing method,diluted or dissolved solvent before preparation and storage time after preparation. RESULTS:Among 266 intravenous drug instructions,there were 45 kinds of finished product infusion varieties and 221 kinds of drugs needing to be prepared. Among these,there were only 30 pieces of drug instructions with labeling dispensing method,accounting for 13.57%;195 pieces of drug instructions stated solvent for dilution and 22 stated solvent for dissolution before preparation,account-ing for 88.24% and 19.13%;69 pieces of drug instructions stated storage time,accounting for 31.22%. CONCLUSIONS:The la-bel information of dispensing method and storage time in intravenous drug instructions is markedly insufficient or not clear. Drug ad-ministration departments are suggested to strengthen the instruction standardization management. Meanwhile,manufacturers should specify the relevant information in intravenous drug instructions.
ABSTRACT
OBJECTIVE: To put forward the suggestions to improve the system of super drug instructions. METHODS: Forming theoreticell understanding of super drug instructions through the analysis of literature in CNKI and Wanfang data.. RESULTS: Super drug instructions are particularly prevalent in clinical medication, the reasons include instructions' reasons, doctors and patients and drug manufacturers' reasons and pharmaceutical dosage form limitation. The corresponding countermeasures include making laws, strengthening the management of drug instructions system, strengthening the approval of prescription, strengthening the management of pharmaceutical companies and pharmaceutical representatives and establishing doctors and patients risk sharing mechanism. CONCLUSION: Under the guidance of laws and regulations, reasonable super drug instructions can treat disease better and promote the progress of clinical medicine.
ABSTRACT
OBJECTIVE:To study the comprehension of drug instructions in licensed physicians in order to promote the rational drug use.METHODS:The licensed physicians were investigated in a randomized sampling questionnaire.RESULTS:All the investigated doctors were found to lack comprehension of drug instructions,the overall rate of which was 11.33%.The rate of not understanding was significantly different between the physicians and the physicians higher than attending physicians in rank(P
ABSTRACT
OBJECTIVE:To investigate the problems in the publicity materials of drugs and to discuss the solutions to these problems.METHODS:35copies of publicity materials were randomly chosen from our hospital's pharmacy and were compared with the drug instructions provided by the same manufacturers.Indication,dosage and administration were the main items compared.RESULTS:Inconsistency was found in8out of35copies(22.86%),which was manifested in three aspects:widening of indications,increase in dosages,and inconsistency in administration.CONCLUSIONS:It is suggested that the technology of manufacturers and the comprehensive quality of salesmen should be improved basically.Furthermore,the su?pervisory administration should establish the law to limit drug promotion sales.