【摘要】：目的:了解河南省和河北省藥品不良反應(yīng)(ADR)報(bào)告單位的工作開(kāi)展現(xiàn)狀,為ADR監(jiān)測(cè)工作的完善提供依據(jù)。方法:通過(guò)查閱文獻(xiàn)了解國(guó)內(nèi)外關(guān)于ADR監(jiān)測(cè)工作的概況,以河南省和河北省ADR報(bào)告單位(藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu))為研究對(duì)象進(jìn)行整群抽樣,發(fā)放調(diào)查問(wèn)卷,運(yùn)用描述性統(tǒng)計(jì)分析等方法對(duì)調(diào)查結(jié)果進(jìn)行處理和分析。結(jié)果:共回收有效問(wèn)卷186份。河南省和河北省受訪ADR報(bào)告單位專門建立ADR監(jiān)測(cè)部門的分別有58家和62家,且全部專門配備了人員負(fù)責(zé)ADR工作;ADR監(jiān)測(cè)工作在藥品生產(chǎn)、經(jīng)營(yíng)企業(yè)中絕大多數(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)、電話等基本辦公設(shè)備;大多數(shù)受訪ADR報(bào)告單位工作職責(zé)仍不夠明確;有專門用于ADR監(jiān)測(cè)工作的預(yù)算的分別為24家和2家;與當(dāng)?shù)谹DR監(jiān)測(cè)中心有交流溝通的分別占95.7%和96.8%,但信息反饋情況不理想;對(duì)工作人員進(jìn)行了相關(guān)培訓(xùn)的分別占86.7%和98.9%;建立標(biāo)準(zhǔn)工作流程的情況河北省較好;發(fā)現(xiàn)ADR后會(huì)立即上報(bào)的分別占96.7%和98.9%,會(huì)對(duì)上報(bào)的ADR進(jìn)行備份記錄的分別占92.3%和97.8%;上報(bào)形式均以網(wǎng)絡(luò)報(bào)告形式為主;工作滿意度評(píng)價(jià)方面,河南省的平均分高于河北省。結(jié)論:針對(duì)調(diào)查結(jié)果,建議通過(guò)明確ADR監(jiān)測(cè)工作職責(zé),優(yōu)化工作條件,保證工作經(jīng)費(fèi),加強(qiáng)工作反饋等措施促進(jìn)其ADR監(jiān)測(cè)工作的開(kāi)展。
[Abstract]:Objective: to understand the status quo of (ADR) reporting units of adverse drug reactions in Henan and Hebei provinces, and to provide basis for the improvement of ADR monitoring. Methods: the general situation of ADR monitoring at home and abroad was investigated by consulting the literature. Cluster sampling was conducted with ADR reporting units (drug manufacturing enterprises, drug trading enterprises, medical institutions) in Henan Province and Hebei Province, and questionnaires were distributed. The method of descriptive statistical analysis is used to deal with and analyze the survey results. Results: 186 valid questionnaires were collected. In Henan Province and Hebei Province, 58 and 62 ADR monitoring departments were established by ADR reporting units interviewed in Henan Province and Hebei Province respectively, and all of them were specially staffed to take charge of ADR work. Most of the enterprises belong to the quality management department, most of the medical institutions belong to the pharmacy department; most of them are equipped with basic office equipment such as computer, printer, telephone, etc. There were 24 and 2 special budgets for ADR monitoring, 95.7% and 96.8% of them had communication with local ADR monitoring center, but the information feedback was not satisfactory. 86.7% and 98.9% of the staff were trained respectively. It was found that 96.7% and 98.9% of the ADR would be reported immediately, 92.3% and 97.8% of the reported ADR would be backed up and recorded, respectively. The main form of the report was in the form of network report, and the average score of Henan Province was higher than that of Hebei Province in terms of job satisfaction evaluation. Conclusion: in view of the investigation results, it is suggested that the work of ADR monitoring should be promoted by clarifying the duties of ADR monitoring, optimizing the working conditions, ensuring the work expenses and strengthening the work feedback and so on.
【作者單位】： 西安交通大學(xué)醫(yī)學(xué)部藥學(xué)院;
【基金】：國(guó)家社會(huì)科學(xué)基金資助項(xiàng)目(No.13BGL132)
【分類號(hào)】：R951

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