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??OBJECTIVE To investigate the varieties and use of oral proprietary Chinese medicines in our hospital, analyze the problems existing in their labelings, and put forward suggestions to provide reference for clinical rational drug use. METHODS The properties of the 101 kinds of oral proprietary Chinese medicines in regard to the category, dosage form, essential drug, health care, OTC, and so on were summarized. Their labelings were collected to analyze the specification, usage and dosage, adverse reactions, contraindications and precautions, etc. RESULTS Among the 101 traditional Chinese medicines, 44.6% were developed specially for children. When counted by categories and dosage forms, the medicines for regulating spleen and stomach and granules accounted for the majority, respectively. Essential drugs, drugs belonging to the directory of insured drugs, and OTC drugs accounted for 19.8%, 70.4%, and 26.7%, respectively. It was found that 51.5% of the labelings included dosage information for different ages in detail, 59.4% did not state adverse reactions and contraindications clearly, and the smallest dosage suggested by 14.9% of the labelings were less than the smallest packaging dose. CONCLUSION Chinese patent medicines are widely used in pediatrics, but the information for children is still incomplete. The problems in the prescribing mainly include inappropriate selection of drugs and combination of medications. It was recommended that the relevant authorities carry out pediatric drug reevaluation and improve the labelings of pediatric drugs.     

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??OBJECTIVE To investigate the off-label uses of drugs in domestic hospitals, so as to provide baseline data for policy-making and strategy for risk management. METHODS The off-label uses of drugs in 24 hospitals were collected and analyzed according to the categories of drugs and off-label uses and the strength of evidence for the off-label use of drugs. RESULTS One thousand six hundred and fifty-two cases of off-label uses involving 998 drugs were included in this study. The top three hospitals with the largest numbers of off-label uses were Beijing Hospital (297 cases, 18.0%), Peking University Third Hospital (282 cases, 17.1%) and Yantai Yuhuangding Hospital (256 cases, 15.5% ). There were 998 kinds of drugs which had off-label uses in these 24 hospitals. The top three categories of drugs with the highest frequncies of off-label uses were antineoplastics (388 cases, 23.5%), immunomodulatingagents (315 cases, 19.1%), and cardiovascular system agents (177 cases, 10.7%). The off-label use of drugs concentrated in indication (1493 cases, 90.4%), dosage (349 cases, 21.1%), route and administration (154 cases, 9.3%), and population (65 cases, 3.9%) in this study. One thousand one hundred and fifty-five (73.3% ) off-labels were supported by foreign package inserts, international guidelines, domestic guidelines, expert consensus, monographs and literatures. CONCLUSION Off-label uses of drugs existed widely in these 24 hospitals, which pose potential risk on medication safety and efficacy, law responsibility and ethical issues. The government should accelerate the development and promulgation of correspondent law to promote rational use of drugs. And the relevant associations should develop guidelines for off-label uses and provide reliable evidence for safe medication.     

减少中药基本药物不良反应的探讨

中药基本药物是我国基本药物目录的特色所在,应充分发挥中药基本药物的独特优势,发挥其"保基本"的重要作用。中药基本药物具有特殊性,同时也具有药品的两重性,不良反应不可避免,但可以通过控制某些条件来尽量减少其不良反应发生的可能。在基本药物制度框架下,针对中药基本药物遴选,中药基本药物自身及其生产、流通和使用环节等分析有可能增加其不良反应发生的各种因素,提出减少其不良反应发生的对策将具有重要意义。该研究以中药基本药物为研究对象,研究结果在一定程度上对普通中药也具有适用性。     

国家基本药物目录中儿科中成药说明书浅析

《国家基本药物目录(2018年版)》中儿科专用药仅22个品种,其中化学药品5个品种,中成药17个品种(13种组方)。临床常使用中成药治疗儿科疾病,中成药的组方多来源于古代经典方剂,以中医辨证论治理论为基础。中成药说明书作为指导药品正确使用的文书,其规范性、完整性直接影响药物是否被安全、有效地使用。对《国家基本药物目录(2018年版)》中儿科使用的中成药说明书进行研究,并对比美国、日本说明书的相关要求,分析儿科中成药毒性、禁忌,概括儿科中成药说明书存在的问题,提出完善建议。结果显示儿科专用中成药品种较少,儿科中成药说明书普遍存在成分含量未标示,功能主治不规范,用法用量、禁忌、注意事项不明确等问题,为进一步完善中成药说明书提供依据,有助于促进儿童安全合理用药。     

国内中、西医治疗脑卒中的药物经济学研究概况

近年来,国内对药物经济学的研究日益重视,日渐受到临床医学、药学、卫生经济学、卫生管理学等方面专家的关注,其研究结果在药品定价、基本药物目录的制定、临床药物合理选择等方面起到了重要作用.该文通过对国内近年来发表的有关脑卒中药物经济学文献进行概述,了解国内治疗脑卒中药物及康复方法的最新研究现状及发现目前研究中存在问题,为进一步开展脑卒中药物经济学研究提供借鉴,为促进临床合理用药提供参考.     

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??OBJECTIVE To analyze 13 judicial precedents involving off-label drug use and explore the legal interpretation on off-label drug use in China in order to provide experience for establishment of off-label drug use and clinical application. METHODS Based on the law databases (China Judgements Online, Chinalawinfo, Jufaanli, Itslaw), 13 cases were searched and screened involving legal off-label drug use. The relationship was investigated and discussed between different results and characteristics of the 13 cases. RESULTS In 13 cases, there are 2 cases probably reasonable for off-label use, 2 cases unreasonable but not correlated with patients?? outcomes, 9 unreasonable and with a causal relationship with patients?? outcomes. In the 9 unreasonable cases, there are 4 cases without sufficient evidence, 3 cases without informed consent, 1 case lack of monitoring after off-label use, 1 case with idiosyncratic reaction, and 1 case not consistent with the label of the drug used. CONCLUSION Major deficiencies of off-label drug use in China are without sufficient evidence, lack of informed consent and with uncompleted system on off-label drug use. Establishing more completed and detailed system, investigating enough clinical evidence, better informed consent and monitoring after off-label use are important measurements to ensure safety on off-label drug use.