發(fā)布時(shí)間：2018-11-18 14:17

【摘要】：目的:了解江蘇省和廣東省藥品不良反應(yīng)(ADR)報(bào)告單位工作開展現(xiàn)狀,為ADR監(jiān)測工作的完善提供依據(jù)。方法:通過查閱文獻(xiàn)了解國內(nèi)外關(guān)于ADR監(jiān)測工作的概況,以江蘇省和廣東省ADR報(bào)告單位(藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu))為研究對象進(jìn)行整群抽樣,發(fā)放調(diào)查問卷,運(yùn)用描述性統(tǒng)計(jì)分析等方法對調(diào)查結(jié)果進(jìn)行處理和分析。結(jié)果:共回收有效問卷205份。江蘇省和廣東省受訪ADR報(bào)告單位專門建立ADR監(jiān)測部門的分別為67家和60家,專門配備人員負(fù)責(zé)ADR工作的分別占98.1%和99.0%;ADR監(jiān)測工作在藥品生產(chǎn)、經(jīng)營企業(yè)絕大多數(shù)隸屬于質(zhì)量管理部門,在醫(yī)療機(jī)構(gòu)大多隸屬于藥劑科;大多數(shù)配備了計(jì)算機(jī)、打印機(jī)、復(fù)印機(jī)等基本辦公設(shè)備;但大多數(shù)工作職責(zé)仍不夠明確;有專門用于ADR監(jiān)測工作的預(yù)算的分別為27家和15家;與當(dāng)?shù)谹DR監(jiān)測中心有交流溝通的分別占97.2%和96.9%,但信息反饋情況不理想;對工作人員進(jìn)行了相關(guān)培訓(xùn)的分別占85.0%和86.7%;制度建設(shè)方面,建立標(biāo)準(zhǔn)工作流程的情況相對較好,其他相關(guān)制度建設(shè)尚不夠理想;發(fā)現(xiàn)ADR后會(huì)立即上報(bào)的分別占91.6%和90.8%,會(huì)對上報(bào)的ADR進(jìn)行備份記錄的分別占92.5%和97.9%,以網(wǎng)絡(luò)報(bào)告形式為主;工作滿意度評價(jià)方面,江蘇省的平均分高于廣東省。結(jié)論:針對調(diào)查結(jié)果,建議通過完善ADR監(jiān)測工作組織建設(shè)、優(yōu)化辦公條件、保證ADR監(jiān)測經(jīng)費(fèi)支持、加強(qiáng)工作交流、加強(qiáng)制度建設(shè)等措施,促進(jìn)其ADR監(jiān)測工作的開展。
[Abstract]:Objective: to understand the present situation of (ADR) reporting units of adverse drug reactions in Jiangsu Province and Guangdong Province, and to provide basis for the improvement of ADR monitoring. Methods: to find out the general situation of ADR monitoring at home and abroad by consulting the literature, taking Jiangsu Province and Guangdong Province ADR reporting units (drug production enterprises, drug trading enterprises, medical institutions) as the research objects, cluster sampling and issuing questionnaires. The method of descriptive statistical analysis is used to deal with and analyze the survey results. Results: 205 valid questionnaires were collected. In Jiangsu province and Guangdong province, 67 and 60 ADR monitoring departments were established, and 98.1% and 99.0% of them were specially staffed to take charge of ADR work, respectively. ADR monitoring work in drug production, most of the business enterprises belong to the quality management department, most of the medical institutions belong to the pharmaceutical department, most of them are equipped with computer, printer, photocopier and other basic office equipment. However, most of the job responsibilities are not clear enough; 27 and 15 special budgets are available for ADR monitoring, 97.2% and 96.9% of the local ADR monitoring centers communicate with each other, respectively, but the information feedback is not satisfactory. 85.0% and 86.7% of the staff were trained respectively. In the aspect of system construction, the establishment of standard work flow is relatively good, and the other related system construction is not ideal. 91.6% and 90.8% of ADR will be reported immediately, 92.5% and 97.9% of them will backup and record the reported ADR respectively, mainly in the form of network report. In terms of job satisfaction evaluation, the average score of Jiangsu Province is higher than that of Guangdong Province. Conclusion: in view of the investigation results, it is suggested to improve the organization and construction of ADR monitoring work, optimize office conditions, ensure the support of ADR monitoring funds, strengthen work communication and strengthen the system construction to promote the development of ADR monitoring work.
【作者單位】： 西安交通大學(xué)醫(yī)學(xué)部藥學(xué)院;
【基金】：國家社會(huì)科學(xué)基金資助項(xiàng)目(No.13BGL132)
【分類號(hào)】：R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前1條

1 劉花;馮變玲;楊世民;張智;;我國省級(jí)藥品不良反應(yīng)監(jiān)測機(jī)構(gòu)發(fā)展現(xiàn)狀的調(diào)查分析[J];中國藥房;2014年12期

【共引文獻(xiàn)】

相關(guān)期刊論文 前2條

1 劉花;馮變玲;楊世民;;藥品不良反應(yīng)研究現(xiàn)狀與展望[J];醫(yī)藥導(dǎo)報(bào);2013年10期

2 郭佳棟;張雪梅;白軍鋒;張智;馮變玲;;陜西省藥品不良反應(yīng)報(bào)告主體工作現(xiàn)狀的實(shí)證研究[J];藥物流行病學(xué)雜志;2015年05期

【二級(jí)參考文獻(xiàn)】

相關(guān)期刊論文 前1條

1 謝金洲;周勇;田月潔;黃傳海;陳易新;;我國省級(jí)藥品不良反應(yīng)監(jiān)測機(jī)構(gòu)模式研究[J];中國藥物警戒;2009年01期

【相似文獻(xiàn)】

相關(guān)重要報(bào)紙文章 前1條

1 張黎明;省級(jí)ADR監(jiān)測工作思路初探[N];中國醫(yī)藥報(bào);2006年

，

本文編號(hào)：2340265