基于官方网站信息分析我国药品召回现状及存在的问题

发布时间：2019-01-09 12:29

【摘要】：目的:探讨我国药品召回的现状及存在的问题并提出建议。方法:以"药品召回"为关键词,检索国家食品药品监督管理总局及国内32个省级食品药品监督管理局官方网站,收集2007年4月-2015年4月有关召回药品的数量、原因、级别与方式、所属省份等基本信息,运用Excel进行统计分析。结果与结论:共收集到完整、有效的药品召回信息108个,其中国产药97个(占89.81%)、进口药11个(占10.19%);召回原因包括不符合药品标准检查项、发生药品不良反应(ADR)、假药、非法添加其他成分等,其中前2项分别为37个(占34.25%)、33个(占30.56%);召回级别分为一、二、三级,总共有47个(占43.51%)注明了召回级别,其中一级召回有42个(占89.36%);召回方式包括主动召回和责令召回,其中国产药中有42个(占43.3%)为主动召回,55个为责令召回(占56.7%);共涉及19个省市的药品生产企业,排前5位的分别为黑龙江(27个)、浙江(12个)、广东(10个)、上海(8个)和吉林/江苏(7个)。另外,我国药品召回还存在召回原因归类不统一、未注明召回级别等问题。因此,需要在实践中逐步建立健全药品召回管理及配套制度、规范药品召回信息管理、完善药品质量公告和ADR监测与报告体系,以及建立有效的召回信息沟通与反馈机制、评估体系、实施指南、召回药品补偿机制等措施,使我国的药品召回管理体系更加科学、规范、高效。
[Abstract]:Objective: to explore the current situation and existing problems of drug recall in China and put forward some suggestions. Methods: using "Drug recall" as the key word, we searched the official websites of the State Food and Drug Administration and 32 provincial food and drug administrations, and collected the number and reasons of the recalled drugs from April 2007 to April 2015. Level and way, the province and other basic information, using Excel statistical analysis. Results & conclusion: a total of 108 complete and effective drug recall information were collected, including 97 domestic drugs (89.81%) and 11 imported drugs (10.19%). The reasons for the recall included nonconformity of drug inspection items, occurrence of adverse drug reactions (ADR),) fake drugs, and illegal addition of other ingredients, among which the first 2 items were 37 (34.25%) and 33 (30.56%) respectively. There are 47 (43.51%) recall grades, 42 (89.36%) of which are first-level recalls. Among them, 42 (43.3%) were active recall and 55 (56.7%) were ordered recall. A total of 19 drug manufacturing enterprises were involved in this study. The top 5 companies were Heilongjiang (27), Zhejiang (12), Guangdong (10), Shanghai (8) and Jilin / Jiangsu (7). In addition, there are some problems in drug recall in China, such as the reasons for recall are not unified and the recall level is not specified. Therefore, it is necessary to establish and perfect drug recall management and supporting system in practice, standardize drug recall information management, perfect drug quality announcement and ADR monitoring and reporting system, and establish effective mechanism of communication and feedback of recall information. The evaluation system, implementation guidelines, recall compensation mechanism and other measures make the drug recall management system more scientific, standardized and efficient.
【作者单位】：南京中医药大学经贸管理学院;南京医科大学医政学院;南京医科大学附属逸夫医院财务科;南京医科大学药学院;
【分类号】：R951

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