【摘要】：目的:探討我國藥品召回的現(xiàn)狀及存在的問題并提出建議。方法:以"藥品召回"為關(guān)鍵詞,檢索國家食品藥品監(jiān)督管理總局及國內(nèi)32個省級食品藥品監(jiān)督管理局官方網(wǎng)站,收集2007年4月-2015年4月有關(guān)召回藥品的數(shù)量、原因、級別與方式、所屬省份等基本信息,運(yùn)用Excel進(jìn)行統(tǒng)計分析。結(jié)果與結(jié)論:共收集到完整、有效的藥品召回信息108個,其中國產(chǎn)藥97個(占89.81%)、進(jìn)口藥11個(占10.19%);召回原因包括不符合藥品標(biāo)準(zhǔn)檢查項、發(fā)生藥品不良反應(yīng)(ADR)、假藥、非法添加其他成分等,其中前2項分別為37個(占34.25%)、33個(占30.56%);召回級別分為一、二、三級,總共有47個(占43.51%)注明了召回級別,其中一級召回有42個(占89.36%);召回方式包括主動召回和責(zé)令召回,其中國產(chǎn)藥中有42個(占43.3%)為主動召回,55個為責(zé)令召回(占56.7%);共涉及19個省市的藥品生產(chǎn)企業(yè),排前5位的分別為黑龍江(27個)、浙江(12個)、廣東(10個)、上海(8個)和吉林/江蘇(7個)。另外,我國藥品召回還存在召回原因歸類不統(tǒng)一、未注明召回級別等問題。因此,需要在實踐中逐步建立健全藥品召回管理及配套制度、規(guī)范藥品召回信息管理、完善藥品質(zhì)量公告和ADR監(jiān)測與報告體系,以及建立有效的召回信息溝通與反饋機(jī)制、評估體系、實施指南、召回藥品補(bǔ)償機(jī)制等措施,使我國的藥品召回管理體系更加科學(xué)、規(guī)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.
【作者單位】： 南京中醫(yī)藥大學(xué)經(jīng)貿(mào)管理學(xué)院;南京醫(yī)科大學(xué)醫(yī)政學(xué)院;南京醫(yī)科大學(xué)附屬逸夫醫(yī)院財務(wù)科;南京醫(yī)科大學(xué)藥學(xué)院;
【分類號】：R951

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8 周s，

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